State of the Art Review of Left Main Interventions
Introduction
Because of the big extent of jeopardized myocardium, obstructive left main coronary artery (LMCA) disease is associated with loftier morbidity and bloodshed. Coronary artery bypass graft (CABG) surgery has long been the standard of intendance for patients with LMCA disease, whereas percutaneous coronary intervention (PCI) was only performed as salvage handling. However, over time, the PCI treatment has undergone considerable therapeutic evolution. Remarkable advancements in stent technology, technical refinement, and adjunctive drug therapy take led to progressively improved PCI outcomes for LMCA illness.1
With such dramatic changes of PCI field, the optimal revascularization for LMCA disease has been the subject field of numerous randomized clinical trials (RCT). In the early period of drug-eluting stents (DES), several RCT suggested that PCI achieved like rates of bloodshed and serious blended outcome, but more than frequent revascularization with PCI and more frequent stroke with CABG.2–8 Still, none of these trials accept been adequately powered or have included contemporary second-generation metallic DES, which accept a better safety and efficacy profile compared with the first-generation DES.nine,10 The long-awaited results of the ii large-sized RCT, the EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and the NOBLE (Nordic-Baltic-British Left Main Revascularization Study), have been published.11,12 However, the two trials showed alien results; EXCEL found that PCI is noninferior to CABG, whereas NOBLE shows that CABG is superior to PCI. This opposing finding may intensify the confusion in clinical decision making for optimal revascularization strategy. On this groundwork, with understanding the evolution in LMCA treatment, we would like to focus on the cutting edge contemporary reviews of the contempo trials, interpret how they chronicle to previous trials in the field, and speculate on the future direction for optimal LMCA direction.
Historical Information for CABG Superiority
The natural prognosis of patients with medically treated LMCA disease was very poor; previous old data showed that v-twelvemonth charge per unit of cardiac mortality was >fifty% in medically treated patients.xiii Since RCTs comparing CABG with medical therapy alone were conducted more than one-half a century agone,14,15 CABG has been the first choice of treat LMCA disease. Withal, the VA (Veterans Assistants) Cooperative Study involved just a subgroup of 113 patients with LMCA lesions (53 medical therapy and threescore CABG) and the ECSS (European Coronary Surgery Written report) group study involved a subgroup of 59 patients with LMCA disease (31 medical therapy and 28 CABG). Although these results represented a subgroup of a subgroup and were hypothesis generating, the VA and ECSS study demonstrated that CABG was striking superior over medical therapy. Other historical observational studies also demonstrated a substantial do good of CABG in patients with LMCA disease.xvi,17 Since and so, CABG has been always the treatment choice for a long time, and PCI was performed on a limited basis, by and large in surgically ineligible weather.
Evolution in PCI for LMCA Illness
Coronary Stents
Although initial menstruum of PCI with airship angioplasty showed unsuccessful results, refinement of the technique and the introduction of coronary stents have led to progressively improved results. The adoption of metallic stents dramatically overcame inherent limitations of balloon angioplasty (ie, acute recoil, abrupt closure, or dissection) and rejuvenated interest in PCI for circuitous LMCA lesions. In the era of bare-metal stents, among elective low-risk patients, PCI with stenting showed adequate in-hospital or midterm outcomes.18–22 Still, excessive risks of restenosis and echo revascularization hampered the broad expansion of LMCA stenting. After a widespread use of DES with a lower risk of angiographic and clinical restenosis, PCI for LMCA disease has become much technically viable and shows favorable brusk- and long-term clinical outcomes.23–26 Since the introduction of the outset-generation DES >ten years ago, the technology and engineering of DES have continuously avant-garde. The second-generation DES has adopted novel stent materials, thinner strut platforms, like shooting fish in a barrel delivery arrangement, and more biocompatible polymers (both durable and bioresorbable) than their predecessors.27 Currently, newer-generation DES have go the default device; several observational studies have suggested similar or amend outcomes with the 2d-generation DES compared with the outset-generation ones for LMCA PCI.28–30
Imaging and Functional Tools
Accurate assessment of LMCA lesion is critical in determining PCI strategies and optimizing procedures. As stent technologies accelerate, at that place has been an development in invasive techniques that let detailed assessment of both anatomy and role and an increased utilization of invasive imaging (intravascular ultrasound [IVUS]) or functional (fractional flow reserve [FFR]) tools.31 The IVUS-guided PCI for LMCA disease has been an arroyo widely adopted in clinical practise. Although RCT data were not bachelor, the prognostic value and stent optimization of LMCA PCI with IVUS accept been examined in recent years.32,33 Considering the benefits of IVUS to ascertain affliction distribution, inform stent sizing and technique, and enhance advisable stent expansion, the function of IVUS in reducing LMCA restenosis and stent thrombosis-related complications may exist clinically meaningful.
The decision well-nigh whether to care for the LMCA stenosis has already changed to include increased apply of FFR.34 Several observational studies demonstrated splendid survival and depression upshot rates in medically treated patients with intermediate LMCA disease and a measured FFR value of >0.75–0.80,35,36; this value is mostly accepted every bit a useful cutoff to determine a functionally significant LMCA stenosis. In the contemporary PCI exercise, FFR-guided intervention tin can help to select advisable patients and lesions for handling, avoid unnecessary procedures, reduce medical costs, and ameliorate clinical outcomes. In addition, an integrated utilize of IVUS and FFR might provide an interactive insight for evaluation of LMCA stenosis.37 There is always ambiguity and conundrum of the FFR evaluation of LMCA stenosis and combined tandem lesions in the large side branch mitigating the ability to maximize hyperemia; IVUS may be an appropriate guide at this betoken and have a complementary office in functional evaluation of LMCA stenosis.
The angiographic SYNTAX (Synergy Betwixt PCI With Taxus and Cardiac Surgery) score is a parameter derived to express the overall anatomic complexity and frequently used in decision making of revascularization for LMCA disease.38,39 However, PCI has essentially evolved since completion of the SYNTAX trial,40 in which the first-generation paclitaxel-eluting stent was used and disease severity was only assessed according to the angiogram alone without use of FFR or IVUS. Future function of this functional or imaging guidance for handling of LMCA or multivessel coronary artery disease (CAD) should be further investigated through subsequent clinical trials.41
PCI Techniques and Adjunctive Pharmacotherapy
Alongside a revolution of stent devices, improved interventional techniques and adjunctive pharmacotherapy have progressively resulted in enhanced PCI outcomes for LMCA disease. Over fourth dimension, in that location has been more than experience and expertise for LMCA PCI and technical advances for PCI optimization. In the Interventional Inquiry IRIS-MAIN registry (Incorporation Gild-Left MAIN Revascularization), stenting technique for LMCA PCI has been more simplified.1 For distal LMCA affliction, although multiple techniques for circuitous stenting have been proposed, a simple strategy with provisional side-branch approach is the preferred strategy and this design is observed in the existent-world practice. In cases requiring complex double stenting, improved stent design, and thinner strut dimensions, evolving 2-stenting techniques with continuous refinement may contribute to improved PCI outcomes after complex LMCA stenting.
In add-on, concomitant development of adjunctive pharmacotherapy, involving periprocedural antithrombotic agents (eg, unfractionated heparin, low molecular weight heparin, glycoprotein IIb/IIIa inhibitor, fondaparinux, or bivalirudin), antiplatelet therapy (eg, ticlopidine, clopidogrel, prasugrel, or ticagrelor), statins (start-, 2nd-, and tertiary-generation statins), or other secondary preventive drugs might substantially contribute to improvement of PCI outcomes for LMCA disease.i
Previous Trials of PCI and CABG for LMCA Affliction: Pre-EXCEL and NOBLE Era
Before EXCEL and NOBLE trial, four RCTs comparing PCI involving the first-generation DES and CABG were conducted.2–8 Written report design, key findings, and strength/weakness of each trial are summarized in Table i.
| Recruitment Period | n (PCI/CABG) | Longest Follow-Up, y | Principal End Indicate | Key Findings | Strength | Weakness | |
|---|---|---|---|---|---|---|---|
| LEMANS2,three | 2001–2004 | 52/53 | x | Change in LVEF | Improvement in LVEF only with PCI, comparable rates of death, MI, stroke, or TVR at 1 and 5 y | Starting time RCT comparison PCI and CABG for LM disease | Very small number of patientsSurrogate principal stop pointDES used merely in 35% |
| SYNTAX-Left Primaryfour,5 | 2005–2007 | 357/348 | five | Death, MI, stroke, or RR | PCI was noninferior to CABG at i and v y | First moderate-sized RCT, mainly used for the current guideline recommendation | Subgroup analysis, only hypothesis generating |
| Boudriot et alhalf-dozen | 2003–2009 | 100/101 | 1 | Cardiac death, MI, or TVR | PCI was inferior to CABG at 1 y | First RCT comparing sirolimus-eluting stents and CABG for LM disease | Express sample sizeLack of long-term follow-upStroke was not included in stop point |
| PRECOMBAT7,8 | 2004–2009 | 300/300 | five | Death, MI, stroke, or TVR | PCI was noninferior to CABG at ane and 5 y | Kickoff LM-specific, moderate-sized RCT comparing DES and CABG for LM illness | Noninferiority margin was wideRoutine angiographic follow-upwardly in the PCI group |
In the left main subgroup of the SYNTAX trial,4,5 in that location were no significant differences in the rates of chief end point of major adverse cardiac and cerebrovascular event (MACCE; 37% versus 31%), expiry (xiii% versus fifteen%), or myocardial infarction (MI; 8% versus five%) between PCI and CABG upwards to v years. PCI patients had a lower stroke (ii% versus 4%), but a higher revascularization (27% versus 16%) compared with CABG patients. According to the SYNTAX score terciles, there was no betwixt-grouping difference in MACCE in the low (0–22) and intermediate (23–32) score groups, merely MACCE was significantly higher afterwards PCI in the high score (≥33) group. However, there were marked swings in bloodshed with the lowest grouping (<32) having much lower mortality with PCI (eight% versus 15%) and a much college mortality (21% versus 14%) in the college score (≥33) group, reflecting the inherent limitation of subanalysis of a subgroup and a potential bias because of pocket-size numbers.
The PRECOMBAT trial (Premier of Randomized Comparing of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) is a commencement, LMCA-specified, moderate-sized, RCT comparing DES and CABG.7,8 Up to 5 years, the rates of MACCE (eighteen% versus xiv%), death (half-dozen% versus viii%), MI (2% versus 2%), or stroke (ane% versus ane%) were similar between PCI and CABG. All the same, target-vessel revascularization occurred more common after PCI than after CABG (11% versus 6%).
The electric current European and US guidelines were primarily based on the prespecified subgroup of 705 patients with LMCA affliction in the SYNTAX trial and likewise refer to the findings of the LEMANS trial (Left Principal Coronary Artery Stenting; 100 patients), PRECOMBAT trial (600 patients), and Boudriot et al trial (201 patients).38,39 Because broad noninferiority margin and the limited power of these studies, overall results should be interpreted with caution and cannot be considered clinically directive. Also, none of trials have included contemporary 2nd-generation DES with a amend condom and efficacy profile. This clinical unmet need motivated 2 big-sized landmark trials of EXCEL and NOBLE.
EXCEL and NOBLE Trials
Similarity or Disparity Between Trial Pattern and Outcomes
Details of design, organization, and major findings of the EXCEL and NOBLE trial are summarized in Table ii. In the EXCEL trial, 1905 patients with LMCA disease and low or intermediate anatomic complexity (SYNTAX score ≤32) were randomly assigned to undergo CABG or PCI with a fluoropolymer-based, cobalt chromium, everolimus-eluting stent. In the NOBLE trial, 1201 patients with the left primary CAD were randomly assigned to CABG or PCI (11% of the patients received a commencement-generation DES and the rest a biolimus-eluting stent). Although a SYNTAX score was non a prespecified inclusion criteria, the NOBLE trial excluded patients with >3 boosted noncomplex lesions or circuitous additional coronary lesions (length >25 mm, chronic total apoplexy, 2-stent bifurcation, calcified or tortuous vessel morphology). Two trials were non blinded, and a clinical and anatomic eligibility for both PCI and CABG was assessed past an interventional cardiologist and a cardiac surgeon at each participating site.
| Design | EXCEL Trialxi | NOBLE Trial12 |
|---|---|---|
| Study features | ||
| Study blazon | Multicenter (126 sites in North/Due south America, Europe, Asia Pacific), prospective, open-characterization, randomized, noninferiority pattern trial comparing PCI and CABG | Multicenter (36 sites in northern Europe), prospective, open up-label, randomized, noninferiority design trial comparing PCI and CABG |
| Main inclusion criteria | Unprotected LMCA disease with angiographic DS >70%, equally estimated visually, or 50%≤DS<seventy% with at least one of post-obit: (i) noninvasive evidence of ischemia referable to LMCA lesion, (2) IVUS MLA ≤vi.0 mmtwo, or (iii) FFR ≤0.80 | Unprotected LMCA disease with angiographic DS >l%, as estimated visually, or FFR <0.8 |
| Key exclusion criteria | SYNTAX score ≥33, prior PCI at left main (any fourth dimension) or any other coronary avenue (within ane y), prior CABG, concomitant valvular or aortic surgery, CK-MB>normal or recent MI with CK-MB notwithstanding elevated, left chief reference vessel diameter <two.25 or >4.25 mm | STEMI within 24 h, >iii or complex boosted coronary lesions (length >25 mm, chronic total occlusion, 2-stent bifurcation, calcified or tortuous vessel morphology), patient is too high take chances for CABG or PCI, expected survival <1 y |
| Recruitment menstruum | September 2010 to March 2014 | Dec 2008 to Jan 2015 |
| Follow-upwardly period (median), y | 3.0 (two.4–3.0) | 3.1 (2.0–five.0) |
| No. of patients (PCI/CABG) | 948/957 | 592/592 |
| Stent blazon used for PCI | XIENCE cobalt chromium, everolimus-eluting stent | BioMatrix biolimus-eluting stent recommended since March 2010, but other CE-marked DES allowed |
| Major findings | ||
| Primary end point | Composite of all-cause death, MI, or stroke | Blended rate of all-cause death, nonprocedural MI, echo revascularization, or stroke |
| 15.four% in PCI and xiv.7% in CABG at 3 y | 28.nine% in PCI and nineteen.one% in CABG at 5 y | |
| 60 minutes (95% CI), 1.00 (0.79–i.26) | Hour (95% CI), 1.48 (1.11–one.96) | |
| Death | 8.2% in PCI and five.nine% in CABG at 3 y | xi.6% in PCI and 9.5% in CABG at 5 y |
| Hr (95% CI), 1.34 (0.94–ane.91) | HR (95% CI), 1.07 (0.67–1.72) | |
| MI | Periprocedural and spontaneous MI was included | Nonprocedural MI was just included |
| 8.0% in PCI and 8.three% in CABG at three y | half dozen.ix% in PCI and 1.9% in CABG at five y | |
| HR (95% CI), 0.93 (0.67–1.28) | Hour (95% CI), 2.88 (1.40–5.90) | |
| Stroke | 2.3% in PCI and 2.ix% in CABG at iii y | 4.nine% in PCI and 1.7% in CABG at 5 y |
| HR (95% CI), 0.77 (0.43–1.37) | 60 minutes (95% CI), two.25 (0.93–v.48) | |
| Expiry, MI, or stroke | 15.four% in PCI and 14.7% in CABG at iii y | 13% in PCI and 22% in CABG at five y |
| Hour (95% CI), 1.00 (0.79–1.26) | HR (95% CI), 1.47 (1.06–2.05) | |
| Revascularization | 12.9% in PCI and 7.half dozen% in CABG at 3 y | xvi.2% in PCI and ten.four% in CABG at 5 y |
| Hr (95% CI), i.72 (1.27–two.33) | 60 minutes (95% CI), 1.50 (1.04–2.17) | |
| Death, MI, stroke, or revascularization | 23.1% in PCI and xix.1% in CABG at 3 y | 28.9% in PCI and 19.one% in CABG at 5 y |
| HR (95% CI), 1.18 (0.97–ane.45) | Hour (95% CI), 1.48 (1.11–1.96) | |
| Definite stent thrombosis or symptomatic graft occlusion | 0.7% in PCI and 5.four% in CABG at 3 y | iii% in PCI and 4% in CABG at v y |
| 60 minutes (95% CI), 0.12 (0.05–0.28) | Hour (95% CI), 0.59 (0.26–1.36) | |
In the EXCEL trial, PCI was noninferior to CABG with respect to the primary blended end point of decease, stroke, or MI at 3 years (15.4% versus fourteen.seven%). The primary finish point events were less common later PCI than later on CABG within 30 days (4.ix% versus vii.ix%), whereas fewer primary end point events occurred in the CABG grouping than in the PCI group betwixt thirty days and 3 years. The rates of early MI and major periprocedural adverse events (ie, haemorrhage, infection, major arrhythmia, and renal failure) within 30 days were significantly lower with PCI than with CABG (3.9% versus 6.2% and viii.1% versus 23.0%, respectively), but ischemia-driven revascularization during follow-upwards was more frequent later PCI than after CABG (12.6% versus 7.5%). In overall, these findings suggest that PCI offer an early safety advantage and CABG offer greater long-term durability.
In the NOBLE trial, the 5-year rate of the master finish point of MACCE (expiry, nonprocedural MI, repeat revascularization, or stroke) was significantly higher after PCI than after CABG (29% versus 19%). The v-year charge per unit of nonprocedural MI (seven% versus 2%) and whatsoever revascularization (xvi% versus 10%) were also higher after PCI. Although a lower rate of stroke was observed after PCI than subsequently CABG within 30 days (0% versus 0.seven%), simply an unexpected, the 5-year of stroke tended to be higher in PCI patients than in CABG patients (5% versus ii%). The 5-yr rate of death was like between PCI and CABG (12% versus 9%). PCI was ever inferior to CABG irrespective of SYNTAX score.
Plausible Explanation of Alien Results of EXCEL and NOBLE
Unexpectedly, the opposing results from 2 novel RCTs raise dubiety rather than clarity with regard to the relative condom and effectiveness of PCI versus CABG for LMCA revascularization. Careful review and interpretation of this discrepancy may be helpful to understand and apply the trial findings for optimal LMCA treatment in the clinical practice. Plausible explanations of alien results could exist (1) substantial between-written report differences in patient assessment, risk profiles, trial process, or procedural characteristics, (2) a differential adoption of the master composite end indicate, (iii) an interstudy heterogeneity for the definition of MI, and (4) an unexplained college risk of stroke after PCI in NOBLE.
At commencement, the integrated and skilled heart team arroyo, which was evident in EXCEL (but non in NOBLE), might influence a fair cess for eligibility and cause the difference of patient's characteristics enrolled in trials. Also, the particulars of clinical practice in the participating sites and the specific expertise of the interventional cardiologists and cardiac surgeons who performed the procedures may influence the comparative outcomes later LMCA revascularization. A careful procedure of participating site option might be a primal component ensuring that the majority of patients with unprotected LMCA disease were equally treated well past ways of 2 strategies of revascularization. In addition, differences in population size or follow-upwards might influence the alien results. In the NOBLE, there was interim change in the protocol and chief outcome reporting with extension of follow-upwardly owing to lower than expected MACCE rates; this drawback may influence trial integrity and internal validation.
As a main stent device, EXCEL used a thin-strut, fluoropolymer-based cobalt chromium, everolimus-eluting stents, which was associated with the lowest risk of stent thrombosis of all available DES.42 In contrast, NOBLE used beginning-generation, thicker-strut, stainless steel, sirolimus-eluting Zip stent (11%) or the biolimus-eluting Biomatrix Flex stent (89%). In both trials, there was a substantial difference in rates of definite stent thrombosis (0.7% in the EXCEL and 3% in the NOBLE); every bit a result, the charge per unit of definite stent thrombosis or symptomatic graft occlusion was much higher subsequently CABG than subsequently PCI (5.4% versus 0.7%) in EXCEL, only similar (4% versus 3%) in NOBLE.
The EXCEL trial was the merely trial adequately powered to assess the hard condom end points as the principal outcome mensurate, not including revascularization. It has been debated for long time that the risk of echo revascularization can be equally balanced against the adventure of death, MI, or stroke. Previous SYNTAX trial showed that the increase in the rate of repeat revascularization with PCI as compared with CABG did non seem to interpret into a significant overall increase in the rate of expiry or MI.forty Past contrast, the NOBLE trials included echo revascularization in the primary blended end point. As such, conflicting main results between the EXCEL and the NOBLE trial are largely driven by differential defining primary composite end point.
In trials comparing PCI and CABG, the composite primary stop betoken is sensitive to the definition of each event. For most of the trials, the definitions of death and stroke were similar. Nevertheless, the protocol definition of MI was generally different in RCTs comparing PCI and CABG for LMCA disease2,4,6,7,xi,12 and in several good consensus documents43–45 (Table iii). Owing to interstudy heterogeneity for MI definition, trial results tin can vary widely and this disparity can pb to an imprecise approximate of the overall treatment effect. Regardless of any symptom, sign, or ECG criteria, an increase of creatine kinase-myocardial band >10× the upper reference limit was considered as MI events in EXCEL, but not in NOBLE. The NOBLE trial did non routinely collect data on periprocedural MI (eg, procedural MI was merely assessable in 45% of patients). Post-procedural increases of cardiac enzyme might be more common after CABG than afterwards PCI because of more extensive manipulation and procedural features; thus, less stringent defining of periprocedural MI based on isolated creatine kinase-myocardial band superlative without boosted electrocardiographic, imaging, or angiographic evidence may induce an unbalanced detection of periprocedural MI later on CABG or PCI. Whether clinically driven MI is only considered or biomarker-driven MI without ischemic symptoms or signs is besides included every bit a relevant clinical end signal is not even so conspicuously determined. Because compatible definition of MI not penalizing one of the revascularization approaches is still defective, additional studies and efforts past trialists are warranted to improve standardization of MI definition for futurity clinical trials comparing PCI and CABG.
| Criteria | PCI | CABG | Observed/Expected MI Rates |
|---|---|---|---|
| By each trial | Observed MI rates | ||
| LEMANSii | CK-MB >iii× the URL | CK-MB >v× the URL | 1 patient in PCI (n=52) and three patients in CABG (n=53) |
| SYNTAX-Left MAIN4 | Periprocedural (<vii d subsequently intervention): new Q waves and either peak CK-MB/total CK >10% or CK-MB >five× the URL | Identical definition used | iv.iii% in PCI and iv.i% in CABG at 1 y |
| Spontaneous (≥7 d after intervention): new Q waves or elevation CK-MB/total CK >ten% or CK-MB >5× the URL or CK >v× the URL | |||
| Boudriot et alhalf dozen | CK-MB >3× the URL and standard ECG criteria | CK-MB >five× the URL and standard ECG criteria | iii% in PCI and 3% in CABG at i y |
| PRECOMBAT7 | Periprocedural (≤two d later intervention): new Q waves and increase in the CK-MB>5× the URL | Identical definition used | 1.3% in PCI and ane.0% in CABG at 1 y |
| Spontaneous (>2 d after intervention): new Q waves or CK-MB> the URL, plus ischemic symptoms or signs | |||
| EXCEL11 | Periprocedural (≤3 d after intervention): CK-MB >x× the URL, or CK-MB >5× the URL plus new pathological Q waves or LBBB, or new native or graft vessel occlusion, or imaging evidence of loss of viable myocardium or new regional wall motion abnormality | Identical definition used | 8.0% in PCI and 8.3% in CABG at 3 y |
| Spontaneous (>3 d after intervention): CK-MB or troponin >1 URL plus ischemic ECG changes, or pathological Q waves, or new native or graft vessel occlusion, or imaging evidence of loss of feasible myocardium or new regional wall movement aberration | |||
| NOBLE12 | Periprocedural: disregarded in primary composite stop point | Identical definition used | half dozen.9% in PCI and ane.9% in CABG at five y |
| Spontaneous: CK-MB or troponin >1 time the URL with at least one of the following: (ane) ischemic symptoms, (ii) ischemic ECG changes; or (3) pathological Q moving ridge | |||
| Past expert consensus document | Expected MI rates | ||
| Second universal definition43 | Periprocedural: cardiac biomarker (troponin or CK-MB) >iii× the URL | Periprocedural: cardiac biomarker (troponin or CK-MB) >5× the URL and whatever of the following: new pathological Q waves or LBBB, new native or graft vessel occlusion, imaging bear witness of loss of viable myocardium | Periprocedural MI events may be much common after PCI than after CABG |
| Spontaneous: cardiac biomarker (troponin or CK-MB) >1× the URL with at to the lowest degree ane of the following: (one) ischemic symptoms, (2) ischemic ECG changes, (3) pathological Q wave, or (4) imaging evidence of new loss of feasible myocardium or new regional wall motion abnormality | Spontaneous: identical definition used | ||
| 3rd universal definition44 | Periprocedural: cardiac biomarker (preferably cardiac troponin) >5× the URL or a ascent >xx% if the baseline values are elevated and are stable or falling, and any of the following: (ane) ischemic symptoms, (2) new ischemic ECG changes, (3) angiographic findings consistent with a procedural complication, or (four) imaging bear witness of new loss of viable myocardium or new regional wall motion abnormality. | Periprocedural: cardiac biomarker (preferably cardiac troponin) >10× the URL or a rise >twenty% if the baseline values are elevated and are stable or falling, and whatsoever of the post-obit: (1) pathological Q wave or new LBBB, (ii) new graft or native vessel occlusion, or (3) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. | Overall rates of periprocedural MI later PCI or CABG may be depression compared to other criteria. Periprocedural MI events may exist slightly common afterwards PCI than after CABG. |
| Spontaneous: cardiac biomarker (preferably cardiac troponin) >ane× the URL with at least one of the post-obit: (1) ischemic symptoms, (2) ischemic ECG changes, (iii) pathological Q wave, (iv) imaging show of new loss of feasible myocardium or new regional wall motion abnormality, or (5) intracoronary thrombus by angiography or autopsy | Spontaneous: identical definition used | ||
| SCAI definition45 | Periprocedural (≤48 h after intervention): CK-MB >ten× the URL, or CK-MB >5× the URL with new pathological Q waves or new persistent LBBB. In the absence of CK-MB, troponin >lxx× the URL, or troponin >35× the URL with new pathological Q waves or new persistent LBBB | Identical definition used | Periprocedural MI events may be much common after CABG than after PCI |
| Spontaneous (>48 d later intervention): CK-MB or troponin >1 URL plus ischemic ECG changes, or pathological Q waves, or new native or graft vessel occlusion, or imaging show of loss of viable myocardium or new regional wall motion abnormality |
Unexpectedly, the v-year risk of stroke was more than twice higher subsequently PCI rather than after CABG in NOBLE, which was the opposite to the results of EXCEL. A higher stroke risk after CABG was consistently observed in the SYNTAX and FREEDOM trials (Time to come Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease).forty,46 Several meta-analyses also showed similar findings.47–49 Because a greater charge per unit of late stroke after PCI in NOBLE lacks biological plausibility and clear explanation for such a contradictory finding in NOBLE is still defective, this event is virtually likely because of chance upshot.l
Representativeness and Generalizability of EXCEL and NOBLE
In the clinical viewpoint, assessing the representativeness and generalizability of patients enrolled in trials compared with the real-globe population is likely to be of considerable interest. Key clinical and procedural characteristics of patients in EXCEL and NOBLE and of those in the second-generation DES era of all-comers IRIS-Chief registryi are summarized in Table four. Approximately one third of patients in EXCEL and IRIS-Master had diabetes mellitus, merely the proportion of diabetes mellitus was substantially lower in NOBLE. In addition, the proportion of patients with astute coronary syndrome was substantially lower in NOBLE. Patients with more complex CAD were more common in IRIS-Main (especially, in the CABG group).
| PCI Patients | CABG Patients | |||||
|---|---|---|---|---|---|---|
| Key Baseline Variables | EXCEL (n=948) | NOBLE (n=592) | IRIS-MAIN (n=1707) | EXCEL (north=957) | NOBLE (n = 592) | IRIS-MAIN (north = 774) |
| Patient characteristics | ||||||
| Historic period (mean, y) | 66 | 66 | 64 | 66 | 66 | 65 |
| Male sexual practice (%) | 76 | 80 | 78 | 78 | 76 | 80 |
| Diabetes mellitus (%) | xxx | 15 | 34 | 28 | 15 | 42 |
| Previous PCI (%) | 18 | 20 | 15 | 16 | xx | thirteen |
| Clinical indication (%) | ||||||
| Stable angina or silent ischemia | 61 | 82 | 41 | 61 | 83 | 44 |
| Acute coronary syndrome | 39 | eighteen | 59 | forty | 17 | 57 |
| Ejection fraction (mean or median) | 57 | 60 (median) | 59 | 57 | lx (median) | 55 |
| CAD extent | ||||||
| LM only | 17 | NA | eleven | 18 | NA | 3 |
| LM plus 1-vessel disease | 31 | NA | 26 | 31 | NA | 6 |
| LM plus 2-vessel illness | 35 | NA | 36 | 32 | NA | 20 |
| LM plus 3-vessel disease | 17 | NA | 27 | nineteen | NA | 71 |
| LM location (%) | ||||||
| Ostium or shaft | eighteen | 19 | 33 | 21 | 19 | 28 |
| Distal bifurcation | 82 | 81 | 67 | 79 | 81 | 73 |
| PCI characteristics | ||||||
| Total stent number (mean or median) | 2.four | two (median) | 2.2 | … | … | … |
| Total stent length (mean or median) | 49 | 52 (median) | 52 | … | … | … |
| IVUS guidance, % | 77 | 74 | 77 | … | … | … |
| DES type, % | ||||||
| CoCr-EES | 98 | … | 37 | … | … | … |
| BES | … | 89 | 8 | … | … | … |
| PtCr-EES | … | … | 22 | … | … | … |
| Re-ZES | … | … | 27 | … | … | … |
| PC-ZES | … | … | ii | … | … | … |
| Other second DES | … | … | 4 | … | … | … |
| SES | … | xi | … | … | … | … |
| CABG characteristics | ||||||
| Off-pump surgery, % | … | … | … | 29 | 16 | 69 |
| No. of conduits (hateful) | … | … | … | ii.vi | 2.5 | 2.ix |
| Utilize of internal mammary artery, % | … | … | … | 99 | 93 | 94 |
| Use of radial artery, % | … | … | … | 6 | five | 37 |
With regard to procedural or operative characteristics, total stent number and total stent length in PCI patients were like betwixt RCTs and registry. In EXCEL and NOBLE, >70% of patients underwent IVUS-guided PCI, which was similar to IRIS-MAIN. In the CABG stratum, there was a significant deviation in operative characteristics between trials and registry. The proportion of patients who underwent off-pump surgery was substantially lower in EXCEL and NOBLE than in IRIS-MAIN. The internal mammary avenue was used in >90% of patients in both RCTs and registry, merely the use of radial artery was <10% of patients in RCTs (saphenous vein grafts were more commonly used in trials), but >xxx% in the registry; thus, information technology is argued that the operative practice in trials is probably less representative of real-world exercise. Although recent CABG trials suggest that a higher arterial revascularization with bilateral internal mammary artery and off-pump CABG would not have whatsoever departure to the outcome,51,52 farther investigation is required to evaluate how the surgical approach influence comparative outcomes in trials of PCI and CABG.
Office of SYNTAX Score
To engagement, several scoring systems accept been developed for take a chance stratification and decision making of optimum revascularization strategy in patients with multivessel CAD with or without LMCA disease.iv,40,53,54 Notwithstanding, piece of cake application of these scoring systems in clinical exercise might exist hampered because of limited clinical functioning and complexities. Also, it is noted that the SYNTAX score (CAD extent) is non of major importance in the EXCEL and NOBLE trials.
In EXCEL, considerable difference of SYNTAX score by site cess and angiographic core laboratory cess exists. The SYNTAX score was underestimated at local sites. Thus, although the investigators recruited simply patients with low and intermediate SYNTAX scores, 24.3% of randomized population (25.1% of PCI patients and 23.4% of CABG patients) had a high SYNTAX score according to the angiographic core laboratory assay. Such finding might propose that if the decision making betwixt CABG and PCI was solely based on the anatomic SYNTAX score, the optimum revascularization method can be inconsistently shifting in a quarter of patients with LMCA disease with regard to interventional and surgical appropriateness and eligibility. In addition, in that location was no remarkable and discriminating interaction between SYNTAX score and revascularization type on clinical outcomes, dissimilarity to the results of the original SYNTAX study.4,5,40
In NOBLE, the predictive and discriminative capacity of the SYNTAX score was much poor. The SYNTAX score was not associated with adverse outcomes afterward PCI or CABG. In item, the unexpected finding of a substantially better issue later CABG than after PCI in the depression SYNTAX score group was plant, suggesting a express predictability of comparative outcomes past this score. These findings in the EXCEL and NOBLE trials may represent a limitation of the SYNTAX score for optimal conclusion making of revascularization strategies in patients with LMCA disease. Therefore, the clinical and applied usefulness of the SYNTAX score for treatment of patients with LMCA illness should be further debated.
Updated Meta-Analysis and Guideline Recommendation
Meta-Analysis
Later on publication of EXCEL and NOBLE trials, subsequent meta-analyses have been reported.55,56 Nerlekar et al55 performed a meta-analysis of 5 RCT (Boudriot et al, PRECOMBAT, SYNTAX, NOBLE, and EXCEL). This study reported that the primary safety end signal of decease, MI, and stroke was similar between PCI and CABG (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.79–i.17; P=0.73). The individual component of expiry (OR, one.03; 95% CI, 0.78–1.35; P=0.61), MI (OR, one.46; 95% CI, 0.88–2.45; P=0.08), and stroke (OR, 0.88; 95% CI, 0.39–1.97; P=0.53) was as well similar, but PCI was associated with higher rates of repeat revascularization (OR, 1.85; 95% CI, one.53–2.23; P<0.001). Upadhaya et al56 performed a similar meta-analysis involving 5 trials. They reported that MACCE (death, MI, stroke, or repeat revascularization) (OR, 1.36; 95% CI, 1.eighteen–one.58; P<0.001) and repeat revascularization (OR, 1.85; 95% CI, 1.53–2.23; P<0.001) was significantly higher afterwards PCI than subsequently CABG. Particularly, based on SYNTAX score, CABG was superior with regard to MACCE only in the subgroup with SYNTAX score of ≥33. At that place were no pregnant differences in the incidence of MI, stroke, or cardiac and all-cause bloodshed.
Guideline Updates
On the basis of cumulative evidence of comparative effectiveness studies of LMCA revascularization, guideline recommendation for LMCA PCI has been less stringent.ane In current 2014 European and U.S. guidelines,38,39 CABG is a class of recommendation/Level of Evidence I B for LM revascularization and PCI is a I B, IIa B, or Three B based on the SYNTAX score tertile. After recent publication of new landmark trials, should the revascularization guidelines change on the basis of the results of this trial? Although a dramatic change in class of recommendation for LMCA PCI is rarely expected, these trials provide additional testify that may influence current guidelines by proposing less restrictive PCI indication and by expanding the patient puddle that might exist eligible for PCI. Also, given that SYNTAX score was not important cistron to guide conclusion making for optimal revascularization and to differentiate the comparative outcomes betwixt CABG and PCI in EXCEL and NOBLE, it may be farther debated whether the SYNTAX score can work every bit the pivotal factor in the future revascularization guidelines.
Future Perspective
In the contemporary existent-world do, although clinical equipoise was nowadays for either PCI or CABG, patients with less complex clinical and anatomic characteristics (ie, isolated left primary affliction, ostial or shaft left main disease, or additional noncomplex one- or 2-vessel disease) might exist preferentially treated by PCI rather than by CABG. The fact that >60% of patients are eligible for PCI in the EXCEL screening registry suggests that the practical threshold in choosing PCI for LMCA illness is likely to exist less stringent in the clinical practice. In addition, the charge per unit of primary end point was like between PCI and CABG even in 24% of the patients with a high SYNTAX score (every bit measured by the angiographic core laboratory) of the EXCEL. However, although PCI with gimmicky DES is less restrictively considered for a broad range of anatomic complexity, further studies are required to decide whether PCI is an acceptable alternative to CABG in patients with loftier anatomic complexity of LMCA affliction.
Another noteworthy finding of EXCEL and NOBLE was a substantial interaction betwixt treatment effect and fourth dimension for the risk of major agin events—belatedly catch-up (in EXCEL) or late divergence (in NOBLE) in handling result of CABG over of PCI during long-term follow-upwardly. Until recently, long-term follow-upward studies up to 5 to 10 years are still limited.57,58 Limited follow-upwards could have penalized the CABG grouping because the long-term benefits of CABG over PCI accept not typically been fully evident until 5 to 10 years after the process. In improver, whether treatment differences between PCI and CABG will proceed to accumulate or diverge or are attenuated by degenerative saphenous vein graft illness with longer-term follow-upwardly deserves further investigation. Study patients in EXCEL and NOBLE will be followed up at 5 and ten years, which will add together additional valuable information.
In addition, as large-sized RCTs comparing PCI versus CABG for patients with LMCA disease are unlikely to be performed in the near future, further analyses in EXCEL and NOBLE and new meta-analysis represent the nearly updated and comprehensive evidence base to inform clinical decision making for the treatment of unprotected LMCA illness.
Summary
Over the several decades, in that location has been a remarkable development in surgical or percutaneous part of revascularization for patients with LMCA disease. The new results of EXCEL and NOBLE trials not merely add to the level of evidence for optimal management of LMCA disease but besides reposition the therapeutic role of each revascularization approach. There might be no clear-cutting (all-or-none) right answer nigh the optimal revascularization strategy (Figure); some patients might prefer CABG surgery, and some patients might adopt PCI. The Heart Team approach may also have the relevant role in the individual patient conclusion making and for patient-centered care. Finally, the optimal option of revascularization modality for LMCA disease should be made afterward discussion among the middle squad members for determining ceremoniousness and eligibility of PCI or CABG and take into account the specific circumstances of each patient and individual preferences.
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Figure. CABG indicates coronary artery featherbed graft; CTO, chronic full occlusion; DAPT, dual antiplatelet therapy; LM, left main; MI, myocardial infarction; and PCI, percutaneous coronary intervention.
Footnotes
References
- ane.
Lee PH, Ahn JM, Chang M, Baek S, Yoon SH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ . Left main coronary artery affliction: secular trends in patient characteristics, treatments, and outcomes. J Am Coll Cardiol . 2016; 68:1233–1246. doi: 10.1016/j.jacc.2016.05.089.CrossrefMedlineGoogle Scholar - 2.
Buszman PE, Kiesz SR, Bochenek A, Peszek-Przybyla E, Szkrobka I, Debinski Chiliad, Bialkowska B, Dudek D, Gruszka A, Zurakowski A, Milewski K, Wilczynski M, Rzeszutko L, Buszman P, Szymszal J, Martin JL, Tendera M . Astute and late outcomes of unprotected left main stenting in comparison with surgical revascularization. J Am Coll Cardiol . 2008; 51:538–545. doi: 10.1016/j.jacc.2007.09.054.CrossrefMedlineGoogle Scholar - 3.
Buszman PE, Buszman PP, Banasiewicz-Szkróbka I, Milewski KP, Żurakowski A, Orlik B, Konkolewska 1000, Trela B, Janas A, Martin JL, Kiesz RS, Bochenek A . Left main stenting in comparing with surgical revascularization: 10-Year Outcomes of the (Left Principal Coronary Artery Stenting) LE MANS Trial. JACC Cardiovasc Interv . 2016; ix:318–327. doi: 10.1016/j.jcin.2015.10.044.CrossrefMedlineGoogle Scholar - 4.
Morice MC, Serruys Pw, Kappetein AP, Feldman TE, Ståhle E, Colombo A, Mack MJ, Holmes DR, Torracca 50, van Es GA, Leadley K, Dawkins KD, Mohr F . Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation . 2010; 121:2645–2653. doi: 10.1161/CIRCULATIONAHA.109.899211.LinkGoogle Scholar - 5.
Morice MC, Serruys PW, Kappetein AP, Feldman TE, Ståhle E, Colombo A, Mack MJ, Holmes DR, Choi JW, Ruzyllo Due west, Religa 1000, Huang J, Roy K, Dawkins KD, Mohr F . Five-yr outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial. Circulation . 2014; 129:2388–2394. doi: x.1161/CIRCULATIONAHA.113.006689.LinkGoogle Scholar - 6.
Boudriot E, Thiele H, Walther T, Liebetrau C, Boeckstegers P, Pohl T, Reichart B, Mudra H, Beier F, Gansera B, Neumann FJ, Gick M, Zietak T, Desch S, Schuler Grand, Mohr FW . Randomized comparing of percutaneous coronary intervention with sirolimus-eluting stents versus coronary avenue featherbed grafting in unprotected left main stem stenosis. J Am Coll Cardiol . 2011; 57:538–545. doi: 10.1016/j.jacc.2010.09.038.CrossrefMedlineGoogle Scholar - 7.
Park SJ, Kim YH, Park DW, Yun SC, Ahn JM, Song HG, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Chung CH, Lee JW, Lim DS, Rha SW, Lee SG, Gwon HC, Kim HS, Chae IH, Jang Y, Jeong MH, Tahk SJ, Seung KB . Randomized trial of stents versus bypass surgery for left main coronary artery disease. N Engl J Med . 2011; 364:1718–1727. doi: 10.1056/NEJMoa1100452.CrossrefMedlineGoogle Scholar - viii.
Ahn JM, Roh JH, Kim YH, Park DW, Yun SC, Lee PH, Chang M, Park HW, Lee SW, Lee CW, Park SW, Choo SJ, Chung C, Lee J, Lim DS, Rha SW, Lee SG, Gwon HC, Kim HS, Chae IH, Jang Y, Jeong MH, Tahk SJ, Seung KB, Park SJ . Randomized trial of stents versus bypass surgery for left main coronary artery disease: 5-year outcomes of the PRECOMBAT study. J Am Coll Cardiol . 2015; 65:2198–2206. doi: 10.1016/j.jacc.2015.03.033.CrossrefMedlineGoogle Scholar - nine.
Bangalore S, Kumar Southward, Fusaro M, Amoroso N, Attubato MJ, Feit F, Bhatt DL, Slater J . Short- and long-term outcomes with drug-eluting and bare-metallic coronary stents: a mixed-treatment comparison assay of 117 762 patient-years of follow-up from randomized trials. Circulation . 2012; 125:2873–2891. doi: x.1161/CIRCULATIONAHA.112.097014.LinkGoogle Scholar - x.
Palmerini T, Benedetto U, Biondi-Zoccai G, Della Riva D, Bacchi-Reggiani L, Smits PC, Vlachojannis GJ, Jensen LO, Christiansen EH, Berencsi K, Valgimigli M, Orlandi C, Petrou M, Rapezzi C, Stone GW . Long-term condom of drug-eluting and blank-metallic stents: evidence from a comprehensive network meta-assay. J Am Coll Cardiol . 2015; 65:2496–2507. doi: 10.1016/j.jacc.2015.04.017.CrossrefMedlineGoogle Scholar - eleven.
Stone GW, Sabik JF, Serruys Pow, Simonton CA, Généreux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Dark-brown WM, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra Pow, van Boven AJ, Ungi I, Bogáts G, Mansour S, Noiseux Due north, Sabaté M, Pomar J, Hickey Chiliad, Gershlick A, Buszman P, Bochenek A, Schampaert E, Pagé P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP ; EXCEL Trial Investigators. Everolimus-eluting stents or bypass surgery for left primary coronary avenue disease. Northward Engl J Med . 2016; 375:2223–2235. doi: 10.1056/NEJMoa1610227.CrossrefMedlineGoogle Scholar - 12.
Mäkikallio T, Holm NR, Lindsay 1000, Spence MS, Erglis A, Menown IB, Trovik T, Eskola Grand, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen One thousand, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sørensen HT, Nielsen PH, Niemelä M, Kervinen K, Lassen JF, Maeng Grand, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Fröbert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH ; NOBLE Study Investigators. Percutaneous coronary angioplasty versus coronary artery featherbed grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet . 2016; 388:2743–2752. doi: 10.1016/S0140-6736(16)32052-9.CrossrefMedlineGoogle Scholar - 13.
Bruschke AV, Proudfit WL, Sones FM Progress written report of 590 consecutive nonsurgical cases of coronary disease followed 5-9 years. Two. Ventriculographic and other correlations. Circulation . 1973; 47:1154–1163.LinkGoogle Scholar - 14.
Takaro T, Hultgren HN, Lipton MJ, Detre KM . The VA cooperative randomized report of surgery for coronary arterial occlusive illness Ii. Subgroup with pregnant left main lesions. Circulation . 1976; 54(half dozen suppl):III107–III117.MedlineGoogle Scholar - 15. European Coronary Surgery Study Group. Long-term results of prospective randomised study of coronary artery bypass surgery in stable angina pectoris. Lancet . 1982; 2:1173–1180.MedlineGoogle Scholar
- 16.
Chaitman BR, Fisher LD, Bourassa MG, Davis K, Rogers WJ, Maynard C, Tyras DH, Berger RL, Judkins MP, Ringqvist I, Mock MB, Killip T . Effect of coronary featherbed surgery on survival patterns in subsets of patients with left master coronary artery affliction. Report of the Collaborative Report in Coronary Artery Surgery (CASS). Am J Cardiol . 1981; 48:765–777.CrossrefMedlineGoogle Scholar - 17.
Campeau L, Corbara F, Crochet D, Petitclerc R . Left master coronary artery stenosis: the influence of aortocoronary bypass surgery on survival. Circulation . 1978; 57:1111–1115.CrossrefMedlineGoogle Scholar - xviii.
Park SJ, Park SW, Hong MK, Cheong SS, Lee CW, Kim JJ, Hong MK, Mintz GS, Leon MB . Stenting of unprotected left main coronary artery stenoses: immediate and late outcomes. J Am Coll Cardiol . 1998; 31:37–42.CrossrefMedlineGoogle Scholar - 19.
Silvestri M, Barragan P, Sainsous J, Bayet G, Simeoni JB, Roquebert PO, Macaluso G, Bouvier JL, Comet B . Unprotected left chief coronary artery stenting: immediate and medium-term outcomes of 140 elective procedures. J Am Coll Cardiol . 2000; 35:1543–1550.CrossrefMedlineGoogle Scholar - 20.
Park SJ, Hong MK, Lee CW, Kim JJ, Song JK, Kang DH, Park SW, Mintz GS . Constituent stenting of unprotected left main coronary artery stenosis: effect of debulking before stenting and intravascular ultrasound guidance. J Am Coll Cardiol . 2001; 38:1054–1060.CrossrefMedlineGoogle Scholar - 21.
Blackness A, Cortina R, Bossi I, Choussat R, Fajadet J, Marco J . Unprotected left master coronary artery stenting: correlates of midterm survival and bear on of patient selection. J Am Coll Cardiol . 2001; 37:832–838.CrossrefMedlineGoogle Scholar - 22.
Takagi T, Stankovic G, Finci L, Toutouzas One thousand, Chieffo A, Spanos V, Liistro F, Briguori C, Corvaja N, Albero R, Sivieri G, Paloschi R, Di Mario C, Colombo A . Results and long-term predictors of agin clinical events after elective percutaneous interventions on unprotected left main coronary artery. Circulation . 2002; 106:698–702.LinkGoogle Scholar - 23.
Park SJ, Kim YH, Lee BK, Lee SW, Lee CW, Hong MK, Kim JJ, Mintz GS, Park SW . Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation. J Am Coll Cardiol . 2005; 45:351–356. doi: x.1016/j.jacc.2004.10.039.CrossrefMedlineGoogle Scholar - 24.
Valgimigli M, van Mieghem CA, Ong AT, Aoki J, Granillo GA, McFadden EP, Kappetein AP, de Feyter PJ, Smits PC, Regar E, Van der Giessen WJ, Sianos G, de Jaegere P, Van Domburg RT, Serruys PW . Curt- and long-term clinical event afterwards drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH). Circulation . 2005; 111:1383–1389. doi: 10.1161/01.CIR.0000158486.20865.8B.LinkGoogle Scholar - 25.
Chieffo A, Park SJ, Valgimigli One thousand, Kim YH, Daemen J, Sheiban I, Truffa A, Montorfano G, Airoldi F, Sangiorgi G, Carlino K, Michev I, Lee CW, Hong MK, Park SW, Moretti C, Bonizzoni East, Rogacka R, Serruys PW, Colombo A . Favorable long-term issue after drug-eluting stent implantation in nonbifurcation lesions that involve unprotected left master coronary artery: a multicenter registry. Apportionment . 2007; 116:158–162. doi: x.1161/CIRCULATIONAHA.107.692178.LinkGoogle Scholar - 26.
Chieffo A, Stankovic G, Bonizzoni E, Tsagalou E, Iakovou I, Montorfano Chiliad, Airoldi F, Michev I, Sangiorgi MG, Carlino K, Vitrella 1000, Colombo A . Early and mid-term results of drug-eluting stent implantation in unprotected left main. Apportionment . 2005; 111:791–795. doi: 10.1161/01.CIR.0000155256.88940.F8.LinkGoogle Scholar - 27.
Stefanini GG, Holmes DR Drug-eluting coronary-artery stents. N Engl J Med . 2013; 368:254–265. doi: ten.1056/NEJMra1210816.CrossrefMedlineGoogle Scholar - 28.
Valenti R, Migliorini A, Parodi Yard, Carrabba N, Vergara R, Dovellini EV, Antoniucci D . Clinical and angiographic outcomes of patients treated with everolimus-eluting stents or kickoff-generation Paclitaxel-eluting stents for unprotected left chief disease. J Am Coll Cardiol . 2012; 60:1217–1222. doi: 10.1016/j.jacc.2012.05.038.CrossrefMedlineGoogle Scholar - 29.
Kim YH, Park DW, Ahn JM, Yun SC, Song HG, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Jang Y, Jeong MH, Kim HS, Hur SH, Rha SW, Lim DS, Her SH, Seung KB, Seong IW, Park SJ ; PRECOMBAT-2 Investigators. Everolimus-eluting stent implantation for unprotected left chief coronary artery stenosis. The PRECOMBAT-two (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Avenue Disease) study. JACC Cardiovasc Interv . 2012; five:708–717. doi: 10.1016/j.jcin.2012.05.002.MedlineGoogle Scholar - thirty.
Buchanan GL, Chieffo A, Bernelli C, Montorfano M, Carlino M, Latib A, Figini F, Giannini F, Durante A, Ielasi A, Castelli A, Colombo A . Two-year outcomes following unprotected left main stenting with first vs. new-generation drug-eluting stents: the FINE registry. EuroIntervention . 2013; 9:809–816. doi: 10.4244/EIJV9I7A134.CrossrefMedlineGoogle Scholar - 31.
Bing R, Yong AS, Lowe HC . Percutaneous transcatheter cess of the left main coronary artery: current status and future directions. JACC Cardiovasc Interv . 2015; 8:1529–1539. doi: 10.1016/j.jcin.2015.07.017.CrossrefMedlineGoogle Scholar - 32.
Park SJ, Kim YH, Park DW, Lee SW, Kim WJ, Suh J, Yun SC, Lee CW, Hong MK, Lee JH, Park SW ; Main-COMPARE Investigators. Touch of intravascular ultrasound guidance on long-term bloodshed in stenting for unprotected left main coronary avenue stenosis. Circ Cardiovasc Interv . 2009; 2:167–177. doi: 10.1161/CIRCINTERVENTIONS.108.799494.LinkGoogle Scholar - 33.
de la Torre Hernandez JM, Baz Alonso JA, Gomez Hospital JA, Alfonso Manterola F, Garcia Camarero T, Gimeno de Carlos F, Roura Ferrer Chiliad, Recalde AS, Martinez-Luengas IL, Gomez Lara J, Hernandez Hernandez F, Perez-Vizcayno MJ, Cequier Fillat A, Perez de Prado A, Gonzalez-Trevilla AA, Jimenez Navarro MF, Mauri Ferre J, Fernandez Diaz JA, Pinar Bermudez E, Zueco Gil J , Ivus-Tronco-Icp Spanish written report. Clinical bear upon of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left master coronary disease: pooled analysis at the patient-level of 4 registries. JACC Cardiovasc Interv . 2014; 7:244–254. doi: x.1016/j.jcin.2013.09.014.CrossrefMedlineGoogle Scholar - 34.
Park SJ, Ahn JM, Park GM, Cho YR, Lee JY, Kim WJ, Han Due south, Kang SJ, Park DW, Lee SW, Kim YH, Lee CW, Mintz GS, Park SW . Trends in the outcomes of percutaneous coronary intervention with the routine incorporation of fractional flow reserve in real practise. Eur Heart J . 2013; 34:3353–3361. doi: 10.1093/eurheartj/eht404.CrossrefMedlineGoogle Scholar - 35.
Hamilos One thousand, Muller O, Cuisset T, Ntalianis A, Chlouverakis 1000, Sarno One thousand, Nelis O, Bartunek J, Vanderheyden M, Wyffels E, Barbato Eastward, Heyndrickx GR, Wijns W, De Bruyne B . Long-term clinical outcome after fractional menstruation reserve-guided handling in patients with angiographically equivocal left main coronary artery stenosis. Apportionment . 2009; 120:1505–1512. doi: x.1161/CIRCULATIONAHA.109.850073.LinkGoogle Scholar - 36.
Courtis J, Rodés-Cabau J, Larose E, Potvin JM, Déry JP, Larochellière RD, Côté Yard, Cousterousse O, Nguyen CM, Proulx Yard, Rinfret S, Bertrand OF . Usefulness of coronary partial flow reserve measurements in guiding clinical decisions in intermediate or equivocal left main coronary stenoses. Am J Cardiol . 2009; 103:943–949. doi: x.1016/j.amjcard.2008.11.054.CrossrefMedlineGoogle Scholar - 37.
Park SJ, Ahn JM, Kang SJ . Unprotected left master percutaneous coronary intervention: integrated use of partial flow reserve and intravascular ultrasound. J Am Heart Assoc . 2012; 1:e004556. doi: ten.1161/JAHA.112.004556.LinkGoogle Scholar - 38.
Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk Five, Filippatos Grand, Hamm C, Caput SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva Thousand, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A . 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Forcefulness on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J . 2014; 35:2541–2619. doi: 10.1093/eurheartj/ehu278.CrossrefMedlineGoogle Scholar - 39.
Fihn SD, Blankenship JC, Alexander KP, Bittl JA, Byrne JG, Fletcher BJ, Fonarow GC, Lange RA, Levine GN, Maddox TM, Naidu SS, Ohman EM, Smith PK . 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and direction of patients with stable ischemic center disease: a report of the American College of Cardiology/American Eye Clan Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation . 2014; 130:1749–1767. doi: 10.1161/CIR.0000000000000095.LinkGoogle Scholar - 40.
Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle Due east, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW ; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-avenue featherbed grafting for severe coronary artery disease. N Engl J Med . 2009; 360:961–972. doi: ten.1056/NEJMoa0804626.CrossrefMedlineGoogle Scholar - 41.
Zimmermann FM, De Bruyne B, Pijls NH, Desai Chiliad, Oldroyd KG, Park SJ, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF . Rationale and blueprint of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 Trial: a comparison of fractional menstruum reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Middle J . 2015; 170:619–626.e2. doi: x.1016/j.ahj.2015.06.024.MedlineGoogle Scholar - 42.
Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, Kimura T, Briguori C, Sabatè M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW . Stent thrombosis with drug-eluting and blank-metal stents: testify from a comprehensive network meta-analysis. Lancet . 2012; 379:1393–1402. doi: 10.1016/S0140-6736(12)60324-9.CrossrefMedlineGoogle Scholar - 43.
Thygesen One thousand, Alpert JS, White HD ; Joint ESC/ACCF/AHA/WHF Chore Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol . 2007; 50:2173–2195. doi: 10.1016/j.jacc.2007.09.011.CrossrefMedlineGoogle Scholar - 44.
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Thygesen K, Alpert JS, White Hard disk, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BR, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani Yard, Hamm CW, Uretsky BF, Steg PG, Wijns West, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong Pw, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos K, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis Southward, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, Morais J, Aguiar C, Almahmeed W, Arnar Practice, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James Due south, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR ; Joint ESC/ACCF/AHA/WHF Chore Force for Universal Definition of Myocardial Infarction; Authors/Job Force Members Chairpersons; Biomarker Subcommittee; ECG Subcommittee; Imaging Subcommittee; Nomenclature Subcommittee; Intervention Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; ESC Committee for Practice Guidelines (CPG); Document Reviewers. Third universal definition of myocardial infarction. Circulation . 2012; 126:2020–2035. doi: 10.1161/CIR.0b013e31826e1058.LinkGoogle Scholar - 45.
Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper Due east, Rock GW . Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an good consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol . 2013; 62:1563–1570.CrossrefMedlineGoogle Scholar - 46.
Farkouh ME, Domanski 1000, Sleeper LA, Siami FS, Dangas G, Mack Grand, Yang G, Cohen DJ, Rosenberg Y, Solomon SD, Desai As, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb Westward, Smith CR, Muratov 5, Bansilal Due south, King South, Bertrand M, Fuster Five ; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med . 2012; 367:2375–2384. doi: ten.1056/NEJMoa1211585.CrossrefMedlineGoogle Scholar - 47.
Bravata DM, Gienger AL, McDonald KM, Sundaram Five, Perez MV, Varghese R, Kapoor JR, Ardehali R, Owens DK, Hlatky MA . Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. Ann Intern Med . 2007; 147:703–716.CrossrefMedlineGoogle Scholar - 48.
Sipahi I, Akay MH, Dagdelen South, Blitz A, Alhan C . Coronary avenue bypass grafting vs percutaneous coronary intervention and long-term bloodshed and morbidity in multivessel disease: meta-analysis of randomized clinical trials of the arterial grafting and stenting era. JAMA Intern Med . 2014; 174:223–230. doi: 10.1001/jamainternmed.2013.12844.CrossrefMedlineGoogle Scholar - 49.
Palmerini T, Biondi-Zoccai G, Reggiani LB, Sangiorgi D, Alessi L, De Servi S, Branzi A, Rock GW . Take chances of stroke with coronary avenue bypass graft surgery compared with percutaneous coronary intervention. J Am Coll Cardiol . 2012; 60:798–805. doi: x.1016/j.jacc.2011.10.912.CrossrefMedlineGoogle Scholar - 50.
Mack Grand, Holmes DR . Randomised trials in left main affliction: a NOBLE effort. Lancet . 2016; 388:2715–2716. doi: x.1016/S0140-6736(16)32067-0.CrossrefMedlineGoogle Scholar - 51.
Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U, Flather K ; Art Investigators. Randomized Trial of Bilateral versus Single Internal-Thoracic-Artery Grafts. N Engl J Med . 2016; 375:2540–2549. doi: 10.1056/NEJMoa1610021.CrossrefMedlineGoogle Scholar - 52.
Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu South, Straka Z, Piegas LS, Avezum A, Akar AR, Lanas Zanetti F, Jain AR, Noiseux Northward, Padmanabhan C, Bahamondes JC, Novick RJ, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Gao P, Pettit Due south, Yusuf South ; CORONARY Investigators. Five-Year Outcomes later on Off-Pump or On-Pump Coronary-Artery Bypass Grafting. N Engl J Med . 2016; 375:2359–2368. doi: 10.1056/NEJMoa1601564.CrossrefMedlineGoogle Scholar - 53.
Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, Kappetein AP, Colombo A, Holmes DR, Mack M, Feldman T, Morice MC, Stahle E, Onuma Y, Morel MA, Garcia-Garcia HM, van Es GA, Dawkins KD, Mohr FW, Serruys Pw . Anatomical and clinical characteristics to guide decision making between coronary avenue bypass surgery and percutaneous coronary intervention for private patients: evolution and validation of SYNTAX score II. Lancet . 2013; 381:639–650. doi: 10.1016/s0140-6736(13)60108-seven.CrossrefMedlineGoogle Scholar - 54.
Farooq V, Serruys Pw, Bourantas CV, Zhang Y, Muramatsu T, Feldman T, Holmes DR, Mack Chiliad, Morice MC, Ståhle E, Colombo A, de Vries T, Morel MA, Dawkins KD, Kappetein AP, Mohr FW . Quantification of incomplete revascularization and its clan with five-twelvemonth mortality in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial validation of the residual SYNTAX score. Circulation . 2013; 128:141–151. doi: ten.1161/CIRCULATIONAHA.113.001803.LinkGoogle Scholar - 55.
Nerlekar N, Ha FJ, Verma KP, Bennett MR, Cameron JD, Meredith Information technology, Dark-brown AJ . percutaneous coronary intervention using drug-eluting stents versus coronary artery featherbed grafting for unprotected left main coronary artery stenosis: a meta-analysis of randomized trials. Circ Cardiovasc Interv . 2016; nine:e004729. doi: x.1161/CIRCINTERVENTIONS.116.004729.LinkGoogle Scholar - 56.
Upadhaya Due south, Baniya R, Madala S, Subedi SK, Khan J, Velagapudi RK, Bachuwa Grand . Drug-eluting stent placement versus coronary artery bypass surgery for unprotected left main coronary artery disease: a meta-analysis of randomized controlled trials. J Card Surg . 2017; 32:70–79. doi: 10.1111/jocs.13090.CrossrefMedlineGoogle Scholar - 57.
Park DW, Seung KB, Kim YH, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Gwon HC, Jeong MH, Jang YS, Kim HS, Kim PJ, Seong IW, Park HS, Ahn T, Chae IH, Tahk SJ, Chung WS, Park SJ . Long-term safe and efficacy of stenting versus coronary artery bypass grafting for unprotected left principal coronary artery affliction: 5-twelvemonth results from the Principal-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry. J Am Coll Cardiol . 2010; 56:117–124. doi: 10.1016/j.jacc.2010.04.004.MedlineGoogle Scholar - 58.
Park DW, Kim YH, Yun SC, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Kim JJ, Choo SJ, Chung CH, Lee JW, Park SW, Park SJ . Long-term outcomes afterwards stenting versus coronary avenue bypass grafting for unprotected left principal coronary artery disease: 10-yr results of bare-metal stents and five-year results of drug-eluting stents from the ASAN-MAIN (ASAN Medical Centre-Left MAIN Revascularization) Registry. J Am Coll Cardiol . 2010; 56:1366–1375. doi: 10.1016/j.jacc.2010.03.097.MedlineGoogle Scholar
Source: https://www.ahajournals.org/doi/10.1161/circinterventions.117.004792
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