提示: 手机请竖屏浏览!

依维莫司洗脱支架和旁路术治疗冠状动脉左主干病变的比较研究
Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease


Gregg W. Stone ... 心脑血管疾病 • 2016.12.08

摘要


背景

对阻塞性冠状动脉左主干病变患者通常采用冠状动脉旁路移植术(CABG)治疗。随机试验提示,对于经选择的冠脉左主干病变患者,依维莫司药物洗脱支架可能是一种可接受的CABG替代治疗。

 

方法

我们将1,905例有低、中度解剖复杂性的冠脉左主干病变患者随机分配到接受经皮冠脉介入治疗组(PCI组,n=948)或CABG组(n=957),其中PCI组患者使用的是基于氟聚合物的钴铬合金依维莫司洗脱支架。解剖复杂性在医疗中心评估,并由采用紫杉类药物释放支架(Taxus)的经皮冠脉介入治疗与心脏外科手术之间的协同作用(Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery,SYNTAX)评分定义,评分≤32分为低、中度复杂性,纳入本研究(SYNTAX评分反映冠脉血管的综合血管造影评估情况,0分为最低评分,分数越高[无上限]表明冠脉解剖越复杂)。主要终点是3年时任何原因死亡、卒中和心肌梗死的复合比例,试验功效采用主要终点的非劣效性检验(非劣效性界值,4.2个百分点)。重大的次要终点包括30天时任何原因死亡、卒中和心肌梗死的复合比例,以及3年时死亡、卒中、心肌梗死或缺血引发的血运重建的复合比例。事件率的首次事件-时间分析采用Kaplan-Meier估计。

 

结果

3年时,PCI组患者主要终点事件发生率为15.4%,CABG组为14.7%(差异,0.7个百分点;97.5%可信上限,4.0个百分点;非劣效性检验,P=0.02;风险比,1.0;95%可信区间,0.79~1.26;优效性检验,P=0.98)。30天时死亡、卒中和心肌梗死的次要终点事件率,PCI组为4.9%,CABG组为7.9%(非劣效性检验,P<0.001;优效性检验,P=0.008)。3年时死亡、卒中、心肌梗死或缺血引发的血运重建的次要终点事件率,PCI组为23.1%,CABG组为19.1%(非劣效性检验,P=0.01;优效性检验,P=0.10)。

 

结论

在由医疗中心评估的SYNTAX评分为低、中度复杂性的冠脉左主干病变患者中,在3年时死亡、卒中或心肌梗死的复合终点率方面,使用依维莫司洗脱支架的PCI治疗不劣于CABG治疗(由雅培公司血管产品部[Abbott Vascular]资助,EXCEL在ClinicalTrials.gov编号为NCT01205776)。





作者信息

Gregg W. Stone, M.D., Joseph F. Sabik, M.D., Patrick W. Serruys, M.D., Ph.D., Charles A. Simonton, M.D., Philippe Généreux, M.D., John Puskas, M.D., David E. Kandzari, M.D., Marie-Claude Morice, M.D., Nicholas Lembo, M.D., W. Morris Brown, III, M.D., David P. Taggart, M.D., Adrian Banning, M.D., Béla Merkely, M.D., Ferenc Horkay, M.D., Piet W. Boonstra, M.D., Ad J. van Boven, M.D., Imre Ungi, M.D., Gabor Bogáts, M.D., Samer Mansour, M.D., Nicolas Noiseux, M.D., Manel Sabaté, M.D., José Pomar, M.D., Mark Hickey, M.D., Anthony Gershlick, M.D., Pawel Buszman, M.D., Andrzej Bochenek, M.D., Erick Schampaert, M.D., Pierre Pagé, M.D., Ovidiu Dressler, M.D., Ioanna Kosmidou, M.D., Roxana Mehran, M.D., Stuart J. Pocock, Ph.D., and A. Pieter Kappetein, M.D., Ph.D., for the EXCEL Trial Investigators*
Address reprint requests to Dr. Stone at Columbia University Medical Center, Cardiovascular Research Foundation, 1700 Broadway, 8th Fl., New York, NY 10019, or at gs2184@columbia.edu. *A complete list of investigators, institutions, and research organizations participating in the Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Fihn SD, Blankenship JC, Alexander KP, et al. 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association 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. J Am Coll Cardiol 2014;64:1929-1949

2. Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force 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

3. Capodanno D, Stone GW, Morice MC, Bass TA, Tamburino C. Percutaneous coronary intervention versus coronary artery bypass graft surgery in left main coronary artery disease: a meta-analysis of randomized clinical data. J Am Coll Cardiol 2011;58:1426-1432

4. Morice MC, Serruys PW, Kappetein AP, et al. Five-year 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

5. Cavalcante R, Sotomi Y, Lee CW, et al. Outcomes after percutaneous coronary intervention or bypass surgery in patients with unprotected left main disease. J Am Coll Cardiol 2016;68:999-1009

6. Palmerini T, Biondi-Zoccai G, Della Riva D, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2014;63:299-307

7. Bangalore S, Kumar S, Fusaro M, et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation 2012;125:2873-2891

8. Kappetein AP, Serruys PW, Sabik JF, et al. Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial. EuroIntervention 2016;12:861-872

9. SYNTAX score calculator (http://ir-nwr.ru/calculators/syntaxscore.htm).

10. Wittes J, Palensky J, Asner D, et al. Experience collecting interim data on mortality: an example from the RALES study. Curr Control Trials Cardiovasc Med 2001;2:59-62

11. Ahn JM, Roh JH, Kim YH, et al. 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

12. Ware JH, Antman EM. Equivalence trials. N Engl J Med 1997;337:1159-1161

13. Com-Nougue C, Rodary C, Patte C. How to establish equivalence when data are censored: a randomized trial of treatments for B non-Hodgkin lymphoma. Stat Med 1993;12:1353-1364

14. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-2351

15. Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011;123:2736-2747

16. Walsh MN, Bove AA, Cross RR, et al. ACCF 2012 health policy statement on patient-centered care in cardiovascular medicine: a report of the American College of Cardiology Foundation Clinical Quality Committee. J Am Coll Cardiol 2012;59:2125-2143

17. Mohr FW, Morice MC, Kappetein AP, et al. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013;381:629-638

18. Farooq V, Serruys PW, Zhang Y, et al. Short-term and long-term clinical impact of stent thrombosis and graft occlusion in the SYNTAX trial at 5 years: Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery trial. J Am Coll Cardiol 2013;62:2360-2369

19. de la Torre Hernandez JM, Baz Alonso JA, Gómez Hospital JA, et al. Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled analysis at the patient-level of 4 registries. JACC Cardiovasc Interv 2014;7:244-254

20. Park SJ, Kim YH, Park DW, et al. Impact of intravascular ultrasound guidance on long-term mortality in stenting for unprotected left main coronary artery stenosis. Circ Cardiovasc Interv 2009;2:167-177

21. Serruys PW, Morice M-C, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009;360:961-972

22. Ong AT, Serruys PW, Mohr FW, et al. The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design, rationale, and run-in phase. Am Heart J 2006;151:1194-1204

23. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol 2012;60:1581-1598

24. Moussa ID, Klein LW, Shah B, et al. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol 2013;62:1563-1570

服务条款 | 隐私政策 | 联系我们