提示: 手机请竖屏浏览!

聚合物支架和非聚合物支架用于高出血风险患者的比较
Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk


Stephan Windecker ... • 2020.03.26
相关阅读
• 冠状动脉左主干病变PCI或CABG后的5年结局比较 • 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 • 一种生物可降解聚合物制成的超细支撑单元西罗莫司洗脱支架:远期结局

摘要


背景

在接受经皮冠状动脉介入治疗(PCI)和1个月双联抗血小板治疗的高出血风险患者中,药物涂层非聚合物支架的临床结局优于裸金属支架。但在此类患者中比较药物洗脱聚合物支架与药物涂层非聚合物支架的数据有限。

 

方法

在一项国际性、随机、单盲试验中,我们在高出血风险患者中比较了佐他莫司(zotarolimus)洗脱聚合物支架和umirolimus涂层非聚合物支架。PCI后,患者接受了1个月的双联抗血小板治疗,随后接受了单药抗血小板治疗。主要结局是由1年时的心脏原因死亡、心肌梗死或支架内血栓形成构成的安全性复合结局。关键次要结局是靶病变治疗失败(由心脏原因死亡、靶血管心肌梗死或有临床指征的靶病变血运重建构成的有效性复合结局)。本试验有足够的统计学功效对上述两项结局进行非劣效性检验。

 

结果

我们以1∶1的比例将总共1,996例高出血风险患者随机分组,分别接受佐他莫司洗脱支架(1,003例患者)或药物涂层非聚合物支架(993例患者)治疗。1年时,佐他莫司洗脱支架组988例患者中的169例(17.1%)和药物涂层非聚合物支架组969例患者中的164例(16.9%)发生了主要结局(风险差异,0.2个百分点;单侧97.5%置信区间[CI]上限,3.5;非劣效界值,4.1;非劣效性P=0.01)。佐他莫司洗脱支架组174例患者(17.6%)和药物涂层非聚合物支架组169例患者(17.4%)发生了关键次要结局(风险差异,0.2个百分点;单侧97.5% CI上限,3.5;非劣效界值,4.4;非劣效性P=0.007)。

 

结论

在PCI后接受1个月双联抗血小板治疗的高出血风险患者中,在安全性和有效性复合结局方面,使用佐他莫司洗脱聚合物支架不劣于使用药物涂层非聚合物支架(由美敦力资助,ONYX ONE在ClinicalTrials.gov注册号为NCT03344653)。





作者信息

Stephan Windecker, M.D., Azeem Latib, M.D., Elvin Kedhi, M.D., Ph.D., Ajay J. Kirtane, M.D., David E. Kandzari, M.D., Roxana Mehran, M.D., Matthew J. Price, M.D., Alexandre Abizaid, M.D., Daniel I. Simon, M.D., Stephen G. Worthley, M.B., B.S., Ph.D., Azfar Zaman, M.D., Martin Hudec, M.D., Petra Poliacikova, M.D., A. Kahar bin Abdul Ghapar, M.D., Kamaraj Selvaraj, M.D., Ivo Petrov, M.D., Ph.D., Darren Mylotte, M.D., Eduardo Pinar, M.D., Raul Moreno, M.D., Franco Fabbiocchi, M.D., Sanjeevan Pasupati, M.D., Hyo-Soo Kim, M.D., Ph.D., Adel Aminian, M.D., Charles Tie, M.D., Adrian Wlodarczak, M.D., Seung-Ho Hur, M.D., Ph.D., Steven O. Marx, M.D., Ivana Jankovic, M.D., Sandeep Brar, M.D., Lisa Bousquette, M.S., Minglei Liu, Ph.D., and Gregg W. Stone, M.D. for the ONYX ONE Investigators*
From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (S.W.); Montefiore Medical Center (A.L.), Columbia University Irving Medical Center–New York–Presbyterian Hospital (A.J.K., S.O.M.), the Cardiovascular Research Foundation (A.J.K., S.O.M., I.J., G.W.S.), Mount Sinai Medical Center (R. Mehran), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S.) — all in New York; Isala Zwolle, Zwolle, the Netherlands (E.K.); Medical University of Silesia, Katowice (E.K.), and Poland Miedziowe Centrum Zdrowia, Lubin (A.W.) — both in Poland; Piedmont Heart Institute, Atlanta (D.E.K.); the Division of Cardiovascular Diseases, Scripps Clinic, La Jolla (M.J.P.), and Medtronic, Santa Rosa (S.B., L.B., M.L.) — both in California; Instituto Dante Pazzanese de Cardiologia, São Paulo (A. Abizaid); University Hospitals Cleveland Medical Center, Cleveland (D.I.S.); GenesisCare Cardiology, Alexandria, NSW (S.G.W.), and St. Andrew’s Hospital, Adelaide, SA (C.T.) — both in Australia; Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom (A.Z.); Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia (M.H., P.P.); Hospital Serdang, Kajang, Malaysia (A.K.A.G., K.S.); Acibadem City Clinic, Sofia, Bulgaria (I.P.); Galway University Hospitals–University Hospital Galway, Galway, Ireland (D.M.); Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar (E.P.), and Hospital Universitario La Paz and Hospital La Paz Institute for Health Research, Madrid (R. Moreno) — all in Spain; Centro Cardiologico Monzino IRCCS, Milan (F.F.); Waikato Hospital, Hamilton, New Zealand (S.P.); Seoul National University Hospital, Seoul (H.-S.K.), and Keimyung University Dongsan Medical Center, Daegu (S.-H.H.) — both in South Korea; and Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium (A. Aminian). Address reprint requests to Dr. Windecker at the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstr., CH-3010 Bern, Switzerland, or at stephan.windecker@insel.ch. *A complete list of the ONYX ONE investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. EuroIntervention 2019;14:1435-1534.

2. Piccolo R, Bonaa KH, Efthimiou O, et al. Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials. Lancet 2019;393:2503-2510.

3. Frigoli E, Smits P, Vranckx P, et al. Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. Am Heart J 2019;209:97-105.

4. Urban P, Mehran R, Colleran R, et al. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J 2019;40:2632-2653.

5. Leon MB, Baim DS, Popma JJ, et al. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. N Engl J Med 1998;339:1665-1671.

6. Varenne O, Cook S, Sideris G, et al. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet 2018;391:41-50.

7. Valgimigli M, Patialiakas A, Thury A, et al. Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol 2015;65:805-815.

8. Watanabe H, Domei T, Morimoto T, et al. Effect of 1-month dual antiplatelet therapy followed by clopidogrel vs 12-month dual antiplatelet therapy on cardiovascular and bleeding events in patients receiving PCI: the STOPDAPT-2 randomized clinical trial. JAMA 2019;321:2414-2427.

9. Urban P, Meredith IT, Abizaid A, et al. Polymer-free drug-coated coronary stents in patients at high bleeding risk. N Engl J Med 2015;373:2038-2047.

10. Serruys PW, Silber S, Garg S, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 2010;363:136-146.

11. von Birgelen C, Zocca P, Buiten RA, et al. Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. Lancet 2018;392:1235-1245.

12. Silber S, Kirtane AJ, Belardi JA, et al. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J 2014;35:1949-1956.

13. Kedhi E, Latib A, Abizaid A, et al. Rationale and design of the Onyx ONE global randomized trial: a randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy. Am Heart J 2019;214:134-141.

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

15. Levine GN, Bates ER, Bittl JA, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention, 2011 ACCF/AHA guideline for coronary artery bypass graft surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease, 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction, 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes, and 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery. Circulation 2016;134(10):e123-e155.

16. Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: the Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2018;39:213-260.

17. Knuuti J, Wijns W, Saraste A, et al. 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J 2020;41:407-477.

18. Costa F, Van Klaveren D, Feres F, et al. Dual antiplatelet therapy duration based on ischemic and bleeding risks after coronary stenting. J Am Coll Cardiol 2019;73:741-754.

19. Spitzer E, de Vries T, Cavalcante R, et al. Detecting periprocedural myocardial infarction in contemporary percutaneous coronary intervention trials. JACC Cardiovasc Interv 2017;10:658-666.

服务条款 | 隐私政策 | 联系我们