依维莫司洗脱支架的支架内血栓形成与双联抗血小板治疗中断：来自Xience V冠状动脉支架系统试验的见解。
Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials.
作者信息
Généreux Philippe, Rutledge David R, Palmerini Tullio, Caixeta Adriano, Kedhi Elvin, Hermiller James B, Wang Jin, Krucoff Mitchell W, Jones-McMeans Jennifer, Sudhir Krishnankutty, Simonton Charles A, Serruys Patrick W, Stone Gregg W
机构信息
From the Columbia University Medical Center, New York, NY (P.G., G.W.S.); Cardiovascular Research Foundation, New York, NY (P.G., G.W.S.); Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada (P.G.); Abbott Vascular, Santa Clara, CA (D.R.R., J.W., J.J.-M., K.S., C.A.S.); Istituto di Cardiologia, University of Bologna, Italy (T.P.); Escola Paulista de Medicina, Universidade Federal de São Paulo and Hospital Israelita Albert Einstein, São Paolo, Brazil (A.C.); Isala Klinieken, Zwolle, the Netherlands (E.K.); St. Vincent Heart Center of Indiana, Indianapolis (J.B.H.); Duke University Medical Center, Durham, NC (M.W.K.); and Erasmus University Hospital, Rotterdam, the Netherlands (P.W.S.).
出版信息
Circ Cardiovasc Interv. 2015 May;8(5). doi: 10.1161/CIRCINTERVENTIONS.114.001362.
BACKGROUND
Whether premature dual antiplatelet therapy (DAPT) interruption is safe in patients receiving cobalt chromium everolimus-eluting stents remains controversial. We sought to examine the relationship between DAPT discontinuation and stent thrombosis (ST) after cobalt chromium everolimus-eluting stents.
METHODS AND RESULTS
Outcomes from 11,219 patients were pooled from 3 randomized trials and 4 registries with 2-year follow-up period after cobalt chromium everolimus-eluting stent implantation. Rates of definite/probable ST were analyzed according to DAPT discontinuation in the following time intervals: 0 to 30, 30 to 90, 90 to 180, 180 to 365, and 365 to 730 days. Eighty-five cases of ST (0.75%) occurred in 83 patients during 2 years, with 41 (48.2%) events occurring within 30 days. The 2-year ST rate in patients interrupting DAPT at any time was similar to that in patients never interrupting DAPT through 2 years (25/4067 [0.63%] versus 58/7152 [0.83%] respectively; P=0.27]. By propensity and DAPT usage-adjusted multivariable analysis, permanent DAPT discontinuation before 30 days was independently associated with the occurrence of ST (hazard ratio [95% confidence interval], 26.8 [8.4-85.4]; P<0.0001), whereas permanent DAPT discontinuation in any interval after 90 days was not associated with ST. Only 2 ST events occurred after DAPT discontinuation between 30 and 90 days (both between 30 and 60 days), and the association between permanent DAPT discontinuation and ST during this period is unclear (hazard ratio [95% confidence interval], 8.7 [2.0-37.3]; P=0.004 for adjusted analysis and 3.4 [0.8-13.8]; P=0.07 for the unadjusted analysis).
CONCLUSIONS
In this large pooled experience, permanent DAPT discontinuation before 30 days after cobalt chromium everolimus-eluting stent implantation was strongly associated with ST, whereas DAPT discontinuation beyond 90 days appeared safe.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180310, NCT00180479, NCT00307047, NCT00402272, NCT00496938, NCT00676520, and NCT00631228.
背景
在接受钴铬依维莫司洗脱支架的患者中，过早中断双重抗血小板治疗（DAPT）是否安全仍存在争议。我们试图研究钴铬依维莫司洗脱支架植入后DAPT中断与支架血栓形成（ST）之间的关系。
方法与结果
从3项随机试验和4个注册研究中汇总了11219例患者的结果，这些患者在钴铬依维莫司洗脱支架植入后有2年的随访期。根据DAPT中断情况，在以下时间间隔分析明确/可能的ST发生率：0至30天、30至90天、90至180天、180至365天以及365至730天。2年内，83例患者发生了85例ST事件（0.75%），其中41例（48.2%）事件发生在30天内。在任何时间中断DAPT的患者2年ST发生率与2年内从未中断DAPT的患者相似（分别为25/4067 [0.63%] 和58/7152 [0.83%]；P = 0.27）。通过倾向评分和DAPT使用情况调整的多变量分析，30天前永久中断DAPT与ST的发生独立相关（风险比[95%置信区间]，26.8 [8.4 - 85.4]；P < 0.0001），而90天后任何时间间隔永久中断DAPT与ST无关。仅2例ST事件发生在30至90天DAPT中断后（均在30至60天之间），在此期间永久中断DAPT与ST之间的关联尚不清楚（风险比[95%置信区间]，8.7 [2.0 - 37.3]；调整分析P = 0.004，未调整分析P = 0.07）。
结论
在这项大型汇总研究中，钴铬依维莫司洗脱支架植入后30天内永久中断DAPT与ST密切相关，而90天后中断DAPT似乎是安全的。
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