在 TAXUS Liberté 紫杉醇洗脱冠状动脉支架置入后，普拉格雷联合阿司匹林超过 12 个月与改善结局相关。

Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after TAXUS Liberté paclitaxel-eluting coronary stent placement.

机构信息

From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).

出版信息

Circulation. 2015 Jan 6;131(1):62-73. doi: 10.1161/CIRCULATIONAHA.114.013570. Epub 2014 Nov 16.

DOI:10.1161/CIRCULATIONAHA.114.013570

PMID:25400062

Abstract

BACKGROUND

The TAXUS Liberté Post Approval Study (TL-PAS) contributed patients treated with TAXUS Liberté paclitaxel-eluting stent and prasugrel to the Dual Antiplatelet Therapy Study (DAPT) that compared 12 and 30 months thienopyridine plus aspirin therapy after drug-eluting stents.

METHODS AND RESULTS

Outcomes for 2191 TL-PAS patients enrolled into DAPT were assessed. The DAPT coprimary composite end point (death, myocardial infarction [MI], or stroke) was lower with 30 compared with 12 months prasugrel treatment (3.7% versus 8.8%; hazard ratio [HR], 0.407; P<0.001). Rates of death and stroke were similar between groups, but MI was significantly reduced with prolonged prasugrel treatment (1.9% versus 7.1%; HR, 0.255; P<0.001). The DAPT coprimary end point, stent thrombosis, was also lower with longer therapy (0.2% versus 2.9%; HR, 0.063; P<0.001). MI related to stent thrombosis (0% versus 2.6%; P<0.001) and occurring spontaneously (1.9% versus 4.5%; HR, 0.407; P=0.007) were both reduced with prolonged prasugrel. MI rates increased within 90 days of prasugrel cessation after both 12 and 30 months treatment. Composite Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) moderate or severe bleeds were modestly increased (2.4% versus 1.7%; HR, 1.438; P=0.234) but severe bleeds were not more frequent (0.3% versus 0.5%; HR, 0.549; P=0.471) in the prolonged treatment group.

CONCLUSIONS

Prasugrel and aspirin continued for 30 months reduced ischemic events for the TAXUS Liberté paclitaxel-eluting stent patient subset from DAPT through reductions in MI and stent thrombosis. Withdrawal of prasugrel was followed by an increase in MI after both 12 and 30 months therapy. The optimal duration of dual antiplatelet therapy with prasugrel after TAXUS Liberté paclitaxel-eluting stent remains unknown, but appears to be >30 months.

CLINICAL TRIAL REGISTRATION URL

http://www.clinicaltrials.gov. Unique identifier: NCT00997503.

摘要

背景

TAXUS Liberté 上市后研究（TL-PAS）为双联抗血小板治疗研究（DAPT）贡献了接受 TAXUS Liberté 紫杉醇洗脱支架和普拉格雷治疗的患者，该研究比较了药物洗脱支架后使用噻吩吡啶加阿司匹林治疗 12 个月和 30 个月的疗效。

方法和结果

评估了 2191 例纳入 DAPT 的 TL-PAS 患者的结局。与 12 个月普拉格雷治疗相比，30 个月治疗的 DAPT 主要复合终点（死亡、心肌梗死[MI]或卒中）较低（3.7% vs. 8.8%；风险比[HR]，0.407；P<0.001）。两组的死亡率和卒中发生率相似，但延长普拉格雷治疗可显著减少 MI（1.9% vs. 7.1%；HR，0.255；P<0.001）。较长的治疗时间也降低了 DAPT 的主要终点，支架血栓形成（0.2% vs. 2.9%；HR，0.063；P<0.001）。与支架血栓形成相关的 MI（0% vs. 2.6%；P<0.001）和自发性 MI（1.9% vs. 4.5%；HR，0.407；P=0.007）均随普拉格雷治疗时间延长而降低。在接受 12 个月和 30 个月治疗后，普拉格雷停药后 90 天内 MI 发生率增加。复合全球应用链激酶和组织型纤溶酶原激活剂治疗闭塞性冠状动脉疾病（GUSTO）中度或重度出血略有增加（2.4% vs. 1.7%；HR，1.438；P=0.234），但严重出血并不更常见（0.3% vs. 0.5%；HR，0.549；P=0.471）在延长治疗组中。

结论

在 DAPT 中，接受 TAXUS Liberté 紫杉醇洗脱支架治疗的患者继续使用普拉格雷和阿司匹林治疗 30 个月，可通过减少 MI 和支架血栓形成来降低缺血事件。在接受 12 个月和 30 个月治疗后，停止使用普拉格雷后 MI 发生率增加。TAXUS Liberté 紫杉醇洗脱支架后使用普拉格雷进行双重抗血小板治疗的最佳持续时间尚不清楚，但似乎>30 个月。