Background:Differences in patient characteristics, changes in treatment algorithms, and advances in medical technology could each influence the applicability of older randomized trial results to contemporary clinical practice. The DAPT Study (Dual Antiplatelet Therapy) found that longer-duration DAPT decreased ischemic events at the expense of greater bleeding, but subsequent evolution in stent technology and clinical practice may attenuate the benefit of prolonged DAPT in a contemporary population. We evaluated whether the DAPT Study population is different from a contemporary population of US patients receiving percutaneous coronary intervention and estimated the treatment effect of extended-duration antiplatelet therapy after percutaneous coronary intervention in this more contemporary cohort.Methods:We compared the characteristics of drug-eluting stent–treated patients randomly assigned in the DAPT Study to a sample of more contemporary drug-eluting stent–treated patients in the National Cardiovascular Data Registry CathPCI Registry from July 2016 to June 2017. After linking trial and registry data, we used inverse-odds of trial participation weighting to account for patient and procedural characteristics and estimated a contemporary real-world treatment effect of 30 versus 12 months of DAPT after coronary stent procedures.Results:The US drug-eluting stent–treated trial cohort included 8864 DAPT Study patients, and the registry cohort included 568 540 patients. Compared with the trial population, registry patients had more comorbidities and were more likely to present with myocardial infarction and receive 2nd-generation drug-eluting stents. After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: –0.40 [95% CI, –0.99% to 0.15%]), major adverse cardiac and cerebrovascular events (reweighted treatment effect, –0.52 [95% CI, –2.62% to 1.03%]), or myocardial infarction (reweighted treatment effect, –0.97% [95% CI, –2.75% to 0.18%]), but the increase in bleeding with prolonged DAPT persisted (reweighted treatment effect, 2.42% [95% CI, 0.79% to 3.91%]).Conclusions:The differences between the patients and devices used in contemporary clinical practice compared with the DAPT Study were associated with the attenuation of benefits and greater harms attributable to prolonged DAPT duration. These findings limit the applicability of the average treatment effects from the DAPT Study in modern clinical practice.

中文翻译：

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当代临床实践中 DAPT 研究治疗效果的估计：EXTEND-DAPT 研究的结果


背景：患者特征的差异、治疗算法的变化以及医疗技术的进步都可能影响旧随机试验结果在当代临床实践中的适用性。 DAPT 研究（双联抗血小板治疗）发现，较长持续时间的 DAPT 可以减少缺血事件，但代价是增加出血量，但支架技术和临床实践的后续发展可能会削弱长期 DAPT 对当代人群的益处。我们评估了 DAPT 研究人群是否与接受经皮冠状动脉介入治疗的当代美国患者人群不同，并评估了在这个更现代的队列中经皮冠状动脉介入治疗后延长持续时间抗血小板治疗的治疗效果。将 DAPT 研究中接受洗脱支架治疗的患者随机分配至 2016 年 7 月至 2017 年 6 月国家心血管数据注册中心 CathPCI 注册中心中更现代的接受药物洗脱支架治疗的患者样本。在链接试验和注册数据后，我们使用了反向考虑患者和手术特征的试验参与权重的几率，并估计冠状动脉支架手术后 30 个月与 12 个月 DAPT 的当代真实治疗效果。结果：美国药物洗脱支架治疗的试验队列包括 8864 名 DAPT 研究患者，注册队列包括 568 540 名患者。与试验人群相比，登记患者有更多的合并症，更有可能出现心肌梗塞并接受第二代药物洗脱支架。 对代表登记人群的试验结果进行重新加权后，延长 DAPT 对减少支架内血栓形成不再具有显着效果（重新加权治疗效果：–0.40 [95% CI，–0.99% 至 0.15%]）、主要不良心脑血管事件（重新加权治疗效果，–0.52 [95% CI，–2.62% 至 1.03%]）或心肌梗死（重新加权治疗效果，–0.97% [95% CI，–2.75% 至 0.18%]），但增加长期 DAPT 持续出血（重新加权治疗效果，2.42% [95% CI，0.79% 至 3.91%]）。 结论：与 DAPT 研究相比，当代临床实践中使用的患者和设备之间的差异与衰减有关延长 DAPT 持续时间带来的好处和更大的危害。这些发现限制了 DAPT 研究的平均治疗效果在现代临床实践中的适用性。