University Hospital Basel, Basel, Switzerland.
University Hospital Basel, Basel, Switzerland.
Am Heart J. 2014 Nov;168(5):698-705. doi: 10.1016/j.ahj.2014.07.019. Epub 2014 Jul 30.
The tradeoff between stent thrombosis (ST) and major bleeding (MB) of 12- versus 6-month dual antiplatelet therapy (DAPT) after coronary stent implantation has not been clearly defined.
Definite/probable ST and MB (TIMI major and Bleeding Academic Research Consortium (BARC) ≥ 3) were compared in 2 subsequent trials with similar inclusion criteria but different DAPT duration, that is, BASKET (6 months; n = 557) and BASKET-PROVE (12 months; n = 2,314), between months 0 to 6 (DAPT in both trials), 7 to 12 (DAPT in BASKET-PROVE only), and 13 to 24 (aspirin in both trials) using propensity score-adjusted, time-stratified Cox proportional hazard models.
Overall, event rates were low with fewer ST but similar MB in prolonged DAPT. Analysis of the 3 periods showed a uniform pattern for ST (interaction DAPT/period; P = .145) but an inconsistent pattern for MB (interaction DAPT/period; P < .001 for TIMI major and P = .046 for BARC ≥ 3), with more MB occurring during months 7 to 12 with prolonged DAPT. Considering observed case fatality rates of 31% with ST and 11% with MB, the extrapolated prevention of 27 ST deaths and the excess of 5 MB deaths resulted in an expected benefit of 22 survivors/10,000 patients treated over 2 years with prolonged DAPT.
Despite overall low event rates, prolonged DAPT was associated with more MB during months 7 to 12 according to the interaction DAPT/period. Given the higher observed case fatality rates of ST versus MB, 12- versus 6-month DAPT was associated with an extrapolated reduction in mortality. Effective treatment periods and case fatality rates seem important in the analysis of different DAPT durations, specifically with regard to ongoing trials.
冠状动脉支架植入术后 12 个月与 6 个月双联抗血小板治疗（DAPT）的支架血栓形成（ST）和主要出血（MB）之间的权衡尚未明确界定。
在 2 项具有相似纳入标准但 DAPT 持续时间不同的后续试验（BASKET[6 个月；n=557]和 BASKET-PROVE[12 个月；n=2314]）中，比较了 0 至 6 个月（2 项试验均使用 DAPT）、7 至 12 个月（仅 BASKET-PROVE 使用 DAPT）和 13 至 24 个月（2 项试验均使用阿司匹林）期间的确定/可能 ST 和 MB（TIMI 主要和 Bleeding Academic Research Consortium[BARC]≥3）。采用倾向评分调整的时间分层 Cox 比例风险模型进行比较。
总体而言，延长 DAPT 治疗后 ST 发生率较低，但 MB 发生率相似。3 个时期的分析显示 ST 呈一致模式（DAPT/时期的交互作用；P=0.145），但 MB 呈不一致模式（DAPT/时期的交互作用；TIMI 主要的 P<0.001，BARC≥3 的 P=0.046），延长 DAPT 治疗期间 7 至 12 个月 MB 发生率更高。考虑到 ST 的观察病死率为 31%，MB 为 11%，延长 DAPT 治疗预计可预防 27 例 ST 死亡和 5 例 MB 死亡，这将使 2 年期间每 10000 例患者多 22 例存活者获益。
尽管总体事件发生率较低，但根据 DAPT/时期的交互作用，延长 DAPT 治疗与 7 至 12 个月期间的 MB 发生率更高相关。鉴于 ST 与 MB 的观察病死率更高，12 个月与 6 个月 DAPT 相关的死亡率降低有预测价值。在分析不同 DAPT 持续时间时，特别是在考虑正在进行的试验时，有效治疗期和病死率似乎很重要。
