Cardiology Department, Cardiovascular Institute, University of Ferrara, Arcispedale S. Anna Hospital, C.rso Giovecca 203, 44100 Ferrara, Italy.
Eur Heart J. 2013 Mar;34(12):909-19. doi: 10.1093/eurheartj/ehs460. Epub 2013 Jan 12.
The purpose of this pre-specified analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) was to assess device-specific outcomes relative to different duration of dual antiplatelet therapy (DAPT) after Everolimus- (EES), Paclitaxel (PES), Zotarolimus- (ZES-S) eluting, or bare metal stents (BMS).
We randomized 2013 patients to BMS, ZES-S, PES, or EES implantation. At 30 days, each stent group underwent up to 6 or 24 months clopidogrel therapy. The primary endpoint, which was a composite of death, myocardial infarction, or cerebrovascular accident, did not differ in patients receiving BMS [HR: 0.89 (95% CI: 0.54-1.45)], PES [HR: 0.74 (95% CI: 0.43-1.25)], or EES [HR: 0.63 (95% CI: 0.33-1.21)] implantation across DAPT groups, whereas it was significantly higher in ZES-S patients undergoing long when compared with short-term DAPT therapy (HR: 2.85, P = 0.0018), with positive interaction testing (P-value = 0.004). At the 6-month landmark analysis, heterogeneity across stent types persisted for the primary study endpoint and other secondary clinical outcomes, whereas patients receiving PES showed a significantly higher rate of definite, probable and definite, probable, possible stent thrombosis in the short DAPT regimen. No association in absolute or relative terms was noted between stent potency in inhibiting intimal hyperplasia and greater vulnerability to shorter DAPT therapy.
Our study suggests that optimal duration of DAPT may be stent-specific and it does not support a clear association between stent potency and vulnerability to shorter DAPT therapy. Trial Registration clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2.
本研究旨在评估不同时长的双联抗血小板治疗（DAPT）对 PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY（PRODIGY）中使用不同药物洗脱支架（DES）的患者的影响，这是一项关于 PRODIGY 研究的预先指定分析。
我们随机将 2013 名患者分配至 BMS、ZES-S、PES 或 EES 支架植入组。在 30 天时，每组患者接受为期 6 或 24 个月的氯吡格雷治疗。主要终点为死亡、心肌梗死或卒中等复合终点，在接受 BMS（HR：0.89，95%CI：0.54-1.45）、PES（HR：0.74，95%CI：0.43-1.25）或 EES（HR：0.63，95%CI：0.33-1.21）治疗的患者中，不同 DAPT 时长组之间无差异，而 ZES-S 支架植入患者中，长期 DAPT 组与短期 DAPT 组相比，主要终点更高（HR：2.85，P=0.0018），且交互检验具有统计学意义（P 值=0.004）。在 6 个月的主要研究终点和其他次要临床终点分析中，不同支架类型之间的异质性仍然存在，而在接受 PES 治疗的患者中，在短期 DAPT 方案中，明确、可能和明确、可能、可能的支架血栓形成发生率更高。支架抑制内膜增生的效力与较短 DAPT 治疗的脆弱性之间无绝对或相对关联。
我们的研究表明，DAPT 的最佳时长可能因支架类型而异，并且不支持支架效力与较短 DAPT 治疗的脆弱性之间存在明确关联。
clinicaltrials.gov 标识符：NCT00611286。http://clinicaltrials.gov/ct2/show/NCT00611286？term=prodigy&rank=2。
