Cardiology Department, University of Ferrara, Ferrara, Italy.
Am Heart J. 2010 Nov;160(5):804-11. doi: 10.1016/j.ahj.2010.07.034.
The optimal duration of clopidogrel therapy after coronary stenting is debated because of the scarcity of randomized controlled trials and inconsistencies arising from registry data. Although prolonged clopidogrel therapy after bare metal stenting is regarded as an effective secondary prevention measure, the safety profile of drug-eluting stents itself has been questioned in patients not receiving ≥ 12 months of dual-antiplatelet therapy.
Twenty-four months of clopidogrel therapy after coronary stenting reduces the composite of death, myocardial infarction, or stroke compared with 6 months of treatment.
PRODIGY is an unblinded, multicenter, 4-by-2 randomized trial. All-comer patients with indication to coronary stenting are randomly treated-balancing randomization-with bare metal stent (no active late loss inhibition), Endeavor Sprint zotarolimus-eluting stent (Medtronic, Santa Rosa, CA) (mild late loss inhibition), Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA) (moderate late loss inhibition), or Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) (high late loss inhibition). At 30 days, patients in each stent group are randomly allocated to receive 24 or up to 6 months of clopidogrel therapy-primary end point randomization. With 1,700 individuals, this study will have >80% power to detect a 40% difference in the primary end point after sample size augmentation of 5% and a background event rate of 8%.
The PRODIGY trial aims to assess whether 24 months of clopidogrel therapy improves cardiovascular outcomes after coronary intervention in a broad all-comer patient population receiving a balanced mixture of stents with various anti-intimal hyperplasia potency.
由于随机对照试验的稀缺性以及来自注册数据的不一致性，关于冠状动脉支架置入术后氯吡格雷治疗的最佳持续时间仍存在争议。虽然裸金属支架置入术后延长氯吡格雷治疗被认为是一种有效的二级预防措施，但在未接受≥12 个月双联抗血小板治疗的药物洗脱支架患者中，药物洗脱支架本身的安全性已受到质疑。
与 6 个月的治疗相比，冠状动脉支架置入术后使用氯吡格雷治疗 24 个月可降低死亡、心肌梗死或中风的复合发生率。
PRODIGY 是一项非盲、多中心、4×2 随机试验。所有适合接受冠状动脉支架置入术的患者均接受随机治疗-平衡随机化-裸金属支架（无主动晚期丢失抑制）、 Endeavor Sprint 佐他莫司洗脱支架（美敦力，圣罗莎，CA）（轻度晚期丢失抑制）、Taxus 紫杉醇洗脱支架（波士顿科学，纳提克，MA）（中度晚期丢失抑制）或 Xience V 依维莫司洗脱支架（雅培血管，圣克拉拉，CA）（晚期丢失抑制）。在 30 天时，每组支架患者随机分为接受 24 个月或最长 6 个月的氯吡格雷治疗-主要终点随机化。在样本量增加 5%并背景事件发生率为 8%的情况下，这项研究将有超过 80%的效力检测主要终点的 40%差异，共纳入 1700 名患者。
PRODIGY 试验旨在评估在接受具有不同抗内膜增生能力的支架混合平衡的广泛所有适合患者人群中，氯吡格雷治疗 24 个月是否能改善冠状动脉介入后的心血管结局。
