Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Versus PacliTaxel-Eluting Stent for Acute Myocardial Infarction Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 328
- 试验地点
- 13
- 主要终点
- The composite of death (all cause-mortality), MI (Q wave and non Q wave) and ischemia-driven target vessel revascularization.
研究概览
简要总结
The trial has the following primary objective:
To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. sirolimus-eluting balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) vs. paclitaxel-eluting stent (Taxus Liberte, Boston Scientific).
详细描述
Previous studies have documented that a slow-release polymeric sirolimus-eluting stent (Cypher, Cordis) and paclitaxel-eluting stent (Taxus, Boston Scientific) reduce neointimal formation and result in decrease of angiographic restenosis and target lesion revascularization at 1-3 years in the multicenter randomized clinical trials RAVEL, SIRIUS, and TAXUS I-VI. From these studies, the two leading drug-eluting stents (DESs) of the Cypher and Taxus have been widely and rapidly accepted as a standard treatment of coronary lesions.
Recently, randomized studies were conducted to reveal different outcomes of the different two DESs. These studies showed that the sirolimus-eluting stent was better than the paclitaxel-eluting stent in terms of lower angiographic restenosis rate or the two DESs were similar in angiographic outcomes. A recent meta-analysis supported results of the former randomized studies. Patients receiving sirolimus-eluting stent had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stent.
With a recent approval of new DES, ABT-578-eluting stent (Endeavor, Medtronic, Minneapolis, MN), other comparison studies have been conducted to compare Endeavor ABT-578-eluting stent with the sirolimus-eluting stent and paclitaxel-eluting stent. The ENDEAVOR clinical trials are currently in progress to evaluate a phosphoryl choline (PC)-coated ABT-578-eluting stent for the prevention of restenosis. Angiographic analysis at 4 months in the 100-patient focal de novo lesion ENDEAVOR I feasibility study demonstrated a mean in-stent percent diameter stenosis of approximately 14% and a late lumen loss of 0.3 mm with a low frequency of target lesion revascularization (1%). The clinical outcomes from the ENDEAVOR II (1,197 patients randomized to ABT-578 or bare metal stent) showed superior efficacy of the PC-coated ABT-578-eluting stent than bare-metal stent.
In patients with acute myocardial infraction (MI), routine stent implantation has been shown to have a better procedural success rate and clinical outcome than balloon angioplasty [11]. However, restenosis and vessel reocclusion remain major challenges limiting the long-term success of percutaneous treatment.
In a clinical study of 400 patients with stent implantation in acute MI, angiographic restenosis occurred in 31%, considerably more than expected for patients with stable coronary disease. There is very little information available as to the efficacy and long-term safety of DES in acute MI. The results from the several registry and randomized trials (Cypher-AMI, Typhoon, PASSION) demonstrated the short-term or long-term safety and efficacy of DES compared to BMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 18 years of age.
- •Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on stent length)
- •Prolonged, continuous (≥ 20 min) chest pain despite nitrate and: (1) at least 1mm ST-segment elevation in at least 2 leads or reciprocal ST-segment depression ≥ 2 contiguous precordial leads, or (2) newly developed left bundle branch block
- •Symptoms < 12 hours
- •The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications:
- •Both Clopidogrel and TIclopidine
- •Sirolimus, paclitaxel, ABT 578
- •Stainless steel and/or
- •Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- •Systemic (intravenous) Sirolimus, paclitaxel or ABT-578 use within 12 months.
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- •Fibrinolytic therapy for current MI treatment
- •Previous coronary intervention on target vessel
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Previously documented LVEF <30%.
- •Evident cardiogenic shock before randomization
- •Patients with left main stem stenosis (>50% by visual estimate)
- •Severe calcification or tortuosity
- •Multi-vessel disease with non-culprit vessel requiring bypass surgery
结局指标
主要结局
The composite of death (all cause-mortality), MI (Q wave and non Q wave) and ischemia-driven target vessel revascularization.
时间窗: At 12 months after the index procedure
次要结局
- Target lesion revascularization (all and ischemia-driven)(1 month, 6 month, 1 year and thereafter annaully up to 5 years)
- Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion(during the hospital stay)
- Cardiac death(1 month, 6 month, 1 year and thereafter annaully up to 5 years)
- Recurrent Myocardial infarction(1 month, 6 month, 1 year and thereafter annaully up to 5 years)
- All-cause Death(1 month, 6 month, 1 year and thereafter annaully up to 5 years)
- Late luminal loss in both in-stent and in-segment(at 8 month angiographic follow-up)
- Target vessel revascularization (all and ischemia-driven)(1 month, 6 month, 1 year and thereafter annaully up to 5 years)
- Stent thrombosis for the patients(1 month, 6 month, 1 year and thereafter annaully up to 5 years)
- Binary restenosis in both in-stent and in-segment(at 8 month angiographic follow-up)
研究者
Seung-Jung Park
Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
CardioVascular Research Foundation, Korea