非计划和择期冠状动脉支架置入术中传统抗凝与抗血小板治疗的随机多中心比较。全量抗凝与阿司匹林和噻氯匹定（奇妙）研究。

Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. The full anticoagulation versus aspirin and ticlopidine (fantastic) study.

作者信息

Bertrand M E, Legrand V, Boland J, Fleck E, Bonnier J, Emmanuelson H, Vrolix M, Missault L, Chierchia S, Casaccia M, Niccoli L, Oto A, White C, Webb-Peploe M, Van Belle E, McFadden E P

机构信息

Dept de Cardiologie B, Hôpital Cardiologique, 59037 Lille, France.

出版信息

Circulation. 1998 Oct 20;98(16):1597-603. doi: 10.1161/01.cir.98.16.1597.

DOI:10.1161/01.cir.98.16.1597

PMID:9778323

Abstract

BACKGROUND

Dual therapy with ticlopidine and aspirin has been shown to be as effective as or more effective than conventional anticoagulation in patients with an optimal result after implantation of intracoronary metallic stents. However, the safety and efficacy of antiplatelet therapy alone in an unselected population has not been evaluated.

METHODS

Patients were randomized to conventional anticoagulation or to treatment with antiplatelet therapy alone. Indications for stenting were classified as elective (decided before the procedure) or unplanned (to salvage failed angioplasty or to optimize the results of balloon angioplasty). After stenting, patients received aspirin and either ticlopidine or conventional anticoagulation (heparin or oral anticoagulant). The primary end point was the occurrence of bleeding or peripheral vascular complications; secondary end points were cardiac events (death, infarction, or stent occlusion) and duration of hospitalization.

RESULTS

In 13 centers, 236 patients were randomized to anticoagulation and 249 to antiplatelet therapy. Stenting was elective in 58% of patients and unplanned in 42%. Stent implantation was successfully achieved in 99% of patients. A primary end point occurred in 33 patients (13.5%) in the antiplatelet group and 48 patients (21%) in the anticoagulation group (odds ratio=0.6 [95% CI 0.36 to 0.98], P=0.03). Major cardiac-related events in electively stented patients were less common (odds ratio=0.23 [95% CI 0.05 to 0.91], P=0.01) in the antiplatelet group (3 of 123, 2.4%) than the anticoagulation group (11 of 111, 9.9%). Hospital stay was significantly shorter in the antiplatelet group (4.3+/-3.6 versus 6. 4+/-3.7 days, P=0.0001).

CONCLUSIONS

Antiplatelet therapy after coronary stenting significantly reduced rates of bleeding and subacute stent occlusion compared with conventional anticoagulation.

摘要

背景

对于冠状动脉内金属支架植入术后效果理想的患者，噻氯匹定与阿司匹林联合治疗已被证明与传统抗凝治疗效果相当或更优。然而，未经筛选的人群单独使用抗血小板治疗的安全性和有效性尚未得到评估。

方法

将患者随机分为接受传统抗凝治疗或仅接受抗血小板治疗。支架置入的适应证分为择期（术前决定）或非计划（挽救失败的血管成形术或优化球囊血管成形术的结果）。支架置入术后，患者接受阿司匹林和噻氯匹定或传统抗凝治疗（肝素或口服抗凝剂）。主要终点是出血或外周血管并发症的发生；次要终点是心脏事件（死亡、梗死或支架闭塞）和住院时间。

结果

在13个中心，236例患者被随机分配接受抗凝治疗，249例接受抗血小板治疗。58%的患者为择期支架置入，42%为非计划置入。99%的患者成功完成支架植入。抗血小板组33例患者（13.5%）出现主要终点事件，抗凝组48例患者（21%）出现主要终点事件（优势比=0.6 [95%可信区间0.36至0.98]，P=0.03）。在择期置入支架的患者中，抗血小板组（123例中的3例，2.4%）发生的主要心脏相关事件比抗凝组（111例中的11例，9.9%）少（优势比=0.23 [95%可信区间0.05至0.91]，P=0.01）。抗血小板组的住院时间明显更短（4.3±3.6天对6.4±3.7天，P=0.0001）。