Savage M P, Goldberg S, Bove A A, Deutsch E, Vetrovec G, Macdonald R G, Bass T, Margolis J R, Whitworth H B, Taussig A
Cardiac Catheterization Suite, Thomas Jefferson University Hospital, Philadelphia, PA 19107, USA.
Circulation. 1995 Dec 1;92(11):3194-200. doi: 10.1161/01.cir.92.11.3194.
Antithromboxane therapy with aspirin reduces acute procedural complications of coronary angioplasty (PTCA) but has not been shown to prevent restenosis. The effect of chronic aspirin therapy on long-term clinical events after PTCA is unknown, and the utility of more specific antithromboxane agents is uncertain. The goal of this study was to assess the effects of aspirin (a nonselective inhibitor of thromboxane A2 synthesis) and sulotroban (a selective blocker of the thromboxane A2 receptor) on late clinical events and restenosis after PTCA.
Patients (n = 752) were randomly assigned to aspirin (325 mg daily), sulotroban (800 mg QID), or placebo, started within 6 hours before PTCA and continued for 6 months. The primary outcome was clinical failure at 6 months after successful PTCA, defined as (1) death, (2) myocardial infarction, or (3) restenosis associated with recurrent angina or need for repeat revascularization. Neither active treatment differed significantly from placebo in the rate of angiographic restenosis: 39% (73 of 188) in the aspirin-assigned group, 53% (100 of 189) in the sulotroban group, and 43% (85 of 196) in the placebo group. In contrast, aspirin therapy significantly improved clinical outcome in comparison to placebo (P = .046) and sulotroban (P = .006). Clinical failure occurred in 30% (49 of 162) of the aspirin group, 44% (73 of 166) of the sulotroban group, and 41% (71 of 175) of the placebo group. Myocardial infarction was significantly reduced by antithromboxane therapy: 1.2% in the aspirin group, 1.8% in the sulotroban group, and 5.7% in the placebo group (P = .030).
Thromboxane A2 blockade protects against late ischemic events after angioplasty even though angiographic restenosis is not significantly reduced. While both aspirin and sulotroban prevent the occurrence of myocardial infarction, overall clinical outcome appears superior for aspirin compared with sulotroban. Therefore, aspirin should be continued for at least 6 months after coronary angioplasty.
使用阿司匹林进行抗血栓素治疗可降低冠状动脉血管成形术（PTCA）的急性手术并发症，但尚未证明能预防再狭窄。慢性阿司匹林治疗对PTCA后长期临床事件的影响尚不清楚，更特异性抗血栓素药物的效用也不确定。本研究的目的是评估阿司匹林（血栓素A2合成的非选择性抑制剂）和舒洛地班（血栓素A2受体的选择性阻滞剂）对PTCA后晚期临床事件和再狭窄的影响。
患者（n = 752）被随机分配至阿司匹林组（每日325毫克）、舒洛地班组（每日四次，每次800毫克）或安慰剂组，在PTCA前6小时内开始用药并持续6个月。主要结局是成功PTCA后6个月时的临床失败，定义为：（1）死亡；（2）心肌梗死；或（3）与复发性心绞痛或再次血运重建需求相关的再狭窄。在血管造影再狭窄发生率方面，两种活性治疗与安慰剂相比均无显著差异：阿司匹林组为39%（188例中的73例），舒洛地班组为53%（189例中的100例），安慰剂组为43%（196例中的85例）。相比之下，与安慰剂（P = 0.046）和舒洛地班（P = 0.006）相比，阿司匹林治疗显著改善了临床结局。阿司匹林组临床失败发生率为30%（162例中的49例），舒洛地班组为44%（166例中的73例），安慰剂组为41%（175例中的71例）。抗血栓素治疗显著降低了心肌梗死发生率：阿司匹林组为1.2%，舒洛地班组为1.8%，安慰剂组为5.7%（P = 0.030）。
尽管血管造影再狭窄未显著降低，但血栓素A2阻断可预防血管成形术后晚期缺血事件。虽然阿司匹林和舒洛地班均可预防心肌梗死的发生，但与舒洛地班相比，阿司匹林的总体临床结局似乎更优。因此，冠状动脉血管成形术后阿司匹林应至少持续使用6个月。
