台风（评价使用 Cypher 西罗莫司洗脱冠状动脉支架治疗急性心肌梗死伴球囊血管成形术的试验）的 4 年随访结果。

Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty).

机构信息

Cochin Hospital, Assistance-Publique Hôpitaux de Paris, Paris Descartes University and INSERM U 970, Paris, France.

出版信息

JACC Cardiovasc Interv. 2011 Jan;4(1):14-23. doi: 10.1016/j.jcin.2010.10.007.

DOI:10.1016/j.jcin.2010.10.007

PMID:21251624

Abstract

OBJECTIVES

The aim of this study was to assess the long-term safety and efficacy of the CYPHER (Cordis, Johnson and Johnson, Bridgewater, New Jersey) sirolimus-eluting coronary stent (SES) in percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).

BACKGROUND

Concern over the safety of drug-eluting stents implanted during PCI for STEMI remains, and long-term follow-up from randomized trials are necessary. TYPHOON (Trial to assess the use of the cYPHer sirolimus-eluting stent in acute myocardial infarction treated with ballOON angioplasty) randomized 712 patients with STEMI treated by primary PCI to receive either SES (n = 355) or bare-metal stents (BMS) (n = 357). The primary end point, target vessel failure at 1 year, was significantly lower in the SES group than in the BMS group (7.3% vs. 14.3%, p = 0.004) with no increase in adverse events.

METHODS

A 4-year follow-up was performed. Complete data were available in 501 patients (70%), and the survival status is known in 580 patients (81%).

RESULTS

Freedom from target lesion revascularization (TLR) at 4 years was significantly better in the SES group (92.4% vs. 85.1%; p = 0.002); there were no significant differences in freedom from cardiac death (97.6% and 95.9%; p = 0.37) or freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85) between the SES and BMS groups. No difference in definite/probable stent thrombosis was noted at 4 years (SES: 4.4%, BMS: 4.8%, p = 0.83). In the 580 patients with known survival status at 4 years, the all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p = 0.61).

CONCLUSIONS

In the 70% of patients with complete follow-up at 4 years, SES demonstrated sustained efficacy to reduce TLR with no difference in death, repeat myocardial infarction or stent thrombosis. (The Study to Assess AMI Treated With Balloon Angioplasty [TYPHOON]; NCT00232830).

摘要

目的

本研究旨在评估 CYPHER（Cordis，Johnson and Johnson，Bridgewater，新泽西州）西罗莫司洗脱冠状动脉支架（SES）在经皮冠状动脉介入治疗（PCI）治疗 ST 段抬高型心肌梗死（STEMI）中的长期安全性和疗效。

背景

对于 STEMI 患者 PCI 中使用药物洗脱支架的安全性仍存在担忧，需要进行随机试验的长期随访。TYPHOON（评估在经球囊血管成形术治疗的急性心肌梗死中使用 cYPHer 西罗莫司洗脱支架的试验）将 712 例 STEMI 患者随机分为接受 SES（n=355）或裸金属支架（BMS）（n=357）治疗的患者。主要终点为 1 年时的靶血管失败，SES 组明显低于 BMS 组（7.3%比 14.3%，p=0.004），不良事件无增加。

方法

进行了 4 年随访。501 例患者（70%）获得完整数据，580 例患者（81%）的生存状态已知。

结果

SES 组 4 年时免于靶病变血运重建（TLR）的比例显著更高（92.4%比 85.1%；p=0.002）；SES 组和 BMS 组在免于心脏死亡（97.6%和 95.9%；p=0.37）或免于再次心肌梗死（94.8%和 95.6%；p=0.85）方面无显著差异。4 年时未观察到确定/可能的支架血栓形成的差异（SES：4.4%，BMS：4.8%，p=0.83）。在 4 年时生存状态已知的 580 例患者中，SES 组的全因死亡率为 5.8%，BMS 组为 7.0%（p=0.61）。