紫杉醇洗脱支架的长期安全性和有效性：TAXUS IV 临床试验的 5 年最终结果（TAXUS IV-SR：使用单枚紫杉醇洗脱支架治疗新发病变冠状动脉疾病）。
Long-term safety and efficacy with paclitaxel-eluting stents: 5-year final results of the TAXUS IV clinical trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent).
机构信息
Cleveland Clinic, Department of Cardiology, Cleveland, Ohio 44195, USA.
出版信息
JACC Cardiovasc Interv. 2009 Dec;2(12):1248-59. doi: 10.1016/j.jcin.2009.10.003.
OBJECTIVES
The pivotal TAXUS IV (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent) trial evaluated the long-term safety and effectiveness of the paclitaxel-eluting stent (PES) compared with an otherwise identical bare-metal stent (BMS) in a relatively uncomplicated population of patients with a single de novo lesion in a native coronary vessel, treated between March and July 2002.
BACKGROUND
Long-term follow-up is required to determine whether the early safety and efficacy of drug-eluting stents are maintained.
METHODS
The primary end point of this prospective, randomized, double-blind trial was 9-month ischemia-driven target vessel revascularization (TVR) for PES versus the BMS control. Follow-up was complete in 1,230 (95.1%) of 1,294 randomized evaluable patients at 5 years.
RESULTS
Compared with BMS, PES significantly reduced TVR at 9 months (12.1% vs. 4.7%; p < 0.0001); this benefit was maintained through 5 years (27.4% vs. 16.9%; p < 0.0001), given comparable TVR rates for BMS and PES between years 1 and 5 (4.1%/year vs. 3.3%/year; respectively, p = 0.16). Similar patterns were observed for composite major adverse cardiac events (MACE) (32.8% BMS vs. 24.0% PES, p = 0.0001 at 5 years). Stent thrombosis was comparable for PES and BMS at 9 months (0.8% BMS vs. 0.8% PES; p = 0.98) and at 5 years (2.1% BMS vs. 2.2% PES, p = 0.87). The overall revascularization benefits of PES were consistent across multiple subgroups, including sex, diabetes, left anterior descending artery lesion location, reference vessel diameter, lesion length, and multiple stents.
CONCLUSIONS
These 5-year results demonstrate the long-term safety and sustained efficacy of PES compared with BMS in patients with noncomplex lesions. (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent; NCT00292474).
目的
关键性 TAXUS IV（TAXUS IV-SR：使用单一紫杉醇洗脱支架治疗新出现的冠状动脉疾病）试验评估了紫杉醇洗脱支架（PES）与相同的裸金属支架（BMS）相比，在 2002 年 3 月至 7 月间治疗单个原生冠状动脉内新出现的单一病变的相对简单的患者人群中的长期安全性和有效性。
背景
需要长期随访以确定药物洗脱支架的早期安全性和疗效是否得以维持。
方法
这项前瞻性、随机、双盲试验的主要终点是 9 个月时 PES 与 BMS 对照组的缺血驱动的靶血管血运重建（TVR）。在 5 年时，1294 名随机可评估患者中 1230 名（95.1%）完成了随访。
结果
与 BMS 相比，PES 在 9 个月时显著降低了 TVR（12.1%对 4.7%；p<0.0001）；这种益处持续到 5 年（27.4%对 16.9%；p<0.0001），因为 BMS 和 PES 在 1 年至 5 年期间的 TVR 率相似（4.1%/年对 3.3%/年；分别，p=0.16）。复合主要不良心脏事件（MACE）的模式也相似（BMS 为 32.8%，PES 为 24.0%，p=0.0001，5 年）。PES 和 BMS 在 9 个月时的支架血栓形成率相似（BMS 为 0.8%，PES 为 0.8%；p=0.98），5 年时相似（BMS 为 2.1%，PES 为 2.2%，p=0.87）。PES 的总体血运重建获益在多个亚组中是一致的，包括性别、糖尿病、左前降支病变部位、参考血管直径、病变长度和多个支架。
结论
这些 5 年的结果表明，在非复杂病变患者中，与 BMS 相比，PES 的长期安全性和持续疗效得到了证实。（TAXUS IV-SR：使用单一紫杉醇洗脱支架治疗新出现的冠状动脉疾病；NCT00292474）。
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