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比较不同药物洗脱支架在真实世界冠心病患者中的晚期支架血栓形成发生率:三年随访结果。

Comparison of the incidence of late stent thrombosis after implantation of different drug-eluting stents in the real world coronary heart disease patients: three-year follow-up results.

机构信息

Center for Coronary Heart Disease, Cardiovascular Institute & Fu Wai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.

出版信息

Chin Med J (Engl). 2010 Apr 5;123(7):778-81.

Abstract

BACKGROUND

Late stent thrombosis (LST) is still concerned by interventional cardiologists in daily clinical practice. This study aimed to compare the incidence of LST after implantation of different drug-eluting stents (DES) in coronary heart disease (CHD) patients in the real world.

METHODS

From December 2001 to February 2009, a total of 11 875 consecutive CHD patients undergone DES implantation were enrolled in this single-center registry study. Patients with acute ST-segment elevation myocardial infarction, mixed DES implantation, restenosis lesions, and patients who could not take dual antiplatelet medication and those who were contraindicated for coronary interventional treatment were excluded. All patients were treated with completed dual antiplatelet medications for at least 9 months after DES deployment. The follow-up was completed by outpatient visits, letter correspondence, phone calls and coronary angiography. Definite LST was diagnosed according to the Academic Research Consortium (ARC) definition.

RESULTS

Cypher or Cypher Select stents were implanted in 4104 cases, Taxus or Taxus Liberty stents in 2271 cases and Firebird stents (Chinese rapamycin-eluting stents) in 5500 cases. One-year follow-up was completed in 9693 patients, including 3346 cases with Cypher or Cypher Select stents, 1529 cases with Taxus or Taxus Liberty stents and 4818 cases with Firebird stents. Two- and three-year follow-up results were obtained in 7133 and 4353 patients, respectively, including 2410 and 1760 cases with Cypher or Cypher Select stents, 1285 and 900 cases with Taxus or Taxus Liberty stents as well as 3438 and 1693 cases with Firebird stents. One-year follow-up results showed that the incidence of LST was 1.08% in patients with Cypher or Cypher Select stents, 1.24% in those with Taxus or Taxus Liberty stents and 0.71% in those with Firebird stents; there was no significant difference between those with Cypher or Cypher Select and Firebird stents, but there was significant difference between those with Taxus or Taxus Liberty and Firebird stents (P = 0.044). The incidence of LST at the 2- and 3-year follow-up was 1.33% and 1.70% in those with Cypher or Cypher Select stents, 1.40% and 1.70% in those with Taxus or Taxus Liberty stents, and 0.83% and 0.95% in those with Firebird stents, respectively. There were no significant differences among the three groups.

CONCLUSIONS

This study indicates that first-generation DES are acceptable to treat complex coronary lesions, and there is no significant difference of LST for three different DES.

摘要

背景

迟发性支架血栓(late stent thrombosis,LST)仍然是介入心脏病医生在日常临床实践中关注的问题。本研究旨在比较冠心病患者在真实世界中使用不同药物洗脱支架(drug-eluting stents,DES)后 LST 的发生率。

方法

2001 年 12 月至 2009 年 2 月,共有 11875 例连续冠心病患者接受 DES 植入术,该单中心注册研究纳入了这些患者。排除急性 ST 段抬高型心肌梗死患者、混合 DES 植入患者、再狭窄病变患者以及不能服用双联抗血小板药物和有禁忌证行冠状动脉介入治疗的患者。所有患者在 DES 植入后至少完成 9 个月的双联抗血小板治疗。通过门诊随访、信件往来、电话联系和冠状动脉造影完成随访。根据学术研究联合会(Academic Research Consortium,ARC)的定义诊断明确的 LST。

结果

Cypher 或 Cypher Select 支架植入 4104 例,Taxus 或 Taxus Liberty 支架植入 2271 例,Firebird 支架(国产雷帕霉素洗脱支架)植入 5500 例。9693 例患者完成了 1 年随访,其中 Cypher 或 Cypher Select 支架植入 3346 例,Taxus 或 Taxus Liberty 支架植入 1529 例,Firebird 支架植入 4818 例。7133 例和 4353 例患者获得了 2 年和 3 年随访结果,其中 Cypher 或 Cypher Select 支架植入分别为 2410 例和 1760 例,Taxus 或 Taxus Liberty 支架植入分别为 1285 例和 900 例,Firebird 支架植入分别为 3438 例和 1693 例。1 年随访结果显示,Cypher 或 Cypher Select 支架植入患者的 LST 发生率为 1.08%,Taxus 或 Taxus Liberty 支架植入患者为 1.24%,Firebird 支架植入患者为 0.71%;Cypher 或 Cypher Select 支架与 Firebird 支架之间差异无统计学意义,但与 Taxus 或 Taxus Liberty 支架之间差异有统计学意义(P = 0.044)。2 年和 3 年随访时,Cypher 或 Cypher Select 支架植入患者的 LST 发生率分别为 1.33%和 1.70%,Taxus 或 Taxus Liberty 支架植入患者分别为 1.40%和 1.70%,Firebird 支架植入患者分别为 0.83%和 0.95%,三组之间差异均无统计学意义。

结论

本研究表明第一代 DES 可用于治疗复杂的冠状动脉病变,三种不同 DES 的 LST 无显著差异。

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