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第二代和第三代佐他莫司洗脱支架治疗冠状动脉分叉病变患者的前瞻性多中心临床性能评估

Prospective multicentre clinical performance evaluation of second and third generation zotarolimus-eluting stents to treat patients with bifurcated coronary lesions.

作者信息

Burzotta Francesco, Summaria Francesco, Latib Azeem, De Vita Maria, Fantoni Cecilia, Benedetto Stefano, Turturo Maurizio, Larosa Claudio, Manzoli Alessandro, Trani Carlo

机构信息

Cardiovascular Department, Catholic University of Sacred Heart, Rome, Italy.

Unità Di Cardiologia, Policlinico Casilino, Rome, Italy.

出版信息

Catheter Cardiovasc Interv. 2016 Jan 1;87(1):15-22. doi: 10.1002/ccd.25954. Epub 2015 Apr 24.

Abstract

AIM

To assess the "real world" clinical outcome of patients with bifurcated lesions undergoing percutaneous coronary intervention with implantation of second and third generations of zotarolimus-eluting stent.

METHODS AND RESULTS

Nine Italian centres participated in a prospective multicentre clinical project evaluating the outcome of patients receiving zotarolimus-eluting Resolute stent and Resolute Integrity stents. Patients with bifurcated lesions entered this evaluation. Clinical characteristics and angiographic and procedural details were prospectively recorded. Clinical outcome was prospectively assessed to evaluate the occurrence of major adverse cardiac events (MACE). A total of 577 patients were enrolled. The target lesion was distal left main in 11.1% and left anterior descending artery in 52.8%, and 30.3% of lesions were Medina 1,1,1. At a mean follow-up time of 27.0 ± 13.5 months, the survival free from MACE was 91.8%. Survival free from MACE was similar in patients grouped according to different bifurcated lesion complexity. On the contrary, patients receiving a single stent had better survival free from MACE as compared with those with double stent (P = 0.005). At multivariable analysis, double stenting (but not bifurcated lesion complexity) was found to be a significant predictor of MACE (hazard ratio, 2.52; 95% confidence interval, 1.28-4.94; P = 0.007). Of note, patients receiving the second stent as a bail-out had worse survival free from MACE compared with those who received it as a planned technique (P = 0.045).

CONCLUSION

The treatment of patients with bifurcated lesions with second and third generation zotarolimus-eluting stents is associated with good long-term clinical outcomes. Clinical outcome seems to be independent of lesion complexity, but may be influenced by the stenting technique (single or double stenting as well as elective or bail-out double stenting). © 2015 Wiley Periodicals, Inc.

摘要

目的

评估接受第二代和第三代佐他莫司洗脱支架植入术的分叉病变患者的“真实世界”临床结局。

方法与结果

9个意大利中心参与了一项前瞻性多中心临床项目,评估接受佐他莫司洗脱的Resolute支架和Resolute Integrity支架的患者结局。分叉病变患者进入该评估。前瞻性记录临床特征、血管造影和手术细节。前瞻性评估临床结局以评估主要不良心脏事件(MACE)的发生情况。共纳入577例患者。靶病变位于左主干远端的占11.1%,位于左前降支的占52.8%,30.3%的病变为Medina 1,1,1型。平均随访时间为27.0±13.5个月,无MACE生存的比例为91.8%。根据不同分叉病变复杂程度分组的患者中,无MACE生存情况相似。相反,与接受双支架置入的患者相比,接受单支架置入的患者无MACE生存情况更好(P = 0.005)。多变量分析发现,双支架置入(而非分叉病变复杂程度)是MACE的显著预测因素(风险比,2.52;95%置信区间,1.28 - 4.94;P = 0.007)。值得注意的是,与作为计划性技术接受第二个支架的患者相比,作为补救措施接受第二个支架的患者无MACE生存情况更差(P = 0.045)。

结论

使用第二代和第三代佐他莫司洗脱支架治疗分叉病变患者具有良好的长期临床结局。临床结局似乎与病变复杂程度无关,但可能受支架置入技术(单支架或双支架置入以及选择性或补救性双支架置入)影响。© 2015威利期刊公司。

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