西罗莫司洗脱支架和紫杉醇洗脱支架植入术后日常临床实践中的支架血栓形成：单中心注册研究分析

Stent thrombosis after sirolimus- and paclitaxel-eluting stent implantation in daily clinical practice: analysis of a single center registry.

作者信息

Trabattoni Daniela, Fabbiocchi Franco, Montorsi Piero, Ravagnani Paolo, Galli Stefano, Teruzzi Giovanni, Calligaris Giuseppe, De Martini Stefano, Bartorelli Antonio L

机构信息

Centro Cardiologico Monzino, IRCCS, Institute of Cardiology, University of Milan, Milan, Italy.

出版信息

Catheter Cardiovasc Interv. 2007 Sep;70(3):415-21. doi: 10.1002/ccd.21149.

DOI:10.1002/ccd.21149

PMID:17722020

Abstract

OBJECTIVES

To evaluate stent thrombosis (ST) rate after sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation in daily clinical practice.

BACKGROUND

The safety profile of drug-eluting stents (DES) was predominantly determined in randomized clinical trials with narrow inclusion criteria. Concerns about ST have been raised in unselected patients treated with DES.

METHODS

We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES, and 249 with PES, in a single academic center.

RESULTS

Multivessel disease was present in 72% of patients, multivessel stenting was performed in 17%, long (>18 mm) lesions were treated in 30%, and multiple stents per lesion were needed in 31%. On average, 1.7 +/- 0.8 stents per patient were implanted (stented segment length: 32 +/- 25 mm/vessel). IIb/IIIa inhibitors were used in 7.5%. Intravascular ultrasound (IVUS) guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Six-month follow-up was performed in all patients, whereas one-year follow-up was completed in 87% patients of the SES group and in 95% of the PES group. We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either ST-elevation or non-ST-elevation myocardial infarction (MI) through the 12-month follow-up period. The overall incidence of ST was 0.9% (0.4% in SES and 2% in PES, P = 0.03). Of the eight ST, two (25%) were acute, four (50%) subacute, one (12.5%) was a late event, and one (12.5%) a very late event. Seven ST were confirmed by angiography. No IVUS guidance was used in 4/8 (50%) ST patients, while antiplatelet therapy was prematurely discontinued in 3/8 (37.5%). Among ST patients, mortality and nonfatal MI rates were 25% and 37.5%, respectively. No ST was diagnosed between 6 and 12 months, while one very late thrombosis occurred at 15 months.

CONCLUSIONS

The incidence of ST after DES use in daily clinical practice is low and similar to that observed in randomized clinical trials.

摘要

目的

评估在日常临床实践中，西罗莫司洗脱支架（SES）和紫杉醇洗脱支架（PES）植入术后的支架内血栓形成（ST）发生率。

背景

药物洗脱支架（DES）的安全性主要在纳入标准狭窄的随机临床试验中确定。对于接受DES治疗的未经过筛选的患者，人们对ST的担忧已经出现。

方法

我们在一个学术中心前瞻性评估了867例接受DES植入的患者，其中618例植入SES，249例植入PES。

结果

72%的患者存在多支血管病变，17%的患者接受了多支血管支架植入，30%的患者治疗长（>18 mm）病变，31%的病变需要植入多个支架。平均每位患者植入1.7±0.8个支架（支架植入段长度：32±25 mm/血管）。7.5%的患者使用了IIb/IIIa抑制剂。65%的SES植入和50%的PES植入采用了血管内超声（IVUS）引导，SES手术成功率为100%，PES手术成功率为99%。所有患者均进行了6个月的随访，SES组87%的患者和PES组95%的患者完成了1年随访。我们认为，当有血栓的血管造影证据，或患者在12个月的随访期内发生心脏性猝死或ST段抬高型或非ST段抬高型心肌梗死（MI）时，发生了ST。ST的总体发生率为0.9%（SES组为0.4%，PES组为2%，P = 0.03）。在8例ST中，2例（25%）为急性，4例（50%）为亚急性，1例（12.5%）为晚期事件，1例（12.5%）为极晚期事件。7例ST通过血管造影得到证实。8例ST患者中有4例（50%）未使用IVUS引导，8例中有3例（37.5%）过早停用抗血小板治疗。在ST患者中，死亡率和非致命性MI发生率分别为25%和37.5%。6至12个月期间未诊断出ST，1例极晚期血栓形成发生在15个月时。