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routinely 检测到的早期和晚期支架贴壁不良的长期影响:TAXUS IV、V 和 VI 以及 TAXUS ATLAS 主力、长病变和直接支架研究的血管内超声综合分析。

Long-term impact of routinely detected early and late incomplete stent apposition: an integrated intravascular ultrasound analysis of the TAXUS IV, V, and VI and TAXUS ATLAS workhorse, long lesion, and direct stent studies.

机构信息

Medical University of South Carolina, Charleston, South Carolina 29425, USA.

出版信息

JACC Cardiovasc Interv. 2010 May;3(5):486-94. doi: 10.1016/j.jcin.2010.03.007.

Abstract

OBJECTIVES

We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events.

BACKGROUND

The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable.

METHODS

We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials.

RESULTS

There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis.

CONCLUSIONS

Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up.

摘要

目的

我们旨在确定早期和晚期获得的不完全支架贴壁不良(ISA)对临床事件的 2 年影响。

背景

裸金属支架(BMS)和 TAXUS 支架(波士顿科学公司,马萨诸塞州纳提克)中早期或晚期获得的 ISA 的晚期临床影响仍存在争议。

方法

我们评估了 TAXUS IV、V、VI 和 TAXUS-ATLAS WH、LL 和 DS 试验的血管内超声(IVUS)子研究中纳入的 1580 例患者。

结果

26 例(7.2%)BMS 患者中出现 96 例早期 ISA,35 例 TAXUS Express 患者(p = 0.28 与 BMS 相比),35 例 TAXUS Liberté 患者(p = 0.21 与 TAXUS Express 相比,p = 1.00 与 BMS 相比)。早期 ISA 患者与无 ISA 的对照患者在 9 个月时主要不良心血管事件相似,BMS 患者分别为 3.8%和 15.2%(p = 0.13),TAXUS 患者分别为 11.6%和 8.8%(p = 0.45)。早期 ISA 不影响支架血栓形成。在 9 个月的随访中,7 例(2.7%)BMS 患者出现 36 例晚期获得的 ISA,17 例 TAXUS 缓释(TAXUS Express 或 TAXUS Liberté)患者,12 例接受 TAXUS 中速释放的患者。在接下来的 2 年中,晚期获得 ISA 的患者与无 ISA 的对照患者在 BMS 患者中主要不良心血管事件相似(14.3%比 7.9%,p = 0.54),TAXUS 患者(总体为 8.3%比 8.1%,p = 0.87),或 TAXUS 缓释制剂(0%比 7.9%,p = 0.28)。晚期获得的 ISA 不影响支架血栓形成。

结论

在 BMS 或 TAXUS 患者中,常规检测到的急性 ISA 或常规检测到的晚期获得的 ISA 与长期随访中的不良临床事件无关。

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