Medical University of South Carolina, Charleston, South Carolina 29425, USA.
JACC Cardiovasc Interv. 2010 May;3(5):486-94. doi: 10.1016/j.jcin.2010.03.007.
We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events.
The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable.
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.
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.
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.
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。
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。
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。
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。
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。