Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.
JAMA Cardiol. 2019 Jul 1;4(7):659-669. doi: 10.1001/jamacardio.2019.1776.
Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce.
To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents.
This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019.
Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods.
In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis.
Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts.
ClinicalTrials.gov identifier: NCT01674803.
支架置入治疗小血管病变的不良心血管事件风险增加。非常薄的支架或超薄支架药物洗脱支架可能会降低这种风险，但数据有限。
评估所有接受 3 种不同类型药物洗脱支架治疗的小冠状动脉病变患者的结局。
这是一项比较生物可吸收聚合物和耐用聚合物药物洗脱支架在所有患者人群中的（BIO-RESORT）试验的预设子研究，这是一项由研究者发起、随机、患者盲法比较的药物洗脱支架临床试验。2012 年 12 月至 2015 年 8 月期间，从 4 个荷兰心脏介入中心纳入接受超薄支架西罗莫司洗脱支架、极薄支架依维莫司洗脱支架或上一代薄支架佐他莫司洗脱支架治疗的患者。这项多中心试验共纳入了 3514 名所有患者的 BIO-RESORT 参与者，其中 1506 名患者至少有 1 处小血管病变（参考血管<2.5 毫米）。数据于 2018 年 9 月至 2019 年 2 月进行分析。
3 年随访时的靶病变失败，由 Kaplan-Meier 方法分析的心脏死亡、靶血管相关心肌梗死或靶病变血运重建的复合终点。
在 1506 名参与者（96.4%）（1057 名男性[70.2%]；449 名女性[29.8%]；平均[标准差]年龄 64.3[10.4]岁）的 1452 名中，获得了随访结果。525 名接受西罗莫司洗脱支架治疗的患者中有 36 例（7.0%）发生靶病变失败，496 名接受依维莫司洗脱支架治疗的患者中有 46 例（9.5%），485 名接受佐他莫司洗脱支架治疗的患者中有 48 例（10.0%）（西罗莫司洗脱与佐他莫司洗脱的风险比[HR]为 0.68；95%置信区间[CI]为 0.44-1.05；P=0.08；依维莫司洗脱与佐他莫司洗脱的 HR 为 0.93；95%CI 为 0.62-1.39；P=0.72）。西罗莫司洗脱支架与佐他莫司洗脱支架之间在靶病变血运重建方面存在差异（2.1% vs 5.3%；HR 为 0.40；95%CI 为 0.20-0.81；P=0.009），这种差异在随访的第一年之后出现（1.0% vs 3.7%；P=0.006）；多变量分析显示，在 3 年随访时，与植入佐他莫司洗脱支架相比，植入西罗莫司洗脱支架与靶病变血运重建率降低独立相关（调整后的 HR 为 0.42；95%CI 为 0.20-0.85；P=0.02）。在依维莫司洗脱支架中，血运重建率为 4.0%（与佐他莫司洗脱支架相比，HR 为 0.74；95%CI 为 0.41-1.34；P=0.31）。支架内血栓形成、靶血管心肌梗死或心脏死亡在支架之间无显著差异。
小冠状动脉病变患者如果接受超薄支架西罗莫司洗脱支架治疗，重复血运重建的可能性较小。需要进一步研究来评估特别薄的支架结构的潜在效果。
ClinicalTrials.gov 标识符：NCT01674803。
