Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.
Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede.
Coron Artery Dis. 2021 Jan;32(1):51-57. doi: 10.1097/MCA.0000000000000891.
Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce.
Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm.
Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents: P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique.
Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.
在常规临床实践中，经常需要治疗冠状动脉分叉病变，但关于极薄支架生物可吸收聚合物药物洗脱支架性能的数据却很少。
在所有患者中比较生物可吸收聚合物和耐用聚合物药物洗脱支架（BIO-RESORT）是一项前瞻性、多中心随机临床试验，共纳入 3514 名所有患者，他们被随机分为极薄支架生物可吸收聚合物涂层的西罗莫司或依维莫司洗脱支架与薄支架耐用聚合物涂层的佐他莫司洗脱支架。分叉支架的方法由术者自行决定，一般首选临时支架。这项预设分析评估了所有至少有一个分支血管直径≥1.5mm的分叉病变患者的 3 年临床结果。
在 BIO-RESORT 试验的所有参与者中，有 1236 名患者接受了分叉病变的治疗并进行了分析。分别采用单支架和双支架技术的患者比例为 85.8%和 14.2%。“真性”分叉病变（主血管和分支血管均阻塞）的治疗比例为 31.1%。在 1236 名患者中，有 1200 名（97.1%）患者获得了 3 年随访。主要终点靶血管失败（包括心源性死亡、靶血管相关心肌梗死或靶血管血运重建）在西罗莫司洗脱支架组中发生 42/412（10.3%）例，在佐他莫司洗脱支架组中发生 49/409（12.1%）例（P-logrank=0.40）。在依维莫司洗脱支架组中，靶血管失败发生在 40/415（9.8%）例患者中（与佐他莫司洗脱支架相比：P-logrank=0.26）。在靶血管失败的各个组成部分中，各支架之间没有差异。在单支血管治疗的患者和采用单支架技术治疗的患者中，结果一致。
在对所有分叉病变患者进行支架置入治疗 3 年后，西罗莫司洗脱支架、依维莫司洗脱支架与佐他莫司洗脱支架的临床结果相似。
