Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial
Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial
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DOI：
10.4244/eijv9i5a98
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发表时间：
2013-09-01
期刊：
影响因子：
6.2
通讯作者：
Rodriguez, Alfredo E.
中科院分区：
文献类型：
--
作者：
Waksman, Ron;Serra, Antonio;Rodriguez, Alfredo E.
目的：本研究旨在评估使用第二代 DIOR 药物涂层球囊 (DCB) 作为普通旧式球囊血管成形术 (POBA) 的辅助治疗新发冠状动脉病变的安全性和有效性。 方法和结果：Valentines If 被设计为前瞻性、多中心、跨国、基于网络的登记处。前瞻性招募患有稳定型或不稳定型心绞痛和/或在压力测试中记录有缺血且狭窄程度大于 50% 的新生病变的合格患者。患者接受 POBA，然后接受 DCB 治疗。如果血管造影成功率不理想（心肌梗死溶栓 [TIMI] 流量 30%），则由操作员自行决定是否进行额外的救援裸金属支架 (BMS)。主要终点是六至九个月时的主要不良心脏事件（MACE；全因死亡、心肌梗塞[MI]、靶血管血运重建[TVR]和血管血栓形成）。一部分患者接受了血管造影随访。治疗了 103 名患者的 109 个病灶。平均年龄为 62.6 +/- 10.2 岁； 79.6%为男性。基线和治疗后病灶狭窄分别为 83.3 +/- 9.5% 和 10.4 +/- 10.6%。手术成功率为 99%。 14.7% 的患者发生冠状动脉夹层，13 名患者 (11.9%) 需要植入 BMS 救援。平均随访时间为 7.5 个月；随访率为99%。随访时累积 MACE 为 8.7%，其中全因死亡 1%，心肌梗死 1%，总体 TVR 6.9%，其中 2.9% 为靶病灶血运重建，无血管血栓形成。对部分患者 (n=35) 的血管造影随访表明，球囊内和节段内分析的晚期管腔损失均为 0.38 +/- 0.39 mm。结论：Valentines II 试验证明了使用第二代 DIOR DCB 作为 POBA 辅助治疗新发冠状动脉病变的可行性。这种方法取得了很高的手术成功率，在中期随访中具有可接受的救助支架率和较低的 MACE 率，并为不适合药物洗脱支架的患者的血运重建提供了一种有吸引力的替代方案。
Aims: This study aimed to evaluate the safety and efficacy of using the second-generation DIOR drug-coated balloons (DCB) as an adjunct to plain old balloon angioplasty (POBA) for the treatment of de novo coronary lesions.Methods and results: Valentines If was designed as a prospective, multicentre, multinational, web-based registry. Eligible patients with stable or unstable angina, and/or documented ischaemia on stress testing with de novo lesions of >50% stenosis were prospectively enrolled. Patients underwent POBA followed by DCB treatment. In cases of suboptimal angiographic success (Thrombolysis In Myocardial Infarction [TIMI] flow 30%), additional bail-out bare metal stenting (BMS) was left at the operator's discretion. The primary endpoint was major adverse cardiac events (MACE; all-cause death, myocardial infarction [MI], target vessel revascularisation [TVR] and vessel thrombosis) at six to nine months. A subset of patients underwent angiographic follow-up. One hundred and nine lesions in 103 patients were treated. Mean age was 62.6 +/- 10.2 years; 79.6% were men. Lesion stenosis at baseline and post treatment was 83.3 +/- 9.5% and 10.4 +/- 10.6%, respectively. Procedural success was 99%. Coronary dissections occurred in 14.7%, and bail-out BMS implantation was required in 13 patients (11.9%). Mean follow-up was 7.5 months; follow-up rate was 99%. Cumulative MACE at follow-up was 8.7%, with 1% all-cause death, 1% MI, 6.9% overall TVR, of which 2.9% were target lesion revascularisations, and no vessel thrombosis. Angiographic follow-up on a subset of patients (n=35) demonstrated late luminal loss of 0.38 +/- 0.39 mm for both the in-balloon and in-segment analyses.Conclusions: The Valentines II trial demonstrates the feasibility of using a second-generation DIOR DCB as adjunct to POBA in de novo coronary lesions. This approach achieved high procedural success with acceptable rates of bail-out stenting and low MACE rates at mid-term follow-up, and offers an attractive alternative for revascularisation of patients who are unsuitable candidates for drug-eluting stents.