Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial

Abstract

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. Valentines II 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 <3 and/or residual stenosis of >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. 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.