Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial
| Autor: | Stefanie Stahnke, Joshua P. Loh, Alfredo E. Rodriguez, Rebecca Torguson, Rembert Pogge von Strandmann, Ron Waksman, Antonio Serra, Fazila Tun Nesa Malik |
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| Rok vydání: | 2013 |
| Předmět: |
Target lesion
Male medicine.medical_specialty Time Factors de novo lesions medicine.medical_treatment Coronary Artery Disease Coronary Restenosis Internal medicine Angioplasty medicine Humans Myocardial infarction Prospective Studies Angioplasty Balloon Coronary Aged business.industry Unstable angina angioplasty Cardiovascular Agents Drug-Eluting Stents Middle Aged medicine.disease Thrombosis Surgery Stenosis Treatment Outcome Cardiology Female Cardiology and Cardiovascular Medicine business drug-coated balloons TIMI Mace |
| Zdroj: | EuroIntervention r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname |
| ISSN: | 1969-6213 1774-024X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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