Author + information
- Joshua P. Loh1,
- Antonio Serra2,
- Fazila T. Malik3,
- Alfredo E. Rodriguez4,
- Stefanie Stahnke5,
- Rembert Pogge von Strandmann5,
- Zhenyi Xue1,
- Rebecca Torguson1 and
- Ron Waksman1
In the Valentines II trial, the use of second-generation DIOR® paclitaxel drug-coated balloon (DCB) as adjunct therapy to plain old balloon angioplasty (POBA) has shown good clinical outcomes in patients with de novo coronary lesions with low rates of major adverse cardiac events (MACE). We report the quantitative coronary angiography (QCA) results of the subset of patients who underwent angiographic follow-up.
Valentines II trial prospectively enrolled 103 patients with de novo lesions of >50% stenosis who presented with angina and/or documented ischemia on stress testing. Patients underwent POBA followed by DCB, and in cases of suboptimal angiographic success additional bail-out stenting was performed. Primary endpoint was MACE at 6-9 months. A subset of patients underwent angiographic follow-up with QCA.
For the study population, MACE, target vessel revascularization and target lesion revascularization rates were 8.7%, 6.9% and 2.9% respectively. Angiogram was performed in 35 patients (34%) at mean follow-up of 227 ± 40 days. The QCA results are shown (Table). Late-luminal loss at follow-up was 0.38 ± 0.39 mm and binary restenosis was 14.3%.
The result of the Valentines II trial angiographic cohort demonstrates the efficacy of second generation DIOR® DCB as adjunct to POBA in treating patients with de novo coronary lesions. This approach achieved low late-luminal loss and binary restenosis at intermediate-term angiographic follow-up and should be considered for patients and lesions not suitable for drug-eluting stents.
- 2013 American College of Cardiology Foundation