Long-Term Results Published for PACCOCATH-ISR Trial

March 20, 2012—Long-term clinical follow-up, including the binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR I and II (Treatment of In-Stent Restenosis by Paclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty [PTCA] Balloons) trials have been published by Bruno Scheller, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2012;5:323–330).

Paccocath technology is a drug matrix, which consists of paclitaxel and a radiologic contrast agent (Ultravis 370, Bayer Schering Pharma AG [Berlin, Germany]) applied to the balloon of an angioplasty catheter, which Medrad Interventional (Warrendale, PA) is developing and marketing it under the brand name Cotavance. Cotavance is not approved or available for sale in the United States.

This study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of the Paccocath balloon (3 μg/mm² balloon surface compared with an uncoated balloon). The main inclusion criteria were a diameter stenosis of 70% and < 30-mm length, with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone.

During a follow-up of 5.4 ± 1.2 years, the rate of major adverse cardiovascular clinical event rate was significantly reduced in patients treated with the drug-coated balloon (59.3% vs 27.8%; P = .009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (P = .004).

The investigators concluded that treatment of coronary ISR with paclitaxel-coated balloon catheters is safe and persistently reduces repeat revascularization during long-term follow-up. The initial results were sustained over the 5-year period.