Long-Term Clinical Results of SeQuent Please® Paclitaxel-Coated Balloon Angioplasty for the Treatment of In-Stent Restenosis

This study aims to evaluate the long-term safety and efficacy of SeQuent Please (R) paclitaxel-coated balloons (PCB) for the treatment of in-stent restenosis (ISR). Between May 2009 and April 2011, 48 patients with 52 ISR lesions (30 bare-metal stents [BMS] and 22 drug-eluting stents [DES]), were prospectively included. The primary endpoint was the clinically driven target lesion revascularization (TLR) rate at 24 months. The secondary endpoint was the rate of major adverse cardiac events (MACE: defined as a composite of cardiac death, myocardial infarction [MI], and TLR) at 24 months. Procedural success was 100 %. The TLR rate was 5.8 %. Cumulative MACE was 9.6 %, with 1.9 % cardiac death and 1.9 % MI. No vessel thrombosis was documented. The TLR rate did not differ for PCB angioplasty for BMS-ISR compared with DES-ISR (3.3% vs. 9.1%, p=0.38).