Background: Paclitaxel-coated balloons (PCB) have been demonstrated to be successful for the treatment of in-stent restenosis. Although their role in the treatment of de novo lesions has not been fully clarified, they are often used for this indication. This prospective study evaluated the long-term efficacy and safety of the SeQuent® Please PCB (B. Braun, Melsungen, Germany) angioplasty for de novo coronary lesions in routine real-world practice.
Methods: Between January 2010 and January 2012, all consecutive patients with de novo coronary lesions treated with the SeQuent® Please PCB at our institution were included. The primary endpoint was the clinically driven target lesion revascularization (TLR) rate at 36 months. The secondary endpoint was the rate of major adverse cardiac events (MACE: cardiac death, myocardial infarction [MI], and TLR).
Results: Fifty-three patients with 56 lesions were included. The mean reference vessel diameter was 2.4±0.4 mm and the mean target lesion length was 18.1±6.2 mm. Procedural success was 98.2%. Coronary dissection occurred in 7 patients (12.5%) and no vessel thrombosis was documented. Additional BMS was implanted in 14 target lesions (25%). Follow-up rate was 94.3%. The TLR rate at 36 months was 5.4%. The MACE rate was 8.9%, with 1.8 % cardiac death and 3.6% MI.
Conclusions: Treatment of de novo coronary lesions with the SeQuent® Please PCB provides good clinical outcomes demonstrated by the low TLR rate and low MACE rates at long-term follow-up.