Efficacy and safety of FIREHAWK® abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort

Abstract

Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK® stent in long coronary artery disease. Methods The long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention (PCI) for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion(s) with diameter stenosis ≥70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month. Results Fifty patients (mean age (57.6±10.2) years) with 59 de novo long lesions (reference vessel diameter (2.85±0.44) mm, lesion length (35.2±9.4) mm, and stent length (41.8±11.3) mm) were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was (0.16±0.16) mm. Proximal edge, distal edge and in-segment late loss (mm) were 0.21±0.35, 0.03±0.33, and 0.07±0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction (MI), or stent thrombosis occurred. Non-Q-wave MI occurred in two patients (4%) due to procedural complications. Conclusions Treatment of long coronary lesions with the FIREHAWK® stent is able to produce similar results as observed in the FIREHAWK® FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK® for long coronary lesions.