Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peiking Union Medical College, Beijing 100037, China.
Chin Med J (Engl). 2013 Mar;126(6):1026-32.
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.
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.
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.
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.
先前的研究表明，长段冠状动脉病变是药物洗脱支架（DES）失败的关键预测因素之一。本研究旨在评估 FIREHAWK®支架治疗长段冠状动脉疾病的疗效和安全性。
TARGET I 长段队列是一项前瞻性、多中心、单臂试验。计划招募 50 名接受经皮冠状动脉介入治疗（PCI）治疗原发性长段病变的患者，病变为冠状动脉内直径狭窄≥70%，参照血管直径 2.5-4.0mm，目测需要至少一枚 33mm 或 38mm 支架或多枚长支架重叠覆盖。计划在 9 个月时进行血管造影随访，临床随访时间长达 5 年。主要终点是 9 个月时支架内晚期管腔丢失。
共纳入 50 名患者（平均年龄 57.6±10.2 岁），59 处原发性长段病变（参照血管直径 2.85±0.44mm，病变长度 35.2±9.4mm，支架长度 41.8±11.3mm）。9 个月时的血管造影随访率为 92%。支架内晚期管腔丢失为（0.16±0.16）mm。近段边缘、远段边缘和节段内晚期管腔丢失分别为 0.21±0.35、0.03±0.33 和 0.07±0.26。未见节段内再狭窄。1 年内无死亡、Q 波心肌梗死（MI）或支架血栓形成。两名患者（4%）因操作并发症发生非 Q 波 MI。
FIREHAWK®支架治疗长段冠状动脉病变可获得与 FIREHAWK®FIM 临床试验相似的结果。基于这一结果，我们对 FIREHAWK®治疗长段冠状动脉病变的前景充满信心。
