EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2016
Biodegradable polymer-based, argatroban-eluting, cobalt-chromium stent (JF-04) for treatment of native coronary lesions: final results of the first-in-man study and lessons learned.
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Morino Yoshihiro, Tobaru Tetsuya, Yasuda Satoshi, Kataoka Kazuaki, Tanabe Kengo, Hirohata Atsushi, Kozuma Ken, Kimura Takeshi
Аннотация
AIMS: The aim of the study was to investigate the six-month angiographic and nine-month clinical follow-up outcomes in a first-in-man study using the biodegradable polymer-based cobalt-chromium argatroban-eluting stent (JF-04) for treatment of native coronary atherosclerotic lesions.
METHODS AND RESULTS: A total of 31 patients with either stable or unstable angina, or silent myocardial ischaemia, exhibiting de novo coronary lesions were enrolled at seven Japanese sites. The lesions were treated with the JF-04 stent after predilatation. The primary endpoint was angiographic in-stent late loss six months after implantation. The secondary endpoints included angiographic restenosis and in-stent volume obstruction by intravascular ultrasound at six months and target vessel failure (TVF) at nine months. Procedural success was achieved in 100% of cases. At six months, angiographic in-stent late loss was 1.01±0.48 mm and binary restenosis was observed in nine cases (29.0%). Among these restenotic cases, most (n=8) demonstrated advanced angiographic restenosis patterns, including diffuse/proliferative restenosis and total occlusion. At nine months, TVF was observed in four cases (12.9%), exclusively attributed to target vessel revascularisation.
CONCLUSIONS: This argatroban-eluting stent failed to inhibit neointimal hyperplasia sufficiently, despite the theoretical benefits and promising clinical experience with local drug delivery.
METHODS AND RESULTS: A total of 31 patients with either stable or unstable angina, or silent myocardial ischaemia, exhibiting de novo coronary lesions were enrolled at seven Japanese sites. The lesions were treated with the JF-04 stent after predilatation. The primary endpoint was angiographic in-stent late loss six months after implantation. The secondary endpoints included angiographic restenosis and in-stent volume obstruction by intravascular ultrasound at six months and target vessel failure (TVF) at nine months. Procedural success was achieved in 100% of cases. At six months, angiographic in-stent late loss was 1.01±0.48 mm and binary restenosis was observed in nine cases (29.0%). Among these restenotic cases, most (n=8) demonstrated advanced angiographic restenosis patterns, including diffuse/proliferative restenosis and total occlusion. At nine months, TVF was observed in four cases (12.9%), exclusively attributed to target vessel revascularisation.
CONCLUSIONS: This argatroban-eluting stent failed to inhibit neointimal hyperplasia sufficiently, despite the theoretical benefits and promising clinical experience with local drug delivery.