Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicentre, first-in-man BIOSOLVE-I trial.
Bioresorbable scaffolds were designed to overcome the limitations of permanent stents. In the BIOSOLVE-I study we aimed to assess the long-term safety and performance of a drug-eluting absorbable metal scaffold (DREAMS) at three years.



In this prospective, multicentre first-in-man study, 46 patients with 47 de novo lesions were enrolled. We report the final results at three-year follow-up. Mean age was 65.3±9.7 years, lesions were 2.73±0.48 mm in diameter and 10.99±4.59 mm long. Follow-up at three years was available for 44 patients (one patient died of a non-cardiac cause and one patient withdrew consent). Three target lesion failures (TLF) occurred (6.6%), consisting of two clinically driven target lesion revascularisations at scheduled six-month angiography (4.3%) and one myocardial infarction after drug-eluting balloon treatment in a non-target lesion but target vessel at 12-month angiography (2.2%). No cardiac death or scaffold thrombosis occurred. Seven patients had additional angiographic follow-up at 28±4 months: in-scaffold late lumen loss had improved from 0.51±0.46 mm (median 0.28 mm) at 12 months to 0.32±0.32 mm (median 0.20 mm).



The BIOSOLVE-I study showed excellent long-term outcomes at three years with a low TLF rate and no cardiac death or scaffold thrombosis. No TLF event was observed beyond 377 days.
Medical Clinic I, Städtische Kliniken-Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.
Michael
M
Haude
Raimund
R
Erbel
Paul
P
Erne
Stefan
S
Verheye
Hubertus
H
Degen
Paul
P
Vermeersch
Neil
N
Weissman
Francesco
F
Prati
Nico
N
Bruining
Ron
R
Waksman
Jacques
J
Koolen
D020341:Absorbable Implants / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D023903:Coronary Restenosis / Q000209:etiology; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D054457:Tissue Scaffolds / Q000009:adverse effects
D020123:Sirolimus