June 12, 2016
View Full PaperCurrent status of transcatheter valve therapy in Europe: results from an EAPCI survey
Key Result
The drug-eluting absorbable metal scaffold (DREAMS) showed excellent long-term safety at three years, with a 6.6% target lesion failure rate and no cardiac death or scaffold thrombosis.
Structured PICO
Does a drug-eluting absorbable metal scaffold (DREAMS) demonstrate long-term safety and performance in patients with de novo coronary lesions?
P
Population
46 patients with 47 de novo coronary lesions, mean age 65.3±9.7 years
I
Intervention
Drug-eluting absorbable metal scaffold (DREAMS)
O
Outcome
Long-term safety and performance (target lesion failure, cardiac death, scaffold thrombosis) at three yearssafety
The DREAMS drug-eluting absorbable metal scaffold demonstrated excellent long-term safety at three years with a low target lesion failure rate and no scaffold thrombosis in a first-in-man study.
Abstract
AIMS: 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. METHODS AND RESULTS: 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). CONCLUSIONS: 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.