Safety and Performance of the Drug-Eluting Absorbable Metal Scaffold (DREAMS) in Patients With De-Novo Coronary Lesions: 12 Month Results of the Prospective, Multicentre, First-in-Man BIOSOLVE-I Trial

Study Questions:

What is the safety and efficacy of a drug-eluting absorbable metal stent?

Methods:

The authors performed a prospective, first-in-man trial (BIOSOLVE-1) of the drug-eluting absorbable metal scaffold (DREAMS). The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization, at 6 and 12 months. Clinical follow-up was scheduled at 1, 6, 12, 24, and 36 months. Patients were consecutively assigned to angiographic and intravascular ultrasound (IVUS) follow-up at 6 months or 12 months. All patients were recommended to take dual antiplatelet therapy for at least 12 months.

Results:

A total of 46 patients with 47 lesions were enrolled at five European centers. Device and procedural success was 100%. Two (4%) patients had target lesion failure at 6 months (both clinically driven target lesion revascularizations). One patient had a periprocedural target vessel myocardial infarction occur during angiography at the 12-month follow-up visit as a complication of percutaneous coronary intervention performed on a more proximal lesion. There was no case of cardiac death or scaffold thrombosis. On IVUS follow-up, at 6 months, the cross-sectional lumen loss was 1.12 mm2, and driven by scaffolding loss (73%) and neointimal proliferation (27%), whereas at 12 months, it was 1.30 mm2 and caused by scaffolding loss (69%) and neointimal proliferation (31%).

Conclusions:

This small study demonstrates the feasibility and safety of the drug-eluting absorbable metal scaffold.

Perspective:

A significant body of research has focused on the development of a bioabsorbable coronary stent. Currently in addition to the DREAMS device, the bioabsorbable everolimus-eluting coronary scaffold is in clinical use in Europe and Asia. Most of the studies involving these devices have been performed in carefully selected patients, and comparative safety and efficacy of these devices vis-a-vis the second-generation drug-eluting stent needs to be established before they can be recommended for routine clinical use.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Neointima, Myocardial Infarction, Drug-Eluting Stents, Europe, Sirolimus, Stents, Percutaneous Coronary Intervention


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