novolimus and Myocardial-Infarction

To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease.. The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor.. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined.. The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths.. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Female; Germany; Humans; Italy; Macrolides; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; Young Adult

The purpose of this study was to compare the 1-year outcome of everolimus-eluting bioresorbable scaffolds (eBRS) and Novolimus-eluting bioresorbable scaffolds (nBRS) in patients undergoing percutaneous coronary intervention in a real-life clinical practice scenario.. eBRS and nBRS are available and have been proved safe for coronary artery stenting in well-selected patients.. Consecutive patients who underwent bioresorbable scaffold implantation were evaluated retrospectively via 2:1 propensity matching. Target lesion failure comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization was examined after 12 months, along with its individual components as well as scaffold thrombosis.. A total 506 patients were available for matching. Of these, 212 eBRS patients (mean age = 62.9 years) and 106 nBRS patients (mean age = 63.1 years) were analyzed after matching. Baseline characteristics and clinical presentation were comparable in both groups. Acute coronary syndromes were present in 53.3% of the eBRS group and in 48.1% of the nBRS group (p = 0.383). Lesion characteristics were also similar. Pre-dilation (99.5% vs. 98.1%; p = 0.218) and post-dilation (84.4% vs. 86.8%; p = 0.576) were performed in the same proportion of matched eBRS and nBRS patients, respectively. The 1-year rates of target lesion failure (4.7% vs. 4.5%; p = 0.851), target lesion revascularization (2.6% vs. 3.5%; p = 0.768), cardiac death (1.5% vs. 2.0%; p = 0.752), and definite scaffold thrombosis (2.0% vs. 1.0%; p = 0.529) did not differ significantly between the eBRS and nBRS groups.. The present study reveals comparable clinical results for the 2 types of bioresorbable scaffolds when used during routine practice, but further evidence from randomized controlled trials is needed.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Everolimus; Female; Humans; Kaplan-Meier Estimate; Macrolides; Male; Matched-Pair Analysis; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome