cardiovascular-agents and novolimus

This study sought to report the late multimodality imaging and clinical outcomes of the novel poly-l-lactic-acid-based DESolve novolimus-eluting bioresorbable coronary scaffold for the treatment of de novo coronary lesions.. Bioresorbable scaffolds are an alternative to drug-eluting metallic stents and provide temporary vascular scaffolding, which potentially may allow vessel restoration and reduce the risk of future adverse events.. Overall, 126 patients were enrolled at 13 international sites between November 2011 and June 2012. The primary endpoint was in-scaffold late lumen loss at 6 months. Major adverse cardiac events, the main safety endpoint, were defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. All patients underwent angiography at 6 months. Serial intravascular ultrasound and optical coherence tomography were performed in a subset of patients.. The scaffold device success rate was 97% (n = 122 of 126), and procedural success was 100% (n = 122 of 122). The major adverse cardiac event rate was 3.3% (n = 4 of 122) at 6 months and 7.4% (n = 9 of 122) at 24 months, including 1 probable stent thrombosis within the first month. At 6-month angiographic follow-up, in-scaffold late lumen loss was 0.20 ± 0.32 mm. Paired intravascular ultrasound analysis demonstrated a significant increase in vessel, lumen and scaffold dimensions between post-procedure and 6-month follow-up, and strut-level optical coherence tomography analysis showed full strut coverage in 99 ± 1.7%.. Our results showed favorable performance of the DESolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years. (Elixir Medical Clinical Evaluation of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System-The DESolve Nx Trial; NCT02086045).

Topics: Absorbable Implants; Aged; Brazil; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Europe; Female; Humans; Hyperplasia; Macrolides; Male; Middle Aged; Neointima; New Zealand; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Limited data exist on bioresorbable scaffolds (BRS) in patients with acute coronary syndrome (ACS). The aim of the present study was to evaluate novolimus-eluting BRS (DESolve) as interventional treatment for patients with ACS, and to compare its 12-month outcomes with the everolimus-eluting bioresorbable scaffolds (Absorb).. In this retrospective study, patients with ACS (including unstable angina pectoris, ST-segment elevation myocardial infarction, or non-ST-segment elevation myocardial infarction) treated with either the Absorb or the DESolve BRS were evaluated in a 1:1 matched-pair analysis. Major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization, were evaluated as a major endpoint. The occurrence of scaffold thrombosis was also assessed.. A total of 102 patients were eligible for this analysis. The rate of MACE at 12 months was comparable between the Absorb and the DESolve group (8.3% vs. 6.8%, p = 0.738). The occurrence of target lesion revascularization (6.2% vs. 4.7%; p = 0.700) and scaffold thrombosis (4.1% vs. 2.1%; p = 0.580) was comparable as well. All instances of scaffold thrombosis occurred within 30 days of the index procedure.. In this study, similar 12-month event rates were observed for both BRS types after implantation for the treatment of ACS.

Topics: Absorbable Implants; Acute Coronary Syndrome; Cardiovascular Agents; Coronary Artery Disease; Everolimus; Humans; Macrolides; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Treatment Outcome

This study of patients treated with novolimus-eluting bioresorbable scaffold (BRS) investigated the impact of plaque burden on the acute mechanical performance of the BRS and the short-term outcome.. A total of 15 patients were enrolled. The following parameters were derived from optical coherence tomography (OCT) during the final pullback: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, scaffold expansion index (SEI), scaffold eccentricity index (SEC), symmetry index, strut fracture, and edge dissection. Fibrous plaque (FP) and calcific plaque (CP) characteristics were measured at each 200 μm longitudinal cross-section. The patients were divided into two groups based on their medians of the respective plaque characteristics.. OCT analysis showed a lumen area of 11.4 ± 1.9 mm. In contrast to previously studied BRS, the expansion and eccentricity characteristics of the novolimus-eluting scaffold did not show the strong dependency of plaque composition, morphology, and burden. As assessed by OCT, only eccentricity was significantly affected by the FP burden. A greater FP plaque arc in our cohort and device-specific properties, e.g. self-correction, may explain the lack of a relationship between plaque, expansion, and eccentricity.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Female; Humans; Macrolides; Male; Middle Aged; Plaque, Atherosclerotic; Predictive Value of Tests; Prosthesis Design; Time Factors; Tomography, Optical Coherence; Treatment Outcome

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

Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolve™ novolimus-eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions.. Single-center, prospective, non-randomized study involving 17 consecutive patients submitted to implantation of the DESolve™ scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months.. Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 ± 1.35 mm. IVUS serial evaluation of the novel DESolve BRS showed an increase in the device dimensions between baseline and 6 months, with concomitant enlargement of lumen dimensions and effective suppression of neointimal proliferation. At 18 months, no footprint of the scaffold was detected and the initial lumen enlargement was sustained.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Female; Humans; Macrolides; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Time Factors; Treatment Outcome; Ultrasonography, Interventional

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

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Macrolides; Male; Prosthesis Design; Prosthesis Failure; Retreatment; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Occlusion; Coronary Vessels; Humans; Macrolides; Male; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Tomography, Optical Coherence; Treatment Failure