Dataset Information

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III.

ABSTRACT: OBJECTIVES:Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data. BACKGROUND:Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. METHODS:The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III). RESULTS:Mean patient age was 65.5?±?10.8 years and mean lesion reference diameter was 2.70?±?0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P?

SUBMITTER: Haude M

PROVIDER: S-EPMC6586164 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III.

Haude Michael M Ince Hüseyin H Kische Stephan S Abizaid Alexandre A Tölg Ralph R Alves Lemos Pedro P Van Mieghem Nicolas M NM Verheye Stefan S von Birgelen Clemens C Christiansen Evald Høj EH Barbato Emanuele E Garcia-Garcia Hector M HM Waksman Ron R

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20180805 7

<h4>Objectives</h4>Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data.<h4>Background</h4>Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures.<h4>Methods</h4>The prospective, multicenter BIOSOLVE- ...[more]

PMID: 30079472

Similar Datasets

Project description:BackgroundThe DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function.MethodsThis international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747).Findings445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), pnon-inferiority < 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI: -3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09 mm [SD 0.34] versus 0.25 mm [SD 0.39], p = 0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p < 0.001).InterpretationThis is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function.FundingThe study was funded by Elixir Medical.

Project description:The role of drug-eluting balloons (DEB) is unclear. Increasing evidence has shown a benefit for the treatment of in-stent restenosis. Its effect on de novo coronary lesions is more controversial. Several smaller randomized trials found conflicting results.This is a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the effect of local Paclitaxel delivery/drug eluting balloons (DEB) (+/- bare metal stent) compared to current standard therapy (stenting) to treat de novo coronary lesions. Data sources for RCT were identified through a literature search from 2005 through 28 December 2012. The main endpoints of interest were target lesion revascularization (TLR), major adverse cardiac events (MACE), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI), late lumen loss (LLL) and mortality. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.Eight studies (11 subgroups) and a total of 1,706 patients were included in this analysis. Follow-up duration ranged from 6 to 12 months. Overall, DEB showed similar results to the comparator treatment. The relative risk (RR) for MACE was 0.95 (0.64 to 1.39); P = 0.776, for mortality it was 0.79 (0.30 to 2.11), P = 0.644, for stent thrombosis it was 1.45 (0.42 to 5.01), P = 0.560, for MI it was 1.26 (0.49 to 3.21), P = 0.629, for TLR it was 1.09 (0.71 to 1.68); P = 0.700 and for binary in-stent restenosis it was 0.96 (0.48 to 1.93), P = 0.918. Compared to bare metal stents (BMS), DEB showed a lower LLL (- 0.26 mm (-0.51 to 0.01)) and a trend towards a lower MACE risk (RR 0.66 (0.43 to 1.02)).Overall, drug-eluting balloons (+/- bare metal stent) are not superior to current standard therapies (BMS or drug eluting stent (DES)) in treating de novo coronary lesions. However, the performance of DEB seems to lie in between DES and BMS with a trend towards superiority over BMS alone. Therefore, DEB may be considered in patients with contraindications for DES. The heterogeneity between the included studies is a limitation of this meta-analysis; different drug-eluting balloons have been used.

Project description:BackgroundOutcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions.ObjectivesThis study sought to compare the relative performance of different types of DES for de novo long (≥25 mm) coronary artery lesions.MethodsUsing a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9 months.ResultsThe primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41 mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12 months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES.ConclusionsIn this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120).

Dataset Information

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III.

Publications

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets