Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the BIOSCIENCE Randomized Trial.
Details
Serval ID
serval:BIB_A0C60132FEAD
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the BIOSCIENCE Randomized Trial.
Journal
Circulation. Cardiovascular interventions
ISSN
1941-7632 (Electronic)
ISSN-L
1941-7640
Publication state
Published
Issued date
08/2019
Peer-reviewed
Oui
Volume
12
Number
8
Pages
e008024
Language
english
Notes
Publication types: Comparative Study ; Equivalence Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
Randomized trials evaluating the Orsiro biodegradable polymer sirolimus-eluting stent (BP-SES; 60 and 80 μm strut thickness for stent diameters ≤3 and >3 mm, respectively) did not stratify according to vessel size and failed to specify the impact of ultrathin-strut thickness on long-term clinical outcomes compared with durable polymer everolimus-eluting stents (DP-EES). We sought to assess the long-term effect of ultrathin-strut (60 μm) BP-SES versus thin-strut (81 μm) DP-EES on long-term outcomes in patients undergoing percutaneous coronary revascularization for small vessel disease.
In a subgroup analysis of the randomized, multicenter, noninferiority BIOSCIENCE trial, patients with stable coronary artery disease or acute coronary syndrome randomly assigned to treatment with BP-SES or DP-EES were stratified according to vessel size (≤3 mm versus >3 mm) as a surrogate to compare patients treated with ultrathin-strut versus thin-strut drug-eluting stent. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, within 5 years.
Among 2109 patients, 1234 (59%) were treated for small vessel disease. At 5 years, target lesion failure occurred in 124 patients (cumulative incidence, 22.3%) treated with ultrathin-strut BP-SES and 109 patients (18.3%) treated with thin-strut DP-EES (rate ratio, 1.22; 95% CI, 0.94-1.58; P=0.13). Cumulative incidences of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization and definite stent thrombosis at 5 years were similar in patients treated with ultrathin-strut BP-SES and thin-strut DP-EES. After adjustment for potential confounders, there was no significant interaction between vessel size and treatment effect of BP-SES versus DP-EES.
We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.
In a subgroup analysis of the randomized, multicenter, noninferiority BIOSCIENCE trial, patients with stable coronary artery disease or acute coronary syndrome randomly assigned to treatment with BP-SES or DP-EES were stratified according to vessel size (≤3 mm versus >3 mm) as a surrogate to compare patients treated with ultrathin-strut versus thin-strut drug-eluting stent. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, within 5 years.
Among 2109 patients, 1234 (59%) were treated for small vessel disease. At 5 years, target lesion failure occurred in 124 patients (cumulative incidence, 22.3%) treated with ultrathin-strut BP-SES and 109 patients (18.3%) treated with thin-strut DP-EES (rate ratio, 1.22; 95% CI, 0.94-1.58; P=0.13). Cumulative incidences of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization and definite stent thrombosis at 5 years were similar in patients treated with ultrathin-strut BP-SES and thin-strut DP-EES. After adjustment for potential confounders, there was no significant interaction between vessel size and treatment effect of BP-SES versus DP-EES.
We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.
Keywords
Acute Coronary Syndrome/diagnostic imaging, Acute Coronary Syndrome/mortality, Acute Coronary Syndrome/physiopathology, Acute Coronary Syndrome/therapy, Aged, Cardiovascular Agents/administration & dosage, Cardiovascular Agents/adverse effects, Coronary Artery Disease/diagnostic imaging, Coronary Artery Disease/mortality, Coronary Artery Disease/physiopathology, Coronary Artery Disease/therapy, Drug-Eluting Stents, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention/adverse effects, Percutaneous Coronary Intervention/instrumentation, Percutaneous Coronary Intervention/mortality, Prosthesis Design, Single-Blind Method, Sirolimus/administration & dosage, Sirolimus/adverse effects, Switzerland, Time Factors, Treatment Outcome, coronary artery disease, drug-eluting stent, everolimus, polymer, sirolimus
Pubmed
Web of science
Open Access
Yes
Create date
20/09/2019 22:54
Last modification date
23/04/2024 7:01