Ultrathin-strut vs thin-strut drug-eluting stents for multi and single-stent lesions: A lesion-level subgroup analysis of 2 randomized trials.


Journal

American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465

Informations de publication

Date de publication:
09 2023
Historique:
received: 11 01 2023
revised: 04 05 2023
accepted: 04 05 2023
medline: 14 8 2023
pubmed: 17 5 2023
entrez: 16 5 2023
Statut: ppublish

Résumé

Whether ultrathin-strut stents are particularly beneficial for lesions requiring implantation of more than 1 stent is unknown. In a post-hoc lesion-level analysis of 2 randomized trials comparing ultrathin-strut biodegradable polymer Sirolimus-eluting stents (BP-SES) vs thin-strut durable polymer Everolimus-eluting stents (DP-EES), lesions were stratified into multistent lesions (MSL) vs single-stent lesions (SSL). The primary endpoint was target lesion failure (TLF), a composite of lesion-related unclear/cardiac death, myocardial infarction (MI), or revascularization, at 24 months. Among 5328 lesions in 3397 patients, 1492 (28%) were MSL (722 with BP-SES, 770 with DP-EES). At 2 years, TLF occurred in 63 lesions (8.9%) treated with BP-SES and 60 lesions (7.9%) treated with DP-EES in the MSL-group (subdistibution hazard ratio [SHR], 1.13; 95% CI, 0.77-1.64; P = .53), and in 121 (6.4%) and 136 (7.4%) lesions treated with BP-SES and DP-EES respectively (SHR, 0.86; 95% CI, 0.62-1.18; P = .35) in the SSL-group (P for interaction = .241). While the rates of lesion-related MI or revascularization were significantly lower in SSL treated with BP-SES as compared to DP-EES (3.5% vs 5.2%; SHR, 0.67; 95% CI 0.46-0.97; P = .036), no significant difference was observed in MSL (7.1% vs 5.4%; SHR, 1.31; 95% CI 0.85-2.03; P = .216) with significant interaction between groups (P for interaction = .014). Rates of TLF are similar between ultrathin-strut BP-SES and thin-strut DP-EES in MSL and SSL. The use of ultrathin-strut BP-SES vs thin-strut DP-EES did not prove to be particularly beneficial for the treatment of multistent lesions. Post-hoc analysis from the BIOSCIENCE (NCT01443104) and BIOSTEMI (NCT02579031) trials.

Sections du résumé

BACKGROUND
Whether ultrathin-strut stents are particularly beneficial for lesions requiring implantation of more than 1 stent is unknown.
METHODS
In a post-hoc lesion-level analysis of 2 randomized trials comparing ultrathin-strut biodegradable polymer Sirolimus-eluting stents (BP-SES) vs thin-strut durable polymer Everolimus-eluting stents (DP-EES), lesions were stratified into multistent lesions (MSL) vs single-stent lesions (SSL). The primary endpoint was target lesion failure (TLF), a composite of lesion-related unclear/cardiac death, myocardial infarction (MI), or revascularization, at 24 months.
RESULTS
Among 5328 lesions in 3397 patients, 1492 (28%) were MSL (722 with BP-SES, 770 with DP-EES). At 2 years, TLF occurred in 63 lesions (8.9%) treated with BP-SES and 60 lesions (7.9%) treated with DP-EES in the MSL-group (subdistibution hazard ratio [SHR], 1.13; 95% CI, 0.77-1.64; P = .53), and in 121 (6.4%) and 136 (7.4%) lesions treated with BP-SES and DP-EES respectively (SHR, 0.86; 95% CI, 0.62-1.18; P = .35) in the SSL-group (P for interaction = .241). While the rates of lesion-related MI or revascularization were significantly lower in SSL treated with BP-SES as compared to DP-EES (3.5% vs 5.2%; SHR, 0.67; 95% CI 0.46-0.97; P = .036), no significant difference was observed in MSL (7.1% vs 5.4%; SHR, 1.31; 95% CI 0.85-2.03; P = .216) with significant interaction between groups (P for interaction = .014).
CONCLUSIONS
Rates of TLF are similar between ultrathin-strut BP-SES and thin-strut DP-EES in MSL and SSL. The use of ultrathin-strut BP-SES vs thin-strut DP-EES did not prove to be particularly beneficial for the treatment of multistent lesions.
TRIAL REGISTRATION
Post-hoc analysis from the BIOSCIENCE (NCT01443104) and BIOSTEMI (NCT02579031) trials.

Identifiants

pubmed: 37192697
pii: S0002-8703(23)00115-1
doi: 10.1016/j.ahj.2023.05.004
pii:
doi:

Substances chimiques

Everolimus 9HW64Q8G6G
Polymers 0
Sirolimus W36ZG6FT64

Banques de données

ClinicalTrials.gov
['NCT02579031', 'NCT01443104']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

73-84

Informations de copyright

Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.

Auteurs

Jonas D Häner (JD)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Miklos Rohla (M)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Sylvain Losdat (S)

Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.

Juan F Iglesias (JF)

Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.

Olivier Muller (O)

Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.

Eric Eeckhout (E)

Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.

David Kurz (D)

Department of Cardiology, Triemli Hospital, Zurich, Switzerland.

Daniel Weilenmann (D)

Department of Cardiology, Kantonsspital, St. Gallen; Switzerland.

Christoph Kaiser (C)

Department of Cardiology, Basel University Hospital, Basel; Switzerland.

Maxime Tapponnier (M)

Department of Cardiology, Hôpital du Valais, Sion; Switzerland.

Marco Roffi (M)

Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.

Dik Heg (D)

Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.

Stephan Windecker (S)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Thomas Pilgrim (T)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: thomas.pilgrim@insel.ch.

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