2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent.

Absorbable Implants Aged Cardiovascular Agents / administration & dosage Coronary Artery Disease / diagnostic imaging Coronary Thrombosis / etiology Drug-Eluting Stents Dual Anti-Platelet Therapy Europe Everolimus / administration & dosage Female Humans Male Middle Aged Percutaneous Coronary Intervention / adverse effects Polymers / chemistry Prospective Studies Prosthesis Design Risk Factors Sirolimus / administration & dosage Time Factors Treatment Outcome

Firehawk clinical outcome drug-eluting stent everolimus-eluting stent

Journal

JACC. Cardiovascular interventions

ISSN: 1876-7605

Titre abrégé: JACC Cardiovasc Interv

Pays: United States

ID NLM: 101467004

Informations de publication

Date de publication:
09 09 2019

Historique:

received: 03 04 2019

revised: 01 05 2019

accepted: 01 05 2019

pubmed: 28 5 2019

medline: 8 9 2020

entrez: 27 5 2019

Statut: ppublish

Résumé

The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

Sections du résumé

OBJECTIVES

BACKGROUND

The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial.

METHODS

The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.

RESULTS

At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34).

CONCLUSIONS

The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

Identifiants

DOI: 10.1016/j.jcin.2019.05.001 PMID: 31129092

pubmed: 31129092

pii: S1936-8798(19)31027-1

doi: 10.1016/j.jcin.2019.05.001

pii:

doi:

Substances chimiques

Cardiovascular Agents 0

Polymers 0

Everolimus 9HW64Q8G6G

Sirolimus W36ZG6FT64

Banques de données

ClinicalTrials.gov

['NCT02520180']

Types de publication

Comparative Study Equivalence Trial Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

1679-1687

Commentaires et corrections

Type : CommentIn