Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry.


Journal

Archives of cardiovascular diseases
ISSN: 1875-2128
Titre abrégé: Arch Cardiovasc Dis
Pays: Netherlands
ID NLM: 101465655

Informations de publication

Date de publication:
Oct 2022
Historique:
received: 18 01 2022
revised: 19 05 2022
accepted: 23 05 2022
pubmed: 20 9 2022
medline: 16 11 2022
entrez: 19 9 2022
Statut: ppublish

Résumé

Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

Sections du résumé

BACKGROUND BACKGROUND
Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years.
AIM OBJECTIVE
The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry.
METHODS METHODS
All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis.
RESULTS RESULTS
Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis.
CONCLUSIONS CONCLUSIONS
Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

Identifiants

pubmed: 36123284
pii: S1875-2136(22)00151-6
doi: 10.1016/j.acvd.2022.05.008
pii:
doi:

Substances chimiques

Everolimus 9HW64Q8G6G
Anticoagulants 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

505-513

Informations de copyright

Copyright © 2022 Elsevier Masson SAS. All rights reserved.

Auteurs

Quentin Landolff (Q)

Clinique Saint-Hilaire, 76000 Rouen, France.

Thierry Lefèvre (T)

Institut cardiovasculaire Paris Sud, Ramsay-Générale de Santé, hôpital privé Jacques-Cartier, 91300 Massy, France.

Jean Fajadet (J)

Clinique Pasteur, 31076 Toulouse, France.

Joel Sainsous (J)

Clinique Rhône-Durance, 84000 Avignon, France.

Thibault Lhermusier (T)

CHU de Toulouse, hôpital Rangueil, 31400 Toulouse, France.

Simon Elhadad (S)

Centre hospitalier de Marne-la-Vallée, 77600 Jossigny, France.

François Tarragano (F)

Hôpital américain, 92200 Neuilly-sur-Seine, France.

Sylvain Ranc (S)

Centre hospitalier Saint-Joseph Saint-Luc, 69007 Lyon, France.

Saïd Ghostine (S)

Hôpital Marie-Lannelongue (groupe hospitalier Paris Saint-Joseph), 92350 Le Plessis-Robinson, France.

Guillaume Cayla (G)

CHU de Nîmes, 30900 Nîmes, France.

Frédéric Marco (F)

Polyclinique du Parc, 31078 Toulouse, France.

Philippe Garot (P)

Hôpital privé Claude-Galien, 91480 Quincy-sous-Sénart, France.

Luc Maillard (L)

Clinique Axium, 13100 Aix-en-Provence, France.

Pascal Motreff (P)

CHU de Clermont-Ferrand, 63003 Clermont-Ferrand, France.

Nicolas Delarche (N)

Centre hospitalier François-Mitterrand, 64000 Pau, France.

Axel De Labriolle (A)

Clinique du Pont de Chaume, 82000 Montauban, France.

Michel Pansieri (M)

Centre hospitalier Henri-Duffaut, 84902 Avignon, France.

Jean-François Morelle (JF)

Hôpital privé Saint-Martin, 14000 Caen, France.

Pierre Cazaux (P)

Centre hospitalier de Bretagne Sud Site de Scorff, 56322 Lorient, France.

Marc Eric Moulichon (ME)

Clinique Saint-Pierre, 66000 Perpignan, France.

Patrick Chopat (P)

Centre hospitalier territorial, hôpital Gaston-Bourret, 98800 Nouméa, Nouvelle-Calédonie, France.

Denis Angoulvant (D)

Hôpital Trousseau, 37170 Chambray-lès-Tours, France.

Vincent Bataille (V)

ADIMEP, université Paul-Sabatier, Toulouse III, 31400 Toulouse, France.

Hervé Le Breton (H)

CHU de Rennes, 35055 Rennes, France.

René Koning (R)

Clinique Saint-Hilaire, 76000 Rouen, France. Electronic address: rkoning@clinique-sainthilaire.fr.

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