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Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry - 10/11/22

Doi : 10.1016/j.acvd.2022.05.008 
Quentin Landolff a, Thierry Lefèvre b, Jean Fajadet c, Joel Sainsous d, Thibault Lhermusier e, Simon Elhadad f, François Tarragano g, Sylvain Ranc h, Saïd Ghostine i, Guillaume Cayla j, Frédéric Marco k, Philippe Garot l, Luc Maillard m, Pascal Motreff n, Nicolas Delarche o, Axel De Labriolle p, Michel Pansieri q, Jean-François Morelle r, Pierre Cazaux s, Marc Eric Moulichon t, Patrick Chopat u, Denis Angoulvant v, Vincent Bataille w, Hervé Le Breton x, René Koning a,
on behalf of the

FRANCE ABSORB investigators

a Clinique Saint-Hilaire, 76000 Rouen, France 
b Institut cardiovasculaire Paris Sud, Ramsay-Générale de Santé, hôpital privé Jacques-Cartier, 91300 Massy, France 
c Clinique Pasteur, 31076 Toulouse, France 
d Clinique Rhône-Durance, 84000 Avignon, France 
e CHU de Toulouse, hôpital Rangueil, 31400 Toulouse, France 
f Centre hospitalier de Marne-la-Vallée, 77600 Jossigny, France 
g Hôpital américain, 92200 Neuilly-sur-Seine, France 
h Centre hospitalier Saint-Joseph Saint-Luc, 69007 Lyon, France 
i Hôpital Marie-Lannelongue (groupe hospitalier Paris Saint-Joseph), 92350 Le Plessis-Robinson, France 
j CHU de Nîmes, 30900 Nîmes, France 
k Polyclinique du Parc, 31078 Toulouse, France 
l Hôpital privé Claude-Galien, 91480 Quincy-sous-Sénart, France 
m Clinique Axium, 13100 Aix-en-Provence, France 
n CHU de Clermont-Ferrand, 63003 Clermont-Ferrand, France 
o Centre hospitalier François-Mitterrand, 64000 Pau, France 
p Clinique du Pont de Chaume, 82000 Montauban, France 
q Centre hospitalier Henri-Duffaut, 84902 Avignon, France 
r Hôpital privé Saint-Martin, 14000 Caen, France 
s Centre hospitalier de Bretagne Sud Site de Scorff, 56322 Lorient, France 
t Clinique Saint-Pierre, 66000 Perpignan, France 
u Centre hospitalier territorial, hôpital Gaston-Bourret, 98800 Nouméa, Nouvelle-Calédonie, France 
v Hôpital Trousseau, 37170 Chambray-lès-Tours, France 
w ADIMEP, université Paul-Sabatier, Toulouse III, 31400 Toulouse, France 
x CHU de Rennes, 35055 Rennes, France 

Corresponding author.

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Graphical abstract

Central illustration: cumulative major adverse cardiac events (MACE) and bioresorbable vascular scaffold (BVS) thrombosis rates after 1, 2, 3, 4 and 5 years.

El texto completo de este artículo está disponible en PDF.

Highlights

Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events (MACE).
MACE increased significantly at 3-year follow-up after Absorb BVS implantation.
The rates of scaffold thrombosis and MACE after 3 years decreased significantly.

El texto completo de este artículo está disponible en PDF.

Summary

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

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

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

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

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.

El texto completo de este artículo está disponible en PDF.

Keywords : Bioresorbable vascular scaffold, Percutaneous coronary intervention, Angioplasty, Registry

Abbreviations : ACS, BMS, BVS, DAPT, DES, MACE, PSP


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 Tweet: bioresorbable vascular scaffold is not dead: 5-year results of the FRANCE ABSORB registry.


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Vol 115 - N° 10

P. 505-513 - octobre 2022 Regresar al número
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