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. 2022 Oct;115(10):505-513.
doi: 10.1016/j.acvd.2022.05.008. Epub 2022 Sep 5.

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

Quentin Landolff  1 , Thierry Lefèvre  2 , Jean Fajadet  3 , Joel Sainsous  4 , Thibault Lhermusier  5 , Simon Elhadad  6 , François Tarragano  7 , Sylvain Ranc  8 , Saïd Ghostine  9 , Guillaume Cayla  10 , Frédéric Marco  11 , Philippe Garot  12 , Luc Maillard  13 , Pascal Motreff  14 , Nicolas Delarche  15 , Axel De Labriolle  16 , Michel Pansieri  17 , Jean-François Morelle  18 , Pierre Cazaux  19 , Marc Eric Moulichon  20 , Patrick Chopat  21 , Denis Angoulvant  22 , Vincent Bataille  23 , Hervé Le Breton  24 , René Koning  25 ; FRANCE ABSORB investigators
Affiliations
Free article

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

Quentin Landolff et al. Arch Cardiovasc Dis. 2022 Oct.
Free article

Abstract

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.

Keywords: Angioplasty; Bioresorbable vascular scaffold; Percutaneous coronary intervention; Registry.

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