# Bioresorbeerbare scaffolds versus metallic stents bij routine-PCI: NEJM AIDA

*geplaatst 2017-06-15 · Algemeen · The New England journal of medicine · doi 10.1056/NEJMoa1614954 · https://hartvaat.nl/2017/06/15/bioresorbeerbare-scaffolds-versus-metallic-stents-bij-routine-pci-nejm-aida/*

NEJM AIDA-trial die bioresorbeerbare scaffolds vergeleek met metallic stents bij routine-PCI. Toonde meer devicetrombose — mede aanleiding voor terugtrekking van bioresorbeerbare scaffolds.

## English: Bioresorbable Scaffolds versus Metallic Stents in Routine PCI.

The AIDA trial showed that bioresorbable vascular scaffolds had significantly higher rates of device thrombosis compared with metallic drug-eluting stents in routine PCI. This safety concern contributed to the withdrawal of bioresorbable scaffolds from widespread clinical use.

## Abstract (original, from the publication)

BACKGROUND: Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice. METHODS: We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events. RESULTS: The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2-year cumulative event rates, 11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P=0.43); event rates were based on Kaplan-Meier estimates in time-to-event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2-year cumulative event rates, 2.0% and 2.7%, respectively), target-vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2-year cumulative event rates, 5.5% and 3.2%), and target-vessel revascularization occurred in 76 patients in the scaffold group and in 65 patients in the stent group (2-year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2-year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001). CONCLUSIONS: In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up. (Funded by Abbott Vascular; AIDA ClinicalTrials.gov number, NCT01858077 .).

Auteurs: Joanna J Wykrzykowska, Robin P Kraak, Sjoerd H Hofma, Rene J van der Schaaf, E Karin Arkenbout, Alexander J IJsselmuiden, Joëlle Elias, Ivo M van Dongen, Ruben Y G Tijssen, Karel T Koch, Jan Baan, M Marije Vis, Robbert J de Winter, Jan J Piek, Jan G P Tijssen, Jose P S Henriques

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Bron: The New England journal of medicine, https://doi.org/10.1056/NEJMoa1614954. Bijgewerkt 2026-07-03T13:26:03Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.