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Bioresorbable Scaffolds versus Metallic Stents in Routine PCI

Open access
Wykrzykowska, Joanna J., Kraak, Robin P., Hofma, Sjoerd H., van der Schaaf, Rene J., Arkenbout, E. Karin, IJsselmuiden, Alexander J., Elias, Joëlle, van Dongen, Ivo M., Tijssen, Ruben Y.G., Koch, Karel T., Baan, Jan, Vis, M. Marije, de Winter, Robbert J., Piek, Jan J., Tijssen, Jan G.P., Henriques, Jose P.S.·2017·New England Journal of Medicine

Abstract

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 .).

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Metadata

Authors
Wykrzykowska, J. J., Kraak, R. P., Hofma, S. H., van der Schaaf, R. J., Arkenbout, E. K., IJsselmuiden, A. J., Elias, J., van Dongen, I. M., Tijssen, R. Y. G., Koch, K. T., Baan, J., Vis, M. M., de Winter, R. J., Piek, J. J., Tijssen, J. G. P., & Henriques, J. P. S.
Venue
New England Journal of Medicine
Published
2017-06-15
Volume
376
Issue
24
Pages
2319-2328
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2598919558
Cited by
441
References
16
FWCI
75.80
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. https://app.cochat.ai/papers/10.1056/nejmoa1614954
The paper
Wykrzykowska, J. J., Kraak, R. P., Hofma, S. H., van der Schaaf, R. J., Arkenbout, E. K., IJsselmuiden, A. J., Elias, J., van Dongen, I. M., Tijssen, R. Y. G., Koch, K. T., Baan, J., Vis, M. M., de Winter, R. J., Piek, J. J., Tijssen, J. G. P., & Henriques, J. P. S. (2017). Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1614954

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.