The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.
Bioresorbable Scaffolds versus Metallic Stents in Routine PCI
Open accessAbstract
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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Cites
Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions
Cutlip, D. E., Windecker, S., Mehran, R., Boam, A., Cohen, D. J., van Es, G.-A., Gabriel Steg, P., Morel, M.-A., Mauri, L., Vranckx, P., et al. (2007) · Circulation · doi:10.1161/circulationaha.106.685313 · Cited by 5,497
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Third Universal Definition of Myocardial Infarction
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Pathology of Drug-Eluting Stents in Humans
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Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents
Mauri, L., Kereiakes, D. J., Yeh, R. W., Driscoll-Shempp, P., Cutlip, D. E., Steg, P. G., Normand, S.-L. T., Braunwald, E., Wiviott, S. D., Cohen, D. J., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1409312 · Cited by 1,928
The Pathology of Neoatherosclerosis in Human Coronary Implants
Nakazawa, G., Otsuka, F., Nakano, M., Vorpahl, M., Yazdani, S. K., Ladich, E., Kolodgie, F. D., Finn, A. V., & Virmani, R. (2011) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2011.01.011 · Cited by 934
Kolandaivelu, K., Swaminathan, R., Gibson, W. J., Kolachalama, V. B., Nguyen-Ehrenreich, K.-L., Giddings, V. L., Coleman, L., Wong, G. K., & Edelman, E. R. (2011) · Circulation · doi:10.1161/circulationaha.110.003210 · Cited by 802
Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease
Ellis, S. G., Kereiakes, D. J., Metzger, D. C., Caputo, R. P., Rizik, D. G., Teirstein, P. S., Litt, M. R., Kini, A., Kabour, A., Marx, S. O., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1509038 · Cited by 630
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Self-citationLong-Term Safety of Drug-Eluting and Bare-Metal Stents
Palmerini, T., Benedetto, U., Biondi-Zoccai, G., Della Riva, D., Bacchi-Reggiani, L., Smits, P. C., Vlachojannis, G. J., Jensen, L. O., Christiansen, E. H., Berencsi, K., et al. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.04.017 · Cited by 470
Cited by
2018 ESC/EACTS guidelines on myocardial revascularization
Neumann, F.-J., Sousa-Uva, M., Ahlsson, A., Alfonso, F., Banning, A. P., Benedetto, U., Byrne, R. A., Collet, J.-P., Falk, V., Head, S. J., et al. (2019) · European Heart Journal · doi:10.1093/eurheartj/ehy394 · Cited by 7,167
Self-citation2018 ESC/EACTS Guidelines on myocardial revascularization
Neumann, F.-J., Sousa-Uva, M., Ahlsson, A., Alfonso, F., Banning, A. P., Benedetto, U., Byrne, R. A., Collet, J.-P., Falk, V., Head, S. J., et al. (2019) · EuroIntervention · doi:10.4244/eijy19m01_01 · Cited by 1,259
2018 ESC/EACTS Guidelines on myocardial revascularization
Sousa-Uva, M., Neumann, F.-J., Ahlsson, A., Alfonso, F., Banning, A. P., Benedetto, U., Byrne, R. A., Collet, J.-P., Falk, V., Head, S. J., et al. (2019) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezy289 · Cited by 989
Self-citationRäber, L., Mintz, G. S., Koskinas, K. C., Johnson, T. W., Holm, N. R., Onuma, Y., Radu, M. D., Joner, M., Yu, B., Jia, H., et al. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehy285 · Cited by 770
Device thrombosis with bioresorbable scaffolds
Mukherjee, D. (2017) · New England Journal of Medicine · doi:10.1056/nejme1703202 · Cited by 22
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
- Publisher
- Massachusetts Medical Society
- 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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- 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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