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Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. / Wykrzykowska, Joanna J.; Kraak, Robin P.; Hofma, Sjoerd H. et al.

In: New England journal of medicine, Vol. 376, No. 24, 2017, p. 2319-2328.

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Wykrzykowska, Joanna J. ; Kraak, Robin P. ; Hofma, Sjoerd H. et al. / Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. In: New England journal of medicine. 2017 ; Vol. 376, No. 24. pp. 2319-2328.

BibTeX

@article{6aa8f49cc5584f2eb20527c77d8d81b9,
title = "Bioresorbable Scaffolds versus Metallic Stents in Routine PCI",
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.)",
author = "Wykrzykowska, {Joanna J.} and Kraak, {Robin P.} and Hofma, {Sjoerd H.} and {van der Schaaf}, {Rene J.} and Arkenbout, {E. Karin} and Ijsselmuiden, {Alexander J.} and Jo{\"e}lle Elias and {van Dongen}, {Ivo M.} and Tijssen, {Ruben Y. G.} and Koch, {Karel T.} and Jan Baan and Vis, {M. Marije} and {de Winter}, {Robbert J.} and Piek, {Jan J.} and Tijssen, {Jan G. P.} and Henriques, {Jose P. S.}",
year = "2017",
doi = "10.1056/NEJMoa1614954",
language = "English",
volume = "376",
pages = "2319--2328",
journal = "New England journal of medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "24",

}

RIS

TY - JOUR

T1 - Bioresorbable Scaffolds versus Metallic Stents in Routine PCI

AU - Wykrzykowska, Joanna J.

AU - Kraak, Robin P.

AU - Hofma, Sjoerd H.

AU - van der Schaaf, Rene J.

AU - Arkenbout, E. Karin

AU - Ijsselmuiden, Alexander J.

AU - Elias, Joëlle

AU - van Dongen, Ivo M.

AU - Tijssen, Ruben Y. G.

AU - Koch, Karel T.

AU - Baan, Jan

AU - Vis, M. Marije

AU - de Winter, Robbert J.

AU - Piek, Jan J.

AU - Tijssen, Jan G. P.

AU - Henriques, Jose P. S.

PY - 2017

Y1 - 2017

N2 - 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.)

AB - 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.)

U2 - 10.1056/NEJMoa1614954

DO - 10.1056/NEJMoa1614954

M3 - Article

C2 - 28402237

VL - 376

SP - 2319

EP - 2328

JO - New England journal of medicine

JF - New England journal of medicine

SN - 0028-4793

IS - 24

ER -

ID: 3774525