Background: It is unknown if acute (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI). We sought to investigate the effect on ischemic and bleeding endpoints, of a randomized short (6 months) or long (24 months) DAPT duration in relation to unstable versus stable clinical presentation. methods: We stratified the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) patient population on the basis of the clinical presentation and randomly allocated DAPT duration. The main study objectives were the cumulative incidence of the composite ischemic endpoint of death, myocardial infarction or cerebrovascular accident, BARC-class 2,3 and 5 bleeding (key safety endpoint) and their combination in the net cardiovascular adverse events (NACE). results: A total of, 1465 (74.3%) patients presented ACS, whereas 505 (25.7%) had a SCAD diagnosis at entry. At 24-months, the main ischemic endpoint did not differ in the long- as compared to the short-term DAPT arms in both ACS (11.1% vs. 11.7%; P=0.67) and SCAD (7.5% vs. 4.8%; P=0.21) patients. Long-term DAPT was associated with a 75% increase of BARC-class 2,3, or 5 bleeding in ACS (7.1% vs. 4.1%; HR 1.75, 95%CI: 1.11-2.74, P=0.015; NNTH: 33.3) and a 5-fold increase in SCAD (8.2% vs. 1.6%; HR 5.37: 95%CI 1.84-15.74, P=0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (PINT=0.056). As a result, NACE were more than doubled in SCAD patients receiving 24-month DAPT whereas they did not differ in ACS patients (PINT =0.024). Conclusion: This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD —but not ACS— patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24- as compared to 6-month therapy.

Impact of Clinical Presentation on Ischemic and Bleeding Outcomes in Patients Receiving 6 or 24 Month Duration of Dual Antiplatelet Therapy After Stent Implantation: A Pre-Specified Analysis from the (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) PRODIGY Trial

COSTA, FRANCESCO;ANDO', Giuseppe;ORETO, Giuseppe;
2015-01-01

Abstract

Background: It is unknown if acute (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI). We sought to investigate the effect on ischemic and bleeding endpoints, of a randomized short (6 months) or long (24 months) DAPT duration in relation to unstable versus stable clinical presentation. methods: We stratified the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) patient population on the basis of the clinical presentation and randomly allocated DAPT duration. The main study objectives were the cumulative incidence of the composite ischemic endpoint of death, myocardial infarction or cerebrovascular accident, BARC-class 2,3 and 5 bleeding (key safety endpoint) and their combination in the net cardiovascular adverse events (NACE). results: A total of, 1465 (74.3%) patients presented ACS, whereas 505 (25.7%) had a SCAD diagnosis at entry. At 24-months, the main ischemic endpoint did not differ in the long- as compared to the short-term DAPT arms in both ACS (11.1% vs. 11.7%; P=0.67) and SCAD (7.5% vs. 4.8%; P=0.21) patients. Long-term DAPT was associated with a 75% increase of BARC-class 2,3, or 5 bleeding in ACS (7.1% vs. 4.1%; HR 1.75, 95%CI: 1.11-2.74, P=0.015; NNTH: 33.3) and a 5-fold increase in SCAD (8.2% vs. 1.6%; HR 5.37: 95%CI 1.84-15.74, P=0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (PINT=0.056). As a result, NACE were more than doubled in SCAD patients receiving 24-month DAPT whereas they did not differ in ACS patients (PINT =0.024). Conclusion: This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD —but not ACS— patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24- as compared to 6-month therapy.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11570/3050574
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