IRCCS Humanitas Research Hospital & Humanitas University
Published November 8, 2022 | Version v1
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Dataset related to article "One-Month Dual Antiplatelet Therapy After Bioresorbable Polymer Everolimus-Eluting Stents in High Bleeding Risk Patients"

Creators

  • 1. IRCCS Humanitas Research Hospital, via Manzoni 56, 20072 Rozzano (Mi) - Italy
  • 2. IRCCS Policlinico San Donato Milan Italy
  • 3. Mirano Hospital Mirano Italy
  • 4. Mediterranea Cardiocentro Naples Italy
  • 5. Department of Cardiosciences A.O. San Camillo-Forlanini Hospital Rome Italy
  • 6. Department of Advanced Biomedical Sciences "Federico II" University of Naples Naples Italy
  • 7. S. Giovanni Evangelista Hospital Tivoli Italy
  • 8. Department of Molecular Medicine and Medical Biotechnology "Federico II" University of Naples Naples Italy AND IRCCS Neuromed-Istituto Neurologico Mediterraneo Pozzilli Pozzilli Italy
  • 9. Department of Cardiology Maasstad Hospital Rotterdam The Netherlands
  • 10. Policlinico Umberto I University Rome Italy
  • 11. Department of Medical and Surgical Sciences "Magna Graecia" University Catanzaro Italy
  • 12. IRCCS Humanitas Research Hospital, via Manzoni 56,20089 Rozzano (Mi) - Italy AND Humanitas University, Department of Biomedical Sciences, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele – Milan, Italy

Description

This record contains raw data related to article "One-Month Dual Antiplatelet Therapy After Bioresorbable Polymer Everolimus-Eluting Stents in High Bleeding Risk Patients"

Abstract:

Background It is unknown whether contemporary drug-eluting stents have a similar safety profile in high bleeding risk patients treated with 1-month dual antiplatelet therapy following percutaneous coronary interventions. Methods and Results We performed an interventional, prospective, multicenter, single-arm trial, powered for noninferiority with respect to an objective performance criterion to evaluate the safety of percutaneous coronary interventions with Synergy bioresorbable-polymer everolimus-eluting stent followed by 1-month dual antiplatelet therapy in patients with high bleeding risk. In case of need for an oral anticoagulant, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1 month, followed by an oral anticoagulant only. The primary end point was the composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 1-year follow-up. The study was prematurely interrupted because of slow recruitment. From April 2017 to October 2019, 443 patients (age, 74.8±9.2 years; women, 29.1%) at 10 Italian centers were included. The 1-year primary outcome occurred in 4.82% (95% CI, 3.17%-7.31%) of patients, meeting the noninferiority compared with the predefined objective performance criterion of 9.4% and the noninferiority margin of 3.85% (Pnoninferiority<0.001) notwithstanding the lower-than-expected sample size. The rates of cardiac death, myocardial infarction, and definite or probable stent thrombosis were 1.88% (95% CI, 0.36%-2.50%), 3.42% (95% CI, 2.08%-5.62%), and 0.94% (95% CI, 0.35%-2.49%), respectively. Conclusions Among high bleeding risk patients undergoing percutaneous coronary interventions with the Synergy bioresorbable-polymer everolimus-eluting stent, a 1-month dual antiplatelet therapy regimen is safe, with low rates of ischemic and bleeding events. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03112707.

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Additional details

Related works

Is supplement to
Journal article: 35114814 (PMID)
Journal article: 10.1161/JAHA.121.023454 (DOI)