Performance of Bioresorbable Polymer-Coated Everolimus-Eluting Synergy® Stent in Patients at High Bleeding Risk Undergoing Percutaneous Coronary Revascularization Followed by 1-Month Dual Antiplatelet Therapy
Overview
- Phase
- Phase 4
- Intervention
- Aspirin
- Conditions
- Coronary Artery Disease
- Sponsor
- Humanitas Hospital, Italy
- Enrollment
- 1023
- Locations
- 1
- Primary Endpoint
- Major Adverse Cardiac Events (MACE)
- Last Updated
- 6 years ago
Overview
Brief Summary
Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk.
Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions.
Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm, multicentre trial, powered for non-inferiority with respect to objective performance criteria (OPC).
Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.
Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 1-year follow-up.
Investigators
Giulio Stefanini
Assistant Professor of Cardiology
Humanitas Hospital, Italy
Eligibility Criteria
Inclusion Criteria
- •All patients will need to have symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, or acute coronary syndromes (including NSTE-ACS and STE-ACS) and presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft that treated with one or multiple Synergy® stents.
- •Moreover, in order to be included patients will need to meet at least 1 of the following HBR criteria:
- •Age ≥75 years
- •Oral anticoagulation planned to continue after PCI
- •Hemoglobin \<11 g/l,
- •Transfusion within 4 week before inclusion
- •Platelet count \<100'000
- •Hospital admission for bleeding in previous 12 months
- •Stroke in previous 12 months
- •History of intracerebral hemorrhage
Exclusion Criteria
- •Cardiogenic shock
- •Major active bleeding at the time of PCI
- •Expected non-adherence with 1 month DAPT
- •Known intolerance to aspirin, clopidogrel, or ticagrelor
- •Inability to provide informed consent
- •Currently participating in another trial before reaching first endpoint
Arms & Interventions
Study arm
1023 real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions will be included in the study.
Intervention: Aspirin
Study arm
1023 real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions will be included in the study.
Intervention: P2Y12 inhibitor
Outcomes
Primary Outcomes
Major Adverse Cardiac Events (MACE)
Time Frame: 1 year
Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis
Secondary Outcomes
- Cardiac death(30 days and 1 year)
- Myocardial infarction(30 days and 1 year)
- Target-lesion revascularization(30 days and 1 year)
- Patient oriented composite endpoint(30 days and 1 year)
- All-cause death(30 days and 1 year)
- Stent thrombosis(30 days and 1 year)
- Target-vessel revascularization(30 days and 1 year)
- Major bleeding(30 days and 1 year)
- Target-lesion failure(30 days and 1 year)
- Cerebrovascular event(30 days and 1 year)