Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Aspirin
* Drug: P2Y12 inhibitor


Participation Criteria
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Eligibility Criteria
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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 Severe chronic liver disease Creatinine clearance <40 ml/min Cancer in previous 3 years Planned major surgery in next 12 months Glucocorticoids or NSAID planned for >30 days after PCI Expected non-adherence to >30 days of dual antiplatelet therapy 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>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. | Drug: Aspirin<br>* After percutaneous coronary intervention with bioresorbable polymer-coated everolimus-eluting Synergy® stent implantation, dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor will be continued 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.<br>Drug: P2Y12 inhibitor<br>* After percutaneous coronary intervention with bioresorbable polymer-coated everolimus-eluting Synergy® stent implantation, dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor will be continued 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) | Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | All-cause death | 30 days and 1 year | 
| Cardiac death | Cardiac death | 30 days and 1 year | 
| Myocardial infarction | Myocardial infarction (defined according to III universal definition) | 30 days and 1 year | 
| Stent thrombosis | Stent thrombosis (defined according to ARC criteria) | 30 days and 1 year | 
| Target-vessel revascularization | Target-vessel revascularization (any and clinically driven) | 30 days and 1 year | 
| Target-lesion revascularization | Target-lesion revascularization (any and clinically driven) | 30 days and 1 year | 
| Major bleeding | Major bleeding (BARC 3 to 5) | 30 days and 1 year | 
| Cerebrovascular event | Cerebrovascular event | 30 days and 1 year | 
| Target-lesion failure | composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization | 30 days and 1 year | 
| Patient oriented composite endpoint | Composite of any death, any MI, any revascularization | 30 days and 1 year |