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

Humanitas Hospital, Italy1,023 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,023

Conditions

Coronary Artery Disease Acute Coronary Syndrome

AspirinDRUG

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.

P2Y12 inhibitorDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. Age ≥75 years 2. Oral anticoagulation planned to continue after PCI 3. Hemoglobin \<11 g/l, 4. Transfusion within 4 week before inclusion 5. Platelet count \<100'000 6. Hospital admission for bleeding in previous 12 months 7. Stroke in previous 12 months 8. History of intracerebral hemorrhage 9. Severe chronic liver disease 10. Creatinine clearance \<40 ml/min 11. Cancer in previous 3 years 12. Planned major surgery in next 12 months 13. Glucocorticoids or NSAID planned for \>30 days after PCI 14. Expected non-adherence to \>30 days of dual antiplatelet therapy Exclusion Criteria: 1. Cardiogenic shock 2. Major active bleeding at the time of PCI 3. Expected non-adherence with 1 month DAPT 4. Known intolerance to aspirin, clopidogrel, or ticagrelor 5. Inability to provide informed consent 6. Currently participating in another trial before reaching first endpoint

Outcomes

Primary Outcomes

Major Adverse Cardiac Events (MACE)

Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis

Time frame: 1 year