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

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanitas Hospital, Italy
• Treatments: Aspirin; Everolimus; Sirolimus

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:

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