Clinical trial NCT03112707: Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Lead sponsor: Humanitas Hospital, Italy
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 1023
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 1 year
Secondary outcomes:
measure: All-cause death
timeFrame: 30 days and 1 year
measure: Cardiac death
timeFrame: 30 days and 1 year
measure: Myocardial infarction
timeFrame: 30 days and 1 year
measure: Stent thrombosis
timeFrame: 30 days and 1 year
measure: Target-vessel revascularization
timeFrame: 30 days and 1 year
measure: Target-lesion revascularization
timeFrame: 30 days and 1 year
measure: Major bleeding
timeFrame: 30 days and 1 year
measure: Cerebrovascular event
timeFrame: 30 days and 1 year
measure: Target-lesion failure
timeFrame: 30 days and 1 year
measure: Patient oriented composite endpoint
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
References:
citation: Pivato CA, Reimers B, Testa L, Pacchioni A, Briguori C, Musto C, Esposito G, Piccolo R, Lucisano L, De Luca L, Conrotto F, De Marco A, Franzone A, Presbitero P, Ferrante G, Condorelli G, Paradies V, Sardella G, Indolfi C, Condorelli G, Stefanini GG. One-Month Dual Antiplatelet Therapy After Bioresorbable Polymer Everolimus-Eluting Stents in High Bleeding Risk Patients. J Am Heart Assoc. 2022 Mar 15;11(6):e023454. doi: 10.1161/JAHA.121.023454. Epub 2022 Feb 3.