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

Coronary Artery Disease Clinical Trial

— POEM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03112707
• Other study ID #: 012017POEM
• Status: Recruiting
• Phase: Phase 4
• Start date: April 14, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2019
• Source: Humanitas Hospital, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1023
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin
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 inhibitor
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.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Hospital, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)	Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis	1 year
Secondary	All-cause death	All-cause death	30 days and 1 year
Secondary	Cardiac death	Cardiac death	30 days and 1 year
Secondary	Myocardial infarction	Myocardial infarction (defined according to III universal definition)	30 days and 1 year
Secondary	Stent thrombosis	Stent thrombosis (defined according to ARC criteria)	30 days and 1 year
Secondary	Target-vessel revascularization	Target-vessel revascularization (any and clinically driven)	30 days and 1 year
Secondary	Target-lesion revascularization	Target-lesion revascularization (any and clinically driven)	30 days and 1 year
Secondary	Major bleeding	Major bleeding (BARC 3 to 5)	30 days and 1 year
Secondary	Cerebrovascular event	Cerebrovascular event	30 days and 1 year
Secondary	Target-lesion failure	composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization	30 days and 1 year
Secondary	Patient oriented composite endpoint	Composite of any death, any MI, any revascularization	30 days and 1 year