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

• ClinicalTrials.gov Identifier: NCT03112707
• Recruitment Status: Recruiting
• First Posted: April 13, 2017
• Last Update Posted: August 7, 2019
• Sponsor: Humanitas Hospital, Italy
• Information provided by (Responsible Party): Giulio Stefanini, Humanitas Hospital, Italy

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Acute Coronary Syndrome	Drug: Aspirin; Drug: P2Y12 inhibitor	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1023 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 14, 2017
• Estimated Primary Completion Date: May 1, 2020
• Estimated Study Completion Date: May 1, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: Study arm; 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; 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.; Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Major Adverse Cardiac Events (MACE) [ Time Frame: 1 year ]
   Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis

Secondary Outcome Measures :

1. All-cause death [ Time Frame: 30 days and 1 year ]
   All-cause death
2. Cardiac death [ Time Frame: 30 days and 1 year ]
   Cardiac death
3. Myocardial infarction [ Time Frame: 30 days and 1 year ]
   Myocardial infarction (defined according to III universal definition)
4. Stent thrombosis [ Time Frame: 30 days and 1 year ]
   Stent thrombosis (defined according to ARC criteria)
5. Target-vessel revascularization [ Time Frame: 30 days and 1 year ]
   Target-vessel revascularization (any and clinically driven)
6. Target-lesion revascularization [ Time Frame: 30 days and 1 year ]
   Target-lesion revascularization (any and clinically driven)
7. Major bleeding [ Time Frame: 30 days and 1 year ]
   Major bleeding (BARC 3 to 5)
8. Cerebrovascular event [ Time Frame: 30 days and 1 year ]
   Cerebrovascular event
9. Target-lesion failure [ Time Frame: 30 days and 1 year ]
   composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization
10. Patient oriented composite endpoint [ Time Frame: 30 days and 1 year ]
    Composite of any death, any MI, any revascularization

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

Humanitas Research Hospital; Recruiting

Rozzano, Milan, Italy, 20089

Contact: Giulio Stefanini, MD, PhD 0282247384 giulio.stefanini@hunimed.eu

Principal Investigator: Giulio Stefanini, MD, PhD

Principal Investigator: Bernhard Reimers, MD

Sponsors and Collaborators

Humanitas Hospital, Italy

More Information

• Responsible Party: Giulio Stefanini, Assistant Professor of Cardiology, Humanitas Hospital, Italy
• ClinicalTrials.gov Identifier: NCT03112707 History of Changes
• Other Study ID Numbers: 012017POEM
• First Posted: April 13, 2017
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Aspirin; Coronary Artery Disease; Acute Coronary Syndrome; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Sirolimus; Everolimus; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors