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

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

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 Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Drug: Aspirin; Drug: P2Y12 inhibitor

• Study Type: Interventional
• Enrollment (Anticipated): 1023
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Recruiting
      • Humanitas Research Hospital
      • Principal Investigator: Bernhard Reimers, MD
      • Principal Investigator: Giulio Stefanini, MD, PhD
      • Contact: Giulio Stefanini, MD, PhD; Phone Number: 0282247384; Email: giulio.stefanini@hunimed.eu

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Events (MACE)	Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	All-cause death	30 days and 1 year
Cardiac death	Cardiac death	30 days and 1 year
Myocardial infarction	Myocardial infarction (defined according to III universal definition)	30 days and 1 year
Stent thrombosis	Stent thrombosis (defined according to ARC criteria)	30 days and 1 year
Target-vessel revascularization	Target-vessel revascularization (any and clinically driven)	30 days and 1 year
Target-lesion revascularization	Target-lesion revascularization (any and clinically driven)	30 days and 1 year
Major bleeding	Major bleeding (BARC 3 to 5)	30 days and 1 year
Cerebrovascular event	Cerebrovascular event	30 days and 1 year
Target-lesion failure	composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization	30 days and 1 year
Patient oriented composite endpoint	Composite of any death, any MI, any revascularization	30 days and 1 year

Collaborators and Investigators

• Sponsor: Humanitas Hospital, Italy

Publications and helpful links

General Publications

• 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. Erratum In: J Am Heart Assoc. 2022 Aug 16;11(16):e020787.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2017
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Acute Coronary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 012017POEM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No