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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | All-cause death | 30 days and 1 year |
| Cardiac death | Cardiac death | 30 days and 1 year |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Recruiting | Rozzano | Milan | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41271123 | Derived | Pivato CA, Mincione G, Gramss L, Pacchioni A, Piccolo R, Musto C, Sardella G, Indolfi C, Antonelli G, Regazzoli D, Paradies V, Reimers B, Condorelli G, Testa L, Briguori C, Stefanini G. Early oral anticoagulation monotherapy after PCI: Insights from the POEM trial. Am Heart J. 2026 Mar;293:107309. doi: 10.1016/j.ahj.2025.107309. Epub 2025 Nov 19. | |
| 39359172 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
| P2Y12 inhibitor | Drug | 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. |
|
| 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 |
| Maurina M, Pivato CA, Kunadian V, Testa L, Briguori C, Pacchioni A, Latini AC, Cesani N, Piccolo R, Musto C, Sardella G, Indolfi C, Regazzoli D, Paradies V, Stefanini G. One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in women at high-bleeding risk: Insights from the POEM trial. Catheter Cardiovasc Interv. 2024 Nov;104(6):1129-1138. doi: 10.1002/ccd.31255. Epub 2024 Oct 3. |
| 38702260 | Derived | Popolo Rubbio A, Testa L, Pivato CA, Regazzoli D, Piccolo R, Esposito G, Musto C, Scalia L, Pacchioni A, Briguori C, Lucisano L, De Luca L, Conrotto F, Tartaglia F, Latini AC, Stankowski K, Chiarito M, Sardella G, Indolfi C, Bedogni F, Reimers B, Condorelli G, Stefanini GG. Application of the Academic Research Consortium High Bleeding Risk criteria in patients treated with coronary bioresorbable polymer everolimus-eluting stents: Insights from the POEM trial. Cardiovasc Revasc Med. 2024 Oct;67:77-83. doi: 10.1016/j.carrev.2024.04.022. Epub 2024 Apr 16. |
| 35114814 | Derived | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |