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

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.

Timeline

Start

2017-04-14

Primary completion

2020-05-01

Completion

2020-05-01

Publications

• 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.
• 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.
• 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.
• 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.

Drugs

Indications