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

Conditions

Coronary Artery Disease, Acute Coronary Syndrome

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.

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.

2025-11-19

10.1016/j.ahj.2025.107309

One‐Month Dual Antiplatelet Therapy After Bioresorbable Polymer Everolimus‐Eluting Stents in High Bleeding Risk Patients

Carlo A. Pivato, Bernhard Reimers, Luca Testa, Andrea Pacchioni, Carlo Briguori et al. (21 authors)

Journal of the American Heart Association2022-02-0420 citations

10.1161/jaha.121.023454

High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial.

Zocca P, Kok MM, van der Heijden LC, Danse PW, Schotborgh CE, Scholte M, Hartmann M, Linssen GCM, Doggen CJM, von Birgelen C.

2018-12-016 citations

10.1007/s10557-018-6823-9

Interventions

DRUGAspirin

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.

DRUGP2Y12 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.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed