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

Phase 4

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Interventions: Drug: Aspirin; Drug: P2Y12 inhibitor

• Registration Number: NCT03112707
• Lead Sponsor: Humanitas Hospital, Italy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-13
• Study Start: 2017-04-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1023

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	P2Y12 inhibitor	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.
Study arm	Aspirin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy