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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1023 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-14

Study Completion Date

2020-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Artery Disease Acute Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Aspirin

Intervention Type 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.

P2Y12 inhibitor

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No