Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

MicroPort CRM2,248 enrolled

Overview

The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The modified antiplatelet therapy consists of a reduced duration of Dual Antiplatelet Therapy post procedure (ie. 1 month duration) followed by P2Y12 inhibitor monotherapy for the next 11 months. It is hypothesized that in the setting of clinically stable, low to moderate complexity acute Myocardial Infarction patients, a modern approach combining a stent with high biocompatibility feature, complete revascularization strategy and modified antiplatelet therapy may be associated with similar outcomes, or even a significant benefit compared with guidelines-recommended 12-month DAPT. This benefit could be driven by a reduced risk in significant bleeding events, while keeping a comparable protection against ischemic risk. Enrolled subjects will be randomized in a 1:1 ratio to either cessation of aspirin at 1 months, either continuation of DAPT. Selection of the P2Y12 inhibitor agent is left to investigator judgment but has to be in line with the current ESC guidelines. Subjects treated with the Firehawk or Firehawk Liberty coronary stent will be included in this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,248

Conditions

Myocardial Infarction, Acute Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria (General): * Troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and PCI occurred within the last 7 days * Subject is eligible for per-protocol antiplatelet treatments * Written informed consent Inclusion Criteria (Procedural/angiographic): * Successful revascularization * All treated lesions: * In native coronary arteries only * In vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm * Implanted with the study device * Maximum 3 lesions treated (\*) * Maximum total stent length ≤ 80 mm * Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 7 days from the index procedure. Exclusion Criteria (General): * Subjects with prior STEMI or prior PCI within 12 months before index admission * Prior Coronary Artery Bypass Graft (CABG) Surgery * Cardiogenic shock * Secondary PCI * Fibrinolysis * Prior stent thrombosis * Planned PCI, CABG, or surgery within 12 months * Need for Oral Anti-Coagulation therapy * Ischemic stroke or ICH within 12 months * eGFR \<30 mL/min/1.73 m2 or dialysis * Active bleeding at time of inclusion or high risk for major bleeding * History of bleeding diathesis or coagulopathy or subject refuse blood transfusions * Stage B or C liver cirrhosis or active cancer within 12 months * Baseline haemoglobin \<13 g/dL (12g/dL for women) or anaemia requiring transfusion in the 4 weeks prior to index procedure * Moderate or severe thrombocytopenia * Expected non-adherence to protocol or estimated life expectancy ≤12 months * Known hypersensitivity or contraindication to any medication used in the study or any of the study stent's components/compounds * Participation in another interventional clinical trial * Woman who is pregnant, nursing or with known intention to procreate Exclusion Criteria (Procedural/Angiographic): * In-stent restenosis or thrombosis * Chronic total occlusion * Severe calcification * True bifurcation disease and side branch diameter ≥ 2mm, or bifurcation treated with 2 stents * Left main coronary artery lesion * Residual untreated dissection ≥ C * Implantation of a non-study stent * Subject is deemed to receive preferentially CABG within 1 year

Outcomes

Primary Outcomes

Net Adverse Clinical and Cerebral Events (NACCE)

(Number of participants with first occurrence of) NACCE, defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or bleeding events (BARC type 3 or 5)

Time frame: 11 months post randomization

Secondary Outcomes

Bleeding events

(Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5)

Time frame: 11 months post randomization

All-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke

(Number of participants with first occurrence of) all-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke

Time frame: At 1 month, 6 months and 12 months

Primary endpoint component 5 - BARC 3 and 5 bleeding events

(Number of participants with first occurrence of) BARC 3 and 5 bleeding events

Time frame: At 1 month, 6 months and 12 months

All-cause death or non-fatal myocardial infarction

(Number of patients with first occurrence of) all-cause death or non-fatal myocardial infarction

Time frame: At 1 month, 6 months and 12 months

Major Adverse Cardiac and Cerebral Events (MACCE) - Patient

Patient-oriented composite of major adverse cardiac and cerebral events (MACCE) including all-cause death, myocardial infarction, definite/probable stent thrombosis, any stroke, any Ischemia driven repeat revascularization, or BARC bleeding events (type 2, 3, or 5)

Time frame: At 1 month, 6 months and 12 months

Target Lesion Failure - Device

Device oriented composite endpoint of Target Lesion Failure (cardiac death, target vessel related myocardial infarction, target lesion Ischemia Driven-revascularization)

Time frame: At 1 month, 6 months and 12 months

Major Adverse Cardiac and Cerebral events (MACE) - Events

Number of Major Adverse Cardiac and Cerebral events (MACE)

Time frame: At 1 Month, 6 months and 12 months

Primary endpoint component 3 - Stent thrombosis

Definite or probable stent thrombosis

Time frame: At 1 months, 6 months and 12 months

Main secondary endpoint component 2 - BARC 3 events

(Number of patients with occurrence of) BARC 3 events

Time frame: At 1 month, 6 months and 12 months

Main secondary endpoint component 3 - BARC 5 events

(Number of patients with occurrence of) BARC 5 events

Time frame: At 1 month, 6 months and 12 months

Main secondary endpoint component 1 - BARC 2 events

(Number of patients with occurrence of) BARC 2 events

Time frame: At 1 month, 6 months and 12 months

Cardiovascular death

Number of patients with cardiovascular death

Time frame: At 1 months, 6 months and 12 months

Cardiac death

Number of patients with cardiac death

Time frame: At 1 month, 6 months and 12 months

Non cardiac death

Number of patients with non cardiac death

Time frame: At 1 month, 6 months and 12 months

Primary endpoint component 2 - Myocardial infarction

Number of patients with myocardial infarction

Time frame: At 1 month, 6 months and 12 months

Cardiac death or non-fatal myocardial infarction

(Number of patients with first occurrence of) cardiac death or non-fatal myocardial infarction

Time frame: At 1 month, 6 months and 12 months

Cardiac death, myocardial infarction, or definite/probable stent thrombosis

(Number of patients with first occurrence of) cardiac death, myocardial infarction, or definite/probable stent thrombosis

Time frame: At 1 month, 6 months and 12 months

Cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke

(Number of patients with first occurrence of) cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke

Time frame: 1 month, 6 months and 12 months

Primary endpoint component 4 - Ischemic stroke

(Number of patients with occurrence of) ischemic stroke

Time frame: At 1 month, 6 months and 12 months

Haemorrhagic stroke

(Number of patients with occurrence of) haemorrhagic stroke

Time frame: At 1 month, 6 months and 12 months

Ischemia-driven target lesion revascularization

(Number of patients with) Ischemia-driven target lesion revascularization

Time frame: At 1 month, 6 months and 12 months

Ischemia-driven target vessel revascularization

(Number of patients with) Ischemia-driven target vessel revascularization

Time frame: At 1 month, 6 months and 12 months

Cardiovascular death, myocardial infarction, or ischemic stroke

(Number of patients with first occurrence of) cardiovascular death, myocardial infarction, or ischemic stroke

Time frame: At 1 month, 6 months and 12 months

Primary endpoint component 1 - All cause death

(Number of patients with) all cause death

Time frame: At 1 month, 6 months and 12 months

Primary endpoint component 2 - Myocardial infarction

(Number of patients with occurrence of) myocardial infarction

Time frame: At 1 month, 6 months and 12 months

Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

Overview

Conditions

Interventions

Eligibility

Locations (40)

Outcomes

Primary Outcomes

Secondary Outcomes