Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)

Rigshospitalet

Status: Active, not recruiting

Conditions: ST-elevation Myocardial Infarction; Multi Vessel Disease

Treatments: Procedure: Percutaneous coronary intervention; Procedure: FFR

Study type: Interventional

Funder types: Other

Identifiers

NCT01960933

DANAMI-3-PRIMULTI

Details and patient eligibility

About

In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.

Full description

STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).

Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR.

Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Acute onset of chest pain of < 12 hours' duration.
• ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
• Culprit lesion in a major native vessel.
• MVD (non-culprit vessels with angiographic stenosis >50%)
• Successful primary PCI

Exclusion criteria

• Pregnancy.
• Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.
• Inability to understand information or to provide informed consent.
• Haemorrhagic diathesis or known coagulopathy.
• Stent thrombosis
• Significant left main stem stenosis
• Cardiogenic shock at admittance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

Culprit lesion revascularization

Active Comparator group

Description:

Only the culprit lesion is treated whereas other study lesions are left un-treated.

Treatment:

Procedure: Percutaneous coronary intervention

Full revascularization

Active Comparator group

Description:

Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically \>50% and FFR \<0.80 are treated in a separate procedure within the index hospitalization. Stenoses \> 90% are treated without prior FFR.

Treatment:

Procedure: FFR

Procedure: Percutaneous coronary intervention