NCT01960933

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

Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• ST-elevation Myocardial Infarction
• Multi Vessel Disease

Interventions

Type	Name	Description
PROCEDURE	Percutaneous coronary intervention
PROCEDURE	FFR

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-02-01
• Completion: 2024-02-01
• First posted: 2013-10-11
• Last updated: 2023-11-28

Locations

2 sites across 1 country: Denmark