In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel disease with an increased cardiovascular morbidity and mortality. Although it is not recommended to revascularize noninfarct lesions during the acute intervention, recent investigations suggest the opposite and show improved outcome after direct revascularization of noninfarct lesions. It is undesirable to risk procedure-related complications by treating noninfarct lesions without impaired flow. It is currently unknown whether pressure guided revascularization of noninfarct lesions in the acute phase improves outcome compared to the current guidelines. The iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel lesions.
Study design: The study is a prospective, randomized controlled, multicentre study. Study population: The research population will be recruited from the general patient population presenting with an acute STEMI. Patients treated with successful primary PCI and one or more additional significant coronary lesions in another coronary artery will be enrolled in the study. A total of 1,146 consecutive patients will be included. Intervention: The patients will be randomized 1:1, to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion \>50% and iFR ≤0.89; (B) a deferred treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects. Main study parameters/endpoints: The primary end point consists of a combined outcome, including all-cause death, recurrent MI and hospitalization for heart failure at 3 years follow-up. Duration: Anticipated recruitment is 2 years. Follow-up will be performed at 6 months, 12 months, 3 years and 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,146
Radboudumc
Nijmegen, Netherlands
Composite end point of Major Adverse Cardiac Events
All-cause death, recurrent myocardial infarction and hospitalization for heart failure
Time frame: 3 years
All cause mortality
All cause mortality at 6 and 12 months, 3 and 5 years
Time frame: 6 and 12 months, 3 and 5 years
Cardiovascular mortality
Cardiovascular mortality at 6 and 12 months, 3 and 5 years
Time frame: 6 and 12 months, 3 and 5 years
Myocardial infarction
Myocardial infarction at 6 and 12 months, 3 and 5 years
Time frame: 6 and 12 months, 3 and 5 years
Cerebral events
Stroke and transient ischemic attack
Time frame: 6 and 12 months, 3 and 5 years
Major bleeding
Haemorrhagic complications
Time frame: 6 months
Unstable angina
Unstable angina including ECG-changes at 6 and 12 months, 3 and 5 years
Time frame: 6 and 12 months, 3 and 5 years
Coronary angiography
Coronary angiography at 6 and 12 months, 3 and 5 years
Time frame: 6 and 12 months, 3 and 5 years
Revascularization
Any revascularization at 6 and 12 months, 3 and 5 years
Time frame: 6 and 12 months, 3 and 5 years
Target lesion failure
Failure and/or revascularization by percutaneous or surgical methods of the target lesion
Time frame: 6 and 12 months, 3 and 5 years
Stent thrombosis
Stent thrombosis at 6 and 12 months, 3 and 5 years
Time frame: 6 and 12 months, 3 and 5 years
Cost effectiveness analysis
Costs related to complete, iFR-guided revascularization versus CMR-guided treatment, including cost utility analysisfrom a societal perspective with the costs per prevented cardiac eventand the costs per QALY as the respective primary health economic outcomes (using a quality of life questionnaire and a health care resource use questionnaire)
Time frame: 6 and 12 months, 3 and 5 years
Quality of life
Quality of life questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years
Time frame: 6 and 12 months, 3 and 5 years
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