Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTiFR
Treatment guided by instantaneous wave-free ratio
DIAGNOSTIC_TESTCMR
Treatment guided by stress perfusion CMR
Sponsors
Volcano Europe BVBA/SPRL
Biotronik AG
Stichting Life Sciences & Health
Duke Cardiovascular Magnetic Resonance Center
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
1:1 randomization to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion \>50% and iFR ≤0.89; or (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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical presentation of STEMI and successful primary PCI within 12 hours from onset of symptoms. * One or more other, noninfarct coronary artery lesions of \>50% stenosis and feasible to be revascularized (i.e. minimal diameter 2mm).
Exclusion criteria
* History of myocardial infarction. * Hemodynamic instability, respiratory failure, Kilips class ≥III. * Known GFR\<30 ml/min. * Known contra-indications for stress CMR (e.g.: severe claustrophobia, metal implants, severe renal failure, severe astma). * Refusal or inability to provide informed consent. * Life expectancy due to noncardiovascular co-morbidity of less than 12 months. * Chronic total occlusion. * Left main stem stenosis (\>50%). * Residual noninfarct lesion in infarct coronary artery. * Complex (e.g. bifurcation) noninfarct target lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite end point of Major Adverse Cardiac Events | 3 years | All-cause death, recurrent myocardial infarction and hospitalization for heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular mortality | 6 and 12 months, 3 and 5 years | Cardiovascular mortality at 6 and 12 months, 3 and 5 years |
| Myocardial infarction | 6 and 12 months, 3 and 5 years | Myocardial infarction at 6 and 12 months, 3 and 5 years |
| Cerebral events | 6 and 12 months, 3 and 5 years | Stroke and transient ischemic attack |
| Major bleeding | 6 months | Haemorrhagic complications |
| Unstable angina | 6 and 12 months, 3 and 5 years | Unstable angina including ECG-changes at 6 and 12 months, 3 and 5 years |
| All cause mortality | 6 and 12 months, 3 and 5 years | All cause mortality at 6 and 12 months, 3 and 5 years |
| Revascularization | 6 and 12 months, 3 and 5 years | Any revascularization at 6 and 12 months, 3 and 5 years |
| Target lesion failure | 6 and 12 months, 3 and 5 years | Failure and/or revascularization by percutaneous or surgical methods of the target lesion |
| Stent thrombosis | 6 and 12 months, 3 and 5 years | Stent thrombosis at 6 and 12 months, 3 and 5 years |
| Cost effectiveness analysis | 6 and 12 months, 3 and 5 years | 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) |
| Quality of life | 6 and 12 months, 3 and 5 years | Quality of life questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years |
| Coronary angiography | 6 and 12 months, 3 and 5 years | Coronary angiography at 6 and 12 months, 3 and 5 years |
Countries
Netherlands
Outcome results
None listed