Fullständig revaskularisering hos patienter med hjärtinfarkt och flerkärlssjukdom - en registerbaserad randomiserad klinisk prövning (FULL REVASC)

Bakgrund:

The best strategy for ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) with remaining multivessel disease, is still not well established. Current guidelines state that you should consider to perform non-culprit PCI in patients with STEMI.

Fractional flow reserve (FFR), a method used to determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI in patients with stable angina. However, it is not clear whether FFR should be performed in non-culprit lesions in patients with STEMI and multivessel disease.

Målsättning:

To test the main hypothesis that a strategy of systematic complete revascularization with FFR-guided PCI following acute STEMI/rescue-PCI/risk assessment following successful thrombolysis/very high risk NSTEMI leads to improved clinical outcomes at two years compared to initial conservative management.

Arbetsplan:

The trial is a prospective international multicentre registry-based randomized controlled trial (RRCT) with combined primary endpoint of all-cause mortality, non-fatal MI and unplanned revascularization at one year. 1545 patients with acute STEMI with multi-vessel disease will be randomized into 2 arms:

1. FFR-guided PCI of non-culprit lesions during index hospital admission or 2. Initial conservative management following acute PCI of the culprit lesion

Randomization and data collection is performed directly in the registry for coronary angiography in Sweden. Patients in other countries will be randomized through a separate web page. Adjudication of clinical events and collection of data from other registries including death cause registries will be performed.

Betydelse:

Cardiovascular disease is common and potentially lethal. Current guidelines state that you should consider to perform non-culprit PCI in patients with STEMI. However, we do not know if this strategy affects hard endpoints and whether FFR should be used.

All 1545 patients have now been included in this multicentre international RRCT. Following this study we will know whether FFR-guided PCI of non-culprit lesions in STEMI affects hard clinical endpoints like death, MI and unplanned revascularizations compared to conservative management of non-culprit lesions. The expected results of the study will potentially have great impact on how we should treat patients with STEMI and multivessel disease.