Does flow measurement guided stenting of non-culprit lesions as compared with visual assessment guided stenting in patients presenting with a heart attack improve outcomes.
A randomized controlled trial to investigate Fractional Flow Reserve (FFR) guided intervention compared to visual assessment of non-culprit lesions in patients presenting with non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) on cardiac death, MI and revascularization
Professor Harvey White
850 participants
Apr 10, 2015
Interventional
Conditions
Summary
The study hypothesis is that assessing the efficacy of stenting heart arteries other than those that caused a heart attack, either by assessing the narrowings by visual assessment or by measuring blood flow across the narrowings, will result in different patient outcomes and costs. Both approaches are used in clinical practice but it not known which is better. There will be 850 patients randomized to either of these approaches and patients will be followed for 2 years. Outcomes will be assessed by National records with names anonymised and will include heart related deaths, heart attacks and need for stenting or bypass surgery. The cost-effectiveness of each approach will also be compared by counting the costs of each procedure and outcomes.
Eligibility
Inclusion Criteria1
- Patients with STEMI undergoing primary angioplasty, rescue PCI or PCI following fibrinolytic therapy, or PCI for non-STEMI
Exclusion Criteria1
- Left main coronary artery disease, previous bypass surgery, cardiogenic shock, extremely tortuous or calcified coronary vessels, life expectancy < 2years, pregnancy, contraindications to DES placement, Patients in whom the preferred strategy is CABG, contraindications to dual antiplatelet therapy, LVEF<30%,randomization previously in the trial
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Interventions
Fractional flow reserve (FFR)-guided stenting vs. visual assessment stenting. FFR will be measured with a coronary pressure wire (St Jude Medical) with maximum hyperaemia achieved using adenosine administered at a rate of 140ug per kilogram per minute over 3 minutes given via a central vein. The procedure takes approximately 15 minutes and the distal pressure beyond a coronary stenosis is compared to a proximal pressure reflecting aortic pressure
Locations(1)
View Full Details on ANZCTR
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ACTRN12615000321549