None listed
Conditions
Brief 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.
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
Sponsors
Professor Harvey White
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with STEMI undergoing primary angioplasty, rescue PCI or PCI following fibrinolytic therapy, or PCI for non-STEMI
Exclusion criteria
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
Outcome results
None listed