May 16, 2012 — A groundbreaking international trial, presented yesterday at EuroPCR, has demonstrated for the very first time the true value of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease. The study highlights the critical importance of targeting these interventions to patients with ischemia and may revolutionize the patient selection procedure for PCI.
The FAME II study is the first of its kind and has shown that targeting fractional flow reserve (FFR)-guided PCI and optimal medical treatment (OMT) to patients with ischemia (having at least one stenosis with FFR ≤ 0.80) can reduce the need for revascularization by a factor of between 6 - 11 compared with OMT alone. This study also provides clear evidence that patients without ischemia do not need to undergo PCI and can be successfully managed using OMT alone.
This randomized, prospective study was conducted among a cohort of over 1,200 patients across 28 centers in Europe and the US. Patients with ischemia were randomized to receive either FFR-guided PCI and OMT, or OMT alone. PCI was conducted using the very latest second-generation drug-eluting stent systems (DES). Patients without ischemia received treatment with OMT alone. The primary end point recorded was a composite of all-cause death, myocardial infarction (MI) and unplanned hospitalization leading to urgent revascularization. Patients were only considered as urgent revascularization cases if they entered the hospital through the emergency ward and their revascularization procedure was performed during the same hospitalization episode, or if they presented at the clinic with increased angina symptoms requiring urgent revascularization.
Bernard DeBruyne believes that these results will have a major impact on clinical practice and outcomes for these patients. “This study has the potential to change the way that we target treatment in the future. Many patients in whom we consider placing stents have no ischemia; this study has shown us that these patients can do very well with medical treatment alone. Targeting PCI to the right patients and the right lesions using second-generation DES systems can have a major impact on the success rate for these interventions.”
The study was halted prematurely due to an overwhelming difference in primary end point outcomes between the treatment arms, with a major advantage for PCI and OMT. The safety management board (SMB) considered that it was not ethically or scientifically justified to submit patients to a risk that had been identified. Patient enrolment began in May 2010 and the study was halted in January 2012, with 90% of recruitment taking place in 2011.