Discussant Philip Urban, MD, director of interventional cardiology at Hospital de la Tour in Geneva, said the take-home message from FAME 2 for him was simple: “If it ain’t broke, don’t fix it; but if it is, don’t procrastinate.”
Martin B. Leon, MD, observed that, up until now, when he has discussed with patients who have stable CAD the possibility of undergoing PCI, he has described the potential benefits as being reduced ischemia and improved symptoms with no significant impact on the hard endpoints of acute MI or death. FAME 2 has changed all that.
“What I really enjoyed about this presentation is that you dissected the improvement and demonstrated clearly that spontaneous MIs are in fact reduced with PCI in patients with stable CAD, which is a hard endpoint. And I would even argue that yours is a minimalistic analysis in the sense that many of the urgent revascularization patients likely would have ended up being nontransmural MIs as well. So I think this gives credence to the understanding that PCI not only affects ischemia but also affects the hard endpoint of spontaneous MI. And you need a large study like this with a 5-year endpoint to clarify those issues,” noted Dr. Leon, professor of medicine at Columbia University in New York.
ORBITA revisited
ORBITA was the first-ever randomized blinded trial of real versus sham PCI in patients with stable CAD. When Rasha Al-Lamee, MD, presented the primary results at the TCT 2017 conference in Denver, reporting that PCI failed to show a significant improvement in exercise time compared with placebo PCI, reaction was swift and furious. Interventionalists criticized the study’s choice of treadmill exercise time as an inappropriately squishy primary endpoint. Noninterventionalists saw ORBITA as confirming their view that many interventional cardiologists are catheter cowboys.