However, with additional time for further data analysis, Dr. Al-Lamee reported at EuroPCR 2018 that, in fact, the degree of ischemia seen on baseline iFR and FFR entirely predicted the extent of objective improvement in ischemia on dobutamine stress echocardiography in response to PCI. The 25% of participants whose iFR and FFR were greater than the generally accepted thresholds for intervention did not derive any significant placebo-subtracted benefit from PCI. In contrast, the lower the baseline FFR and iFR values – meaning the greater the impairment of blood flow across a stenotic lesion – the greater the reduction in ischemia in response to true PCI.
Moreover, patients who underwent real PCI were 2.47-fold more likely than were those who received sham PCI to experience freedom from angina at follow-up as measured by the Seattle Angina Questionnaire. That translates to an impressively low number-needed-to-treat of 5, noted Dr. Al-Lamee, ORBITA principal investigator and an interventional cardiologist at Imperial College London.Of note, at the end of the 6-week blinded study period, 85% of patients in the control group opted for PCI.
“This is the trial everyone is talking about. Even on Twitter, it’s really dominating,” observed discussant Davide Capodanno, MD, PhD, of the University of Catania, Italy. “And this new freedom from angina endpoint, this is a win for PCI.”