The Define PCI (Physiologic Assessment of Coronary Stenosis Following PCI) study showed that if patients with residual ischemia had been treated upfront, the rate of significant ischemia could theoretically be reduced from 24% to 5%, according to the study's research team.
In the majority of those patients (82%), the residual ischemia was the result of a focal, potentially treatable lesion, which suggests the patients could have benefited from instant wave-free ratio (iFR) co-registration, Philips said. Using iFR co-registrations also means physicians could have planned stent length and placed a virtual stent to predict physiologic improvement before performing an intervention.
The blinded, multicenter study assessed the level of residual ischemia found in 500 patients after PCI and demonstrated that patients whose baseline ischemia was more effectively treated had improved outcomes and less angina after one year. Patients with a post-PCI iFR of ≥ 0.95 had 68% fewer clinical events than patients with less than optimal post-PCI iFR values (1.8% vs. 5.7%), Philips said.
Next, the firm is sponsoring Define GPS, a randomized, controlled prospective trial to evaluate whether iFR co-registration guidance improves patient outcomes. The study will include up to 3,000 participants at approximately 100 sites globally with enrollment expected to begin in the first quarter of 2021.
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