Abbott touts reduced major adverse cardiac events in 5-year PressureWire study
Abbott (NYSE:ABT) today released five-year results from the Fame 2 study exploring the benefits of heart stent procedures guided by the company’s PressureWire fractional flow reserve diagnostic tool, touting reduced major adverse cardiac events.
Researchers in the study analyzed data from 733 patients with stable coronary artery disease who had significant blockages or narrowing of the arteries as determined by FFR, the company said.
Results from the trial indicated a 13.9% of patients in the FFR-guided PCI group experienced a major adverse cardiac event, significantly less than the 27% MACE rate reported in the medical therapy group. Abbott said that the lower rate of MACE was driven by reduced urgent revascularization.
Patients in the FFR-guided PCI cohort experienced fewer heart attacks than the non FFR-guided cohort, at 8.1% versus 12%, respectively. Rates of all-cause mortality were 5.1% for the FFR cohort versus 5.2% in the medical therapy only group, Abbott reports.
“For the first time, a study has shown that patients with stable coronary artery disease who received a stent guided by an FFR diagnostic had a benefit over medical therapy alone, including fewer heart attacks and needs for urgent revascularization. Data from this study confirm the importance of FFR-guided stenting decisions combined with medical therapy over medical therapy alone,” principal investigator Dr. Bernard De Bruyne of Belgium’s Cardiovascular Center Aalst, Onze Lieve Vrouw Ziekenhuis said in a press release.
Abbott also presented data from a second study exploring the company’s resting full-cycle ratio diagnostic test, which uses a different approach to FFR that analyzes the heart at rest instead of during stress.
A study of 672 coronary artery narrowings from 504 patients aimed to compare the RFR test with instant wave-free radio diagnostics, also used to measure blood flow in resting hearts.
Data from the study showed that RFR was highly correlated to iFR and diagnostically equivalent to 1%, Abbott said. The RFR technlogy is currently pending an FDA 510(k) clearance and CE Mark approval in the European Union.
“We’re committed to bringing life-saving technologies to people with heart disease including diagnostic tools that help doctors make treatment decisions, which lead to better outcomes for patients. These results continue to support that measuring blood flow prior to implanting a stent is an effective way to help doctors determine which vessels to treat, and can improve patient outcomes over medical therapy alone,” Abbott vascular biz chief medical officer Dr. Charles Simonton said in a prepared statement.
