iFR noninferior to FFR for revascularization in patients with stable angina, ACS
WASHINGTON — At 1 year, rates of MACE in patients who underwent revascularization guided by instantaneous wave-free ratio were comparable to those in patients who underwent revascularization guided by fractional flow reserve, according to data from two studies presented at the American College of Cardiology Scientific Sessions.
Both studies — DEFINE-FLAIR and IFR-SWEDEHEART — enrolled patients with stable angina or ACS who were indicated for physiologically guided assessment of a coronary lesion. The primary endpoint in both studies was a composite of all-cause mortality, nonfatal MI or unplanned revascularization within 12 months after the procedure.
In DEFINE-FLAIR, Justin Davies, MBBS, PhD, consultant cardiologist at Imperial College London, and colleagues randomly assigned 2,492 patients at 49 centers in 17 countries to undergo iFR-guided (n = 1,242) or FFR-guided revascularization (n = 1,250). The margin for noninferiority was 3.4 percentage points for the difference in risk.
Among patients who received iFR, 45% underwent PCI, 2% underwent CABG and treatment was deferred in 53%. Among those who received FFR, 50% underwent PCI, 3% underwent CABG and treatment was deferred in 47%.
The primary endpoint occurred in 6.79% of patients who underwent if-guided revascularization and 7.02% of those who underwent FFR-guided revascularization, with a difference of 0.2 percentage points (95% CI, 2.3 to 1.8; P < .001 for noninferiority; HR = 0.95; 95% CI, 0.68-1.33), according to the study results. There were no significant differences between the two groups for any of the individual components of the primary endpoint.
Event rates were also similar between patients in the iFR group and the FFR group in whom treatment was deferred, with MACE occurring in 4.7% of patients who received iFR and 6.14% of those who received FFR (P = 0.26).
However, the iFR group, compared with the FFR group, had considerably fewer procedural symptoms and clinical signs (3.1% vs. 30.8%; P < .001), which included dyspnea (1% vs. 20%), chest pain (1.5% vs. 7.2%), heart rhythm disturbances (0.2% vs. 4.8%), hypotension (0.3% vs. 1%) and serious adverse events such as bronchospasm or ventricular tachycardia (0.1% vs. 0.6%).
Procedure time was shorter by 4.5 minutes with iFR vs. FFR (40.5 vs. 45 minutes; P = .001).
“This study confirms that in patients with stable angina or ACS and coronary stenosis, iFR or FFR can safely guide coronary revascularization, and iFR improves procedural safety and reduces time,” Davies said.
iFR SWEDEHEART, conducted by Matthias Götberg, MD, PhD, of Lund University and Skane University Hospital in Sweden and colleagues, employed a registry-based randomized, controlled clinical trial design using data from the Swedish Coronary Angiography and Angioplasty Registry. A total of 2,037 patients were randomly assigned to iFR-guided revascularization (n = 1,012) or FFR-guided revascularization (n = 1,007). The margin for noninferiority was 3.2 percentage points.
Importantly, no patients were lost to follow-up, Götberg said.
Similar to results from DEFINE-FLAIR, rates of the primary endpoint were similar between the iFR group and the FFR group (6.7% vs. 6.1%), with a difference in event rates of 0.7 percentage points (95% CI, 1.5 to 2.8; P = .007 for noninferiority; HR = 1.12; 95% CI, 0.79-1.58).
There were also no significant differences between groups in secondary endpoints, including the individual components of the primary endpoint as well as target lesion revascularization, restenosis or stent thrombosis, at 12 months.
Procedural symptoms were significantly different, with 3% of the iFR group vs. 68.3% of the FFR group experiencing chest discomfort (P < .0001).
“iFR-SWEDEHEART demonstrates that iFR is a safe and feasible alternative to FFR in physiology-guided revascularization,” Götberg said during his presentation.
In an editorial published in The New England Journal of Medicine, Deepak L. Bhatt, MD, MPH, Chief Medical Editor of Cardiology Today’s Intervention, commented on the potential implications of the findings from DEFINE-FLAIR and iFR-SWEDEHEART.
“In the treatment of stable coronary lesions, PCI is performed primarily for control of angina, and the use of if could help to guide decisions regarding PCI more rationally,” Bhatt, executive director of interventional cardiology programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, wrote.
“In the future, it would be an advance if noninvasive methods that provide simultaneous anatomical and physiological assessment of coronary lesions could supplant the need for invasive angiography. Nevertheless, there will always be patients in the catheterization laboratory who have a coronary stenosis of intermediate severity on angiography,” he wrote. “FFR has been the evidence-based standard for invasive evaluation of such lesions, but it now appears that if may be the new standard.” – by Melissa Foster
Götberg M. Late-Breaking Clinical Trials: Interventional. Presented at: American College of Cardiology Scientific Sessions; March 17-19, 2017; Washington, D.C.
Davies JE. N Engl J Med. 2017;doi:10.1056/NEJMe1702728.
Götberg M. N Engl J Med. 2017;doi:10.1056/NEJMoa1616540.
Disclosure: Davies reports financial ties with Medtronic and Volcano Corp. Götberg reports receiving consultant fees, honoraria and/or research grants from Boston Scientific, Medtronic and Volcano Corp. Bhatt reports receiving research grants, personal fees or other financial ties with Amarin, Amgen, AstraZeneca, Biotronik, Boston Scientific, Bristol-Myers Squibb, Cardax, Chiesi, Eisai, Eli Lilly, Ethicon, FlowCo, Forest Laboratories, Ironwood, Ischemix, Medtronic, Pfizer, PLx Pharma, Regado Biosciences, Roche, Sanofi Aventis, St. Jude Medical, Takeda and The Medicines Company.