FAME 2: PCI improves outcomes in stable CAD, abnormal FFR

William F. Fearon

Patients with stable coronary disease and an abnormal fractional flow reserve who underwent PCI in addition to medical therapy had improved outcomes and similar costs to those who received medical therapy alone, according to data presented at TCT 2017.

As Cardiology Today’s Intervention has previously reported, 2-year outcomes of the FAME 2 trial were presented at the European Society of Cardiology Congress in 2014, and patients with stable CAD who received FFR-guided PCI had a reduction in the composite endpoint of nonfatal MI, all-cause death or urgent revascularization.

“The key difference between FAME 2 and previous studies like COURAGE is that FFR was measured in all target lesions,” William F. Fearon, MD, professor of cardiovascular medicine, member of the Cardiovascular Institute and director of interventional cardiology at Stanford University School of Medicine, said during a press conference. “The reason this was important is because in one-quarter of the patients who were planned to be enrolled in FAME 2, all of their lesions had FFRs above 0.8, and we know that these patients do just as well with medical therapy as compared with PCI.”

Researchers analyzed data from 1,220 patients with stable CAD who were scheduled for one-, two- or three-vessel drug-eluting stent PCI. FFR was performed in all target lesions. Patients in the randomized trial (n = 888) had at least one stenosis with FFR up to 0.8 and were assigned to PCI with medical therapy or medical therapy alone. Those in the registry (n = 332) had FFR above 0.8.

“In previous studies, they were included in the randomized trial and likely diluted any potential benefit from PCI,” Fearon said.

Patients were followed up periodically up to 5 years.

At 3 years, patients assigned PCI with medical therapy had significantly lower rates of MACE (10.1% vs. 22%), death (2.7% vs. 3.6%), MI (6.3% vs. 7.7%) and urgent revascularization (4.3% vs. 17.2%) compared with patients assigned medical therapy alone.

The percentage of patients with class II to IV angina at each time point was significantly lower in the PCI arm vs. the medical therapy arm.

“This was despite the fact that patients in the PCI arm received significantly fewer amounts of antianginal medications and despite the fact that patients in the medical therapy arm, almost 50% crossed over to PCI sometime during the 3 years of follow-up,” Fearon said during the press conference.

Costs at baseline were higher for the PCI group ($9,944) compared with the medical therapy only group ($4,439), but there was no difference in total cost between the two groups at 3 years.

Patients assigned PCI had higher quality-adjusted life-years at 2 years (1.716) compared with those assigned medical therapy only (1.691; P = .23). Costs were also higher in the PCI group vs. the medical therapy only group ($14,853 vs. $14,421; P = .56), which led to an incremental cost-effectiveness ratio of $17,300 per QALY for the PCI group. At 3 years, the ratio per QALY was $1,600 for those assigned PCI.

“These results were robust on a variety of sensitivity analyses, including eliminating the cost of the initial angiogram and FFR from the medical therapy group,” Fearon said.

“Since heart disease is a major driver of health care costs, treatments that improve clinical outcomes for patients, while also being cost-effective, are increasingly important to health care systems and payors,” Chuck Brynelsen, senior vice president of Abbott Vascular, said in a press release. “These data demonstrate that FFR-guided stenting in combination with medical therapy can have greater long-term benefits for patients, as well as health systems, over medical therapy alone.” – by Darlene Dobkowski

Reference:

Fearon WF, et al. Late-Breaking Clinical Trials 4. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.

Fearon WF, et al. Circulation. 2017;in press.

Disclosure: The FAME 2 trial was funded by St. Jude Medical. Fearon reports he received grant/research support from Abbott, ACIST, CathWorks, Edwards Lifesciences and Medtronic; and has minor stock options with HeartFlow.