Research presented Nov. 2 at the Transcatheter Cardiovascular Therapeutics scientific symposium in Denver demonstrates patients with stable coronary artery disease (CAD) and abnormal fractional flow reserve (FFR) derive better clinical outcomes with PCI at similar cost to medical therapy alone.
A total of 888 patients were randomly assigned to either PCI or medical therapy alone during the prospective clinical trial conducted at 28 sites in Europe and North America. All patients had stable angina; one, two or three-vessel CAD, and FFR of 0.80 or less in at least one major coronary artery.
Major adverse cardiac events (MACE)—a composite of death, MI and urgent revascularization—occurred in 10.1 percent of the PCI group compared to 22 percent of the medical therapy group over three years of follow-up. This difference was driven primarily by a lower rate of urgent revascularization for PCI (4.3 percent versus 17.2 percent). Overall, 10.3 percent of patients in the PCI group experienced a repeat vascularization—including urgent and non-urgent procedures—while 44.2 percent in the medical therapy group eventually required a PCI.
Initial procedural and hospitalization costs were higher in the PCI group mostly due to the cost of the procedure, but follow-up costs were higher in the medical therapy group. Mean cumulative costs at three years were $16,792 for PCI and $16,737 for medical therapy, a nonsignificant difference.
But based on the improved clinical outcomes, the incremental cost-effectiveness ratio for PCI compared with medical therapy was $17,300 per quality adjusted life year (QALY) at two years and $1,600 per QALY at three years—both well below the established threshold of $50,000 per QALY.
“Compared with medical therapy alone, performing PCI in patients with stable CAD and at least one coronary lesion with an abnormal FFR leads to improved clinical outcomes, less angina, and improved quality of life at similar cost over three years of follow-up,” said lead researcher William F. Fearon, MD, from Stanford University Medical Center. “With better clinical outcomes at similar cost, PCI of coronary lesions with reduced FFR is an economically attractive strategy.”
Fearon and colleagues reported in Circulation that trial enrollment ended early based on advice from the Data Safety Monitoring Board, which could have enhanced the differences between PCI and medical therapy. Also, the differences for death and MI were nonsignificant between the two strategies.