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OCT confers improved outcomes vs. FFR for intermediate lesions: FORZA
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SAN FRANCISCO — Guidance with OCT led to a lower occurrence of significant angina or the composite of MACE compared with guidance with fractional flow reserve in patients with angiographically intermediate coronary lesions, according to 13-month data from the FORZA trial presented at TCT 2019.
FFR was also linked to an increased rate of medical management and lower costs, according to the presentation.
Results from this trial were simultaneously published in JACC: Cardiovascular Interventions.
“This is the first trial comparing OCT vs. FFR in patients with coronary artery disease,” Francesco Burzotta, MD, PhD, director of the valve heart diseases clinical pathway, head of the stable heart diseases unit and senior interventional cardiologist at Gemelli University Hospital in Rome and assistant professor at the Institute of Cardiology at Catholic University of the Sacred Heart in Rome, said during the press conference. “The selection of OCT is safe, causes an initially higher number of PCIs — it was doubled as compared to FFR — but is associated with lower occurrence of the combined endpoint.”
Patients with coronary lesions
Researchers analyzed data from 350 patients with 446 angiographically intermediate coronary lesions. For this study, angiographically intermediate coronary lesions were defined as a coronary lesion with an estimated percentage diameter stenosis between 30% and 80% in a major epicardial vessel.
Patients were assigned either FFR (n = 176; mean age, 68 years; 72% men) or OCT (n = 174; mean age, 69 years; 78% men). PCI was performed if FFR was less than 0.8. For patients assigned OCT, PCI was performed when at least one of the following were met: aortic stenosis between 50% and 75% and minimal lumen area less than 2.5 mm2, aortic stenosis greater than 75%, and aortic stenosis between 50% and 75% and plaque rupture.
“We tried to not overtreat patients, so we relied on the presence of severe stenosis,” Burzotta said during the press conference.
Costs were assessed at 13-month follow-up in addition to the primary endpoint, which was significant angina or the composite of MACE at 13 months. MACE was defined as MI, death or target vessel revascularization.
At 13 months, MACE or significant angina occurred in 14.8% of patients assigned FFR and 8% in those assigned OCT (P = .048). This was primarily driven by a lower occurrence of all components of the primary endpoint that was not statistically significant.
“When you perform OCT before performing PCI, you have all the measures for the interventionalist to select the best stent, the best technique, the best optimization,” Burzotta said during the discussion portion of the press conference. “Then you assess after stenting your result, and if you are not satisfied, you may optimize. You have precision for the treatment of the lesion that cannot be matched with any other technique.”
Medical management, costs
The FFR group had more patients who were medically managed compared with the OCT group (62.5% vs. 44.8%; P < .001). These patients also had significantly lower costs (2,577 euros; 95% CI, 2,038-3,470) compared with those assigned OCT (3,750 euros; 95% CI, 2,734-4,503).
“The observed results open the door for further evaluations of imaging guidance in the management of coronary artery disease patients presenting with different angiographic or clinical features,” Burzotta and colleagues wrote. – by Darlene Dobkowski
References:
Burzotta F. Late-Breaking Science 4. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Burzotta F, et al. JACC Cardiovasc Interv. 2019;doi:10.1016/j.jcin.2019.09.034.
Disclosures: Burzotta reports he receives speakers fees from Abbott, Abiomed and Medtronic. Please see the study for all other authors’ relevant financial disclosures.