(In para 13, corrects typo (changes 3.1 to 13.1).)
By Marilynn Larkin
NEW YORK (Reuters Health) - Fractional flow reserve (FFR) can help guide cardiovascular disease management strategies, including revascularization deferral, for patients with diabetes, a cross-sectional study suggests.
Approximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes and often influences revascularization decisions, note Dr. Luis Raposo of Santa Cruz Hospital in Carnaxide, Portugal, and colleagues.
"Although patients with diabetes have been included in randomized FFR trials, specific data on the utility and safety of using FFR in this subset were lacking, and published reports are somewhat controversial concerning its potential pitfalls," Dr. Raposo told Reuters Health on behalf of the authors. "This was why we decided to undertake the study."
The study included data from two large registries of patients in 40 centers in France and in Portugal, and "reflects real-world practice and a robust mix of clinical scenarios," he said by email.
"Our results are very reassuring," he noted. "As such, clinicians and interventionalists managing these patients should be encouraged to use and rely on FFR for risk stratification and decision making."
"Of relevance," he added, "clinical events were not increased in patients treated in a different way, other than that suggested by angiographic findings alone; and, although the proportion of patients ultimately undergoing revascularization was actually higher in diabetics, those in whom revascularization was deferred based on an FFR >0.80 had an event rate that was reasonably low and comparable to deferred patients without diabetes."
As reported in JAMA Cardiology, the study included all-comers in whom angiography disclosed ambiguous lesions. Rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, were analyzed for patients with and without diabetes.
Investigators prospectively defined a baseline management strategy for each patient based on coronary angiography findings and available clinical information before FFR was performed. After FFR, a final management strategy was defined and recorded. Options included medical therapy, percutaneous coronary intervention or coronary artery bypass surgery.
FFR was considered to have been disregarded whenever treatment was performed contrary to the FFR result - for example, revascularization when FFR was >0.80.
Among 1,983 patients (mean age, 65; 77% male), 701 had diabetes. FFR was performed for 1.4 lesions per patient, with 58.2% located in the left anterior descending artery (mean stenosis, 56%; mean FFR, 0.81).
Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs. 37.5%); however, reclassification from medical treatment to revascularization was more frequent in diabetics (41.5% vs. 31.5%).
One-year rates of major adverse cardiovascular events (MACEs) were similar in reclassified (9.7%) and nonreclassified patients (12%).
Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (8.4%) compared with those undergoing revascularization (13.1%), and the rate was of the same magnitude as the rate among deferred patients without diabetes (7.9%).
Insulin status was not associated with outcomes. Patients in whom FFR was disregarded (6.6%) had the highest MACE rates, regardless of diabetes status.
Dr. Leandro Slipczuk, Director of Advanced Cardiac Imaging at Montefiore Einstein Center in New York City, told Reuters Health, "These findings demonstrate the importance of cardiometabolic medical therapy in high-risk patients. Longer follow-up of current data will be important, as it may reveal different outcomes. The type of medical therapy and goals achieved in different groups should also be taken into account."
"The assessment of plaque characteristics and the appropriate medical and interventional therapies remain highly debated," he said by email. "In particular, the decision to defer revascularization in a diabetic patient with multivessel disease should be thought (about) with caution."
"It is my opinion that in most cases a physiological assessment should guide revascularization, and medical therapy should be optimized in particular in high-risk diabetic patients," he added. "Intensification of medical therapy requires a multidisciplinary team with expertise in lipid, diabetic and hypertensive management, together with nutrition and lifestyle counseling."
The study was supported by grants from Abbott and Biotronik. Dr. Raposo and two coauthors reported receiving fees from Abbott.
SOURCE: http://bit.ly/2NsL8Kd JAMA Cardiology, online January 8, 2020.