In the Journals

FFR may confer treatment reclassification in CAD, diabetes

Eric Van Belle

Routine use of fractional flow reserve to manage CAD among patients with diabetes may be linked to an increased rate of treatment reclassification, according to a study published in JAMA Cardiology.

“Our results in this large, multicenter, international cohort are very reassuring regarding the use of invasive physiology (FFR) at time of coronary angiography,” Eric Van Belle, MD, PhD, head of the department of cardiology at Centre Hospitalier Régional Universitaire Lille in France, told Healio. “As such, clinicians and interventionalists managing these patients should definitely be encouraged to use and rely on FFR for risk stratification and decision-making in patients with diabetes mellitus.”

Researchers analyzed data from 1,983 patients (mean age, 65 years; 77% men; 35% with diabetes) from the PRIME-FFR study, which resulted from merging the R3F and POST-IT cohorts. Patients were referred for coronary angiography at 40 centers in Europe. Clinical and angiographic measures were recorded at baseline.

Patient management strategy reclassification was defined as difference between the baseline and final strategies. Revascularization deferral was considered when the final strategy was to treat all lesions after FFR without performing a revascularization procedure.

The primary endpoint was a composite of MI, all-cause death or unplanned revascularization at 12 months. Information on angina status was also obtained at 1 year.

Patients with diabetes were more likely to have an FFR evaluation more extensively performed compared with those without diabetes (1.4 lesions vs. 1.3 lesions; P = .007). The investigated lesions in patients with diabetes was in the left anterior descending artery in 58.2% of the cases. The mean stenosis for patients with diabetes was 56% with a mean FFR of 0.81.

There were high and similar rates of reclassification by FFR in patients with and without diabetes (41.2% vs. 37.5%, respectively; P = .13). Despite this, reclassification from medical treatment to revascularization was more common among patients with diabetes vs. without diabetes (41.5% vs. 31.5%; P = .001). The rates of MACE were similar for patients who were reclassified and those who were not reclassified (9.7% vs. 12%, respectively; P = .37).

FFR-based deferral was able to identify patients with diabetes with a lower risk for MACE at 12 months vs. those who underwent revascularization (8.4% vs. 13.1%; P = .04). This rate was similar for patients without diabetes who were deferred (7.9%; P = .87). Insulin treatment status was not linked to outcomes.

The highest rates of MACE were seen in 6.6% of patients in whom FFR was disregarded regardless of diabetes status.

“There are several reports in the literature and also some ongoing prospective studies looking at the relationships between coronary anatomy, plaque composition, microvascular function and various physiological indexes, such as FFR, index of microcirculatory resistance and coronary flow reserve,” Van Belle said in an interview. “However, to our best knowledge, no randomized trial, either in the past or actively enrolling, specifically addresses this issue from a clinical perspective, despite patients with diabetes have actually been included in seminal randomized controlled trials.” – by Darlene Dobkowski

For more information:

Eric Van Belle, MD, PhD, can be reached at ericvanbelle@aol.com; Twitter: @eric_van_belle.

Disclosures: Van Belle reports he received personal fees from Abbott (St. Jude Medical) and Philips Volcano. Please see the study for all other authors’ relevant financial disclosures.

Eric Van Belle

Routine use of fractional flow reserve to manage CAD among patients with diabetes may be linked to an increased rate of treatment reclassification, according to a study published in JAMA Cardiology.

“Our results in this large, multicenter, international cohort are very reassuring regarding the use of invasive physiology (FFR) at time of coronary angiography,” Eric Van Belle, MD, PhD, head of the department of cardiology at Centre Hospitalier Régional Universitaire Lille in France, told Healio. “As such, clinicians and interventionalists managing these patients should definitely be encouraged to use and rely on FFR for risk stratification and decision-making in patients with diabetes mellitus.”

Researchers analyzed data from 1,983 patients (mean age, 65 years; 77% men; 35% with diabetes) from the PRIME-FFR study, which resulted from merging the R3F and POST-IT cohorts. Patients were referred for coronary angiography at 40 centers in Europe. Clinical and angiographic measures were recorded at baseline.

Patient management strategy reclassification was defined as difference between the baseline and final strategies. Revascularization deferral was considered when the final strategy was to treat all lesions after FFR without performing a revascularization procedure.

The primary endpoint was a composite of MI, all-cause death or unplanned revascularization at 12 months. Information on angina status was also obtained at 1 year.

Patients with diabetes were more likely to have an FFR evaluation more extensively performed compared with those without diabetes (1.4 lesions vs. 1.3 lesions; P = .007). The investigated lesions in patients with diabetes was in the left anterior descending artery in 58.2% of the cases. The mean stenosis for patients with diabetes was 56% with a mean FFR of 0.81.

There were high and similar rates of reclassification by FFR in patients with and without diabetes (41.2% vs. 37.5%, respectively; P = .13). Despite this, reclassification from medical treatment to revascularization was more common among patients with diabetes vs. without diabetes (41.5% vs. 31.5%; P = .001). The rates of MACE were similar for patients who were reclassified and those who were not reclassified (9.7% vs. 12%, respectively; P = .37).

FFR-based deferral was able to identify patients with diabetes with a lower risk for MACE at 12 months vs. those who underwent revascularization (8.4% vs. 13.1%; P = .04). This rate was similar for patients without diabetes who were deferred (7.9%; P = .87). Insulin treatment status was not linked to outcomes.

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The highest rates of MACE were seen in 6.6% of patients in whom FFR was disregarded regardless of diabetes status.

“There are several reports in the literature and also some ongoing prospective studies looking at the relationships between coronary anatomy, plaque composition, microvascular function and various physiological indexes, such as FFR, index of microcirculatory resistance and coronary flow reserve,” Van Belle said in an interview. “However, to our best knowledge, no randomized trial, either in the past or actively enrolling, specifically addresses this issue from a clinical perspective, despite patients with diabetes have actually been included in seminal randomized controlled trials.” – by Darlene Dobkowski

For more information:

Eric Van Belle, MD, PhD, can be reached at ericvanbelle@aol.com; Twitter: @eric_van_belle.

Disclosures: Van Belle reports he received personal fees from Abbott (St. Jude Medical) and Philips Volcano. Please see the study for all other authors’ relevant financial disclosures.