Femoropopliteal DCB effective in women, patients with diabetes, CTO

A drug-coated balloon was effective in women, in patients with diabetes and in those with chronic total occlusions, according to new data.

Analyses of patients with femoropopliteal lesions from those subgroups receiving the DCB (In.Pact Admiral, Medtronic) were presented at the Charing Cross International Symposium in London.

Women, diabetes

Peter A. Schneider, MD, presented results for women and patients with diabetes in the IN.PACT SFA study of patients with superficial femoral artery disease. He said women have had lower rates of success with some DCBs than men, and patients with diabetes often present with complex forms of peripheral artery disease that can be difficult to treat.

Peter A. Schneider

“The IN.PACT trial was extremely successful from a scientific standpoint in knowing that this particular [DCB] works in this setting,” Schneider, chief of vascular therapy at Kaiser Foundation Hospital, Honolulu, told Cardiology Today’s Intervention. “In addition, the two groups where we have traditionally struggled to get good results — diabetic patients and the female cohort — had very clear positive benefits. For a subset analysis of a randomized trial, this was as unambiguous as it gets in demonstrating the advantage of this device in these high-risk, high-worry patients.”

For both analyses, he presented 2-year outcomes of the primary efficacy endpoint of primary patency, defined as freedom from clinically driven target lesion revascularization and duplex ultrasound-derived restenosis, and the primary safety endpoint of freedom from device- and procedure-related death, target limb major amputation and clinically driven TLR.

Among the women in the IN.PACT SFA study (mean age, 70 years), 77 were assigned the DCB and 36 were assigned percutaneous transluminal angioplasty (PTA).

According to the results, at 2 years, primary patency for women was 76.7% in the DCB group and 42.3% in the PTA group (P = .0035), and a similar difference was seen in men (P < .001), whereas freedom from clinically driven TLR in women was 87.4% for the DCB group vs. 62.5% for the PTA group (P < .001), with men having a similar difference (P < .001).

There were 89 patients with diabetes assigned to DCB (mean age, 67 years; 65% men) and 54 assigned to PTA (mean age, 67 years; 74% men).

In patients with diabetes, the 2-year primary patency rate was 73.3% in the DCB group and 45.8% in the PTA group (P = .0025), reflecting a similar difference seen in those without diabetes (P < .001), Schneider reported.

The rate of freedom from clinically driven TLR at 2 years for patients with diabetes was 90% in the DCB group and 71.4% in the PTA group (P = .003), a difference close to what was seen in patients without diabetes (P < .001), according to the results.

Chronic total occlusion

Gunnar Tepe, MD, chief of radiology, RoMed Klinikum, Rosenheim, Germany, presented data from the 126 patients enrolled in the CTO Imaging Cohort of the IN.PACT Global study (mean age, 68 years; 69% men).

In this cohort, device success was 99.3%, procedure success was 100% and clinical success — defined as procedure success without death, major target limb amputation, target lesion thrombosis or target vessel revascularization at discharge — was 99.2%, he said.

At 1 year in the CTO imaging cohort, primary patency was 84.4% and freedom from clinically driven TLR was 88.2%, according to the results.

“Despite the complexity of these challenging and complex long [CTO] lesions, the outcomes were excellent and remarkably consistent [with] that of the overall cohort,” Tepe said in a press release. “These results show the effectiveness of the In.Pact Admiral [DCB] as a primary treatment in this complex lesion subset.” – by Erik Swain

Reference:

Schneider PA, Tepe G. Current status and expectations of drug-coated balloons. Both presented at: Charing Cross International Symposium; April 26-29, 2016; London.
Disclosure: The IN.PACT SFA and IN.PACT Global studies were funded by Medtronic. Schneider reports receiving research support from Bard, Gore, Medtronic and Silk Road Medical and serving as an uncompensated adviser for Boston Scientific, Cardinal Health and Medtronic. Tepe reports receiving research support from and serving on an advisory board for Medtronic.