IN.PACT Global Study: 5-Year Diabetic and Gender Subgroup Outcomes

The IN.PACT Global Study continues to provide interventionalists with practical information on the use of the IN.PACT Admiral DCB (Medtronic) in complex femoropopliteal lesions. This time it was confirmatory evidence of the safety and effectiveness of the paclitaxel-coated PTA catheter in females and diabetics.

In a late-breaking ISET 2022 session, Marianne Brodmann, MD, from the Medical University Graz in Graz, Austria, presented 5-year outcomes stratified according to gender and diabetes status.

The data fill an important void: currently, there are no long-term data on the use of drug-coated balloons for femoropopliteal artery disease in distinct populations such as females and patients with diabetes—both subgroups understood to be at increased risk for poor outcomes.

As a reminder, IN.PACT was a real-world, prospective, multicenter, single-arm study assessing the effectiveness and safety of the IN.PACT Admiral DCB and provided both independently adjudicated endpoints and prospective analysis of imaging cohort utilizing a core laboratory.

Of the 1406 subject who comprised the intention-to-treat cohort, 453 were female. The women enrolled in the trial were significantly more likely than their male counterparts to be hypertensive and have concurrent below-the-knee disease, but less likely to be current smokers, have coronary heart disease, renal insufficiency, or previous peripheral revascularization.

Dr. Brodmann noted that there was a somewhat lower rate of provisional stenting in the female subgroup and a higher rate of dissection. “So, maybe the physicians did not want to stent the women because they feared worse outcomes,” she suggested.

Overall 5-year freedom from clinically-driven target lesion revascularization (CD-TLR) was 69.1% in women and 69.6% in men (log-rank P=0.602). Freedom from all-cause mortality with vital status through 5 years was 76.9% in both groups (P=0.229).  

As expected, patients with diabetes (n=603) were sicker than those without (n=914). They were more likely to be current smokers and have hypertension, hyperlipidemia, obesity, coronary heart disease, carotid artery disease, and concomitant BTK disease. Diabetic patients were also more likely to have calcified lesions (71.8% vs. 66.5%; p=0.019) and even severe calcification (12.4% vs. 8.7%).

Despite all this, no difference was seen in 5-year freedom from CD-TLR between diabetics and nondiabetics (67.7% vs. 70.5%, respectively; P=0.246). No differences were seen in the rates of any TLR or in the incidence of the primary safety composite (freedom from device- and procedure-related mortality through 30 days, freedom from major limb amputation within 60 months, and freedom from CD-target vessel revascularization within 60 months).

All-cause mortality through 5 years was 23.8% in diabetic subjects vs. 16.6% in non-diabetic subjects (P<0.001). This rate of 23.8%, noted Dr. Brodmann, is in the lower range for mortality for diabetic PAD patients in epidemiologic studies (23%-52%).

There was low major target limb amputation cumulative incidence through 5 years in both groups (1.1% in the nondiabetic and 2.5% in the diabetic; log-rank P=0.085).

There were no differences in reintervention rates in either females or diabetics demonstrating consistent, long-term effectiveness in both groups.

“Five-year real-world data from the IN.PACT Global study continues to confirm the safety and effectiveness of the IN.PACT Admiral paclitaxel-coated PTA catheter in females and diabetics,” concluded Dr. Brodmann.

“Despite the complex disease state and anatomically disadvantaged characteristics, major amputation rates remain low in diabetic and female subgroups and show similar results to their respective counterparts. No difference was seen in mortality between the male and female subgroups through five years, although mean age was significantly higher in females and the five-year mortality rate of 23.8% in the diabetic subgroup is in the lower range of mortality rates in epidemiologic studies,” she added.