Medtronic's In.Pact Admiral Drug-Coated Balloon Studied in Complex PAD Patients

April 25, 2017—Medtronic announced the presentation of results for its In.Pact Admiral drug-coated balloon (DCB) from two new subanalyses from the IN.PACT Global Study in patients with peripheral artery disease (PAD). The new data were reported at the annual 2017 Charing Cross Symposium in London, United Kingdom.

Gary Ansel, MD, presented 1-year results analyzing outcomes in patients from the IN.PACT Global Study with complex lesions. The analysis compared standard usage patients (n = 281) who met similar inclusion criteria for the IN.PACT SFA pivotal trial, an investigational device exemption study, with use in a broader spectrum of patients (n = 1,125) who had wider inclusion criteria reflecting more real-world patients.

According to Medtronic, results in both groups demonstrated consistent and positive outcomes with In.Pact Admiral at 1 year. In the standard IN.PACT Global Study group, clinically driven target lesion revascularization (CD-TLR) was 3.4%, which was comparable to 2.4% in a similar population in the IN.PACT SFA pivotal trial. CD-TLR for the group with complex lesions was 8.5%, despite the disease complexity observed in these patient types.

These results were also consistent with the full clinical cohort for the IN.PACT Global Study (N = 1,406), in which 1-year CD-TLR was 7.5%. Results of the primary safety endpoint were generally consistent across the cohorts and no safety signals were observed, advised the company.

In Medtronic's press release, Dr. Ansel commented, “These subanalyses show that In.Pact Admiral continues to deliver durable and consistent results across our more typically treated patient populations Notably, the data in this study highlight that the In.Pact Admiral DCB can be safe and effective when used in our patients with complex PAD, such as those with challenging calcified lesions and with significant comorbidities.”

Also at the Charing Cross Symposium, Fabrizio Fanelli, MD, shared results of a new subset analysis of patients with complex, calcified lesions from the long lesion and chronic total occlusion (CTO) imaging cohort of the IN.PACT Global Study.

The company advised that the analysis included long lesion and CTO patients defined as having moderately severe or severely calcified lesions (n = 72). Calcium levels were assessed by the site according to protocol and confirmed by core laboratory assessment. At 1 year, patients achieved primary patency rates of 88.8% as calculated by Kaplan-Meier analysis. The analysis also demonstrated a CD-TLR rate of 8.5%. No safety signals were observed, which is consistent with other data sets. Provisional stenting occurred in 51.4% of patients.