Studies Evaluate Medtronic's In.Pact Admiral DCB in Long Lesions

May 20, 2015—Medtronic plc announced the presentation of new clinical data from two different studies, the IN.PACT Global Study's long lesion imaging cohort and the DEB SFA-LONG Study, showing that the company’s In.Pact Admiral drug-coated balloon (DCB) successfully treated long lesions in the superficial femoral and popliteal arteries. The data were presented during the “Hot Line” session on peripheral interventions at the EuroPCR 2015 conference being held in Paris, France.

Prof. Dierk Scheinert, MD, presented 12-month results for 157 patients enrolled in the IN.PACT Global Study’s long lesion imaging cohort. The average lesion length in this subset was 26.4 ± 8.61 cm, which is approximately three times longer than the average lesion length of 8.9 ± 5.07 cm in the randomized controlled IN.PACT SFA Trial.

The 157 patients in the long lesion imaging cohort had a total of 164 lesions of at least 15 cm in length. In addition to lesion length, they also featured other challenging characteristics: 71.8% had calcified lesions, 60.4% had total occlusions, and 41% had diabetes.

Prof. Scheinert reported that the outcomes of treatment with the In.Pact Admiral DCB included a 6% rate of clinically driven target lesion revascularization and primary patency of 91.1% according to Kaplan-Meier analysis at 360 days postprocedure. Key safety data included 94% freedom from major adverse safety events and no major target limb amputations through 12-month follow-up.

In Medtronic’s press release, Prof. Scheinert commented, “For patients with peripheral arterial disease in the lower extremities, long lesions pose a notoriously difficult treatment challenge. That’s why the 12-month results in this long-lesion subset are so impressive. The results are also remarkably consistent with those from similar studies of the In.Pact Admiral DCB, irrespective of lesion length.” Prof. Scheinert is Chairman of the Division for Interventional Angiology at University Hospital Leipzig in Leipzig, Germany.

Also at EuroPCR, Antonio Micari, MD, presented 12-month results from the DEB SFA-LONG study, which was conducted at six sites in Italy and enrolled 105 patients with an average lesion length of 25.2 cm. Dr. Micari is Director of GVM Care & Research at Maria Cecilia Hospital in Palermo, Italy.

Medtronic stated that the results were consistent with those from the long-lesion subset of the IN.PACT Global Study’s imaging cohort. Using the same definitions, the clinically driven target lesion revascularization rate in this independent, multicenter Italian study was 4%, and primary patency was 89.3% by Kaplan-Meier analysis at 360 days postprocedure.

According to Medtronic, the IN.PACT Global Study is a large and rigorous postmarket evaluation that has enrolled more than 1,500 patients at 64 sites worldwide to characterize the performance of the In.Pact Admiral DCB in the context of routine clinical practice.

The IN.PACT Global Study’s imaging cohort consists of three subgroups, each with at least 150 patients: de novo in-stent restenosis; long lesions (at least 15 cm); and chronic total occlusions (at least 5 cm). All patients in the imaging cohort were required to undergo duplex ultrasound at 12 months postprocedure and at the time of a reintervention (if one occurred) to assess for patency.

Medtronic advised that outcomes for patients in the in-stent restenosis and chronic total occlusion subgroups are expected to be presented at meetings over the next 12 months, as are 2-year results from the IN.PACT SFA Trial, including the economic outcomes analysis.

The In.Pact Admiral DCB received approval from the US Food and Drug Administration in December 2014 for percutaneous transluminal angioplasty, after predilatation, of de novo or restenotic lesions up to 18 cm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4 to 7 mm. The device received European CE Mark approval in 2009 for percutaneous transluminal angioplasty in patients with obstructive disease of peripheral arteries. The broader European indication does not specify lesion length or reference vessel diameter, noted Medtronic.