9-Month Data of the IN.PACT BTK Randomized Pilot Study: A Paclitaxel DCB vs Standard PTA for Infrapopliteal CTOs

Written by Cynthia Laufenberg, MA

Presented by Ido Weinberg, MD

One of the presentations at Wednesday’s session, “The Role of Drug-Eluting Technologies in CLI,” was “9-Month Data of the IN.PACT BTK Randomized Pilot Study: A Paclitaxel DCB vs Standard PTA for Infrapopliteal CTOs,” by Ido Weinberg, MD, from Harvard Medical School/Massachusetts General Hospital.

The IN.PACT BTK study utilized a .014 BTK DCB balloon consistent with the 3.5 μg/mm² drug formulation used in the IN.PACT SFA, Global, and AV trials. Its objective was to assess the safety and effectiveness of the IN.PACT .014 DCB (Medtronic) vs percutaneous transluminal angioplasty (PTA) for the treatment of CLTI patients with CTOs in the infrapopliteal arteries.

Dr. Weinberg reviewed the endpoints; baseline clinical, lesion, and procedural characteristics; and 9-month safety outcomes of the trial. 

In conclusion, the IN.PACT 014 BTK DCB demonstrated effectiveness through 9 months compared to PTA in a complex population. “There were no safety concerns from the outcomes of the IN.PACT 014 BTK study,” Dr. Weinberg said, “and the results support the consistency of the full IN.PACT clinical program. Safety composite was 91.3% (DCB) compared to 87.5% (PTA), and there were no  major amputations within 9 months in either arm. Low all-cause death was 4.3% (DCB) and 8.0% (PTA). The study provides opportunity to affect future BTK studies and treatment algorithms.