IN.PACT DEEP Global Shows Real-World Effectiveness, Safety

Hollywood, FL (January 23, 2020)- Results of the IN.PACT DEEP Global study show durable effectiveness and safety of the IN.PACT Admiral drug-coated balloon (DCB) (Medtronic) through 4 years, according to data presented by Gunnar Tepe, MD, at the International Symposium on Endovascular Therapy (ISET).

IN.PACT DEEP was a real-world, prospective, multicenter, single-arm independently-adjudicated femoropopliteal study. The study enrolled more than 1500 participants at 64 participating sites throughout the world and showed results through 4 years. Although patients with complex lesions are typically excluded from randomized controlled trials (RCTs), their outcomes are often reflected in real-world studies, such as IN.PACT DEEP.

IN.PACT DEEP included three major cohorts — de novo in-stent restenosis, long lesion, and chronic total occlusion (CTO). There was also a group with 150 mm DCBs used, noted Dr. Tepe, Head of the Department of Radiology at RoMed Rosenheimat in Germany.

Inclusion criteria were broad. “Almost everything could be included except patients who were Rutherford 5 and 6,” Dr. Tepe said. Other exclusion criteria were acute or sub-acute thrombus in the target vessel, previous bypass surgery to the target lesion, and failure to successfully cross the target lesion with a guide wire.

The primary efficacy endpoint of the study was freedom from clinically-driven target lesion revascularization (TLR) within 12 months,  while the primary safety endpoint was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically-driven TLR within 12 months.

At 4 years, the TLR-free survival rate for IN.PACT DEEP was 73.4%. “That means that three out of four patients didn't need any reintervention after treatment with the IN.PACT DEEP DCB,” said Dr. Tepe. At 3 years, the TLR-free survival rate was 76.9%, meaning that there was a 3.5% change between years 3 and 4, Dr. Tepe explained.

“The first TLR in the mean of all patients was almost 600 days,” said Dr. Tepe. He highlighted other key findings, such as a death rate of 15.1% through 4 years and a major amputation rate of 1.1%, which is “quite low,” he said, when taking into consideration that 3% of patients were Rutherford 5 patients.

“In summary, the IN.PACT global study remains the largest real-world drug-coated balloon study with independent adjucation throughout four years. We have really good patency rates and low TLR rates for 4 years, and we didn't see any problems with an increase in death rates throughout the time,” said Dr. Tepe.