Two-year results from the IN.PACT Global Study were recently published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. The results confirm positive findings regarding treatment of femoropopliteal artery disease with drug-coated balloons (DCBs) and show that the outcomes endure up to 24 months after treatment.
Previously reported results showed consistent safety and efficacy through 1 year, but the current report covers data through 2 years for IN.PACT Global, the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel DCB in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery. The study includes complex lesions beyond what are typically included in randomized controlled trials, the authors noted.
There were 1,535 participants in the IN.PACT Global Study, with 1,406 patients and 1,773 lesions included in the pre-defined clinical cohort analysis. Researchers evaluated freedom from clinically driven target lesion revascularization at 24 months. In addition, the safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months.
Results showed that 83.3% were free from clinically driven target lesion revascularization at 24 months. The composite safety endpoint was reached in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%.
Patients had a mean lesion length of 12.1 cm, with 35.5% of lesions being total occlusions and 18.0% with in-stent restenosis. There was a link between increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease with increased risk for clinically driven target lesion revascularization by 24 months.
“This real-world study of femoropopliteal artery disease treatment with DCBs confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment,” the authors concluded.
Micari A, Brodmann M, Keirse K, et al. Drug-coated balloon treatment of femoropopliteal lesions for patients with intermittent claudication and ischemic rest pain: 2-year results from the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 28;11(10):945-953.