Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions: Five-Year Outcomes From the IN.PACT SFA Randomized Trial

• Published in: Circulation. Cardiovascular interventions Vol. 12; no. 6; p. e007702
• Main Authors: Laird, John A., Schneider, Peter A., Jaff, Michael R., Brodmann, Marianne, Zeller, Thomas, Metzger, D. Chris, Krishnan, Prakash, Scheinert, Dierk, Micari, Antonio, Wang, Hong, Masters, Michele, Tepe, Gunnar
• Format: Journal Article
• Language: English
• Published: American Heart Association, Inc 01.06.2019; Lippincott Williams & Wilkins
• Subjects: Original
• ISSN: 1941-7632; 1941-7640; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.118.007702

BACKGROUND:While randomized trials have demonstrated the superiority of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease, the long-term durability of DCB angioplasty remains uncertain. METHODS AND RESULTS:IN.PACT SFA is a prospective, multicenter, randomized single-blinded trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 subjects with symptomatic (Rutherford 2–4) femoropopliteal lesions. Subjects were randomly assigned 2:1 to the IN.PACT Admiral DCB or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the primary safety end point, and major adverse events. Through 5 years, patients treated with the IN.PACT Admiral DCB demonstrated a sustained treatment effect with superior freedom from clinically driven target lesion revascularization when compared with PTA (Kaplan-Meier estimate of 74.5% versus 65.3%; log-rank P=0.020). The primary safety composite was achieved in 70.7% of subjects in the DCB and 59.6% in the PTA groups (P=0.068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA (P=0.459). There were no device- or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee. CONCLUSIONS:The IN.PACT SFA randomized trial demonstrates that the IN.PACT Admiral DCB continues to perform better than PTA through 5 years with higher freedom from clinically driven target lesion revascularization. The sustained safety and effectiveness profile of this DCB supports its use as a preferred treatment choice compared with PTA for femoropopliteal lesions. CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT01175850 (IN.PACT SFA phase I) and NCT01566461 (IN.PACT SFA phase II).