Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions

Abstract

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 URL: https://www.clinicaltrials.gov . Unique identifier: NCT01175850 (IN.PACT SFA phase I) and NCT01566461 (IN.PACT SFA phase II).

Keywords: angioplasty; drug-coated balloons; paclitaxel; peripheral artery disease.

Figure 1.

Subject flow chart in the IN.PACT SFA trial though 60 mo. Three hundred thirty-one subjects were randomized 2:1 into groups that received angioplasty with a paclitaxel drug-coated balloon (DCB) or a standard percutaneous transluminal angioplasty (PTA). Subjects were followed for 5 y. IN.PACT SFA indicates 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).

Figure 2.

Treatment effect of a drug-coated balloon (DCB) in femoropopliteal lesions at 60 mo. Freedom from clinically driven target lesion revascularization (CD-TLR) by Kaplan-Meier estimate was significantly higher in the DCB group than in the percutaneous transluminal angioplasty (PTA) group (74.5% vs 65.3%; log-rank P=0.020) at 60 mo. Bars represent 95% CI. All target lesion revascularization events were adjudicated by the independent and blinded Clinical Events Committee.

Figure 3.

Subgroup analysis of freedom from clinically driven target lesion revascularization (CD-TLR) by Kaplan-Meier estimate at 60 mo. A, Freedom from CD-TLR was significantly higher in the drug-coated balloon (DCB) group than percutaneous transluminal angioplasty (PTA; 77.1% vs 66.3%; P=0.046) in the nondiabetic subgroup. B, Freedom from CD-TLR was numerically higher in the DCB group than PTA but not statistically significant (70.3% vs 64.4%; P=0.243) in the diabetic subgroup. Bars represent 95% CI. All target lesion revascularization events were adjudicated by the independent and blinded Clinical Events Committee.

Figure 4.

Post hoc analysis of freedom from clinically driven target lesion revascularization (CD-TLR) at 60 mo. Forest plot shows CD-TLR based on Kaplan-Meier estimate in key subgroups at 60 mo. Subjects with Rutherford category 4, nondiabetic, age greater than 75 y, longer lesion length (≥10 cm and ≤18 cm), total occlusion and female sex favored drug-coated ballon (DCB), while both DCB and percutaneous transluminal angioplasty (PTA) performed nonsignificantly in remaining subgroups. P value of hazard ratio between DCB and PTA was calculated using Cox Proportion Hazards model for each subgroup. Treatment-by-subgroup interactions were tested using a Cox proportional hazards model containing the main effects of treatment (IN.PACT DCB and Control PTA), subgroup and the treatment-by-subgroup interaction. ITT indicates intent-to-treat.