Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial

Abstract

Background: Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term.

Methods and results: IN.PACT SFA is a single-blind, randomized 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 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank P<0.001). The rates of clinically driven target lesion revascularization were 15.2% and 31.1% (P=0.002) for the DCB and PTA groups, respectively. Functional outcomes were similarly improved between treatment groups even though subjects in the DCB group required significantly fewer reinterventions versus those in the PTA group (P<0.001 for target lesion revascularization, P=0.001 for target vessel revascularization). There were no device- or procedure-related deaths as adjudicated by an independent Clinical Events Committee.

Conclusions: Three-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States.

Keywords: angioplasty; peripheral arterial disease; target lesion revascularization.

Figure 1.

Subject flow in the IN.PACT SFA trial through 36 months. Three hundred thirty-one subjects were randomized 2:1 into groups that received percutaneous transluminal angioplasty (PTA) with a paclitaxel drug-coated balloon (DCB) or a standard uncoated balloon (PTA). Subjects are being followed for 5 years, and the results of intent-to-treat analyses have been previously reported for 12 months and 24 months.

Figure 2.

Durability of effect after treatment with a paclitaxel drug-coated balloon (DCB) for femoropopliteal lesions: primary patency and freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Top, Primary patency by Kaplan–Meier estimate was significantly higher in the DCB group compared with the percutaneous transluminal angioplasty (PTA) group (log-rank test, P<0.001). Bottom, Freedom from CD-TLR by Kaplan–Meier estimate was significantly higher in the DCB group compared with the PTA group (log-rank test, P<0.001). Top, Bottom, Bars represent 95% confidence intervals. The number of subjects at risk represents the number of evaluable subjects at the beginning of each 90-day interval. An independent and blinded Clinical Events Committee adjudicated all target lesion revascularization events, and independent and blinded core laboratories reviewed all ultrasound and angiographic images.