IN.PACT SFA: Benefits of DCB Persist at 2 Years
Patients with superficial femoral artery (SFA) disease are more likely to retain primary patency at 2 years when treated with a drug-coated balloon (DCB) rather than with conventional balloon angioplasty, according to extended follow-up data from the IN.PACT SFA trial presented at TCT 2015 and published in the Journal of the American College of Cardiology.
John Laird, MD, of the University of California, Davis, Sacramento, Calif., and colleagues randomized 331 patients with symptomatic femoropopliteal lesions up to 18 cm long to receive the Admiral paclitaxel-eluting balloon (Medtronic; n = 220) or standard angioplasty (n = 111).
Patients in the two groups were comparable with regard to age, sex and Rutherford classification. A similar proportion of patients in each arm had diabetes (40.5% vs. 48.6%), had hypertension (91.4% vs. 88.3%), and were current smokers (38.6% vs. 36%).
Patients in the DCB arm had 221 lesions with a length of 8.94 ± 4.89 cm, while those in the comparison arm had 113 lesions with a length of 8.81 ± 5.12 cm.
No late catch-up
Primary patency within 12 months (defined as freedom from clinically driven TLR and duplex ultrasound-derived restenosis) served as the primary efficacy endpoint. The composite safety endpoint included freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization (TVR).
Two-year data showed more patients assigned DCB achieved primary patency (Figure) and freedom from clinically driven TLR (91% vs. 72.2%; P < .0001). Patients who received DCB also were more likely to experience primary sustained clinical improvement (76.9% vs. 59.2%; P = .003).
“Importantly, there was no late treatment catch-up after 1 year in the Kaplan-Meier analysis,” Laird observed.
Safety outcomes through 2 years favoring DCB included major adverse events (composite of death, clinically driven TLR, target limb major amputation and thrombosis; 19.2% vs. 31.1%; P < .023), clinically driven TVR (12.6% vs. 30.2%; P < .001) and thrombosis (1.5% vs. 3.8%; P = .243). There was no target limb major amputation in either group. Although all-cause death was higher in the DCB arm at 2 years (8.1% vs. 0.9%; P = .008), no deaths were attributed to the device or procedure.
Furthermore, in subgroup analyses, the benefits of DCB were consistent by both sex and diabetes status. Patients in both treatment groups demonstrated similar functional outcomes with regard to the 6-minute walk test and the rate of walking impairment; however, the DCB cohort achieved these comparable function levels with 58% fewer reinterventions.
“These excellent and durable results have the potential to drive a paradigm shift around the world with regard to SFA interventions,” Laird concluded.
- Laird reports receiving grant/research support from Medtronic and W.L. Gore; consultant/honoraria fees from Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corporation, Cordis and Medtronic; and holding equity in AngioSlide, BioCardia, Endoluminal Sciences, Eximo, Ostial, PQ Bypass, Reflow Medical, Shockwave and Syntervention.