Drug-Coated Balloons Demonstrate Favorable Outcomes for Patients With PAD

SAN FRANCISCO – Drug-coated balloon (DCB) use in patients with peripheral artery disease (PAD) demonstrated significantly higher primary patency as well as reduction in repeat interventions compared with percutaneous transluminal angioplasty (PTA), according to IN.PACT SFA trial results.

Lead author John R. Laird Jr, MD, Medical Director of the Vascular Center and Professor of Medicine at UC Davis Medical Center presented results at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting. Their work was simultaneously published in the Journal of the American College of Cardiology.

Patients with PAD are typically treated with PTA of the superficial femoral artery (SFA) and popliteal artery, despite the high incidence of restenosis following the procedure. While stent use is beneficial, it can result in unwanted complications including in-stent restenosis and stent fractures.

The aim of the IN.PACT SFA trial was to examine the safety and effectiveness of the DCB (IN.PACT, Admiral, Medtronic, Santa Rosa, California) compared with standard PTA for the treatment of femoropoliteal artery disease.  In this randomized, multicenter, single-blinded trial, patients were randomly assigned DCB (n=220) or PTA (n=111).

Primary end points were defined as freedom from clinically driven target lesion revascularization (CD-TLR) or freedom from restenosis; the primary composite end point was freedom from device-related and procedure-related death through 30 days, as well as target limb major amputation and clinically driven target vessel revascularization (CD-TVR) through 24 months.

The DCB group demonstrated a higher primary patency rate (78.9% through 24 months; 73.5% after the 30-day follow-up) compared with the PTA group (50.1% through 24 months; 47.4% after the 30-day follow-up; P<.001).  Fewer re-interventions were required (58%) for the DCB group compared with the PTA group, and quality of life improvements were similar between the two arms (6-minute walk test: 253.2 m ± 123 m for DCB vs 256.0 m ± 114.7 m for PTA; P=.883).

In addition, patients with diabetes treated with DCB had significantly higher primary patency compared with PTA (73.3% vs 45.8%; P<.001). Female patients also demonstrated a higher primary patency (76.7% for DCB vs 42.3% for PTA; P<.001). “It’s important to highlight [the] benefit in females,” Dr. Laird mentioned at a TCT press conference. “Previous trial [results] showed no benefit.”

The DCB group suffered a higher all-cause mortality rate compared with the PTA group (8.1% vs 0.9%, P=.008). However, Dr. Laird pointed out that “usual mortality rates in a trial like this are in the 3% to 11% range.” He continued, “The deaths … were late—560 days. This is long after the drug has disappeared from the arterial wall.”

Dr Laird noted that there has been some concern regarding late-occurring restenosis in DCBs, but that this trial “highlights that not all DCBs are, perhaps, the same. The doses for the balloons are different, coating processes are different, drug delivery systems are different. Not all are created equal.”

Disclosures: This study was funded by Medtronic plc (Santa Rosa, California). John R. Laird Jr, MD, is a compensated consultant for and received research grants from Medtronic.

References

1. Laird JR, Schneider PA, Tepe G, et al. Two-year outcomes reinforce IN.PACT Admiral’s durability, consistency and safety as a best-in-class treatment option for PAD.  Presented at: 27th Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium; October 10-15, 2015; San Francisco, CA. 
2. Laird JR, Schneider PA, Tepe G, et al. Sustained durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015; Oct 14. doi:10.1016/j.jacc.2015.09.063.