Drug-Coated Balloon Beats Angioplasty Alone in PAD Patients
Primary patency rates are higher in patients with SFA or popliteal artery disease following treatment with a drug-coated balloon (DCB) compared with standard percutaneous transluminal angioplasty (PTA), according to 1-year data from the IN.PACT SFA trial published online December 3, 2014, ahead of print in Circulation. Clinically driven TLR was dramatically lower in the DCB arm.
John R. Laird, MD, of the University of California, Davis Vascular Center (Sacramento, CA), and colleagues randomized 331 patients with intermittent claudication or ischemic rest pain due to SFA and/or popliteal artery disease to treatment with the IN.PACT Admiral paclitaxel-eluting DCB (Medtronic; n = 220) or standard PTA (n = 111) at 13 sites in Europe and 44 in the United States. Enrollment was conducted in 2 phases; the first ran from September 2010 to April 2011, and the second ran from April 2012 to January 2013.
Baseline characteristics were similar between the 2 groups, with mean lesion length of 8.94 ± 4.89 cm in the DCB group and 8.81 ± 5.12 cm in the PTA group. Total occlusions were present in 25.8% and 19.5% of patients, respectively.
DCB Yields Better Patency
At 12 months, the rate of primary patency (primary endpoint; defined as freedom from restenosis or clinically driven TLR) was higher following treatment with the DCB. Other efficacy outcomes favored the DCB as well (table 1).
Safety did not differ between the DCB and PTA arms, with no cases of device- or procedure-related death at 30 days or target limb major amputation at 12 months. Rates of all-cause death and vessel thrombosis at 12 months were low in both groups.
DCB the Clear Choice?
The IN.PACT SFA results make a compelling case for choosing a DCB over conventional PTA in patients who are candidates for the balloon procedure, Mark W. Burket, MD, of the University of Toledo Medical Center (Toledo, OH), told TCTMD in a telephone interview.
“The revascularization rate seen in this study is much lower than that seen in any comparable trial,” he said. “If this rate is sustained in clinical practice it would be phenomenal. Even if we see a doubling or even tripling of the TLR seen in this study, it would still be really good.”
He added that patients who are not likely to get adequate enlargement of the lumen with DCB alone are probably not good candidates for the procedure.
“If, for example, there is significant recoil of the vessel or if there is severe dissection, the balloon by itself will not be sufficient to address that,” he said. “In those cases, the operator typically would resort to stent placement.”
Cost an Obstacle to Wider DCB Use
Dr. Burket said that cost is presently the biggest drawback to the adoption of DCB use in patients with SFA and/or popliteal PAD.
“Drug-coated balloons will be significantly more expensive than bare balloons. Traditionally hospitals have had to absorb similar increases, which translates into decreased profit margins,” he said. “So we now have this discordant set of incentives where from the patient’s standpoint, this is absolutely the best treatment and from the hospital’s standpoint, it makes it harder to clear a profit.”
This is further complicated by the fact that most femoral procedures are performed on an outpatient basis, and, at present, the Centers for Medicare & Medicaid Services pays only for inpatient stent procedures, he said.
In a telephone interview with TCTMD, William A. Gray, MD, of Columbia University Medical Center (New York, NY), agreed that cost may be a short-term deterrent to the use of DCB in patients with SFA disease.
“Hospital reimbursements will clearly fall short right now if [DCBs are] broadly adopted, but I believe this will be sorted out for the treatment of both inpatients and outpatients over the next year,” he said.
Dr. Gray added that it will be difficult to deny eligible patients DCBs based on cost if the results seen in the IN.PACT SFA trial extend to clinical practice.
“The difference in revascularization rates in this trial was startling,” he said. “Nothing close to the 2.4% rate [in the DCB arm] has been seen.”
Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and/or popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2014;Epub ahead of print.
- The trial was funded by Medtronic.
- Dr. Laird reports receiving research grants from Medtronic and WL Gore and serving as a compensated advisory board member and consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Covidien, and Medtronic.
- Dr. Burket reports receiving research support from Bard Vascular, Biotronik, and Cook Medical and serving as a consultant to Biotronik and Covidien and a speaker for Cook Medical.