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DCB remains superior to PTA at 5 years
LAS VEGAS — A drug-coated balloon conferred a lower rate of clinically driven target lesion revascularization at 5 years compared with percutaneous transluminal angioplasty in patients with peripheral artery disease, according to the final results of the IN.PACT SFA study presented at VIVA 18.
In addition, in the TOTAL IN.PACT pooled analysis from four cohorts, the DCB (IN.PACT Admiral, Medtronic) was associated with better 1-year outcomes compared with PTA regardless of lesion complexity.
IN.PACT SFA
For IN.PACT SFA, researchers assigned 220 patients (mean age, 68 years; 65% men) to receive the DCB and 111 patients (mean age, 68 years; 68% men) to receive PTA. Most patients were Rutherford category 2 or 3. Mean lesion length was 8.94 cm in the DCB group and 8.81 cm in the PTA group.
At 5 years, the primary outcome of freedom from clinically driven TLR was 74.5% in the DCB group and 65.3% in the PTA group (difference, 9.2%; log-rank P = .0196), John Laird Jr., MD, medical director of the Adventist Heart and Vascular Institute in St. Helena, California, and Cardiology Today’s Intervention Editorial Board Member, said during a presentation.
In addition, he said, mean time to first clinically driven TLR was 807.5 days in the DCB group compared with 474.9 days in the PTA group (P < .001).
The primary safety endpoint — freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization at 5 years — was achieved in 70.7% of the DCB group and 59.6% of the PTA group (P = .068), according to the researchers.
Major adverse events at 5 years, defined as all-cause death, clinically driven TVR, target limb major amputation and thrombosis, occurred in 42.9% of the DCB group and 48.1% of the PTA group (P = .459). There were no device- or procedure-related deaths in either group, Laird said.
“We can say from the IN.PACT SFA trial that for patients with moderately complex lesions up to 15 cm without in-stent restenosis or critical limb ischemia, we can expect a very durable result with drug-coated balloon angioplasty,” Laird told Cardiology Today’s Intervention. “The 3-year data from the IN.PACT Global registry further confirm this and give us confidence that perhaps we will have equally durable results in more complex lesions.”
He noted in a press conference that the difference between the groups in clinically driven TLR was less than it had been at previous time points, but it was still significant.
The next step, he told Cardiology Today’s Intervention, is to investigate “combination therapies, particularly drug-coated balloons with atherectomy, such as in the ongoing REALITY trial. We have good results, but there is always room for improvement. If we can improve things further by removing some of the plaque prior to delivering the drug, it is worth investigation.”
TOTAL IN.PACT
In the TOTAL IN.PACT pooled analysis of four studies of 1,837 patients treated for PAD with the DCB and 143 treated with PTA (mean age, 69 years; 69% men), 1-year freedom from clinically driven TLR was 93.8% in the DCB group and 80.2% in the PTA group (log-rank P < .001), Cardiology Today’s Intervention Editorial Board Member Mehdi Shishehbor, DO, PhD, MPH, professor of medicine at Case Western Reserve University School of Medicine, director of the Interventional Cardiovascular Center at University Hospitals and co-director of the Vascular Center at Harrington Heart and Vascular Institute, University Hospitals, said during a presentation.
The researchers also stratified patients by whether they met standard inclusion criteria for randomized controlled trials of DCBs (n = 712; mean lesion length, 8.68 cm; 51.3% with calcification) or were part of a broader patient population (n = 1,125; mean lesion length, 12.88 cm; 73.3% with calcification).
The standard group that received the DCB had a 1-year rate of freedom from clinically driven TLR of 97.1% and the broader group that received the DCB had a rate of 91.7%, both of which were significantly better than the PTA group, Shishehbor said.
“The TOTAL IN.PACT all-subject initiative is the largest independently adjudicated DCB analysis to date,” he said. “The IN.PACT Admiral DCB continues to demonstrate superior safety and freedom from revascularization compared to angioplasty. We have previously shown that the clinical significance of the DCB appears to be independent of lesion length. We have extended these findings to lesion complexity and shown excellent clinical efficacy between the broader and standard use, and that both were superior to angioplasty.” – by Erik Swain
References:
Laird J, et al. Late-Breaking Clinical Trials.
Shishehbor M, et al. Late-Breaking Clinical Trials. Both presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.
Disclosures: The studies were funded by Medtronic. Laird reports he received honoraria from Medtronic, received consultant fees from Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Medtronic and Reflow Medical and holds equity in Angioslide, Eximo, P.Q. Bypass, Reflow Medical, Shockwave Medical and Syntervention. Shishehbor reports he is a consultant and adviser to Abbott Vascular, Boston Scientific, Medtronic, Philips/Spectranetics and Terumo.
Perspective
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The 5-year results of IN.PACT SFA showed clinical benefit, but the space under the curve between plain balloon angioplasty and DCBs starts to narrow at 5 years. It will be interesting to see what the curves look like in the 5-year results of drug-eluting stent trials. But there is still a strong case for using DCBs instead of plain balloon angioplasty. If you can decrease the number of repeat procedures for 4 or 5 years, you have made a big difference in the application of health care. This population was mostly claudicants. It will be interesting to see, once we start using DCBs in patients with critical limb ischemia, whether that catch-up is noticeable.
It is nice to have large data subsets like TOTAL IN.PACT. The larger the patient population we study, the more reliable the results. We can see the benefit of the DCB is still there across many different subsets, including in more complex real-world lesions. That’s a very big positive.