HOLLYWOOD, Fla. — Drug-coated balloons have the strongest evidence, compared with other technologies, as a solution for peripheral in-stent restenosis, a speaker said at the International Symposium on Endovascular Therapy.
“Drug-coated balloon technology — either alone or in combination with debulking — shows superior results to [percutaneous transluminal angioplasty] and is likely to emerge as the standard of care for in-stent restenosis,” Brian DeRubertis, MD, FACS, associate professor of surgery in the division of vascular and endovascular surgery at David Geffen School of Medicine and UCLA Ronald Reagan Medical Center, said during a presentation.
Until recently, stents were the dominant approach to endovascular treatment for peripheral artery disease, as they were superior to plain balloon angioplasty and DCB technology was not yet proven, DeRubertis said.
However, he said, “stents may be a trigger for intimal hyperplastic response” and in-stent restenosis is not uncommon.
Treatments for peripheral in-stent restenosis include plain balloon angioplasty, debulking with atherectomy, repeat stent implantation, relining with a covered stent or anti-restenosis therapy with DCBs.
The DEBATE-ISR, PACUBA and FAIR trials all showed that DCBs were effective for peripheral in-stent restenosis. In these three trials, a DCB was vastly superior to plain balloon angioplasty for the outcomes of primary patency and freedom from clinically driven target lesion revascularization, according to DeRubertis.
Similar results were seen in the IN.PACT Global and PLAISIR registries. In the in-stent restenosis cohort of IN.PACT Global, 12-month primary patency with a DCB (IN.PACT Admiral, Medtronic) was 88.7%, “which is similar to what has been seen in trials of less complicated patients,” DeRubertis said. In PLAISIR, which also studied the Medtronic DCB, the 12-month primary patency rate was 83.7%.
Most registries and randomized trials of patients with peripheral in-stent restenosis have shown DCBs are superior to plain balloon angioplasty and laser atherectomy and are similar to an endoprosthesis (Viabahn, W.L. Gore and Associates) without requiring a permanent implant, he said.
Combination therapies may be beneficial in this population. DeRubertis referenced a trial that demonstrated better performance of a DCB (Freeway, Eurocor) plus laser atherectomy (TurboElite, Spectranetics) compared with a DCB alone.
Studies of a DES (Zilver PTX, Cook Medical) for in-stent restenosis have shown benefit, but, again, a permanent implant is required in that case, DeRubertis said.
“In-stent restenosis is a common problem with current stent technology,” he said. “Percutaneous transluminal angioplasty and/or debulking alone is insufficient for achieving optimal long-term results.” – by Erik Swain
DeRubertis B. Townhall. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 27-30, 2019; Hollywood, Fla.
Disclosure: DeRubertis reports he has financial ties with Abbott Vascular, BD/Bard, Boston Scientific, Cook Medical and Medtronic