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Self-expanding, balloon-expandable stents confer similar outcomes in iliac artery stenosis
LAS VEGAS — Self-expanding and balloon-expandable stents were equally safe and effective in patients with iliac artery stenosis, according to findings presented at VIVA 15.
Researchers enrolled 75 patients (mean age, 62 years) in the DURABILITY Iliac study of self-expanding stents (EverFlex or Protégé GPS; Medtronic/Covidien/ev3) and 75 patients (mean age, 64 years) in the VISIBILITY Iliac study of balloon-expandable stents (Visi-Pro, Medtronic/Covidien/ev3).
The two groups were compared for the primary outcome of major adverse events at 9 months — defined as periprocedural death, in-hospital MI, clinically driven target lesion revascularization and amputation of treated limb — and secondary outcomes of device success, patency according to duplex ultrasound, ankle-brachial index and Walking Impairment Questionnaire score.
John H. Rundback
Compared with the DURABILITY Iliac group, the VISIBILITY Iliac group was more likely to have diabetes (36% vs. 17%; P = .0158) and hyperlipidemia (77.3% vs. 61.3%; P = .0508), John H. Rundback, MD, FAHA, FSVM, FSIR, medical director of the Interventional Institute at Holy Name Medical Center and managing partner of Advanced Interventional Radiology Services LLP, both in Teaneck, New Jersey, said during a presentation.
The lesions treated with the self-expanding stents were longer (45 cm vs. 29 cm; P = .0001), more stenosed (74.3% vs. 68.3%; P = .0255) and more occluded (22.1% vs. 7.9%; P = .0144), while those treated with balloon-expandable stents were more likely to be eccentric (73.7% vs. 57.1%; P = .0413), Rundback said.
Major adverse events at 9 months occurred in 1.3% of those in the DURABILITY Iliac study and in 4% of those in the VISIBILITY Iliac study (P = .081).
All major adverse events were clinically driven TLR, Rundback said. He also noted that there were no cases of periprocedural death, amputation or in-hospital MI.
The primary patency rate at 9 months was 95.8% in both groups. “This an important message, that as you’re making your clinical decisions and trying to determine … the best stent platform to use, at least based on these data, it did not matter,” he said.
Both groups improved in ankle-brachial index at 1 month, and this was sustained out to 9 months, Rundback said.
There were “dramatic improvements” in all domains of the Walking Impairment Questionnaire score for both groups, he said.
The endpoints “are the same as, or exceeding data seen for other bare-metal stents as well as for covered stents,” Rundback said. – by Erik Swain
Reference:
Rundback JH, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.
Disclosure: The studies were funded by Medtronic Endovascular. Rundback reports receiving honoraria from Abbott Vascular and Cardiovascular Systems Inc.; consulting for Biotronix, Boston Scientific, Cardiovascular Systems Inc., Christie Medical, Cook Medical, Covidien, Intact Vascular, Medtronic, SiL Vascular, Simbonix, St. Jude Medical and VIVA Physicians; and receiving research funding from Abbott Vascular, Anges, Atrium Medical, Bard Peripheral Vascular, Cardiovascular Systems Inc., Christie Medical, Daiichi Sankyo, Ekos, Harvest Technologies, Intact Vascular, the NIH, Simbonix, Terumo and W.L. Gore.
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These were two separate trials of a balloon-expandable and a self-expanding stent to treat iliac occlusive disease, and there were no significant differences in any of the result parameters that were measured. Asking why is appropriate. In the past, we thought that maybe for common iliac disease, a balloon-expandable stent might be better, and for external iliac disease, maybe a self-expanding stent might be better. But one of the take-home messages is that the sites that were enrolling in this trial had the ability to look at the lesion and consider what features might be more amenable to one of these two technologies. With that sort of paradigm, we see that we can get results that are almost identical between the two. In measurable parameters, there were no significant differences, with very high patencies and low revascularization rates in self-expanding and balloon-expandable stents. All in all, it’s a very good message for endovascular. It’s a very rare lesion now — likely patients with very small vessels, diffusely diseased — that is an indication for surgery.