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MOBILITY: Major adverse event rate low with self-expanding, balloon-expandable iliac stents
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Results of the MOBILITY trial suggest that a self-expanding stent system and a balloon-expandable stent system are effective for the treatment of iliac artery disease in a real-world population.
The MOBILITY trial was designed to test the effectiveness of the Absolute Pro Peripheral Self-Expanding Stent System (Abbott Vascular) and the Omnilink Elite Peripheral Balloon-Expandable Stent System (Abbott Vascular) in patients with intermittent claudication or critical limb ischemia with even the most complex lesions. Researchers enrolled 304 patients between November 2009 and December 2010; 151 patients (181 lesions) were treated with the self-expanding stent system and 153 (203 lesions) with the balloon-expandable stent system.
Michael R. Jaff
At 9 months, the primary endpoint — composite major adverse event rate (all-cause death, MI, major amputation, clinically driven target lesion revascularization) — was 6.1% for the self-expanding stent system and 5.4% for the balloon-expandable stent system, significantly lower than the prespecified objective performance goal of 19.5% (P<.0001).
The patients’ walking ability significantly improved, although 99% of patients had multilevel peripheral arterial disease. Other results showed Rutherford-Becker improvement 1 category in 93.9% of limbs in the self-expanding stent system group and 89% of limbs in the balloon-expandable stent system group.
Although 90% of lesions had moderate to severe calcification, the restenosis rate was 8.4% with the self-expanding stent system and 9% with the balloon-expandable stent system. Freedom from clinically drive target lesion revascularization was 97.1% and 94.9%, respectively, according to Kaplan-Meier analysis.
“The study shows even patients with severe lesions can be successfully treated, helping restore their movement,” Michael R. Jaff, DO, FSCAI, medical director of the Vascular Ultrasound Core Laboratory at Massachusetts General Hospital and Cardiology Today Editorial Board member, said in a press release.
For more information:
- Das T. Late-breaking clinical trials. Presented at: the Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 9-12, 2012; Las Vegas.
Disclosure: Dr. Jaff serves as a noncompensated adviser to Abbott Vascular and is a board member for VIVA Physicians.
Perspective
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Kenneth Rosenfield, MD
The MOBILITY trial confirms that endovascular treatment with stents really does represent first-line treatment for virtually all iliac disease, almost regardless of the complexity. The trial involved patients with very advanced degrees of plaque burden, including task C and D lesions. It did not just focus on the simple isolated stenoses that are pretty easy to deal using any type of stent or endovascular therapy. This trial was all-inclusive and had a representative cohort of patients with fairly complex disease, including heavy calcification, total occlusions and other parameters that would make them task C or D — the kind of blockages that previously many would have said requires a trip to the operating room. The results of this trial would suggest that — even in patients with those advanced levels of disease — the first approach should be endovascular, unless there is an extreme circumstance. In the current era, very few patients need to go for open surgery as a first modality of treatment.
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