MOBILITY Supports Iliac Stenting in Extensive PAD Cases

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Stenting of iliac artery disease in patients with severely calcified lesions or extensive peripheral artery disease (PAD)—who historically have been excluded from clinical trials—is safe and effective. The findings, presented at the Society for Cardiovascular Angiography Interventions Scientific Sessions on May 10, 2012, in Las Vegas, NV, shore up current practice patterns.

For the MOBILITY trial, researchers led by Michael R. Jaff, DO, of Massachusetts General Hospital (Boston, MA), enrolled 304 patients with intermittent claudication or critical limb ischemia between November 2009 and December 2010. Rutherford Becker classifications ranged from 2 to 4, and the majority (99%) had multilevel PAD. Moderate to severe calcification was present in more than 90% of lesions.

Patients in the 2-arm study underwent intervention using either the Absolute Pro self-expanding stent system or the Omnilink Elite balloon-expandable stent system (both Abbott Vascular, Santa Clara, CA). In all, 151 patients (n = 181 lesions) received the Absolute Pro, known for its precise deployment and radial force, while 153 patients (n = 203 lesions) received the Omnilink Elite, which provides flexibility and deliverability, Dr. Jaff reported. Both are US Food and Drug Administration approved for the treatment of PAD.

Improved Function with Few Adverse Events

At 9 months, the primary endpoint of major adverse events (composite of all-cause death, MI, major amputation, and clinically driven TLR) fell below the prespecified objective performance goal of 19.5% for each stent system (P < 0.0001). Other outcomes also were positive (table 1).

Table 1. Nine-Month Outcomes

 

Absolute Pro

Omnilink Elite

Major Adverse Events

6.1%

5.4%

Restenosis

8.4%

9.0%

Hemodynamic Success

95.9%

93.4%

Rutherford Becker Improvement ≥ 1

93.9%

89.0%


Functional improvements were noted in walking distance and speed as well as in stair climbing (P < 0.0001 for all endpoints vs. baseline) for both stent arms.

Kaplan-Meier analysis showed that freedom from clinically driven TLR was similar between the 2 systems at 97.1% for the Absolute Pro and 94.9% for the Omnilink Elite.

“These results demonstrate that balloon-expandable and self-expandable stent systems are effective even in real-world patients,” Dr. Jaff commented in a press release. “This study shows that even patients with severe lesions can be treated, helping restore their movement.”

Confirms Current Practice

Issam D. Moussa, MD, of the Mayo Clinic (Jacksonville, FL), told TCTMD in a telephone interview that, unlike superficial femoral artery disease where stenting is only used as a bailout, current American College of Cardiology/American Heart Association guidelines give stenting a class I indication for the treatment of stenosis and occlusion in the common iliac and external iliac arteries.

Stenting is clearly superior to angioplasty for iliac artery disease overall, Dr. Moussa said, but few US stent makers have studied how their specific products fare in real-world patients. He seemed impressed by what MOBILITY documents. “Restenosis rates less than 10 [percent]? That’s very good. I think it’s better than historical rates with other stents,” he commented, stressing that it is difficult to compare these results with those of other devices used in different populations, however.

While not practice changing, “this study confirms prior [studies] and extends them to specific platforms available in the United States,” Dr. Moussa concluded.

 


Source:
Jaff MR. Modern endovascular management of patients with iliac artery disease: Results from the MOBILITY trial. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 10, 2012; Las Vegas, NV.

 

 

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Disclosures
  • Dr. Jaff reports serving as a noncompensated advisor to Abbott Vascular.
  • Dr. Moussa reports no relevant conflicts of interest.

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