Courtesy of Dr. Carlos Fava.

Severe atherosclerotic disease in iliac arteries is experienced by 15% of all men and 5% of all women. TAC II recommends angioplasty for type-A, -B, and -C lesions.

As regards stent type, self-expanding stent (SE, more elasticity) vs. balloon-expandable stent (SB, more radial strength), Reekers indicates superior target lesion revascularization (TLR) with SE. However, there are no current randomized studies providing information in that sense.

This prospective multicenter randomized study analyzed SE vs. SB in severe or occlusive lesions in the iliac arteries.

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The study included patients with Rutherford class 1-4 intermittent claudication and ≥70% lesion as observed through Doppler echocardiography, and excluded patients with lesions in the aorta or the common femoral artery.

The trial enrolled 660 patients; 340 received SE and 320, SB. Populations were well-balanced: mean age was 63 years old (most patients were male), 25% had diabetes, and 60% were smokers. The presence of coronary disease was higher among patients who received SB. The most frequent Rutherford class was 3 (55%), followed by 2 (26%). Only 2% experienced ischemia at rest.

The most treated artery was the primitive iliac (60%), SE lesion length was 41 mm vs. 33.7 mm (p = 0.005); stent length was 56.7 vs. 47.6 (p < 0.0001). No differences were observed as regards technical success.

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The incidence of restenosis was lower for patients who received SE: 6.1% vs. 14.9% (p = 0.0006). At 12 months, the Kaplan Meier estimate for primary patency was 94.5% vs. 87% (p = 0.026), TLR was 3% vs. 6.4% (p = 0.04), and freedom from TLR at 12 months was 97.2% vs. 93.6 % (p = 0.04).

The Ankle-Brachial Index (ABI) test results were better and clinical improvement was superior for patients who received SE.

The rates of target limb amputation and stroke were similar for both groups, but global mortality and major adverse vascular event (MAVE) rates were higher among patients who received SB.

Conclusion

The treatment of iliac arteries with SE as compared with BE resulted in a lower 12-month restenosis rate and a significant reduction in the TLR rate. No safety concerns arose in any of the groups.

Editorial Comment

This study is important because it shows the superiority of self-expanding stents in the iliac arteries. This is surely due to a lower radial strength (producing lower circumferential stress and lower neointimal proliferation) and a higher flexibility, which favors the preservation of arterial distensibility as opposed to SB rigidity.

It should be noted that post-dilation is mandatory with SE, in order to ensure correct stent expansion.

Courtesy of Dr. Carlos Fava.

Original title: Self-Expanding Versus Ballon-Expandable Stents for Iliac Artery Occlusive Disease. The Randomized ICE Trial.

Reference: Hans Krankernberg, et al. J Am Coll Cardiol Int 2017;10:1694-1704

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