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Use of drug-eluting stents (DES) to treat infrapopliteal disease after failed balloon angioplasty achieves prolonged patency in patients with critical limb ischemia (CLI), according to a study presented April 14, 2013, at the Society of Interventional Radiology Scientific Meeting in New Orleans, LA.

For the single-center study, Robert A. Lookstein, MD, and colleagues, all from Mount Sinai Medical Center (New York, NY), looked at outcomes in 107 CLI patients considered poor surgical candidates who received 171 DES (106 sirolimus, 62 everolimus, and 3 paclitaxel) in 120 infrapopliteal lesions immediately after failed balloon angioplasty. The patients, who were treated between October 2005 and October 2012, had Rutherford scores of 4 (n = 35), 5 (n = 53), or 6 (n = 19).

Strong Patency at 2 Years

Initial technical success was 100%, with all lesions showing less than 10% residual stenosis. Primary patency was 90% at 6 months, 84% at 12 months, and 72% at 2 years. At a mean follow-up of 25 months, freedom from amputation was 89.3% for the entire cohort and 100% for patients in Rutherford classes 4 and 5. All 12 major amputations occurred in Rutherford grade 6 patients.

Only 1 death occurred within 30 days; the cumulative mortality rate was 22.4%.

“The study shows that this technology is superior to balloon angioplasty and rivals the results of surgical bypass,” Dr. Lookstein said in a press release. “It’s safe, it’s durable, and the outcomes are spectacular. The vast majority of patients were able to avoid amputation and dramatically improve their quality of life.”

Patency Signal Needs Clinical Confirmation

In a telephone interview with TCTMD, Michael D. Dake, MD, of Stanford University School of Medicine (Stanford, CA), said that over the past 2 or 3 years several randomized trials have shown clear improvement in 1-year patency with DES—better than with BMS or balloon angioplasty—but no benefit in limb salvage. Only with 2-year data from the Yukon trial (Rastan A, et al. J Am Coll Cardiol. 2012;60:587-591) has a difference in event-free survival started to emerge, he noted.

“It took longer than we would expect [to see a clinical advantage] based on experience in other arterial segments,” he commented. “But it means that it’s probably better in the long run to have a vessel that’s open than one that’s closed.”

“What is a little new” about the current study is that the lesions are longer and therefore require multiple stents, Dr. Dake continued, adding that the positive signal seen in these more challenging types of lesion “moves the meter” for the DES field.

However, any comparison of the current DES results with those achieved by surgical bypass is “perilous” because the 2 groups of patients tend to be very different, he said. “All you can do is use a broad brush stroke and say that these [DES] results are good,” Dr. Dake noted. “What we really need to think about is not just patency but clinical benefit, and the way to do that is with a head-to-head comparison. This single-arm study just gives us an initial signal.”

Taking a wider perspective, Dr. Dake observed that “going forward, most people would like to road-test long drug-coated balloons. Implanting a full-metal jacket [of multiple DES] doesn’t seem intuitively a good thing to do if you can get similar results with a drug-coated balloon and leave nothing behind.” The extra cost of several DES must also be factored in, he added.

However, Dr. Dake acknowledged, “there are going to be cases where the initial results [of a drug-coated balloon] are not sustainable. If there is significant recoil, or the lumen is highly calcified post treatment, it’s hoped that you could just spot-stent.”

Study Details

Mean age was 82 years, and almost two-thirds were men. About three-quarters (73%) were diabetic and two-thirds (64%) had chronic renal disease. Simultaneous femoral-popliteal intervention was performed in 69% of patients. Thirty-five percent of lesions were total occlusions. Mean lesion length was 52 mm (range, 13 mm-147 mm), and mean 1.6 stents (range, 1-5) were used per lesion

All patients were placed on clopidogrel and aspirin periprocedurally and remained on the regimen indefinitely.

 

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Source:
Lookstein RA, Ward TJ, Fischman AM, et al. Single-center experience with drug-eluting stents for infrapopliteal occlusive disease in patients with critical limb ischemia: Mid-term follow-up. Presented at: 38th Annual Society of Interventional Radiology Scientific Meeting; April 14, 2013; New Orleans, LA.

 

 

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