Findings Presented at SIR Support DES to Treat CLI

April 14, 2013—At the Society of Interventional Radiology's 38th Annual Scientific Meeting in New Orleans, Louisiana, a study was presented evaluating the use of drug-eluting stents (DES) in the treatment of critical leg ischemia (CLI) to prevent amputation. In the retrospective study of 107 patients with CLI treated with DES, 90% showed patency at 6 months and 70% at 2 years. All patients in the study who were treated in the early stages of CLI were able to avoid amputation.

“Peripheral arterial disease (PAD) is becoming increasingly prevalent due to our aging population and the obesity and diabetes epidemics,” commented the study's lead investigator Robert A. Lookstein, MD, in the SIR press release. Dr. Lookstein is Chief of Interventional Radiology at Mount Sinai Medical Center in New York, New York. He added, “Many PAD patients are not candidates for surgery and are seeking minimally invasive options. This therapy is an emerging technology that is safe and effective for treating critical limb ischemia. This treatment helps alleviate pain and avoid amputation.”

Dr. Lookstein stated, “The study shows that this technology is superior to balloon angioplasty and rivals the results of surgical bypass. 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.”

Abstract #13, “Single-Center Experience with Drug-Eluting Stents in the Treatment of Critical Limb Ischemia: Midterm Follow-Up,” was presented on April 14 during the Arterial Interventions: Stents and Dissection session.

In the study abstract, the investigators note that endovascular treatment of infrapopliteal arterial disease in the setting of CLI is increasing in use. When percutaneous transluminal angioplasty (PTA) results in suboptimal angiographic results, flow-limiting dissection or recoil is thought to limit acute and long-term clinical success. This single-center experience at Mount Sinai Medical Center in New York, New York, examines the angiographic and clinical results when DES were placed in a large cohort of patients with CLI after immediate infrapopliteal PTA failure.

As summarized in the SIR abstract, the investigators performed a retrospective review of a prospectively collected single-center endovascular database. The investigators found in the database that 107 patients with Rutherford grade 4, 5, or 6 were treated between October 2005 and October 2012 with PTA because lack of an acceptable autologous vein for bypass grafting or severe medical comorbidities precluded them from surgical bypass. The study cohort had suboptimal angiographic results immediately after PTA that were subsequently treated with DES. Patients were then placed on clopidogrel and aspirin indefinitely. Angiographic and clinical data, as well as the results of noninvasive vascular examinations, were collected and reviewed.

The investigators reported that 171 stents (106 sirolimus-, 62 everolimus-, and three paclitaxel-eluting) were placed in 107 patients to treat a total of 143 angiographic lesions. Simultaneous femoral-popliteal intervention was performed in 71% of the patients, whereas 41% of the treated lesions were total occlusions. Lesion length ranged from 13 mm to 147 mm (mean, 52 mm). Initial technical success was 100%, with all 143 lesions being treated successfully with < 10% stenosis after stent implantation. Mean follow-up was 25 months (1–75 months) with 6-, 12-, and 24-month primary patency rates of 92%, 84%, and 70%, respectively. Freedom from major amputation was 89% (95/107), with all 12 major amputations occurring in the Rutherford grade 6 group (12/25). Overall mortality rate was 21% (22/107), with one death occurring within 30 days.

From this retrospective review, the investigators concluded that the use of DES after suboptimal PTA for the treatment of infrapopliteal arterial disease in this cohort of patients with CLI produced high primary patency and limb salvage rates, thereby supporting the efficacy of this treatment strategy.