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OLIVE: Infrainguinal endovascular therapy shows modest 3-year benefit for CLI
Follow-up data from the OLIVE registry demonstrate improvements in survival at 3 years among patients with critical limb ischemia and infrainguinal lesions who underwent endovascular therapy.
The prospective, multicenter OLIVE registry study enrolled 314 patients in Japan who had infrainguinal endovascular therapy. Endovascular intervention included provisional nitinol stenting for superficial femoral lesions or balloon angioplasty for below-the-knee and popliteal lesions. The current report includes data on 95% of patients who were observed for the entire 3-year follow-up (mean age, 73 years; 65% men).
The 3-year rate of amputation-free survival, the primary outcome, was 55.2%. According to the researchers, “this [finding] is comparable with 3-year outcomes of previous trials, although the present study included sicker patients such as those on hemodialysis.”
At 3 years, 84% of patients were free of major adverse limb events, the 3-year rate of wound-free survival was 49.6% and the rate of wound recurrence was 43.9%.
Predictors of major amputation or mortality included age (HR = 1.43; P = .001), BMI less than 18.5 kg/m2 (HR = 2.17; P = .001), dialysis (HR = 2.91; P < .001) and Rutherford classification of 6 (HR = 1.64; P = .047), according to multivariate analysis. Predictors of major adverse limb events were statin use (HR = 0.28; P = .02), Rutherford classification of 6 (HR = 2.4; P = .02), straight-line flow to the foot (HR = 0.27; P = .001) and HF (HR = 1.96; P = .04). Patients with critical limb ischemia (CLI) due to an isolated lesion below the knee were most likely to experience wound recurrence (HR = 4.28; P ≤ .001).
“It is noteworthy that factors predicting major amputation or death changed over time,” the researchers wrote. For example, BMI predicted major amputation or death at 1 and 3 years, whereas HF and wound infection were predictors only within the first 6 months after endovascular therapy.
In other results, the 3-year survival rate was 63%. Also at 3 years, 87.9% of patients were free of major amputation and 43.2% required reintervention.
“The follow-up data for the OLIVE registry demonstrated that the 3-year clinical results of endovascular therapy were reasonable in CLI patients with infrainguinal lesions despite high reintervention and moderate ulcer recurrence rates,” the researchers concluded. – by Rob Volansky
Disclosure: Several researchers report consulting for Boston Scientific, Japan Lifeline Company, Kaneka Medix Corporation, Medicon Inc. and Terumo. One researcher reports receiving grant support from Boston Scientific Japan.