Three-Year Outcomes of the Japanese OLIVE Registry Published

September 22, 2015—The 3-year follow-up results of the OLIVE registry were published by Osamu Iida, MD, et al in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2015;8:1493–1502). OLIVE is a Japanese prospective multicenter study of endovascular treatment for infrainguinal vessel disease in patients with critical limb ischemia (CLI).

According to the investigators, OLIVE consecutively enrolled patients who underwent infrainguinal endovascular therapy for CLI. The primary outcome was 3-year amputation-free survival. Secondary outcome measures were 3-year freedom from major adverse limb events, wound-free survival, and wound recurrence rate. Prognostic predictors for each outcome were also elucidated by Cox proportional hazard regression analysis or the log-rank test.

As summarized in JACC: Cardiovascular Interventions, the investigators reported that the completion rate of 3-year follow-up was 95%. The 3-year amputation-free survival, freedom from major adverse limb events, and wound-free survival rates were 55.2%, 84%, and 49.6%, respectively. Wound recurrence out to 3 years was 43.9%. 

After multivariable analysis, age, body mass index ≤ 18.5, dialysis, and Rutherford category 6 were identified as predictors of 3-year major amputation or death. Statin use, Rutherford category 6, straight-line flow to the foot, and heart failure were identified as 3-year predictors of major adverse limb events. Finally, CLI caused by isolated below-the-knee lesions was a wound recurrence predictor. The 3-year survival, freedom from major amputation, and reintervention rates were 63.%, 87.9%, and 43.2%, respectively.

In CLI patients with infrainguinal lesions, the 3-year clinical results of endovascular treatment were reasonable despite high reintervention and moderate ulcer recurrence rates, concluded the investigators in JACC: Cardiovascular Interventions.