OLIVE: Endovascular Treatment Shows Positive Results for Critical Limb Ischemia

LOS ANGELES, CA—Roughly three-fourths of patients with infrainguinal disease who undergo endovascular treatment are amputation free 1 year after treatment, although roughly one-third require reintervention, according results of a Japanese, prospective, multicenter registry presented November 7, 2012, at the American Heart Association Scientific Sessions.

Masato Nakamura, MD, PhD, of Toho University Ohashi Medical Center (Tokyo, Japan), and colleagues studied 312 patients with critical limb ischemia (CLI) treated at 19 centers in Japan from December 2009 to July 2011. Most of the patients (71%) had diabetes, while just over half (52%) had end-stage renal disease requiring dialysis.

Patients with femoropopliteal lesions received plain angioplasty (43%), nitinol-stent implantation (43%), cutting balloon (8%), or cutting balloon and nitinol stenting (6%). Patients with infrapopliteal lesions received plain angioplasty (84%) or cutting balloon therapy (16%).

Technical Success High, with Few Amputations

The initial procedure success rate was 93%, while the primary endpoint of amputation-free survival was 74% at 1 year. The secondary endpoint of major adverse limb event (major amputation or surgical bypass of the index limb) was 88% at 1 year.

Other important 1-year outcomes were freedom from major amputation (92%) and survival (81%). Freedom from reintervention, though, was only 63%, while freedom from reintervention or above-ankle amputation was only 58%. About one-third (34%) underwent reintervention, consisting of bypass surgery (2.6%) or repeat endovascular therapy (31.7%). The median time for wound healing was 97 days.

Multivariate analysis showed several predictors of amputation free survival, major adverse limb events, and time to wound healing (table 1).

Table 1. Multivariate Predictors at 1 Year

Quality of life scores on the EQ-5D scale showed positive changes from baseline to 12 months, with endovascular therapy, improving from roughly 0.63 to 0.76 (P < 0.001).

“The high reintervention rate notwithstanding, endovascular therapy was an effective treatment for Japanese critical limb ischemia patients with infrainguinal disease, with satisfactory amputation-free and major adverse limb event-free rates,” Dr. Nakamura said.

Commenting on the study, Michael S. Conte, MD, of the University of California, San Francisco, Medical Center (San Francisco, CA), noted that “the investigators have shown that when they select patients properly for endovascular therapy, technical success rates were high.”

Overall, the primary outcomes at 1 year “appear consistent with other series, and they also meet some of the recently published Society of Vascular Surgeons performance goal targets,” Dr. Conte added.

Unanswered Questions

But key questions remain, he emphasized, such as why bypass patients were excluded. “It would be ideal to have registries that include both therapies,” Dr. Conte said.

“It would be good if they could shed light on important questions,” he continued. “What was the relationship between hemodynamic improvement and wound healing or quality of life? What was the specific influence of dialysis status on outcomes? Hospitalizations and costs are also an important issue they could potentially add to this dataset.”

Follow-up beyond 1 year is also important. “Increasingly, we’re recognizing that most of these patients will survive two years and beyond,” Dr. Conte said. “The BASIL randomized trial data suggest the choice of optimal initial strategy depends on whether patients are likely to survive to 2 years.”

The BASIL trial compared surgery and angioplasty in patients with severe limb ischemia, demonstrating that after 6 months, the 2 strategies did not differ in amputation-free survival, while short-term costs were higher with surgery.

Study Details

Culprit lesions in the OLIVE registry were divided between femoropopliteal only (17%), femoropopliteal and below the knee (41%), and below the knee only (42%).

 

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Source:
Nakamura M. Endovascular treatment for infrainguinal vessels with critical limb ischemia: OLIVE registry, a prospective, multicenter study in Japan with 12-month follow-up. Presented at: American Heart Association Scientific Sessions; November 7, 2012; Los Angeles, CA.

 

Disclosures:

• Dr. Nakamura reports no relevant conflicts of interest.
• Dr. Conte reports serving as a consultant/advisory board member for Baxter Healthcare, Humacyte, and Talecris Biotherapeutics.

 

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