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NEW YORK -- Endovascular interventions increasingly are being tried as initial treatment for severe limb ischemia, even though data from the only randomized controlled trial comparing bypass surgery with balloon angioplasty favored the open approach over the long term.

The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) study, which compared the clinical outcomes and cost-effectiveness of the two approaches among 452 patients, initially found "broadly similar outcomes in terms of amputation-free survival," and a slightly higher cost in the short term for surgery (Lancet 2005;366:1925-34).

"However, if you look at all-cause mortality, you will see that the survival curves cross at between 2 and 3 years, after which there is a highly significant advantage for those patients initially randomized to surgery," said BASIL lead investigator Dr. Andrew W. Bradbury at the Veith symposium on vascular medicine sponsored by the Cleveland Clinic.

Although surgery was more costly in the first year, after 3 years the costs of the two procedures were not significantly different because patients who have angioplasty tend to have more subsequent hospitalizations and interventions.

Surgery appears to be better in the long term because it is associated with a more complete and durable revascularization of the leg, said Dr. Bradbury of the vascular surgery department, University of Birmingham, and the Heart of England NHS Foundation Trust, Birmingham (England).

There also was some evidence from BASIL that patients randomized to surgery possibly had better aftercare in terms of antiplatelet treatment, use of statins, and control of blood pressure and diabetes.

"However, I would say that angioplasty is a good first-line strategy for high-risk patients who are predicted to live less than 18 months to 2 years, because they will not enjoy the benefits of surgery," he added.

Dr. Glenn LaMuraglia of Harvard Medical School and Massachusetts General Hospital, Boston, disagreed that surgery is generally preferable.

"We all know that the goals for lower-extremity reconstruction also must include acute 30-day morbidity and mortality as well as long-term patency because of the dismal natural history of patients with critical limb ischemia," Dr. LaMuraglia said at the meeting.

He explored those outcomes by analyzing data for 2005-2006 from the National Surgical Quality Improvement Program (NSQIP), an independently adjudicated prospective database that includes more than 120 academic and nonacademic hospitals in the United States.

Among the 1,144 patients identified in the database who had lower-extremity bypass, the combined 30-day morbidity and mortality was 25%.

"In contrast, among 144 patients who had infrapopliteal balloon angioplasty at our institution recently, we had only 2% deaths and 3% major complications at 30 days, which is far less than you have with open surgery," Dr. LaMuraglia said. "Patients with critical limb ischemia have limited longevity, and therefore perioperative outcomes are much more important than with a lot of other surgeries we undertake."

Also in favor of angioplasty as initial treatment was Dr. Samuel E. Wilson of the University of California, Irvine, and the Veterans Affairs Medical Center, Long Beach (Calif.), who reported on a retrospective analysis of his single-center experience.

Between 2003 and 2006, when approximately 2,000 patients were seen annually in the VA Medical Center's vascular outpatient clinic, the number of femoral-to-distal bypass procedures dropped from 40-50 per year to 15, while angioplasties increased from 7 per year to 60 in the most recent year.

The amputation rate has remained reasonably steady at about 40 per year, with patients receiving distal bypasses more likely to have an amputation (odds ratio, 4.2) (Ann. Vasc. Surg. 2008;22:195-9).

"We found that open bypass procedures had a higher risk of amputation, but this was probably due to patient selection of more severely ill patients and because we had more bypasses early and had a longer period of time to follow up their outcomes," he noted.

"Despite a decrease in open bypass, there has been no increase in our amputation rate, so we now believe that endovascular methods should be the first approach to reduce both morbidity and cost," Dr. Wilson said.

As to why such different results were seen in the U.S. and the U.K. cohorts, the answer may be the patient populations, according to Dr. LaMuraglia.

"I pooled the data from BASIL, NSQIP, and the PREVENT III [Project of Ex-Vivo Vein Graft Engineering via Transfection] trial, and found that myocardial infarction, hematoma, and wound complications were significantly higher in the U.K., but there were no differences in mortality or graft failure between the U.S. and the U.K.," he said.

Comparison of patient characteristics, however, revealed significant differences in every area except male sex.

"Therefore, I think the results reflect different patient cohorts rather than different surgical outcomes," Dr. LaMuraglia said.