This article is more than 5 years old. Information may no longer be current.
Amputation-free survival in CLI similar between surgery, endovascular therapy at 3 years
There is no significant difference in 3-year amputation-free survival between surgical reconstruction and endovascular therapy in patients with critical limb ischemia, according to the results of the SPINACH study published in Circulation: Cardiovascular Interventions.
“Clinical guidelines recommend both surgical reconstruction and endovascular therapy, largely based on the findings of the BASIL trial. Although this classical trial was no doubt an important and informative study, clinical settings have changed during the past decade.” Osamu Iida, MD, from the cardiovascular center at Kansai Rosai Hospital in Amagasaki, Japan, and colleagues wrote. “It remains uncertain whether the evidence presented by the trial would be still valid and true in current clinical practice.”
To compare clinical outcomes between surgical reconstruction and endovascular therapy for CLI in a real-world setting, the researchers conducted a multicenter, prospective, observational study consisting of 548 Japanese patients with CLI.
Surgical reconstruction was scheduled for 197 patients, whereas 351 patients were scheduled to receive endovascular therapy.
The primary endpoint of the study was 3-year amputation-free survival, compared between the two cohorts in an intention-to-treat manner, using propensity-score matching.
The researchers performed interaction analysis to compare outcomes of surgical reconstruction vs. endovascular therapy.
There were no significant differences in 3-year amputation-free survival between the groups after propensity-score matching (surgery, 52%; 95% CI, 43-60; endovascular therapy, 52%; 95% CI, 44-60).
The following characteristics conferred favorable outcomes with surgery:
- wound, ischemia and foot infection (WIfI) classification W-3;
- foot infection classification 2 or 3;
- history of ipsilateral minor amputation;
- history of revascularization after CLI onset; and
- bilateral CLI.
Those who had less favorable outcomes with surgery were more likely to have:
- diabetes;
- renal failure;
- anemia;
- history of nonadherence to CV risk management; and
- contralateral major amputation.
The researchers devised a favorability score for surgical reconstruction, with 1 point added for each of the five favorable factors and 1 point subtracted for each of the five unfavorable factors. They found the score was positively associated with favorability for surgery over endovascular therapy in amputation-free survival (P < .001), overall survival (P < .001) and major amputation (P = .009); patients in the highest quartile of the score derived more benefit from surgery (P < .001), whereas patients in the lowest quartile derived more benefit from endovascular therapy (P = .018).
“CLI patients with severe wound status might be more suited for surgical reconstruction, whereas those with a poor general condition might benefit from [endovascular therapy] in terms of [amputation-free survival],” the researchers wrote. – by Dave Quaile
Disclosures: The study was sponsored by Abbott Vascular Japan Co. Ltd., Boston Scientific Japan K.K., Cook Japan Inc., Goodman Co. Ltd., Johnson & Johnson K.K., Kaken Pharmaceutical Co. Ltd., Kaneka Medix Corp., Medicon Inc., Medikit Co. Ltd., Medtronic Japan Co. Ltd., Mitsubishi Tanabe Pharma Corp., Merck Sharpe and Dohme K.K., St. Jude Medical Japan Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., Terumo and W.L. Gore and Associates. The authors report no relevant financial disclosures.