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Bypass may be best option in CLI with insulin-dependent diabetes
Among patients with critical limb ischemia, those with insulin-dependent diabetes had worse outcomes than those without it, and for those with insulin-dependent diabetes, a bypass-first strategy was associated with fewer complications than an endovascular-first strategy, according to two studies.
In one study, the researchers compared comorbidities and outcomes in patients with insulin-dependent diabetes vs. patients with noninsulin diabetes or no diabetes. In another, they analyzed the patients with insulin-dependent diabetes to determine whether a bypass-first strategy and an endovascular-first strategy differed in outcomes.
Risks of insulin dependence
The researchers analyzed 1,294 limbs revascularized between 2005 and 2014 at Beth Israel Deaconess Medical Center, stratifying them by insulin-dependent diabetes (n = 703), noninsulin-dependent diabetes (n = 262) and no diabetes (n = 329), as well as by bypass-first (n = 646) or endovascular-first (n = 648) strategy.
The insulin-dependent group, compared with the noninsulin-dependent group and the no-diabetes group, was younger (69 years vs. 73 years vs. 77 years, respectively; P < .001), more often presented with tissue loss (89% vs. 77% vs. 67%, respectively; P < .001), had a higher rate of CAD (57% vs. 48% vs. 43%, respectively; P < .001) and were more likely to have end-stage renal disease (26% vs. 13% vs. 12%, respectively; P < .001).
Although perioperative complications, including mortality, were not significantly different between the groups (insulin-dependent, 3%; noninsulin-dependent, 2%; no diabetes, 5%), complete wound healing at 6 months was lowest in the insulin-dependent group (41% vs. 49% vs. 61%, respectively; P < .001), whereas major amputation at 3 years was highest in the insulin-dependent group (23% vs. 11% vs. 8%; P < .001), according to the researchers.
After adjustments, the researchers found that compared with patients with CLI and no diabetes, patients with CLI and insulin-dependent diabetes were at higher risk for major amputation (HR = 2; 95% CI, 1.1-4.1), reintervention/major amputation/stenosis (HR = 1.4; 95% CI, 1.1-1.8) after a first-time intervention.
The results were similar among patients who underwent endovascular intervention, but were not significant among patients who underwent a bypass procedure.
Compared with patients with CLI and no diabetes, patients with CLI and insulin-dependent diabetes had lower late mortality (HR = 0.7; 95% CI, 0.5-0.9), according to the researchers.
“Overall, this study demonstrates the importance of distinguishing between diabetes type, as each of the three cohorts presented with differing degrees of disease and comorbid conditions that harbor varying degrees of limb-based and patient-based risk,” Marc Schermerhorn, MD, chief of the division of vascular and endovascular surgery at Beth Israel Deaconess Medical Center and professor of surgery at Harvard Medical School, said in a press release. “Although insulin dependence is associated with the greatest risk of adverse outcomes, these data suggest that these adversities may be most mitigated by initial bypass, provided the patient is appropriately selected and anatomically suitable for such treatment.”
Bypass vs. endovascular
In another analysis of the 703 limbs revascularized in 682 patients with insulin-dependent diabetes, Schermerhorn and colleagues compared outcomes between those who had a bypass-first strategy and those who had an endovascular-first strategy.
At baseline, the groups were similar in age (bypass, 69 years; endovascular, 68 years; P = .51), rate of tissue loss (bypass, 87%; endovascular, 91%; P = .055) and dialysis dependence (bypass, 25%; endovascular, 28%; P = .34), but the endovascular group was more likely to be hypertensive (84% vs. 93%; P < .01) and the endovascular group was more likely to be currently smoking (21% vs. 14%; P = .02).
The groups also did not differ in mean HbA1c level (bypass, 7.9%; endovascular, 8%; P = .52), mean fasting blood glucose level (bypass, 152 mg/dL; endovascular, 156 mg/dL; P = .47), perioperative acute kidney injury (bypass, 20%; endovascular, 23%; P = .26), perioperative hematoma (bypass, 7.3%; endovascular, 4.2%; P = .07), perioperative acute MI (bypass, 1.5%; endovascular, 2.2%; P = .46) and perioperative mortality (bypass, 3.8%; endovascular, 2.8%; P = .45).
In multivariable analysis, endovascular-first intervention was associated with higher risk for restenosis (HR = 1.6; 95% CI, 1.1-2.4) and reintervention (HR = 2; 95% CI, 1.3-3), Schermerhorn and colleagues found. – by Erik Swain
Disclosures: Schermerhorn reports he has financial ties with Abbott, Cook Medical and Endologix. Another author reports he is on the data and safety monitoring board for Endologix.