Critical limb ischemia (CLI) is associated with high rates of amputation and mortality. Although smoking cessation improves outcomes after revascularization, the impact of the duration of smoking abstinence prior to the procedure had not been clearly established. This study evaluated whether different intervals of smoking cessation before revascularization were associated with differences in perioperative and mid-term outcomes in patients with CLI.
A retrospective study was conducted based on a prospective multicenter database from the United States (Vascular Quality Initiative), including patients between 2016 and 2024 who underwent their first revascularization for critical limb ischemia, defined as rest pain or tissue loss. A total of 50,656 patients were analyzed, of whom 42,896 (84.7%) were active smokers within 30 days prior to surgery, 4,875 (11.4%) were recent former smokers (1–9 months of cessation), and 2,885 (5.7%) were former smokers with 9–21 months of cessation. The mean age was 65 ± 10 years, and 62% were men. Revascularization procedures included both endovascular interventions and surgical bypasses (infrainguinal, suprainguinal, and multilevel).
The primary endpoint was long-term major amputation (above the ankle) during a follow-up period of 9 to 21 months. Secondary endpoints included thrombosis of the treated vessel or bypass, need for reintervention, overall mortality, and perioperative complications (cardiac, pulmonary, renal, infectious, and 30-day mortality).
Results: smoking cessation ≥9 months significantly reduces major amputation after revascularization in CLI
In the perioperative analysis, no significant differences were observed between active smokers and either group of former smokers. Rates of cardiac complications ranged from 2.5% to 2.6%, pulmonary complications from 1.2% to 1.5%, renal complications from 2.2% to 2.4%, perioperative major amputation from 2.4% to 2.8%, and 30-day mortality from 1.9% to 2.6%, with no statistically significant differences between groups.
During mid-term follow-up, no significant differences were observed between active smokers and recent former smokers (1–9 months) in thrombosis (3.47% vs 2.88%; p=0.19), reintervention (16.5% vs 15.5%; p=0.40), major amputation (9.15% vs 9.22%; p=0.75), or mortality (12.2% vs 11.5%; p=0.24). In contrast, patients with smoking cessation of 9 to 21 months showed a significant reduction in major amputation compared with active smokers (7.73% vs 10.2%; p=0.006), with an absolute risk reduction of 2.5% at one year, increasing to 3.6% at 18 months. No differences were observed in thrombosis, reintervention, or mortality between these groups.
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Multivariate Cox regression analysis confirmed that smoking cessation for 9 to 21 months was independently associated with a 28% reduction in the risk of major amputation (hazard ratio 0.72; 95% CI: 0.58–0.90). Factors associated with a higher risk of amputation included male sex, Black race, diabetes, end-stage renal disease, low body mass index, urgent procedures, and infrainguinal bypass using alternative conduits.
Conclusion: only sustained smoking cessation improves limb salvage in critical limb ischemia
In conclusion, among patients with critical limb ischemia undergoing revascularization, only sustained smoking cessation of at least 9 months was associated with a significant reduction in the risk of major amputation, whereas shorter periods of cessation did not demonstrate clinical benefit. These findings reinforce the importance of promoting smoking cessation at early stages of peripheral arterial disease, before the development of limb-threatening ischemia, in order to maximize limb salvage outcomes.
Original Title: Smoking cessation duration and risk of amputation after revascularization for chronic limb-threatening ischemia.
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