Association Between Pack-Years and Smoking Cessation on Outcomes After Vascular Interventions.

INTRODUCTION: The influence of pack-year history and smoking cessation timing on postoperative morbidity and mortality in a highly comorbid cohort is uncertain. We examined whether the association between smoking and adverse postoperative events is modified by pack-year history and smoking cessation timing. METHODS: We collected single-institution, retrospective data from consecutive patients undergoing open operations for carotid, aortic, and infrainguinal arterial disease. Active smoking was defined as smoking on the day of the index surgical intervention. Duration of smoking cessation was calculated as the time between smoking cessation and index surgery. The primary outcome was a composite of 30-day mortality and morbidity. Logistic and time-to-event Cox regressions estimated associations with interactions between cessation duration and pack-year history for nonactive smokers. RESULTS: Between 2010 and 2019, 1087 patients underwent 1640 high-risk vascular interventions. Median pack-year history was 40.0 pack-years (interquartile range [IQR]: 20.0-60.0) among nonactive smokers and 46.0 pack-years (IQR: 31.0-61.0) among active smokers (P < 0.001). The median smoking cessation time was 15.5 y (IQR: 4.4-30.9). Smoking status did not independently predict an increased risk of postoperative mortality or morbidity (odds ratio [OR] = 0.99, P = 0.96). Among nonactive smokers, neither smoking cessation duration (OR = 0.99, P = 0.16) nor pack-year history (OR = 1.00, P = 0.88) were significantly associated with adverse events (interaction P = 0.11). CONCLUSIONS: After high-risk vascular interventions in a single institution, active smoking, cessation period, and pack-year history are not associated with an increased risk of postoperative morbidity or mortality-highlighting the benefit of cessation as independent of frequency or intensity.

Transfusion trigger after operations in high cardiac risk patients (TOP) trial protocol. Protocol for a multicenter randomized controlled transfusion strategy trial.

BACKGROUND: There is substantial uncertainty regarding the effects of restrictive postoperative transfusion among patients who have underlying cardiovascular disease. The TOP Trial's objective is to compare adverse outcomes between liberal and restrictive transfusion strategies in patients undergoing vascular and general surgery operations, and with a high risk of postoperative cardiac events. METHODS: A two-arm, single-blinded, randomized controlled superiority trial will be used across 15 Veterans Affairs hospitals with expected enrollment of 1520 participants. Postoperative transfusions in the liberal arm commence when Hb is <10 g/ dL and continue until Hb is greater than or equal to 10 g/dL. In the restrictive arm, transfusions begin when Hb is <7 g/dL and continue until Hb is greater than or equal to 7 g/dL. Study duration is estimated to be 5 years including a 3-month start-up period and 4 years of recruitment. Each randomized participant will be followed for 90 days after randomization with a mortality assessment at 1 year. RESULTS: The primary outcome is a composite endpoint of all-cause mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or stroke occurring up to 90-days after randomization. Events rates will be compared between restrictive and liberal transfusion groups. CONCLUSIONS: The TOP Trial is uniquely positioned to provide high quality evidence comparing transfusion strategies among patients with high cardiac risk. Results will clarify the effect of postoperative transfusion strategies on adverse outcomes and inform postoperative management algorithms. TRIAL REGISTRATION: http://clinicaltrials.gov identifier: NCT03229941.