E-cigarettes versus nicotine patch for perioperative smoking cessation: a pilot randomized trial

Methods : Preoperative patients were randomized to either the nicotine patch group (n=10) or the e-cigarette group (n=20). Both groups were given a free 6-week supply in a tapering dose. All patients received brief counseling, a brochure on perioperative smoking cessation, and referral to the California Smokers’ Helpline. The primary outcome was rate of smoking cessation on day of surgery confirmed by exhaled carbon monoxide. Secondary outcomes included smoking habits, pulmonary function, adverse events, and satisfaction with the products on day of surgery and at 8-weeks follow-up. Results : Biochemically verified smoking cessation on day of surgery was similar in both groups. Change in forced expiratory volume in one second (FEV1) was 592ml greater in the e-cigarette group (95% CI 153-1031ml, p=0.01) and change in forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC ratio) was 40.1% greater in the e-cigarette group (95% CI 18.2%-78.4%, p=0.04). Satisfaction with the product was similar in both groups. Discussion : E-cigarettes are a feasible tool for perioperative smoking cessation in veterans with quit rates comparable to nicotine replacement patch. Spirometry appears to be improved 8-weeks after initiating e-cigarettes compared to nicotine patch, possibly due to worse baseline spirometry and more smoking reduction in the END group. An adequately powered study is recommended to determine if these results can be duplicated. Abstract 31 Introduction: Cigarette smoking by surgical patients is associated with increased 32 complications. E-cigarettes have emerged as a potential smoking cessation tool. We sought to 33 determine the feasibility and acceptability of e-cigarettes, compared to nicotine patch, for 34 perioperative smoking cessation in veterans. 35 Methods : Preoperative patients were randomized to either the nicotine patch group (n=10) or the 36 e-cigarette group (n=20). Both groups were given a free 6-week supply in a tapering dose. All 37 patients received brief counseling, a brochure on perioperative smoking cessation, and referral to 38 the California Smokers’ Helpline. The primary outcome was rate of smoking cessation on day of 39 surgery confirmed by exhaled carbon monoxide. Secondary outcomes included smoking habits, 40 pulmonary function, adverse events, and satisfaction with the products on day of surgery and at 41 8-weeks follow-up. 42 Results : Biochemically verified smoking cessation on day of surgery was similar in both groups. 43 Change in forced expiratory volume in one second (FEV1) was 592ml greater in the e-cigarette 44 group (95% CI 153-1031ml, p=0.01) and change in forced expiratory volume in one second to 45 forced vital capacity ratio (FEV1/FVC ratio) was 40.1% greater in the e-cigarette group (95% CI 46 18.2%-78.4%, p=0.04). Satisfaction with the product was similar in both groups. 47 Discussion : E-cigarettes are a feasible tool for perioperative smoking cessation in veterans with 48 quit rates comparable to nicotine replacement patch. Spirometry appears to be improved 8-49 weeks after initiating e-cigarettes compared to nicotine patch, possibly due to worse baseline 50 spirometry and more smoking reduction in the END group. An adequately powered study is 51 recommended to determine if these results can be duplicated.

224 Analysis Plan 225 The study was analyzed by intention-to-treat. No adjustments for multiple comparisons were 226 made, because all outcomes were pre-specified and were limited to a relatively small number.   289 Product usage was similar between groups (Table 5).
290 No participants in either group experienced intraoperative complications. The rate of 291 postoperative complications was similar in both groups (60% in the NRT group and 26% in the 292 END group, p=0.11).
293 Common adverse events related to both NRT and END included headache, nausea, cough, and 294 throat irritation, as shown in Table 6. There were no statistically significant differences between 295 event rates in each group.  Table 7. Manuscript to be reviewed 303 usage on the day of surgery. Usage increased by 8-week follow-up, particularly in the END 304 group, which reported 80% (n=16) regular use compared with 67% (n=6) in the NRT group, 305 although the difference was not statistically significant (p=0.64).
306 Satisfaction was also similar at both time points between NRT and END groups, with both 307 groups being at least somewhat satisfied with the products they were given, as shown in Table 5.
308 More in-depth explorations of how each product was used, patient attitudes towards smoking 309 cessation in relation to the assigned products, and satisfaction with the products were conducted 310 in qualitative interviews at 8-weeks follow-up and will be reported separately.

Feasibility of Study Processes
312 As a pilot study, feasibility of study processes were also analyzed. As with prior perioperative 358 The results could also be explained by a higher baseline prevalence of COPD in the END group 359 in addition to the possible increased smoking reduction and cessation in the END group. Given 360 the small sample size and effort-dependence of spirometry, further studies would be needed to 361 verify the consistency of the spirometry findings.
362 As is typical of pilot studies, our study was limited by small sample size, such that we were 363 underpowered to detect all but the largest of differences between groups. Nevertheless, we were 364 able to demonstrate the acceptability of e-cigarettes for perioperative smoking cessation, as 365 evidenced by similar satisfaction scores between END and NRT groups, with most patients in 366 the END group indicating that the product was helpful in their quit attempt and that they would 367 recommend the product.
368 Participants were given a set 6-week supply based on baseline cigarettes per day of either END Manuscript to be reviewed Of the 35 patients approached for inclusion but found to be ineligible, the reasons for ineligibility included: smoking less than 2 cigarettes per day (n=10), already being on smoking cessation pharmacotherapy (n=9), smoking non-cigarette tobacco only (n=5), prior adverse reaction to NRT patch (n=3), already enrolled in smoking cessation program (n=3), regular use of e-cigarettes (n=2), surgical date changed (n=2) and currently experiencing an unstable cardiac condition (n=1). One patient was found to be ineligible after consent, but prior to randomization. All patients were given the treatment (END or NRT) to which they were randomized. Losses to follow-up were minimal and balanced between groups.

Baseline characteristics
Values are mean (SD) or n (percentage). Percentages may not add to 100 due to rounding.   Manuscript to be reviewed    Manuscript to be reviewed Manuscript to be reviewed Manuscript to be reviewed