In Reply We thank Sentilhes and colleagues for their comment on our systematic review and meta-analysis of the association of tranexamic acid (TXA) with thromboembolic events and mortality1 and their important perspective on a sufficient follow-up period.
Sentilhes et al2 recently performed a randomized clinical trial among women undergoing cesarean delivery with an outstanding long-term follow-up of more than 3 months after delivery. Overall, TXA was associated with a significant reduction of postpartum hemorrhage or red blood cell transfusion (adjusted risk ratio, 0.84; 95% CI, 0.75-0.94; P = .003). Venous thromboembolic events are rare with an incidence of approximately 1 per 1000 patients. Of the included patients in the trial by Sentilhes and colleagues,2 thromboembolic events occurred in 0.1% (2 of 2056) and 0.4% (8 of 2049) of patients in the placebo and TXA group, respectively (adjusted risk ratio, 4.01; 95% CI, 0.85-18.92; P = .08).2 The authors raised an important point concerning the follow-up after discharge in trials included in our meta-analysis assessing the adverse events after TXA administration. Particularly, women with delivery have an increased risk of developing thromboembolic events. In our meta-analysis, 19 trials addressed cesarean delivery or postpartum hemorrhage, of which 8 trials (cited in our meta-analysis1) including 22 388 patients provided a detailed follow-up period: Ducloy-Bouthors et al, 6 weeks; Gungorduk et al, 6 weeks; WOMAN trial, 6 weeks; Maged et al, 4 weeks; Gungorduk et al, 3 weeks; Ahmed et al, 1 week; Abdel-Aleem et al, hospital stay; and Goswami et al, 24 hours. Overall, we found no association of intravenous TXA and thromboembolic events (risk difference, 0; 95% CI, 0; P = .41). Furthermore, our analysis revealed that the risk for vascular occlusive events (49 trials including 4753 patients) or overall mortality rate (20 trials including 2266 patients) was not increased in studies including patients with increased risks for thromboembolism. However, several risk factors such as age, metabolic syndrome, smoking, cancer, hormone therapy, or immobilization promote the development of thromboembolic events and should be assessed in future studies. As pointed out by Sentilhes and colleagues, future research should also focus on an extended assessment and follow up the included patients for at least 3 months to assess the thromboembolic events throughout a longer period. Moreover, a risk adjustment for multifactorial causes of thromboembolic events should be considered. Innovative tools such as telemedicine could help to collect these comprehensive data in future.
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Taeuber I, Choorapoikayil S, Meybohm P. Importance of the Assessment Time Window for Intravenous Tranexamic Acid and Thromboembolic Events—Reply. JAMA Surg. 2022;157(1):80–81. doi:10.1001/jamasurg.2021.4141
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