Sanjit S. Jolly, John A. Cairns, Salim Yusuf, Brandi Meeks, Peggy Gao, Robert G. Hart, Sasko Kedev, Goran Stankovic, Raul Moreno, Vladimír Džavík, Brandi Meeks, Robert G. Hart, Saleem Kassam, Michael J. Rokoss, Magdi El-Omar, Hannu O. Romppanen, Ashraf Alazzoni, Aiman Alak, Anthony Fung, Dimitros Alexopoulos, John D. Schwalm, Nicholas Valettas,
Anotace:
AimsZobrazit více »
TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction, showed no difference in the primary efficacy outcome but a significant increase in stroke. We sought to understand these findings.
Methods and results
A detailed analysis of stroke timing, stroke severity, and stroke subtype was performed. Strokes were adjudicated by neurologists blinded to treatment assignment. Stroke within 30 days, the primary safety outcome, was increased [33 (0.7%) vs. 16 (0.3%), hazard ratio (HR) 2.06; 95% confidence interval (CI) 1.13–3.75]. The difference in stroke was apparent within 48 h [15 (0.3%) vs. 5 (0.1%), HR 3.00; 95% CI 1.09–8.25]. There was an increase in strokes within 180 days with minor or no disability (Rankin 0–2) [18 (0.4%) vs. 13 (0.3%) HR 1.38; 95% CI 0.68–2.82] and in strokes with major disability or fatal (Rankin 3–6) [35 (0.7%) vs. 13 (0.3%), HR 2.69; 95% CI 1.42–5.08]. Most of the absolute difference was due to an increase in ischaemic strokes within 180 days [37 (0.7%) vs. 21 (0.4%), HR 1.71; 95% CI 1.03–3.00], but there was also an increase in haemorrhagic strokes [10 (0.2%) vs. 2 (0.04%), HR 4.98; 95% CI 1.09–22.7]. Patients that had a stroke had a mortality of 30.8% within 180 days vs. 3.4% without a stroke (P < 0.001). A meta-analysis of randomized trials (N = 21 173) showed an increase in risk of stroke (odds ratio 1.59; 95% CI 1.11–2.27) but a trend towards reduction in mortality odds ratio (odds ratio 0.87; 95% CI 0.76–1.00).
Conclusion
Thrombectomy was associated with a significant increase in stroke. Based on these findings, future trials must carefully collect stroke to determine safety in addition to efficacy.
Citace: JOLLY, Sanjit S., John A. CAIRNS, Salim YUSUF, et al. Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction. European Heart Journal: journal of the European Society of Cardiology. Oxford: Oxford University Press, 2015, 36(35), 2364–2372. ISSN 0195-668x. Dostupné z: doi:10.1093/eurheartj/ehv296