Emergency Medicine, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada
Emergency Medicine, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.
Heart. 2022 Oct 28;108(22):1777-1783. doi: 10.1136/heartjnl-2021-320513.
Clinical trials for patients with shock-refractory out-of-hospital cardiac arrest (OHCA), including the Amiodarone, Lidocaine or Placebo (ALPS) trial, have been unable to demonstrate definitive benefit after treatment with antiarrhythmic drugs. A Bayesian approach, combining the available evidence, may yield additional insights.
We conducted a reanalysis of the ALPS trial comparing treatment with amiodarone or lidocaine with placebo in patients with OHCA following shock-refractory ventricular fibrillation or ventricular tachycardia (VF/VT). We used Bayesian regression to assess the probability of improved survival or improved neurological outcome on the 7-point modified Rankin Scale. We derived weak, moderate and strong priors from a previous clinical trial.
The original ALPS trial randomised 3026 adult patients with OHCA to amiodarone (n=974, survival to hospital discharge 24.4%), lidocaine, (n=993, survival 23.7%) or placebo (n=1059, survival 21.0%). In our reanalysis the probability of improved survival from amiodarone ranged from 83% (strong prior) to 95% (weak prior) compared with placebo and from 78% (strong) to 90% (weak) for lidocaine-an estimated improvement in survival of 2.9% (IQR 1.4%-3.8%) for amiodarone and 1.7% (IQR 0.84%-3.2%) for lidocaine over placebo (moderate prior). The probability of improved neurological outcome from amiodarone ranged from 96% (weak) to 99% (strong) compared with placebo and from 88% (weak) to 96% (strong) for lidocaine.
In a Bayesian reanalysis of patients with shock-resistant VF/VT OHCA, treatment with amiodarone had high probabilities of improved survival and neurological outcome, while treatment with lidocaine had a more modest benefit.
对于休克难治性院外心脏骤停(OHCA)患者的临床试验,包括胺碘酮、利多卡因或安慰剂(ALPS)试验,在使用抗心律失常药物治疗后,均未能证明明确的益处。贝叶斯方法,结合现有证据,可能会产生更多的见解。
我们对 ALPS 试验进行了重新分析,该试验比较了胺碘酮或利多卡因与安慰剂在休克难治性室颤或室性心动过速(VF/VT)后 OHCA 患者中的治疗效果。我们使用贝叶斯回归评估 7 点改良 Rankin 量表上生存或神经功能改善的概率。我们从先前的临床试验中得出了弱、中、强先验概率。
原始的 ALPS 试验将 3026 名 OHCA 成年患者随机分为胺碘酮组(n=974,出院时存活率 24.4%)、利多卡因组(n=993,存活率 23.7%)或安慰剂组(n=1059,存活率 21.0%)。在我们的重新分析中,与安慰剂相比,胺碘酮改善生存的概率范围从 83%(强先验)到 95%(弱先验),利多卡因的概率范围从 78%(强)到 90%(弱),胺碘酮估计可使生存提高 2.9%(IQR 1.4%-3.8%),利多卡因提高 1.7%(IQR 0.84%-3.2%)。胺碘酮改善神经功能结局的概率从 96%(弱)到 99%(强)不等,而利多卡因则从 88%(弱)到 96%(强)不等。
在对休克抵抗性 VF/VT OHCA 患者进行贝叶斯重新分析后,胺碘酮治疗有很高的生存和神经功能改善的可能性,而利多卡因的获益则更为适度。