Letter to the editor regarding manuscript “Resuscitation Outcomes Consortium–Amiodarone, Lidocaine or Placebo: Rationale and methodology behind out-of-hospital cardiac arrest antiarrhythmic drug trial” Dear Editor, I would raise serious concerns about the design and rationale of the announced ROC-ALPS trial 1 addressing the role of antiarrhythmic drugs for refractory ventricular tachycardia/fibrillation during out-of-hospital cardiac arrest. In fact, both lidocaine and placebo arms of the trial are not justified because amiodarone was definitely superior in a head-to-head randomized comparison either I with lidocaine 2 or placebo 3 for achieving higher survival rates to hospital admission. As consequence, amiodarone is considered as the standard of care in current guidelines 4. Testing lidocaine (or placebo) against amiodarone for an even higher and ambitious target (survival-to-hospital discharge) is counterintuitive and not supported by a balanced assessment of the literature. Therefore, giving placebo or lidocaine in this context exposes patients to unnecessary harm, does not help the progress of research in this field, and is barely justifiable on ethical grounds. Eventually, Helsinki principles of biomedical research recommend to test any new drug against the best active treatment available (standard of care) and when there is true uncertainty about whichever of 2 is better. Furthermore, placebo is justified only when no effective treatment does exist. I do not think that these conditions are fulfilled in the ROC-ALPS trial. Moreover, I wonder how the same brilliant investigators who demonstrated the superiority of amiodarone over lidocaine or placebo will participate to this flawed study. Rather than a true

uncertainty about the most effective pharmacologic treatment of refractory ventricular tachycardia/fibrillation, it is inertia of previous practice, inability to acknowledge the existing evidence, and lack of proper clinical stewardship of the emergency medicine services the main drive of continuous use of lidocaine in this setting. This is not a good reason to do a costly and large randomized trial. I suspect that this study will contribute to the research waste 5 much more than helping us save more patients with out-ofhospital cardiac arrest and refractory ventricular tachycardia/fibrillation. Am Heart J 2014;168:e17. 0002-8703 http://dx.doi.org/10.1016/j.ahj.2014.07.013

Primiano Iannone, MD Head of Emergency Department Ospedali del Tigullio, Lavagna, GE, Italy E-mail: [email protected]

References 1. Kudenchuk PJ, et al. Resuscitation Outcomes Consortium–Amiodarone, Lidocaine or Placebo study (ROC-ALPS): rationale and methodology behind out of hospital cardiac arrest antiarrhythmic drug trial. Am Heart J 2014;167:653-9. 2. Dorian P, et al. Amiodarone as compared with lidocaine for shockresistant ventricular fibrillation. N Engl J Med 2002;346:884-90. 3. Kudenchuk PJ, et al. Amiodarone for resuscitation after out of hospital cardiac arrest due to ventricular fibrillation. N Engl J Med 1999;341: 871-8. 4. Neumar RW, et al. Part 8: adult advanced cardiovascular life support: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation 2010;122:S729-67. 5. Chalmers J, et al. Avoidable waste in the production and reporting of research evidences. Lancet 2009;374:86-9.