Ventricular tachycardia landmark trials

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor-in Chief: Avirup Guha, M.B.B.S.[2]

Landmark Clinical Trials

Studies of secondary prevention of sudden cardiac death

1. AVID (The Antiarrhythmics versus Implantable Defibrillators)

1. 1. Strategy: ICD vs medication either amiodarone or sotalol

1. 1. Demographics: Total: 1016 ICD: 507 Medications (predominantly amiodarone): 509 (80% with ischemic heart disease)

1. 1. Mean EF: 32 (inclusion<40)

1. 1. Result: Relative risk reduction: 1-year: 39% ; 2-year: 27% ; 3-year: 31% (p = 0.02)

1. CIDS (Canadian Implantable Defibrillator Study)

1. 1. Strategy: ICD vs amiodarone

1. 1. Demographics: Total: 659 ICD: 328 Amiodarone: 331 (82% with ischemic heart disease)

1. 1. Mean EF: <35

1. 1. Result: Relative risk reduction: 20% (p = 0.142)

1. CASH (Cardiac Arrest Study Hamburg)

1. 1. Strategy: ICD vs amiodarone vs beta blocker

1. 1. Demographics: Total: 288 (74% with ischemic heart disease) ICD: 99 Amiodarone: 92 Metoprolol: 97

1. 1. Mean EF: 45

1. 1. Result: Relative risk reduction at 5 years: 23% (p = 0.081)

Trials of primary prevention of sudden cardiac death with implantable cardiac defibrillators.

1. MADIT I (Multicenter Automatic Defibrillator Implantation Trial)

1. 1. Strategy: Conventional medical therapy vs ICD in patients with clinical NSVT and inducible VT during EPS that is not suppressible with procainamide

1. 1. Demographics: Medical therapy: 101 ICD arm: 95

1. 1. Mean EF: 35

1. 1. Result: RR reduction in mortality in favor of ICD; 95% CI: 0.26-0.82; p = 0.009

1. CABG-PATCH (Coronary Artery Bypass Graft (CABG) Patch Trial)

1. 1. Strategy: CAD patients undergoing CABG with abnormal signal averaged ECG randomized to ICD or control group

1. 1. Demographics: ICD epicardial: 446 Control arm: 45 Total: 900 30days and revascularization > 90 days) randomized 3:2 to ICD vs conventional medical therapy ICD: 42 Conventional medical therapy: 490

1. 1. Mean EF: 30

1. 1. ’’Result’’: 31% RR reduction in favor of ICD; 95% CI: 0.51-0.93; p = 0.16

1. ‘’AMIOVIRT (Amiodarone versus Implantable Defibrillator)’’

1. 1. ’’Strategy’’: Nonischemic dilated cardiomyopathy patients with nonsustained

VT, randomized to ICD vs amiodarone

1. 1. ’’Demographics’’: ICD: 51 Amiodarone: 52 Total: 103

1. 1. ’’Mean EF’’: 35

1. 1. ’’Result’’: No significant difference in survival

1. ‘’DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation)’’

1. 1. ’’Strategy’’: Nonischemic dilated cardiomyopathy patients with nonsustained VT, randomized to ICD vs standard medical therapy

1. 1. ’’Demographics’’: Singlechamber ICD: 229 Standard medical therapy: 229 Total: 458 120 ms) in both ischemic and nonischemic causes 1520 randomized in 1:2:2 ratio to receive optimum pharmacological therapy, biventricular pacemaker alone or biventricular pacemaker defibrillator

1. 1. ’’Mean EF’’: 35

1. 1. ’’Result’’: Combined end point of hospitalization and death reduced by the pacemaker alone 34% (p = 0.002) and pacemaker-ICD by 40% (p = 0.001). Secondary end point all-cause mortality reduced by defibrillator by RR-36% (p = 0.003) but not by pacemaker alone. RR: 24% (p = 0.059)

1. ’’DINAMIT (Defibrillator in Acute Myocardial Infarction Trial)’’

1. 1. ’’Strategy’’: Benefit of an ICD early after an MI within 6-40 days towards reduction of mortality when compared with medical therapy

1. 1. ’’Demographics’’: ICD: 332 Control: 342 Total: 674

1. 1. ’’Mean EF’’: 35

1. 1. ’’Result’’: 62 deaths in the ICD group and 58 in the control group (p = 0.66; CI: 0.76-1.55). Arrhythmic causes were less in the ICD group but nonarrhythmic causes were significantly higher and thus overall mortality was not significantly different

1. ’’SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial)’’

1. 1. ’’Strategy’’: To assess prognostic effect of ICD vs amiodarone vs placebo in class II and III heart failure regardless of etiology.

1. 1. ’’Demographics’’: Conventional therapy and placebo: 847 Conventional therapy and amiodarone: 845 Conventional therapy and single lead, shock only ICD: 829 Total: 2521

1. 1. ’’Mean EF’’: 35 (ischemic etiology patients 52% and nonischemic etiology 48%)

1. 1. ’’Result’’: Amiodarone and placebo outcome were comparable. ICD arm absolute risk reduction: 7.2% after 5 years; RR: 23% (p = 0.007)

References

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