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)
- Strategy: ICD vs medication either amiodarone or sotalol
- Demographics: Total: 1016 ICD: 507 Medications (predominantly amiodarone): 509 (80% with ischemic heart disease)
- Mean EF: 32 (inclusion<40)
- Result: Relative risk reduction: 1-year: 39% ; 2-year: 27% ; 3-year: 31% (p = 0.02)
2. CIDS (Canadian Implantable Defibrillator Study)
- Strategy: ICD vs amiodarone
- Demographics: Total: 659 ICD: 328 Amiodarone: 331 (82% with ischemic heart disease)
- Mean EF: <35
- Result: Relative risk reduction: 20% (p = 0.142)
3. CASH (Cardiac Arrest Study Hamburg)
- Strategy: ICD vs amiodarone vs beta blocker
- Demographics: Total: 288 (74% with ischemic heart disease) ICD: 99 Amiodarone: 92 Metoprolol: 97
- Mean EF: 45
- Result: Relative risk reduction at 5 years: 23% (p = 0.081)
4. CASCADE(The Cardiac Arrest in Seatle Conventional Versus Amiodarone Drug Evaluation study)
- Strategy: Amiodarone vs conventional therapy in patients with/without AICD
- Demographics: Total: 228 Amiodarone: 113 conventional antiarrhythmic drugs: 115(quinidine (n=33), procainamide (n = 26), combination therapy (n = 17), flecainide (n = 12). AICD: 105 (Amiodarone: 53, Conventional therapy: 52)
- Mean EF: 35
- Result: 13% more survival in patient population at the primary end point (total cardiac mortality, resuscitated cardiac arrest due to ventricular fibrillation, and syncopal Implanted defibrillator shocks) at the end of 6 years. (p=0.007). With AICD 16% survival more at the primary end point( shocks preceded by complete syncope)(p=0.032) conclusively showing superiority of Amidarone over convetional therapy in secondary prevention.
5. ESVEM (Electrophysiologic Study Versus Electrocardiographic Monitoring for Selection of Antiarrhythmic Therapy of Ventricular Tachyarrhythmias)
- Strategy: EP testing and Holter monitor of 7 antiarrhythmics (imipramine, mexiletine, procainamide, quinidine, sotalol, pirmenol, propafenone)
- Demographics: 486 patients were randomized and 296 patients were eventually followed up.
- Mean EF: 33% in all 296 and 34% in Sotalol group
- Result: No difference between Holter- and EP-guided groups. Sotalol group had lowest recurrence rate of VT (risk ratio, 0.43; 95 percent confidence interval, 0.29 to 0.62; p<0.001), arrhythmic death (risk ratio, 0.50; 95 percent confidence interval, 0.26 to 0.96; P = 0.04), total death (risk ratio, 0.50; 95 percent confidence interval, 0.30 to 0.80; P = 0.004).
Trials of primary prevention of sudden cardiac death with implantable cardiac defibrillators.
1. MADIT I (Multicenter Automatic Defibrillator Implantation Trial)
- Strategy: Conventional medical therapy vs ICD in patients with clinical NSVT and inducible VT during EPS that is not suppressible with procainamide
- Demographics: Medical therapy: 101 ICD arm: 95
- Mean EF: 35
- Result: RR reduction in mortality in favor of ICD; 95% CI: 0.26-0.82; p = 0.009
2. CABG-PATCH (Coronary Artery Bypass Graft (CABG) Patch Trial)
- Strategy: CAD patients undergoing CABG with abnormal signal averaged ECG randomized to ICD or control group
- 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
- Mean EF: 30
- Result: 31% RR reduction in favor of ICD; 95% CI: 0.51-0.93; p = 0.16
3. AMIOVIRT (Amiodarone versus Implantable Defibrillator)
- Strategy: Nonischemic dilated cardiomyopathy patients with nonsustained VT, randomized to ICD vs amiodarone
- Demographics: ICD: 51 Amiodarone: 52 Total: 103
- Mean EF: 35
- Result: No significant difference in survival
4. DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation)
- Strategy: Nonischemic dilated cardiomyopathy patients with nonsustained VT, randomized to ICD vs standard medical therapy
- 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
- Mean EF: 35
- 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)
5. DINAMIT (Defibrillator in Acute Myocardial Infarction Trial)
- Strategy: Benefit of an ICD early after an MI within 6-40 days towards reduction of mortality when compared with medical therapy
- Demographics: ICD: 332 Control: 342 Total: 674
- Mean EF: 35
- 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
6. SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial)
- Strategy: To assess prognostic effect of ICD vs amiodarone vs placebo in class II and III heart failure regardless of etiology.
- Demographics: Conventional therapy and placebo: 847 Conventional therapy and amiodarone: 845 Conventional therapy and single lead, shock only ICD: 829 Total: 2521
- Mean EF: 35 (ischemic etiology patients 52% and nonischemic etiology 48%)
- Result: Amiodarone and placebo outcome were comparable. ICD arm absolute risk reduction: 7.2% after 5 years; RR: 23% (p = 0.007)