Table 1.
Summary of included implantable cardioverter–defibrillator (ICD) randomized controlled trials
| Study characteristic | Vorobiof16 (2006)∗ | Albert12 (2008) | Russo15 (2008) | Køber14 (2016) | De Waard13 (2019) |
|---|---|---|---|---|---|
| Trial name | MADIT-II | DEFINITE | SCD-HeFT | DANISH | RAFT |
| Trial sites/ region | North America, Europe | North America | North America, Australia | Europe | North America, Europe, Australia, Asia |
| No. of trial sites | 76 | NR | 148 | 5 | 34 |
| Eligible age, y | > 21 | NR | ≥ 18 | NR | NR |
| Enrollment by sex (male vs female) | 1039 (84), 197 (16) | 326 (71), 132 (29) | 1933 (76.7), 588 (23.3) | 809 (72.5), 307 (27.5) | 1490 (83), 308 (17) |
| Male enrollment by race (White, Black, Hispanic, other) | 934 (93.7) White, 63 (6.3) Black | 232 (71), 69 (21), 20 (6), 5 (2) | 1527 (79) White, 406 (21) reported as non-White race | NR | NR |
| Female enrollment by race (White, Black, Hispanic, other) | 140 (78.2), White 39 (21.8) Black | 77 (58%, 49 (37), 6 (5), 0 (0) | 406 (69) White, 182 (31) reported as non-White race | NR | NR |
| Mean age, y | 64 ± 10 | 58.3 | 60 (median) | 63.5 (median) | 66.1 ± 9.4 |
| Patient population | Past MI, LVEF < 0.30 | LVEF < 36%, HF, or arrhythmias | NYHA class II or class II chronic, stable CHF, and LVEF ≥ 35% | LVEF < 36%, arrhythmias, HF, or non-ischemic DCM | NYHA class II HF, LVEF < 30%, prolonged QRS duration, sinus rhythm/AF/AFL < 60 bpm at rest, or planned ICD for indicated prevention of SCD |
| Trial subgroup | MI | Non-ischemic DCM | SCD, CHF | Systolic HF | HF, ventricular arrhythmia |
| Primary outcome(s) | Death from any cause† | Death from any cause | Death from any cause† | Death from any cause | Death from any cause or HFH† |
| Secondary outcome(s) | N/A | Sudden death from arrhythmia† | Arrhythmic death | SCD, CV death, cardiac arrest, sustained ventricular tachycardia, and change in quality of life | Death from any cause, death from any CV cause, and HFH |
| Treatment arm | ICD | ICD | ICD | ICD | ICD |
| Control arm | Conventional medical therapy | Standard medical therapy | Amiodarone or placebo | Usual clinical care | ICD-CRT |
| No. of patients (treatment vs control) | 1232 (742† vs 490) |
458 (229† vs 229) |
2521 (Tx1: 845, Tx2: 829† vs 847) |
1116 (556 vs 560) |
1798 (904 vs 894†) |
| Overall quality of the evidence (GRADE) ‡ | ⊕⊕⊕⊕ High (n = 5 studies) |
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Values are n (%), unless otherwise indicated.
AF, atrial fibrillation; AFL, atrial flutter; bpm, beats per minute; CHF, congestive heart failure; CRT, cardiac resynchronization therapy; CV, cardiovascular; DANISH, Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on Mortality; DCM, dilated cardiomyopathy; DEFINITE, Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation Trial; GRADE, Grading of Recommendations, Assessment, Development, and Evaluations; HF, heart failure; HFH, heart failure hospitalization; ICD, implantable cardioverter-defibrillator; LVEF, left ventricular ejection fraction; MADIT-II, Multicenter Automatic Defibrillator Implantation Trial II; MI, myocardial infarction; NR, not reported; NYHA, New York Heart Association; RAFT, Resynchronization–Defibrillation for Ambulatory Heart Failure Trial; RCT, randomized controlled trial; SCD, sudden cardiac death; SCD-HeFT, Sudden Cardiac Death in Heart Failure Trial; Tx, treatment.
Vorobiof et al.16 reported data on MADIT-II and included 1073 White patients, 102 Black Patients, and 37 Hispanic patients, and 20 patients categorized as ‘other’. However, race characteristics were only documented for White and Black patients, so not all participants are included for those characteristics.
Indicates significance at P < 0.05.
Studies were assessed for all-cause death only.