Clinical trials of antiarrhythmic drugs in patients with sustained ventricular tachyarrhthymias

Current Opinion in Cardiology

Volumn 12, Issue 1, 1997, Pages 33-40

  Mitchell, L Brent ^a  

^a UNIVERSITY OF CALGARY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

AMIODARONE; ANTIARRHYTHMIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT;

CATHETER ABLATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEFIBRILLATOR; DRUG EFFICACY; HEART VENTRICLE TACHYCARDIA; HUMAN; IMPLANT; LONG TERM CARE; META ANALYSIS; PRIORITY JOURNAL; REVIEW;

EID: 0031057126     PISSN: 02684705     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001573-199701000-00006     Document Type: Review

References (45)

1. Trevor Cooke W, White PD: Paroxysmal ventricular tachycardia. Br Heart J 1943, 5:33-54.
2. Herrmann GR, Park HM, Hejtmancik MR: Paroxysmal ventricular tachycardia: a clinical and electrocardiographic study. Am Heart J 1959, 57:166-176.
3. Liberthson RR, Nagel EL, Hirschman JC, Nussenfeld SR: Prehospital ventricular fibrillation. Prognosis and follow-up course. N Engl J Med 1974, 291:317-321.
4. Cobb LA, Baum RS, Alvarez H III, Schaffer WA: Resuscitation from outof-hospital ventricular fibrillation: 4 years of follow-up. Circulation 1975, 52(Suppl III):III-23-III-228.
5. Leitch JW, Gillis AM, Wyse DG, Yee R, Klein GJ, Guiraudon G, Sheldon RS, Duff HJ, Kieser TM, Mitchell LB: Reduction in defibrillator shocks with an implantable device combining antitachycardia pacing and shock therapy. J Am Coll Cardiol 1991, 18:145-151.
6. Bardy GH, Hofer B, Johnson G, Kudenchuk PJ, Poole JE, Dolack L, Gleva M, Mitchell R, Kelso D: Implantable transvenous cardioverter-defibrillators. Circulation 1993, 87:1152-1168.
7. Mitchell LB: Pharmacological therapy. In Implantable Cardioverter-Defibrillator. Edited by Singer I. Armonk, NY: Futura Publishing Company; 1994:557-613.
8. Winkle RA, Alderman EL, Fitzgerald JW, Harrison DC: Treatment of recurrent symptomatic ventricular tachycardia. Arch Intern Med 1976, 85:1-7.
9. Lown B, Graboys TB: Management of patients with malignant ventricular tachyarrhythmias. Am J Cardiol 1977, 39:910-918.
10. Wu D, Wyndham CR, Denes P, Amat-Y-Leon F, Miller RH, Dhingra RC, Rosen KM: Chronic electrophysiological study in patients with recurrent paroxysmal tachycardia: a new method for developing successful oral antiarrhythmic therapy. In Reentrant Arrhythmia: Mechanisms and Treatment. Edited by Kulbertus HE. Lancaster, PA: MTP Press Limited; 1977:294-311.
11. Mason JW, Winkle RA: Electrode-catheter arrhythmia induction in the selection and assessment of antiarrhythmic drug therapy for recurrent ventricular tachycardia. Circulation 1978, 58:971-985.
12. Horowitz LN, Josephson ME, Farshidi A, Spielman SR, Michelson EL, Greenspan AM: Recurrent sustained ventricular tachycardia: 3. Role of the electrophysiologic study in selection of antiarrhythmic regimens. Circulation 1978, 58:986-997.
13. Mitchell LB, Duff HJ, Manyari DE, Wyse DG: A randomized clinical trial of the noninvasive and invasive approaches to drug therapy of ventricular tachycardia. N Engl J Med 1987, 317:1681-1687.
14. The ESVEM Investigators: The ESVEM trial: electrophysiologic study versus electrocardiographic monitoring for selection of antiarrhythmic therapy of ventricular tachyarrhythmias. Circulation 1989, 79:1354-1360.
15. Mason JW, ESVEM Investigators: A comparison of electrophysiologic testing with Holter monitoring to predict antiarrhythmic drug efficacy for ventricular tachyarrhythmias. N Engl J Med 1993, 329:445-451.
16. Mason JW, ESVEM Investigators: A comparison of seven antiarrhythmic drugs in patients with ventricular tachyarrhythmias. N Engl J Med 1993, 329:452-458.
17. Mitchell LB, Duff HJ, Gillis AM, Ramadan D, Wyse DG: A randomized •• clinical trial of the noninvasive and invasive approaches to drug therapy for ventricular tachycardia: long-term follow-up of the Calgary trial. Prog Cardiovasc Dis 1996, 38:377-384. An update of the first randomized clinical trial comparing the invasive and noninvasive approaches to the selection of individualized antiarrhythmic drug therapy for patients with recurrent VT or VF. This study enrolled only those patients that had not failed a previous trial of individualized antiarrhythmic drug therapy and used stringent definitions of predicted-effective drug therapy. This update extends the minimum event-free follow-up period to 6.5 years. The data support the conclusion that individualized antiarrhythmic drug therapy selected by the invasive approach prevents subsequent VT or VF recurrence better than does that selected by the noninvasive approach.
18. Mason JW, Marcus FI, Bigger JT, Lazarra R, Reiffel JA, Reiter MJ, Mann D: •• A summary and assessment of the findings and conclusions of the ESVEM trial. Prog Cardiovasc Dis 1996, 38:347-358. This review summarizes the major findings of the ESVEM study. The ESVEM study enrolled a different population than the Calgary study, selected therapy using less stringent criteria than the Calgary study, and reached a different conclusion than the Calgary study. Specifically, in the ESVEM study the invasive and noninvasive approaches to individualized antiarrhythmic drug therapy selected therapies that were equivalent. However, each approach was associated with a high VT or VF recurrence probability on follow-up. This review also includes an extensive rebuttal of the published criticisms of the ESVEM study.
19. Reiffel JA, Reiter MJ, Freedman RA, Mann D, Huang SKS, Han E, Mason • JW, ESVEM Investigators: Influence of Holter monitor and electrophysiologic study methods and efficacy criteria on the outcome of patients with ventricular tachycardia and ventricular fibrillation in the ESVEM trial. Prog Cardiovasc Dis 1996, 38:359-370. In response to suggestions that the definitions of predicted-effective drug therapy used in ESVEM were too lax and encouraged subsequent VT or VF recurrences, this report describes post hoc analyses of the results that might have accompanied use of more stringent criteria. Unfortunately, the analysis is retrospective and produces subgroups that are too small to support statistical analyses even where trends are evident. Nevertheless, the authors conclude that the main results of the ESVEM study would not have been altered had other criteria of predicted-effective drug therapy been used.
20. Anderson KP, Hartz VL, Hahn E, Moon TE, ESVEM Investigators: Design •• and analysis of the ESVEM Trial. Prog Cardiovasc Dis 1996, 38:489-502. This review provides further background for some of the procedural decisions made in the preparation and subsequent conduct of the ESVEM study. The article also includes many of the subgroup analyses that have been requested by ESVEM critics. Of these, perhaps the most intriguing is an interaction analysis providing further support for preferential use of the invasive approach to individualized standard antiarrhythmic drug therapy in patients with ischemic heart disease.
21. Omoigui NA, Marcus FI, Mason JW, Hahn EA, Hartz VL, Hlatky MA, • ESVEM Investigators: Cost of initial therapy in the electrophysiologic study versus ECG monitoring trial (ESVEM). Circulation 1995, 91:1070-1076. The study provides a cost analysis of the consequences of being randomized to the invasive or noninvasive approaches to individualized antiarrhythmic drug therapy in the ESVEM study. Initial hospital charges for patients randomly assigned to the invasive approach were substantial and were 32% higher than those of patients randomly assigned to the noninvasive approach.
22. Hlatky MA: Cost and efficacy analysis in the ESVEM trial: implications for diagnosis and therapy for ventricular tachyarrhythmias. Prog Cardiovasc Dis 1996, 38:371-376.
23. Biblo LA, Carlson MD, Waldo AL: Insights into the Electrophysiologic Study Versus Electrocardiographic Monitoring trial: its programmed stimulation protocol may introduce bias when assessing long-term antiarrhythmic drug therapy. J Am Coll Cardiol 1995, 25:1601-1604.
24. Mitchell LB, Sheldon RS, Gillis AM, Gardner MJ, Duff HJ, Connolly SJ, Hui WK, Ramadan DE, Wyse DG: Definition of predicted effective therapy for VT/VF by programmed stimulation: randomized comparison of patient response criteria [Abstract]. Circulation 1994, 90:1-339.
25. Steinbeck G, Andresen D, Bach P, Haberl R, Oeff M, Hoffmann E, von Leitner ER: A comparison of electrophysiologically guided antiarrhythmic drug therapy with β-blocker therapy in patients with symptomatic, sustained ventricular tachycardia. N Engl J Med 1992, 327:987-992.
26. Siebels J, Cappato R, Ruppel R, Schneider MAE, Kuck KH, CASH Investigators: ICD versus drugs in cardiac arrest survivors: preliminary results of the Cardiac Arrest Study Hamburg. PACE Pacing Clin Electrophysiol 1993, 16:552-558.
27. Jazayeri MR, VanWyhe G, Avitall B, McKinnie J, Tchou P, Akhtar M: Isoproterenol reversal of antiarrhythmic effects in patients with inducible sustained ventricular tachyarrhythmias. J Am Coll Cardiol 1989, 14:705-711.
28. Meredith IT, Broughton A, Jennings GL, Esler MD: Evidence of a selective increase in cardiac sympathetic activity in patients with sustained ventricular tachyarrhythmias. N Engl J Med 1991, 325:618-624.
29. Szabó BM, Crijns HJGM, Wiesfeld ACP, van Veldhuisen DJ, Hillege HL, •• Lie KI: Predictors of mortality in patients with sustained ventricular tachycardias or ventricular fibrillation and depressed left ventricular function: importance of β-blockade. Am Heart J 1995, 130:281-286. This study examines the predictors of all-cause mortality and the predictors of sudden cardiac death using multivariate analysis of a database of 85 patients treated for an evident propensity to sustained VT or VF. As always, left ventricular function is the overriding determinant of mortality in patients with VT or VF. This analysis also indicated the importance of concomitant β-blocking drug therapy in these patients.
30. Nademanee K, Hendrickson J, Kannan R, Singh BN: Antiarrhythmic efficacy and electrophysiologic actions of amiodarone in patients with life-threatening ventricular arrhythmias: potent suppression of spontaneously occurring tachyarrhythmias versus inconsistent abolition of induced ventricular tachycardia. Am Heart J 1982, 103:950-959.
31. Herre JM, Sauve MJ, Malone P, Griffin JC, Helmy I, Langberg JJ, Goldberg H, Scheinman MM: Long-term results of amiodarone therapy in patients with recurrent sustained ventricular tachycardia or ventricular fibrillation. J Am Coll Cardiol 1989, 13:442-449.
32. Myers M, Peter J, Weiss D, Nalos PC, Gang ES, Oseran DS, Mandel WJ: Benefits and risks of long-term amiodarone therapy for sustained ventricular tachycardia/fibrillation: minimum of three-year follow-up. Am Heart J 1990, 119:8-14.
33. Weinberg BA, Miles WM, Klein LS, Bolander JE, Dusman RE, Stanton MS, Heger JJ, Langefeld C, Zipes DP: Five-year follow-up of 589 patients treated with amiodarone. Am Heart J 1993, 125:109-120.
34. The CASCADE Investigators: Cardiac arrest in Seattle: conventional versus amiodarone drug evaluation (the CASCADE study). Am J Cardiol 1991, 67:578-584.
35. The CASCADE Investigators: Randomized antiarrhythmic drug therapy is survivors of cardiac arrest (the CASCADE study). Am J Cardiol 1993, 72:280-287.
36. Connolly SJ, Jent M, Roberts RS, Dorian P, Green MS, Klein GJ, Mitchell LB, Sheldon RS, Roy D: Canadian Implantable Defibrillator Study (CIDS): study design and organization. Am J Cardiol 1993, 72:103F-108F.
37. AVID Investigators: Antiarrhythmics versus Implantable Defibrillators (AVID): rationale, design and methods. Am J Cardiol 1995, 75:470-475.
38. Zipes DP, Roberts D, Pacemaker-Cardioverter-Defibrillator Investigators: Results of the international study of the implantable cardioverter-defibrillator: a comparison of epicardial and endocardial lead systems. Circulation 1995, 92:59-65.
39. Powell AC, Fuchs T, Finkelstein DM, Garan H, Cannom DS, McGovern BA, Kelly E, Vlahakes GJ, Torchiana DF, Ruskin JN: Influence of implantable cardioverter-defibrillators on the long-term prognosis of out-of-hospital cardiac arrest Circulation 1993, 88:1083-1092.
40. Fogoros RN, Fielder SB, Elson JJ: The automatic implantable cardioverter-defibrillator in drug-refractory ventricular tachyarrhythmias. Ann Intern Med 1987, 107:635-641.
41. Newman D, Sauve MJ, Herre J, Langberg JJ, Lee MA, Titus C, Franklin J, Scheinman MM, Griffin JC: Survival after implantation of the cardioverter defibrillator. Am J Cardiol 1992, 69:899-903.
42. Böcker D, Haverkamp W, Block M, Borggrefe M, Hammel D, Breithardt G: •• Comparison of d,1-sotalol and implantable defibrillators for treatment of sustained ventricular tachycardia or fibrillation in patients with coronary artery disease. Circulation 1996, 94:151-157. This intriguing study follows a case-control format to compare the outcomes of patients with both atherosclerotic heart disease and sustained VT or VF who were treated with an ICD to the outcomes of such patients who were treated with sotalol predicted to be effective by the invasive approach. The study suggested that patients treated with the ICD were less likely to die, in general, or to die from sudden cardiac death, specifically.
43. Wever EFD, Hauer RNW, van Capelle FJL, Tisjssen JGP, Crijns JGM, • Algra A, Wiesfeld ACP, Bakker PFA, Robles de Medina EO: Randomized study of implantable defibrillator as first-choice therapy versus conventional strategy in postinfarct sudden death survivors. Circulation 1995, 91:2195-2203. This report describes the outcome of the first randomized comparison of initial use of ICD and conventional therapy in patients resuscitated from a cardiac arrest. In this study, conventional therapy was considered to be individualized standard antiarrhythmic drug therapy selected by the invasive approach and, when this approach was unsuccessful, one or more of empiric amiodarone therapy, electrosurgery, or secondary ICD therapy. The study suggested the superiority of primary ICD therapy but did so with an enormous effect-size that used a combined end point in a very small patient sample.
44. Singer I: Clinical results: an overview. In Implantable Cardioverter-Defibrillator. Edited by Singer I. Armonk, NY: Futura Publishing Company; 1994:471-485.
45. Saksena S, Madan N, Lewis C: Implantable cardioverter-defibrillators are preferable to drugs as primary therapy in sustained ventricular tachyarrhythmias. Prog Cardiovasc Dis 1996, 38:445-454.