HOLTER MONITORING LABORATORY
National Institute of Cardiology
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Last edited December 07, 99: HELLO AZZAM!
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Comparison of Ticlopidine and Aspirine in Unstable Angina
Z.Sadowski, D.Luczak, A.Dyduszynski, L.Giec, A.Kalicinski, T.Kraska, E.Nartowicz, T.Petelenz, W.Piwowarska, G.Swiatecka, J.Wodniecki, K.Wrabec. Multicenter Trial coordinated by the National Institute of Cardiology, Warsaw, Poland.
Randomized, double blind study in 320 patients (pts) with unstable angina (UA) type "angina crescendo" (204) or rest angina (116) was performed. All pts were treated with i.v. NTG and heparin during 48 hour and randomly assigned to one of 4 groups by 2 times 2 design: 1.Ticlopidine (T) and Metoprolol (M) 2.Ticlopidine and Gallopamil (G) 3.Aspirin (ASA) and Metoprolol 4.Aspirin and Gallopamil Medical tretment was continued during 3 month follow-up. PTCA (12.5%) or CABG (24.4%) was performed in the acute period or follow-up if medical treatment failed. In the group treated medically therapy was effective clinically in 74.7% (no rest angina). Rest angina did not reccur in G group in 78.0% and in M group in 71.1% (NS). During 3 months rest angina recurrence was observed more often in ASA than T group (38.5% and 22.5% respectively, p<0.05). Myocardial infarction (MI) was diagnosed during follow-up only in the group treated with ASA (7.4%), there was no MI in T group (p<0.05). Mortality rate in the group treated medically was low 2.0% (3 pts in ASA and 1 in T group died). Pts treated with M presented more often sinus bradycardia, heart failure, lower BP and HR compared with G (p<0.05). Drugs were discontinued due to side effects in 3.8%. Coronary angiography performed in 200 pts (62.5%) revealed significant coronary disease in the majority of patients, frequently multivessel disease (54.0%).
Conclusions: 1. Medical treatment of UA was effective during 3 month follow-up with no rest angina recurrence in 74.7%. Mortality rate and number of MI were low after 3 months: 2.0% and 7.5% respectively. 2. Rest angina was less often observed during 3 month follow-up in patients treated with T than ASA (22.5% vs 38.5%). MI was recognized in 7.4% in ASA group, there was no MI in T group.
Zygmunt P. Sadowski, MD [MEDLINE LOOKUP]
John H. Alexander, MD [MEDLINE LOOKUP]
Bogdan Skrabucha, MD [MEDLINE LOOKUP]
Andrzej Dyduszynski, MD [MEDLINE LOOKUP]
Jerzy Kuch, MD [MEDLINE LOOKUP]
Edmund Nartowicz, MD [MEDLINE LOOKUP]
Grazyna Swiatecka, MD [MEDLINE LOOKUP]
David F. Kong, MD [MEDLINE LOOKUP]
Christopher B. Granger, MD, FACC [MEDLINE LOOKUP]
Warsaw, Poland, and Durham, NC
| Abstract | TOP |
Background More than 20 randomized trials
and 4 meta-analyses have been conducted on the use of prophylactic lidocaine
in acute myocardial infarction (MI). The results suggest that lidocaine reduces
ventricular fibrillation (VF) but increases mortality rates in acute MI.
Methods and Results Patients with ST-elevation MI who
were examined <6 hours after symptom onset (n = 903) were randomly assigned
to either lidocaine or no lidocaine and to either streptokinase and heparin
or heparin alone. Lidocaine was given as 4 boluses of 50 mg each every 2 minutes,
then an infusion of 3 mg/min for 12 hours, then 2 mg/min for 36 hours. We
compared the incidence of in-hospital death and ventricular arrhythmias. We
then performed a meta-analysis of prophylactic lidocaine in acute MI that
included these and prior trial results. The rates of VF and death with and
without lidocaine were calculated for each trial, then odds ratios (OR) with
confidence intervals (CI) were calculated for the risk of these events overall
with and without lidocaine. Patients given lidocaine in the randomized study
had significantly less VF (2.0% vs 5.7% without lidocaine, P = .004) and a trend toward increased mortality rates (9.7% vs
7.0%, P = .145). Meta-analysis revealed nonsignificant
trends toward reduced VF (OR 0.71, 95% CI 0.47 to 1.09) and increased mortality
rates (OR 1.12, 95% CI 0.91 to 1.36) with lidocaine.
Conclusions Lidocaine reduces VF but may adversely affect mortality
rates. The routine use of prophylactic lidocaine in acute MI is not recommended.
(Am Heart J 1999;137:792-8.)
| Publishing and Reprint Information | TOP |
Copyright © 1999 by Mosby, Inc.
DISCORDANCE BETWEEN CLINICAL AND HOLTER MONITORING CRITERIA OF TREATMENT EFFICACY IN PATIENTS WITH UNSTABLE ANGINA
D.Luczak, Z.Sadowski, S.Jasek, A.Matar, A.Dyduszynski, L.Giec, T.Kraska, A.Kalicinski, E.Nartowicz, T.Petelenz, W.Piwowarska, G.Swiatecka, J.Wodniecki, K.Wrabec. Multicentre trial coordinated by the National Institute of Cardiology, Warsaw, Poland. Holter monitoring (HM) to assess total ischemic burden was performed in 223 patients (pts) with unstable angina (UA) treated with i.v. NTG, heparin and randomly assigned by 2 times 2 factorial design to Metoprolol (M) or Gallopamil (G) and Aspirin (A) or Ticlopidine (T) therapy. Comparison of treatment efficacy based on clinical data and Holter parameters was performed. The endpoints of trial were: presence and number of ischemic episodes, time of ischemia, maximal ST segment changes and heart rate during HM, combined number of cardiac death, acute myocardial infarctions and recurrence of rest angina. Results: In-hospital treatment was effective clinically in 71.3% (no angina) and electrocardiographically in 51.6% (no ischemia during HM). Discordance between clinical and HM criteria of treatment efficacy was found in 35.0%. According to HM criteria no improvement during treatment was observed in 42.1% and aggravation of ischemia in 6.3%. More than 2 ischemic episodes in pts with average HR # 60/min on HM at discharge increased > 2 times the risk of cardiac death or MI during 3 months follow-up (p < 0.04). During 3 months of treatment rest angina did not recur in 55% pts (in 59% in M group and in 48% of G group (NS). Using HM criteria, M was more effective than G (54% vs. 44% respectively, p<0.05). Conclusions: 1. Discordance between clinical and HM criteria of treatment efficacy in pts with UA was found in 35.0%. In 6.8% aggravation of ischemia on HM was found. 2. More than 2 ischemic episodes in pts with achieved target HR (# 60/min) on HM increase > 2 times the risk of cardiac death or MI during 3 months follow-up in pts with UA (high risk group).
