9th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 19-21 July 2007, Sydney, Australia

EFFECT OF ALTERNATE TREATMENT PROTOCOLS ON THE INCIDENCE OF ELECTROCARDIOGRAPHIC ABNORMALITIES AMONG HIV-INFECTED ADULTS IN THE SMART TRIAL

Antiviral Therapy 2007; 12(Suppl. 2):L11 (abstract no. O-11)

R Prineas¹, M Roediger², A Carr³, W El-Sadr⁴, S Esser⁵, G Grandits⁶, B Knysz⁷ and A Palfreeman⁸ for the SMART Study Group and INSIGHT
¹University of Wake Forest School of Medicine, Division of Public Health Sciences, Winston-Salem, USA; ²University of Minnesota School of Public Health, Biostatistics, Minneapolis, USA; ³St Vincents Hospital, Sydney, Australia; ⁴Columbia University, New York, USA; ⁵Universittklinikum Essen, Essen, Germany; ⁶University of Minnesota, Biostatistics, Minneapolis, USA; ⁷Wroclaw University, Infectious Diseases, Wroclaw, Poland; ⁸Edith Cavell Hospital, Sexual Health, Peterborough, UK

OBJECTIVES: The SMART trial compared strategies of continuous antiretroviral therapy (ART) (viral suppression arm; VS) and CD4-guided ART (drug conservation arm; DC). On January 11, 2006 the trial was stopped due to increased risk of progression of HIV disease, death, and cardiovascular disease (CVD), in the DC arm. We compared the effects of VS and DC on incidence of electrocardiogram (ECG) abnormalities.

METHODS: Twelve-lead ECGs, recorded at baseline and annually, were transmitted electronically and centrally analysed blinded to treatment. Incidence of Q wave abnormalities during mean follow-up of 16 months and one-year changes in measures of cardiac function were compared between study arms for participants who had a baseline and a follow- up ECG. Cox models estimated hazard ratios (HRs) (DC/VS) adjusted for demographics, clinical history, HIV- related parameters and ART status at baseline. Changes between treatment groups for heart rate and spatial QRS/T angle (a global measure of repolarization) were compared using ANOVA and adjusted for age, race and sex.

RESULTS: One-thousand one-hundred and twenty-three participants (41%) in the DC and 1,078 (39%) in the VS arm had a baseline and at least one follow-up ECG. The DC arm had a higher incidence of Q wave abnormalities (signifying myocardial damage) compared with the VS arm: HR 1.48, 95%CI 1.06–2.07. There was also an increase in resting heart rate, and in the QRS/T spatial angle (each of which indicates increased risk of future CVD mortality) in the DC arm.

CONCLUSIONS: Intermittent, CD4-guided ART was associated with evidence of myocardial damage, increasing repolarization abnormality, and increase in heart rate — consistent with the outcome in the main trial results of excess CVD outcomes in the DC arm.

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2007-07-24
O-11

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