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1 ATRIAL FIBRILLATION AT BASELINE AND DURING FOLLOW-UP in The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial November 9, 2003.

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Presentation on theme: "1 ATRIAL FIBRILLATION AT BASELINE AND DURING FOLLOW-UP in The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial November 9, 2003."— Presentation transcript:

1 1 ATRIAL FIBRILLATION AT BASELINE AND DURING FOLLOW-UP in The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial November 9, 2003 ALLHAT L. Julian Haywood, Charles E. Ford, Richard S. Crow, Barry R. Davis, Paula T. Einhorn, Angela Williard, and Barry Massie

2 2Purpose To document the prevalence of atrial fibrillation (AF) or atrial flutter (AFL) at baseline and its new appearance during follow-up in ALLHAT.To document the prevalence of atrial fibrillation (AF) or atrial flutter (AFL) at baseline and its new appearance during follow-up in ALLHAT. To determine the influence of AF/AFL at baseline on outcome in ALLHAT.To determine the influence of AF/AFL at baseline on outcome in ALLHAT. ALLHAT

3 3ALLHAT Background Randomized, double-blind, multicenter trialRandomized, double-blind, multicenter trial Determined whether fatal CHD or nonfatal MI was lower for high-risk hypertensives treated with amlodipine (CCB), lisinopril (ACEI), doxazosin (alpha blocker) vs chlorthalidone (diuretic)Determined whether fatal CHD or nonfatal MI was lower for high-risk hypertensives treated with amlodipine (CCB), lisinopril (ACEI), doxazosin (alpha blocker) vs chlorthalidone (diuretic) Atrial fibrillation (AF) is the most common serious arrhythmia affecting morbidity and mortality.Atrial fibrillation (AF) is the most common serious arrhythmia affecting morbidity and mortality.

4 4

5 5ALLHAT Methods Standard 12-lead ECGs, recorded at baseline and at 2-year intervals during follow-up, were coded for Q-wave abnormalities, ST-segment depression, T-wave inversion, LVH, bundle branch block, and atrial fibrillation or flutter, using the Minnesota Code.Standard 12-lead ECGs, recorded at baseline and at 2-year intervals during follow-up, were coded for Q-wave abnormalities, ST-segment depression, T-wave inversion, LVH, bundle branch block, and atrial fibrillation or flutter, using the Minnesota Code. Univariate and multivariate statistical methods were used to determine prevalence, incidence, and prognosis as relates to multiple clinical parameters, and according to treatment group.Univariate and multivariate statistical methods were used to determine prevalence, incidence, and prognosis as relates to multiple clinical parameters, and according to treatment group.

6 6ALLHAT ChlorthalidoneAmlodipineLisinoprilDoxazosinTotal Sample Size15,2559,0489,0549,06142,418 No ECGs597(3.9)311(3.4)350(3.9)369(4.1)1,627 No Baseline ECG a 596(3.9)409(4.5)390(4.3)340(3.8)1,735 Atrial Fibrillation 138(0.9)97(1.1)83(0.9)85(0.9)403 Atrial Flutter9(0.06)2(0.02)5(0.06)4(0.04)20 No AF or AFL13,915(91.2)8,229(90.9)8,226(90.9)8,263 (91.2)38,633 Total with Baseline ECG b 14,062(92.2)8,328(92.0)8,314(91.8)8,352 (92.2)39,056 Sample Size and Number (%) of Participants with AF a.Missing a baseline ECG, but with one or more follow-up ECGs on file. b.Sample size less those with no ECGs and no baseline ECG.

7 7ALLHAT ChlorthalidoneAmlodipineLisinoprilDoxazosin aTotal Sample Size15,2559,0489,0549,06133,357 No ECGs597(3.9)311(3.4)350(3.9)369(4.1)1,258 No Baseline ECG b 596(3.9)409(4.5)390(4.3)340(3.8)1,395 AF c 147(0.9)99(1.1)88(0.9)89(0.9)334 No AF or AFL13,915(91.2)8,229(90.9)8,226(90.9)8,263 (91.2)30,370 Total with Baseline ECG 14,062(92.2)8,328(92.0)8,314(91.8)8,352 (92.2)30,704 Sample Size and Number (%) of Participants with AF, Excluding Doxazosin Group a.The doxazosin arm of ALLHAT was stopped in January 2000 due to higher CV events and virtually no chance to show a difference in CHD. b.Missing baseline ECG but one or more follow-up ECGs on file. c.Atrial fibrillation and flutter, combined.

8 8AFPresentAFAbsent N33430,370 Mean age, y 72.1 66.9 * Age 70+, % 63.8 35.3 ** Black, % 18.9 34.5 * Women, % 29.3 46.2 ** Mean SBP 144.1144.8 Mean DBP 83.083.3 Type 2 diabetes, % 30.2 35.7 * History of CHD, % 35.0 25.4 ** ECG LVH, % 6.65.2 Cigarette Smokers, % 13.8 22.0 ** Baseline Characteristics Stratified By Atrial Fibrillation Status * Indicates statistical significance of difference (p < 0.05). ** Indicates statistical significance of difference (p < 0.01). ALLHAT

9 9AFPresentAFAbsent N33430,370 On BP Medication, % 91.690.2 With ASCVD, % 62.3 46.6 ** Serum Creatinine >= 1.5, % 7.36.4 3-Month Potassium < 3.5, % 6.96.0 Mean Serum Glucose, mg/dL 117.6122.7 Mean Cholesterol, mg/dL 204.8 216.0 ** Mean LDL-C, mg/dL 129.7 135.8 ** Mean HDL-C, mg/dL 43.9 46.8 ** Mean Triglycerides, mg/dL 164.7176.4 Mean BMI, kg/m 2 29.829.7 Baseline Characteristics Stratified By Atrial Fibrillation Status * Indicates statistical significance of difference (p < 0.05). ** Indicates statistical significance of difference (p < 0.01). ALLHAT

10 10ALLHAT Prevalence of Atrial Fibrillation Per 1000 Participants, by Randomized Treatment Group * Compared with chlorthalidone, neither the amlodipine nor lisinopril group differed significantly. Events per 1000 AF prevalence was 10.9 per 1000, overall (334/30,704).

11 11ALLHAT Prevalence of Atrial Fibrillation Per 1000 Participants, by Baseline Characteristics * Subgroup differs significantly from comparison group (55-69, women, black) before and after adjusting for age, race, and sex (p < 0.01). Age at Entry, years Events per 1000

12 12ALLHAT Prevalence of Atrial Fibrillation Per 1000 Participants, by Baseline Characteristics * ASCVD subgroup differs significantly from comparison group (no ASCVD) before and after adjusting for age, race, and sex (p < 0.01). Events per 1000

13 13ALLHAT Prevalence of Atrial Fibrillation Per 1000 Participants, by Baseline Characteristics Subgroups do not differ significantly from comparison groups after adjustment for age, race, and sex differences. Events per 1000

14 14ALLHAT Occurrence of New Atrial Fibrillation Chlorthalidone n % n %Amlodipine Lisinopril Total Unknown 6254.1 3283.6 3624.0 1,3153.9 Negative 14,38694.3 8,56594.7 8,55494.5 31,50594.4 AF 2301.5 1451.6 1301.4 5051.5 Flutter 280.2 100.1 80.1 460.1 Total 15,255-- 9,048-- 9,054-- 33,357--

15 15ALLHAT Occurrence of Atrial Fibrillation Per 1000 Participants, by Randomized Treatment Group * Compared with chlorthalidone, neither the amlodipine nor lisinopril group differed significantly. RR (95% CI) p value A/C1.07 (0.87-1.31)0.53 L/C0.95 (0.77-1.17)0.64 Events per 1000 AF incidence was 17.2 per 1000, overall (551/32,042).

16 16ALLHAT Occurrence of Atrial Fibrillation Per 1000 Participants, by Baseline Characteristics Adj. RR (95% CI) p value M/W2.10 (1.74-2.54)< 0.001 NB/B2.00 (1.61-2.48)< 0.001 70-79/55-692.39 (2.00-2.86)< 0.001 80+/55-692.38 (1.74-3.26)< 0.001 Events per 1000 Age, years

17 17ALLHAT Occurrence of Atrial Fibrillation Per 1000 Participants, by Baseline Characteristics Adj. RR (95% CI) p value CHD1.48 (1.23-1.76)< 0.001 ASCVD1.42 (1.19-2.70)< 0.001 LVH2.01 (1.47-2.77)< 0.001 Events per 1000 Left Ventricular Hypertrophy by ECG.

18 18ALLHAT Occurrence of Atrial Fibrillation Per 1000 Participants, by Baseline Characteristics Adj. RR (95% CI) p value Smoker0.76 (0.60-0.97) 0.03 BMI>301.54 (1.29-1.84)< 0.001 K+ < 3.50.95 (0.62-1.47)< 0.001 Events per 1000 Serum potassium at 3-month visit.BMI = Body Mass Index

19 19ALLHAT 0.00 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 Cumulative Event Rate 0123456 Years to Death AF Absent AF Present Cumulative Event Rates for All-Cause Mortality by Entry AF Status RR (95% CI) p value AF/Not 2.86 (2.38-3.43) < 0.001 AF 334 334 313 313 288 288 260 260 220 220 138 13881 No AF 30,37029,76429,06328,165 25,126 25,126 14,851 14,8517,439

20 20ALLHAT 0.00 0.05 0.10 0.15 0.20 Cumulative Event Rate 0123456 Years to Fatal CHD or Nonfatal MI Cumulative Event Rates for Fatal CHD or Nonfatal MI, by Entry AF Status AF Present AF Absent RR (95% CI) p value AF/Not 1.61 (1.20-2.17) < 0.01 AF 334 334 304 304 278 278 248 248 206 206 123 12374 No AF 30,37028,85227,57626,248 22,939 22,939 13,250 13,2506,502

21 21ALLHAT 0.00 0.03 0.05 0.07 0.10 0.13 0.15 0.17 0.20 Cumulative Event Rate 0123456 Years to Stroke Cumulative Event Rates for Stroke by Entry AF Status AF Present AF Absent RR (95% CI) p value AF/Not 3.61 (2.70-4.83) < 0.001 AF 334 334 298 298 270 270 240 240 201 201 118 11866 No AF 30,37028,95927,82926,646 23,433 23,433 13,628 13,6286,795

22 22ALLHAT 0.00 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 Cumulative Event Rate 0123456 Years to Death Chlorthalidone Amlodipine Lisinopril Cumulative Event Rates for All-Cause Mortality in Those with AF at Entry, by Treatment Group RR (95% CI) p value A/C 0.75 (0.48-1.16 0.20 L/C 0.71 (0.45-1.12) 0.14 C:147 134 134 122 122 105 105 89 89 57 5737A: 99 99 95 95 85 85 80 80 68 68 41 4125 L: 88 88 84 84 81 81 75 75 63 63 40 4019

23 23ALLHAT Cumulative Event Rates for Fatal CHD or Nonfatal MI in Those with AF, by Treatment Group 0.00 0.05 0.10 0.15 0.20 Cumulative Event Rate 0123456 Years to Fatal CHD or Nonfatal MI Chlorthalidone Amlodipine Lisinopril RR (95% CI) p value A/C 0.62 (0.28-1.36 0.24 L/C 0.81 (0.39-1.70) 0.58 C:147 129 129 118 118 100 100 84 84 49 4932A: 99 99 92 92 81 81 75 75 63 63 39 3924 L: 88 88 83 83 79 79 73 73 59 59 35 3518

24 24ALLHAT 0.00 0.05 0.10 0.15 0.20 0.25 0.30 Cumulative Event Rate 0123456 Years to Stroke Cumulative Event Rates for Stroke by Treatment Group In Participants with AF at Baseline Chlorthalidone Amlodipine Lisinopril RR (95% CI) p value A/C 1.53 (0.79-2.97 0.21 L/C 1.10 (0.53-2.31) 0.79 C:147 128 128 117 117 101 101 84 84 49 4932A: 99 99 91 91 80 80 71 71 61 61 34 3419 L: 88 88 79 79 73 73 68 68 56 56 35 3515

25 25Conclusion-1 1.Prevalence of AF in ALLHAT at baseline was increased by: age, non-Black status, male gender, and presence of ASCVD. 2.AF at baseline was associated during follow-up with: increased overall mortality increased fatal CHD and MI increased stroke ALLHAT In high-risk hypertensive patients :

26 26Conclusion-2 3.Likelihood of new onset of AF during follow-up was increased by: Age, male gender, non-Black race, CHD, ASCVD, LVH 4.Randomization to chlorthalidone, amlodipine and lisinopril did not influence prevalence of AF at baseline or its new appearance during follow-up. 5.Among participants with AF/AFL at baseline, there were no differences among randomized groups for mortality, major CHD events, or stroke. ALLHAT

27 27 Thank You

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