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Randomized Controlled Trial
. 2017;109(3):172-181.
doi: 10.1016/j.jnma.2017.02.005. Epub 2017 Mar 18.

Influence of Prevalent and Incident Atrial Fibrillation on Post-Trial Major Events in ALLHAT

L Julian Haywood  1 , Barry R Davis  2 , Linda B Piller  3 , William C Cushman  4 , Jeffrey A Cutler  5 , Charles E Ford  2 , Lara M Simpson  2 , Alokananda Ghosh  2 , Elsayed Z Soliman  6 , Jackson T Wright Jr  7 ; ALLHAT Collaborative Research Group
Affiliations
Randomized Controlled Trial

Influence of Prevalent and Incident Atrial Fibrillation on Post-Trial Major Events in ALLHAT

L Julian Haywood et al. J Natl Med Assoc. 2017.

Abstract

Aims: Limited information is available on long-term antihypertensive and lipid-lowering therapy effects on hypertensive patients with atrial fibrillation/flutter (AF/AFL) compared to those without. AF/AFL at baseline or during the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) (mean follow-up 4.9 years) markedly increased risk of stroke, heart failure, CHD, and all-cause mortality. We aimed to determine if AF/AFL continued to impact outcomes during post-trial follow-up (mean 3.8 years).

Methods: Patients were randomized to chlorthalidone, amlodipine, or lisinopril, and to pravastatin vs. usual care in the lipid-lowering trial (LLT). Of 31,473 available subjects, AF/AFL occurred in 854; 383/14,371 chlorthalidone (2.7%), 247/8565 amlodipine (2.9%), and 224/8537 lisinopril (2.6%). Post-hoc analyses utilized administrative databases for post-trial data. Individuals with AF/AFL were compared to those without during post-trial. Outcomes were analyzed by treatment groups for the antihypertensive and LLT trials.

Results: Among 854 AF/AFL participants, 491 (57.5%) died: 220 in-trial, 271 post-trial. Ten-year all-cause mortality rates for those with in-trial AF/AFL were similar for chlorthalidone and lisinopril, but lower for amlodipine (68, 66, and 49 per 100 persons, respectively); adjusted HR for amlodipine vs. chlorthalidone was 0.68 (95% CI, 0.54-0.87). Ten-year all-cause mortality rates were 57 vs. 65 per 100 persons (pravastatin vs. usual care); non-CVD mortality rates, 18 vs. 39 per 100 persons (pravastatin vs. usual care) (adjusted HR = 0.46, 95% CI, 0.24-0.86).

Conclusion: Post-trial follow-up revealed continued deleterious AF/AFL effects. The amlodipine (ALLHAT) and pravastatin (ALLHAT-LLT) treatment groups showed lower all-cause and non-CVD mortality compared to the chlorthalidone and usual-care groups, respectively.

Keywords: Antihypertensive therapy; Atrial fibrillation; Heart failure; Stroke.

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Conflict of interest statement

Financial conflict of interest statement

William Cushman reports grants from Eli Lilly, Boerhinger Ingelheim, and Merck. Drs. Davis and Piller report grants from NHLBI. All other authors have no financial interests to disclose. Jeffrey Cutler is a contractor for NHLBI; no specific funding was allocated for this work. The views expressed in this manuscript are those of the authors and do not necessarily represent those of NHLBI.

Figures

Figure 1
Figure 1
Consort diagrams
Figure 2
Figure 2
Kaplan-Meier curves of cumulative incidence of all-cause mortality, cardiovascular death, and non-cardiovascular death for cases with baseline atrial fibrillation/atrial flutter or in-trial atrial fibrillation/atrial flutter, for all chlorthalidone, amlodipine, and lisinopril groups
Figure 3
Figure 3
Kaplan-Meier curve of cumulative incidence of all cause-mortality, cardiovascular death, and non-cardiovascular death for cases with either baseline atrial fibrillation/atrial flutter or incident baseline atrial fibrillation/atrial flutter, for the pravastatin and usual care groups
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