Piller LB, Simpson LM, Baraniuk S, Habib GB, Rahman M, Basile JN, Dart RA, Ellsworth AJ, Fendley H, Probstfield JL, Whelton PK, Davis BR, ALLHAT Collaborative Research Group., et al.
Journal of general internal medicine. Date of publication 2014 Nov 1;volume 29(11):1475-83.
1. J Gen Intern Med. 2014 Nov;29(11):1475-83. doi: 10.1007/s11606-014-2947-1.
Characteristics and long-term follow-up of participants with peripheral arterial
disease during ALLHAT.
Piller LB(1), Simpson LM, Baraniuk S, Habib GB, Rahman M, Basile JN, Dart RA,
Ellsworth AJ, Fendley H, Probstfield JL, Whelton PK, Davis BR; ALLHAT
Collaborative Research Group.
Author information:
(1)The University of Texas School of Public Health, 1200 Herman Pressler St.,
W-906, Houston, TX, 77030, USA, Linda.b.piller@uth.tmc.edu.
Comment in
J Gen Intern Med. 2014 Nov;29(11):1527.
BACKGROUND: Hypertension is a major risk factor for peripheral artery disease
(PAD). Little is known about relative efficacy of antihypertensive treatments for
preventing PAD.
OBJECTIVES: To compare, by randomized treatment groups, hospitalized or
revascularized PAD rates and subsequent morbidity and mortality among
participants in the Antihypertensive and Lipid-Lower Treatment to Prevent Heart
Attack Trial (ALLHAT).
DESIGN: Randomized, double-blind, active-control trial in high-risk hypertensive
participants.
PARTICIPANTS: Eight hundred thirty participants with specified secondary outcome
of lower extremity PAD events during the randomized phase of ALLHAT.
INTERVENTIONS/EVENTS: In-trial PAD events were reported during ALLHAT
(1994-2002). Post-trial mortality data through 2006 were obtained from
administrative databases. Mean follow-up was 8.8 years.
MAIN MEASURES: Baseline characteristics and intermediate outcomes in three
treatment groups, using the Kaplan-Meier method to calculate cumulative event
rates and post-PAD mortality rates, Cox proportional hazards regression model for
hazard ratios and 95 % confidence intervals, and multivariate Cox regression
models to examine risk differences among treatment groups.
KEY RESULTS: Following adjustment for baseline characteristics, neither
participants assigned to the calcium-channel antagonist amlodipine nor to the
ACE-inhibitor lisinopril showed a difference in risk of clinically advanced PAD
compared with those in the chlorthalidone arm (HR, 0.86; 95 % CI, 0.72-1.03 and
HR, 0.98; 95 % CI, 0.83-1.17, respectively). Of the 830 participants with
in-trial PAD events, 63 % died compared to 34 % of those without PAD; there were
no significant treatment group differences for subsequent nonfatal myocardial
infarction, coronary revascularizations, strokes, heart failure, or mortality.
CONCLUSIONS: Neither amlodipine nor lisinopril showed superiority over
chlorthalidone in reducing clinically advanced PAD risk. These findings reinforce
the compelling need for comparative outcome trials examining treatment of PAD in
high-risk hypertensive patients. Once PAD develops, cardiovascular event and
mortality risk is high, regardless of type of antihypertensive treatment.
DOI: 10.1007/s11606-014-2947-1
PMCID: PMC4238201
PMID: 25002161 [Indexed for MEDLINE]
