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J Am Heart Assoc. 2017 Nov 13;6(11). pii: e007509. doi: 10.1161/JAHA.117.007509.

Systolic Blood Pressure Response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes): A Possible Explanation for Discordant Trial Results.

Author information

1
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT.
2
National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, CT.
3
Veterans Affairs Connecticut Healthcare System, West Haven, CT.
4
Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT.
5
Department of Biostatistics, Yale School of Public Health, New Haven, CT.
6
Center for Healthcare Advancement and Outcomes Research and Miami Cardiac and Vascular Institute, Baptist Health South Florida, Miami, FL.
7
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT harlan.krumholz@yale.edu.
8
Department of Health Policy and Management, Yale School of Public Health, New Haven, CT.

Abstract

BACKGROUND:

SPRINT (Systolic Blood Pressure Intervention Trial) and the ACCORD (Action to Control Cardiovascular Risk in Diabetes) blood pressure trial used similar interventions but produced discordant results. We investigated whether differences in systolic blood pressure (SBP) response contributed to the discordant trial results.

METHODS AND RESULTS:

We evaluated the distributions of SBP response during the first year for the intensive and standard treatment groups of SPRINT and ACCORD using growth mixture models. We assessed whether significant differences existed between trials in the distributions of SBP achieved at 1 year and the treatment-independent relationships of achieved SBP with risks of primary outcomes defined in each trial, heart failure, stroke, and all-cause death. We examined whether visit-to-visit variability was associated with heterogeneous treatment effects. Among the included 9027 SPRINT and 4575 ACCORD participants, the difference in mean SBP achieved between treatment groups was 15.7 mm Hg in SPRINT and 14.2 mm Hg in ACCORD, but SPRINT had significantly less between-group overlap in the achieved SBP (standard deviations of intensive and standard groups, respectively: 6.7 and 5.9 mm Hg in SPRINT versus 8.8 and 8.2 mm Hg in ACCORD; P<0.001). The relationship between achieved SBP and outcomes was consistent across trials except for stroke and all-cause death. Higher visit-to-visit variability was more common in SPRINT but without treatment-effect heterogeneity.

CONCLUSIONS:

SPRINT and ACCORD had different degrees of separation in achieved SBP between treatment groups, even as they had similar mean differences. The greater between-group overlap of achieved SBP may have contributed to the discordant trial results.

KEYWORDS:

ACCORD (Action to Control Cardiovascular Risk in Diabetes); SPRINT (Systolic Blood Pressure Intervention Trial); outcome; systolic blood pressure

PMID:
29133522
PMCID:
PMC5721802
DOI:
10.1161/JAHA.117.007509
[Indexed for MEDLINE]
Free PMC Article

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