TY - JOUR
T1 - Systolic blood pressure response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes)
T2 - A possible explanation for discordant trial results
AU - Huang, Chenxi
AU - Dhruva, Sanket S.
AU - Coppi, Andreas C.
AU - Warner, Frederick
AU - Li, Shu Xia
AU - Lin, Haiqun
AU - Nasir, Khurram
AU - Krumholz, Harlan M.
N1 - Funding Information:
recipient of a grant from Medtronic and the Food and Drug Administration, through Yale, to develop methods for post-market surveillance of medical devices; works under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures; chairs a cardiac scientific advisory board for UnitedHealth; is a participant/ participant representative of the IBM Watson Health Life Sciences Board; is a member of the Advisory Board for Element Science and the Physician Advisory Board for Aetna; and is the founder of Hugo, a personal health information platform. Nasir is a member of the Advisory Board for Quest Diagnostics and a consultant for Regeneron. The other authors have no potential conflicts to disclose.
Publisher Copyright:
© 2017 The Authors.
PY - 2017/11/1
Y1 - 2017/11/1
N2 - 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.
AB - 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.
KW - ACCORD (Action to Control Cardiovascular Risk in Diabetes)
KW - Outcome
KW - SPRINT (Systolic Blood Pressure Intervention Trial)
KW - Systolic blood pressure
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U2 - 10.1161/JAHA.117.007509
DO - 10.1161/JAHA.117.007509
M3 - Article
C2 - 29133522
AN - SCOPUS:85034782188
SN - 2047-9980
VL - 6
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 11
M1 - e007509
ER -