TY - JOUR
T1 - Pulse Pressure, Cardiovascular Events, and Intensive Blood-Pressure Lowering in the Systolic Blood Pressure Intervention Trial (SPRINT)
AU - Pareek, Manan
AU - Vaduganathan, Muthiah
AU - Biering-Sørensen, Tor
AU - Byrne, Christina
AU - Qamar, Arman
AU - Almarzooq, Zaid
AU - Pandey, Ambarish
AU - Olsen, Michael Hecht
AU - Bhatt, Deepak L.
N1 - Funding Information:
Funding: SPRINT was supported by the National Heart, Lung, and Blood Institute. This exploratory analysis was unfunded.Conflicts of Interest: MP discloses the following relationships: Advisory Board: AstraZeneca; Speaker's Fee: AstraZeneca and Bayer. MV is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst | The Harvard Clinical and Translational Science Center (NIH/NCATS Award UL 1TR002541), and serves on advisory boards for AstraZeneca, Bayer AG, and Baxter Healthcare. AQ is supported by the NHLBI T32 postdoctoral training grant (T32HL007604) and the American Heart Association Strategically Focused Research Network in Vascular Disease grant (18SFRN3390085). AP is funded by the Texas Health Resources Clinical scholarship. MHO discloses that he has received a part-time clinical research grant from the Danish Diabetes Academy supported by the Novo Nordisk Foundation. DLB discloses the following relationships: Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and US national coleader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site Coinvestigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, PLx Pharma, Takeda.
Funding Information:
Funding: SPRINT was supported by the National Heart, Lung, and Blood Institute. This exploratory analysis was unfunded.Conflicts of Interest: MP discloses the following relationships: Advisory Board: AstraZeneca; Speaker's Fee: AstraZeneca and Bayer. MV is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst | The Harvard Clinical and Translational Science Center (NIH/NCATS Award UL 1TR002541), and serves on advisory boards for AstraZeneca, Bayer AG, and Baxter Healthcare. AQ is supported by the NHLBI T32 postdoctoral training grant (T32HL007604) and the American Heart Association Strategically Focused Research Network in Vascular Disease grant (18SFRN3390085). AP is funded by the Texas Health Resources Clinical scholarship. MHO discloses that he has received a part-time clinical research grant from the Danish Diabetes Academy supported by the Novo Nordisk Foundation. DLB discloses the following relationships: Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and US national coleader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site Coinvestigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, PLx Pharma, Takeda.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/6
Y1 - 2019/6
N2 - Background: The efficacy and tolerability of intensive blood-pressure lowering may vary by pulse pressure (systolic minus diastolic blood pressure). Methods: SPRINT randomized 9361 high-risk adults without diabetes and who were ≥50 years with systolic blood pressure 130-180 mm Hg to intensive or standard antihypertensive treatment. The primary efficacy end point was the composite of acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. The primary safety end point was composite serious adverse events. We examined the prognostic implications of baseline pulse pressure and the effects of intensive blood-pressure lowering on clinical outcomes across the spectrum of pulse-pressure values using restricted cubic splines. Results: Mean baseline pulse pressure was similar between the 2 study groups (intensive treatment 61±14 mm Hg vs standard treatment 62±14 mm Hg; P = 0.59). Except stroke, for which the association with pulse pressure was best defined as linear, pulse pressure displayed a nonlinear U-shaped relationship with the risk of all tested clinical end points (P <0.05), though no association remained significant upon multivariable adjustment (P >0.05). The benefit of intensive blood-pressure management on mortality appeared greatest in patients with a pulse pressure ∼60 mm Hg (P = 0.03 for interaction). Pulse pressure did not modify the effect of intensive blood-pressure lowering for other clinical end points (P >0.05 for interaction). Conclusion: In a large randomized clinical trial of patients with a high risk of cardiovascular events, risks and benefits of intensive blood-pressure lowering did not appear to be modified by baseline pulse pressure. Selection of appropriate candidates for intensive blood-pressure lowering should not be limited by this parameter.
AB - Background: The efficacy and tolerability of intensive blood-pressure lowering may vary by pulse pressure (systolic minus diastolic blood pressure). Methods: SPRINT randomized 9361 high-risk adults without diabetes and who were ≥50 years with systolic blood pressure 130-180 mm Hg to intensive or standard antihypertensive treatment. The primary efficacy end point was the composite of acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. The primary safety end point was composite serious adverse events. We examined the prognostic implications of baseline pulse pressure and the effects of intensive blood-pressure lowering on clinical outcomes across the spectrum of pulse-pressure values using restricted cubic splines. Results: Mean baseline pulse pressure was similar between the 2 study groups (intensive treatment 61±14 mm Hg vs standard treatment 62±14 mm Hg; P = 0.59). Except stroke, for which the association with pulse pressure was best defined as linear, pulse pressure displayed a nonlinear U-shaped relationship with the risk of all tested clinical end points (P <0.05), though no association remained significant upon multivariable adjustment (P >0.05). The benefit of intensive blood-pressure management on mortality appeared greatest in patients with a pulse pressure ∼60 mm Hg (P = 0.03 for interaction). Pulse pressure did not modify the effect of intensive blood-pressure lowering for other clinical end points (P >0.05 for interaction). Conclusion: In a large randomized clinical trial of patients with a high risk of cardiovascular events, risks and benefits of intensive blood-pressure lowering did not appear to be modified by baseline pulse pressure. Selection of appropriate candidates for intensive blood-pressure lowering should not be limited by this parameter.
KW - Blood pressure
KW - Hypertension
KW - Pulse pressure
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85061563720&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85061563720&partnerID=8YFLogxK
U2 - 10.1016/j.amjmed.2019.01.001
DO - 10.1016/j.amjmed.2019.01.001
M3 - Article
C2 - 30659811
AN - SCOPUS:85061563720
SN - 0002-9343
VL - 132
SP - 733
EP - 739
JO - American Journal of Medicine
JF - American Journal of Medicine
IS - 6
ER -