Achieved blood pressures in the secondary prevention of small subcortical strokes (SPS3) study: challenges and lessons learned.
Journal: 2015/May - American Journal of Hypertension
ISSN: 1941-7225
Abstract:
BACKGROUND
Lowering blood pressure (BP) after stroke remains a challenge, even in the context of clinical trials. The Secondary Prevention of Small Subcortical Strokes (SPS3) BP protocol, BP management during the study, and achieved BPs are described here.
METHODS
Patients with recent symptomatic lacunar stroke were randomized to 1 of 2 levels of systolic BP (SBP) targets: lower: <130mm Hg, or higher: 130-149mm Hg. SBP management over the course of the trial was examined by race/ethnicity and other baseline conditions.
RESULTS
Mean SBP decreased for both groups from baseline to the last follow-up, from 142.4 to 126.7mm Hg for the lower SBP target group and from 143.6 to 137.4mm Hg for the higher SBP target group. At baseline, participants in both groups used an average of 1.7±1.2 antihypertensive medications, which increased to a mean of 2.4±1.4 (lower group) and 1.8±1.4 (higher group) by the end-study visit. It took an average of 6 months for patients to reach their SBP target, sustained to the last follow-up. Black participants had the highest proportion of SBP ≥150mm Hg at both study entry (40%) and end-study visit (17%), as compared with whites (9%) and Hispanics (11%).
CONCLUSIONS
These results show that it is possible to safely lower BP even to a SBP goal <130mm Hg in a variety of patients and settings, including private and academic centers in multiple countries. This provides further support for protocol-driven care in lowering BP and consequently reducing the burden of stroke.
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Am J Hypertens 27(8): 1052-1060

Achieved Blood Pressures in the Secondary Prevention of Small Subcortical Strokes (SPS3) Study: Challenges and Lessons Learned

+5 authors

BACKGROUND

Lowering blood pressure (BP) after stroke remains a challenge, even in the context of clinical trials. The Secondary Prevention of Small Subcortical Strokes (SPS3) BP protocol, BP management during the study, and achieved BPs are described here.

METHODS

Patients with recent symptomatic lacunar stroke were randomized to 1 of 2 levels of systolic BP (SBP) targets: lower: <130mm Hg, or higher: 130–149mm Hg. SBP management over the course of the trial was examined by race/ethnicity and other baseline conditions.

RESULTS

Mean SBP decreased for both groups from baseline to the last follow-up, from 142.4 to 126.7mm Hg for the lower SBP target group and from 143.6 to 137.4mm Hg for the higher SBP target group. At baseline, participants in both groups used an average of 1.7±1.2 antihypertensive medications, which increased to a mean of 2.4±1.4 (lower group) and 1.8±1.4 (higher group) by the end-study visit. It took an average of 6 months for patients to reach their SBP target, sustained to the last follow-up. Black participants had the highest proportion of SBP ≥150mm Hg at both study entry (40%) and end-study visit (17%), as compared with whites (9%) and Hispanics (11%).

CONCLUSIONS

These results show that it is possible to safely lower BP even to a SBP goal <130mm Hg in a variety of patients and settings, including private and academic centers in multiple countries. This provides further support for protocol-driven care in lowering BP and consequently reducing the burden of stroke.

DISCLOSURE

The authors declared no conflict of interest.

Supplementary Material

Supplementary Data:
Department of Medicine, University of Texas Health Sciences Center at San Antonio and Renal Associates PA, San Antonio, Texas;
School of Nursing, University of Texas Health Sciences Center at San Antonio, San Antonio, Texas;
Department of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama;
College of Pharmacy, University of Texas at Austin, Austin, Texas;
Department of Neurological Sciences, Hospital-Clínica Kennedy, and School of Medicine, Universidad Espíritu Santo–Ecuador, Guayaquil, Ecuador;
Department of Neurology, Hospital Universitari Dr. Josep Trueta of Girona, Barcelona, Spain;
Division of Nephrology and Hypertension College of Medicine, Mayo Clinic, Rochester, Minnesota;
Unidad de Neurologia, Hospital Naval A. Nef, Vina del Mar, Chile;
Hospital Alberto Sabogal, Lima, Peru;
Nephrology and Hypertension, Henry Ford Hospital, Detroit, Michigan;
Department of Medicine, Dalhousie University, Halifax, Canada;
Division of Neurology, Department of Medicine, Brain Research Center, University of British Columbia, Vancouver, Canada.
Corresponding author.
Correspondence: Carole L. White (ude.ascshtu@2cetihw).
Received 2013 Nov 6; Accepted 2014 Jan 23.

Abstract

BACKGROUND

Lowering blood pressure (BP) after stroke remains a challenge, even in the context of clinical trials. The Secondary Prevention of Small Subcortical Strokes (SPS3) BP protocol, BP management during the study, and achieved BPs are described here.

METHODS

Patients with recent symptomatic lacunar stroke were randomized to 1 of 2 levels of systolic BP (SBP) targets: lower: <130mm Hg, or higher: 130–149mm Hg. SBP management over the course of the trial was examined by race/ethnicity and other baseline conditions.

RESULTS

Mean SBP decreased for both groups from baseline to the last follow-up, from 142.4 to 126.7mm Hg for the lower SBP target group and from 143.6 to 137.4mm Hg for the higher SBP target group. At baseline, participants in both groups used an average of 1.7±1.2 antihypertensive medications, which increased to a mean of 2.4±1.4 (lower group) and 1.8±1.4 (higher group) by the end-study visit. It took an average of 6 months for patients to reach their SBP target, sustained to the last follow-up. Black participants had the highest proportion of SBP ≥150mm Hg at both study entry (40%) and end-study visit (17%), as compared with whites (9%) and Hispanics (11%).

CONCLUSIONS

These results show that it is possible to safely lower BP even to a SBP goal <130mm Hg in a variety of patients and settings, including private and academic centers in multiple countries. This provides further support for protocol-driven care in lowering BP and consequently reducing the burden of stroke.

Keywords: achieved blood pressures, blood pressure, blood pressure management, hypertension, ischemic stroke, lacunar stroke, stroke prevention.
Abstract

Hypertension is the most important risk factor for stroke with data from both randomized trials and meta-analyses supporting the importance of blood pressure (BP) lowering for secondary stroke prevention.1–5 Despite the evidence, studies continue to report inadequate BP control in those with prior stroke.6–9 The challenges of lowering BP are not unique to clinical practice, and even within the context of BP clinical trials, achieving goal systolic BP (SBP) has proven difficult.10–12

The Secondary Prevention of Small Subcortical Strokes (SPS3) trial13 was conducted in 81 sites across 8 countries between May 2003 and April 2012. The primary objective was to identify effective strategies for secondary stroke prevention, including lowering SBP to a target of <130mm Hg. The purpose of this report is to provide detailed information on the implementation of the SPS3 BP protocol, including strategies used to enhance fidelity to the protocol, achieved BPs, and factors associated with failure to achieve SBP goal.

Abbreviations: BP, blood pressure; DBP, diastolic blood pressure; SBP, systolic blood pressure.

* Difference between higher and lower groups is significant at P < 0.001.

** Difference between higher and lower groups is significant at P < 0.0001.

Abbreviation: FAAT, failure to achieve assigned target.

There were 37 subjects who had only a baseline visit (22 subjects in the lower SBP group and 15 in the higher SBP group) and 33 participants who did not have valid SBP measurements at their quarterly follow-ups (17 in the higher group and 15 in the lower group).

*P < 0.0001

Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; SBP, systolic blood pressure.

Abbreviation: SBP, systolic blood pressure.

Because of the small numbers and heterogeneity of the group, the table excludes 74 participants who reported their race as American Indian/Alaskan Native, Asian/Pacific Islander, or Other.

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ACKNOWLEDGMENT

The SPS3 work was funded by the National Institute of Neurological Disorders and Stroke (NINDS # 2 U01 NS38529-04A1).

ACKNOWLEDGMENT

REFERENCES

REFERENCES

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