Search

Importance: The Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive blood pressure control reduced cardiovascular morbidity and mortality. However, the legacy effect of intensive treatment is unknown., Objective: To evaluate the long-term effects of randomization to intensive treatment with the incidence of cardiovascular and all-cause mortality approximately 4.5 years after the trial ended., Design, Setting, and Participants: In this secondary analysis of a multicenter randomized clinical trial, randomization began on November 8, 2010, the trial intervention ended on August 20, 2015, and trial close-out visits occurred through July 2016. Patients 50 years and older with hypertension and increased cardiovascular risk but without diabetes or history of stroke were included from 102 clinic sites in the US and Puerto Rico. Analyses were conducted between October 2021 and February 2022., Interventions: Randomization to systolic blood pressure (SBP) goal of less than 120 mm Hg (intensive treatment group; n = 4678) vs less than 140 mm Hg (standard treatment group; n = 4683)., Main Outcomes and Measures: Extended observational follow-up for mortality via the US National Death Index from 2016 through 2020. In a subset of 2944 trial participants, outpatient SBP from electronic health records during and after the trial were examined., Results: Among 9361 randomized participants, the mean (SD) age was 67.9 (9.4) years, and 3332 (35.6%) were women. Over a median (IQR) intervention period of 3.3 (2.9-3.9) years, intensive treatment was beneficial for both cardiovascular mortality (hazard ratio [HR], 0.66; 95% CI, 0.49-0.89) and all-cause mortality (HR, 0.83; 95% CI, 0.68-1.01). However, at the median (IQR) total follow-up of 8.8 (8.3-9.3) years, there was no longer evidence of benefit for cardiovascular mortality (HR, 1.02; 95% CI, 0.84-1.24) or all-cause mortality (HR, 1.08; 95% CI, 0.94-1.23). In a subgroup of participants, the estimated mean outpatient SBP among participants randomized to intensive treatment increased from 132.8 mm Hg (95% CI, 132.0-133.7) at 5 years to 140.4 mm Hg (95% CI, 137.8-143.0) at 10 years following randomization., Conclusions and Relevance: The beneficial effect of intensive treatment on cardiovascular and all-cause mortality did not persist after the trial. Given increasing outpatient SBP levels in participants randomized to intensive treatment following the trial, these results highlight the importance of consistent long-term management of hypertension., Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.

Importance: COVID-19 vaccines are effective, but inequities in vaccine administration and waning immunity may limit vaccine effectiveness., Objectives: To report statewide trends in vaccine administration and vaccine effectiveness in Minnesota., Design, Setting, and Participants: This cohort study used COVID-19 vaccine data from the Minnesota Immunization Information Connection from October 25, 2020, through October 30, 2021 that were linked with electronic health record (EHR) data from health systems collaborating as part of the Minnesota EHR Consortium (MNEHRC). Participants included individuals who were seen at a participating health system in Minnesota., Exposures: Individuals were considered fully vaccinated in the second week after receipt of a second dose of a BNT162b2 or mRNA-1273 vaccine or a single dose of an Ad26.COV.2.S vaccine., Main Outcomes and Measures: A completed vaccination series and vaccine breakthrough, defined as either a positive SARS-CoV-2 polymerase chain reaction (PCR) test or a hospital admission the same week or within the 3 weeks following a positive SARS-CoV-2 PCR test. A test-negative design and incident rate ratio were used to evaluate COVID-19 vaccine effectiveness separately for the BNT162b2, mRNA-1273, and Ad26.COV.2.S vaccines. Rurality and social vulnerability index were assessed at the area level., Results: This study included 4 431 190 unique individuals at participating health systems, and 3 013 704 (68%) of the individuals were fully vaccinated. Vaccination rates were lowest among Minnesotans who identified as Hispanic (116 422 of 217 019 [54%]), multiracial (30 066 of 57 412 [52%]), American Indian or Alaska Native (22 190 of 41 437 [54%]), and Black or African American (158 860 of 326 595 [49%]) compared with Minnesotans who identified as Asian or Pacific Islander (159 999 of 210 994 [76%]) or White (2 402 928 of 3 391 747 [71%]). Among individuals aged 19 to 64 years, vaccination rates were lower in rural areas (196 479 of 308 047 [64%]) compared with urban areas (151 541 of 1 951 265 [77%]) and areas with high social vulnerability (544 433 of 774 952 [70%]) compared with areas with low social vulnerability (571 613 of 724 369 [79%]). In the 9 weeks ending October 30, 2021, vaccine effectiveness as assessed by a test-negative design was 33% (95% CI, 30%-37%) for Ad26.COV.2.S; 53% (95% CI, 52%-54%) for BNT162b2; and 66% (95% CI, 65%-67%) for mRNA-1273. For SARS-CoV-2-related hospitalizations, vaccine effectiveness in the 9 weeks ending October 30, 2021, was 78% (95% CI, 75%-81%) for Ad26.COV.2.S; 81% (95% CI, 79%-82%) for BNT162b2; and 81% (95% CI, 79%-82%) for mRNA-1273., Conclusions and Relevance: This cohort study of data from a Minnesota statewide consortium suggests disparities in vaccine administration and effectiveness. Vaccine effectiveness against infection was lower for Ad26.COV.2.S and BNT162b2 but was associated with protection against SARS-CoV-2-related hospitalizations despite the increased prevalence of the Delta variant in Minnesota.

Importance: There are concerns with translating results from the Systolic Blood Pressure Intervention Trial (SPRINT) into clinical practice because the standardized protocol used to measure blood pressure (BP) may not be consistently applied in routine clinical practice., Objectives: To evaluate the concordance between BPs obtained in routine clinical practice and those obtained using the SPRINT protocol and whether concordance varied by target trial BP., Design, Setting, and Participants: This observational prognostic study linking outpatient vital sign information from electronic health records (EHRs) with data from 49 of the 102 SPRINT sites was conducted from November 8, 2010, to August 20, 2015, among 3074 adults 50 years or older with hypertension without diabetes or a history of stroke. Statistical analysis was performed from May 21, 2019, to March 20, 2020., Main Outcomes and Measures: Blood pressures measured in routine clinical practice and SPRINT., Results: Participant-level EHR data was obtained for 3074 participants (2482 men [80.7%]; mean [SD] age, 68.5 [9.1] years) with 3 or more outpatient and trial BP measurements. In the period from the 6-month study visit to the end of the study intervention, the mean systolic BP (SBP) in the intensive treatment group from outpatient BP recorded in the EHR was 7.3 mm Hg higher (95% CI, 7.0-7.6 mm Hg) than BP measured at trial visits; the mean difference between BP recorded in the outpatient EHR and trial SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]). Bland-Altman analyses demonstrated low agreement between outpatient BP recorded in the EHR and trial BP, with wide agreement intervals ranging from approximately -30 mm Hg to 45 mm Hg in both treatment groups. In addition, the difference between BP recorded in the EHR and trial BP varied widely by site., Conclusions and Relevance: Outpatient BPs measured in routine clinical practice were generally higher than BP measurements taken in SPRINT, with greater mean SBP differences apparent in the intensive treatment group. There was a consistent high degree of heterogeneity between the BPs recorded in the EHR and trial BPs, with significant variability over time, between and within the participants, and across clinic sites. These results highlight the importance of proper BP measurement technique and an inability to apply 1 common correction factor (ie, approximately 10 mm Hg) to approximate research-quality BP estimates when BP is not measured appropriately in routine clinical practice., Trial Registration: SPRINT ClinicalTrials.gov Identifier: NCT01206062.