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Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention on cardiovascular disease has not been established. We aimed to test the effectiveness of such an intervention compared with usual care on risk of cardiovascular disease and all-cause death among individuals with hypertension. In this open-label, blinded-endpoint, cluster-randomised trial, we recruited individuals aged at least 40 years with an untreated systolic blood pressure of at least 140 mm Hg or a diastolic blood pressure of at least 90 mm Hg (≥130 mm Hg and ≥80 mm Hg for those at high risk for cardiovascular disease or if currently taking antihypertensive medication). We randomly assigned (1:1) 326 villages to a non-physician community health-care provider-led intervention or usual care, stratified by provinces, counties, and townships. In the intervention group, trained non-physician community health-care providers initiated and titrated antihypertensive medications according to a simple stepped-care protocol to achieve a systolic blood pressure goal of less than 130 mm Hg and diastolic blood pressure goal of less than 80 mm Hg with supervision from primary care physicians. They also delivered discounted or free antihypertensive medications and health coaching for patients. The primary effectiveness outcome was a composite outcome of myocardial infarction, stroke, heart failure requiring hospitalisation, and cardiovascular disease death during the 36-month follow-up in the study participants. Safety was assessed every 6 months. This trial is registered with ClinicalTrials.gov, NCT03527719. Between May 8 and Nov 28, 2018, we enrolled 163 villages per group with 33 995 participants. Over 36 months, the net group difference in systolic blood pressure reduction was –23·1 mm Hg (95% CI –24·4 to –21·9; p<0·0001) and in diastolic blood pressure reduction, it was –9·9 mm Hg (–10·6 to –9·3; p<0·0001). Fewer patients in the intervention group than the usual care group had a primary outcome (1·62% vs 2·40% per year; hazard ratio [HR] 0·67, 95% CI 0·61–0·73; p<0·0001). Secondary outcomes were also reduced in the intervention group: myocardial infarction (HR 0·77, 95% CI 0·60–0·98; p=0·037), stroke (0·66, 0·60–0·73; p<0·0001), heart failure (0·58, 0·42–0·81; p=0·0016), cardiovascular disease death (0·70, 0·58–0·83; p<0·0001), and all-cause death (0·85, 0·76–0·95; p=0·0037). The risk reduction of the primary outcome was consistent across subgroups of age, sex, education, antihypertensive medication use, and baseline cardiovascular disease risk. Hypotension was higher in the intervention than in the usual care group (1·75% vs 0·89%; p<0·0001). The non-physician community health-care provider-led intensive blood pressure intervention is effective in reducing cardiovascular disease and death. The Ministry of Science and Technology of China and the Science and Technology Program of Liaoning Province, China.

The prevalence of uncontrolled hypertension is high and increasing in low-income and middle-income countries. We tested the effectiveness of a multifaceted intervention for blood pressure control in rural China led by village doctors (community health workers on the front line of primary health care). In this open, cluster randomised trial (China Rural Hypertension Control Project), 326 villages that had a regular village doctor and participated in the China New Rural Cooperative Medical Scheme were randomly assigned (1:1) to either village doctor-led multifaceted intervention or enhanced usual care (control), with stratification by provinces, counties, and townships. We recruited individuals aged 40 years or older with an untreated blood pressure of 140/90 mm Hg or higher (≥130/80 mm Hg among those with a history of cardiovascular disease, diabetes, or chronic kidney disease) or a treated blood pressure of 130/80 mm Hg or higher. In the intervention group, trained village doctors initiated and titrated antihypertensive medications according to a standard protocol with supervision from primary care physicians. Village doctors also conducted health coaching on home blood pressure monitoring, lifestyle changes, and medication adherence. The primary outcome (reported here) was the proportion of patients with a blood pressure of less than 130/80 mm Hg at 18 months. The analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03527719, and is ongoing. Between May 8 and November 28, 2018, we enrolled 33 995 individuals from 163 intervention and 163 control villages. At 18 months, 8865 (57·0%) of 15 414 patients in the intervention group and 2895 (19·9%) of 14 500 patients in the control group had a blood pressure of less than 130/80 mm Hg, with a group difference of 37·0% (95% CI 34·9 to 39·1%; p<0·0001). Mean systolic blood pressure decreased by −26·3 mm Hg (95% CI −27·1 to −25·4) from baseline to 18 months in the intervention group and by −11·8 mm Hg (−12·6 to −11·0) in the control group, with a group difference of −14·5 mm Hg (95% CI −15·7 to −13·3 mm Hg; p<0·0001). Mean diastolic blood pressure decreased by −14·6 mm Hg (−15·1 to −14·2) from baseline to 18 months in the intervention group and by −7·5 mm Hg (−7·9 to −7·2) in the control group, with a group difference of −7·1 mm Hg (−7·7 to −6·5 mm Hg; p<0·0001). No treatment-related serious adverse events were reported in either group. Compared with enhanced usual care, village doctor-led intervention resulted in statistically significant improvements in blood pressure control among rural residents in China. This feasible, effective, and sustainable implementation strategy could be scaled up in rural China and other low-income and middle-income countries for hypertension control. Ministry of Science and Technology of China.

Although intensive blood pressure control is recommended by major guidelines, its overall benefit–harm balance remains uncertain. In particular, it is unclear how net clinical benefit varies by blood pressure target and patient characteristics. We aimed to quantify the benefit–harm trade-offs of intensive blood pressure control versus standard blood pressure control. We conducted a post-hoc, pooled participant-level analysis of six randomised controlled trials (ACCORD BP, SPRINT, ESPRIT, BPROAD, STEP, and CRHCP). Trial selection was based on our collaborative framework, the Blood Pressure Reduction Union-Landmark Evidence, and a targeted literature search, guided by five predefined inclusion criteria: (1) comparison of intensive systolic blood pressure targets (<120 mm Hg or <130 mm Hg) versus standard treatment; (2) reporting of composite major cardiovascular outcomes; (3) enrolment of more than 2000 participants; (4) standardised reporting of treatment-related adverse events; and (5) availability of individual participant data. We also conducted a systematic review in which we searched PubMed for studies published from database inception up to June 15, 2025, with no language restrictions. We used search terms related to cardiovascular outcomes, hypertension, intensive blood pressure lowering, and randomised trials. Study screening and data extraction were independently conducted in pairs by ten reviewers, with discrepancies resolved by discussion or adjudication. Participants in the six trials were randomly assigned to intensive blood pressure treatment (systolic blood pressure target <120 mm Hg or <130 mm Hg) versus standard treatment (systolic blood pressure target <140 mm Hg, <150 mm Hg in older adults, or usual care), depending on the trial design. The primary benefit outcome was a composite of myocardial infarction, stroke, heart failure, and cardiovascular death. The primary harm outcomes were adverse events of interest (eg, hypotension and syncope) and renal-related events. Statistical analyses were performed on an intention-to-treat basis using Bayesian hierarchical models. The initial dataset included 80 676 participants, of whom 80 220 were included in our analyses (intensive blood pressure control group n=40 503; standard blood pressure control group n=39 717). The median age was 64·0 years (IQR 59·0–70·0), 39 043 (48·7%) participants were male, and 41 177 (51·3%) were female. Most participants were Asian (66 290 [82·6%]) or White (8097 [10·1%]). During a median follow-up of 3·2 years (IQR 3·0–3·5), the composite cardiovascular disease outcome occurred in 2158 (5·3%) participants in the intensive blood pressure control group and 2811 (7·1%) participants in the standard blood pressure control group (hazard ratio 0·76, 95% credible interval [CrI] 0·72–0·81; p<0·0001). Compared with standard blood pressure control, intensive blood pressure control was associated with a 1·73% absolute risk reduction (95% CrI 1·65–1·81) in cardiovascular disease (number needed to treat 58 [95% CrI 55–61]) and a 1·82% absolute risk increase (95% CrI 1·63–2·01) for adverse events of interest (number needed to harm 55 [95% CrI 49–61]). Overall, intensive blood pressure control showed a favourable benefit–harm profile, with a net benefit of 1·14 (95% CrI 1·03–1·25), using adjudicated weighting. The net benefit remained positive when considering kidney-related adverse events (1·13 [95% CrI 1·01–1·24]). Compared with standard blood pressure control, intensive blood pressure control provides a net benefit between the reduction in cardiovascular events and the increase in adverse events, including renal events. National Key Research and Development Program, the Ministry of Science and Technology of China; National Science and Technology Major Project; National Natural Science Foundation of China; China Academy of Chinese Medical Sciences Innovation Fund for Medical Science; and Science and Technology Program of Liaoning Province.