Project description:BackgroundStroke is the prime cause of morbidity and mortality in the general population, and hypertension will increase the recurrence and mortality of stroke. We report a protocol of a pragmatic randomized controlled trial (RCT) using blood pressure (BP)-lowering acupuncture add-on treatment to treat patients with hypertension and stroke.MethodsThis is a large-scale, multicenter, subject-, assessor- and analyst-blinded, pragmatic RCT. A total of 480 patients with hypertension and ischemic stroke will be randomly assigned to two groups: an experimental group and a control group. The experimental group will receive "HuoXueSanFeng" acupuncture combined with one antihypertensive medication in addition to routine ischemic stroke treatment. The control group will only receive one antihypertensive medication and basic treatments for ischemic stroke. HuoXueSanFeng acupuncture will be given for six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks. A 9-month follow-up will, thereafter, be conducted. Antihypertensive medication will be adjusted based on BP levels. The primary outcome will be the recurrence of stroke. The secondary outcomes including 24-h ambulatory BP, the TCM syndrome score, the Short Form 36-item Health Survey (SF-36), the National Institute of Health Stroke Scale (NIHSS), as well as the Barthel Index (BI) scale will be assessed at baseline, 6 weeks and 12 weeks post initiating treatments; cardiac ultrasound, carotid artery ultrasound, transcranial Doppler, and lower extremity ultrasound will be evaluated at baseline and 12 weeks after treatment. The safety of acupuncture will also be assessed.DiscussionWe aim to determine the clinical effects of controlling BP for secondary prevention of stroke with acupuncture add-on treatment.Trial registrationClinicalTrials.gov, ID: NCT02967484 . Registered on 13 February 2017; last updated on 27 June 2017.
Project description:Background We aimed to determine whether cerebral white matter hyperintensities ( WMHs ) can distinguish stroke survivors susceptible to rapid kidney function decline from intensive blood pressure ( BP ) lowering. Methods and Results The SPS3 (Secondary Prevention of Small Subcortical Strokes) trial randomized participants with recent lacunar stroke to systolic BP targets of 130 to 149 and <130 mm Hg. We included 2454 participants with WMH measured by clinical magnetic resonance imaging at baseline and serum creatinine measured during follow-up. We tested interactions between BP target and WMH burden on the incidence of rapid kidney function decline (≥30% decrease from baseline estimated glomerular filtration rate at 1-year follow-up) and recurrent stroke. Rapid kidney function decline incidence was 11.0% in the lower- BP -target arm and 8.1% in the higher-target arm (odds ratio=1.40; 95% CI=1.07-1.84). Odds ratio for rapid kidney function decline between lower- and higher-target groups ranged from 1.26 in the lowest WMH tertile (95% CI , 0.80-1.98) to 1.71 in the highest tertile (95% CI , 1.05-2.80; P for interaction=0.65). Overall incidence of recurrent stroke was 7.9% in the lower-target arm and 9.6% in the higher-target arm (hazard ratio=0.80; 95% CI , 0.63-1.03). Hazard ratio for recurrent stroke in the lower-target group was 1.13 (95% CI , 0.73-1.75) within the lowest WMH tertile compared with 0.73 (95% CI , 0.49-1.09) within the highest WMH tertile ( P for interaction=0.04). Conclusions Participants with higher WMH burden appeared to experience greater benefit from intensive BP lowering in prevention of recurrent stroke. By contrast, intensive BP lowering increased the odds of kidney function decline, but WMH burden did not significantly distinguish this risk. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 00059306.
Project description:We aimed to study the effects of hypothetical interventions on systolic blood pressure (SBP) and smoking on risk of stroke and dementia using data from 15 years of follow-up in the Rotterdam Study. We used data from 4930 individuals, aged 55-80 years, with no prior history of stroke, dementia or cognitive impairment, followed for 15 years within the Rotterdam Study, a population-based cohort. We defined the following sustained interventions on SBP: (1) maintaining SBP below 120 mmHg, (2) maintaining SBP below 140 mmHg, (3) reducing SBP by 10% if above 140 mmHg, (4) reducing SBP by 20% if above 140 mmHg, and a combined intervention of quitting smoking with each of these SBP-lowering strategies. We considered incident stroke and incident dementia diagnoses as outcomes. We applied the parametric g-formula to adjust for baseline and time-varying confounding. The observed 15-year risk for stroke was 10.7%. Compared to no specified intervention (i.e., the "natural course"), all interventions that involved reducing SBP were associated with a stroke risk reduction of about 10% (e.g., reducing SBP by 20% if above 140 mmHg risk ratio: 0.89; 95% CI 0.76, 1). Jointly intervening on SBP and smoking status further decreased the risk of stroke (e.g., risk ratio: 0.83; 95% CI 0.71, 0.94). None of the specified interventions were associated with a substantive change in dementia risk. Our study suggests that a joint intervention on SBP and smoking cessation during later life may reduce stroke risk, while the potential for reducing dementia risk were not observed.
Project description:BackgroundStroke is an important cause of death and disability worldwide. Since high blood pressure is an important risk factor for stroke and stroke recurrence, drugs that lower blood pressure might play an important role in secondary stroke prevention.ObjectivesTo investigate whether blood pressure-lowering drugs (BPLDs) started at least 48 hours after the index event are effective for the prevention of recurrent stroke, major vascular events, and dementia in people with stroke or transient ischaemic attack (TIA). Secondary objectives were to identify subgroups of people in which BPLDs are effective, and to investigate the optimum systolic blood pressure target after stroke or TIA for preventing recurrent stroke, major vascular events, and dementia.Search methodsIn August 2017, we searched the Trials Registers of the Cochrane Stroke Group and the Cochrane Hypertension Group, the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 8), MEDLINE Ovid (1946 to August 2017), Embase Ovid (1974 to August 2017), ClinicalTrials.gov, the ISRCTN Registry, Stroke Trials Registry, Trials Central, and the World Health Organization (WHO) International Clinical Trials Registry Platform Portal.Selection criteriaRandomised controlled trials (RCTs) of BPLDs started at least 48 hours after stroke or TIA.Data collection and analysisTwo review authors independently screened all titles and abstracts, selected eligible trials, extracted the data, assessed risk of bias, and used GRADE to assess the quality of the evidence. If necessary, we contacted the principal investigators or corresponding authors for additional data.Main resultsWe included 11 studies involving a total of 38,742 participants: eight studies compared BPLDs versus placebo or no treatment (35,110 participants), and three studies compared different systolic blood pressure targets (3632 participants). The risk of bias varied greatly between included studies. The pooled risk ratios (RRs) of BPLDs were 0.81 (95% confidence interval (CI) 0.70 to 0.93; 8 RCTs; 35,110 participants; moderate-quality evidence), 0.90 (95% CI 0.78 to 1.04; 4 RCTs; 28,630 participants; high-quality evidence) for major vascular event, and 0.88 (95% CI 0.73 to 1.06; 2 RCTs; 6671 participants; high-quality evidence) for dementia. We mainly observed a reduced risk of recurrent stroke in the subgroup of participants using an angiotensin-converting enzyme (ACE) inhibitor or a diuretic (I2 statistic for subgroup differences 72.1%; P = 0.006). The pooled RRs of intensive blood pressure-lowering were 0.80 (95% CI 0.63 to 1.00) for recurrent stroke and 0.58 (95% CI 0.23 to 1.46) for major vascular event.Authors' conclusionsOur results support the use of BPLDs in people with stroke or TIA for reducing the risk of recurrent stroke. Current evidence is primarily derived from trials studying an ACE inhibitor or a diuretic. No definite conclusions can be drawn from current evidence regarding an optimal systolic blood pressure target after stroke or TIA.
Project description:BackgroundGuidelines recommend lowering systolic blood pressure below 130 mm Hg, irrespective of previous strokes. However, there is a concern that lowering systolic blood pressure in people with low baseline diastolic blood pressure might increase the risk of stroke.MethodsWe conducted a secondary analysis of the Secondary Prevention of Small Subcortical Strokes trial that randomly assigned participants with a history of subcortical strokes to an intensive (<130 mm Hg; N=1519) or standard (130-149 mm Hg; N=1501) systolic targets. We examined the effects of blood pressure intervention on stroke and cardiovascular composite across the range of baseline diastolic blood pressure in spline regression models and tested for interaction of baseline diastolic blood pressure with the intervention on outcomes.ResultsMean baseline systolic and diastolic blood pressures were 143±19 and 78±11 mm Hg, respectively. Within each baseline diastolic blood pressure tertile, the achieved diastolic was lower in the intensive versus standard arm. There were 275 stroke events over 10 889 years of follow-up. Lower baseline diastolic blood pressure was associated with increased risk of stroke in an observational spline regression model. Hazard ratios relating blood pressure intervention with the risk of stroke in the lowest (hazard ratio, 0.78 [95% CI, 0.52-1.16]) and the highest (hazard ratio, 0.80 [95% CI, 0.53-1.21]) baseline diastolic tertiles were similar (P=0.95). Results were similar for the cardiovascular composite.ConclusionsIntensive systolic control does not appear to increase the risk of stroke in those with low baseline diastolic blood pressure and prior stroke.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT00059306.
Project description:Background and purposeRecent clinical trials and expert consensus guidelines have typically focused on the issue of systolic blood pressure (SBP) targets for reducing vascular risk. However, little is known about the relationship of the diastolic BP (DBP) level with vascular outcomes after a stroke.MethodsA multicenter trial dataset involving 3680 recent (<4 months) non-cardioembolic stroke patients followed for 2 years was analyzed. Subjects were categorized per mean DBP level (mmHg) during follow-up: low-normal (<70), normal (70 to <80), high-normal (80-89) and high (≥90). Pulse pressure (PP) was prespecified by three categories of <60, 60 to <70, and ≥70 mmHg. Independent associations of mean DBP level with major vascular events (MVEs) and ischaemic stroke were assessed.ResultsMajor vascular events occurred in 20.7% of the low-normal, 15.1% of the normal, 16.9% of the high-normal and 19.2% of the high DBP groups, whilst stroke occurred in 9.9%, 6.8%, 8.5% and 10.8%, respectively. Compared with the normal DBP group, risk of MVEs was higher in the low-normal DBP group (adjusted hazard ratio 1.33; 95% confidence interval 1.04-1.71). Amongst those with SBP 120 to <140 mmHg, risk of MVEs (1.89; 1.13-3.15) and stroke (2.87; 1.48-5.53) was higher in subjects with PP ≥70 (mean DBP 62.4 ± 3.8) than those with the lowest PP (mean DBP 78.0 ± 5.9) whilst, amongst those with SBP <120 mmHg, PP 60 to <70 (mean DBP 52.7 ± 2.5) was associated with increased risk of stroke (5.85; 1.25-27.5).ConclusionDiastolic BP levels in the low-normal range, particularly accompanied by an increased PP of >60, confer increased risk of MVEs and stroke amongst patients after recent non-cardioembolic stroke.
Project description:Background It remains unclear whether physicians' attitudes toward timely management of elevated blood pressure affect the risk of stroke recurrence. Methods and Results From a multicenter stroke registry database, we identified 2933 patients with acute ischemic stroke who were admitted to participating centers in 2011, survived at the 1-year follow-up period, and returned to outpatient clinics ≥2 times after discharge. As a surrogate measure of physicians' attitude, individual treatment intensification (TI) scores were calculated by dividing the difference between the frequencies of observed and expected medication changes by the frequency of clinic visits and categorizing them into 5 groups. The association between TI groups and the recurrence of stroke within 1 year was analyzed using hierarchical frailty models, with adjustment for clustering within each hospital and relevant covariates. Mean±SD of the TI score was -0.13±0.28. The TI score groups were significantly associated with increased risk of recurrent stroke compared with Group 3 (TI score range, -0.25 to 0); Group 1 (range, -1 to -0.5), adjusted hazard ratio (HR) 13.43 (95% CI, 5.95-30.35); Group 2 (range, -0.5 to -0.25), adjusted HR 4.59 (95% CI, 2.01-10.46); and Group 4 (TI score 0), adjusted HR 6.60 (95% CI, 3.02-14.45); but not with Group 5 (range, 0-1), adjusted HR 1.68 (95% CI, 0.62-4.56). This elevated risk in the lowest TI score groups persisted when confining analysis to those with hypertension, history of blood pressure-lowering medication, no atrial fibrillation, and regular clinic visits and stratifying the subjects by functional capacity at discharge. Conclusions A low TI score, which implies physicians' therapeutic inertia in blood pressure management, was associated with a higher risk of recurrent stroke. The TI score may be a useful performance indicator in the outpatient clinic setting to prevent recurrent stroke.
Project description:BackgroundWhile hypertension is a leading risk factor for an initial stroke, the role of blood pressure lowering to prevent subsequent stroke is less clear. The results of recent large clinical trials investigating effects of antihypertensive agents in patients with a history of stroke have not shown a significant benefit; findings that are at odds with previous data. Our meta-analysis systematically evaluates the available, relevant trials to examine the role of antihypertensive drugs in preventing recurrent stroke.MethodsMEDLINE, CENTRAL, and ClinicalTrials.gov were systematically searched and bibliographies from key reports were examined. All randomized, placebo-controlled trials that tested blood pressure lowering agents in patients with stroke or transient ischemic attack were identified. The results from these trials were combined and meta-analyses were performed.ResultsTen studies were found to contain relevant endpoints and presented data allowing meta-analysis. Agents that lowered blood pressure reduced recurrent stroke (OR 0.71, 95% CI 0.59-0.86, P = 0.0004) and cardiovascular events (OR 0.69, 95% CI 0.57-0.85, P = 0.0004) in patients with a previous stroke or TIA. These agents did not affect the rate of myocardial infarction (OR 0.86, 95% CI 0.73-1.01, P = 0.07) or all-cause mortality (OR 0.95, 95% CI 0.83-1.07, P = 0.39) in this patient population.ConclusionDespite recent large trials showing no significant effect, in patients that have experienced a TIA or stroke, blood pressure lowering agents reduced the occurrence of subsequent stroke and cardiovascular events. The rate of myocardial infarction and all-cause mortality was unchanged.
Project description:Recurrent stroke increases mortality and aggravates the disability of stroke patients. We hypothesized that increased inter-arm systolic blood pressure difference and inter-arm diastolic blood pressure difference would be related to recurrent stroke in non-cardioembolic stroke patients. A total of 1226 consecutive non-cardioembolic first-ever ischemic stroke patients, in whom bilateral brachial blood pressures were measured by an automated ankle-brachial index measuring device, were included in our study. Recurrent stroke was defined as newly developed neurologic symptoms with relevant lesions on brain CT and/or MRI after 7 days or hospital discharge. Inter-arm systolic and diastolic blood pressure differences ≥10 mmHg were noted in 9.7% (120/1226) and 5.0% (62/1226) of patients, respectively. During a median 24 months of follow-up, 105 (8.5%) patients experienced recurrent stroke. Patients who had inter-arm systolic blood pressure difference ≥10 mmHg showed increased risk of recurrent stroke (hazard ratio:1.77, 95% confidence interval: 1.04-3.00, p = 0.033). Moreover, inter-arm diastolic blood pressure difference ≥10 mmHg was also independently associated with increased risk of recurrent stroke (hazard ratio:2.92, 95% confidence interval: 1.59-5.34, p = 0.001). In conclusion, inter-arm blood pressure difference ≥10 mmHg may be associated with increased risk recurrent stroke in non-cardioembolic stroke patients.