Table 1 Summary of published clinical trials in blood pressure control for Stroke prevention
From: Blood pressure management to prevent recurrent stroke: current evidence and perspectives
Trial | Participants | Design | Follow-Up | Results |
|---|---|---|---|---|
SPS3 Trial (Secondary Prevention of Small Subcortical Strokes)2 | 3020 patients > 30 years with recent lacunar stroke. | Randomized to systolic BP targets of < 140 mmHg vs. < 130 mmHg. | Mean of 3.7 years. | • Systolic BP averages were 138 and 127 mmHg respectively. • 277 endpoints occurred, including 243 ischemic strokes. • Nonsignificant reduction in stroke recurrence in the intensive group (P = 0.08). • Significant reduction in intracerebral hemorrhage (P = 0.03). |
RESPECT (Recurrent Stroke Prevention Clinical Outcome)3 | In total, 1280 patients were randomized 1:1 to BP control to less than 140/90 mmHg (standard treatment) (n = 640) or to less than 120/80 mmHg (intensive treatment) (n = 640) | Randomized clinical trial (RCT) of standard vs intensive BP control in an intent-to-treat population of patients who had a history of stroke. | Mean of 3.9 (1.5) years | • Stroke Recurrence: 91 first recurrent strokes occurred during the study. • Rate Reductions: Nonsignificant rate reductions for recurrent stroke were observed in the intensive group compared to the standard group (HR, 0.73; 95% CI, 0.49–1.11; wew = 0.15) • Meta-Analysis: When pooled with three previous RCTs, the meta-analysis favored intensive BP control (relative risk, 0.78; 95% CI, 0.64–0.96; P = 0.02) • Trend: Intensive BP lowering tended to reduce stroke recurrence. Recommendation: The updated meta-analysis supports a target BP of less than 130/80 mmHg for secondary stroke prevention |
SPRINT Trial (Systolic Blood Pressure Intervention Trial)6 | 9361 patients >50 years with systolic BP 130 to 180 mmHg and increased CVD risk, without diabetes or prior stroke. | Randomized to systolic BP targets of <140 mmHg vs. <120 mmHg. | Mean of 3.26 years. | • Systolic BP averages were 121.4 and 136.2 mmHg respectively. • 319 primary endpoints in the standard group vs. 243 in the intensive group (P < 0.001). • Significant reduction in all-cause deaths (P < 0.003) and CVD deaths (P < 0.005) in the intensive group. • More frequent adverse events related to BP lowering in the intensive group (P < 0.001). |
PROGRESS - Perindopril Protection Against Recurrent Stroke Study11 | Both hypertensive and non-hypertensive patients were eligible for inclusion. The study was conducted in 172 centers from 10 countries (Australia, Belgium, China, France, Italy, Ireland, Japan, New Zealand, Sweden and the United Kingdom). About 6100 patients were randomized. Mean age of participants at study entry was 64 years, 30% of whom were female, 84% had an entry diagnosis of stroke, and the remainder had an entry diagnosis of TIA alone. | Patients were randomly assigned to treatment with the ACE inhibitor perindopril (and the diuretic indapamide for those with no definite indication or contraindication to treatment with a diuretic) versus matching placebo(s) | Mean of 3.9 year | • Treatment significantly reduced the risk of stroke and major vascular events, with a 28% reduction in stroke and a 26% reduction in major vascular events overall. These reductions were consistent across different subgroups based on age, sex, and region, with particularly notable benefits observed among younger participants and those from Asia. • The treatment was deemed safe and well-tolerated, and the absolute benefits were substantial, with an estimate that treating 20 patients for 5 years would prevent at least one major vascular event. • Blood pressure lowering effectively reduces the risk of secondary stroke, with significant benefits across various demographic groups. |
PROFESS (Prevention Regimen for Effectively Avoiding Second Strokes) trial14 | The trial included over 20,000 patients who had experienced an ischemic stroke within the previous 90 days. | Patients were randomly assigned to one of two groups: • Telmisartan Group: Patients received telmisartan, an angiotensin II receptor blocker. • Placebo Group: Patients received a placebo. | The follow-up period for the trial was approximately 2.5 years | • Stroke Recurrence: The trial found no significant difference in the recurrence of stroke between the telmisartan group and the placebo group. • Cardiovascular Events: There was also no significant difference in the incidence of major cardiovascular events between the two groups. • Blood Pressure Control: Telmisartan effectively reduced blood pressure, but this did not translate into a significant reduction in stroke recurrence or major cardiovascular events. • Safety and Tolerability: The safety profile of telmisartan was consistent with previous studies, with no unexpected adverse effects. |
PODCAST (Prevention of Decline in Cognition after Stroke Trial)15 | Subjects with recent stroke, absence of dementia, and systolic BP (SBP) 125–170 mmHg were assigned randomly to at least 6 months of intensive (target SBP < 125 mmHg) or guideline (target SBP < 140 mmHg) BP lowering. | Multicenter and partial-factorial trial | The median was 24 months (range 1–48) | • In patients with recent stroke and normal cognition, intensive treatment led to significant reductions in mean blood pressure (difference −10.6/−5.5 mmHg) compared to guideline treatment. • However, there was no significant difference in the ACE-R score between the treatments for blood pressure lowering. • The mean difference for BP lowering was −3.6 (95% CI −9.7 to 2.4). • There was no difference in rates of dementia or serious adverse events for either comparison. • Overall, intensive BP lowering were feasible and safe but did not alter cognition over two years. |
PAST-BP (Prevention After Stroke -Blood Pressure)15 | People with a history of stroke or transient ischaemic attack. Interventions Intensive systolic blood pressure target ( < 130 mmHg or 10 mmHg reduction from baseline if this was <140 mmHg) or standard target ( < 140 mmHg). Apart from the different target, patients in both arms were actively managed in the same way with regular reviews by the primary care team. | Open label randomized controlled trial. Setting 99 general practices in England, with participants recruited in 2009-11. | 12 months | • The intensive target arm aimed for a systolic blood pressure below 130 mmHg, resulting in a drop of 16.1 mmHg−127.4 mmHg. • The standard arm aimed for a systolic blood pressure below 140 mmHg, resulting in a drop of 12.8 mmHg to 129.4 mmHg. • The difference between the groups was 2.9 mmHg (95% confidence interval: 0.2–5.7 mmHg; P = 0.03). • Targeting below 130 mmHg provided a small additional reduction in blood pressure compared to targeting below 140 mmHg. • Active management aiming for a target below 140 mmHg resulted in a clinically significant reduction in blood pressure in this population. |
