Effect of Standard vs Intensive Blood Pressure Control on the Risk of Recurrent Stroke: A Randomized Clinical Trial and Meta-analysis.

IMPORTANCE: The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that a systolic blood pressure (BP) target less than 120 mm Hg was superior to less than 140 mm Hg for preventing vascular events. This trial excluded patients with prior stroke; therefore, the ideal BP target for secondary stroke prevention remains unknown. OBJECTIVE: To assess whether intensive BP control would achieve fewer recurrent strokes vs standard BP control. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial (RCT) of standard vs intensive BP control in an intent-to-treat population of patients who had a history of stroke. Patients were enrolled between October 20, 2010, and December 7, 2016. For an updated meta-analysis, PubMed and the Cochrane Central Library database were searched through September 30, 2018, using the Medical Subject Headings and relevant search terms for cerebrovascular disease and for intensive BP lowering. This was a multicenter trial that included 140 hospitals in Japan; 1514 patients who had a history of stroke within the previous 3 years were approached, but 234 refused to give informed consent. INTERVENTIONS: In total, 1280 patients were randomized 1:1 to BP control to less than 140/90 mm Hg (standard treatment) (n = 640) or to less than 120/80 mm Hg (intensive treatment) (n = 640). However, 17 patients never received intervention; therefore, 1263 patients assigned to standard treatment (n = 630) or intensive treatment (n = 633) were analyzed. MAIN OUTCOMES AND MEASURES: The primary outcome was stroke recurrence. RESULTS: The trial was stopped early. Among 1263 analyzed patients (mean [SD] age, 67.2 [8.8] years; 69.4% male), 1257 of 1263 (99.5%) completed a mean (SD) of 3.9 (1.5) years of follow-up. The mean BP at baseline was 145.4/83.6 mm Hg. Throughout the overall follow-up period, the mean BP was 133.2/77.7 (95% CI, 132.5-133.8/77.1-78.4) mm Hg in the standard group and 126.7/77.4 (95% CI, 125.9-127.2/73.8-75.0) mm Hg in the intensive group. Ninety-one first recurrent strokes occurred. Nonsignificant rate reductions were seen for recurrent stroke in the intensive group compared with the standard group (hazard ratio [HR], 0.73; 95% CI, 0.49-1.11; P = .15). When this finding was pooled in 3 previous relevant RCTs in a meta-analysis, the risk ratio favored intensive BP control (relative risk, 0.78; 95% CI, 0.64-0.96; P = .02; absolute risk difference, -1.5%; 95% CI, -2.6% to -0.4%; number needed to treat, 67; 95% CI, 39-250). CONCLUSIONS AND RELEVANCE: Intensive BP lowering tended to reduce stroke recurrence. The updated meta-analysis supports a target BP less than 130/80 mm Hg in secondary stroke prevention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01198496.

The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study.

BACKGROUND: Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients. METHODS: This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints. FINDING: Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events. INTERPRETATION: Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis. FUNDING: This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

[Adenoid cystic carcinoma with striking intracranial extension: a case report].

We report a case of intracranial adenoid cystic carcinoma in the middle cranial fossa. A 40-year-old woman had noticed a tumor in the left external auditory canal 8 years previously. It was totally resected at that time. Histologically, the tumor was diagnosed as an adenoid cystic carcinoma. Recently the patient presented with loss of consciousness, suffering from mild recent-memory disturbance. Neurological examination revealed no other abnormalities. Magnetic resonance imaging (MRI) demonstrated an enhanced solid mass with a multicystic component in the left temporal lobe. She underwent subtotal removal of the tumor. It was well-demarcated, and was confirmed to be adhesive to the dura matter of the middle cranial fossa. Histology of the tumor was the same as it was 8 years ago. She was discharged from our hospital without neurological deficits. Two months after surgery, gamma knife radiosurgery was performed against the residual tumor.

[Growth of asymptomatic unruptured aneurysms in follow-up study: report of three cases].

The natural history of asymptomatic unruptured aneurysms that have not been subjected to surgery was studied radiologically using MRA and MRI and 3D-CT angiography (3D-CTA) commencing in 1993. We report on the growth of documented asymptomatic unruptured aneurysms in three patients. Growth of the aneurysms was followed by repeated MRA, MRI and 3D-CTA. In Case 1, a 71-year-old woman had been diagnosed as having a 3 mm unruptured anterior communicating artery aneurysm. The size of the aneurysm had expanded to 4 mm, 2 years later. This was detected during a follow-up MRA and confirmed by angiography. After this follow-up MRA, the aneurysm showed no change in size or shape for 8 years. Case 2 was that of a 75-year-old woman who had a 4.5 mm aneurysm involving the basilar artery and the superior cerebellar artery. 12 months later, an MRA was carried out as a follow-up study. This MRA revealed that the aneurysm had developed a bleb and was expanding. 8 months later the patient bled from the aneurysm and underwent surgery, but died. Before surgery, the diameter of the aneurysm, confirmed by angiogram, was 5.5 mm including the bleb. The third patient was a 66-year-old woman who had a 7 mm internal aneurysm involving the carotid artery and the posterior communicating artery. 3 years later a 3D-CTA detected the expansion of the aneurysm and development of an aneurysm bleb. 6 years later more expansion occurred and 3 months after that the patient bled from the aneurysm and underwent clipping. At that time, the diameter of the aneurysm, confirmed by angiography, was 13 mm including the bleb. In this follow-up study, patients with diagnosed asymptomatic unruptured aneurysms were followed up by MRA and MRI and 3D-CTA to determine risk factors for aneurysm rupture. We emphasize the fact that growth of an unruptured aneurysm and formation of blebs are important risk factors of aneurysm rupture.

[Rupture of previously documented asymptomatic unruptured aneurysms--aneurysm size: risk factor for aneurysm rupture].

The natural history of asymptomatic unruptured aneurysms is not clear. We conducted a follow up study of 100 patients (since 1993) with 122 asymptomatic unruptured aneurysms that had not been operated on. We report five patients with previously documented asymptomatic unruptured aneurysms smaller than 10 mm in diameter that subsequently ruptured. Among the 100 patients, five had suffered subarachnoid hemorrhage (SAH) due to rupturing of an aneurysm. Of the 5 cases, 1 was male and 4 were female, with ages ranging from 59-73 years (mean age, 68 years). The aneurysms were on the MCA in 3, on the BA-SCA in 1, on the IC-PC in 1. The maximal diameter of the aneurysms at diagnosis ranged from 4.5 to 8 mm. The period from discovery to SAH was from 4 to 69 months and the cumulative rate of rupture of the aneurysms was 1.5 percent per year. Four of the 5 cases increased in size after the rupture. In our series, 2 of the 5 cases showed enlargement and the development of an aneurysmal bleb in the follow up MRA and 3D-CTA. The present study demonstrates that five asymptomatic unruptured aneurysms less than 10 mm in diameter subsequently ruptured. We ought to seriously consider the assertion published in the New England Journal of Medicine (Dec. 10, 1998), that unruptured aneurysms less than 10 mm in diameter have a very low probability of subsequent rupture.