Department of Neurology, School of Medicine, Prisma Health and University of South Carolina, Columbia (S.S., J.M., E.M., M.L.).
Department of Dentistry, Prisma Health Medical Group, Columbia, SC (J.C., D.H., C.N.).
Stroke. 2023 Sep;54(9):2214-2222. doi: 10.1161/STROKEAHA.122.042047. Epub 2023 Aug 7.
Patients with stroke/transient ischemic attack and periodontal disease (PD) are at increased risk for cardiovascular events. PD treatments that can improve stroke risk factors were tested if they might assist patients with cerebrovascular disease.
In this multicenter phase II trial, patients with stroke/transient ischemic attack and moderately severe PD were randomly assigned to intensive or standard PD treatment arms. The primary outcome measure was a composite of death, myocardial infarction, and recurrent stroke, as well as adverse events. Secondary outcome included changes in stroke risk factors.
A total of 1209 patients with stroke/transient ischemic attack were screened, of whom 481 met the PD eligibility criteria; 280 patients were randomized to intensive arm (n=140) and standard arm (n=140). In 12-month period, primary outcome occurred in 11 (8%) in the intensive arm and 17 (12%) in the standard arm. The intensive arm was nonsuperior to the standard arm (hazard ratio, 0.65 [95% CI, 0.30-1.38]) with similar rates of adverse events (sepsis 2.1% versus 0.7%; dental bleeding 1.4% versus 0%; and infective endocarditis 0.7% versus 0%). Secondary-outcome improvements were noted in both arms with diastolic blood pressure and high-density lipoprotein cholesterol (<0.05).
In patients with recent stroke/transient ischemic attack and PD, intensive PD treatment was not superior to standard PD treatment in prevention of stroke/myocardial infarction/death. Fewer events were noted in the intensive arm and the 2 arms were comparable in the safety outcomes. Secondary-outcome measures showed a trend toward improvement, with significant changes noted in diastolic blood pressure and high-density lipoprotein in both the treatment arms.
患有中风/短暂性脑缺血发作和牙周病（PD）的患者发生心血管事件的风险增加。如果 PD 治疗可以改善中风的危险因素，那么就会对患有脑血管疾病的患者进行测试。
在这项多中心 II 期试验中，患有中风/短暂性脑缺血发作和中度严重 PD 的患者被随机分配到强化 PD 治疗组或标准 PD 治疗组。主要观察指标是死亡、心肌梗死和复发性中风的复合终点，以及不良事件。次要观察指标包括中风危险因素的变化。
共筛选了 1209 例中风/短暂性脑缺血发作患者，其中 481 例符合 PD 入选标准；280 例患者被随机分配到强化组（n=140）和标准组（n=140）。在 12 个月期间，强化组有 11 例（8%）发生主要终点事件，标准组有 17 例（12%）发生主要终点事件。强化组并不优于标准组（风险比，0.65[95%CI，0.30-1.38]），不良事件发生率相似（败血症 2.1%比 0.7%；牙龈出血 1.4%比 0%；感染性心内膜炎 0.7%比 0%）。两组的舒张压和高密度脂蛋白胆固醇都有改善（<0.05）。
在近期发生中风/短暂性脑缺血发作和 PD 的患者中，强化 PD 治疗在预防中风/心肌梗死/死亡方面并不优于标准 PD 治疗。强化组的事件较少，且两组在安全性结果方面相当。次要观察指标显示出改善的趋势，两个治疗组的舒张压和高密度脂蛋白胆固醇都有显著变化。
