Martinez-Majander N, Ntaios G, Liu Y Y, Ylikotila P, Joensuu H, Saarinen J, Perera K S, Marti-Fabregas J, Chamorro A, Rudilosso S, Prats-Sanchez L, Berkowitz S D, Mundl H, Themeles E, Tiainen M, Demchuk A, Kasner S E, Hart R G, Tatlisumak T
Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland.
Department of Internal Medicine, University of Thessaly, Larissa, Greece.
Eur J Neurol. 2020 May;27(5):841-848. doi: 10.1111/ene.14172. Epub 2020 Mar 11.
Cancer is a frequent finding in ischaemic stroke patients. The frequency of cancer amongst participants in the NAVIGATE ESUS randomized trial and the distribution of outcome events during treatment with aspirin and rivaroxaban were investigated.
Trial participation required a recent embolic stroke of undetermined source. Patients' history of cancer was recorded at the time of study entry. During a mean follow-up of 11 months, the effects of aspirin and rivaroxaban treatment on recurrent ischaemic stroke, major bleeding and all-cause mortality were compared between patients with cancer and patients without cancer.
Amongst 7213 randomized patients, 543 (7.5%) had cancer. Of all patients, 3609 were randomized to rivaroxaban [254 (7.0%) with cancer] and 3604 patients to aspirin [289 (8.0%) with cancer]. The annual rate of recurrent ischaemic stroke was 4.5% in non-cancer patients in the rivaroxaban arm and 4.6% in the aspirin arm [hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.78-1.24]. In cancer patients, the rate of recurrent ischaemic stroke was 7.7% in the rivaroxaban arm and 5.4% in the aspirin arm (HR 1.43, 95% CI 0.71-2.87). Amongst cancer patients, the annual rate of major bleeds was non-significantly higher for rivaroxaban than aspirin (2.9% vs. 1.1%; HR 2.57, 95% CI 0.67-9.96; P for interaction 0.95). All-cause mortality was similar in both groups.
Our exploratory analyses show that patients with embolic stroke of undetermined source and a history of cancer had similar rates of recurrent ischaemic strokes and all-cause mortality during aspirin and rivaroxaban treatments and that aspirin appeared safer than rivaroxaban in cancer patients regarding major bleeds. www.clinicaltrials.gov (NCT02313909).
癌症在缺血性中风患者中很常见。本研究调查了NAVIGATE ESUS随机试验参与者中癌症的发生率以及阿司匹林和利伐沙班治疗期间结局事件的分布情况。
试验参与者需有近期来源不明的栓塞性中风。在研究入组时记录患者的癌症病史。在平均11个月的随访期间，比较了有癌症患者和无癌症患者中阿司匹林和利伐沙班治疗对复发性缺血性中风、大出血和全因死亡率的影响。
在7213例随机分组的患者中，543例（7.5%）患有癌症。所有患者中，3609例被随机分配至利伐沙班组[254例（7.0%）患有癌症]，3604例患者被随机分配至阿司匹林组[289例（8.0%）患有癌症]。利伐沙班组非癌症患者复发性缺血性中风的年发生率为4.5%，阿司匹林组为4.6%[风险比（HR）0.98，95%置信区间（CI）0.78 - 1.24]。在癌症患者中，利伐沙班组复发性缺血性中风的发生率为7.7%，阿司匹林组为5.4%（HR 1.43，95% CI 0.71 - 2.87）。在癌症患者中，利伐沙班的大出血年发生率略高于阿司匹林，但差异无统计学意义（2.9%对1.1%；HR 2.57，95% CI 0.67 - 9.96；交互作用P值为0.95）。两组的全因死亡率相似。
我们的探索性分析表明，有来源不明的栓塞性中风病史且有癌症病史的患者在阿司匹林和利伐沙班治疗期间复发性缺血性中风和全因死亡率相似，并且在大出血方面，阿司匹林在癌症患者中似乎比利伐沙班更安全。www.clinicaltrials.gov（NCT02313909）。
