Abstract
Background: Secondary stroke prevention after a high-risk, non-disabling ischemic cerebrovascular event needs to be enhanced. The study was conducted to investigate whether remote ischemic conditioning (RIC) is effective in preventing recurrent ischemic events within 3 months.Methods: This was a four-center, single-arm, open-label Phase IIa futility trial (PICNIC-One Study). Adult patients (≥18 years of age) who had an acute minor ischemic stroke (AMIS) with a National Institutes of Health Stroke Scale score ≤ 3 or a transient ischemic attack (TIA) with moderate-to-high risk of stroke recurrence (ABCD score ≥ 4) within 14 days of symptom onset were recruited. Patients received RIC as adjunctive therapy to routine secondary stroke prevention regimen. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuffs (45 min) on bilateral upper limbs twice a day for 90 days.Results: A total of 285 patients met the study criteria, of which 167 provided signed informed consent and were enrolled. Data from 162 were analyzed with five subjects excluded. Recurrent AIS/TIA occurred in 6/162 (3.7%) patients within 3 months, with no occurrence of hemorrhagic stroke. The top three adverse events were upper limb pain (44/162, 27.2%), petechia (26/162, 16.0%), and heart palpitation (5/162, 3.1%). About 68 (42.0%) subjects completed ≥ 50% of 45-min RIC sessions.Conclusions: RIC is a safe add-on procedure and it has a potential benefit in reducing recurrent cerebrovascular events in patients with high-risk, non-disabling ischemic cerebrovascular events as the risk of stroke/TIA events is lower than expected; however, its compliance needs to be improved. Our study provides critical preliminary data to plan a large sample size, randomized controlled clinical study to systematically investigate the safety and efficacy of RIC in this population.
Highlights
Stroke is the most common cause of mortality and disability in China [1]
The latest American and Chinese guidelines for the secondary prevention of stroke has recommended the combination of aspirin and clopidogrel within 24 h of a high-risk non-disabling ischemic cerebrovascular event, which is continued for 21 days [4, 5]
A total of 162 patients were included in the final analysis, whereas 118 patients declined to participate for various reasons, including skepticism of the study device or clinical trials, inability to commit to follow-up visits, and other non-specific reasons
Summary
Stroke is the most common cause of mortality and disability in China [1]. High-risk non-disabling ischemic cerebrovascular events consist of acute minor ischemic stroke (AMIS) and moderate-to-high risk transient ischemic attack (TIA). A large-scale clinical trial among Chinese patients with AMIS/TIA (CHANCE study) has indicated that dual antiplatelet therapy (clopidogrel and aspirin) reduced the risk of recurrent stroke, as compared to single antiplatelet therapy [3]. The latest American and Chinese guidelines for the secondary prevention of stroke has recommended the combination of aspirin and clopidogrel within 24 h of a high-risk non-disabling ischemic cerebrovascular event, which is continued for 21 days [4, 5]. According to the CHANCE study results, 9.4% of patients would still have another ischemic stroke/TIA within the 3 months, despite receiving the recommended dual-antiplatelet therapy [3]. Only fewer than two-thirds of stroke patients were reported to arrive at hospitals within 24 h to receive dual-antiplatelet therapy in China [6]. Secondary stroke prevention after a high-risk, non-disabling ischemic cerebrovascular event needs to be enhanced. The study was conducted to investigate whether remote ischemic conditioning (RIC) is effective in preventing recurrent ischemic events within 3 months
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