Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial

 

 

 

Chen HS, et al. JAMA 2022. PMID: 35972485

 

 

 

Introduction

 

급성 뇌경색의 가장 효과적인 치료 방법은 intravenous thrombolysis, endovascular thrombectomy와 같은 재관류 치료(reperfusion therapies)로 알려져 있다. 하지만 기존 재관류 치료 가능 시기의 한계로 인해 많은 뇌경색 환자에서는 여전히 적절한 재관류 치료를 받고 있지 못하다. 전임상시험을 통해 remote ischemic conditioning (RIC)가 신경보호효과(neuroprotective action)를 통해 뇌경색의 병변 크기를 감소시키며 기능 호전에 효과적인 것이 알려져 있다.

 

 

 

Objectives

 

본 논문에서는 다기관 무작위 배정 임상시험을 통해 급성 중증도 뇌경색 환자(acute moderate ischemic stroke)에서 RIC의 효과를 알아보고자 한다.

 

 

 

Methods

 

• The Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke (RICAMIS) Study

  • 연구 디자인: multicenter, open-label, blinded–end point, randomized clinical trial

  • 대상자:

    1. Adults aged 18 years or older

    2. Acute moderate ischemic stroke at the time of randomization (baseline National Institutes of Health Stroke Scale [NIHSS] scores, 6-16)

    3. Pre-morbid functional level: modified Rankin Scale (mRS) scores, 0-1

  • 추적관찰: 최소 12개월 이상 경과 시점에 대면 혹은 전화 면담 시행

• RIC (remote ischemic conditioning) protocol

  • 5 cycles of cuff inflation (200 mmHg for 5 minutes) and deflation (for 5 minutes), for a total procedure time of 50 minutes

  • Twice daily for 10 to 14 days

• Primary outcome: Excellent functional outcome (0 to 1 on the mRS) at 90 days

• Secondary outcome

  • Favorable functional outcome (mRS scores, 0-2) at 90 days

  • A shift in measures of functioning according to the full range of scores on the mRS at 90 days

  • Occurrence of early neurologic deterioration compared with baseline at 7 days

  • Occurrence of stroke-associated pneumonia at 12 days

  • Change in NIHSS score compared with baseline at 12 days

  • Occurrence of stroke or other vascular events at 90days

  • Time from randomization to the occurrence of death due to any cause within 90 days

 

 

 

Results

 

• 대상자 (Table 1)

  • RIC group: 922 patients

  • Control group: 971 patients

    Table 1. Baseline characteristics in the full analysis set

 

	Remote ischemic conditioning (n = 863)	Control (n = 913)
Baseline characteristics
Age, mean±SD, y	65.3 ± 10.5	65.3 ± 10.1
Sex (male : female)	556 : 307	614 : 299
Duration after stroke (days)	756.1 ± 321.9	694.1 ± 197.3
Time from the onset of symptom to remote ischemic conditioning treatment, mean±SD, h	24.8 ± 13.2	25.0 ± 13.7

 

 

 

• Primary outcome (Fig. 1): Excellent functional outcome (0 to 1 on the mRS) at 90 days

  • RIC group: 67.4%

  • Control group: 62.0%

 

Figure 1. Distribution of Modified Rankin Scale Scores at 90 Days in the Full Analysis Set

 

 

 

• Secondary outcome (Table 2)

  • 양군에서 부작용 발현에서 통계적 차이를 보이지 않았음

    .

    	Remote ischemic conditioning (n = 863)	Control (n = 913)
    Early neurologic deterioration within 7 d	77 (8.9%)	64 (7.0%)
    Stroke-associated pneumonia within 12 d	26 (3.0%)	19 (2.1%)
    Change in NIHSS score at day 12 from baseline	4 (2 to 6)	4 (2 to 5)
    Stroke or other vascular events within 90 d	7 (0.8%)	6 (0.7%)
    Death within 90 d	7 (0.8%)	10 (1.1%)

     

     

     

    Conclusions

     

    본 연구 결과를 통해 급성 중등도 뇌경색(Acute moderate ischemic stroke) 환자에서 remote ischemic conditioning (RIC) 치료는 기존의 고식적 치료에 비해 발병 3개월의 기능 수준을 향상시킬 수 있는 치료임을 알 수 있었다.