Neuro-Chirurgie · 2026
Understanding statistical versus clinical significance: a critical appraisal of the CREST-2 study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Darsaut Tim E, Boisseau William, Raymond Jean
Аннотация
BACKGROUND: A widespread practice is to label trials as positive or negative based on whether the P value for the primary outcome is less than 0.05. A more reasonable approach is to examine the totality of evidence, particularly when results approach the threshold of statistical significance.
METHODS: We review the CREST-2 study which included two parallel trials on ≥70% asymptomatic carotid stenoses: one trial (n = 1245) compared stenting with an intensive medical management group (IMM1); a second trial (n = 1240) compared endarterectomy with another IMM2 group.
RESULTS: A significantly lower rate of the 4-year primary composite endpoint of stroke or death (2.8%) was reported with stenting compared to IMM1 (6.0%; ARR 3.2%; P = 0.02), while results of endarterectomy (3.7%) vs IMM2 (5.3%) were not significantly better (ARR 1.6%; P = 0.24). Closer examination shows that overall, only 104 infarctions occurred in 2485 patients (4.2%) over 4 years, and most (70 or 67%) were minor strokes. A 'tipping point analysis' revealed that if 3 more primary outcome events had occurred in the stenting group, significance would have been lost; if 6 more events had occurred in the IMM2 group, endarterectomy would have attained significance. Stenting resulted in as many major strokes (n = 4) as IMM1 (n = 5) over 4 years. Major strokes after endarterectomy (n = 3) and IMM2 (n = 5) were similar.
CONCLUSION: Stenting or endarterectomy provide similar results but should be reserved for patients who fail intensive medical management. A global interpretation of all the evidence is required when interpreting results that are close to statistical significance.
METHODS: We review the CREST-2 study which included two parallel trials on ≥70% asymptomatic carotid stenoses: one trial (n = 1245) compared stenting with an intensive medical management group (IMM1); a second trial (n = 1240) compared endarterectomy with another IMM2 group.
RESULTS: A significantly lower rate of the 4-year primary composite endpoint of stroke or death (2.8%) was reported with stenting compared to IMM1 (6.0%; ARR 3.2%; P = 0.02), while results of endarterectomy (3.7%) vs IMM2 (5.3%) were not significantly better (ARR 1.6%; P = 0.24). Closer examination shows that overall, only 104 infarctions occurred in 2485 patients (4.2%) over 4 years, and most (70 or 67%) were minor strokes. A 'tipping point analysis' revealed that if 3 more primary outcome events had occurred in the stenting group, significance would have been lost; if 6 more events had occurred in the IMM2 group, endarterectomy would have attained significance. Stenting resulted in as many major strokes (n = 4) as IMM1 (n = 5) over 4 years. Major strokes after endarterectomy (n = 3) and IMM2 (n = 5) were similar.
CONCLUSION: Stenting or endarterectomy provide similar results but should be reserved for patients who fail intensive medical management. A global interpretation of all the evidence is required when interpreting results that are close to statistical significance.