Patent Foramen Ovale Closure in Older Patients With Stroke: Patient Selection for Trial Feasibility.
Обработка статьи · этапы, ошибки и управление
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.
Wang Andy Y, Rothwell Peter M, Nelson Jason, Saver Jeffrey L, Kasner Scott E, Carroll John, Mas Jean-Louis, Derumeaux Geneviève, Chatellier Gilles, Furlan Anthony J, Herrmann Howard C, Jüni Peter, Kim Jong S, Koethe Benjamin, Lee Pil H, Lefebvre Benedicte, Mattle Heinrich P, Meier Bernhard, Reisman Mark, Smalling Richard W, Sondergaard Lars, Song Jae-Kwan, Di Angelantonio Emanuele, DiTullio Marco, Elkind Mitchell S V, Homma Shunichi, Jaigobin Cheryl, Michel Patrik, Mono Marie-Luise, Nedeltchev Krassen, Papetti Federica, Serena Joaquin, Weimar Christian, Li Linxin, Mazzucco Sara, Silver Louise E, van Klaveren David, Thaler David E, Kent David M
Аннотация
METHODS: Effectiveness estimates are derived from major observational studies (Risk of Paradoxical Embolism [RoPE] Study and Oxford Vascular Study, together referred to as the "RoPE-Ox" database) and all 6 major RCTs (Systematic, Collaborative, PFO Closure Evaluation [SCOPE] Consortium). To estimate stroke recurrence risk, observed outcomes were calculated for patients older than 60 years in the age-inclusive observational databases (n = 549). To estimate the reduction in the rate of recurrent stroke associated with PFO closure vs medical therapy based on the RoPE score and the presence of high-risk PFO features, a Cox proportional hazards regression model was developed on the RCT data in the SCOPE database (n = 3,740). These estimates were used to calculate sample sizes required for a future RCT.
RESULTS: Five-year risk of stroke recurrence using Kaplan-Meier estimates was 13.7 (95% CI 10.5-17.9) overall, 14.9% (95% CI 10.2-21.6) in those with high-risk PFO features. Predicted relative reduction in the event rate with PFO closure was 12.9% overall, 48.8% in those with a high-risk PFO feature. Using these estimates, enrolling all older patients with cryptogenic stroke and PFO would require much larger samples than those used for prior PFO closure trials, but selectively enrolling patients with high-risk PFO features would require totals of 630 patients for 90% power and 471 patients for 80% power, with an average of 5 years of follow-up.
DISCUSSION: Based on our projections, anticipated effect sizes in older patients with high-risk features make a trial in these subjects feasible. With lengthening life expectancy in almost all regions of the world, the utility of PFO closure in older adults is increasingly important to explore.