Pietzsch Jan B, Geisler Benjamin P, Daniels Matthew J, Busca Rachele M, Tarantini Giuseppe, Søndergaard Lars, Kasner Scott E
Wing Tech Inc., Menlo Park, CA, USA.
Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Eur Stroke J. 2021 Mar;6(1):72-80. doi: 10.1177/2396987320939804. Epub 2020 Sep 24.
Patent foramen ovale closure reduces recurrence of cryptogenic ischaemic stroke compared to anti-platelet therapy. Our goal was to determine procedure volumes and closure utilisation as a proportion of candidates in four large European countries.
National statistics were obtained for Germany, England, France, and Italy for the last available five years (2014-2018). Eligibility was aligned to the enrolment criteria of pivotal trials and current consensus documents. Stroke and transient ischaemic attack incidences were obtained from epidemiological registries and claims data. The eligible candidate pool for analysis included current year candidates plus untreated patients from the prior two years. Absolute strokes avoided assumed the hazard ratio for ischaemic stroke recurrence from a recent meta-analysis.
In 2018, closure incidence rates were 5.64, 0.53, 2.94 and 5.26 per 100,000 in Germany, England, France and Italy, respectively. This reflects five-year increases of 128% in Germany, 462% in France and 36% in Italy ( < 0.05 for all), and a decline of 37% in England. The proportions of treated patients versus candidates for the combined stroke and transient ischaemic attack pool were 55%, 30%, 80%, and 6%, respectively.
Patent foramen ovale closure volumes increased after the 2017 announcement of positive trial results but still differ substantially across large European countries. If all closure candidates in 2018 with prior ischaemic stroke were treated, the resulting absolute reduction of recurrent ischaemic strokes, compared to anti-platelet therapy alone, would be between 782 and 2295 across the four countries over five years.
Many eligible patients at risk for a recurrent cryptogenic event might remain untreated due to regional practice variations.
与抗血小板治疗相比，卵圆孔未闭封堵术可降低不明原因缺血性卒中的复发率。我们的目标是确定四个欧洲大国的手术量以及封堵术在候选患者中的应用比例。
获取了德国、英国、法国和意大利过去五年（2014 - 2018年）的国家统计数据。入选标准与关键试验的入组标准及当前共识文件一致。卒中及短暂性脑缺血发作的发病率来自流行病学登记处和索赔数据。用于分析的合格候选患者池包括当年的候选患者以及前两年未治疗的患者。避免的绝对卒中数假设采用近期一项荟萃分析中缺血性卒中复发的风险比。
2018年，德国、英国、法国和意大利的封堵术发病率分别为每10万人5.64例、0.53例、2.94例和5.26例。这反映出德国五年内增长了128%，法国增长了462%，意大利增长了36%（均P < 0.05），而英国下降了37%。在合并的卒中和短暂性脑缺血发作患者池中，接受治疗的患者占候选患者的比例分别为55%、30%、80%和6%。
2017年阳性试验结果公布后，卵圆孔未闭封堵术的手术量有所增加，但在欧洲大国之间仍存在显著差异。如果2018年所有既往有缺血性卒中的封堵术候选患者都接受治疗，则与单独抗血小板治疗相比，在这四个国家五年内缺血性卒中复发绝对减少数在782至2295例之间。
由于地区实践差异，许多有复发性不明原因事件风险的合格患者可能仍未接受治疗。
