{"id":"388a10c21b59","type":"article","url":"https://hartvaat.nl/2026/03/06/kouno-tori-antitrombine-verlengt-de-zwangerschap-niet-bij-vroege-ernstige-pre-ec/","title":"KOUNO-TORI: antitrombine verlengt de zwangerschap niet bij vroege ernstige pre-eclampsie en geeft meer bloedingen","title_en":"Randomized Study of Antithrombin in Early-Onset Preeclampsia: KOUNO-TORI Study","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["abelacimab","dubbele-trombocytenremming","trombocytenaggregatieremmers","zwangerschap-hart"],"journal":"Hypertension","doi":"https://www.ahajournals.org/doi/abs/10.1161/HYPERTENSIONAHA.125.25431","source_url":"https://doi.org/https://www.ahajournals.org/doi/abs/10.1161/HYPERTENSIONAHA.125.25431","authors":["Jun Takeda"],"significance":5,"published":"2026-03-06","source_date":"2026-03-06","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-zwangerschap/","https://hartvaat.nl/kennis/nierziekte/nsaids-en-nierziekte/"],"congress":"","summary_en":"In preeclampsia, prolonging pregnancy reduces fetal risks. This randomised, double-blind, placebo-controlled study (KOUNO-TORI; 61 institutions) tested whether recombinant human antithrombin-gamma prolongs pregnancy in women with early-onset severe preeclampsia (24-32 weeks, antithrombin activity ≤100%). Pregnancy was prolonged by 13 days in the placebo group (n=92) and 16.9 days in the antithrombin group (n=90) — not a significant difference (p=0.07). The antithrombin group had more haemorrhage-related adverse events (+19.0%) and more anaemia (+16.8%). Antithrombin thus does not significantly prolong pregnancy in early-onset severe preeclampsia and appears to increase bleeding risk.","created":"2026-07-03T10:32:24Z","updated":"2026-07-03T13:31:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Bij pre-eclampsie vermindert het verlengen van de zwangerschap de risico's voor de foetus. Deze gerandomiseerde, dubbelblinde, placebogecontroleerde studie (KOUNO-TORI; 61 instellingen) onderzocht of recombinant humaan antitrombine-gamma de zwangerschap verlengt bij vrouwen met vroege ernstige pre-eclampsie (24-32 weken, antitrombine-activiteit ≤100%). De zwangerschap werd verlengd met 13 dagen in de placebogroep (n=92) en 16,9 dagen in de antitrombinegroep (n=90) — geen significant verschil (p=0,07). In de antitrombinegroep traden wel meer bloedingsgerelateerde bijwerkingen (+19,0%) en meer anemie (+16,8%) op. Antitrombine verlengt de zwangerschap bij vroege ernstige pre-eclampsie dus niet significant en lijkt het bloedingsrisico te verhogen.","abstract_original":"Hypertension, Volume 83, Issue 6, Page e25431, June 1, 2026. BACKGROUND:In preeclampsia, prolonging pregnancy decreases the risks of fetal morbidity and death. This study aimed to evaluate the efficacy and safety of antithrombin in prolonging pregnancy early-onset severe preeclampsia.METHODS:This was a randomized, double-blind, placebo-controlled study involving women with early-onset preeclampsia from 61 institutions. Participants developed early-onset severe preeclampsia from 24+0 to 31+6 weeks’ gestation and had ≤100% antithrombin activity. Two groups were created, with random and blinded assignment of the participants 1:1 to a placebo (saline) group (n=92) or a recombinant human antithrombin-gamma (rhAT-gamma) group (n=90). The number of days from treatment initiation to delivery was recorded in each group, as the primary end point.RESULTS:Pregnancy was prolonged by 13 days (95% CI, 10.4–15.6) in the placebo group and 16.9 days (95% CI, 13.8–20.0) in the rhAT-gamma group (P=0.07). Compared with the placebo group, hemorrhage-related adverse events occurred at a 19.0% higher rate in the rhAT-gamma group (mean difference [95% CI, 4.3%–32.7%]), and anemia occurred at a 16.8% higher rate (mean difference [95% CI, 2.0%–30.6%]).CONCLUSIONS:No significant difference in pregnancy prolongation was found between the placebo and rhAT-gamma participants with early-onset severe preeclampsia. However, compared with the placebo group, the rhAT-gamma group appeared to have higher rates of hemorrhage-related adverse events and anemia.REGISTRATION:URL:https://jrct.niph.go.jp/en-top; Unique identifier: jRCT2080224912. URL:https://clinicaltrials.gov/; Unique identifier: NCT04182373."}