TY - JOUR
T1 - Short-term prediction of preeclampsia using the sFlt-1/PlGF ratio
T2 - a subanalysis of pregnant Japanese women from the PROGNOSIS Asia study
AU - Ohkuchi, Akihide
AU - Saito, Shigeru
AU - Yamamoto, Tatsuo
AU - Minakami, Hisanori
AU - Masuyama, Hisashi
AU - Kumasawa, Keiichi
AU - Yoshimatsu, Jun
AU - Nagamatsu, Takeshi
AU - Dietl, Angela
AU - Grill, Sonja
AU - Hund, Martin
N1 - Funding Information:
Acknowledgements The authors wish to acknowledge Toshio Nakayama (Department of Obstetrics and Gynecology, The University of Tokyo Hospital) for recruitment of study participants at The University of Tokyo Hospital. This study was supported in the initial phase by Deirdre Allegranza from Roche Diagnostics International Ltd, Rotkreuz, Switzerland. W.D.J. Verhagen-Kamerbeek of Roche Diagnostics provided clinical science support throughout the study; support for study conduct, monitoring, and measurement of sFlt-1 and PlGF was provided by the Contract Research Organization Covance, Inc. Third-party medical writing assistance, under the direction of the authors, was provided by David Evans, Ph.D., and Chloe Fletcher, MSc (Ashfield MedComms [Macclesfield, UK], an Ashfield Health company) and was funded by Roche Diagnostics International Ltd (Rotkreuz, Switzerland). COBAS, COBAS E, and ELECSYS are trademarks of Roche. The trade name of ELECSYS in Japan is ECLUSYS.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/7
Y1 - 2021/7
N2 - Two prospective multicenter studies demonstrated that a soluble fms-like tyrosine kinase 1 (sFlt-1)/placental growth factor (PlGF) ratio cutoff of ≤38 can rule out preeclampsia within 1 week with a negative predictive value (NPV) of 99.3% (PROGNOSIS) and 98.6% (PROGNOSIS Asia). We report a subanalysis of the Japanese cohort from the PROGNOSIS Asia study. Pregnant women with suspected preeclampsia between gestational weeks 18 + 0 days and 36 + 6 days were enrolled at eight Japanese sites. Primary objectives: Assess the performance of the Elecsys® sFlt-1/PlGF ratio cutoff ≤38 to rule out preeclampsia within 1 week and of the cutoff >38 to rule in preeclampsia within 4 weeks. Key secondary objectives: Prediction of maternal and fetal adverse outcomes (MAOs/FAOs) and their relationship with duration of pregnancy. Of 192 women enrolled, 180 (93.8%)/175 (91.1%) were evaluable for primary/combined endpoint analyses. Overall preeclampsia prevalence was 13.3%. A sFlt-1/PlGF ratio of ≤38 provided an NPV of 100% (95% confidence interval [CI], 97.5–100) for ruling out preeclampsia within 1 week, and a ratio of >38 provided a positive predictive value of 32.4% (95% CI, 18.0–49.8) for ruling in preeclampsia within 4 weeks. The area under the curve for the prediction of preeclampsia/maternal/fetal adverse outcomes within 1 week was 94.2% (95% CI, 89.3–97.8). After adjusting for gestational age and final preeclampsia status, Cox regression indicated a 2.8-fold greater risk of imminent delivery for women with a sFlt-1/PlGF ratio >38 versus ≤38. This subanalysis of Japanese women with suspicion of preeclampsia showed high predictive value for a Elecsys sFlt-1/PlGF ratio cutoff of 38 for short-term prediction of preeclampsia.
AB - Two prospective multicenter studies demonstrated that a soluble fms-like tyrosine kinase 1 (sFlt-1)/placental growth factor (PlGF) ratio cutoff of ≤38 can rule out preeclampsia within 1 week with a negative predictive value (NPV) of 99.3% (PROGNOSIS) and 98.6% (PROGNOSIS Asia). We report a subanalysis of the Japanese cohort from the PROGNOSIS Asia study. Pregnant women with suspected preeclampsia between gestational weeks 18 + 0 days and 36 + 6 days were enrolled at eight Japanese sites. Primary objectives: Assess the performance of the Elecsys® sFlt-1/PlGF ratio cutoff ≤38 to rule out preeclampsia within 1 week and of the cutoff >38 to rule in preeclampsia within 4 weeks. Key secondary objectives: Prediction of maternal and fetal adverse outcomes (MAOs/FAOs) and their relationship with duration of pregnancy. Of 192 women enrolled, 180 (93.8%)/175 (91.1%) were evaluable for primary/combined endpoint analyses. Overall preeclampsia prevalence was 13.3%. A sFlt-1/PlGF ratio of ≤38 provided an NPV of 100% (95% confidence interval [CI], 97.5–100) for ruling out preeclampsia within 1 week, and a ratio of >38 provided a positive predictive value of 32.4% (95% CI, 18.0–49.8) for ruling in preeclampsia within 4 weeks. The area under the curve for the prediction of preeclampsia/maternal/fetal adverse outcomes within 1 week was 94.2% (95% CI, 89.3–97.8). After adjusting for gestational age and final preeclampsia status, Cox regression indicated a 2.8-fold greater risk of imminent delivery for women with a sFlt-1/PlGF ratio >38 versus ≤38. This subanalysis of Japanese women with suspicion of preeclampsia showed high predictive value for a Elecsys sFlt-1/PlGF ratio cutoff of 38 for short-term prediction of preeclampsia.
KW - Japan
KW - Predictive performance
KW - Preeclampsia
KW - Prognosis
KW - Soluble fms-like tyrosine kinase 1/placental growth factor ratio
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UR - http://www.scopus.com/inward/citedby.url?scp=85100903674&partnerID=8YFLogxK
U2 - 10.1038/s41440-021-00629-x
DO - 10.1038/s41440-021-00629-x
M3 - Article
C2 - 33727707
AN - SCOPUS:85100903674
SN - 0916-9636
VL - 44
SP - 813
EP - 821
JO - Hypertension Research
JF - Hypertension Research
IS - 7
ER -