Noninvasive Assessment of portal Hypertension in Patients With Primary Biliary Cholangitis is Affected by Severity of Cholestasis

Background&aims: Non-invasive tests (NITs) for ruling-out clinical significant portal hypertension (CSPH) and high-risk varices (HRV) in patients with primary biliary cholangitis(PBC) and compensated advanced chronic liver disease (cACLD) are lacking. We evaluated NITs in these patients and the influence of cholestasis on their performance. Methods: Consecutive patients from the "Italian PBC registry" and two UK large-volume PBC referral centres with upper endoscopy within 6 months from biochemical evaluation and transient elastography were included. RESIST, Baveno-VI (BVI) and Expanded Baveno-VI (EBVI) criteria for ruling-out HRV were assessed according to alkaline phosphatase levels (ALP)(1.5 ULN). Decision curve analysis (DCA) was performed. Prevalence of any-sized esophageal varices among patients fitting Baveno VII (BVII) criteria was also calculated. Results: The final cohort consisted of 293 patients with cACLD. RESIST criteria were associated with the lowest rate of missed HRV (2.5% vs 9.8% for BVI and 8.9% for EBVI). In patients with ALP levels>1.5 times ULN, BVI and EBVI missed a higher rate of HRV (15.5% and 14.5%, respectively) than RESIST (3.1%). DCA demonstrated the highest net benefit of RESIST criteria for ruling out HRV, regardless ALP levels. Among 75 patients classified as low risk of CSPH according to BVII, 14 (18.7%) showed esophageal varices. Conclusions: Biochemical-based RESIST criteria demonstrate the highest net benefit compared to elastography-based criteria for ruling out HRV. The severity of cholestasis affects NITs performance to rule out HRV and CSPH in patients with PBC and cACLD.

Background & aims: Noninvasive tests (NITs) for ruling-out clinical significant portal hypertension (CSPH) and high-risk varices (HRVs) in patients with primary biliary cholangitis (PBC) and compensated advanced chronic liver disease (cACLD) are lacking. We evaluated NITs in these patients and the influence of cholestasis on their performance. Methods: Consecutive patients from the "Italian PBC registry" and 2 United Kingdom large-volume PBC referral centers with upper endoscopy within 6 months from biochemical evaluation and transient elastography were included. Rete Sicilia Selezione Terapia (RESIST), Baveno VI (BVI), and Expanded Baveno VI (EBVI) criteria for ruling out HRV were assessed according to alkaline phosphatase (ALP) levels (< or ≥1.5 × upper limit of normal). Decision curve analysis was performed. Prevalence of any sized esophageal varices among patients fitting Baveno VII (BVII) criteria was also calculated. Results: The final cohort consisted of 293 patients with cACLD. RESIST criteria were associated with the lowest rate of missed HRV (2.5% vs 9.8% for BVI and 8.9% for EBVI). In patients with ALP levels ≥1.5 × upper limit of normal, BVI and EBVI missed a higher rate of HRV (15.5% and 14.5%, respectively) than RESIST (3.1%). Decision curve analysis demonstrated the highest net benefit of RESIST criteria for ruling out HRV, regardless of ALP levels. Among 75 patients classified as low risk of CSPH according to BVII, 14 (18.7%) showed esophageal varices. Conclusions: Biochemical-based RESIST criteria demonstrate the highest net benefit compared with elastography-based criteria for ruling out HRV. The severity of cholestasis affects NITs performance to rule out HRV and CSPH in patients with PBC and cACLD.