RESIST-HCV criteria to monitor progression of low-risk esophageal varices in patients with compensated cirrhosis after HCV eradication. The SIMPLE study

Objectives: Non-invasive criteria to predict progression of low-risk esophageal varices (EV) in patients with compensated HCV cirrhosis after sustained virological response (SVR) by direct-acting antivirals (DAAs) are lacking. Our aim was to assess the diagnostic performance of RESIST-HCV criteria for EV progression compared to elastography-based criteria (Baveno VI, Expanded Baveno VI and Baveno VII-HCV criteria). Methods: All consecutive patients observed at three referral centers with compensated HCV cirrhosis with or without F1 EV who achieved SVR by DAAs were classified at last esophagogastroduodenoscopy (EGDS) as RESIST-HCV Low Risk (LR - i.e. low probability of high-risk varices-HRV) if platelets were >120 x 109/L and serum albumin >3.6 g/dL or RESIST-HCV High Risk (HR-i.e. high probability of HRV) if platelets were <120 x 109/L or serum albumin <3.6 g/dL. Primary outcome was the progression to HRV. Area under the receiver operating characteristic (AUROC) curve and decision curve analysis (DCA) of non-invasive criteria were calculated. Results: The cohort consisted of 353 patients in Child-Pugh A class (mean age 67.2 years, 53.8% males). During a mean follow-up of 44.2 months, 34 patients (9.6%, 95%CI 6.7%-13.5%) developed HRV. At the last EGDS, 178 patients(50.4%) were RESIST-LR and 175(49.6%) were RESIST-HR. RESIST-HCV criteria showed the highest AUROC (0.70, 95%CI 0.65-0.75), correctly sparing the highest number of EGDS (54.3%), with the lowest false positive rate (45.7%), compared to elastography-based criteria. DCA showed that RESIST-HCV had higher clinical utility than elastography-based criteria. Conclusions: Biochemical-based RESIST-HCV criteria are useful to easily predict HRV development after HCV eradication by DAAs in patients with compensated cirrhosis and low-risk EV.