Key result
ESC very-high-risk status linked to ~3.8-fold higher incidence of major cardiovascular events.
Why the study?
Data on cardiovascular risk stratification in patients with unresectable hepatocellular carcinoma receiving atezolizumab plus bevacizumab remain limited, despite the cardiovascular toxicity risk of bevacizumab.
Do the ESC Cardio-Oncology classification and CARDIOSOR scores effectively stratify the risk of major adverse cardiovascular events in patients with unresectable hepatocellular carcinoma receiving atezolizumab/bevacizumab?
Cohort (n=538)
Yes
Do the ESC Cardio-Oncology classification and CARDIOSOR scores effectively stratify the risk of major adverse cardiovascular events in patients with unresectable hepatocellular carcinoma receiving atezolizumab/bevacizumab?
Hazard Ratio: 3.8 (95% CI 1.52–9.45)
Absolute Event Rate: 10.6% vs 2.7%
p-value: p=0.004
The ESC Cardio-Oncology and CARDIOSOR scores can identify patients with hepatocellular carcinoma at high risk for cardiovascular complications during atezolizumab/bevacizumab therapy, supporting patient-tailored treatment approaches.
May support ESC stratification for monitoring in HCC on atezolizumab/bevacizumab; hypothesis-generating, needs prospective validation.
Background & Aims The management of comorbidities has become increasingly relevant in unresectable hepatocellular carcinoma (uHCC) as immunotherapy prolongs survival. Atezolizumab plus bevacizumab (AB) is a standard first‐line option, but bevacizumab carries a risk of cardiovascular toxicities. Data on cardiovascular risk stratification in patients with cirrhosis remain limited. Identifying patients at increased cardiovascular risk is therefore clinically important, particularly given the availability of bevacizumab‐free alternatives. Methods We retrospectively analysed prospectively collected data from the multicenter Italian ARTE database, including patients with uHCC treated with first‐line AB between June 2022 and July 2025. Traditional major adverse cardiovascular events (tMACE) were defined as acute coronary syndromes, heart failure, cerebrovascular events, or peripheral ischemia, while an extended composite (eMACE) additionally included venous thromboembolism and immune‐related myocarditis. Cardiovascular risk was stratified using the European Society of Cardiology (ESC) Cardio‐Oncology classification and the CARDIOSOR score. Competing‐risk analyses were performed considering treatment discontinuation as a competing event. Results This study included 538 patients (median age 69.8 years). During follow‐up, 20 patients (3.7%) experienced tMACE, and 30 (5.6%) experienced eMACE. Patients assigned to the very high‐risk category by ESC criteria and those with a high‐risk CARDIOSOR score had a significantly increased risk of tMACE and eMACE. Both scores demonstrated a moderate ability to stratify cardiovascular risk (Harrell's c‐index 0.68 for ESC and 0.59 for CARDIOSOR). Conclusions Cardiovascular adverse events were uncommon overall, but their incidence was not negligible in patients in high‐risk subgroups. Risk scores may help identify vulnerable subgroups and support patient‐tailored treatment strategies, including consideration of bevacizumab‐free regimens in selected cases. Trial Registration Multicenter ARTE database (NCT06806579)
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Stefanini et al. (2026) conducted a cohort in Unresectable hepatocellular carcinoma (n=538). Very high cardiovascular risk by ESC Cardio-Oncology criteria vs. Lower cardiovascular risk categories was evaluated on Traditional major adverse cardiovascular events (tMACE) (sHR 3.80, 95% CI 1.52-9.45, p=0.004). Patients classified as very high cardiovascular risk by ESC criteria had a significantly increased incidence of traditional major adverse cardiovascular events (sHR 3.80) compared to those in lower risk categories.
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