External validation of SCORE2-Diabetes risk prediction model in Chinese patients with diabetes

Abstract Aims The updated 2023 European Guideline recommended SCORE2-Diabetes to estimate cardiovascular disease (CVD) risk in patients with diabetes; however, external validation is lacking. The study aims to validate SCORE2-Diabetes in Chinese and assess its broader applicability and adaptability across diverse settings. Methods and results This study included patients with diabetes aged 40–90 without prior CVD from a population-based Chinese cohort. Ten-year CVD risk was calculated using the original and recalibrated SCORE2-Diabetes, where four sets of scaling factors for different risk regions were provided. The outcome was defined consistently with SCORE2-Diabetes. During a median follow-up of 7.09 years, 50 426 Chinese patients experienced 6540 CVD events and 2852 non-CVD deaths. The C-statistic of the SCORE2-Diabetes was 0.702 (95% confidence interval: 0.691–0.713) in men and 0.726 (0.716–0.736) in women. The original SCORE2-Diabetes underestimated risk by 30% in men and 50% in women, whereas the recalibrated SCORE2-Diabetes using high-risk region scaling factor had the best calibration, overestimating risk by only 4% in men and underestimating by 7% in women. Of the patients, 14 501 (28.76%) and 20 789(41.23%) were classified as very high (≥20%) and high (10–20%) risk categories, respectively. The significant difference between average baseline and targeted LDL-C was observed in the very high-risk group (2.85 vs. 1.40 mmol/L). Conclusion With the appropriate selection of the scaling factor, SCORE2-Diabetes shows satisfactory discrimination and calibration in Chinese, indicating its good generalizability. According to the latest guideline, the risk assessment in this real-world population indicated a significant demand for medications with cardiovascular efficacy and a substantial burden for lipid management.