The effect of dapagliflozin on cardiorespiratory fitness in patients with coronary heart disease and type 2 diabetes mellitus following PCI: a single-center prospective randomized controlled study

To evaluate the effect of dapagliflozin on cardiorespiratory fitness (CRF) in patients with coronary heart disease (CHD) and type 2 diabetes mellitus (T2DM) following percutaneous coronary intervention (PCI). A total of 180 patients with CHD and T2DM who underwent PCI at Yuebei People’s Hospital between April 2021 and April 2023 were enrolled and randomly divided into the dapagliflozin group and the non-dapagliflozin group. CRF, brachial artery flow-mediated dilation (FMD), as well as the incidence of cardiovascular events and adverse reactions were compared between the two groups. After 3 months of intervention, compared with the non-dapagliflozin group, the dapagliflozin group exhibited significantly higher peak oxygen uptake (VO2peak) (Adjusted mean difference [AMD] in VO2peak for the dapagliflozin group: 21.87 ml/kg/min, 95% confidence interval [CI]: 21.05–22.69; AMD in VO2peak for the non-dapagliflozin group: 19.65 ml/kg/min, 95% CI: 18.2–20.48; P < 0.001), and a similar beneficial effect was observed for FMD (AMD in FMD for the dapagliflozin group: 5.63%, 95% CI: 5.12–6.14; AMD in FMD for the non-dapagliflozin group: 3.22%, 95% CI: 2.7–3.74; P < 0.001). No statistically significant between-group differences were detected in the remaining indicators (all P > 0.05). Over a 3-month observational period, dapagliflozin improved CRF, vascular endothelial function, and reduced the incidence of adverse cardiovascular events in patients with CHD and T2DM following PCI. This trial was registered with the Chinese Clinical Trial Registry (ChiCTR), registration number ChiCTR2100047856, on June 27, 2021 (retrospective registration). The study protocol adheres to the CONSORT guidelines.