Bleeding Risk Following Percutaneous Intervention in Patients with Diabetes Prescribed Dual Anti Platelet Therapy
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Patients with diabetes (DM) experience higher rates of in-stent restenosis and therefore greater benefit from drug eluting stent (DES) implant at the time of percutaneous coronary intervention (PCI). DES stent implantation necessitates prolonged dual anti-platelet therapy (DAPT). While DAPT reduces the risk of ischemic events post-PCI, it also increases the risk for bleeding. Whether long-term rates of bleeding differ among patients with and without DM receiving DAPT in real-world practice is unknown. Among patients who underwent PCI and were maintained on DAPT for 1 year in a multicenter US PCI registry, OPS/PRISM, we assessed patient-reported bleeding (defined according to the Bleeding Academic Research Consortium, BARC) over the year following PCI in patients with and without DM. Bleeding assessments were conducted by a study coordinator at index hospitalization (baseline) and at 1, 6 and 12 months following discharge. Multivariable logistic regression was used to evaluate the association of DM with bleeding during follow-up. In a sensitivity analysis, we excluded bruising from BARC-defined bleeding events. Covariates included in the model were selected a priori and were abstracted from the medical record by study coordinators. Covariates included demographic (e.g. age, insurance status) and clinical (e.g. medical history, procedural indication) variables. Among 2270 PCI patients (mean age 64, 72% male, 54% ACS), 32.6% had DM. In unadjusted analyses, patients with DM had fewer BARC ≥1 bleeding events over the year following PCI (DM vs no DM: BARC ≥1: 77.7% vs 87.6%, p<0.001; BARC ≥ 2: 4.5% vs 5.3%, p=0.41). After adjusting for demographic and clinical factors, patients with DM had lower odds of BARC ≥1 bleeding during follow-up (odds ratio [OR] 0.52, 95% CI 0.39-0.68, p<0.001 vs. no DM). This decreased odds of bleeding persisted after removing bruising from the endpoint definition (OR 0.77, 95% CI 0.62-0.96). In a real-world PCI registry, patients with DM experienced lower bleeding on DAPT than those without DM. As patients with DM also derive greater ischemic benefit from DES, which requires prolonged DAPT, our findings suggest that the balance between benefit and risk of this therapeutic approach is even more favorable in patients with DM than previously considered.
Table of Contents
Introduction -- Methodology -- Results -- Discussion -- Appendix