Vessel-oriented cardiovascular events in patients with diabetes undergoing intracoronary physiology-guided revascularization

Abstract Background The safety of intracoronary physiology guided coronary revascularization in patients with diabetes mellitus is not well established. Purpose The aim of this work is to assess the risk of vessel oriented cardiovascular events (VOCE) in patients with and without diabetes mellitus (DM) who underwent physiology-guided coronary revascularization. Moreover, we sought to identify clinical features associated with increased risk of adverse outcomes among patients with DM particularly when coronary intervention was deferred based on intracoronary functional assessment. Methods This is a retrospective analysis of a multicenter registry of patients evaluated with fractional flow reserve and/or non-hyperaemic pressure ratio. The primary endpoint was a composite of VOCE including cardiac death, vessel-related myocardial infarction (MI), and ischemia-driven target vessel revascularization (TVR). Results A large cohort of 2828 patients and 3353 coronary lesions with and without DM was analysed to assess the risk of VOCE at long-term follow up (23, interquartile range 14-36 months). The primary endpoint occurred in 222 (6.6%) coronary lesions without difference between patients with and without DM (7.8% vs. 6.1%, P=0.078). Diabetes was not associated with the primary endpoint (adjusted hazard ratio, aHR, 1.20, 95% CI 0.89-1.61, P=0.226) or with its individual components. Conversely, insulin-dependent diabetes mellitus (IDDM) demonstrated an increased risk of VOCE (aHR 1.76, 95% CI 1.07-2.91, P=0.027). In particular, IDDM was independently associated with ischemia-driven TVR (aHR 2.13, 95% CI 1.22-3.72, P=0.008) but not with vessel-oriented MI and cardiac death. Myocardial revascularization was deferred in 2316 (69%) coronary lesions without difference between patients with and without DM (68.8% vs. 69.2%, P=0.820). In multivariable analysis, lesion localization in the proximal segment of the coronary artery (aHR 2.20, 95% CI 1.33-3.63, P=0.002), abnormal coronary physiology (aHR 5.95, 95% CI 2.27-15.59, P<0.0001) and IDDM (aHR 2.77, 95% CI 1.11-6.93, P=0.029) were independently associated with the risk of VOCE in the shared frailty Cox regression model. Conversely, overall DM was not associated with the primary endpoint (HR 1.39, 95% CI 0.98-1.98, P=0.069). Moreover, in patients with DM and deferred coronary lesions, lesion localization on the left anterior descending artery (aHR 3.13, 95%CI 1.31-7.51, P=0.010) and IDDM (aHR 2.47 95% CI 1.29-4.73, p=0.006) were associated with increased risk of VOCE after adjustment for clinical confounders. Conclusion Patients with non-IDDM and coronary lesions assessed with coronary physiology demonstrated low risk of VOCE at long-term follow up, similar to the risk of patients without DM. Conversely, IDDM represents a subgroup at high-risk of vessel-related adverse events and require close monitoring at follow up, even in presence of non-ischemic findings at coronary functional assessment.Overall cohortDeferred cohort