Control of diabetes mellitus and the risk of neointimal hyperplasia after percutaneous coronary intervention: Post-hoc analysis from the BLADE-PCI trial

Background and aims: Diabetes-mellitus (DM) is associated with increased risk of neointimal hyperplasia (NIH) and restenosis after percutaneous coronary intervention (PCI). We examined a possible association of DM severity at the time of PCI with the development of NIH. Methods: This post-hoc analysis from the BLADE-PCI randomized, multi-center trial included only patients with DM and baseline data of HbA1c within 14 days prior to the index PCI. All patients were treated with zotarolimus-eluting stents. The primary endpoint was percent of NIH volume at 9 months as evaluated by optical coherence tomography. This endpoint was compared between patients with uncontrolled DM (HbA1c ≥ 7.5%) and controlled DM (HbA1c <7.5%) at the index PCI. Results: The mean percentages of NIH volume were 16.5% ± 9.9 and 12.75% ± 7.9 among patients with baseline HbA1c ≥ 7.5% (n = 74) and <7.5% (n = 102), respectively (p < 0.05). In multivariable analysis, HbA1c ≥ 7.5% was not associated with higher risk of NIH development [95% CI; 2.2 (−0.8, 5.3; p = 0.15)]. Higher HbA1c was not associated with increased risk of NIH at the minimum lumen area site [95% CI; 0.9 (−5.0, 6.7); p = 0.77) or percent stent strut coverage [95% CI; −0.3 (−1.3, 0.6); p = 0.45]. Secondary clinical endpoints including major adverse cardiac and cerebrovascular events, target lesion failure and death were similar between patients with worse and better DM control. Conclusions: Uncontrolled DM at the time of PCI performed with contemporary drug-eluting stents was not associated with an increased risk of NIH development.