Author + information
- Dinesh Shah1,
- Sameer Dani2,
- Keyur Parikh3,
- Prathap Kumar N. Pillai4,
- Ranjan Shetty5 and
- Jagdish Hiremath6
Patients with diabetes mellitus (DM) have worse clinical outcomes after percutaneous coronary intervention as compared with their non-diabetic counter parts. We sought to assess the efficacy of Magictouch sirolimus-coated balloons (SCB) (Concept Medical) in diabetic patients with stenosis in atherosclerosis in coronary arteries.
The NANOLUTE registry is a prospective, multi-centre, non-randomized, all-comers registry evaluating the safety and performance of sirolimus-coated balloons (SCB) in patients under real-world conditions with treatment according to standard of care. The major study endpoint encompassed MACE (major adverse cardiac events) at 12 months. MACE is defined as a composite of target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiac death.
A total 438 patients were enrolled in the NANOLUTE study. One hundred ninety-four (44.29%) patients had a diagnosis of DM, while 244 (55.70%) patients had no documented history of DM. Patients with diabetes were more frequently treated for hypertension (67.01% vs. 31.96%, p<0.001). MACE characteristics are depicted in Figure 1. At 1-year follow up, the incidence of MACE was reported as 4.49% vs. 4.19, p=0.881 for both groups. The MACE rate in both the groups was mainly propelled by TLR. There was no statistically significant difference between both the DM and non-DM cohorts.
The present study demonstrated that diabetes does not appear to have a negative impact on the efficacy of SCB in coronary stenosis. The use of SCB is associated with good clinical outcomes at 1 year without significant difference between the cohorts.