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After percutaneous coronary intervention, patients with diabetes mellitus have higher risk of death, restenosis, and stent thrombosis compared to non-diabetic patients. We hereby report the clinical outcomes of the Abluminus DES+™, which has unique fusion coating technology, merging the properties of a sirolimus-coated balloon with those of a bioresorbable-polymer DES in diabetic patients.
Two thousand three hundred seventy-two patients were enrolled in the en-ABL e-registry, 817 patients suffered from diabetes mellitus (DM), 128 of them being insulin-dependent (IDDM). The primary and secondary endpoints were major adverse cardiac events (MACE), composite of cardiac death, target vessel myocardial infarction (TV-MI), or target lesion/vessel revascularization (TLR/TVR) and stent thrombosis (ST) at 1 year, respectively.
At 1 year, 83.56% of the patients were available for follow-up. Five patients (0.21%) were lost at follow-up. Clinical follow-up of remaining patients is yet to come. The event characteristics are shown in Table 1. The reported MACE rates at 1 year were 3.31% in DM group and 2.33% in non-DM group; (p= 0.198). In the DM group, the MACE rate in patients with IDDM was numerically but not statistically higher than in the non-IDDM subgroup (5.10% vs. 2.73%; p=0.209). The rate of ST at 1 year was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM.
|%||DM N=695*||NO-DM N=1287*||P||IDDM N=98*||Non-IDDM N= 597*||P|
The overall performance of PCI in the treatment of patients with DM is still an unmet clinical need. The Novel Abluminus DES+ performed well in patients with DM, perhaps consistently with patients without DM. Patients with DM, particularly those with IDDM, had worse but not significantly different outcomes compared to non-IDDM. These results, to the best of our knowledge, are unprecedented with other second-/third-generation DES.