Aim of this registry was to compare the long-term (up to 7 years) clinical outcomes after implantation of the Supralimus-Core; ultrathin-strut (60 µm), biodegradable polymer coated
sirolimus-eluting stent (SES); in diabetic and non-diabetic patients.
METHODS AND RESULTS:
We conducted a retrospective, singe-arm, open-label, multicenter registry of 517 patients, who had treated exclusively with the Supralimus-Core SES (Sahajanand Medical Technologies Pvt. Ltd.,
Surat, India), between April-2008 and May-2015 at two centers in Saudi Arabia. Of these, 279 patients were diabetic, whereas 238 had non-diabetic. The primary endpoint was long-term (up to 7 years)
combined major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR)/ coronary artery
bypass graft (CABG) and stent thrombosis; according to ARC definitions. A total of 517 patients [279 (54.0%) diabetic patients and 238 (46.0%) non-diabetic patients], with mean age of
55.0±10.2 years, were evaluated in this registry. Diabetic patients had a higher prevalence of arterial hypertension (59.5% vs. 39.9%, p<0.001), hyperlipidemia (71.7% vs. 40.8%,
p<0.001) and unstable angina (40.9% vs. 29.8%, p=0.009) compare to non-diabetic patients. There were no significant differences in lesion complexity like long lesions (≥30mm), bifurcation
lesions, calcified lesions, restenotic lesions, and total occlusion between diabetic and non-diabetic patients. A median follow-up of 5.6 years; interquartile range: 3 to 7 years was achieved in
95.6% of patients (494/517) and during follow-up, the cumulative incidence of MACE in patients with diabetes was comparable to that of non-diabetics [46 (17.2%) vs. 29 (12.8%), p=0.169]. Diabetic
patients had higher risks of cardiac death [25 (9.4%) vs. 9 (4.0%), p=0.018] during follow-up compared with non-diabetic patients. However, the rates of TLR [15 (5.6%) vs. 15 (6.6%), p=0.656] and
TVR/CABG [4 (1.5%) vs. 5 (2.2%), p=0.560] were not significantly different between diabetic and non-diabetic patients during follow-up. Also, there was no difference in stent thrombosis between
diabetic and non-diabetic patients [2 (0.7%) vs. 0 (0), p=0.502)].
Despite complex lesion morphology, this registry demonstrates satisfactory and sustained long-term clinical outcomes as evidenced by the low rates of MACE, for the Supralimus-Core SES, in diabetic
and non-diabetic patients.