Safety and Efficacy of Sirolimus-Eluting Stent in Diabetic Patients Compared with Non-Diabetic Patients Undergoing Percutaneous Coronary Intervention Pages 21-26
D. Rajasekhar1, V. Vanajakshamma1, Sarath Babu1, C. Sivasankara1, Bhavesh M. Khambhati 2 and Ashok S. Thakkar2
1Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh-517507, India; 2Sahajanand Medical Tech. Pvt. Ltd., Gujarat, India
DOI: http://dx.doi.org/10.12970/2311-052X.2014.02.01.5Download PDF
Abstract: Background: The research has been shown that the clinical outcomes of diabetic patients undergoing revascularization either coronary artery bypass grafting or percutaneous coronary intervention (PCI) are inferior to that of non-diabetic patients.
Objectives: We have carried out the registry to assess the clinical outcomes of the patients with diabetes mellitus (DM) compared to the patients without DM after the PCI with sirolimus-eluting stent.
Methods: Indolimus Diabetic registry is a single-centre; single-armed, retrospective registry that enrolled 530 patients who underwent PCI with Indolimus® stent at the Sri Venkateswara Institute of Medical Sciences, Tirupati, India during the study period. The endpoint of the registry was a major adverse cardiac event (MACE) defined as a composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave not clearly attributable to a non-target vessel), target lesion revascularization (TLR) and target vessel revascularization (TVR) and that were observed at 30-days and at 6-monthsfollow-up.
Results: Among 530 patients, 169 patients were having DM. It is noteworthy that the patients with DM were more often women (29.6% vs. 18.0%), hypertensive (54.4% vs. 34.1%) and higher incidence of revascularization (4.2% vs. 2.5%). Double vessel disease was more prevalent in diabetic population as compared to non-diabetics (37.9% vs. 24.9%). Total 617 lesions were encountered in 530 patients (202 in diabetic patients and 415 in non-diabetic patients). There was no significant difference observed in the lesion class. There was no statistical significant difference observed for cardiac death (1.8% vs. 1.7%, p=1.00) and MACE (1.8% vs. 1.9%, p=1.00) in diabetic and non-diabetic patients at 30-days follow-up. However, at 6-month follow-up, it has been observed that the occurrence of MACE was higher but not statistically significant in diabetic patients as compared to non-diabetic patients (4.1% vs. 2.5%, p=0.29).
Conclusions: In this Indolimus Diabetic registry, MACE rate did not significantly differ between diabetic and non-diabetic population at 30-days and at 6-months follow-up. However, long term follow-up is needed to determine whether a similar safety profile is maintained.
Keywords: Percutaneous coronary intervention, Diabetes, Drug eluting stent. Read more