Paclitaxel eluting stents are safe and effective in diabetic patients compared to bare metal stents

February 12, 2008 By Vijayalakshmi Kunadian MBBS MD MRCP [mailto:vkunadian@perfuse.org]

New York: Researchers from the TAXUS drug eluting stent studies have demonstrated that paclitaxel eluting coronary stents are safe and effective compared to bare metal stents among diabetic patients.

Recent studies have demonstrated the relative safety and efficacy of drug eluting stents including off label uses compared to bare metal stents. Diabetic patients are at risk of restenosis. A comparison between the use of sirolimus eluting stents and bare metal stents has previously been published. In the latest issue of JACC, Kirtane and colleagues performed an analysis of 5 randomized, double blind TAXUS trials (TAXUS I, II, IV, V and VI) to compare the use of paclitaxel eluting stents (PES) and bare metal stents (BMS) [both Boston Scientific, Natick, Massachusetts], among diabetic patients (see link below).

This analysis consisted of 3513 patients. Of these 827 patients had diabetes mellitus with single de novo coronary lesions and stable ischemic syndromes. Follow-up results were available for up to 4 years.

Among diabetic patients, compared to BMS, PES was associated with significant reduction in the incidence of target lesion revascularization (12.4% vs. 24.7%, p<0.0001). There were no differences in the incidence of death (8.4% vs. 10.3%, p=0.61), myocardial infarction (6.9% versus 8.9%, p=0.17) and stent thrombosis (1.4% versus 1.2%, p=0.92) between the PES and BMS groups.

The investigators also analyzed diabetic and non diabetic population. Compared to the non diabetic patients, diabetic patients had smaller vessels (p<0.001), long lesions (p=0.002), more stents (p=0.001) and longer overall stent length (p=0.002). In the overall study population, the incidence of TLR (18.6% versus 14.1%, p=0.005), TVR (27.3% vs. 19.2% p<0.001) and death (9.4% vs. 5.5% p<0.001) was significantly greater in the diabetics compared to the non-diabetics. On the other hand, there was no difference in the incidence of myocardial infarction (7.9% vs. 6.3% p=0.13) and stent thrombosis (1.3% vs. 1% p=0.63) rates among the diabetic and non diabetic patients in the overall patient population.

The use of PES significantly reduced the incidence of TLR and TVR among the diabetic and non diabetic patients without significantly influencing the occurrence of death, myocardial infarction and stent thrombosis. The investigators also performed an analysis on patients with insulin dependent diabetes mellitus and non-insulin dependent diabetes mellitus and demonstrated similar safety and efficacy between the two diabetic groups.

This study demonstrates that the use of PES in single de novo lesions among diabetic and non diabetic patients with stable ischemic coronary syndromes is associated significant reduction in the occurrence of target lesion revascularization. This was not associated with an increase in the incidence of death, myocardial infarction and stent thrombosis with the use of PES. These benefits were seen in patients who do and do not require insulin therapy.

The investigators note that the present study is limited by the fact that this included select group of patients with de novo single vessel disease. Results are awaited from large randomized trials which are underway comparing the use of drug eluting stents and coronary artery bypass surgery among diabetic patients with severe three vessel coronary artery disease.

Reference
http://content.onlinejacc.org/cgi/content/abstract/51/7/708