Project Description

 
 

Diabetes has always adversely affected the outcome of percutaneous coronary intervention (PCI) first angioplasty and then later stenting. Patients with diabetes mellitus are known to have a higher adverse event rate after PCI and stenting compared with those without diabetes. This is mainly due to increased restenosis and subsequent need for repeat revascularization. Patients with diabetes have often smaller diameter vessels and diffuse disease. This deadly triad (diabetes, small vessel size and diffuse disease) leads to higher restenosis and perhaps worse outcomes compared with CABG surgery.

Drug eluting stents have reduced the restenosis and the need for repeat revascularization. However diabetes remains a risk-factor for restenosis with drug eluting stents. The number of patients with diabetes in randomized trials of drug eluting stents are relatively low.  Since these trials were primarily conducted for regulatory approval, single de-novo focal lesions were treated. Thus the complex disease in diabetics was not studied extensively.  Finally, the impact of diabetes treatment mode (insulin requiring versus non-insulin requiring) on clinical outcomes following drug eluting stents remains unknown. In a real world registry of drug eluting stents in diabetic patients there was only a 23% reduction in major adverse cardiac events compared with bare metal stents, less than that is reported in randomized pivotal trials. Presence of small vessel disease in diabetics may perhaps cause an additive effect on restenosis following drug eluting stents.

In a comprehensive meta-analysis of all studies with DES in diabetics, Mahmud et al. found single digit revascularization rates and average major adverse cardiac event (MACE) rates of 12% with the Paclitaxel eluting stents. The sub-set of diabetic patients with small vessels studied in trials remains very low. In the small vessel sub-set of the SIRTAX study there were only 35 patients with diabetes with small vessels treated with Paclitaxel eluting Taxus stent. At the TCT 2009 the results of SPIRIT IV study comparing Everolimus eluting stent (Xience/Promus) were compared with the older first generation Paclitaxel eluting Taxus Express stent. In the diabetic sub-group there were 1140 patients, and there was no difference in the primary end point (target lesion failure) between the Paclitaxel or the Everolimus eluting stents 6.9% vs. 6.4%, P= 0.80. Thus in diabetic patients there was equivalent efficacy for both stents.

Saudi Arabia has a unique population with a very high incidence of diabetes. Twenty-four percent of the adult population is diabetic and a further sixteen percent have an impaired glucose tolerance test. The Taxus Olympia Phase I study, in which a significant number of patients were recruited from this region, had a high 50% of incidence of diabetes. Therefore this offers a fertile ground for study of drug eluting stents in this high risk patient and vessel subset.

 

Study Design

Prospective, multi-center, observational registry.

The study is designed to be non experimental: all enrolled patients should be treated according to the current routine hospital practice and standards of care.

Study stent

Paclitaxel eluting Taxus Element stent (Boston Scientific, Natick, Massachusetts) CE marked.

Randomized controlled study presented.

Patient population

Patients with diabetes mellitus suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions

Number of Centers and Patients

Up to 750 patients will be enrolled at centers where Taxus Element is available in Middle-East, Africa, and Asia.

Centers are allowed to enrol a maximum of number of allotted patients per center or until study enrolment has been completed, whichever comes first. The center's clinical investigation plan compliance will be assessed on an ongoing basis.

In case of serious non-compliance, the Steering Committee may decide to stop patient enrolment in a center based on its assessment.

Follow-up

Clinical follow-up at 6 months, 12 months, 18 months and at 2 years.

 

 

 

   
 
 

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