Comparison of Cypher Select and Taxus Express Coronary Stents

Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.

Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.

Design:

• Randomized open multicentre trial.

Patients:

• 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.

Inclusion criteria:

• Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.
• Signed informed consent.

Exclusion criteria:

• Participation in other stent studies.

Randomization:

• Implantation of Taxus Express og Cypher Select stents.

Primary end-point:

• Combined end-point of cardiac death, new revascularization (PCI or CABG) or myocardial infarction after nine months.

Secondary end-points:

• Total death after nine months
• Cardiac death after nine months
• Myocardial infarction after nine months
• Index vessel myocardial infarction after nine months
• Target lesion revascularization
• Target vessel revascularization
• Stent thrombosis after nine months

End-point evaluation:

• End-points will be adjudicated by an independent end-point committee

Inclusion Criteria:

• Planned implantation of drug eluting stent
• Written informed consent

Exclusion Criteria:

• Planned intervention with other stents than study stents