Which stent should be regarded as the gold standard for treatment of coronary artery stenoses? Danish randomised multicentre comparison of implantation of the Palmaz-Schatz and the NIR stent - Rationale, design and protocol of the DANSTENT study

Coronary stenting using the first-generation Palmaz-Schatz stent in patients with ischaemic heart disease has proved efficient compared with balloon angioplasty. The objective of the DANSTENT study is to evaluate the clinical and angiographic outcome of implantation of a second-generation slotted-tube stent in coronary artery lesions. The DANSTENT study is a randomised multicentre trial comparing procedural success, clinical outcome and angiographic determination of the minimal lumen diameter and frequency of restenosis in the target vessel 6 months after implantation of a 15-mm Palmaz-Schatz or a 16-mm second-generation rigid-flex NIR stent. Both stents are hand-crimped onto balloons and deployed at high pressure. All angiograms will be evaluated by a core laboratory. The relationship between polymorphism of the angiotensin-converting enzyme gene and the occurrence of coronary restenosis will also be investigated. More than 450 patients will be included in the study, which will determine the level of coronary restenosis at 6-month follow-up and the clinical outcome 6 and 12 months after implantation of the stents. Sub-study analyses will evaluate possible differences between the two groups with regard to the size of the target vessel and total number of coronary occlusions.