Clinical and angiographic follow-up after coronary drug-eluting and bare metal stent implantation. Do drug-eluting stents hold the promise?

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Abstract

Objectives

To investigate the influence of drug-eluting stent (DES) implantation on clinical and angiographic restenosis.

Design

Registry study of data from the Swedish Coronary Angiography and Angioplasty Registry with a coronary angiographic substudy.

Setting

Multi-centre study.

Subjects

During October 2002 to May 2004 a total of 23 590 percutaneous coronary intervention (PCI) procedures were performed at 25 hospitals. After selection, to achieve comparable groups, a total of 5068 patients of whom 4111 had a bare metal stent (BMS) implanted and 957 had a DES implanted, remained. End-point in the registry follow-up was >50% diameter restenosis at clinically driven reangiography within 12 months after index PCI. The primary end-point in the angiographic substudy was late loss in patients' DES at 6-month angiographic follow-up.

Results

The rate of clinically driven restenosis, within 12 months, in patients receiving DES was less (3.9%) compared with those who received BMS (7.0%). In multivariate analysis the risk of clinical restenosis was one-third for DES compared with BMS (HR 0.36, 95% CI 0.25–0.52). In the angiographic substudy late loss was 0.07 ± 0.53 mm (range −0.88 to 1.62). The amount of late loss was related to the presence of diabetes mellitus or not (0.19 ± 0.45 mm vs. −0.12 ± 0.58 mm), and lack of postdilatation of the stent or not (0.23 ± 0.51 mm vs. −0.09 ± 0.50 mm).

Conclusions

The use of DES in the Swedish ‘real world’ is effective in reducing the clinically driven restenosis rate, when compared with patients with BMS treatment. In the angiographic follow-up the average late loss was as low as observed in recent randomized multi-centre trials.

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