Safety and efficacy of a second-generation coronary sirolimus-eluting stent with biodegradable polymers in daily clinical practice: a 12-month follow-up of the ALEX registry

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Abstract

Background

Second-generation drug-eluting stents (DESs) have shown higher safety and efficacy compared with first-generation DESs. This effect was achieved by improving biocompatibility using an interalia cobalt–chromium construction, thinner stent struts and biodegradable polymers.

Objectives

To assess clinical and angiographic outcomes of patients receiving a novel second-generation cobalt–chromium sirolimus-eluting stent.

Materials and methods

A total of 424 consecutive patients who received an Alex stent were enrolled in the registry from January to December 2012. The primary outcome measure was the occurrence of 12-month major cardiac adverse events, defined as cases of death, nonfatal myocardial infarction and target lesion revascularization. Quantitative coronary angiography for 240 randomly selected patients was performed by an independent Corelab.

Results

The primary endpoint occurred in 31 of 424 patients (7.3%). The rates of death, nonfatal myocardial infarction and target lesion revascularization were 3.3, 2.6 and 3.5%, respectively. According to the definition established by the Academic Research Foundation, definitive and probable stent thrombosis (ST) occurred in 1.6% (7/424) of patients, including six cases of early ST and one case of late ST. The acute device success rate was 98.5%.

Conclusion

The ALEX Registry provides evidence for the safety and effectiveness of the study device in a relevant population. Quantitative analysis showed a satisfactory performance of the study device for complex coronary lesions. The 12-month rates of major cardiac adverse event and ST were similar to those of other second-generation DES registries.

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