Long-term clinical safety and efficacy of drug-eluting stents in real-world patients

Since the fi rst balloon angioplasty was performed in the late 1970’s, percutaneous coronary intervention (PCI) has undergone rapid transformation to become an essential treatment option for coronary artery disease as an alternative to surgery. PCI is now widely accepted across the globe, with over half a million procedures being performed annually in the United States alone. Coronary stents were developed in the mid-1980s, and the fi rst randomized trials comparing stenting to balloon angioplasty demonstrated improved angiographic and clinical outcomes. Consequently, coronary artery stenting has progressively replaced balloon angioplasty as the preferred method of PCI. In these initial trials, acute stent thrombosis was a major concern because of high morbidity and mortality. The introduction of dual-antiplatelet therapy with aspirin and a thienopyridine (such as Clopidogrel) as well as improved PCI techniques, decreased the risk of thrombosis to an acceptable level, although the incidence of stent thrombosis remained higher when bare metal stents (BMS) were placed in more complex patients and lesions. Subsequently, the development of in-stent restenosis emerged as the main clinical problem with BMS with reported rates varying between 15% to 60% depending on patient co-morbidity, including vessel size, and lesion complexity. The widespread adoption of drug-eluting stents (DES) has reduced the rates of restenosis by 60-75% across all lesion and patient subsets. The success of DES is refl ected by the fact that they were quickly embraced by the entire interventional cardiology community as the ultimate approach to prevent restenosis. In the years since their approval, DES have become the predominant devices used in PCI, regardless of indication. For example, up to December 2006, more than 2 million patients had received the Cypher sirolimus-eluting stent (SES) worldwide.

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