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• W4256178047 abstract "As we celebrate the 30th anniversary of the first coronary balloon angioplasty, performed by Andreas Grüntzig in September 1977, we are seeing significant innovation and evolution in the devices and pharmacotherapy available for catheter-based percutaneous coronary intervention. One of the major breakthroughs after the balloon was the introduction of the coronary bare metal stent (BMS), which optimized balloon angioplasty results by eliminating acute and late recoil, tackling dissections, and reducing overall restenosis rates. The BMS, however, was associated with 2 major limitations: subacute stent thrombosis and in-stent restenosis. The refinement of stent deployment techniques guided by intravascular ultrasound (IVUS), including postimplantation high-pressure balloon dilation, and recent developments in pharmacotherapy, including antiplatelet therapy, have helped significantly reduce stent thrombosis rates to <1%. In-stent restenosis, however, has remained a serious limitation of the technology, especially in complex subsets of patients and lesions. The main mechanism of BMS in-stent restenosis is the formation of neointima, which has been the subject of research for nearly a decade. Vascular brachytherapy was introduced to treat in-stent restenosis by inhibiting the cell cycle and limiting proliferation. The sought-after ideal outcome, however, is to eliminate the occurrence of BMS restenosis or at least to significantly minimize its incidence. Drug-eluting stents (DESs) were developed to inhibit the postimplantation proliferation of neointima by the administration and controlled release of antiproliferative agents, such as sirolimus and its analogs (everolimus, zotarolimus, Biolimus A9 [Biosensors International Pte Ltd., Singapore]) and paclitaxel, from a polymer-based coating. On the basis of randomized clinical trials that demonstrated the superiority of DESs over BMSs, marketing approval for these stents was granted by the regulatory agencies in Europe in 2002 and by the US Food and Drug Administration (FDA) in 2003. The introduction and dissemination of the technology occurred at a brisk pace, with usage rates increasing up to 90% within a few months after the FDA approvals. To date, nearly 7 million DESs have been implanted, greatly reducing the need for repeat revascularization of coronary patients. Although DESs effectively reduce the rate of restenosis and the need for repeat revascularization, they have been found to be associated with the new phenomenon of very late stent thrombosis, and their use now consequently entails prolonged dual-antiplatelet therapy. Late and very late stent thrombosis are associated with severe consequences, such as mortality and massive myocardial infarction. With the spread of these major safety concerns, the DES usage rate in the United States has been reduced to <65%. In Europe, the procedural penetration of the DES does not exceed 50%. The safety of the DES has thus become a priority issue for regulatory agencies, scientists, physicians, patients, and the press. The current consensus is that DES thrombosis is multifactorial and that a safer DES is desirable and achievable. This special supplement to The American Journal of Cardiology is dedicated to discussion of the safety aspects of DES and to description of the research-and-development program for the Endeavor zotarolimus-eluting stent (Medtronic Vascular, Santa Rosa, CA), which is already approved in Europe and for which FDA approval is anticipated by the end of 2007. On behalf of all of the leading experts in interventional cardiology featured in these pages, it is my pleasure to introduce this array of outstanding reports addressing the key questions related to the safety of DESs. What are the design criteria for that ideal, safer, next-generation DES? What are the mechanisms contributing to DES thrombosis, and what are the consequences? What does the latest research tell us about postimplantation dual-antiplatelet therapy? What great range of information about the features and parameters of DES deployment is discoverable by IVUS? Besides respectful answers to these questions, you will find here an interesting summary of the testing of different DES programs in animal models. Then, in a series of reports, the broad Endeavor zotarolimus-eluting stent program is surveyed and viewed in detail: preclinical and clinical evaluation programs, specifics on long-term clinical results, angiographic and IVUS data, and ongoing and future trials. I wish to thank these contributors for their hard work and dedication in presenting the data objectively and accurately. With regard to the safety of DESs in general and the specifics of the Endeavor program, I trust that the information presented will prove useful, educational, and interesting. The author who contributed to this article has disclosed the following industry relationship. Ron Waksman, MD, is a member of the Speakers Bureau for Medtronic, Inc., Boston Scientific, and BIOTRONIK; has served as a consultant for BIOTRONIK; has served as an advisory board member for Medtronic, Inc., Boston Scientific, and BIOTRONIK; and has received research/grant support from Boston Scientific and BIOTRONIK." @default.
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• W4256178047 date "2007-10-01" @default.
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• W4256178047 title "Introduction" @default.
• W4256178047 doi "https://doi.org/10.1016/j.amjcard.2007.08.015" @default.
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