Since the first percutaneous balloon angioplasty was performed in 1977,1 significant advances have been made in the percutaneous treatment of coronary artery disease. The development of bare-metal stents addressed the issue of acute vessel closure. Although bare-metal stents prevented elastic recoil and constrictive remodeling, high rates of in-stent restenosis remained due to significant neointimal hyperplasia.2,3 This prompted the development of drug-eluting stents (DES), which were able to reduce the incidence of in-stent restenosis with the addition of antiproliferative drugs to the stent platform, thereby reducing the occurrence of neointimal hyperplasia.4-6 However, safety issues were raised with the first generation of DES when a new entity of late stent thrombosis became a significant problem, with a risk of 0.6% per year.7 Second-generation DES, with more biocompatible antiproliferative drugs and thinner struts/improved designs were able to significantly decrease the incidence of major adverse cardiac events and late stent thrombosis.8-10 However, the presence of any permanent endoprosthesis has led to other consequences: decreased vasoreactivity/impaired physiology of the artery, prevention of positive remodeling, obstruction of the side branch by stent struts, impaired imaging of the lesion with CT or MRI, and inability to insert a coronary bypass graft at the site that a stent was implanted.11 These limitations led to the development of bioresorbable scaffolds (BRS; Table 1), which would theoretically allow for the benefits of transient scaffold support by preventing acute vessel recoil/closure, but overcome the limitations of metallic stents such as impaired vasomotor response and late stent thrombosis, while facilitating repeat treatments of the lesion site.11
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Ideal BRS: Poly Salicylic Acid Stent
The Ideal BRS (Xenogenics Corporation) is made of polylactide anhydride mixed with a polymer of salicylic acid and sebacic acid (Figure 1). It is coated with sirolimus (8.3 mg/mm) and salicylate, which controls the release of sirolimus. The first-in-man study, WHISPER FIM trial (N = 11) reported suboptimal results secondary to neointimal hyperplasia.25 It was hypothesized that a suboptimal timing/rapid release of sirolimus was responsible for the negligible suppression of neointimal proliferation. A new generation of the Ideal stent with a better profile and optimized sirolimus dose-release kinetics is in preclinical studies.
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CONCLUSION Numerous other bioresorbable vascular scaffolds are currently in development. We have presented only the platforms for which in-human results are available.32 The quest for a temporary scaffold that could disappear and restore normal vascular function, as well as eliminate the risk of late stent thrombosis while providing deliverability and vessel support as good as the one provided with the current DES will continue for the next several years. If pending current and future investigations provide long-term safety and efficacy results, such devices could eventually contribute to moving interventional cardiology toward the field of preventive interventions, thereby addressing the important issue of vulnerable plaques before they manifest as an acute coronary syndrome.
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