"The Caveats of Drugs-Eluting Stents": a critical appraisal of the safety Concerns

Coronary heart disease has been the leading cause of death in developed countries for many years. At the same time, the developments in the field of interventional cardiology occurred at an incredible speed and it took no more than 15 years for the first balloon-mounted stent by Palmaz et al. in 1985 to evolve into a modern first generation drug-eluti ng stent (DES). As early as 1999, stenting comprised 84.2% of percutaneous coronary interventions (PCI). In the same year, several preclinical studies reported that sirolimus (rapamycin), a macrocyclic lactone that inhibits cytokine-mediated and growth-factor–mediated proliferation of lymphocytes and smooth-muscle cells, reduced neointimal proliferation (i.e. renarrowing of the vascular lumen at the site of stent implantation, leading to recurrence of angina - the largest limitation of stenting thus far). In 2002, the first DES, coated with sirolimus, were introduced into clinical practice in order to reduce restenosis which occurred in 15% to 25% of patients receiving bare-metal stents.6, 7 Subsequent trials with different types of DES confirmed their efficacy in this regard.8 In 2002, the pivotal RAVEL trial reported that none of the patients in the sirolimus-stent group, as compared with 26.6% of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001).

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