FDA Advisory Panel on the Safety and Efficacy of Drug‐Eluting Stents: Summary of Findings and Recommendations

Efetividade e segurança dos stents farmacológicos em um serviço de cardiologia em Curitiba-PR

“…Thus, this procedure has been verified to be well accepted by the scientific community, except for the cases of high-risk patients with more complex lesions, as was recently established by the Food and Drug Administration (FDA) 10 in a consensus for the use of drug-eluting stents. According to this consensus for the indications of DES, the lesions are classified as on-label, which include short lesions, de novo lesions, and arteries with greater diameter; and as off-label, which include long lesions, small-diameter arteries, venous or arterial grafts, …”

Selection of Patients for Drug-Eluting Stents Based on Insurance Coverage

“…The percentage of DES usage dropped rapidly starting in the third quarter of 2006 (15). The U.S. Food and Drug Administration convened an advisory committee that supported the DES as safe, but did recommend that DAPT be continued for 1 year in complex lesions (off-label usage) (16). This early alert led to a chaotic situation in which physicians became aware that critical data were lacking.…”

Diagnosis and Evaluation of Stent Thrombosis with Optical Coherence Tomography

“…Therefore, the US Food and Drug Administration finally concluded with an advisory suggesting that DES were associated with an higher late incidence of ST compared with BMS, but they were recognized as safe and effective when used for on-label indications. 25 Second-generation DES, with advanced stent design features such as thinner struts and more compatible biopolymer or bioabsorbable polymers, have been effective at reducing the incidence of ST. Second-generation DES, especially cobalt-chromium alloy everolimus eluting stents have undergone extensive investigation in clinical randomized trials and real-world registries. 26,27 Direct comparison between the different types of second-generation DES, firstgeneration DES, and BMS is challenging, especially considering the wide range of indications for stent implantation (from stable coronary disease to acute coronary syndromes).…”

“…76 Similarly, in a study using propensity score-matched analysis, patients undergoing IVUS-guided DES implantation had lower definite ST at 30 days and 12 months compared with those who had not received IVUS guidance. 25 Especially in complex lesions, intravascular imaging used for PCI guidance through the different procedural steps (ie, before the intervention, before stenting, and after stent deployment) might be effective to minimize ST.…”