Background: Percutaneous interventions in saphenous vein grafts (SVG) result in lower rates of angiographic success and higher risk of complications, due to the increased risk of embolization of debris from the friable atherosclerotic plaque. With the advent of distal protection devices, improvements in efficacy and safety were achieved in the procedure. Our objective was to compare the MGuard TM and SESAME TM stents, dedicated for SVG treatment, during the first 30 days of follow up. Methods: This is a retrospective study comparing angiographic and ultra-sonographic variables and clinical events within 30 days in patients with SVG lesions treated with MGuard TM balloon-expandable stents (n = 11) vs. SESAME TM self-expandable stents (n = 14). Results: Patients treated with MGuard TM and SESAME TM stents had similar clinical profiles (mean age 69 years; male gender, 72%; diabetic, 28%; treated for acute coronary syndrome, 44%), equivalent age of aortocoronary venous grafts (9.7 ± 6.2 years vs. 10.1 ± 3.2 years; p = 0.80) and SGV with the same degree of atherosclerotic impairment. Post-procedure angiographic success was reached in all cases, however with a tendency towards better stent expansion in the MGuard TM group (87% vs. 68%; p = 0.08). Over the 30-day clinical follow-up, patients treated with the SESAME TM stent had higher frequency of major cardiac events (two cases of non-Q myocardial infarction RESUMO Fundamento: As intervenções percutâneas em pontes de safena (PS) apresentam menores taxas de sucesso angiográfico e maior risco de complicações, pelo risco aumentado de embolização dos fragmentos da placa aterosclerótica friável. Com o advento dos dispositivos de proteção distal, observou-se maior eficácia e segurança do procedimento. Nosso objetivo foi comparar os stents MGuard ® e SESAME ® , dedicados ao tratamento de PS, nos primeiros 30 dias de evolução. Método: Estudo retrospectivo, comparando as variáveis angiográficas e ultra-sonográficas e a evolução clínica aos 30 dias de pacientes portadores de lesões em PS tratados com stent balão-expansível MGuard ® (n = 11) vs. stent auto-expansível SESAME ® (n = 14). Resultados: Os pacientes tratados com stents MGuard ® e SESAME ® demonstraram perfis clínicos superponíveis (média de idade, 69 anos; sexo masculino, 72%; diabéticos, 28%; tratados na vigência de síndrome coronária aguda, 44%), idade dos enxertos venosos aortocoronários equivalentes (9,7 ± 6,2 anos vs. 10,1 ± 3,2 anos; p = 0,80) e PS com o mesmo grau de acometimento aterosclerótico. O sucesso angiográfico pós-procedimento foi alcançado em todos os casos, porém com tendência a melhor expansão do stent no grupo MGuard ® (87% vs. 68%; p = 0,08). No seguimento clínico de 30 dias, os pacientes tratados com stent SESAME ® apresentaram maior freqüência de eventos cardíacos maiores (dois casos de infarto do miocárdio não-Q e um caso de revascularização do vaso-alvo), comparativamente a nenhum evento no grupo MGuard ® . Conclusões: Nessa análise retrospectiva de pequena série de pacientes pré-selecionados d...

SUMMARY Safety and Efficacy of a Novel Stent System with a Protection Net to Prevent Distal Embolization: Preliminary Results of the INSPIRE TrialBackground: Disturbances in coronary flow due to embolization of thrombus/atheroma fragments are associated with poor prognosis after percutaneous coronary intervention (PCI). Lesions in saphenous vein grafts (SVG) and acute coronary syndromes (ACS) are typically associated with these complications. Although embolic protection devices have shown to reduce the incidence of such complications, they add time and costs to the procedure, and their use is limited to SVG. The newly developed MGuard™ stent combines a microscopic net connected to the struts of a bare metal stent, characterizing this new low-profile device. Objective: To evaluate safety and efficacy of the novel MGuard™ stent system through clinical and angiographic outcomes. Methods: Single-center study including 19 patients with de novo lesions in SVG or with unstable lesions in native vessels as evidenced by angiography. Primary end point included 30-day incidence of major adverse cardiac events (MACE). Results: ACS was the clinical presentation in 60% of cases, and in 55% of the patients the lesion was in a SVG. The MGuard™ stent was successfully delivered in all cases, reaching TIMI 3/blush 3 flow at the end of all procedures. There were no cases of angiographic complications, CK-MB elevations > 3x the reference values after PCI, or MACE at 30 day-follow-up. Conclusion: In this preliminary evaluation, the MGuard™ stent showed high efficacy in a group of patients with highly complex angiographic profile (without the use of adjunctive embolic protection devices). Six-month angiographic follow-up and a larger cohort of patients are necessary to corroborate these results.