Escolha do melhor stent na atualidade / Selecting the best drug-eluting stent

RESUMO

Desde 2002, estão disponíveis, para uso clínico, no Brasil e em vários países do mundo, os stents com liberação de sirolimus (Cypher) e de paclitaxel (Taxus). Esses instrumentais, foram primeiramente testados, em nosso Serviço, em pacientes que constituíam o registro FIM (First in Man), cujas avaliações sequenciais de 4 meses, 12 meses, 24 meses e 48 meses foram de grande impacto, pela observação da importante e mantida redução da reestenose na evolução tardia. O stent liberador de paclitaxel (Taxus) foi introduzido no mercado cerca de um ano após, mostrando, igualmente, bons resultados clínicos e excelente aceitação por parte dos intervencionistas. Até o momento, dispomos de seis estudos comparativos entre Cypber e Taxus (TAXI, REALITY, SIRTAX, CORPAL, ISAR-DESIRE), cujos resultados foram divulgados a partir de setembro de 2004. Desses estudos, os dois que recrutaram o maior número de casos foram o REALITY (n igual 1.353; 1.911 lesões) e o SIRTAX (n igual 1.012; 1.601 lesões). O stent com sirolimus produz maior inibição da hiperplasia...

ABSTRACT

Drug-eluting stents (DES) were first clinically and market approved in Brazil in 2002. Sirolimus-eluting stent (Cypher®) was initially tested in our service and the first patients to receive this new device were enrolled in the FIM (First in Man) registry. The sequential angiographic follow-up studies of this population (4, 12, 24 and 48 months) were determinant to demonstrate the sustained long term reduction in restenosis rates. Paclitaxel-eluting stent (Taxus®) was commercially approved one year later after equally encouraging preliminary clinical results and excellent acceptance from the interventionists. To the present there are six “head-to-head” studies comparing Cypher® to Taxus®: TAXI, REALITY, SIRTAX, CORPAL, ISAR-DIABETES and ISAR-DESIRE. Their preliminary results started to be released in September 2004. Two of these studies deserve special attention due to the large amount of patients enrolled: REALITY (1,353 patients, 1,911 lesions) and SIRTAX (1,012 patients, 1,601 lesions). Cypher® was shown to be more efficient than Taxus® in suppressing neointimal formation irrespective of the angiographic parameter analyzed: late minimal lumen diameter, percentage of stenosis, late lumen loss and net gain. However, in the REALITY study, this superiority did not translate into clinical benefit and both stents had equivalent angiographic restenosis (7.0% for Cypher® versus 8.3% for Taxus®; p = NS) and target-lesion revascularization (5.0% for Cypher® vs. 5.4% for Taxus®; p = NS). Conversely, in the SIRTAX, Cypher® proved to be significantly superior to Taxus® in reducing binary restenosis (6.7% vs. 11.9%; p = 0,01) and target-lesion revascularization (4.8% versus 8.3%; p = 0,01). The other four previously mentioned studies did not contribute with definite evidence of superiority of one over the other drug-eluting stents since they analyzed less complex populations (TAXI) or did not reflect the multicentric reality (ISAR-DIABETES, ISARDESIRE)...