A Pooled Analysis of Data Comparing Sirolimus-Eluting Stents with Bare-Metal Stents

Abstract

BackgroundAlthough randomized studies have shown a beneficial effect of drug-eluting stents in reducing the risk of repeated revascularization, these trials were underpowered to compare rates of death and myocardial infarction. The long-term safety of drug-eluting stents has been questioned recently. MethodsWe performed a pooled analysis of 1748 patients in four randomized trials evaluating the safety of sirolimus-eluting stents as compared with bare-metal stents. Patientlevel data were obtained and analyzed at independent statisticians at two academic institutions. The primary safety end point was survival at 4 years. We tested for heterogeneities in treatment effect in patient subgroups. ResultsThe survival rate at 4 years was 93.3% in the sirolimus-stent group, as compared with 94.6% in the bare-metal-stent group (hazard ratio for death, 1.24; 95% confidence interval [CI], 0.84 to 1.83; P = 0.28). In the 428 patients with diabetes, a significant difference in the survival rate was observed in favor of the bare-metal-stent group over the sirolimus-stent group (95.6% vs. 87.8%; hazard ratio for death in the sirolimus-stent group, 2.9; 95% CI, 1.38 to 6.10; P = 0.008). The lower survival rate among patients with diabetes who were treated with sirolimus-eluting stents was due to increased numbers of deaths from both cardiovascular and noncardiovascular causes. No difference in survival rate was detected among the patients without diabetes. Rates of myocardial infarction and stent thrombosis were similar in the two groups. ConclusionsIn a pooled analysis of data from four trials comparing sirolimus-eluting stents and bare-metal stents, no significant differences were found between the two treatments in rates of death, myocardial infarction, or stent thrombosis. (ClinicalTrials.gov numbers, NCT00233805, NCT00381420, NCT00232765, and NCT00235144.)The databases of the individual studies were obtained from Cordis. Study coordination and data management were performed at two independent central research organizations (Cardialysis, Rotterdam, the Netherlands, for RAVEL, and Harvard

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

“…Patients undergoing percutaneous angioplasty with drugeluting stent implantation have a more favorable outcome, with less need for repeat interventions in comparison to bare metal stents 8,9 . 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.…”

Fundamento e desenho do teste randomizado PAINT

“…Paclitaxel and sirolimus have been extensively proven to be efficacious in preventing restenosis when used in drug-eluting stent formulations [1][2][3][4] . However, it is clear that drug-eluting stents are complex biodevices that do not follow a "class effect" 14 .…”

“…It occurs as a consequence of an exacerbated healing process of the vessel wall triggered by the mechanical dilatation of the atherosclerotic lesion. Over the last years, drug-eluting stents (DES) have been proven effective in reducing restenosis and the need for subsequent revascularization [1][2][3][4] . Recently, however, the safety profile of drug-eluting stents have been questioned, especially with regards to the risk of stent thrombosis and thrombosis-related clinical events 5 .…”

Conflitos éticos e judiciais no emprego dos stents farmacológicos no Brasil: análise das principais controvérsias para incorporação dessa tecnologia nos sistemas de saúde público e privado no país

“…A principal conclusão dessa fase de reavaliação foi a ênfase na importância do uso, por um ano, de terapia antiplaquetária dupla com ácido acetilsalicílico (AAS) e tienopiridínicos 21 . Constatou-se, também, que nas indicações ditas on label (descritas na bula do produto), e respaldadas por estudos controlados e aleatorizados, não havia incremento do nú-mero de infartos e óbitos a médio e longo prazos, comparativamente ao grupo controle que recebera stents convencionais 22 . Todavia, se considerados os casos mais complexos, que não estavam incluídos nos estudos que avaliaram os stents farmacológicos, observava-se tendência a maior frequência da taxa de eventos trombóticos tardios e muito tardios (além de um ano após o implante).…”