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      Does the use of paclitaxel or rapamycin-eluting stent decrease further need for coronary-artery bypass grafting when compared with bare-metal stent? Translated title: O uso de stents recobertos com paclitaxel ou rapamicina diminui o número de cirurgias de revascularização cardíaca quando comparado aos stents convencionais?

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          ABSTRACT

          CONTEXT AND OBJECTIVE:

          The safety and efficacy of drug-eluting stents reduce the need for surgical revascularization. The objective of the present study was to investigate whether paclitaxel or rapamycin-eluting stent are effective in avoiding the need for coronary-artery bypass grafting.

          METHODS:

          This was a systematic review of the literature using the methodology of the Cochrane Collaboration. The type of study considered was controlled randomized trials; the type of intervention was drug-eluting or bare-metal stents; and the main outcome investigated was coronary-artery bypass grafting.

          RESULTS:

          The ten studies included in this systematic review did not show any statistically significant difference between the drug-eluting stents and the bare-metal stents with regard to the outcome of coronary-artery bypass grafting (confidence interval: 0.31 to 1.42).

          CONCLUSION:

          The surgical revascularization rate was not reduced by the use of drug-eluting stents.

          RESUMO

          CONTEXTO E OBJETIVO:

          A segurança e eficácia dos stents recobertos com drogas reduz a necessidade da cirurgia de revascularização cardíaca. O objetivo foi verificar se os stents recobertos com paclitaxel ou rapamicina são efetivos para evitar a necessidade de revascularização cirúrgica das coronárias.

          MÉTODOS:

          Revisão sistemática da literatura usando a metodologia do Centro Cochrane. Tipos de estudos: estudos clínicos randomizados; tipo de intervenção: stents recobertos com drogas ou stents convencionais; desfecho principal: cirurgia de revascularização cardíaca.

          RESULTADOS:

          Os 10 estudos incluídos nesta revisão sistemática não mostram diferença estatisticamente significante entre os stents recobertos com drogas e os stents convencionais no desfecho principal, com intervalo de confiança de 0.31, 1.42.

          CONCLUSÃO:

          A taxa de revascularização cardíaca não é reduzida pelo uso de stents recobertos com drogas.

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          Most cited references56

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          Assessing the quality of reports of randomized clinical trials: is blinding necessary?

          It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.
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            A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.

            The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.
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              Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.

              Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization. We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days. The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting stent (P<0.001)--a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion (16.6 percent in the standard-stent group vs. 4.1 percent in the sirolimus-stent group, P<0.001). The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined. In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed. Copyright 2003 Massachusetts Medical Society
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                Author and article information

                Journal
                Sao Paulo Med J
                Sao Paulo Med J
                Sao Paulo Med J
                São Paulo Medical Journal
                Associação Paulista de Medicina - APM
                1516-3180
                1806-9460
                01 July 2007
                2007
                : 125
                : 4
                : 242-245
                Author notes
                [Address for correspondence: ] Centro Cochrane do Brasil Rua Pedro de Toledo, 598 — Vila Clementino São Paulo (SP) – CEP 04039-001 Tel./Fax.(+55 11) 5575-2970 — (+55 11) 5579-0469 E-mail: cochrane.dmed@ 123456epm.br

                Conflicts of interest: None

                Article
                10.1590/S1516-31802007000400010
                11020538
                17992397
                d97761e5-0dfe-454d-8e30-66f417156448

                This is an open access article distributed under the terms of the Creative Commons license.

                History
                : 08 December 2006
                : 29 June 2007
                : 18 July 2007
                Page count
                Figures: 1, Tables: 1, Equations: 0, References: 32, Pages: 4
                Categories
                Systematic Review

                angina pectoris,coronary artery bypass,percutaneous transluminal coronary angioplasty,myocardial revascularization,thoracic surgery,ponte de artéria coronária,angioplastia transluminal percutânea coronária,revascularização miocárdica,cirurgia cardíaca

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