TAXUS III Trial

Tanabe, Kengo; Serruys, Patrick W.; Grube, Eberhard; Smits, Pieter C.; Selbach, Guido; Giessen, Willem J. van der; Staberock, Manfred; Feyter, Pim de; Müller, Ralf; Regar, Evelyn; Değertekin, Muzaffer; Ligthart, Jürgen; Disco, Clemens; Backx, Bianca; Russell, Mary E.

doi:10.1161/01.cir.0000048184.96491.8a

Cited by 280 publications

(47 citation statements)

References 30 publications

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“…[5][6][7][8][9] In contrast, several recent drug-eluting stent (DES) trials have demonstrated a breakthrough in the reduction of late restenosis compared with bare metal stents, with a consistent incidence of BAR and TLR below 10%. 10,11 Even with the achieved low rates, which may underestimate the rate in actual practice or in high-risk groups, [12][13][14][15][16][17] cost-effectiveness analysis provides economic and quality-of-life incentives to distinguish therapies with restenosis rates below 10%. 18 However, the statistical power available to determine superiority (or demonstrate noninferiority) in competing DES treatments is markedly reduced when sample sizes of 2000 subjects or less are used.…”

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confidence: 99%

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

et al. 2005

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Background-Observed rates of restenosis after drug-eluting stenting are low (Ͻ10%). Identification of a reliable and powerful angiographic end point will be useful in future trials. Methods and Results-Late loss (postprocedural minimum lumen diameter minus 8-month minimum lumen diameter) was measured in the angiographic cohorts of the SIRIUS (nϭ703) and E-SIRIUS (nϭ308) trials. Two techniques, the standard normal approximation and an optimized power transformation, were used to predict binary angiographic restenosis rates and compare them with observed restenosis rates. The mean in-stent late loss observed in the SIRIUS trial was 0.17Ϯ0.45 mm (sirolimus) versus 1.00Ϯ0.70 mm (control). If a normal distribution was assumed, late loss accurately estimated in-stent binary angiographic restenosis for the control arm (predicted 35.4% versus observed 35.4%) but underestimated it in the sirolimus arm (predicted 0.6% versus observed 3.2%). Power transformation improved the reliability of the estimate in the sirolimus arm (predicted 3.2% [CI 1.0% to 6.7%]) with similar improvements in the E-SIRIUS trial (predicted 4.0% [CI 1.2% to 7.0%] versus observed 3.9%). In the sirolimus-eluting stent arm, in-stent late loss correlated better with target-lesion revascularization than in-segment late loss (c-statisticϭ0.915 versus 0.665). Conclusions-Because distributions of late loss with a low mean are right-skewed, the use of a transformation improves the accuracy of predicting low binary restenosis rates. Late loss is monotonically correlated with the probability of restenosis and yields a more efficient estimate of the restenosis process in the era of lower binary restenosis rates.

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confidence: 99%

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

et al. 2005

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“…After collecting the crossreferences and references obtained from the internet, 17 potentially relevant trials were retrieved. Out of these 17 studies, three [13][14][15] were excluded because of lack of a control group and one [16] was excluded because the patient population was different from the rest of the studies. A total of 13 trials [17][18][19][20][21][22][23][24][25][26][27][28][29], with 4372 patients were included in the meta-analysis.…”

Section: Resultsmentioning

confidence: 99%

A meta‐analysis of clinical trials of paclitaxel‐ and sirolimus‐eluting stents in patients with obstructive coronary artery disease

Shafiq¹,

Malhotra²,

Pandhi³

et al. 2004

Brit J Clinical Pharma

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Br J Clin PharmacolAim This meta-analysis was conducted to compare the effects of drug (paclita xel and sirolimus)-eluting stents with bare metal stents on major adverse cardiac events, restenosis rates and late loss of arterial lumen diameter in patients with obstructive coronary artery disease. MethodsRandomized, controlled clinical trials comparing sirolimus-and paclita xel-eluting stents with bare metal stents were identified through electronic and manual search. Fixed effects method of Mantel-Haenszel and random effects method of DerSimonian and Laird were used for computing the pooled odds ratio (OR) and 95% confidence intervals (CI) for major adverse cardiac events and restenosis rates. Standardized mean difference with 95% CI was calculated for late-loss of ar terial lumen diameter. ResultsA total of 13 studies were included in the meta-analysis. As compared with bare metal stents, the use of sirolimus-and paclitaxel-eluting stents significantly reduced the major adverse cardiac events (pooled OR 0.35; 95% CI 0.24-0.50), restenosis rates (pooled OR 0.27; 95% CI 0.15-0.47), and late loss of arterial lumen diameter (mean difference 0.57 mm, 95% CI 0.49-0.68). ConclusionPaclitaxel-and sirolimus-eluting stents significantly reduced the incidence of major adverse cardiac events, restenosis rates, and late loss of ar terial lumen diameter as compared with bare metal stents.

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“…As a result, long DES tend to be selected for complete lesion coverage, but if this approach is not possible or a residual segment of the lesion is left uncovered, additional stenting is considered, with some overlap to eliminate the risk of a residual stent gap 18,19. Some reports have shown an increased rate of peri-procedural myonecrosis in overlapping stents, which may be a limitation of this approach 9,20.…”

Section: Discussionmentioning

confidence: 99%

Outcomes of stenting with overlapping drug-eluting stents versus overlapping drug-eluting and bare-metal stents for the treatment of diffuse coronary lesions

Kassaian

Salarifar²,

Dehkordi³

et al. 2010

CardioVascular Journal of Africa

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IntroductionWe investigated the outcomes of stenting with overlapping drug-eluting stents (DES) versus overlapping stenting with a combination of drug-eluting and bare metal stents (BMS) in very long ≥(≥ 25 mm).Methods and ResultsFifty-two patients treated with either overlapping DES-DES (n = 22) or DES-BMS (n = 30) were selected from a registry of 588 patients with very long coronary lesions. Patients with acute myocardial infarction (MI) within the preceding 48 hours were excluded. The DES-DES combination was more frequently used for longer lesions compared with the DES-BMS group (47.95 ± 9.25 vs 39.98 ± 9.15 mm, p = 0.003). Left anterior descending artery lesions were also more frequently treated with the DES-DES combination (95.5 vs 66.7%, p = 0.02). In four patients in the DES-BMS group, overlapping stents were used for the coverage of dissections. Peri-procedural non-Q-wave MI occurred in one patient in the DES-BMS group. On follow up, only one case of non-fatal MI occurred in a patient with overlapping DES-DES.ConclusionOverlapping a BMS in the proximal part of a long DES instead of exclusive deployment of two or more overlapped DES seems to be a safe and feasible therapeutic strategy in our practice.

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TAXUS III Trial

Cited by 280 publications

References 30 publications

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

A meta‐analysis of clinical trials of paclitaxel‐ and sirolimus‐eluting stents in patients with obstructive coronary artery disease

Outcomes of stenting with overlapping drug-eluting stents versus overlapping drug-eluting and bare-metal stents for the treatment of diffuse coronary lesions

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