Final results of a randomized trial comparing the NIR stent to the Palmaz-Schatz stent for narrowings in native coronary arteries

Baim, Donald S.; Cutlip, Donald E.; Midei, Mark; Linnemeier, Thomas J.; Schreiber, Theodore; Cox, David A.; Kereiakes, Dean J.; Popma, Jeffrey J.; Robertson, Linda K.; Prince, Rebecca M.; Lansky, Alexandra J.; Ho, Kalon K.L.; Kuntz, Richard E.

doi:10.1016/s0002-9149(00)01307-2

Cited by 71 publications

(35 citation statements)

References 17 publications

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“…25 BAR rates and TLR rates ranging between 15% and 25% for stents and between 20% and 40% for other angioplasty devices [5][6][7][8] allowed detection of modest differences in restenosis rates in clinical trials of fewer than 1000 subjects. 26,27 The evaluation of restenosis in the DES era is more complex.…”

Section: Discussionmentioning

confidence: 99%

“…1,31 Bare metal stent trials and registries have demonstrated mean late losses varying from 0.6 to 1.2 mm. 5,6,26,27,[32][33][34][35] The RAVEL trial of the sirolimus-eluting Bx Velocity stent was the first randomized trial to report a stent with an average late loss well below the expected historical range, as well as its own control arm (in-stent late loss Ϫ0.01 mm active versus 0.80 mm control), which corresponded to a BAR rate of 0% for the active arm versus 26% in the control arm. 36 As the positive mean of any normal distribution is reduced enough so that its spread becomes significantly bounded by zero, it becomes right-skewed.…”

Section: Late Loss and Its Skewed Distribution For Dessmentioning

confidence: 99%

“…4 The moderately high rates of BAR and TLR seen in conventional trials (15% to 40%) have provided enough power for adequate discrimination between competing percutaneous therapies enrolling Ϸ1000 subjects. [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%.…”

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confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Late Loss and Its Skewed Distribution For Dessmentioning

confidence: 99%

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confidence: 99%

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

et al. 2005

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“…19 Angiographic studies in patients treated with BMS have reported binary restenosis rates within the stent and within the treated arterial segment that included its nonstented margins. 6,7 Although previous BMS stent studies did not examine the specific lumen changes at the proximal or distal nonstent margins, intravascular ultrasound studies have shown that balloon injury proximal and distal to the stent may result in lumen renarrowing resulting from arterial remodeling at the edges of the stent. 9 Studies evaluating angiographic outcomes in patients undergoing radiation brachytherapy or using radioactive stents have also shown that proliferation at the stent edges may be associated with higher-than-expected restenosis rates at the stent margins ("candy wrapper effect") because of an untoward effect of low-dose radiation at the stent margins.…”

Section: Restenosis After Bms Implantationmentioning

confidence: 99%

Quantitative Assessment of Angiographic Restenosis After Sirolimus-Eluting Stent Implantation in Native Coronary Arteries

et al. 2004

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Background-Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Methods and Results-Angiographic follow-up at 240 days was obtained in 701 patients with long (15-to 25-mm) lesions in small-diameter (2.5-to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (Ͼ50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; PϽ0.001) and within the stent (3.2% versus 35.4% with the BMS; PϽ0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all PϽ0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Conclusions-Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.

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“…The NIR stent showed excellent deliverability with slightly better acute angiographic results and an equivalent or better 9-month target vessel failure rate when compared with the PS stent. 34) Our study shows that the NIR stent is as favorable as the heparin-coated Jostent with regard to early and late clinical and angiographic outcomes. Our findings that both MACE and acute thrombosis rates were similar in the heparin-coated Jostent and the NIR stent groups could be explained by the state that procedural failure is mainly due to dissection or inadequate expansion of the stent and is independent from the stent structure or stent coating.…”

Section: Discussionmentioning

confidence: 61%

<b>Comparison of Initial Efficacy and Long-term Follow-up of Heparin-coated Jostent With Conventional NIR Stent</b>

et al. 2003

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SUMMARYThe implantation of heparin-coated stents was reported to be well tolerated, but there are conflicting results about acute in-hospital complications, (sub)acute thrombosis rates, and long-term follow-up compared to uncoated stents. We compared the angiographic and clinical results after coronary placement of two stent models: the heparin-coated premounted Jostent and the uncoated premounted NIR stent. Of 710 patients revascularized, a total of 426 patients received Jostent (n = 230) or NIR stent (n = 196) implantation. The primary end points were acute or subacute thrombosis, urgent CABG, AMI or death, while the secondary end points were the comparison of the restenosis rates of the stents at the 6 th month and of the functional angina classification of the stent groups at the 1 st , 6 th and 12 th months. There were no significant differences between the Jostent and NIR stent groups regarding angiographic and procedural success. Acute thrombosis rates in the Jostent and NIR stent groups were similar while no subacute thrombosis was observed in either group. The major adverse cardiac event rates of the groups also did not differ. Angiographic restenosis occurred in 17% of the Jostent group and 16% of the NIR stent group (NS). The combined clinical and angiographic restenosis rate was also similar between the Jo and NIR groups (19% and 18%, respectively). Comparison of functional angina classes at the 1 st , 6 th and 12 th months revealed no significant difference between the study groups.In conclusion, when compared with implantation of an uncoated premounted NIR stent, implantation of a heparin-coated premounted Jostent does not provide any more benefit with respect to initial efficacy, sub(acute) thrombosis and 6-month restenosis rates and 12-month clinical outcomes. (Jpn Heart J 2003; 44: 889-898)

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Final results of a randomized trial comparing the NIR stent to the Palmaz-Schatz stent for narrowings in native coronary arteries

Cited by 71 publications

References 17 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

Quantitative Assessment of Angiographic Restenosis After Sirolimus-Eluting Stent Implantation in Native Coronary Arteries

<b>Comparison of Initial Efficacy and Long-term Follow-up of Heparin-coated Jostent With Conventional NIR Stent</b>

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