Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery

Moses, Jeffrey W.; Leon, Martin B.; Popma, Jeffrey J.; Fitzgerald, Peter J.; Holmes, David R.; O’Shaughnessy, Charles; Caputo, Ronald P.; Kereiakes, Dean J.; Williams, David O.; Teirstein, Paul S.; Jaeger, Judith; Kuntz, Richard E.

doi:10.1056/nejmoa035071

Cited by 3,898 publications

(2,521 citation statements)

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“…1,2 The introduction of drugeluting stents (DES) has greatly alleviated this problem, 3 and their use in coronary intervention has markedly increased. DES decreases angiographic and clinical measurements of restenosis compared with bare metal stents 4,5 in elective patients and those with STEMI.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Zheng

Lu³

et al. 2010

Clinical Cardiology

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Background: It has been reported that sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been more effective than bare-metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there might be differences between these two drug-eluting stents in terms of efficacy and safety in the setting of acute ST-segment elevation myocardial infarction (STEMI). Hypothesis: The aim of the present study was to compare SES with PES in patients with acute STEMI undergoing primary percutaneous coronary intervention (PCI). Methods: The published research was scanned by formal searches of electronic databases (PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials) from January 2001 to February 2010. Internet-based sources of information on the results of clinical trials in cardiology were also searched. Results: A total of 4 randomized trials were included in the present meta-analysis, involving 1105 patients (550 in the SES group, 555 in the PES group). SES were significantly more effective in the reduction of angiographic binary (≥50%) restenosis (4.0% vs 9.6%, odds ratio 0.38, 95% confidence interval 0.19 to 0.74, P = 0.004) compared to PES. The differences between SES and PES were not statistically significant with respect to target vessel revascularization (TVR), stent thrombosis, cardiac death, and myocardial infarction. Conclusions: SES are superior to PES in reducing the incidence of restenosis in patients undergoing primary PCI for STEMI, with nonsignificant differences in terms of TVR, cardiac death, myocardial infarction, and stent thrombosis. IntroductionPrimary angioplasty has become the standard of care for acute ST-segment elevation myocardial infarction (STEMI); however, its long-term success is limited by the occurrence of restenosis. 1,2 The introduction of drugeluting stents (DES) has greatly alleviated this problem, 3 and their use in coronary intervention has markedly increased. DES decreases angiographic and clinical measurements of restenosis compared with bare metal stents 4,5 in elective patients and those with STEMI. A meta-analysis in a broad population has shown that sirolimus-eluting stents (SES) are superior to paclitaxel-eluting stents (PES) in terms of late loss and target lesion revascularization (TLR). 6 However, the relative efficacy and safety of SES and PES in STEMI patients remains unclear. We therefore performed a meta-analysis of randomized

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Section: Introductionmentioning

confidence: 99%

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Zheng

Lu³

et al. 2010

Clinical Cardiology

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“…5,6 Recently, several randomized and controlled trials have demonstrated great advantages of drug-eluting stents (DESs) in significantly reducing restenosis and recurrence of symptoms, and improving clinical outcomes after percutaneous coronary intervention (PCI). 7,8 Little is known about the comparative effects of 1-DES plus the kissing balloon technique with the 2-DES for bifurcation angioplasty in a Chinese population. Therefore, we conducted the present study to evaluate the immediate and 7-mo follow-up results of PCI for coronary bifurcation lesions treated with implantation of 1-or 2-DES.…”

Section: Introductionmentioning

confidence: 99%

Comparative Study of Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions in Daily Practice in Chinese Patients

Gao

Yang

2008

Clinical Cardiology

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Background: Recently, several randomized and controlled trials have demonstrated great advantages of a drug-eluting stent (DES) with respect to significant reduction in restenosis and recurrence of symptoms, and improvement in clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects of the 1-DES plus the kissing balloon technique with the 2-DES for bifurcation angioplasty in a Chinese population. Methods: From April 2004 to June 2006, 566 consecutive Chinese patients underwent DES implantation for true bifurcation lesions, including 346 1-DES with the kissing balloon technique (300 male, 57.7±11.5 y old) and 220 2-DES (183 male, 58.1±10.7 y old) were analyzed. Clinical and angiographic follow-up was performed after 7 mo. Results: The major adverse cardiac event (MACE) rates were higher in the 2-DES group than in the 1-DES group (5.5% versus 2.0%; p=0.032), which was mainly contributed to by acute myocardial infarction (AMI) (4.5% versus 1.4%; p=0.032), rather than death and target lesion revascularization (TLR) (0% versus 0.5%; p=0.389, 1.4% versus 2.7%; p=0.352). Stent thrombosis rates were higher in the 2-DES group than in the 1-DES group (0.6% versus 2.7%; p=0.042), except for 1 late-stent thrombosis in the 2-DES group, and all of them were subacute stent thrombosis (2 in the 1-DES group and 5 in the 2-DES group). The 7 mo angiographic follow-up rate was 36.4%. In the main branch there was no difference in restenosis rate in the 1-DES group compared with the 2-DES group (9.8% versus 11.9%; p=0.652), but in the side branch the restenosis rate was higher in the 1-DES group (33.6% versus 15.5%; p=0.004). However, there was no difference in in-segment late loss between the 2 groups, either in the main or side branch. Conclusion: Compared with the 2-DES strategy, if a final kissing balloon could be achieved, the 1-DES strategy may be more efficient and safe.

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“…Despite this, in-stent restenosis for patients treated with either PTA or bare metal stenting continues to be a problem with 3-year primary patency rates below 25% [1]. Drug-eluting stents have markedly reduced restenosis in the coronary vasculature compared to bare metal stents [2,3]. However, drugeluting stents are more expensive and the risk of stent thrombosis mandates longer-term dual antiplatelet therapy.…”

Section: Introductionmentioning

confidence: 99%

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Grant

White

Collins

et al. 2007

Cathet Cardio Intervent

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Objective: We report our experience with the elective placement of below-knee, drugeluting stents in patients with chronic limb ischemia. Background: Infrapopliteal percutaneous transluminal angioplasty has been associated with a lower rate of procedural success and high rate of restenosis because of the small size of the tibial vessels and the prevalence of calcified and diffuse atherosclerotic disease. Prior published data reports 3-year patency rates below 25%. Bare metal stents have been reported in bailout situations. Drug-eluting stents have markedly reduced restenosis compared to bare metal stents in the coronary vasculature, but there is little data supporting the use of these devices below the knee. Methods: Elective placement of drug-eluting stents in infrapopliteal lesions was performed on 10 patients with severe (≥Fontaine Stage IIb) claudication (n 5 1) or limb-threatening ischemia (n 5 9) (rest pain, nonhealing ulcers and gangrene). Results: A total of 17 drug-eluting stents were electively placed in 12 below-knee arteries in 10 patients, resulting in an average of 1.7 6 0.7 stents per patient. The mean lesion length was 24.8 6 10.9 mm, the mean total stent length was 38.3 6 19.1 mm, and the mean nominal stent diameter was 2.8 6 0.3 mm. One patient required target vessel revascularization (TVR) at 3 weeks because of stent thrombosis. TVR was 10% at 12.4 6 6.5 months of follow-up. Clinically driven angiography in three different patients was performed at 4, 15, and 16 months and confirmed drug-eluting stent patency in each case. Conclusions: The use of below-knee drug-eluting stents is feasible and appears to be safe in our small series of complex infrapopliteal lesions causing chronic limb ischemia. The occurrence of a single case of stent thrombosis warrants continued observation in this cohort. Prospective clinical trials will be necessary to confirm the benefits and justify the costs of this strategy for treating patients with infrapopliteal culprit lesions and chronic limb ischemia. '

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Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery

Abstract: 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.

Cited by 3,898 publications

References 36 publications

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Comparative Study of Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions in Daily Practice in Chinese Patients

Infrapopliteal drug‐eluting stents for chronic limb ischemia

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