Predictive Factors of Restenosis After Coronary Implantation of Sirolimus- or Paclitaxel-Eluting Stents

Kastrati, Adnan; Dibra, Alban; Mehilli, Julinda; Mayer, Sandra Mara; Pinieck, Susanne; Pache, Jürgen; Dirschinger, Josef; Schömig, Albert

doi:10.1161/circulationaha.105.601823

Cited by 284 publications

(207 citation statements)

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“…13,14 However, lesion length has remained a strong predictor of in-stent restenosis. 15,16 Although the pattern of restenosis after drug eluting stents is more focal rather than diffuse, as with bare metal stents, and therefore more easily treated, it still remains increased for long lesions. 5,7 Paclitaxel eluting stents have been shown to be inferior to sirolimus eluting stents with TVR rates of 7.6% versus 3.2%…”

Section: Discussionmentioning

confidence: 99%

Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy

Wykrzykowska

Räber²,

Vries³

et al. 2009

EuroIntervention

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Aims: Lesion length remains a predictor of target lesion revascularisation and results of long lesion stenting remain poor. Sirolimus-eluting stents have been shown to perform better than paclitaxel eluting stents in long lesions. In this substudy of the LEADERS trial, we compared the performance of biolimus biodegradable polymer (BES) and sirolimus permanent polymer stents (SES) in long lesions. Methods and results: A total of 1,707 'all-comer' patients were randomly allocated to treatment with BES and SES. A stratified analysis of angiographic and clinical outcomes at nine months and one year, respectively was performed for vessels with lesion length <20 mm versus >20 mm (as measured by quantitative angiography). Of 1,707 patients, 592 BES patients with 831 lesions and 619 SES patients with 876 lesions had only short lesions treated. One hundred and fifty-three BES patients with 166 lesions and 151 SES patients with 162 lesions had long lesions. There were no significant differences in baseline clinical characteristics, except for higher number of patients with long lesions presenting with acute myocardial infarction in both stent groups. Long lesions tended to have lower MLD and greater percent diameter stenosis at baseline than short lesions. Late loss was greater for long lesions than short lesions. There was no statistically significant difference in late loss between BES and SES stents (0.32±0.69 vs 0.24±0.57, p=0.59). Binary in-segment restenosis was present in 23.2% versus 13.1% of long lesions treated with BES and SES, respectively (p=0.042). In patients with long lesions, the overall MACE rate was similar for BES and SES (17% vs 14.6%; p=0.62). There was a trend towards higher overall TLR rate with BES (12.4 % vs 6.0%; HR=2.06; p=0.07) and clinically driven TLR (10.5% vs 5.3%: HR 1.94; p=0.13). Rates of definite stent thrombosis were 3.3% in the long lesion group and 1.3-1.7 % in the short lesion group. Conclusions: BES and SES appear similar with respect to MACE in long lesions in this "all-comer" patient population. However, long lesions tended to have a higher rate of binary in-segment restenosis and TLR following BES than SES treatment. KEYWORDS

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Section: Discussionmentioning

confidence: 99%

Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy

Wykrzykowska

Räber²,

Vries³

et al. 2009

EuroIntervention

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“…[31][32][33] While some authors have concluded that diabetes is an independent predictor of restenosis, others have reported that diabetes per se may not be an independent risk factor for repeat revascularization. Local variables such as small vessels and diffuse disease may be more important for predicting restenosis than simply diabetes.…”

Section: Patient-related Factorsmentioning

confidence: 99%

Predictive Factors for Restenosis after Drug-Eluting Stent Implantation

Lee

Park

2007

Korean Circ J

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Background and Objectives：Despite the dramatic reduction in restenosis conferred by drug-eluting stents (DES), restenosis remains a significant problem for real-world patients. Restenosis is a complex phenomenon, and a variety of stent-, drug-, patient-and lesion-related factors have been studied as the determinants of restenosis after DES implantation. Methods and Results：The stent delivery system, the polymer and the drug are integral components of DES, and these are the device-specific factors that can affect restenosis. While the sirolimuseluting Cypher stent appears to provide better outcomes than the paclitaxel-eluting Taxus stent in high-risk patient groups with complex lesions, such differences between the two DES are not apparent in the low-risk groups. Diabetic patients are generally prone to restenosis after percutaneous coronary intervention, but there are conflicting findings regarding the impact of diabetes mellitus on restenosis after DES implantation. The postintervention final lumen area continues to be the most important determinant of restenosis after DES implantation, indicating that a greater stented area contributes to a decreased rate of restenosis even in the DES era. Nonuniform strut distribution and stent fracture also contribute to the development of restenosis after DES implantation. In addition, the risk of restenosis increases linearly according to lesion length, and a "full metal jacket" approach in small vessels is related to a high risk of DES failure. Conclusion：Small vessel disease, diffuse disease and the type of DES are important predictors of restenosis after DES implantation. However, predicting restenosis remains difficult, and this indicates the need for further studies in order to ultimately identify those patients who are at high risk for DES failure.

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“…In addition, predictors of clinical outcomes in both BMS- (16) and DES-treated (17) patients have been identified; although, for the large part, these studies were again limited to reporting restenosis at six months in patients enrolled in RCTs. With recent concerns raised regarding very late outcomes in patients enrolled in clinical trials, particularly in the context of DES use (18), it is important to examine the long-term outcomes of 'all-comers' who undergo PCI.…”

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confidence: 99%

Late outcomes following percutaneous coronary interventions: Results from a large, observational registry

Appleby¹,

Mackie²,

Džavík³

et al. 2010

Canadian Journal of Cardiology

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T he introduction of coronary stent implantation heralded a major advance in percutaneous coronary intervention (PCI), with dramatically improved in-hospital mortality and morbidity compared with plain old balloon angioplasty for the treatment of coronary artery disease. Several randomized controlled trials (RCTs) have established the superior long-term safety and efficacy of bare-metal stenting (BMS) compared with plain old balloon angioplasty (1-3). The introduction of drug-eluting stents (DES) resulted in a further significant reduction in restenosis, and has been associated with improved procedural outcomes in a more complex subset of patients and lesions (4-7). Thus, coronary stenting using bare-metal or drug-eluting platforms has become the cornerstone of PCI, and the indications for PCI have vastly expanded beyond those originally proposed.Pooled data from randomized DES trials have shown acceptable rates of all-cause mortality, myocardial infarction (MI) and revascularization in extended follow-up, up to four years (8). Although RCTs have excellent internal validity, direct extrapolation of their findings to the general population has been problematic due to their restrictive inclusion and exclusion criteria. Early data (9,10) regarding clinical outcomes in real-world patient reports from registries had limitations in both the follow-up period and the patient cohort size; the large New York State registry (11) comparing three-year outcomes in patients undergoing coronary stenting versus coronary artery bypass graft (CABG) surgery excluded all those with previous revascularization, left main stem (LMS) disease or MI within 24 h of the index procedure (11). More recently, several registries have compared two-(6,12-14) or three-year (15) outcomes in patients undergoing BMSonly versus DES-only PCI, and confirmed higher rates of subsequent revascularization in BMS-treated patients with either lower (12-14) or equivalent (6) rates of mortality or MI in DES-treated patients, or a HeaLtH outcomes/pubLic poLicy ©2010 Pulsus Group Inc. All rights reserved BACKgRounD: Randomized controlled trials report short-and medium-term outcomes following percutaneous coronary intervention (PCI), but their applicability to the general population is not known. Data regarding the long-term clinical outcomes of patients undergoing PCI are lacking. oBJECTIVE: To determine the long-term outcomes of 'all-comers' undergoing PCI at a large-volume tertiary cardiac referral centre. METhoDs: A total of 12,662 consecutive patients undergoing an index procedure and entered into the University Health Network's (Toronto, Ontario) prospective registry between April 2000 and September 2007 were identified. In-hospital outcomes were assessed. Follow-up data were obtained through linkage to a provincial registry. Kaplan-Meier analysis was performed to calculate unadjusted survival rates, and Cox multiple regression analysis identified independent predictors of late mortality, major adverse cardiac events and all cardiovascular events. REsuLTs: T...

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Predictive Factors of Restenosis After Coronary Implantation of Sirolimus- or Paclitaxel-Eluting Stents

Cited by 284 publications

References 50 publications

Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy

Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy

Predictive Factors for Restenosis after Drug-Eluting Stent Implantation

Late outcomes following percutaneous coronary interventions: Results from a large, observational registry

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