First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial.

Background: Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI.

Methods And Results: The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.

A prospective, non-randomized comparison of SAPIEN XT and CoreValve implantation in two sequential cohorts of patients with severe aortic stenosis.

Objectives: Few data is available comparing Edwards SAPIEN XT - SXT (Edwards Lifesciences, Irvine, California) with Medtronic CoreValve - CoV (Medtronic Inc., Minneapolis, Minnesota) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).

Methods: We selected consecutive patients undergoing transfemoral TAVR with SXT or CoV at our Institution.

Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial.

Objectives: This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial.

Background: The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES.

Methods: The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707).

Aortic valve calcium score as a predictor for outcome after TAVI using the CoreValve revalving system.

Background: TAVI is a novel treatment option for patients at too high risk for surgery. Risk scores for surgical valve replacement failed to accurately predict outcomes after TAVI and alternative risk parameters are lacking so far.

Objective: We evaluated the CT-derived aortic valve calcification score as a predictor for outcome during and after TAVI.

Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial.

Background: The effectiveness of durable polymer drug-eluting stents comes at the expense of delayed arterial healing and subsequent late adverse events such as stent thrombosis (ST). We report the 4 year follow-up of an assessment of biodegradable polymer-based drug-eluting stents, which aim to improve safety by avoiding the persistent inflammatory stimulus of durable polymers.

Methods: We did a multicentre, assessor-masked, non-inferiority trial.

The three year follow-up of the randomised "all-comers" trial of a biodegradable polymer biolimus-eluting stent versus permanent polymer sirolimus-eluting stent (LEADERS).

Aims: The current study reports clinical outcomes at three year follow-up of the LEADERS clinical trial which was the first all-comers trial comparing a new generation biodegradable polymer biolimus drug-eluting stent (BES) with the first generation permanent polymer sirolimus-eluting stent (SES).

Methods And Results: One thousand seven hundred and seven patients were randomised to unrestricted use of BES (n=857) or SES (n=850) in an all-comers population. Three year follow-up was available in 95% of the patients, 812 treated with BES and 809 treated with SES.

Implantation of the biodegradable polymer biolimus-eluting stent in patients with high SYNTAX score is associated with decreased cardiac mortality compared to a permanent polymer sirolimus-eluting stent: two year follow-up results from the "all-comers" LEADERS trial.

Background: The SYNTAX score (SXscore) has been shown to be an effective predictor of clinical outcomes in patients undergoing percutaneous coronary intervention (PCI).

Methods And Results: The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the "all-comers" LEADERS trial (patients post-surgical revascularisation were excluded). Post hoc analysis was performed by stratifying clinical outcomes at two-year follow-up, according to one of three SXscore tertiles: SXlow ≤8 (n=464), 816 (n=461).

2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice.

Objectives: This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with sirolimus-eluting stents (SES) with durable polymer through 2 years of follow-up.

Background: BES with a biodegradable polymer provide similar efficacy and safety as SES with a durable polymer at 9 months. Clinical outcomes beyond the period of biodegradation of the polymer used for drug release and after discontinuation of dual antiplatelet therapy are of particular interest.

The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention).

Objectives: The aim of this study was to investigate the impact of patient and lesion complexity on outcomes with newer-generation zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES).

Background: Clinical and angiographic outcomes of newer-generation stents have not been described among complex patients.

Methods: Patients enrolled in the RESOLUTE All Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) were stratified into "complex" and "simple.

The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial.

Objectives: This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.

Background: The SXscore can identify patients treated with PCI who are at highest risk of adverse events.

Methods: The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention).

The outcome of bifurcation lesion stenting using a biolimus-eluting stent with a bio-degradable polymer compared to a sirolimus-eluting stent with a durable polymer.

Aims: This study investigated the differences in clinical outcomes between patients with bifurcation lesions (BL) treated with a biolimus-eluting stent (BES) with a biodegradable polymer, and a sirolimus-eluting stent (SES) with a durable polymer.

Methods And Results: The clinical outcomes were assessed in the 497 patients (BES 258, SES 239) enrolled in the multicentre, randomised LEADERS trial who underwent treatment of ≥1 BL (total=534 BL). At 12-months follow-up there was no significant difference in the primary endpoint of MACE, a composite of cardiac death, myocardial infarction and clinically indicated target vessel revascularisation (BES 12.

Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial.

Background: The age, creatinine, and ejection fraction (ACEF) score (age/left ventricular ejection fraction+1 if creatinine >2.0 mg/dL) has been established as an effective predictor of clinical outcomes in patients undergoing elective coronary artery bypass surgery; however, its utility in "all-comer" patients undergoing percutaneous coronary intervention is yet unexplored.

Methods And Results: The ACEF score was calculated for 1208 of the 1707 patients enrolled in the LEADERS trial.

Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial.

Objectives: We aimed to assess the predictive value of the SYNTAX score (SXscore) for major adverse cardiac events in the all-comers population of the LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial.

Background: The SXscore has been shown to be an effective predictor of clinical outcomes in patients with multivessel disease undergoing percutaneous coronary intervention.

Methods: The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the LEADERS trial (patients after surgical revascularization were excluded).

Carotid artery interventions for restenosis after prior stenting: is it different from interventions of de novo lesions? Results from the carotid artery stent (CAS)--registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

Objective: To compare characteristics and outcome of patients with re-stenoses after prior carotid artery stenting (CAS) treated with repeat carotid interventions (Re-CI) with CAS for de novo lesions.

Background: The treatment of re-stenosis is a major problem in vascular interventions. Patients with re-stenoses after prior CAS treated with Re-CI are not well defined.

The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer.

Aims: This study reports the 12-month clinical outcomes of the LEADERS clinical trial which compared a biolimus eluting stent with a biodegradable polymer (BES) to a sirolimus eluting stent with a durable polymer (SES).

Methods And Results: The multicentre LEADERS trial employed an all-comers approach to recruit 1,707 patients who were randomised to treatment with either BES (n=857) or SES (n=850) in a non-inferiority design. The primary clinical endpoint of this study was a composite of cardiac death, myocardial infarction and clinical-indicated target vessel revascularisation.

Comparison of zotarolimus-eluting and everolimus-eluting coronary stents.

Background: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration.

Methods: In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus.

The impact of body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial).

The aim of this analysis was to assess the effect of body mass index (BMI) on 1-year outcomes in patients enrolled in a contemporary percutaneous coronary intervention trial comparing a sirolimus-eluting stent with a durable polymer to a biolimus-eluting stent with a biodegradable polymer. A total of 1,707 patients who underwent percutaneous coronary intervention were randomized to treatment with either biolimus-eluting stents (n = 857) or sirolimus-eluting stents (n = 850). Patients were assigned to 1 of 3 groups according to BMI: normal (<25 kg/m(2)), overweight (25 to 30 kg/m(2)), or obese (>30 kg/m(2)).

Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy.

Objectives: We assessed the impact of vessel size on outcomes of stenting with biolimus-eluting degradable polymer stent (BES) and sirolimus-eluting permanent polymer stent (SES) within a randomized multicenter trial (LEADERS).

Background: Stenting of small vessels might be associated with higher rates of adverse events.

Methods: "All-comer" patients (n = 1,707) were randomized to BES and SES.

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

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.

Effectiveness and safety of carotid artery stenting for significant carotid stenosis in patients with contralateral occlusion (from the German ALKK-CAS Registry experience).

Data on the safety of carotid artery stenting (CAS) in a large number of unselected patients with contralateral occlusion and significant ipsilateral stenosis are less known. Accordingly, we evaluated 3,137 patients undergoing CAS who were enrolled in a German Registry from 2000 to 2008 and compared the clinical features and in-hospital outcomes of those with and without contralateral carotid occlusion. Contralateral carotid occlusion was present in 191 patients (6.

Carotid artery stenting: do procedural complications relate to the side intervened upon?: results from the Carotid Artery Stent (CAS)-Registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

Objectives: To determine the influence of the side intervened upon on outcomes during carotid artery stenting (CAS).

Background: Anatomic and technical aspects may influence the results of CAS. The value of the side intervened upon has not been analyzed yet.

Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial.

Background: A novel stent platform eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a sirolimus-eluting stent (with durable polymer).

Methods: We undertook a multicentre, assessor-blind, non-inferiority study in ten European centres.

Comparison of in-hospital outcomes of patients with versus without previous carotid endarterectomy undergoing carotid stenting (from the German ALKK CAS Registry).

Repeat carotid endarterectomy (CEA) for recurrent stenosis remains a challenging treatment option associated with high morbidity and mortality. Carotid artery stenting (CAS) is an attractive alternative management option for these patients. However, data about the effectiveness and safety of CAS in a large number of unselected patients are less known.

Carotid artery stenting in octogenarians: results from the ALKK Carotid Artery Stent (CAS) Registry.

Aims: We tried to determine the influence of age on complication rates of carotid artery stenting (CAS).

Methods And Results: Two thousand seven hundred eighty CAS procedures were included in the registry. Median age of the patients was 70.