Limus Eluted From A Durable Versus ERodable Stent Coating

Conditions

Coronary Disease, Coronary Stenosis

Keywords

Coronary Disease, Coronary Stenosis, Angioplasty, Coronary Restenosis, Drug Eluting Stent

Brief summary

The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

Detailed description

Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

Yuan H, Wu Z, Lu T, Wei T, Zeng Y, Liu Y, Huang C.

2022-06-088 citations

10.1136/bmjopen-2021-058075

Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity

Konstantinos C. Koskinas, George C.M. Siontis, Raffaele Piccolo, Anna Franzone, Alan G. Haynes et al. (13 authors)

Circulation Cardiovascular Interventions2016-01-29116 citations

10.1161/circinterventions.115.003255

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

Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, Garg S, de Vries T, Garcia-Garcia HM, Onuma Y, de Winter RJ, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Meier B, Jüni P, Yazdani A, Copt S, Windecker S, Serruys PW.

2015-12-0944 citations

10.1002/ccd.26344

Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention

Pascal Vranckx, Bindu Kalesan, Giulio Stefanini, Vasim Farooq, Yoshinobu Onuma et al. (10 authors)

EuroIntervention2015-06-0110 citations

10.4244/eijv11i2a31

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.

Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, Rademaker-Havinga T, van Es GA, Meier B, Jüni P, Windecker S.

2013-08-01240 citations

10.1016/j.jcin.2013.04.011

Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents.

Stefanini GG, Kalesan B, Pilgrim T, Räber L, Onuma Y, Silber S, Serruys PW, Meier B, Jüni P, Windecker S.

2012-03-0149 citations

10.1016/j.jcin.2011.11.011

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.

Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Jüni P.

2011-11-08244 citations

10.1016/s0140-6736(11)61672-3

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.

Klauss V, Serruys PW, Pilgrim T, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, van Es GA, Kalesan B, Wenaweser P, Jüni P, Windecker S.

2011-08-0126 citations

10.1016/j.jcin.2011.03.017

Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography.

Gutiérrez-Chico JL, Regar E, Nüesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni P, Serruys PW.

2011-07-1890 citations

10.1161/circulationaha.110.014514

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.

Wykrzykowska JJ, Garg S, Girasis C, de Vries T, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW.

2010-07-01163 citations

10.1016/j.jacc.2010.03.044

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

Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P.

2008-08-31457 citations

10.1016/s0140-6736(08)61244-1

Interventions

DEVICECoronary stent placement

Coronary stent placement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Age \>= 18 years; * Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction; * Presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents; * No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion criteria

* Pregnancy; * Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material; * Inability to provide informed consent; * Currently participating in another trial before reaching first endpoint; * Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period

Design outcomes

Primary

Measure	Time frame	Description
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.	9 month	Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

Secondary

Measure	Time frame	Description
Cardiac death	30 days	Cardiac death
In-stent and in-segment late luminal loss	9 month	In-stent and in-segment late luminal loss as assessed by QCA
All deaths	30 days	All deaths (cardiac and non-cardiac)
Myocardial infarction	30 days	Myocardial infarction (Q-wave and NQWMI)
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.	30 days	Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
In-stent and in-segment binary restenosis rate as assessed by QCA.	9 month	In-stent and in-segment binary restenosis rate as assessed by QCA.
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.	9 month	In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA
In-segment percent diameter stenosis (%DS).	9 month	In-segment percent diameter stenosis (%DS) as assessed by QCA
Device success, lesion success and procedural success.	at implant	—
Angiographic and clinical stent thrombosis.	30 days	Angiographic and clinical stent thrombosis

Countries

Belgium, France, Germany, Netherlands, Poland, Switzerland, United Kingdom

Outcome results

None listed