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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.
JACC Cardiovasc Interv. 2013 Aug; 6(8):777-89.JC

Abstract

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). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat.

RESULTS

At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005).

CONCLUSIONS

The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

Authors+Show Affiliations

Thoraxcenter, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23968698

Citation

Serruys, Patrick W., et al. "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." JACC. Cardiovascular Interventions, vol. 6, no. 8, 2013, pp. 777-89.
Serruys PW, Farooq V, Kalesan B, et al. 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. JACC Cardiovasc Interv. 2013;6(8):777-89.
Serruys, P. W., Farooq, V., Kalesan, B., de Vries, T., Buszman, P., Linke, A., Ischinger, T., Klauss, V., Eberli, F., Wijns, W., Morice, M. C., Di Mario, C., Corti, R., Antoni, D., Sohn, H. Y., Eerdmans, P., Rademaker-Havinga, T., van Es, G. A., Meier, B., ... Windecker, S. (2013). 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. JACC. Cardiovascular Interventions, 6(8), 777-89. https://doi.org/10.1016/j.jcin.2013.04.011
Serruys PW, et al. 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. JACC Cardiovasc Interv. 2013;6(8):777-89. PubMed PMID: 23968698.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Serruys,Patrick W, AU - Farooq,Vasim, AU - Kalesan,Bindu, AU - de Vries,Ton, AU - Buszman,Pawel, AU - Linke,Axel, AU - Ischinger,Thomas, AU - Klauss,Volker, AU - Eberli,Franz, AU - Wijns,William, AU - Morice,Marie Claude, AU - Di Mario,Carlo, AU - Corti,Roberto, AU - Antoni,Diethmar, AU - Sohn,Hae Y, AU - Eerdmans,Pedro, AU - Rademaker-Havinga,Tessa, AU - van Es,Gerrit-Anne, AU - Meier,Bernhard, AU - Jüni,Peter, AU - Windecker,Stephan, PY - 2013/04/03/received PY - 2013/04/11/accepted PY - 2013/8/24/entrez PY - 2013/8/24/pubmed PY - 2014/3/25/medline KW - ACS KW - ARC KW - Academic Research Consortium KW - BES KW - BMS KW - CI KW - DES KW - KM KW - Kaplan-Meier KW - MACE KW - MI KW - PCI KW - POCE KW - RR KW - SES KW - ST KW - ST-segment elevation myocardial infarction KW - STEMI KW - TVR KW - acute coronary syndrome KW - bare-metal stent(s) KW - biodegradable polymer KW - biolimus-eluting stent(s) KW - confidence interval KW - drug-eluting stent(s) KW - drug-eluting stents KW - durable polymer KW - major adverse cardiac events KW - myocardial infarction KW - patient-oriented composite endpoint KW - percutaneous coronary intervention KW - rate ratio(s) KW - sirolimus-eluting stent(s) KW - stent thrombosis KW - target vessel revascularization SP - 777 EP - 89 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 6 IS - 8 N2 - 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). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. RESULTS: At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). CONCLUSIONS: The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220). SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/23968698/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(13)00986-2 DB - PRIME DP - Unbound Medicine ER -