Impact of Vessel Size on Angiographic and Clinical Outcomes of Revascularization With Biolimus-Eluting Stent With Biodegradable Polymer and Sirolimus-Eluting Stent With Durable PolymerThe LEADERS Trial Substudy
Joanna J. Wykrzykowska, MD*,
Patrick W. Serruys, MD, PhD*,*,
Yoshinobu Onuma, MD*,
Ton de Vries, MA ,
Gerrit-Anne van Es, PhD,
Pawel Buszman, MD ,
Axel Linke, MD ,
Thomas Ischinger, MD||,
Volker Klauss, MD¶,
Roberto Corti, MD#,
Franz Eberli, MD, PhD#,¶¶,
William Wijns, MD**,
Marie-Claude Morice, MD,
Carlo di Mario, MD, PhD,
Robert Jan van Geuns, MD, PhD*,
Peter Juni, MD, PhD,
Stephan Windecker, MD, PhD||||
* Department of Interventional Cardiology Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
Cardialysis, Rotterdam, the Netherlands
Medical University of Silesia, Katowice, Poland
Herzzentrum Leipzig, Leipzig, Germany
|| Department of Cardiology, Hospital Bogenhausen, Munich, Germany
¶ Department of Cardiology, University Hospital Munich (Innenstadt), Munich, Germany
# Department of Cardiology, University Hospital, Zurich, Switzerland
** Department of Cardiology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
Institut Cardiovasculaire, Paris-Sud, France
Department of Cardiology, Royal Brompton Hospital, London, United Kingdom
Clinical Trials Unit Bern, Bern University Hospital, Bern, Switzerland
|||| Department of Cardiology, Bern University Hospital, Bern, Switzerland
¶¶ Triemlispital, Zurich, Switzerland
* Reprint requests and correspondence: Dr. Patrick W. Serruys, Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, ‘s Gravendijkwal 230, Bd 412, 3015CE Rotterdam, the Netherlands (Email: p.w.j.c.serruys{at}erasmusmc.nl).
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. Post-hoc–stratified analysis of angiographic and clinical outcomes at 9 months and 1 year, respectively, was performed for vessels with reference diameter  2.75 mm versus >2.75 mm.
Results: Of 1,707 patients, 429 patients in the BES group with 576 lesions and 434 patients in the SES group with 557 lesions had only small vessels treated (50.6% of the patient cohort). In patients with small vessels there was no significant difference in overall major adverse cardiac events (MACE) rate (12.1% vs. 11.8%; p = 0.89) or target lesion revascularization (TLR) rate (9.6% vs. 7.4%; p = 0.26) between BES and SES. The MACE and TLR rates in the small-vessel patient population were higher than in the large-vessel population. The TLR rate was 9.6% versus 2.6%, and MACE rate was 12.1% versus 7.1% for small versus large vessels in the BES arm (TLR: hazard ratio [HR] = 3.724, p = 0.0013; MACE: HR = 1.720, p = 0.0412). In the SES arm, TLR was 7.4% versus 5.1%, and MACE was 11.8% versus 10.3% in small versus large vessels (TLR: HR = 1.435, p = 0.2594; MACE: HR = 1.149, p = 0.5546).
Conclusions: Prevalence of small vessel disease is high in an "all-comer" population with higher TLR and MACE rates. The BES and SES seem equivalent in treatment outcomes of small vessels in this "all-comer" patient population.
Key Words: biodegradable polymer • biolimus-eluting stent • long lesions • sirolimus-eluting stent • small vessels • target vessel revascularization
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Abbreviations and Acronyms
| | BES = biolimus-eluting stent(s) | | MACE = major adverse cardiac events | | MI = myocardial infarction | | MLD = minimal lumen diameter | | PES = paclitaxel-eluting stent(s) | | RVD = reference vessel diameter | | SES = sirolimus eluting stent(s) | | TLR = target lesion revascularization | | TVR = target vessel revascularization |
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