Author + information
- Received May 4, 2009
- Accepted May 15, 2009
- Published online September 1, 2009.
- 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§§ and
- Stephan Windecker, MD, PhD∥∥
- ↵⁎Reprint requests and correspondence:
Dr. Patrick W. Serruys, Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, ‘s Gravendijkwal 230, Bd 412, 3015CE Rotterdam, the Netherlands
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.
- biodegradable polymer
- biolimus-eluting stent
- long lesions
- sirolimus-eluting stent
- small vessels
- target vessel revascularization
This work was funded by Biosensors Europe SA, Morges, Switzerland.
- Received May 4, 2009.
- Accepted May 15, 2009.
- American College of Cardiology Foundation