Intra-individual head-to-head comparison of Sirolimus®- and Paclitaxel®-eluting stents for coronary revascularization. A randomized, multi-center trial

M Kollum; T Heitzer; C Schmoor; M Brunner; B Witzenbichler; M Wiemer; R Hoffmann; K J Gutleben; H P Schultheiss; D Horstkotte; J Brachmann; T Meinertz; Ch Bode; M Zehender; FreRace Trial Investigators

doi:10.1016/j.ijcard.2012.04.095

Intra-individual head-to-head comparison of Sirolimus®- and Paclitaxel®-eluting stents for coronary revascularization. A randomized, multi-center trial

Int J Cardiol. 2013 Aug 20;167(4):1552-9. doi: 10.1016/j.ijcard.2012.04.095. Epub 2012 May 8.

Authors

M Kollum¹, T Heitzer, C Schmoor, M Brunner, B Witzenbichler, M Wiemer, R Hoffmann, K J Gutleben, H P Schultheiss, D Horstkotte, J Brachmann, T Meinertz, Ch Bode, M Zehender; FreRace Trial Investigators

Affiliation

¹ University Hospital Freiburg, Dept. of Cardiology and Angiology, Hugstetter Straße 55, 79106 Freiburg i Br, Germany. marc.kollum@uniklinik-freiburg.de

PMID: 22575624
DOI: 10.1016/j.ijcard.2012.04.095

Abstract

Background: Despite the known effects of drug-eluting stents (DES), other cofactors attributed to patient characteristics affect their success. Interest focused on designing a study minimizing these factors to answer continuing concerns on the heterogeneity of response to different DESs. The study's aim was to investigate the feasibility and impact of an intra-individual comparison design in patients (pts) with two coronary artery stenosis treated with a Sirolimus- (SES) and a Paclitaxel- (PES) eluting stent.

Methods and results: The study was conducted as a prospective, randomized, multi-center trial in 112 pts who consented to treatment with a SES and a PES. Pts were eligible if they suffered from the presence of two single primary target lesions in two different native coronary arteries. Lesions were randomized to either SES or PES treatment. The primary endpoint was in-stent luminal late loss (LLL), as determined by quantitative angiography at 8 months; clinical follow up was obtained at 1, 8, and 12 months additionally. The LLL (0.13 ± 0.28 mm SES vs. 0.26 ± 0.35 mm PES, p=0.011) showed less neointima in SES. With a predefined cut-off criterion of 0.2mm difference in LLL, 53/87 pts SES and PES were similar effective. 34/87 pts had a divergent result, 26 pts had greater benefit from SES while 8 pts had greater benefit from PES. Overall, MACE (MI, TLR, and death) occurred in 19 (17%) pts. Based on lesion analysis of 108 lesions treated with SES and 110 lesions treated with PES, 5 (4.6%) lesions with SES and 3 (2.7%) lesions with PES required repeated TLR.

Conclusion: An intra-individual comparison design to assess differences in efficacy of different DESs is feasible, safe and achieves similar results to inter-individual studies. This study is among the first to show that failure of one DES does not necessarily implicate failure of another DES and vice versa.

Keywords: Angiography; Coronary artery disease (CAD); Drug eluting stents; Head to head study design; Intra-individual comparisons; Vessel stenosis.

Publication types

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

MeSH terms

Adult
Aged
Aged, 80 and over
Coronary Stenosis / diagnosis*
Coronary Stenosis / epidemiology
Coronary Stenosis / surgery*
Drug-Eluting Stents*
Female
Follow-Up Studies
Humans
Male
Middle Aged
Observer Variation
Paclitaxel / administration & dosage*
Percutaneous Coronary Intervention / methods*
Percutaneous Coronary Intervention / standards
Prospective Studies
Sirolimus / administration & dosage*

Substances

Paclitaxel
Sirolimus