Related Experiment Video
Updated: May 22, 2026
Implantation of Human-Sized Coronary Stents into Rat Abdominal Aorta Using a Trans-Femoral Access
Published on: November 19, 2020
Intra-individual head-to-head comparison of Sirolimus®- and Paclitaxel®-eluting stents for coronary
M Kollum1, T Heitzer, C Schmoor
1University Hospital Freiburg, Dept. of Cardiology and Angiology, Hugstetter Straße 55, 79106 Freiburg i Br, Germany. marc.kollum@uniklinik-freiburg.de
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.
Insights
This study shows that comparing drug-eluting stents (DES) within the same patient is feasible and safe. Sirolimus-eluting stents (SES) demonstrated less neointima than Paclitaxel-eluting stents (PES), though outcomes varied individually.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Patient characteristics can influence drug-eluting stent (DES) success.
- Heterogeneity in response to different DES necessitates further investigation.
- Intra-individual study designs can minimize confounding patient factors.
Purpose of the Study:
- To assess the feasibility and impact of an intra-individual comparison design for DES.
- To compare the efficacy of Sirolimus-eluting stents (SES) versus Paclitaxel-eluting stents (PES) within the same patient.
- To address concerns regarding response variability to different DES.
Main Methods:
- Prospective, randomized, multi-center trial involving 112 patients.
- Patients with two distinct coronary artery lesions were treated with one SES and one PES.
- Primary endpoint: in-stent luminal late loss (LLL) at 8 months via quantitative angiography.
Main Results:
- Sirolimus-eluting stents (SES) showed significantly less neointima (LLL: 0.13 ± 0.28 mm) compared to Paclitaxel-eluting stents (PES) (0.26 ± 0.35 mm; p=0.011).
- 53/87 patients had similar efficacy between SES and PES; 34/87 showed divergent results (26 favoring SES, 8 favoring PES).
- Major adverse cardiac events (MACE) occurred in 17% of patients; repeated target lesion revascularization (TLR) was low for both SES (4.6%) and PES (2.7%).
Conclusions:
- Intra-individual comparison of DES is feasible, safe, and yields comparable results to inter-individual studies.
- This design highlights that the failure of one DES does not predict the failure of another.
- Individual patient responses can significantly influence the comparative effectiveness of different DES.
