Related Experiment Video
Updated: May 13, 2026
A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair
Published on: October 16, 2021
The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture
Michael Haude1, Stephen W L Lee, Stephen G Worthley
1Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. mhaude@lukasneuss.de
Insights
The Combo stent demonstrated noninferiority to the Taxus Liberté stent (PES) in reducing late lumen loss, showing comparable safety and efficacy in coronary artery stenting. Both drug-eluting stents had low rates of major adverse cardiac events and no reported stent thrombosis.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Background:
- Drug-eluting stents (DES) reduce restenosis and reintervention but are associated with late stent thrombosis and neoatherosclerosis.
- Novel stent technologies are needed to overcome the limitations of current DES.
- The sirolimus-eluting Combo stent with CD34 antibody coating presents an alternative approach.
Purpose of the Study:
- To compare the efficacy and safety of the sirolimus-eluting Combo stent versus the paclitaxel-eluting Taxus Liberté stent (PES).
- To evaluate angiographic, intravascular ultrasound, and clinical outcomes up to 12 months in the REMEDEE trial.
- To assess the noninferiority of the Combo stent regarding in-stent late lumen loss.
Main Methods:
- A randomized, controlled, multicenter trial (REMEDEE) involving 183 patients with de novo coronary artery stenoses.
- Patients were randomized 2:1 to receive either the Combo stent or the PES.
- Primary endpoint: in-stent late lumen loss at 9 months; Secondary endpoints: major adverse cardiac events (MACE).
Main Results:
- The Combo stent was noninferior to PES for 9-month in-stent late lumen loss (0.39 ± 0.45 mm vs. 0.44 ± 0.56 mm; pnoninferiority = 0.0012).
- At 12 months, MACE occurred in 8.9% of Combo patients and 10.2% of PES patients (p = 0.80), with no significant differences in mortality, myocardial infarction, or target lesion revascularization.
- No stent thrombosis was reported in either stent group.
Conclusions:
- The Combo stent met its primary noninferiority angiographic endpoint, demonstrating effectiveness.
- The Combo stent proved safe, with a low rate of clinical events comparable to PES.
- Both stent types showed no instances of stent thrombosis up to 12 months, suggesting a favorable safety profile.
Objectives:
This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months.
Background:
Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations.
Methods:
One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events.
Results:
The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group.
Conclusions:
In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.