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Interaction Between Guiding-Extension Catheter and Drug-Eluting Stents: Always Safe or Sometimes Harmful?
Salvatore Colangelo1, Riccardo Mangione1, Mario Iannaccone1
1Cardiovascular Intervention, San Giovanni Bosco Hospital, Torino, Italy.
Insights
This study found that polymer-free drug-eluting stents (DES) significantly reduce adverse events during complex percutaneous coronary intervention (PCI) when used with guiding-extension catheters (GECs). The polymer-free DES demonstrated superior safety and efficacy in preventing stent damage and improving patient outcomes.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Guiding-extension catheters (GECs) enhance support during complex percutaneous coronary intervention (PCI).
- GECs can increase friction with drug-eluting stents (DES), potentially damaging stent struts.
- This interaction risk necessitates evaluating alternative DES designs.
Purpose of the Study:
- To compare the performance of a polymer-free DES (Amphilimus Cre8 EVO) against surface-coated DES.
- To assess if the polymer-free DES's abluminal reservoir technology mitigates abrasion risk within GECs.
- To evaluate the safety and efficacy of different DES types during complex PCI with GEC use.
Main Methods:
- A prospective study enrolled 218 patients undergoing complex PCI with DES and GEC use.
- Patients were divided into two groups: polymer-free DES (Group A, 39 patients) and other DES (Group B, 179 patients).
- A device-oriented composite endpoint (DoCE) was assessed at one-year follow-up, including cardiovascular death, target vessel MI, and target lesion revascularization.
Main Results:
- Event-free survival from DoCE was significantly higher in the polymer-free DES group (97.4%) compared to the other DES group (85.5%) (Log rank = 0.027).
- A significant difference in mean stent length was observed (Group A: 52.4 ± 38.6 mm vs. Group B: 40.4 ± 22.6 mm, p=0.01).
- No significant differences were noted in other clinical or procedural variables.
Conclusions:
- The polymer-free DES demonstrated superior one-year outcomes in preventing DoCE during complex PCI with GECs.
- The abluminal reservoir design of the polymer-free DES may prevent adverse interactions with GECs.
- This suggests polymer-free DES are a preferred option when GECs are employed in complex PCI procedures.
Background:
Guiding-extension catheters (GECs) provide enhanced support to guiding catheter (GC) during complex percutaneous coronary intervention (PCI). However, by reducing the inner cross-sectional diameter, they can create high friction between the GEC and the drug-eluting stents (DES), potentially causing abrasion and damage to the abluminal struts.
Aim:
This study aims to compare the performances of the Amphilimus Cre8 EVO polymer-free DES with all the other surface-coated DES. The abluminal grooves of this polymer-free DES, which contain the drug and avoid any risk of its abrasion and detachment (abluminal reservoir technology), may offer a protective effect during stent advancement within the GEC.
Methods:
Between January 2019 and April 2024, 218 patients who underwent complex PCI procedures with the insertion of a DES and the use of GEC were enrolled in the study. They were divided into Group A (39 patients) received the Amphilimus polymer-free DES, while Group B (179 patients) received other types of DES. To evaluate the efficacy and safety of the DES used, a device-oriented composite endpoint (DoCE) was assessed at one year of follow-up. This composite endpoint included Cardiovascular Death, Target Vessel Myocardial Infarction, and Clinically and Physiologically indicated Target Lesion Revascularization.
Results:
At the one-year follow-up, the primary endpoint demonstrated a statistically significant difference between the two groups. Event-free survival from DoCE was 97.4% in Group A compared to 85.5% in Group B (Log rank = 0.027). Additionally, there was a significant difference in mean stent length between the groups: Group A had a longer mean stent length of 52.4 ± 38.6 mm, while Group B had a mean length of 40.4 ± 22.6 mm, with a p-value of 0.01. All other clinical and procedural variables were similar between the two groups.
Conclusion:
Our findings suggest that the polymer-free DES tested in this study appears to be the most effective option when using GECs, as it may help prevent negative interactions between the inner surface of GEC and the abluminal struts of the DES.
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