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Published on: September 20, 2020
Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention
Thomas A Meijers1, Adel Aminian2, Marleen van Wely3
1Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.
Insights
Transradial percutaneous coronary intervention (PCI) is safer than transfemoral PCI for complex coronary lesions, significantly reducing bleeding and vascular complications. This approach offers a superior safety profile without compromising procedural success in large-bore interventions.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Transfemoral artery access is the standard for percutaneous coronary intervention (PCI) with large-bore guiding catheters in complex coronary lesions.
- Transradial equipment advancements suggest transradial PCI may offer a safer alternative for these complex cases.
Purpose of the Study:
- To compare the safety and efficacy of transradial (TR) versus transfemoral (TF) percutaneous coronary intervention (PCI) in patients with complex coronary lesions requiring large-bore guiding catheters.
- To determine if TR PCI reduces access site-related bleeding or vascular complications compared to TF PCI.
Main Methods:
- An international prospective multicenter trial randomized 388 patients undergoing PCI for complex coronary lesions (e.g., chronic total occlusion, left main, heavy calcification, complex bifurcation) to either 7-F TR access or 7-F TF access.
- The primary endpoint was access site-related clinically significant bleeding or vascular complications requiring intervention.
- Procedural success was assessed as a secondary endpoint.
Main Results:
- The primary endpoint event rate was significantly lower in the transradial access group (3.6%) compared to the transfemoral access group (19.1%) (p < 0.001).
- Procedural success rates were comparable between the groups (89.2% for TFA vs. 86.0% for TRA, p = 0.285).
- No significant differences were observed in procedural duration, contrast volume, or radiation dose between the transradial and transfemoral approaches.
Conclusions:
- Transradial access significantly reduces clinically relevant access-site bleeding and vascular complications in patients undergoing PCI for complex coronary lesions with large-bore catheters compared to transfemoral access.
- The transradial approach is a safer alternative for these procedures without negatively impacting procedural success.
Objectives:
The aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding catheters with respect to clinically relevant access site-related bleeding or vascular complications.
Background:
The femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach.
Methods:
An international prospective multicenter trial was conducted, randomizing 388 patients with planned PCI for complex coronary lesions, including chronic total occlusion, left main, heavy calcification, or complex bifurcation, to either 7-F TR access (TRA) or 7-F TF access (TFA). The primary endpoint was defined as access site-related clinically significant bleeding or vascular complications requiring intervention at discharge. The secondary endpoint was procedural success.
Results:
The primary endpoint event rate was 3.6% for TRA and 19.1% for TFA (p < 0.001). The crossover rate from radial to femoral access was 3.6% and from femoral to radial access was 2.6% (p = 0.558). The procedural success rate was 89.2% for TFA and 86.0% for TRA (p = 0.285). There was no difference between TFA and TRA with regard to procedural duration, contrast volume, or radiation dose.
Conclusions:
In patients undergoing PCI of complex coronary lesions with large-bore access, radial compared with femoral access is associated with a significant reduction in clinically relevant access-site bleeding or vascular complications, without affecting procedural success. (Complex Large-Bore Radial Percutaneous Coronary Intervention [PCI] Trial [Color]; NCT03846752).
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