COMPLEX LARGE-BORE RADIAL PCI TRIAL

The radial artery has become the standard access site for percutaneous coronary
interventions (PCI). This is driven by the lower rate of major bleeding and
vascular complications, particularly in patients with acute coronary syndromes
(ACS) treated with more intensive antithrombotic therapy. The lower mortality
rate in ST-elevation myocardial infarction (STEMI) has led to a strong
recommendation in current guidelines for TR intervention.
A patient group that may also benefit from TR intervention are patients with
complex coronary lesions requiring treatment with large-bore guiding catheters
(>= 7 fr). Large-bore guiding catheters provide better back-up and materials*
compatibility, leading to better procedural success rates in more complex
lesions. In most instances, the femoral artery is used for complex PCI with
large-bore guiding catheters due to the radial artery - sheath mismatch which
is in return associated with vascular bleeding complications and adverse
clinical outcome.
With the introduction of the 7 Fr. thin-wall TR introducer sheath (Glidesheath
Slender®, Terumo), TR complex PCI may still be performed in the majority of
patients with standard large-bore guiding catheters. The outside diameter is
reduced by 1 Fr while maintaining the inner-diameter equivalent. It was
recently shown that complex PCI with a 7 Fr Glidesheath Slender is safe and
effective.

Primary objective
To investigate if TR PCI is associated with less access site related bleeding
and/or vascular complications as compared with TF PCI for complex coronary
lesions with large-bore 7 Fr. guiding catheters.

Secondary objectives: To compare the TR and TF approach with regard to
procedural success, procedural time, fluoroscopy time, contrast use, crossover
and MACE rates for complex PCI with large-bore 7 Fr. guiding catheters.

Exploratory objectives:
Upper and lower extremity dysfunction (TR vs TF access)
Pain (VAS)(TR vs TF access)

international, multicentre, randomized study

patients will be randomized to:
- complex PCI with 7Fr catheter via the artery radialis
or
- complex PCI with 7Fr catheter via the artery femoralis

The feasibility and safety of complex PCI with a 7 Fr Glidesheath Slender has
been previously confirmed11. All participating centers have large experience
with complex PCI through the radial and femoral artery. PCI and medical
treatment are performed according to the local standards and current
international guidelines. Patients will not be exposed to extra visits. The
clinical status and patient reported outcomes will be gathered by a phone call
at 1-month follow-up. Blood collection during hospitalization will be part of
standard care. Based on the available data we consider the risks and burden of
this research project to be small. With minimal effort and risk, patients
included in this study are able to contribute to research to that may improve
the treatment of complex coronary lesions with large bore-guiding catheters,
which may have large impact on clinical practice and guidelines. This study
will be conducted in full accordance with the principles of the Declaration of
Helsinki.