The DRAGON trial (1) recently presented at the recent TCT meeting in San Francisco, which included more than 1700 consecutive patients from 29 centers in China, showed that subjects who were randomized to the transradial (TRI) access PCI arm and individuals randomly assigned to the transfemoral (TRF) access arm had similar major adverse cardiac or cerebrovascular event (MACCE)-free rates at one year of follow up. Furthermore, less major bleeding events were reported to occur in the TRI group in the week following PCI (P<0.001), which was the major secondary end point in the study.
Surprisingly, the use of TRI varies considerably among countries and even in different centres within countries. Cardio Debate asked Dr P Lim, from St George’s Hospital in London, what are the implications of the DRAGON study regarding the adoption of a TRI approach as opposed to the more traditional TRF approach. How compelling are these results?
What factors do really come into play when considering the right PCI approach in a given patient?:
- technical issues
- training of the operator
- time required for the intervention
- patient preference
Saito S. A prospective randomized trial of transradial vs transfemoral access in patients undergoing coronary angiography and intervention. TCT; October 12, 2015; San Francisco, CA.
In most countries the horses have already bolted and the world has moved on, radial PCI is the default approach as opposed to femoral PCI. This accounts for 75% of cases in the UK in 2014, even higher in most far eastern countries like China where the Dragon Study was undertaken. This study looked at all comers, but excluded those with an abnormal Allen’s test which is not in line with current practice and would inevitably exclude up to 10% of cases. Furthermore there appeared to be a bias towards younger men who are easier radial cases. Radial PCI has mortality benefit in patients with acute coronary syndrome who are on multiple anticoagulants which predispose to access site bleeding. The 1% absolute difference in bleeding seen in the study is probably an underestimate. The European and British guidelines now recommend radial PCI for these patients taking into account the findings of large studies such as the RIVAL and RIFLE-ACS studies. It’s strange that the US’s rate of radial PCI is what UK’s was 10 years ago. This will change as and when patients are better informed, indeed in the UK the private insurance companies are driving up radial PCI by offering a premium rate.
There are many levels of radial expertise, the opportunists, taking on radial cases in mostly young men, the default operators, expanding the range to include most women and the elderly, and finally the diehards, who would perform radial PCI in all comers and in all settings. There are now no technical limitations with radial PCI. It’s known that as reported in the above studies, radial PCI outcome is better when performed by the default operators who do at least 70% of cases radially with no increase in procedural time. There is indeed a steeper learning curve, but the general consensus is that basic understanding of radial PCI can be had after 50 cases. The main benefits of radial PCI are lack of access site complications and patient comfort. As such, radial PCI is ideally suited for the outpatient setting reducing costs and for in-patients, it reduces nursing care and the need to deal with femoral access site complications encompassing femoral pseudoaneurysm, groin haematoma and retroperitoneal haemorrhage. These have significant implications for bed stay, morbidity and sometimes mortality. Therefore the practice of default femoral PCI is no longer defensible from the patient safety point of view.