Thanks so much, Shripal. Very comprehensive lecture and you addressed the major questions. So without further ado, we don't have much time. So we're going to talk to Sunil Rao, who has been the leader of the implementation of transradial access across in this country. And when you ask him, what was your role in the clinical guidelines? Just make sure the radial approach has class one indication, right, Sunil? Yeah, thanks, Mauricio. It's fantastic to be part of this group and really a pleasure to talk about the guidelines and vascular access. These are my disclosures. I have none related to this topic. So here's the guidelines. Let me start with what the guideline recommendations say. In section 10.1 of the guidelines, radial access and femoral access is reviewed. And there is a class one recommendation, level of evidence A for patients with ACS undergoing PCI. A radial approach is indicated in preference to a femoral approach to reduce the risk of death, vascular complications, or bleeding. In patients with stable ischemic heart disease undergoing PCI, radial approach is recommended to reduce access site bleeding and vascular complications. Also given a class of recommendation one, level of evidence A. So let's talk a little bit about the background of all of this and where this comes from. This is what I'm going to talk about over the next few minutes. Bleeding complications are common and associated with increased morbidity and mortality. Radial access is increasingly being adopted in the United States and worldwide. Randomized trials have shown that radial approach reduces bleeding across the spectrum of ischemic heart disease and randomized trials have shown that radial approach reduces mortality in high-risk patients. These are data from the American College of Cardiology, NCDR-Cath PCI registry, showing that the most common complication in patients with ST elevation MI and non-STEMI undergoing PCI is bleeding. It's more common than in-hospital mortality, recurrent infarction, or even shock, and therefore strategies to try and reduce that bleeding risk have taken on clinical priority. If you look at the proportion and the incidence of bleeding across the clinical presentations, bleeding is relatively low in patients with stable angina undergoing PCI, but the vast majority is related to the vascular access site. In contrast, the patients with a non-ST segment elevation ACS have a higher rate of bleeding, but only 30% of the bleeds are related to the vascular access site. The vast majority of bleeding is actually GI bleeding in that group. And then finally, in patients with ST segment elevation MI, they have the highest rate of bleeding and more than three quarters of those bleeding events are related to the vascular access site. I mention this because if you have a vascular access site strategy to reduce bleeding risk, and bleeding risk is associated with increased mortality, that strategy to reduce access site bleeding is going to have the biggest effect in patients with ST segment elevation myocardial infarction, and that is in fact what the randomized trials show. This is just one representative study. Many other groups have published on this, including Dr. Moran, showing that there is a strong relationship between the occurrence of in-hospital bleeding in patients with ACS and subsequent 30-day and longer-term mortality. The worse the bleeding complication, the higher the mortality risk. Therefore, reducing bleeding is something that potentially could improve survival in patients with ACS. Now, as I mentioned, there has been increased adoption of radial access worldwide. The United States has lagged a little bit. These are data from the NCDR-Cath PCI registry. Dimitri Feldman looked at this in 2013. At the time, radial access had gone from 1% of all the PCI procedures in the United States to somewhere around 11% in 2011. If you look at the NCDR data, at least the latest data that I've seen, as of the second quarter of 2021, 63% of all diagnostic caths and 54% of all PCIs in the United States are now performed via radial access, and I believe that that trend is continuing to increase. What do the data show? Well, there are several pooled analyses. This is one of the more recent ones. There's actually been an even more recent one presented at the ESC and published in circulation recently. But this is a meta-analysis of 24 studies in patients across the spectrum of presentation from stable ischemic heart disease to non-ST-segment elevation ACS and STEMI. If you look at major bleeding, clearly you see that radial access reduces major bleeding compared to femoral access by 47%. If you look at mortality, this is a pooled analysis of four ACS trials, including three that included patients with ST-segment elevation, MI, 17,000 patients. You see that not only is there a reduction in bleeding, but there's also a reduction in mortality with radial access. And again, if you follow the logic that bleeding is associated with increased mortality and bleeding is the highest in patients with STEMI, then a bleeding avoidance strategy should have a survival benefit in patients with ST-segment elevation, MI. This is just the STEMI patients. This is a pooled analysis of all the STEMI trials that have been done, including a neutral trial called Safari STEMI. And again, when you pool all the data together, you see that radial access reduces mortality compared with femoral access in patients with ST-segment elevation, MI. And then when you look at the patient-level meta-analysis, which was just published this year in circulation, again, you see the exact same thing, which is a significant benefit of radial access compared with femoral access in higher risk patients, such as those with ACS and those with ST-segment elevation, MI. So in summary, bleeding is the most common complication of PCI, and it's associated with both short- and long-term morbidity and mortality. Prospective randomized trials have shown that radial access reduces bleeding, and in high-risk patients, such as those with ST-segment elevation, MI, it reduces mortality. Therefore, based on those randomized trials, radial approach does meet criteria for class 1, level of evidence A, recommendation in the ACC AHA Sky revascularization guidelines in both patients with disabled ischemic heart disease and those with ACS undergoing PCI. Thanks very much.

transradial access

bleeding risk

mortality

percutaneous coronary intervention

PCI