Welcome to Dr. Warrick's podcast channel. Warrick is a practicing cardiologist and author with a passion for improving care by helping patients understand their heart health through education. Warrick believes educated patients get the best health care. Discover and understand the latest approaches and technology in heart care and how this might apply to you or someone you love. Hi, my name's Dr. Warrick Bishop and I'd like to welcome you to my podcast station and to the Healthy Heart Network. Today I'd like to share with you an amazingly important trial in cardiology. It's a trial called the Ischemia Trial. This trial was just literally recently released in the last days at the American Heart Association meeting in Philadelphia. called the ischemic trial, is it's earth shattering. It's game changing. It is defining of really the way we do cardiology. And let me explain it because I really do want to share it with you because it's an amazing trial. They took about 5,000 people. And they did a blinded, randomized controlled trial. So this means it's going to have a very high level of evidence. They also looked for major acute coronary outcomes or major coronary events. They call that MACE, and that includes heart attack, hospitalization, cardiac failure, admissions to hospital. So major adverse... cardiac events. And the question they wanted to ask was that in stable patients who have narrowings in the arteries demonstrated on a treadmill test with a moderate or even significant amount of lack of blood flow to the heart, can these patients be managed better through an invasive strategy where we jump in early and put in stents and open up whatever narrowings we can see or culprit narrowings? Or can these patients be better managed using a conservative approach where we dial up their therapy and give them optimal medical therapy? The rationale behind that is that there's been a feeling for some time based on a couple of trials, one called Barry 2 and one called the Courage trial, that if we take patients who are stable, not people who've had a heart attack or a recent acute chest pain syndrome, but people who are stable and we follow those people, if we manage them with a conservative strategy by getting their cholesterol down, making sure they're on aspirin, checking that their blood pressure is good. Making sure that we've addressed those risk factors as best as possible, which also includes diet and exercise, I might add. Can we manage those people without necessarily sending them to have stenting done? Well, this is really, really important because there's a large number of cardiologists who make a lot of money out of stenting because it's a procedure and those procedures pay handsomely. So for a long time, there's been a very strong advocacy and push. to be putting stents in two arteries that look narrowed, particularly if there's a problem with the stress test. So this trial, called the ischemia trial, was designed to follow on from Barry 2 and Courage trial to really answer the question, is what we're seeing there true or not? Are we really benefiting these people by taking them to an early, interventional strategy where we put in stents, or should we, in our early stages, be looking to simply give these people the best possible medical treatment? Well, the study has run for about three and a half years, approximately. There's over 5,000 people, double-blind, randomised, controlled trial in multiple centres across. America, and there may even be centres outside of the United States. I'd have to come back to you on that. All the patients were considered moderate to high risk with narrowings in their arteries as demonstrated on stress testing. To be enrolled into the trial, the main thing that they did was they did a CT coronary angiogram of the arteries just to make sure that there wasn't a severe or critical narrowing of the artery called the left main primary artery. Quick recap on the anatomy for you. If we think about the arteries that supply the heart, they are the first branches off the aorta, literally a centimetre or so above the aortic valve. So as the heart squeezes, blood squirted into the aorta, a centimetre or so, and two blood vessels come off the aorta. There's one that comes off to the right, that's the right coronary artery, and it goes and supplies the so-called inferior surface or diaphragmatic surface of the heart. The other blood vessel that comes off is called the left main, and it's called the left main because that main artery supplies two other major arteries, one called the left anterior descending artery, which runs down the front of the heart nearest the chest wall. and the circumflex artery, which runs around towards the back of the heart or nearest the spine. You can imagine if you've only got three main arteries supplying blood to the heart and one of those, sorry, two of those arteries can be shut down by the left main blocking, then that's a really, really important and serious place to have buildup of plaque and a heart attack occur. So, in the ischemia trial, all cases went through a CT coronary angiogram to make sure they did not have left main disease because that would have skewed the results. And those people, without question, are going to be at high risk and shouldn't be randomised to this sort of study. So, that very, very high risk... group taken out of the equation, the 5,000 people randomised to an early interventional strategy, which is an early intervention putting in stents where the narrowings are, versus an optimal medical therapy strategy. Well, it turns out after the three and a half odd years of the trial, that by the end of the trial, the outcomes in terms of major adverse coronary events were essentially the same it shows us it reminds us that there's an opportunity for us to not have to leap in and do stents at the first inclination of lack of blood flow to the heart in the stable patient so an amazing certainly one that I think will challenge our angioplasty cardiologists, who I believe will have thought they've been doing all the right things for patients for the last decade, putting in stents in stable angina and seeing the patients continue. Well, a very, very interesting... set of data, absolutely fascinating in terms of outcome. They did report that there was less symptoms at the end of one year in the early intervention group. So the people who had a procedure and got stented appeared to have a lower rate of symptoms at the end of a one-year period. Interestingly, In between the time that this trial was conceived, established and started to now, another trial has been released in that intervening period. So the trial that was released could not have informed the trial design of the ischemia trial. The trial that was done in the intervening period of time is called the Orbiter trial. And the Orbiter trial literally looked at doing a sham procedure for PCI. And that means that they did everything, including the angiogram and squirting dye and all that stuff, but they didn't actually fix the lesions. They showed nearly as good a response in reduction of angina for the people who had the sham event as the people who had a stent deployed. So go figure. That's a rather impressive demonstration of placebo effect and the power of doing something to someone. So the ischemia trial, it should change the way we view cardiology. It should slow down some of our angioplastias who are very quick to get people to the lab and put stents in. It should... start to filter through but it'll take a while it's only just been released in at the american heart association meeting which i believe was in philadelphia just literally days ago i really hope it encourages patients who hear about it to make sure they are on optimal medical therapy regardless of whether they're going to get a stent or not and also inform that conversation about really do i need to rush into this or not what are the pros and cons for me certainly in my own practice i would be i would already be dealing or working in that sort of with that sort of guide i've got a good number of patients who i've performed ct coronary angiography on who i know have a lot of plaque in their arteries i've managed them with optimal medical therapy and i have checked them with stress testing from time to time to see really what their functional capacity is like what their symptoms are like and really how much heart or myocardium which is the word we use for heart muscle myocardium could be at risk based on how much myocardium could be at risk the location of the plaque the age of the patient younger patients might be more likely to have an interventional strategy because they're likely to be more active. The symptoms the patient has, the difficulty in trying to control their cholesterol levels, I think we're now in a position where we don't have to rush in and plonk a stent in an artery. I think we're in a position where we can have a really sensible, thought-through conversation about what are the pros and cons in this particular situation and why would we advance knowing. from the ischemia trial that in stable, moderate to high risk patients with coronary artery disease, an early interventional study, sorry, an early interventional strategy really gives rise to a very similar outcome to an optimal medical therapy strategy after a three year, three and a half year period. So for what it's worth, if you have the opportunity to speak with your doctor about whether this case, this particular study, these results are relevant for you, please have that conversation. If you have any queries or questions about today's podcast, please drop us a note, let us know. The email is members at drWarrickbishop.online. As always, if you have any suggestions for future podcasts, please let us know. We'd love to hear. And as always, I'd really like to thank you for joining me. I really hope you found this informative and interesting. As always, I wish you the very best until next time. And please don't die from a heart attack. Goodbye. You have been listening to another podcast from Dr. Warrick. Visit his website at drWarrickbishop.com for the latest news on heart disease. If you love this podcast, feel free to leave us a review.