New Trial ORBITA cast doubt on angioplasty effectiveness to relieve chest pain and improve quality of life and exercise tolerance.
Cardiology recommendation for angioplasty in stable patients is questioned as ORBITA trial shows no benefit.
Hello doctor in order to have an effective discussion about the medical field it must be important to actually discuss evidence-based medical researches and trials isn't that doctor? yeah, so doctor I've read about a medical trial called ORBITA. The ORBITA it was published in the Lancet Journal and I heard that the Lancet journal is one of the well known and prestigious medical journals in the world and also I've heard that the results of the ORBITA trial are very important to ordinary heart patients, May I know why is it so important?
Okay the trial ORBITA is published on a 2nd November and I think every cardiologist in this globe should know about the ORBITA trail. I believe it's our responsibility as a physician or a cardiologist we should able to communicate this ORBITA trial result to the general public and cardiac patient. Every patient should know what actually the trial stood for and what actually the result which came out. Even before explaining the ORBITA trial I would be open with you to say that the trial result is a big shock for all the cardiology community in the world because they expect something but what came out is contrary to what they have always believed for the past 30 40 years. The simple reason is this kind of confirmatory trial has not been initiated in cardiology for a very long time. This trial is an eye-opener.
I think from the 1970s the first time the angioplasty is done we all assumed that when you do an angioplasty we open up the vessel which I explained to you before. Angioplasty is a simple procedure where they put the catheter into your femoral artery in the groin area in the leg and move the catheter into the coronary artery where there is a blockage. Then they opened the artery by using a balloon so that the obstruction is compressed against the vessel wall. Now the vessels are open and the blood flow is restored and to prevent this part being closed again they put a wire mesh they call as a stent. Now logically speaking I think everyone will accept the simple fact if I can open the vessel and restore the blood supply then basically the patient would get betters relief of symptoms. I mean the patient who cannot even walk for two-three minutes they believe after opening the vessel they can do more exercise they have less frequency of angina and good quality of life. Now you should be very clear in this because it's not only angioplasty, these patients are already on medical management so they are taking a lot of pills and over the pills, they are taking, we are doing an angioplasty. When you do an angioplasty which is very expensive to do and also expose the patient's lot of complication so the simple thing we expect is at least it should provide improved quality of life and decrease your symptoms and reduce your nitrate intakes which are the medicine which you take for chest pain. So simply the patient expects to get better, feel better with no pain and increase exercise time without annoying or fearful chest pain.
Now I will explain the ORBITA trial. So the hypothesis or assumption tested in this trial is by adding an angioplasty over medical management the patients would get a better outcome, in the sense they can do more exercise and get better relief of their chest pain. In the ORBITA trial, the investigators tested this hypothesis or this popular assumption by taking patients in two groups. They call it as a Randomized Placebo-Controlled Double-Blind Trial. What they really did is they randomized the patients into two groups without patients knowing it. Each group has 100 patients each. First, all these patients are being asked to go for an angioplasty but one group they managed to do only medical management another group they managed with the medical management and angioplasty. The important point is the patient who kept on medical management alone didn't know they're kept at medical management alone, actually, they are also taken to the catheterization lab, they put a catheter up to their coronary artery but they didn't do angioplasty or stent. So these group patients assumed that they actually underwent an angioplasty but is the fact they weren't so this is called placebo.
In these two groups neither the patient nor the treating cardiologist knows who have not gone for a stent and who have gone for a stent so it's called blinded. Now the investigated followed up these patients for six weeks. Any interventional procedure in cardiac patients there should be a significant improvement in the quality of life and symptom immediately after the procedure, so after six weeks they analyzed a couple of important parameters. First is the quality of life, then exercise tolerance and then angina ( chest pain) frequency, what they find is surprised the investigators and actually devastating to all the cardiologists. They found out in spite of these people who have undergone stenting they did the same exercise they have the same quality of life they have the same angina symptom when compared to this group who have not done angioplasty.
So both this group behave in the same manner so it shows clearly even after opening the vessel with angioplasty we are not able to change the symptoms better than medication. This infers either the angioplasty you have undergone is ineffective to relive any cardiac symptoms or the patient with medical management has derived the maximum benefit already and subjecting the patient for an angioplasty would not have any additional improvement in the quality of life or exercise tolerance or reduction in chest pain.
So when you communicate or apply the results in your clinical practice you find it hard to recommend angioplasty to a stable patient.
Cardiologist usually convinces the patients to do angioplasty, by saying that I have placed you on optimal medical management (maximum drug ) and still not able to control your symptoms. Now I cannot rely upon the medical management alone and I have to move beyond this and to do an angioplasty to save your heart and have to improve your quality of life. Now this logical approach to angioplasty as per previous guideline recommendation has taken huge damage after ORBITA trial. If we still continue to recommend angioplasty to stable patients for symptoms relief its not an evidence-based medicine anymore.