Dr.S.Ramasamy EECP Consultant.
Director of Heal your Heart EECP Centres.
In Charge of Vaso-Meditech EECP PPP program in TN Government Medical Colleges.
New trial published on Nov 2nd 2017 in Lancet a prestigious and one of the world's leading medical journal sends shock wave to Invasive cardiology circles across the world.This break through study called ORBITA was done on stable angina patients. Stable patients are those who have chest pain when: they are walking, emotional stress, climbing staircase etc., their pain is short lived and goes off immediately when the patients rest, taken a nitrate medication or both. This study showed Invasive procedure angioplasty with stent done on these stable patients with chest pain does not result in any greater improvement in patient walking distance, chest pain or overall quality of life when compared to a sham placebo procedure.
ORBITA trial shows Angioplasty does not result in greater improvements in walking distance or chest pain frequency compared with a sham procedure. This was despite the presence of proven coronary artery blockage by Angiogram
This sham placebo study directly compare the effectiveness of angioplasty in two groups.The first group underwent real treatment by opening the blocked artery and placing a stent. The second group underwent fake treatment without opening the artery or placing the stent. All the patients were blinded and didn't know whether they had undergone a real treatment or a fake ( Placebo) treatment. This kind of Placebo controlled trial was usually done to test the efficacy of drugs. This is the first time Placebo controlled trial was done to angioplasty from the day it was introduced to patients from 1977. This result will be intensively debated in cardiology circle and question the role of Angioplasty in stable patients with coronary artery blockage.
Previously many large trials Like COURAGE and BARI 2D in cardiology showed Angioplasty when compared to standard medical management. Angioplasty does not offer any superiority in reducing the chances of death or heart attack in patients who are stable and have chest pain. In simple sense its well accepted and known to cardiologist that angioplasty does not improve the patients survival and future heart attacks. These facts were downplayed when educating the patients when they were offered angioplasty. Patients were made to believe, and were effectively convinced by cardiologist that the blockage is very critical and they may get heart attack at any time or they are ticking time bomb with lethal consequence if not treated immediately.
But the same logical explanation was not applied in the Academic circle and in guideline recommendations contrary to whats been said to the patients. Here Angioplasty was recommended over medical management only due to its superiority in relieving chest pain. Its been argued here. The patients were offered Angioplasty in the first place only to relive chest pain and improve the quality of life. Also because many patient don't like to take multiple medication or don't want to wait until the medication starts working to relive their chest pain. Quick fix to get rid of the chest pain was considered the main reason for Angioplasty in these group of patients. However in real world setting how many patients would undergo angioplasty if they are explained clearly in plain words the following facts. The Invasive procedure Angioplasty they undergo will have some procedural risks, they will need long term medication to protect their stent, stent may close in future which needs repeat operation, stent may complicate and cause heart attack, and finally its done only for chest pain relief and will not give them an extension of life or will it prevent getting a heart attack in the future. The undue benefit of angioplasty, assumed by the patients and not properly explained by their cardiologist has lead to a very high number of procedures across the country. However in the western world the number of angioplasty in stable patients are in decline. If the patients were explained only for symptom relief they were recommended angioplasty, then only few patients may accept to undergo this procedure. Many patients accept to undergo angioplasty for fear of death not to just relive chest pain.
Now, shockingly even that traditional wisdom of past 40 yrs that angioplasty can relive your chest pain and quality of life was also now shattered by the well controlled sham trial ORBITA. This study may also influence guideline committees to downgrade the Angioplasty recommendation for stable patients. Now it appears deferring angioplasty in many patients and optimising the medical management could be the best treatment option.
Another question which baffles cardiologists is if the coronary blockage is fixed and blood flow is restored then why is angioplasty not able to improve chest pain, longevity and heart attack? The answer is much complex than what we all believe. This is where the microvascular circulation may play a major role. Traditionally angioplasty and Bypass surgery may not affect the microvascular flow which may be a major determinant of reducing chest pain, future chances of heart attack and hospitalisation. Now new treatments which can promote microcirculation and improve natural collaterals will be the future treatments in cardiology. Gene therapy and growth factor injection are under evaluation of US FDA.One such treatment is Vaso-Meditech Enhanced External CounterPulsation(EECP), which is a safe non invasive treatment option. The treatment is already approved by FDA approved and proven to work through microcirculation enhancement and restoring blood flow to heart muscle. The lesson now learned after decades of introduction of angioplasty is that even a successful angioplasty done to your coronary blockage as a elective procedure will not guarantee you the following. Add more life years to you, prevent a heart attack, decrease your chest pain or improve your quality of life. This is the lesson we have learned after three major trials COURAGE , BARI 2D and ORBITA. The next question is then what will Angioplasty offer to me if i undergo the procedure electively? simple answer is nothing until now and only further study has to clarify this grey area in cardiology.
Now the heroic declaration by cardiologist that fixing the blockage by opening it and securing it with stent can improve your symptoms or cure your disease or protect you against future cardiac problem can no longer be claimed with confidence. A word of caution is patients should also understand this results are applicable only to stable patients. In another group called unstable angina patients those who have long duration chest pain even with rest, not relived by medication, the heart is signalling a impending heart attack. The role of angioplasty is shown to be far more effective and life saving in these group of patients. Currently Patients are still blinded and ill-informed to understand the distinction between stable and unstable angina. They are not aware when angioplasty can offer greater benefit and when there is no reasonable benefit at all. The need for educating the patients what is expected of when they are advise for angioplasty is now of paramount importance to avoid unnecessary procedures. Currently more than 5 lakh angioplasty are done world wide in this group of stable patients ,which is now appears to be not required. In India the data is still not available.