Since Robert A. Ersek, M.D. patented the first heart stent in 1972, the procedure has become a common practice in hospitals around the world. Hundreds of thousands of patients annually undergo a surgical procedure that includes inserting a stent into an artery. However, new research indicates that some of these patients may have undergone this procedure needlessly. One of the key reasons many patients have heart stents implanted is to ease chest pain, but research led by Dr. Justin E. Davies has found that heart stents fail to accomplish this.
The UK study titled “Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomized controlled trial” has astounded many physicians around the world. The practice of inserting heart stents in patients with chest pain and at least one severely blocked artery is common. Nearly every cardiac surgeon offers the procedure and several medical device manufacturers offer a vast array of stent options.
Part of what made the UK research unique was the way it was conducted. During the double-blind study, the team randomly assigned 105 patients to undergo percutaneous coronary intervention (PCI). Another 95 patients received a placebo effect, undergoing surgery but without receiving the stent. This is one of the few studies to provide fake surgical procedures to human participants.
Patients later underwent physical exercises and were interviewed regarding pain. The team noted no significant difference between the groups. Those who underwent the placebo performed as well physically and those who received the stent reported the same levels of pain well after the procedure.
This indicates that in most cases when a patient suffers from chest pain, having a heart stent inserted is not the solution.
The team also concluded that heart stents are still helpful in the event of a heart attack. By getting the stent in place, surgeons can restore vital blood flow and save a life.
Surgeons and cardiologists from around the world were stunned by the findings. Dr. Brahmajee K. Nallamothu of the University of Michigan called the study “humbling.” Dr. William E. Boden of Boston University School of Medicine said the results were “unbelievable.”
Dr. David Maron of Stanford University expressed a need for caution. Although the study was well conducted in his opinion, he also believes it left many important questions unanswered. For example, the study only examined people with a single major blockage. Whether the results hold for persons with several blockages is unknown.
In addition, Dr. Maron suggested that time may be a factor which needs further study. The UK study only considered results after six-week window had elapsed. It is not yet known if longer assessments would yield the same results.
If you or a loved one has been harmed by a defective medical device, contact a Pennsylvania defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. For a free consultation, call 800-369-0899 or 215-569-4000 or contact us online. We serve clients throughout the Philadelphia area and New Jersey including Philadelphia County, Chester County, and Delaware County.