The findings of the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) trial were published in the New England Journal of Medicine in the June 7, 2009 issue.
The conclusion of this trial was much anticipated because it was supposed to give clear directions on how to treat people with diabetes who also have heart disease.
The study involved 2,368 people with non-insulin dependent diabetes (also called type 2 diabetes) and stable chronic angina.
This is a term applied to people who have blockages in the heart arteries, which are manifested by chest pain (angina).
The disease is called stable if chest pain does not last long and is promptly relieved by medications.
Unstable angina is a condition where the symptoms are worse than usual, more frequent than usual, are not controlled by medications, and may be associated with arrhythmia (irregular or rapid heart beats).
This is a more dangerous condition that can lead to a heart attack.
Patients with chronic angina may be treated only with drugs, but many doctors favor a more aggressive approach and recommend revascularization, which means either bypass surgery or angioplasty.
Bypass surgery is a very invasive procedure in which the chest is opened, heart is stopped, and the blockages in the heart arteries are "bypassed" by using a vein or an artery from another part of the body.
Balloon angioplasty is a procedure during which a catheter is inserted into an artery in the groin, threaded into the heart artery until it reaches the point of obstruction.
Then a balloon at the tip of the catheter is inflated to compress the plaque and create an opening.
Often a stent (a metal mesh tube) is inserted to keep that part of the artery from collapsing.
This can be done to one or several arteries at the same time.
Angioplasty may seem less invasive than the bypass, but it has frequent complications, such as bleeding, damage to the arteries, abnormal heart rhythms, allergic reaction to the dye or even kidney damage from the dye used during the procedure.
About 3% to 5% of people get a heart attack, 1% get a stroke, and 2% to 4% end up getting the bypass surgery anyway.
In this study half of the patients were assigned to revascularization (bypass or angioplasty), the other half was treated only with medications (statins, aspirin, beta blockers and ACE inhibitors).
The surgery was performed during the first 4 weeks of the study.
765 people had angioplasty, 347 had bypass surgery.
Five years later, 88.
3% of people were alive in the revascularization group, compared with 87.
8% in the medication group.
77.
2% of people in the revascularization group did not have cardiovascular events (heart attacks or strokes) vs.
75.
9% in the medication group.
In other words, after 5 years, there was no difference between the groups in either the overall survival or the rate of cardiovascular events.
This means that the revascularization surgeries were completely useless.
There are well over 1 million such procedures performed in the US every year with the estimated cost of about $300 billion.
I am sure that some of them were really necessary, but it is clear that the vast majority of them are not.
They do not save lives and they do not reduce the risk of heart attacks or strokes.
They are a complete waste of healthcare dollars.
According to this study, people with stable angina can be treated with medications alone without all the expense and complications of either bypass surgery or angioplasty.
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