Story of a clinical trial provides serious food for thought

A still from the video of my PFO closure.
Click here to watch the video.

Something to think about: Clinical trials are necessary but can be thought-provoking.

The Houston Chronicle recently published a look at a clinical trial to find answers about closing a heart defect called a patent foramen ovale, or a PFO. It's potentially a stroke-causing defect. It was the probable cause of my stroke in 1998. It got patched up in 2007. You can click here to read about it.

But even though mine was fixed almost 10 years ago, it didn't end the controversy over whether the procedure - done in a cardiac catheterization lab - was really better than treating the defect with medication. One of my personal choices involved not taking blood-thinning warfarin - click here to read about it - for the rest of my life.

Thus, more clinical trials. Now, it's pretty clear that the procedure can prevent another stroke. But in this trial, there were some people who get the procedure, and some who didn't. So read the whole story how in a clinical trial, there are two patients, two paths:

"Bottom line, when you compare those with metal in their chest with those who don't, you see a 75 percent reduction in recurrent strokes with the device," said Smalling, professor and director of cardiovascular medicine at UT Health's McGovern Medical School.

The findings have significant implications. The heart defect is known as a PFO, or a patent foramen ovale, and is found in about a quarter of the U.S. population. It's believed to be a leading cause of otherwise inexplicable strokes in people under the age of 55, possibly leading to as many as 70,000 incidents each year.

By the time Garza signed up for the clinical trial in 2007, Smalling and the study's three other primary investigators had already amassed evidence to suggest the procedure was safe and effective. But to prove it, they needed to record at least 25 recurrent strokes in patients like Garza, who were being treated only with medication, and compare those outcomes with the patients who'd had the procedure.

It's a harsh reality at the heart of many clinical trials: To demonstrate a treatment is beneficial, a certain number of patients must go without — and sometimes suffer for it.