Now, as if it weren’t scary enough having a heart attack at a young age and emerging with three drug-eluding stents in my arteries, there’s this news today:
New drug-oozing stents widely used to prop open clogged arteries are associated with an increased risk of blood clots, heart attacks and death for the majority of patients receiving the devices, an expert panel concluded yesterday.
Based on the finding, the special 21-member Food and Drug Administration panel recommended that the agency issue new warnings to doctors and patients that the devices’ safety has not been established except for relatively low-risk patients, for whom the stents were originally tested and approved.
“If you use the device outside that indication, you’re going to have a higher incidence of complications,” said William H. Maisel of the Beth Israel Deaconess Medical Center in Boston, who chaired the panel.
The panel stressed that the tiny metal-lattice struts, known as drug-eluting stents, offer advantages over older bare-metal versions for some patients, with the benefits outweighing the risks for the relatively healthy patients for whom the devices have been tested.
It remains unclear whether the devices are causing the complications in other patients; the side effects could be occurring because these patients tend to be sicker. But panel members concluded that until that question can be answered, doctors and patients should be alerted about the potential risks. Several members said they hoped that would make doctors more cautious about using the devices.
… The panel also recommended that patients who have the stents take anti-clotting drugs for at least a year.
More than 6 million people worldwide have gotten the drug-coated devices, including perhaps 3 million in the United States. At least 800,000 new patients get them each year, making the stents the most common device used to treat heart disease and one of the most common medical procedures of any kind. The panel’s recommendations apply to at least 60 percent of those patients.
… The newer stents are coated with a polymer impregnated with drugs that are released slowly, inhibiting scar-tissue growth. Because the devices were shown to be highly effective, they were hailed as a major advance and quickly replaced bare-metal versions for most patients, though the newer stents were tested on and approved for only low-risk patients.
The FDA called for the meeting after studies looking at patients outside tightly controlled clinical trials indicated that a year or more after implantation, patients with drug-coated stents faced increased risks compared with those with bare-metal models. Some researchers have estimated the newer devices might be causing thousands of heart attacks and deaths a year.
Some researchers, along with Boston Scientific Corp. and Johnson & Johnson, which make the two drug-eluting stents sold domestically, say any risks from the devices are offset by the reduced need for repeated procedures and bypass surgery, which carry their own risks.
Patients who get the stents had been advised to take aspirin and the drug Plavix for three to six months to reduce the risk of blood clots. Recent studies have indicated that patients may need to take the drugs longer, perhaps indefinitely. But Plavix is expensive and increases the risk of serious bleeding.
I bet there will be a flurry of questions waiting for cardiologists on Monday, mine included. Am I one of the “relatively healthy” patients to which this warning doesn’t apply? Or am I part of the 60% who should be worried? My cardiologist does have me on Plavix for a year, I’m on Coumadin right now to prevent clots but I think I’ll be going off that shortly. Or will I?
I’ll preface this by repeating that I’m married to an RN, an RN with 30+ years in the field. Here’s his point of view.
You are alive, I’ll say it again, you are alive. Alive because Dr’s were able to correct damaged blood vessels near or in your heart. Heart surgery, any surgery carries with it risks. But what ever those risks are, it still better than being dead.
Yes stints carry with them some risk (even unmedicated stints) but that risk pales in comparison to not getting treatment. Even if the stints only give you ten additional years, how many years do you think you would have had without them?
You got a second chance, make the most of it.
(I couldn’t agree with him more.)
I hope you’re getting off the Coumadin soon, I know an elderly person on that and it’s almost more than a curse than a cure. If they stub their toe or God forbid, get in some type of accident the resulting bruise can be quite disastrous- due to the lack of blood clotting. Gosh, I hate to spook you even more, but what good is a Gene without all the fretting.
Oh, man.
Tim, while that may seem like the attitude one should have, it just makes me more depressed — because the upshot of all that is that here I am at 40, living on borrowed time. Not very uplifting.
And Kirk, you have no idea — for the last 5 months, I have been covered in ugly dark bruises, I look like I have been in a serious car wreck or was beaten up. And I find bruises in the oddest places, prompting me to wonder just WHAT was I DOING to get a bruise there? Today, I have a big bruise and a knot on the back of my right hand. It looks like I was hammering a nail and hit my hand instead. Where it came from, I have no idea.
Still, this is better than when I was taking Lovanox back in August, which required twice-daily injections and left my entire torso with huge black bruises.
The heart attack was nothing compared to the recovery.
It all boils down to attitude.
At age 38 my brother was suffering from a serious bout of Hep C which was destroying his liver. After a grave discussion with his Dr ( I was there) he said, “You make it sound like I won’t hit forty” The Dr replied “Forty? Quit dreaming, I’m hoping we can keep you alive till Saturday”
My brother all 92 lbs of him, his skin a yellowish orange wept in my arms for what seemed like hours. The next day he started a high dose of Interferon Alpha 2B a hellish drug with very nasty side effects. He did that for a year. Then off the drug for a year, then back on again for another year.
His motivating factor was his wanting to see his young son graduate from High School. This spring he saw his son graduate from college with a degree in Criminal Law.
If you ask him if he’s living on ‘borrowed time’ he’ll laugh and say “Hell no, I was issued a new life and I’m making the most of it”
My older brother Les is now 62 and still going strong. Not bad for someone that had no chance to hit 40.