Heartfelt with Dr Melissa Walton-ShirleyView all posts »
Gamblers Anonymous: Help for those who make blanket statements on clopidogrel duration following DESMar 16, 2010 08:51 EDT
We need help controlling continuing behavior in spite of negative consequences
I've rarely left a more troubling trial than the presentation entitled "Extended Use of Dual Antiplatelet Therapy Not Effective." Since I'm no gambler, I've chosen to risk the small incidence of bleeding over catastrophic late stent thrombosis in my drug-eluting-stent (DES) patients, and I've extended my recommendation for clopidogrel therapy to an "indefinite time period" since shortly after their advent. I didn't come to that conclusion on a whim. Personally, I recall those frightening trials presented between 2005 through 2008 that dealt with the issue. I've sat beside and at the feet of Dr Renu Virmani, who actually alerted us to the problems with the entire DES platform when we were in the infancy of coating stents with antimitotic drugs. Although I could not locate the most concerning study, I recall one particular presentation in which the late stent thrombosis rate was 3.8% at four years with a >50% mortality. Studies that I could locate include the article on late stent thrombosis (JAMA 2005: 293:2126-2130), defined as occurrence of thrombosis later than 30 days; stent thrombosis yielded a 45% mortality. There are many other studies with both higher and lower late stent-thrombosis rates and higher and lower mortality rates reported. The concerning issue is that we have not reached any kind of consensus through adequately powered controlled randomized trials on the duration of clopidogrel therapy in the setting of DES utilization (see Circulation 2007: 115:1433-1439 and Anesthesia and Intensive Care 2007; 35:939-944). We have also refused to acknowledge that instruction for the utilization of clopidogrel cannot be a "one-size-fits-all" recommendation. Subsequently, stopping clopidogrel in DES patients is always somewhat of a gamble.
Problem gambling is a serious social problem and help is available
This study, presented by Dr Seung-Jung Park of Seoul, South Korea, randomized 2701 patients to either discontinuation or continuation of clopidogrel at 12 months following a DES implant. In the follow-up period of 19.2 months, there was a 1.8% incidence of the composite end point of cardiac death and heart attack in patients taking aspirin and clopidogrel vs 1.25% in the aspirin-only arm. An underpowered study with a short follow-up period and small sample size do nothing to reassure us that we are telling our patients that stopping clopidogrel is the right thing to do.
Problem gambling manifests itself in the form of various dysfunctional behaviors
Then there are the concerning issues of population variables such as genetics, lifestyle choices, and the effect of comorbidities that can have an impact on the risk of late stent thrombosis, not to mention lesion length and diameter. Throw into the mix the tawdry history of medical noncompliance of even a simple aspirin, and you have a recipe for disaster for many patients in both the DES and bare-metal populations. Heck, even with platelet-reactivity studies, we still can't come to a consensus about who needs what and for how long. In light of that issue, no one would argue that we would do any better by guessing.
Gambling addiction can cause disruption in every major area of life including psychological, physical, social, and vocational
For now, until I hear more reliable long-term data, I'm a "lifer" when it comes to clopidogrel use in DES patients--that is, until we have an adequate trial to suggest otherwise or until we have a better compound that will keep our patients safer. Of course, the patient's and the healthcare system's financial fitness determine duration of therapy more than any other issue in this current economic climate, and the occasional patient with big fat juicy vessels and few comorbidities stop their clopidogrel with a lot less protest from me than others, but I still document like crazy that I've presented the information that their outcome is "largely uncertain."
In the name of those patients who've gambled and lost, let's wait for a solid answer before we make broad sweeping recommendations on this issue.
Cognitive behavior therapy aims at replacing negative beliefs with healthy and positive ones.
If you or your patient need help, contact Gamblers Anonymous today.