March 19th, 2010
“Doc, I’m so confused. Do I stop or continue the clopidogrel?”
Richard A. Lange, MD, MBA
A recent study suggested that clopidogrel can be discontinued 12 months after drug-eluting stent placement. What do I tell my patient who had a drug eluting stent placed a year ago? He’s not the only one who’s confused.
I’m concerned that the study was underpowered and the duration of follow-up too short to provide a firm conclusion about the appropriate duration of clopidogrel therapy. I’m not comfortable recommending my patients stop clopidogrel after 12 months. Are you?
How would you explain your opinion to the patient?
6 Responses to ““Doc, I’m so confused. Do I stop or continue the clopidogrel?””
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When to stop dual antiplatelet therapy in patients with drug eluting stents
recent data from the combined studies REAL-LATE and ZEST-LATE suggest that stopping dual antiplatelet therapy (DAPT) after 12 months does not alter clinical outcomes when compared to continued DAPT. However, these results must be interpreted with caution. For instance, given the low event rates, the study may have been underpowered to detect a definitive difference. Also, the statistical analyses were made based on an assumption of 50% reduction in clinical outcomes (i.e. cardiac death and MI). This may have been an unrealistic assumption. Another limitation of the study is the fact that 3/4th of the patients in the study did not reach the preset 24-month followup time frame. This can alter the results of the study.
Although this study will clearly provoke attention and discussion, it will not definitively answer the ongoing debate on duration of DAPT. Much larger, randomized, placebo controlled studies are currently ongoing. I personally am eagerly awaiting the results of these studies.
And, what about the patient?
Amir:
When your patient asks if they should continue plavix 12 months after DES placement, what are you telling them?
Extremely important clinical dilemma; especially when more and more patients, perhaps due to financial hardship, are looking to reduce medication cost. The clopidogrel question after DES is a very common one in clinical practice. I have to say that I have been reluctant to stop clopidogrel immediately after 12 months. But recently I have seen several patients that are still on plavix more than 2 years after stent placement. I tell them that the benefit of staying on plavix for that long is unknown and that it is know that dual antiplatelet therapy is associated with a mild increase in bleeding risk. Unknown benefit versus real risk, albeit not that “serious”. Facing these 2 options, I have opted for recommending stopping clopidogrel. I would appreciate feedback from the interventional folks.
what about events in other circulations
Clopidogrel is clearly a strong anti-atherosclerotic and anti-thrombotic therapy, and was effective in CAPRIE, CURE, CREDO, and COMMIT; with benefit also seen in the secondary prevention group of CHARISMA. What about non-stent related events such as carotid strokes, peripheral emboli, mesenteric ischemia, and renal atherothrombosis – I usually NEVER stop clopidogrel, unless there is an imminent bleeding hazard. Why should I stop a therapy which has demonstrated clear evidence of efficacy in both non-coronary and coronary circulation? Richard, what has been your practice on this issue?
Dual antiplatelet therapy with clopidogrel plus aspirin has been validated in the settings of ACS and coronary stenting. However, in CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance) no benefit was found in the overall broad population of stable patients studied. So I’m selective as to who I prescribe clopidogrel.
In the absence of bleeding complications, I typically continue clopidogrel indefinitely after DES placement (4 yrs after placement 40% of the struts are not endothelialized). As Juan mentions, however, patients really complain about the cost of the medication….especially after hearing that clopidogrel can be stopped after 12 months.
Beware of misleading statistics
If you are looking for no difference and you under-power the study, you will find no difference. Based on a number of prior studies showing an improvement in outcomes up to 3 years after DES with dual anti-platelet therapy, I hesitate to change clinical practice based on this one study. I find Dr. Kashani’s remarks compelling.