Applying Real-World Evidence in the Management of CAD/PAD - Episode 7
Deepak Bhatt, MD, MPH: This case is a 66-year-old man. He presents with worsening claudication despite being enrolled in a walking program. The doctor before you has already done that, so you can’t say that the patient should start a walking program. He has a history of hypertension and hyperlipidemia. The blood pressure is well controlled with an ACE inhibitor. He’s on ramipril 10 mg a day, and the LDL [low-density lipoprotein] is 68 mg/dL with 40 mg of atorvastatin. He’s found to have an occlusion of the right superficial femoral artery [SFA], and the doctors managing him decided he needs a stent placed for that right-sided claudication, so that is done. He also has a moderately severe left-sided SFA stenosis, but it isn’t stented.
After the procedure, would you recommend aspirin and clopidogrel, aspirin plus rivaroxaban, or aspirin plus clopidogrel plus rivaroxaban? If you choose the triple antithrombotic regimen, how long would you continue the aspirin, clopidogrel, and rivaroxaban if that’s your choice? Marc Cohen, I’ll start with you. This is a patient for whom you may be involved in their initial care, or maybe you’re involved with their subsequent care. What would you recommend?
Marc Cohen, MD: I would reach back to the pioneer days with Michael Gibson and say that our infatuation with triple therapy or our concern that we need to cover all the bases aggressively may be a little overrated. If someone sent this patient home for a month of triple therapy, I wouldn’t go crazy about it, but I would definitely not perpetuate triple therapy and the bleeding risks involved with triple therapy for any length of time longer. That’s my way of doing things. We have data across many agents and many trials that substantially support the efficacy as well as the enhanced safety of funneling down to double therapy quickly.
Deepak Bhatt, MD, MPH: Yes. That seems like good advice based on other trial data, but clopidogrel remains popular among peripheral interventionists. The trial data from the VOYAGER-PAD trial shows that about half the patients were getting it. Manesh, what do you do in your clinical practice [Duke University School of Medicine]? Let’s say that this is a patient unilateral SFA stenting. The plan may be to bring this patient back for the other side. That’s not clear from the way I presented the data. All we have is what I’m saying right now, so what would you do with this patient on discharge from the procedure? There had been procedure. You just stented their right SFA. What are they going home on? It’s probably a same-day discharge. What are you sending them home on?
Manesh Patel, MD: Deepak, this is a great question, and it’s very much in-line with what we did in the VOYAGER-PAD trial. These days, we had to do a bit of work in our cardiac catheterization outpatient holding area because, as is probably true for you all, many of our patients are going home the same day as fast as possible, especially in the time of COVID-19 [coronavirus disease 2019]. This may be as soon as they’re hemodynamically stable and the groin site is OK. This is a patient who we know had a right-side SFA occlusion, so they probably accessed the left femoral. Postprocedure, we’re usually treating the patient with aspirin daily when they come in. We don’t preload the patient as we do in the coronary world. We treat that patient because we’re going in endovascularly.
Today most of these patients in our practice are going home on aspirin and rivaroxaban. Whether clopidogrel is added to that is dependent a bit on the operator’s comfort in letting go of clopidogrel. I’ll be honest: In our lab, it may also depend on whether drug-coated products are being used, although there are some interesting data from the VOYAGER-PAD trial that Marc and others can speak about where it didn’t seem to make a big difference there either. Most of the time, if this is uncomplicated, the patient is going home with aspirin and rivaroxaban 2.5 mg bid [twice daily]. We’re trying to make sure that the work we had to do will make sure that they can get that therapy in the lab and then make sure they could fill that prescription when they went home. That’s our standard of care.
Deepak Bhatt, MD, MPH: In terms of duration, I know Marc reviewed the duration of the VOYAGER-PAD trial, and we alluded to the COMPASS trial, and we alluded to longer-term therapy. Specifically for the audience, about how long would you the continue that regimen in this post-right-sided SFA stent? Would it be for some period of time after the procedure, or would you keep them on it indefinitely, assuming there are no bleeding complications, obviously?
Marc Bonaca, MD, MPH: That’s a great question because it was a procedural trial too with shorter-term follow-up, although we presented 3-year outcomes. For rivaroxaban, I would start early. The acute limb ischemia benefit was apparent within 30 days, even shorter regardless of clopidogrel. There was about a halving of the risk of acute limb ischemia even if you use clopidogrel. You don’t want to delay the start. The interesting thing was part of the synergy with the COMPASS trial; these patients evolved from a postprocedural, very high-risk patient, almost like an analogy of a patient with ACS [acute coronary syndrome] who then becomes a patient with chronic PAD [peripheral artery disease] like those who were studied in the COMPASS trial. There, the results are clear. My practice is to start it, not to withhold it or delay it, and I then continue it long term.
For clopidogrel, it’s hard to say if there’s a benefit. It’s hard to say that there’s not a benefit. From the VOYAGER-PAD trial at least, it wasn’t randomized. It certainly doesn’t attenuate or doesn’t erase acute limb ischemia, which I would think would be the reason. You don’t want the stent to clot, but it’s not doing that to the extent that rivaroxaban is not efficacious. I have to say, at our institution [University of Colorado School of Medicine], people are still using clopidogrel after endoscopy. We’re adding rivaroxaban on top because we know it’s safe to do so, and we’re then limiting the duration of clopidogrel to about 30 days because we think the bleeding risk is acceptable there. With time, we’ll be dropping the clopidogrel; there’s just the question of transition.
Deepak Bhatt, MD, MPH: That’s interesting. I’ll throw out 1 set of data that we haven’t mentioned, and it’s from the ATLAS ACS-2 TIMI 51 trial paper Michael Gibson published in JACC [Journal of the American College of Cardiology] looking at stent thrombosis from that trial. There didn’t seem to be a beneficial effect of rivaroxaban vs no rivaroxaban at the vascular doses we’re talking about with respect to stent thrombosis. That is for coronary stents obviously, so we’re talking about whatever size coronary stents were in that trial, let’s say 2.5 to 4 mm or so. That is probably still useful information for an SFA stent. I didn’t say what diameter this was, but it may be somewhere between 5 and 7 mm, depending on the size of the person. If it’s helping stent thrombosis in that range, the rate of stent thrombosis with a larger diameter stent is probably being reduced as well. There are some data if we’re willing to extrapolate from the CAD [coronary artery disease] with the PAD-type stents.
Transcript Edited for Clarity