This article is more than 5 years old. Information may no longer be current.
ARTE: Aspirin regimen confers fewer major adverse events after TAVR vs. DAPT
Click Here to Manage Email Alerts
Compared with dual antiplatelet therapy with clopidogrel and aspirin, single antiplatelet therapy with aspirin reduced the incidence of major or life-threatening bleeding events after transcatheter aortic valve replacement without increasing the risk for stroke or MI, according to results presented at EuroPCR.
“The ARTE trial, which included about twice as many patients as previous trials, showed the lack of any beneficial effect of DAPT (not as much as a tendency) in the prevention of cerebrovascular events post-TAVR,” Josep Rodés-Cabau, MD, from the Quebec Heart and Lung Institute and professor at Laval University in Quebec, and colleagues wrote in a simultaneous publication in JACC: Cardiovascular Interventions. “In fact, the stroke rate was numerically higher in the DAPT group (three strokes) as compared to the [single antiplatelet therapy] group (one stroke).”
The ARTE study was a prospective, randomized clinical trial with 222 patients (mean age, 79 years; 58% men) with a clinical indication for TAVR from nine centers throughout Canada, Europe and South America. Patients were assigned either aspirin alone (80 mg to 100 mg per day) or aspirin (80 mg to 100 mg per day) with clopidogrel (75 mg per day). At hospital discharge, both groups did not exhibit differences in valve hemodynamics.
Aspirin therapy began 24 hours before TAVR implantation and lasted for at least 6 months. Clopidogrel therapy started either 24 hours before the procedure in transfemoral approach patients or 24 hours after the procedure in non-transfemoral approach patients. Patients received 300 mg of clopidogrel in the initial dose, then 75 mg per day, which lasted for 3 months. Patients in both groups were followed up through clinical visits or phone interviews at intervals up to 1 year.
The primary endpoint was the rate of death, ischemic stroke or transient ischemic attack, MI or major/life-threatening bleeding at 3 months after TAVR. The rates of each individual component of the primary endpoint (MI, death, major/life-threatening bleeding and ischemic stroke/TIA) at 3 months were secondary endpoints.
At 3 months, patients assigned DAPT had a tendency towards a higher incidence of major or life-threatening bleeding, MI, death and ischemic stroke or TIA (15.3%) vs. the single antiplatelet therapy group (7.2%; OR = 2.31; 95% CI, 0.95-5.62). No difference was seen in the occurrence of MI in both the DAPT (3.6%) and single antiplatelet therapy groups (0.9%; OR = 4.13; 95% CI, 0.45-37.60). Researchers also did not observe differences in patients assigned to DAPT vs. single antiplatelet therapy for death (6.3% vs. 3.6%, respectively; OR = 1.78; 95% CI, 0.51-6.27), or ischemic stroke or TIA (2.7% vs. 0.9%, respectively; OR = 3.11; 95% CI, 0.32-30.43).
At 3 months, the DAPT group had a higher rate of major or life-threatening events (10.8%) vs. patients assigned single antiplatelet therapy (3.6%; OR = 3.22; 95% CI, 1.01-10.34).
“With the valvular disease guidelines endorsing blockage of either platelets or the coagulation cascade to prevent thrombus formation, physicians are now puzzled with the challenge of choosing between antiplatelets and anticoagulants for secondary prevention of cerebrovascular events after TAVR,” Davide Capodanno, MD, PhD, associate professor of cardiology at the University of Cantania in Italy, and Dominick J. Angiolillo, MD, PhD, professor of medicine at the University of Florida College of Medicine in Jacksonville and a member of the Cardiology Today’s Intervention Editorial Board, wrote in a related editorial in JACC: Cardiovascular Interventions. “This dilemma resembles the early days of [PCI], when historical trials comparing anticoagulant and antiplatelet drugs contributed to defining current adjunctive pharmacotherapy strategies to prevent stent thrombosis. Future trials will hopefully address the issue within the TAVR landscape.” – by Darlene Dobkowski
Reference:
Rodés-Cabau J, et al. Transcatheter Valves Interventions: Session Comprising Selected EuroPCR Late-Breaking Trial Submissions. Presented at: EuroPCR; May 16-19, 2017; Paris.
Capodanno D, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.05.005.
Rodés-Cabau J, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.04.014.
Disclosure: This trial was supported in part by a grant from Edwards Lifesciences. Rodés-Cabau reports receiving research grants from Edwards Lifesciences. Capodanno reports receiving consultant fees or honoraria from AstraZeneca, Bayer, Daiichi Sankyo, Eli Lilly and The Medicines Company. Angiolillo reports receiving consultant fees or honoraria from Amgen, AstraZeneca, Bayer, Chiesi, Daiichi Sankyo, Eli Lilly, Janssen, Merck, PLx Pharma, Pfizer and Sanofi; participating in review activities for CeloNova and St. Jude Medical; and receiving grants from Amgen, AstraZeneca, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Matsutani Chemical Industry Co, Merck, Novartis and Renal Guard Solutions. Please see the full study for a list of the other researchers’ relevant financial disclosures.
Perspective
Back to Top
David J. Moliterno, MD, FACC
One of the first things they found is that it’s difficult to enroll these patients in randomized studies at this point. That’s going to be one of the challenges for small, individual niche questions that people are trying to answer. Obviously, if it’s a new device, the companies that are developing the new device are going to have to come up with the funds for the research, but it’s a challenge if we’re trying to answer a question that doesn’t potentially have a lot of financial implications. Whenever we want to study aspirin, who wants to pay for it?
In brief, 222 patients that were allocated to receive either aspirin alone or aspirin plus clopidogrel, and after a number of months of trying to enroll patients — they were shooting for 300 — they decided to stop the study once reaching 222.
What they were able to show is that the events for the aspirin-alone group were not higher than the [DAPT] group, which is a good thing, but the conundrum is that the sample size is so small that it probably wasn’t adequately powered. Even with that powering, it looked numerically like the DAPT group had a higher event rate, which doesn’t always make sense to us. That’s why I can’t strongly endorse saying, “This is it. This is the answer. Now we can switch to aspirin monotherapy.”
With regard to bleeding, it’s obviously very encouraging. It looks [like] statistically less major life-threatening bleeding with the aspirin alone, probably largely related to vascular access site. The reduction was largely in the first 1 or 2 days, but that all the other events, the ischemic events, be it death, [MI] or stroke are numerically higher in the [DAPT] group is encouraging for aspirin monotherapy, though again they were all similar with regard to the statistical analysis.
For those patients in whom we’re concerned about bleeding, especially periprocedural bleeding, we don’t need to preload them with clopidogrel and can probably treat them with aspirin alone. Larger-scale studies will need to be done to be certain of that, but for now, we have some comfort.
Click Here to Manage Email Alerts