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WASHINGTON – For antithrombotic therapy after transcatheter aortic valve implantation (TAVI), ticagrelor plus aspirin may be a better strategy than clopidogrel plus aspirin even though the latter combination is guideline recommended, according to a late-breaking, randomized study presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Unlike the ticagrelor regimen, which did deliver the goal antiplatelet effect for all 3 months of the study, “clopidogrel did not achieve adequate platelet inhibition before or after TAVI in most patients,” reported Victor A. Jimenez Diaz, MD, a cardiologist at University Hospital, Vigo, Spain.
The current American Heart Association/American College of Cardiology guidelines label the clopidogrel/aspirin combination for the first 6 months after TAVI “reasonable,” but Dr. Jimenez Diaz said that the value of this combination over other antiplatelet strategies has not been supported by a randomized clinical trial. The known variability in response to clopidogrel is among the reasons such data are needed.
Thrombotic and hemorrhagic complications are frequent after TAVI, making choice of antithrombotic treatment an important consideration for improving outcomes, according to Dr. Jimenez Diaz. The aim of the REAC TAVI trial was to evaluate whether ticagrelor provides a more consistent antiplatelet effect than clopidogrel for TAVI patients, which was undertaken at seven participating centers in Spain.
A total of 65 candidates for TAVI were enrolled in this study. The key exclusion criterion was chronic oral anticoagulation therapy. In a baseline assessment, patients in the study, all of whom were on 75 mg clopidogrel plus aspirin, were evaluated for high on-treatment platelet reactivity (HTPR), defined as a score of at least 208 platelet reaction units (PRU) on a standard assay.
The 46 (71%) patients found to have HTPR were randomized to 90 mg ticagrelor twice daily plus aspirin or to remain on the clopidogrel/aspirin combination. Unlike those with HTPR, in whom the mean PRU was 274 units, all of the patients without HTPR, who had a mean PRU of 134 units, remained on the baseline dual antiplatelet therapy. The study was open label.
The primary endpoint was adequate platelet antiaggregation, defined as absence of HTPR (less than 208 PRU), which was greater in the ticagrelor-treated group than the clopidogrel-treated group at 6 hours (91% vs. 4%), 5 days (100% vs. 10%), and 3 months (100% vs. 21%). In the patients without HTPR, the proportion with adequate platelet antiaggregation at these three time points were 73%, 64%, and 78%, respectively.
“The net difference in the randomized arms over the course of the study was 79%,” reported Dr. Jimenez Diaz, emphasizing that the study verified the hypothesis that ticagrelor would provide a more consistent antiplatelet effect than clopidogrel.
Although in-hospital bleeding complications were numerically higher in the clopidogrel-treated group (25% vs. 4%), this difference did not reach significance, and there were no significant differences in bleeding complications at any other time points or overall. There were two deaths in the clopidogrel-treated group, two deaths in the group without baseline HTPR, but no deaths in the ticagrelor-treated group.
While acknowledging that this study was small and not powered to show a difference in clinical events, Dr. Jimenez Diaz said it is important to emphasize that two-thirds of patients had HTPR at baseline. The high rate of HTPR among TAVI patients on clopidogrel and aspirin at baseline was identified as an important message from this study. However, a study is now needed to determine whether a ticagrelor strategy improves clinical outcomes when compared with a clopidogrel strategy.
A panel of experts at the CRT late-breaker session where these results were presented offered mixed reactions. While Jeffrey Popma, MD, director of interventional cardiology at Beth Israel Deaconess Hospital, Boston, called the results both “intriguing” and “provocative,” Ron Waksman, MD, associate director of the division of cardiology at the Medstar Health Institute, Washington, offered a note of caution, commenting that this application of ticagrelor “is off label, and then you would have to be concerned about the bleeding risk.”
However, all agreed that the optimal antithrombotic therapy for TAVI remains poorly defined and that randomized trials are needed to explore this issue.
This investigator-initiated study had no commercial sponsor. Dr. Jimenez Diaz reported no relevant financial relationships.
SOURCE: Jimenez Diaz VA. CRT 2018, Abstract LBT-10.
WASHINGTON – For antithrombotic therapy after transcatheter aortic valve implantation (TAVI), ticagrelor plus aspirin may be a better strategy than clopidogrel plus aspirin even though the latter combination is guideline recommended, according to a late-breaking, randomized study presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Unlike the ticagrelor regimen, which did deliver the goal antiplatelet effect for all 3 months of the study, “clopidogrel did not achieve adequate platelet inhibition before or after TAVI in most patients,” reported Victor A. Jimenez Diaz, MD, a cardiologist at University Hospital, Vigo, Spain.
The current American Heart Association/American College of Cardiology guidelines label the clopidogrel/aspirin combination for the first 6 months after TAVI “reasonable,” but Dr. Jimenez Diaz said that the value of this combination over other antiplatelet strategies has not been supported by a randomized clinical trial. The known variability in response to clopidogrel is among the reasons such data are needed.
Thrombotic and hemorrhagic complications are frequent after TAVI, making choice of antithrombotic treatment an important consideration for improving outcomes, according to Dr. Jimenez Diaz. The aim of the REAC TAVI trial was to evaluate whether ticagrelor provides a more consistent antiplatelet effect than clopidogrel for TAVI patients, which was undertaken at seven participating centers in Spain.
A total of 65 candidates for TAVI were enrolled in this study. The key exclusion criterion was chronic oral anticoagulation therapy. In a baseline assessment, patients in the study, all of whom were on 75 mg clopidogrel plus aspirin, were evaluated for high on-treatment platelet reactivity (HTPR), defined as a score of at least 208 platelet reaction units (PRU) on a standard assay.
The 46 (71%) patients found to have HTPR were randomized to 90 mg ticagrelor twice daily plus aspirin or to remain on the clopidogrel/aspirin combination. Unlike those with HTPR, in whom the mean PRU was 274 units, all of the patients without HTPR, who had a mean PRU of 134 units, remained on the baseline dual antiplatelet therapy. The study was open label.
The primary endpoint was adequate platelet antiaggregation, defined as absence of HTPR (less than 208 PRU), which was greater in the ticagrelor-treated group than the clopidogrel-treated group at 6 hours (91% vs. 4%), 5 days (100% vs. 10%), and 3 months (100% vs. 21%). In the patients without HTPR, the proportion with adequate platelet antiaggregation at these three time points were 73%, 64%, and 78%, respectively.
“The net difference in the randomized arms over the course of the study was 79%,” reported Dr. Jimenez Diaz, emphasizing that the study verified the hypothesis that ticagrelor would provide a more consistent antiplatelet effect than clopidogrel.
Although in-hospital bleeding complications were numerically higher in the clopidogrel-treated group (25% vs. 4%), this difference did not reach significance, and there were no significant differences in bleeding complications at any other time points or overall. There were two deaths in the clopidogrel-treated group, two deaths in the group without baseline HTPR, but no deaths in the ticagrelor-treated group.
While acknowledging that this study was small and not powered to show a difference in clinical events, Dr. Jimenez Diaz said it is important to emphasize that two-thirds of patients had HTPR at baseline. The high rate of HTPR among TAVI patients on clopidogrel and aspirin at baseline was identified as an important message from this study. However, a study is now needed to determine whether a ticagrelor strategy improves clinical outcomes when compared with a clopidogrel strategy.
A panel of experts at the CRT late-breaker session where these results were presented offered mixed reactions. While Jeffrey Popma, MD, director of interventional cardiology at Beth Israel Deaconess Hospital, Boston, called the results both “intriguing” and “provocative,” Ron Waksman, MD, associate director of the division of cardiology at the Medstar Health Institute, Washington, offered a note of caution, commenting that this application of ticagrelor “is off label, and then you would have to be concerned about the bleeding risk.”
However, all agreed that the optimal antithrombotic therapy for TAVI remains poorly defined and that randomized trials are needed to explore this issue.
This investigator-initiated study had no commercial sponsor. Dr. Jimenez Diaz reported no relevant financial relationships.
SOURCE: Jimenez Diaz VA. CRT 2018, Abstract LBT-10.
WASHINGTON – For antithrombotic therapy after transcatheter aortic valve implantation (TAVI), ticagrelor plus aspirin may be a better strategy than clopidogrel plus aspirin even though the latter combination is guideline recommended, according to a late-breaking, randomized study presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Unlike the ticagrelor regimen, which did deliver the goal antiplatelet effect for all 3 months of the study, “clopidogrel did not achieve adequate platelet inhibition before or after TAVI in most patients,” reported Victor A. Jimenez Diaz, MD, a cardiologist at University Hospital, Vigo, Spain.
The current American Heart Association/American College of Cardiology guidelines label the clopidogrel/aspirin combination for the first 6 months after TAVI “reasonable,” but Dr. Jimenez Diaz said that the value of this combination over other antiplatelet strategies has not been supported by a randomized clinical trial. The known variability in response to clopidogrel is among the reasons such data are needed.
Thrombotic and hemorrhagic complications are frequent after TAVI, making choice of antithrombotic treatment an important consideration for improving outcomes, according to Dr. Jimenez Diaz. The aim of the REAC TAVI trial was to evaluate whether ticagrelor provides a more consistent antiplatelet effect than clopidogrel for TAVI patients, which was undertaken at seven participating centers in Spain.
A total of 65 candidates for TAVI were enrolled in this study. The key exclusion criterion was chronic oral anticoagulation therapy. In a baseline assessment, patients in the study, all of whom were on 75 mg clopidogrel plus aspirin, were evaluated for high on-treatment platelet reactivity (HTPR), defined as a score of at least 208 platelet reaction units (PRU) on a standard assay.
The 46 (71%) patients found to have HTPR were randomized to 90 mg ticagrelor twice daily plus aspirin or to remain on the clopidogrel/aspirin combination. Unlike those with HTPR, in whom the mean PRU was 274 units, all of the patients without HTPR, who had a mean PRU of 134 units, remained on the baseline dual antiplatelet therapy. The study was open label.
The primary endpoint was adequate platelet antiaggregation, defined as absence of HTPR (less than 208 PRU), which was greater in the ticagrelor-treated group than the clopidogrel-treated group at 6 hours (91% vs. 4%), 5 days (100% vs. 10%), and 3 months (100% vs. 21%). In the patients without HTPR, the proportion with adequate platelet antiaggregation at these three time points were 73%, 64%, and 78%, respectively.
“The net difference in the randomized arms over the course of the study was 79%,” reported Dr. Jimenez Diaz, emphasizing that the study verified the hypothesis that ticagrelor would provide a more consistent antiplatelet effect than clopidogrel.
Although in-hospital bleeding complications were numerically higher in the clopidogrel-treated group (25% vs. 4%), this difference did not reach significance, and there were no significant differences in bleeding complications at any other time points or overall. There were two deaths in the clopidogrel-treated group, two deaths in the group without baseline HTPR, but no deaths in the ticagrelor-treated group.
While acknowledging that this study was small and not powered to show a difference in clinical events, Dr. Jimenez Diaz said it is important to emphasize that two-thirds of patients had HTPR at baseline. The high rate of HTPR among TAVI patients on clopidogrel and aspirin at baseline was identified as an important message from this study. However, a study is now needed to determine whether a ticagrelor strategy improves clinical outcomes when compared with a clopidogrel strategy.
A panel of experts at the CRT late-breaker session where these results were presented offered mixed reactions. While Jeffrey Popma, MD, director of interventional cardiology at Beth Israel Deaconess Hospital, Boston, called the results both “intriguing” and “provocative,” Ron Waksman, MD, associate director of the division of cardiology at the Medstar Health Institute, Washington, offered a note of caution, commenting that this application of ticagrelor “is off label, and then you would have to be concerned about the bleeding risk.”
However, all agreed that the optimal antithrombotic therapy for TAVI remains poorly defined and that randomized trials are needed to explore this issue.
This investigator-initiated study had no commercial sponsor. Dr. Jimenez Diaz reported no relevant financial relationships.
SOURCE: Jimenez Diaz VA. CRT 2018, Abstract LBT-10.
REPORTING FROM CRT 2018
Key clinical point: For platelet reactivity after transcatheter aortic valve implantation (TAVI), ticagrelor is more effective than clopidogrel.
Major finding:
Study details: A multicenter, randomized trial with 65 patients.
Disclosures: This investigator-initiated study had no commercial sponsor. Dr. Jimenez Diaz reported no relevant financial relationships.
Source: Jimenez Diaz VA. CRT 2018, Abstract LBT-10.