Aspirin Versus Clopidogrel as Single Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry

Abstract

Background: Current guidelines recommend dual antiplatelet therapy for the first 1 to 6 months after transcatheter aortic valve replacement (TAVR); however, recent studies have reported better outcomes with single antiplatelet therapy than with dual antiplatelet therapy in the occurrence of bleeding events, while not increasing thrombotic events. However, no data exist about optimal single antiplatelet therapy following TAVR. Methods: Patients who underwent TAVR between October 2013 and May 2017 were enrolled from the OCEAN-TAVI Japanese multicenter registry (Optimized Transcatheter Valvular Intervention). After excluding 1759 patients, 829 who received aspirin (100 mg/d) or clopidogrel (75 mg/d) after TAVR were identified and stratified according to the presence or absence of anticoagulation. Propensity score matching was performed to adjust the baseline characteristics between the aspirin and clopidogrel groups. Outcomes of interest were all-cause and cardiovascular deaths, stroke, and life-threatening or major bleeding within 2 years following TAVR. Results: After propensity score matching, 98 and 157 pairs of patients without and with anticoagulation, respectively, were identified. Falsification end points of pneumonia, urinary tract infection, and hip fracture were evaluated, and their rates were not different between groups. All-cause deaths were not statistically different between the groups in patients with (aspirin, 17.5%; clopidogrel, 11.1%; log-rank P =0.07) and without (aspirin, 29.6%; clopidogrel, 20.1%; log-rank P =0.15) anticoagulation at 2 years post-TAVR, whereas clopidogrel was associated with a lower cardiovascular mortality at 2 years in patients with (aspirin, 8.5%; clopidogrel, 2.7%; log-rank P =0.03) and without (aspirin, 18.0%; clopidogrel, 5.2%; log-rank P =0.02) anticoagulation. Conclusions: We demonstrated that clopidogrel monotherapy was associated with a lower incidence of cardiovascular death compared with aspirin monotherapy during the 2-year follow-up after TAVR regardless of anticoagulation use. Registration: URL: https://upload.umin.ac.jp ; Unique identifier: UMIN000020423.

Impact of On-Clopidogrel Platelet Reactivity on Incidence of Peri-Interventional Bleeding in Patients Undergoing Transcatheter Aortic Valve Implantation

“…Yet, all patients were on clopidogrel and ASA, so a potential general effect of ASA therapy on bleeding events cannot be excluded by our study. Indeed, it is known that bleeding events also occurred in patients undergoing TAVI if they are on ASA monotherapy [ 20 , 22 ]. This study was not powered to analyze if the previously described cut-off value for a high bleeding risk in patients on clopidogrel undergoing coronary stenting [ 17 ] is also suitable for patients undergoing TAVI.…”

Bayesian Meta-analysis of Direct Oral Anticoagulation Versus Vitamin K Antagonists With or Without Concomitant Antiplatelet After Transcatheter Aortic Valve Implantation in Patients With Anticoagulation Indication

“…Our study extends the findings of a previous meta-analysis that compared aspirin and clopidogrel with and without anticoagulant post-TAVI, which found clopidogrel associated with a lower incidence of cardiovascular-related mortality compared with aspirin, regardless of the presence of an anticoagulant. 50 Fourthly, with the paucity of data on the stratification of outcomes based on gender, sex-disaggregated subgroup analysis on prognostic outcomes for VKA vs DOACs was not possible. Larger prospective studies on gender differences in prognostic outcomes in TAVI patients receiving DOAC or VKA will be the next important step.…”

Antithrombotic therapy with Transcatheter aortic valve replacement

“…In the RCTs evaluating the use of SAPT post‐TAVR, low‐dose aspirin (81–100 mg) is typically the agent selected. Investigators of the Japanese OCEAN‐TAVI (Optimized Transcatheter Valvular Intervention) registry evaluated the use of aspirin or clopidogrel as SAPT for TAVR 51 . Between October 2013 and May 2017, the OCEAN‐TAVI registry enrolled 2618 patients receiving TAVR, with 849 receiving aspirin or clopidogrel as SAPT.…”