5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.
The Evolut Low Risk trial demonstrated that transcatheter aortic valve replacement (TAVR) was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. Outcomes at 5 years have not been reported.
This study sought to evaluate 5-year clinical and hemodynamic outcomes with TAVR vs surgery in patients from the Evolut Low Risk trial.
We randomly assigned low-risk patients with severe aortic stenosis to TAVR or surgery. The primary endpoint was a composite of all-cause mortality or disabling stroke. Secondary endpoints included clinical, echocardiographic, and quality-of-life outcomes through 5 years.
A total of 1,414 patients underwent an attempted implant (n = 730 TAVR, n = 684 surgery). The mean age was 74 years (range 51-88 years), and women accounted for 35% of patients. At 5 years the Kaplan-Meier estimate for the primary endpoint of all-cause mortality or disabling stroke was 15.5% for the TAVR group and 16.4% for the surgery group (P = 0.47). The Kaplan-Meier estimates in the TAVR and surgery groups for all-cause mortality were 13.5% and 14.9% (P = 0.39) and for disabling stroke were 3.6% and 4.0% (P = 0.57). Cardiovascular mortality was 7.2% in the TAVR group and 9.3% in the surgery group (P = 0.15). Noncardiovascular mortality in the TAVR group was 6.8% and 6.2% in the surgery group (P = 0.73). A site-level vital status sweep was performed for patients who were lost to follow-up or withdrew from the study. With the addition of these patients, the all-cause mortality rate at 5 years for patients undergoing TAVR was 14.7% and for surgery was 15.2% (P = 0.74). Over 5 years, valve reintervention rate was 3.3% for TAVR and 2.5% for surgery (P = 0.44). A sustained improvement in quality of life was observed in both treatment arms with mean Kansas City Cardiomyopathy Questionnaire summary score of 88.3 ± 15.8 in TAVR and 88.5 ± 15.8 in surgery.
At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke. Valve durability and performance were excellent in both arms. This midterm evaluation reinforces the position of TAVR as noninferior to surgery in patients with severe aortic stenosis at low surgical risk (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).
Forrest JK
，Yakubov SJ
，Deeb GM
，Gada H
，Mumtaz MA
，Ramlawi B
，Bajwa T
，Crouch J
，Merhi W
，Wai Sang SL
，Kleiman NS
，Petrossian G
，Robinson NB
，Sorajja P
，Iskander A
，Berthoumieu P
，Tchétché D
，Feindel C
，Horlick EM
，Saito S
，Oh JK
，Jung Y
，Reardon MJ
，Low Risk Trial Investigators
... -
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Meta-analysis of longitudinal comparison of transcatheter versus surgical aortic valve replacement in patients at low to intermediate surgical risk.
Surgical aortic valve replacement (SAVR) is the commonly used approach for aortic valve replacement (AVR) in patients with aortic stenosis at low or intermediate surgical risk. However, transcatheter aortic valve replacement (TAVR) has emerged as an alternative to SAVR for AVR. This meta-analysis aims to assess the comparative efficacy and safety of TAVR versus SAVR in low-to-intermediate surgical risk patients by analyzing temporal trends in the outcomes of TAVR and SAVR at various follow-up intervals, providing a more detailed understanding.
A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception up to May 2024 to identify eligible randomized controlled trials (RCTs). Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% CIs.
A total of 17 studies reporting data at different follow-ups for nine trials were included (n=9092). No statistically significant difference was observed between TAVR and SAVR for reducing all-cause death at 30 days, 1 year, and 2 years but significantly increased risk with TAVR at 5 years or longer follow-up (RR=1.13, 95% CI: 1.03-1.23). However, TAVR was associated with a significantly decreased risk for cardiac death at 1-year follow-up (RR=0.79, 95% CI: 0.64-0.96) and comparable risk for cardiac death at 30 days, 2 years, and 5 years or longer follow-up when compared with SAVR. No statistically significant difference was observed between TAVR and SAVR for reducing the risk of myocardial infarction (MI) at 30 days, 1 year, 2 years, and 5 years or longer follow-up.TAVR was associated with a significantly lower risk of major bleeding events at 30 days (RR=0.38, 95% CI: 0.21-0.67); lower risk of acute kidney injury (AKI) at 30 days (RR=0.38, 95% CI: 0.26-0.54) and 1 year (RR=0.58, 95% CI: 0.41-0.82) and lower risk of new onset or worsening atrial fibrillation (AF) at 30 days (RR=0.25, 95% CI: 0.18-0.34), 1 year (RR=0.26, 95% CI: 0.16-0.41) and 2 years (RR=0.32, 95% CI: 0.20-0.49) when compared with SAVR. However, TAVR was associated with a significantly increased risk of permanent pacemaker implantation (PPI) at 30 days (RR: 2.62, 95% CI: 1.40-4.91), at 1 year (RR: 2.19, 95% CI: 1.24-3.87), at 2 years (RR: 2.74, 95% CI: 1.31-5.71), and beyond 5 years (RR: 1.95, 95% CI: 1.20-3.15). TAVR was also associated with a significantly increased risk of prosthetic valve thrombosis at 2 years (RR=2.70, 95% CI: 1.08-6.71), though no significant association was observed at 30 days, 1 year, or 5 years. Similarly, no significant differences were observed in aortic-valve reintervention rates at 30 days, 2 years, or 5 years, but TAVR showed a significantly increased risk at 1 year (RR=1.98, 95% CI: 1.21-3.24). TAVR was associated with a significantly increased risk of major vascular complications at 30 days (RR=2.37, 95% CI: 1.38-4.04) and a significantly increased risk of TIA at 2 years (RR: 1.43, 95% CI: 1.02-2.00, I2=0%). The risk of hospitalizations was comparable between the groups.
TAVR and SAVR demonstrated comparable rates of all-cause death up to 2 years of follow-up. However, at 5 years or longer follow-up, TAVR was associated with a higher risk of all-cause death. While TAVR showed certain procedural advantages, such as a lower risk of major bleeding, AKI, and new-onset or worsening AF, the choice between TAVR and SAVR in patients with low or intermediate surgical risk should consider long-term outcomes, with SAVR potentially being more favorable due to better survival observed on longer follow-up durations.
Ahmed M
，Ahsan A
，Shafiq A
，Nadeem ZA
，Arif F
，Zulfiqar E
，Kazmi MH
，Yadav R
，Jain H
，Ahmed R
，Alam M
，Shahid F
... -
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Non-vitamin K antagonist oral anticoagulants (NOACs) after transcatheter aortic valve replacement (TAVR): a network meta-analysis.
Balancing the risk of thromboembolism and bleeding after transcatheter aortic valve replacement (TAVR) remains clinically challenging. Questions regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) after TAVR still need to be definitively answered.
To evaluate the efficacy and safety of NOACs after TAVR in individuals with and without indication for anticoagulation.
We searched CENTRAL, MEDLINE, Embase, Web of Science, ClinicalTrials.gov, and WHO ICTRP on 7 October 2023 together with reference checking and citation searching to identify additional studies.
We searched for randomised controlled trials (RCTs) that compared NOACs versus antiplatelet therapy or vitamin K antagonists (VKAs) after TAVR in adults with or without an indication for anticoagulation.
We used standard Cochrane methods and conducted random-effects pair-wise analyses and network meta-analyses (NMAs). Our primary outcomes were all-cause mortality, cardiovascular mortality, stroke, and major bleeding. We used GRADE to assess the certainty of evidence.
We included four RCTs with 4808 participants in the NMA. Of these, one compared rivaroxaban versus antiplatelet therapy in people without an indication for anticoagulation after TAVR; one compared apixaban versus antiplatelet therapy in people without an indication for anticoagulation or versus VKA in people with an indication for anticoagulation after TAVR; one compared edoxaban versus VKA in people with an indication for anticoagulation after TAVR; and one compared edoxaban with antiplatelet therapy in people without an indication for anticoagulation after TAVR. The mean age of trial participants was 81 years. Follow-up duration ranged from 6 to 18 months. Overall, we judged the risk of bias in the included trials to be low in all domains except for blinding, which was assessed as high in all four studies. No studies evaluated dabigatran. In people without an indication for anticoagulation, rivaroxaban and apixaban may increase all-cause mortality after TAVR as compared to antiplatelet therapy (rivaroxaban: risk ratio (RR) 1.67, 95% confidence interval (CI) 1.13 to 2.46; studies = 1, participants = 1644; moderate-certainty evidence; apixaban: RR 1.71, 95% CI 0.97 to 3.02; studies = 1, participants = 1049; low-certainty evidence), while edoxaban may result in little or no difference (RR 1.59, 95% CI 0.27 to 9.36; studies = 1, participants = 229; low-certainty evidence). Low-certainty evidence suggests little or no difference between rivaroxaban, apixaban, or edoxaban and antiplatelet therapy in cardiovascular mortality (rivaroxaban: RR 1.28, 95% CI 0.78 to 2.10; studies = 1, participants = 1644; apixaban: RR 1.30, 95% CI 0.64 to 2.65; studies = 1, participants = 1049; edoxaban: RR 7.44, 95% CI 0.39 to 142.38; studies = 1, participants = 229) and between rivaroxaban or edoxaban and antiplatelets in stroke (rivaroxaban: RR 1.19, 95% CI 0.71 to 2.00; studies = 1, participants = 1644; edoxaban: RR 1.06, 95% CI 0.15 to 7.42; studies = 1, participants = 229). While rivaroxaban versus antiplatelets probably increases major bleeding after TAVR (RR 1.98, 95% CI 1.07 to 3.65; studies = 1, participants = 1644; moderate-certainty evidence), there may be little or no difference between apixaban and antiplatelet therapy (RR 1.07, 95% CI 0.70 to 1.64; studies = 1, participants = 1049; low-certainty evidence). It is unclear if edoxaban has an effect on major bleeding, although the point estimate suggests increased bleeding (versus antiplatelets: RR 2.13, 95% CI 0.54 to 8.30; studies = 1, participants = 229; low-certainty evidence). In people with an indication for anticoagulation, low-certainty evidence suggests apixaban or edoxaban may result in little to no difference in our predefined primary efficacy outcomes after TAVR when compared to VKA (all-cause mortality: apixaban: RR 1.02, 95% CI 0.59 to 1.77; studies = 1, participants = 451; edoxaban: RR 0.91, 95% CI 0.69 to 1.20; studies = 1, participants = 1426; cardiovascular mortality: apixaban: RR 1.43, 95% CI 0.76 to 2.70; studies = 1, participants = 451; edoxaban: RR 1.07, 95% CI 0.72 to 1.57; studies = 1, participants = 1426; stroke: apixaban: RR 1.28, 95% CI 0.35 to 4.70; studies = 1, participants = 451; edoxaban: RR 0.83, 95% CI 0.51 to 1.34; studies = 1, participants = 1426). While apixaban may result in a similar rate of bleeding as VKA in this population, edoxaban probably increases major bleeding after TAVR in people with an indication for anticoagulation (apixaban: RR 0.90, 95% CI 0.53 to 1.54; studies = 1, participants = 451; low-certainty evidence; edoxaban: RR 1.44, 95% CI 1.08 to 1.93; studies = 1, participants = 1426; moderate-certainty evidence).
In people without an indication for oral anticoagulation, rivaroxaban and apixaban may increase all-cause mortality when compared to antiplatelet therapy, while edoxaban may result in little or no difference. There might be little or no difference between rivaroxaban, apixaban, or edoxaban and antiplatelet therapy in cardiovascular mortality, and between rivaroxaban or edoxaban and antiplatelets in stroke. While rivaroxaban probably increases major bleeding following TAVR, there might be little or no difference between apixaban and antiplatelet therapy, and the effect of edoxaban on major bleeding remains unclear. In people with an indication for anticoagulation, apixaban and edoxaban may be as effective as VKA in preventing all-cause mortality, cardiovascular death, and stroke. Apixaban may lead to a similar rate of major bleeding as VKA in this population. However, edoxaban probably increases major bleeding following TAVR when compared to VKA. Our NMA did not show superiority of one NOAC over another for any of the primary outcomes. Head-to-head trials directly comparing NOACs against each other are required to increase the certainty of the evidence.
Al Said S
，Kaier K
，Nury E
，Alsaid D
，Gibson CM
，Bax J
，Westermann D
，Meerpohl JJ
... -
《Cochrane Database of Systematic Reviews》
ResearchGate
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