Safety and Efficacy of Different Antithrombotic Strategies After Transcatheter Aortic Valve Implantation: A Network Meta-Analysis

Author(s):  
Eliano Pio Navarese ◽  
Leonardo Grisafi ◽  
Enrico Spinoni ◽  
Marco Giovanni Mennuni ◽  
Andrea Rognoni ◽  
...  

Background. The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) remains uncertain. We compared efficacy and safety of various antiplatelet and anticoagulant approaches after TAVI by a network meta-analysis. Methods. A total of 14 studies (both observational and randomized) were considered, with 24,119 patients included. Primary safety endpoint was the incidence of any bleeding complications during follow-up. Secondary safety endpoint was major bleeding. Efficacy endpoints were stroke, myocardial infarction and cardiovascular mortality. A frequentist network meta-analysis was conducted with a random-effects model. The following strategies were compared: dual antiplatelet therapy (DAPT), single antiplatelet therapy (SAPT), oral anticoagulation (OAC), OAC+SAPT. Mean follow-up was 15 months. Results. In comparison to DAPT, SAPT was associated with a 44% risk reduction of any bleeding (OR, 0.56 [95% CI, 0.39-0.80]). SAPT was ranked as the safest strategy for the prevention of any bleeding (P-score, 0.704), followed by OAC alone (P-score, 0.476) and DAPT (P-score, 0.437). Consistent results were observed for major bleeding. The incidence of cardiovascular death and secondary ischemic endpoints did not differ among the tested antithrombotic approaches. In patients with indication for long-term anticoagulation, OAC alone showed similar rates of stroke (OR 0.92 [95% CI 0.41-2.05], p=0.83) and reduced occurrence of any bleeding (OR 0.49 [95% CI 0.37-0.66], p<0.01) vs OAC+SAPT. Conclusions. The present network meta-analysis supports after TAVI the use of SAPT in patients without indication for OAC and OAC alone in those needing long-term anticoagulation.

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
T J Carvalho Mendonca ◽  
L Patricio ◽  
M Oliveira ◽  
I Rodrigues ◽  
G Portugal ◽  
...  

Abstract Introduction Transcatheter aortic valve implantation (TAVI) is an established treatment in patients (P) with aortic stenosis. Despite the continuous developments of this procedure, high-grade conduction disturbances requiring permanent pacemaker (PPM) implantation is still a major and common complication of TAVI. Furthermore, long-term chronic right ventricular pacing has been associated with negative effects on ventricular function and heart failure (HF). Aim   to evaluate the long-term impact of PPM after TAVI focusing on mortality and HF hospitalization. Methods  We retrospectively examined P who underwent TAVI with a self-expanding valve from 2009 to 2018 at our institution. All P had pre-procedural clinical evaluation, including ECG, cardiac computed tomographic angiography and transthoracic echocardiography. P with previous PPM were excluded. Results  265P (57% male, mean age 81.4 years, 20% with left ventricular ejection fraction &lt;40%) were analysed. Mean STS score and mean Euroscore II were 6.33% and 7.07%, respectively. Mean transvalvular gradient was 52.78 mmHg and mean aortic valve area 0.67 cm2. Forty-seven P (17%) underwent PPM implantation during the first 30 days after TAVI. P requiring PPM had higher prevalence of diabetes mellitus, chronic renal disease, atrial fibrillation and right bundle branch block. During a mean follow-up of 20.3 months, post-TAVI PPM was associated with similar mortality rate (29.8% vs. 25.6%, HR 1.28, 95% CI 0.72-2.29, p = 0.42) and similar cardiovascular mortality (9.8% vs. 6.4%, HR 0.72, 95% CI 0.21-2.4, p = 0.59) compared to P without PPM. There were no significant differences in HF hospitalization (4.9% vs. 2.4%, p = 0.47). Kaplan-Meier curves of total mortality and cardiovascular mortality according to the need for PPM post-TAVI were similar.  Conclusions  In P submitted to TAVI, PPM implantation is a relatively common finding, not associated with higher risk of total mortality, cardiovascular mortality or HF hospitalization in a long-term follow-up.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Gonçalo Costa ◽  
Lino Gonçalves ◽  
rogerio teixeira

Background: Ischemic and bleeding complications after transcatheter aortic valve implantation (TAVI) remain prevalent and affect survival. Atrial fibrillation (AF) is common in patients undergoing TAVI and constitutes an indication for long-term oral anticoagulation (OAC). Current guidelines on antithrombotic treatment in patients who have an indication for OAC after TAVI are based on expert opinion and suggest the use of vitamin K antagonist (VKA) either alone or in combination with aspirin or clopidogrel. Purpose: To compare OAC (VKA or direct oral anticoagulant) versus OAC in combination with single antiplatelet therapy (SAPT), either aspirin or clopidogrel, as antithrombotic treatment following TAVI in patients with an indication for long-term OAC or the prevention of cerebrovascular events, bleeding events and all-cause mortality. Methods: We systematically searched PubMed, Embase and Cochrane databases, in April 2020, for both interventional or observational studies comparing OAC with OAC plus SAPT. Random-effects meta-analysis for OAC and OAC combined with SAPT were performed. Results: Four studies were included (three registry-based and one randomized clinical trial) providing a total of 1218 patients, and 69 pooled cerebrovascular events. There was no statistical difference between OAC and OAC plus SAPT for the prevention of cerebrovascular events after TAVI (pooled OR 0.89 [0.51, 1.55], P=0.69, I 2 = 0%) - Figure. Similarly, there was a similar rate of all-cause mortality (pooled OR 0.98 [0.72, 1.35], P=0.91, I 2 = 0%). Furthermore, the rate of major bleeding or life-threatening events was significantly lower for OAC compared with the combined therapy (pooled OR 0.45 [0.29, 0.70], P<0.01, I 2 = 5%). Conclusions: Our pooled data suggests that for patients with indication for long-term oral anticoagulation after TAVI, the routine use of double anti-thrombotic therapy (SAPT+OAC) compared to the use of OAC, conferred an increased risk of bleeding


2020 ◽  
Vol 125 (8) ◽  
pp. 1209-1215 ◽  
Author(s):  
Nicola Corcione ◽  
Giuseppe Biondi-Zoccai ◽  
Paolo Ferraro ◽  
Alberto Morello ◽  
Sirio Conte ◽  
...  

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Avinee ◽  
E Durand ◽  
T Levesque ◽  
P Y Litzler ◽  
J N Dacher ◽  
...  

Abstract Background Since the first-in-man transcatheter aortic valve implantation (TAVI) performed in 2002, the number of procedures has dramatically increased. However, long-term data regarding outcome and valve durability remain poor. Purpose We aimed to evaluate the evolution of 30-day outcomes over years and long-term mortality and valve durability after TAVI. Methods All consecutive patients presenting with severe symptomatic aortic stenosis treated by TAVI in our center were included prospectively. Clinical and echocardiographic follow-up was performed at 30 days and annually thereafter. Survival curves were constructed using Kaplan-Meier analysis. We also evaluated valve durability according to the European standardized definition of structural valve deterioration. Results Between 2002 and 2018, 1530 consecutive patients underwent TAVI including 1285 (84.0%) patients via a femoral approach. A balloon-expandable transcatheter heart valve was predominantly used (1421 patients; 92.9%). The annual transfemoral approach rate increased progressively to reach 93.3%. Age of patients remained stable over time with a global mean age of 83.7±6.5 years old. Logistic EuroSCORE decreased from 49.2±8.2% to 14.3±8.6% (p<0.0001). Thirty-day mortality dramatically decreased below 3% since 2015 and was 0% in 2018. Similarly, major vascular complications decreased from 50.0% in the first year to less than 1% since 2017 (p=0.001). The length of hospital-stay progressively shortened up to a median of 2 days in 2018. The Kaplan-Meier survival estimation was 82.3%, 60.3%, 33.0%; 11.7% and 8.9% respectively at 1, 3, 5, 8 and 10 years. On long-term follow-up the mean aortic gradient remained unchanged (Figure), and only five patients presented a severe prosthetic valve deterioration. Among them, four patients successfully benefited from a valve in valve TAVI procedure. The competing risk analysis at 10 years estimates risk for severe and moderate-or-severe valve deterioration of 1.9±0.9% and 4.3±1.3% respectively. TEE mean transaortic gradient Conclusions Long-term (up to 10 years) follow-up of our large pioneer series of patients treated by TAVI shows a dramatic improvement of outcomes and no warning signs of valve deterioration suggesting very encouraging valve durability, using predominantly, a balloon expandable prosthesis. Further studies are warranted to study valve durability after TAVI before extension to lower risk patients.


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