Comparison of Two Antiplatelet Therapy Strategies in Patients Undergoing Transcatheter Aortic Valve Implantation

doi:10.1016/j.amjcard.2013.09.033

The American Journal of Cardiology

Volume 113, Issue 2, 15 January 2014, Pages 355-360

https://doi.org/10.1016/j.amjcard.2013.09.033 Get rights and content

Dual antiplatelet therapy is commonly used in patients undergoing transcatheter aortic valve implantation (TAVI), but the optimal antiplatelet regimen is uncertain and remains to be determined. The objective of this study was to compare 2 strategies of antiplatelet therapy in patients undergoing TAVI. A strategy using monoantiplatelet therapy (group A, n = 164) was prospectively compared with a strategy using dual antiplatelet therapy (group B, n = 128) in 292 consecutive patients undergoing TAVI. The primary end point was a combination of mortality, major stroke, life-threatening bleeding (LTB), myocardial infarction, and major vascular complications at 30 days. All adverse events were adjudicated according to the Valve Academic Research Consortium. The primary end point occurred in 22 patients (13.4%) in the group A and in 30 patients (23.4%) in the group B (hazard ratio 0.51, 95% confidence interval 0.28 to 0.94, p = 0.026). LTB (3.7% vs 12.5%, p = 0.005) and major bleedings (2.4% vs 13.3%, p <0.0001) occurred less frequently in the group A, whereas the incidence of stroke (1.2% vs 4.7%, p = 0.14) and myocardial infarction (1.2% vs 0.8%, p = 1.0) was not significantly different between the 2 groups. The benefit of a strategy using mono versus dual antiplatelet therapy persisted after multivariate adjustment and propensity score analysis (hazard ratio 0.53, 95% confidence interval 0.28 to 0.95, p = 0.033). In conclusion, a strategy using mono versus dual antiplatelet therapy in patients undergoing TAVI reduces LTB and major bleedings without increasing the risk of stroke and myocardial infarction. The results of our study question the justification of dual antiplatelet therapy and require confirmation in a randomized trial.

Section snippets

Methods

We prospectively compared 2 strategies of antiplatelet regimen using mono versus dual antiplatelet therapy in 362 consecutive patients enrolled in the FRANCE 2 TAVI registry from January 2010 and December 2011 in 3 French tertiary centers (Clinique Saint Gatien, Tours; European Georges Pompidou Hospital, Paris; and University Hospital of Rouen, Rouen).⁶

On the basis of criteria specified by the French Ministry of Health, patients included in the registry were symptomatic adults with severe

Results

Baseline characteristics are listed in Table 2. Patients implanted in the group A were younger, with a greater proportion of men, had more frequently previous coronary artery disease, previous cardiac surgery, peripheral artery disease, and chronic obstructive pulmonary disease than in those implanted in the group B. Left ventricular ejection fraction was also significantly lower in the group A. In contrast, patients implanted in the group B had a greater incidence of atrial fibrillation. The

Discussion

TAVI has emerged as an alternative to surgical aortic valve replacement in patients considered at very high or prohibitive surgical risk. Nowadays, the procedure is associated with a very high success rate, but major periprocedural ischemic complications such as myocardial infarction and stroke occur in about 2% (0% to 17%) and 3% (2% to 7%), respectively.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 Dual antiplatelet therapy including aspirin (long-term) and clopidogrel (300-mg loading dose and 75-mg/day

Acknowledgment

The authors thank the scientific committee of the FRANCE 2 study organization and Axonal for providing the database of the patients included in 3 of 34 centers of the national FRANCE 2 TAVI registry.

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Cited by (90)

Comparing Single- and Dual-Antiplatelet Therapies After Transcatheter Aortic Valve Implantation
2022, Annals of Thoracic Surgery
Citation Excerpt :
In TSA, the cumulative number of patients did not exceed the required information size of 19 175, and the Z-curves did not surpass any significance boundary either, suggesting an inconclusive result, and further studies would be warranted to provide a convincing statistical evidence (Figure 3B). Six studies30-35,37 with 1962 patients were included in the analysis of short-term all-cause mortality. The mortality rate showed no significant difference between the DAPT and SAPT treatment regimens (random-effects model: OR, 0.84; 95% CI, 0.42-1.69; I2 = 43%; Cochran Q test P = .12).
Transcatheter aortic valve implantation has been an established treatment in patients with symptomatic severe aortic stenosis. However, the postoperative antiplatelet regimen after transcatheter aortic valve implantation has not been established with certainty. This meta-analysis compared the safety and efficacy of single- antiplatelet therapies (SAPTs) and dual-antiplatelet therapies (DAPT) in patients undergoing transcatheter aortic valve implantation.
Eligible randomized controlled trials and cohort studies published before February 2021 were retrieved from PubMed, Embase, and the Cochrane Library. We calculated odds ratios (ORs) with 95% CIs.
Nine articles, involving 19 277 patients, met the selection criteria. In the short-term outcome, compared with SAPT, DAPT was associated with a significantly higher rate of bleeding (OR, 3.00; 95% CI, 1.67-5.38) and showed no significant differences in thrombotic events (OR, 1.25; 95% CI, 0.74-2.11) and all-cause mortality (OR, 0.84; 95% CI, 0.42-1.69). In the long-term outcome, DAPT was associated with a significantly higher bleeding rate (OR, 1.85; 95% CI, 1.24-.78) and showed no differences in thrombotic events (OR, 1.13; 95% CI, 0.86-1.48) and all-cause mortality (OR, 1.12; 95% CI, 0.95-1.32). Our trial sequential analysis confirmed DAPT did not confer any benefit for reducing all-cause mortality and thrombotic events and carried a higher risk of bleeding than SAPT.
SAPT should be a sufficient antiplatelet strategy in patients after transcatheter aortic valve implantation who do not have indications for oral anticoagulation medication, especially in the long-term follow-up period.
Usefulness of Antiplatelet Therapy After Transcatheter Aortic Valve Implantation
2021, American Journal of Cardiology
The rationale for dual antiplatelet therapy (DAPT) after transcatheter aortic valve implantation (TAVI) is to facilitate endothelialization of metallic struts of the transcatheter heart valve and to prevent thrombosis that could lead to thromboembolic events. Based on expert consensus, current societal guidelines recommend DAPT for 1 to 6 months after TAVI with weak evidence. Although the pivotal TAVI trials mandated this regimen, the evidence for the efficacy of DAPT to prevent transcatheter heart valve thrombosis is limited to 3 small trials and a handful of observational studies. Multiple coronary trials have demonstrated that DAPT is associated with increased bleeding in comparison with single antiplatelet therapy, especially in elderly patients. TAVI patients are predominantly elderly and frequently have risk factors that predispose them to bleeding. Herein, we summarize the evidence for antiplatelet therapy after TAVI and explore the theoretical benefit of DAPT to prevent thromboembolic events versus the risk of increased bleeding.
Standardized Measurement of Femoral Artery Depth by Computed Tomography to Predict Vascular Complications After Transcatheter Aortic Valve Implantation
2021, American Journal of Cardiology
Vascular complications (VCs) are difficult to predict and remain an important issue after transfemoral (TF) transcatheter aortic valve implantation (TAVI) although their incidence has decreased with size reduction of introducers. We aimed to evaluate a standardized measurement of femoral artery depth (FAD) using computed tomography (CT) to predict VCs after TAVI. We performed a retrospective study of 679 TF TAVI patients. We evaluated a standardized CT method to measure FAD immediately above the bifurcation. Sheath-to-femoral-artery ratio (SFAR), calcification, and tortuosity were also evaluated. VCs were defined by the Valve Academic Research Consortium (VARC)-2. Receiver operating characteristic (ROC) curves were used to predict major VCs and the need for a stent-graft. The median values of FAD and SFAR were 49.0 (36.2 to 66.7) mm and 0.95 (0.81 to 1.18), respectively. Major VCs occurred in 37 (5.4%) patients and a stent-graft was required in 49 (7.1%) patients. FAD predicted the need for a stent-graft [0.61 (0.51 to 0.70), p = 0.04] but not major VCs [0.52 (0.40 to 0.63), p = 0.76]. In contrast, SFAR did not predict the need for a stent-graft [0.53 (0.43 to 0.62), p = 0.61] but predicted major VCs [0.70 (0.58 to 0.81), p = 0.001]. Calcification and tortuosity predicted neither major VCs nor the need for a stent-graft. In conclusion, the results of our study suggest that CT measurements of FAD and SFAR provide additional information to predict major VCs and the need for a femoral stent-graft after TF TAVI.
Meta-Analysis Comparing the Safety and Efficacy of Single vs Dual Antiplatelet Therapy in Post Transcatheter Aortic Valve Implantation Patients
2021, American Journal of Cardiology
The relative safety and efficacy of aspirin versus dual antiplatelet therapy (DAPT; aspirin+clopidogrel) in patients who underwent transcatheter aortic valve implantation (TAVI) and did not have a long-term indication for oral anticoagulation remains controversial. Digital databases were searched to identify relevant articles. The major safety end point was bleeding, while the efficacy end points included after-TAVI ischemic and thrombotic events. Data were analyzed using a random effect model to calculate the pooled unadjusted odds ratio (OR) for dichotomous outcomes. Eleven studies comprising 4805 patients (aspirin 2258, DAPT 2547) were included in the quantitative analysis. Patients receiving aspirin-alone had significantly lower odds of all cause bleeding (OR 0.41, 95% CI 0.29 to .057, p <0.00001), major vascular bleeding (OR 0.51, 95% CI 0.34 to 0.77, p = 0.001), Valve Academic Research Consortium 2 (VARC-2) major bleeding (OR 0.50, 95% CI 0.30 to 0.83 p = 0.008), VARC-2 minor bleeding (OR 0.55, 95% CI 0.31 to 0.97, p = 0.04), transfusion requirement (OR 0.39, 95%CI 0.15 to 0.0.98, p = 0.05) and major vascular complications (OR0.41, 95% CI 0.26 to 0.66, p = 0.0002) compared with after-TAVI patients receiving both aspirin and clopidogrel. These was no significant difference in the odds of VARC-2 life threatening bleeding (OR 0.52, 95% CI 0.25 to 1.07, p = 0.08), prosthetic valve thrombosis (OR 1.17, 95% CI 0.22 to 6.30, p = 0.85), cardiac tamponade (OR 0.77, 95% CI 0.20 to 2.98, p = 0.70), conversion to open procedure (OR 1.99, 95 % CI 0.42 to 9.44, p = 0.39), MI (OR 0.79 95% CI 0.38 to 1.64, p = 0.52), transient ischemic attack (TIA) (OR 0.89, 95% CI 0.12 to 6.44, p = 0.91), major stroke (OR 0.68 95 % CI 0.43 to 1.08, p = 0.10), disabling stroke (0R 1.01, 95% CI 0.41 to 2.48, p = 0.99), cardiovascular mortality (OR 0.81 95% CI 0.38 to 1.74, p = 0.59) and all-cause mortality (OR 0.86, 95% CI 0.63 to 1.16, p = 0.31) between the 2 groups. In conclusion, after-TAVI patients who received aspirin alone had lower bleeding events with no significant differences in mortality and stroke rate compared with those who received DAPT.
What antithrombotic treatment should we prescribe after transvalvular aortic valve implantation?
2019, Annales de Cardiologie et d'Angeiologie
Le remplacement valvulaire aortique percutané ou TAVI est devenu en moins de 10 ans le traitement par défaut de la sténose aortique sévère. La FDA vient tout juste d’accepter son utilisation en première intention chez les patients à faible risque. Les patients, souvent âgés et fragiles, sont à risque de complications ischémiques, particulièrement d’accidents vasculaires cérébraux ou de thromboses partielles et infracliniques de bioprothèse, ou hémorragiques, fortement corrélées à la mortalité. Sur le modèle des stents intracoronaires, une double thérapie antiplaquettaire a été recommandée par des consensus d’expert. Ce paradigme est désormais remis en cause devant le constat d’une majoration du risque hémorragique sans baisse du risque ischémique. Par ailleurs, la place des anticoagulants oraux directs dans le post-TAVI reste encore à préciser. Les essais randomisés en cours évaluent ces différentes possibilités thérapeutiques et devraient changer notre pratique.
The performance and indications of transvalvular aortic valve implantation or TAVI has considerably expanded and is now the first therapeutic line option in the management of severe aortic stenosis. The targeted population shares both high risk of ischemic complications, particularly stroke or subclinical leaflet thrombosis of the bioprothesis, as well as hemorrhagic complications, strongly correlated to death. Based on previous experience with intracoronary stents, a dual antiplatelet therapy has been recommended by experts’ consensus. This paradigm is now challenged by the observed increased risk of hemorrhagic complications without a reduction of ischemic events. Moreover, the role of non-vitamin K oral anticoagulant in patients undergoing TAVI remains to be determined. Several large ongoing randomized controlled trials will likely change our practice within the next coming year.
Thrombotic Versus Bleeding Risk After Transcatheter Aortic Valve Replacement: JACC Review Topic of the Week
2019, Journal of the American College of Cardiology
A large amount of evidence supports the widespread use of transcatheter aortic valve replacement (TAVR) among patients who are at low to intermediate risk for surgery. However, several controversies exist about the optimal antithrombotic regimen to use in these patients. On the one hand, concerns about ischemic stroke, subclinical leaflet thrombosis, valve thrombosis, and long-term durability suggest the need for a stronger antithrombotic regimen to ensure a better patient and valve outcome. On the other hand, the high bleeding risk of this population and the current lack of strong evidence in favor of a more aggressive antithrombotic strategy require caution. This review analyzes the rationale of antithrombotic therapy in TAVR illustrating the present scenario and future perspectives.

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Valvular Heart DiseaseComparison of Two Antiplatelet Therapy Strategies in Patients Undergoing Transcatheter Aortic Valve Implantation

Section snippets

Methods

Results

Discussion

Acknowledgment

J Am Coll Cardiol

J Am Coll Cardiol

JACC Cardiovasc Interv

Am J Cardiol

Am J Cardiol

Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description

Circulation

Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) registry. A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve

Circulation

One-year follow-up of the multi-center European PARTNER transcatheter heart valve study

Eur Heart J

Valvular Heart Disease
Comparison of Two Antiplatelet Therapy Strategies in Patients Undergoing Transcatheter Aortic Valve Implantation