Systematic Review/Meta-analysis
Comparison of Dual-antiplatelet Therapy to Mono-antiplatelet Therapy After Transcatheter Aortic Valve Implantation: Systematic Review and Meta-analysis

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Abstract

Background

Post–transcatheter aortic valve implantation (TAVI) dual-antiplatelet therapy (DAPT) with acetylsalicylic acid and clopidogrel is common practice to reduce ischemic complications despite the lack of clinical trial evidence demonstrating superiority over mono-antiplatelet therapy (MAPT).

Methods

A systematic search was conducted to retrieve studies that investigated DAPT vs MAPT in patients who have undergone TAVI. Outcomes of interest included both ischemic and bleeding events at 30 days and 6 months.

Results

Four studies met inclusion criteria–2 randomized control trials and 2 observational studies, with 286 patients in the DAPT group and 354 patients in the MAPT group. For the primary outcome of a combined end point of 30-day major stroke, spontaneous myocardial infarction (MI), all-cause mortality, and combined lethal and major bleeding, there was a trend toward increased harm in the DAPT group (29%) compared with the MAPT group (16%), with an odds ratio (OR) of 1.88 (P = 0.05). Secondary outcome analysis revealed that there was no significant difference between groups regarding 30-day stroke, 30-day spontaneous MI, and 30-day all-cause mortality. Patients who received DAPT had a significant increase in combined 30-day lethal and major bleeding (OR, 2.62; P = 0.008). Further analysis revealed that increased adverse events were driven by observational studies, with no difference in outcomes between groups in randomized controlled trials.

Conclusions

DAPT in patients who have undergone TAVI demonstrated no benefit over MAPT in reduction of ischemic events, with a trend toward increased harm because of bleeding. Future considerations should be given to MAPT with clopidogrel alone, as well as the omission of clopidogrel loading before the procedure.

Résumé

Introduction

La bithérapie antiplaquettaire (BTAP) par l’acide acétylsalicylique et le clopidogrel après l’implantation valvulaire aortique par cathéter (IVAC) est une pratique fréquente pour réduire les complications d’origine ischémique en dépit du manque de données provenant d’essais cliniques démontrant sa supériorité par rapport à la monothérapie antiplaquettaire (MTAP).

Méthodes

Nous avons mené une recherche systématique pour extraire les études qui avaient examiné la BTAP vs la MTAP chez les patients ayant subi l’IVAC. Les résultats d’intérêt ont inclus les événements ischémiques et les événements hémorragiques à 30 jours et à 6 mois.

Résultats

Quatre études ont répondu aux critères d’inclusion (2 essais cliniques aléatoires et 2 études observationnelles totalisant 286 patients dans le groupe BTAP et 354 patients dans le groupe MTAP). Pour ce qui est du critère d’évaluation principal d’un critère de jugement combiné de l’accident vasculaire cérébral à 30 jours, de l’infarctus du myocarde (IM) spontané, de la mortalité toutes causes confondues, et de l’incidence combinée d’hémorragie mortelle et d’hémorragie majeure, nous avons observé une tendance à l’augmentation du risque dans le groupe BTAP (29 %) par rapport au groupe MTAP (16 %), et un ratio d’incidence approché (RIA) de 1,88 (P = 0,05). L’analyse du critère d’évaluation secondaire a révélé qu’il n’existait aucune différence significative entre les groupes concernant l’accident vasculaire cérébral à 30 jours, l’IM spontané à 30 jours et la mortalité toutes causes confondues à 30 jours. Les patients qui recevaient la BTAP ont montré une augmentation significative de l’incidence combinée de l’hémorragie mortelle et de l’hémorragie majeure à 30 jours (RIA, 2,62; P = 0,008). D’autres analyses ont révélé que l’augmentation des événements indésirables avait été soulevée par des études observationnelles, qui n’ont montré aucune différence dans les résultats entre les groupes des essais cliniques aléatoires.

Conclusions

La BTAP chez les patients ayant subi l’IVAC n’a démontré aucun avantage par rapport à la MTAP sur la réduction des événements d’origine ischémique, mais a plutôt montré une tendance à l’augmentation des dommages causés par l’hémorragie. Nous devrons nous pencher sur la MTAP par le clopidogrel seul, ainsi que sur l’omission de la dose de charge du clopidogrel avant l’intervention.

Section snippets

Study selection

This meta-analysis was performed in accordance with PRISMA (Preferred Reporting Items for Systemic Reviews and Meta-Analyses) recommendations.5 A systematic search was conducted to retrieve studies that investigated DAPT compared with MAPT in patients who have undergone TAVI. We searched for candidate articles in PubMed, MEDLINE, EMBASE, and Cochrane databases from 1950-November 2014 using OVID software with the “explode” feature. The following keywords were used: (transcatheter aortic valve

Search results

Figure 1 outlines the search strategy. Our search strategy yielded 138 results, 69 of which were duplicate studies that were removed. Sixty-nine studies were screened, 48 of which were excluded on review of the title and abstract. A further 17 studies were excluded after careful review of the full text (7 observational studies that did not report the outcome of interest,7, 8, 9, 10, 11, 12, 13 9 review articles,14, 15, 16, 17, 18, 19, 20, 21, 22 and 1 meta-analysis23). Thus, 4 studies with 640

Discussion

The results of our study show that DAPT compared with MAPT in patients who have undergone TAVI demonstrated a trend toward an increase in the primary outcome measure of combined 30-day stroke, spontaneous MI, all-cause mortality, and combined lethal and major bleeding; this was driven by increased events in observational studies alone, with no difference in randomized studies. For the secondary outcome measures, there was increased risk of 30-day and 6-month combined lethal and major bleeding.

Conclusions

DAPT in comparison with MAPT in patients who have undergone TAVI suggested a trend toward increased harm caused by increased bleeding, with no observed benefit in reduction of 30-day and 6-month major stroke, spontaneous MI, and all-cause mortality. The trend toward increased harm is driven by observational studies, with no significant difference in randomized trials. The optimal antiplatelet regimen after TAVI is currently being studied in the ARTE trial. Future consideration should also be

Disclosures

The authors have no conflicts of interest to disclose.

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