Clinical Research
Bivalirudin vs Heparin in Patients Who Undergo Transcatheter Aortic Valve Implantation

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Abstract

Background

We aimed to compare safety and efficacy of the direct thrombin inhibitor bivalirudin with unfractionated heparin (UFH) during transcatheter aortic valve implantation (TAVI).

Methods

In this retrospective analysis, 461 patients underwent TAVI between 2007 and 2012; 339 patients received bivalirudin, and 122 patients received UFH. In the bivalirudin group, the Sapien XT valve was implanted in 159 (46.9%) patients, and 180 (53.1%) received a Medtronic CoreValve. In the UFH group, only the Medtronic CoreValve was implanted. The primary outcome of interest was the incidence of any bleeding. Secondary outcomes of interest were all-cause mortality and cardiovascular mortality at 72 hours after the procedure and at 30 days.

Results

No significant difference between the groups was observed for life-threatening bleeding (2.4% for bivalirudin vs 3.3% for UFH; P = 0.59), major bleeding (8.3% vs 8.2%, respectively; P = 0.98) and minor bleeding (8.3% vs 7.4%, respectively; P = 0.76). At 72 hours after the procedure, all-cause mortality was 3.0% in the bivalirudin group and 3.3% for the UFH group (P = 0.88), whereas cardiovascular mortality was 3.0% in the bivalirudin group and 2.5% in the heparin group (P = 0.77). At 30 days, all-cause mortality was 5.3% vs 4.1% in the bivalirudin and heparin groups (P = 0.57) and cardiovascular mortality was 4.4% vs 2.5% (P = 0.33). Device success (Valve Academic Research Consortium 2 composite end point) was 94.0% in the bivalirudin-treated and 92.6% in the UFH-treated patients (P = 0.60). The early safety at 30 days was 85.3% in the bivalirudin-treated group compared with 83.6% in the UFH-treated group (P = 0.65).

Conclusions

Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure.

Résumé

Introduction

Nous avions pour but de comparer l’innocuité et l’efficacité de la bivalirudine, un inhibiteur direct de la thrombine, à l’héparine non fractionnée (HNF) au cours de l’implantation valvulaire aortique par cathéter (IVAC).

Méthodes

Dans cette analyse rétrospective, 461 patients ont subi une IVAC entre 2007 et 2012; 339 patients ont reçu la bivalirudine et 122 patients ont reçu l’HNF. Dans le groupe recevant la bivalirudine, 159 (46,9 %) patients ont subi l’implantation de la valve Sapien XT et 180 (53,1 %) ont subi l’implantation d’une valve Medtronic CoreValve. Dans le groupe recevant la HNF, seule la valve Medtronic CoreValve a été implantée. Le critère d’intérêt principal était l’incidence de toute hémorragie. Les critères d’intérêt secondaires étaient la mortalité toutes causes confondues et la mortalité d’origine cardiovasculaire 72 heures après l’intervention et à 30 jours.

Résultats

Nous n’avons observé aucune différence significative entre les groupes en ce qui concerne l’hémorragie mettant la vie en danger (2,4 % pour la bivalirudine vs 3,3 % pour la HNF; P = 0,59), l’hémorragie grave (8,3 % vs 8,2 %, respectivement; P = 0,98) et l’hémorragie minime (8,3 % vs 7,4 %, respectivement; P = 0,76). Soixante-douze heures après l’intervention, la mortalité toutes causes confondues a été de 3,0 % dans le groupe recevant la bivalirudine et de 3,3 % dans le groupe recevant la HNF (P = 0,88), tandis que la mortalité d’origine cardiovasculaire a été de 3,0 % dans le groupe recevant la bivalirudine et de 2,5 % dans le groupe recevant l’héparine (P = 0,77). À 30 jours, la mortalité toutes causes confondues a été de 5,3 % vs 4,1 % dans les groupes recevant la bivalirudine et l’héparine (P = 0,57) et la mortalité d’origine cardiovasculaire a été de 4,4 % vs 2,5 % (P = 0,33). Le taux de réussite des dispositifs (critère de jugement combiné du Valve Academic Research Consortium 2) a été de 94,0 % chez les patients traités par bivalirudine et de 92,6 % chez les patients traités par HNF (P = 0,60). L’innocuité à 30 jours a été de 85,3 % dans le groupe traité par bivalirudine comparativement à 83,6 % dans le groupe traité par HNF (P = 0,65).

Conclusions

La bivalirudine montre un profil d’innocuité et d’efficacité similaire à la HNF ajustée au poids durant l’IVAC.

Section snippets

Patients

From November 2007 until October 2012, 461 consecutive patients (mean age 81.2 ± 6.7 years) underwent a TAVI because of symptomatic high-grade aortic stenosis at the Medizinische Klinik und Poliklinik I, University of Munich, Munich, Germany. Two different valve types were implanted: Medtronic CoreValve prosthesis (n = 302 patients) and Edwards Sapien XT prosthesis (n = 159). The decision about TAVI was made by the multidisciplinary heart board considering the patients' age, comorbidities, and

Results

Of the 461 patients included in this retrospective analysis, 339 patients (73.5%) received bivalirudin, and 122 patients (26.5%) received UFH peri-TAVI. No differences were observed between the 2 groups regarding baseline characteristics except for a lower incidence of PCI > 30 days before TAVI in the bivalirudin group (19.8% vs 36.1% in the UFH group; P < 0.001; Table 1). The most frequently implanted prosthesis was the Medtronic CoreValve in 53.1% of patients in the bivalirudin group and 100%

Discussion

In this analysis of a large number of patients who underwent TAVI and received either bivalirudin or UFH, there was no difference regarding life-threatening, or major or minor bleeding complications using the VARC 2 bleeding definitions. We found no difference between bivalirudin and heparin with respect to 72-hour and 30-day mortality (cardiovascular and all cause) or early 30-day safety.

The study extends previous findings with bivalirudin used as an anticoagulant in patients who underwent

Acknowledgements

Philipp Lange, Martin Greif, and Dario Bongiovanni contributed equally to this work.

References (19)

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