Pubblicazioni

Autori:

Nijenhuis, Vincent Johan; Bennaghmouch, Naoual; Hassell, Mariella; Baan, Jan; van Kuijk, Jan Peter; Agostoni, Pierfrancesco; van 't Hof, Arnoud; Kievit, Peter C; Veenstra, Leo; van der Harst, Pim; van den Heuvel, Ad F M; den Heijer, Peter; Kelder, Johannes C; Deneer, Vera H; van der Kley, Frank; Onorati, Francesco; Collet, Jean Philippe; Maisano, Francesco; Latib, Azeem; Huber, Kurt; Stella, Pieter R; Ten Berg, Jurrien M

Titolo:

Rationale and design of POPular-TAVI: antiPlatelet therapy fOr Patients undergoing Transcatheter Aortic Valve Implantation

Anno:

2016

Tipologia prodotto:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Lingua:

Inglese

Referee:

No

Nome rivista:

American Heart Journal

ISSN Rivista:

0002-8703

N° Volume:

173

Intervallo pagine:

77-85

Parole chiave:

Administration, Oral; Aortic Valve Stenosis; Aspirin; Clopidogrel; Dose-Response Relationship, Drug; Drug Therapy, Combination; Europe; Follow-Up Studies; Humans; Incidence; Platelet Aggregation Inhibitors; Postoperative Complications; Preoperative Care; Prospective Studies; Survival Rate; Thromboembolism; Ticlopidine; Time Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome

Breve descrizione dei contenuti:

Background Despite improving experience and techniques, ischemic and bleeding complications after transcatheter aortic valve implantation (TAVI) remain prevalent and impair survival. Current guidelines recommend the temporary addition of clopidogrel in the initial period after TAVI to prevent thromboembolic events. However, explorative studies suggest that this is associated with a higher rate of major bleeding without a decrease in thromboembolic complications. Methods The POPular TAVI trial is a prospective randomized, controlled, open-label multicenter clinical trial to test the hypothesis that monotherapy with aspirin or oral anticoagulation (OAC) after TAVI is safer than the addition of clopidogrel for 3 months, without compromising clinical benefit. This trial encompasses 2 cohorts: cohort A, patients are randomized 1:1 to aspirin vs aspirin + clopidogrel, and cohort B, patients on OAC therapy are randomized 1:1 to OAC vs OAC + clopidogrel. Primary outcome is freedom from non-procedure-related bleeding at 1 year. Secondary net-clinical benefit outcome is freedom from the composite of cardiovascular death, non-procedural-related bleeding, myocardial infarction, or stroke at 1 year. The primary outcome is analyzed for superiority, whereas the secondary outcome is analyzed for noninferiority. Recruitment began in February 2014, and the trial will continue until a total of 1,000 patients (684 expected in cohort A and 316 in cohort B) are included and followed up for 1 year. Summary The POPular TAVI trial (NCT02247128) is the first large randomized controlled trial to test if monotherapy with aspirin or OAC vs additional clopidogrel after TAVI reduces bleeding with a favorable net-clinical benefit.

Id prodotto:

109429

Handle IRIS:

11562/997848

ultima modifica:

7 novembre 2022

Citazione bibliografica:

Nijenhuis, Vincent Johan; Bennaghmouch, Naoual; Hassell, Mariella; Baan, Jan; van Kuijk, Jan Peter; Agostoni, Pierfrancesco; van 't Hof, Arnoud; Kievit, Peter C; Veenstra, Leo; van der Harst, Pim; van den Heuvel, Ad F M; den Heijer, Peter; Kelder, Johannes C; Deneer, Vera H; van der Kley, Frank; Onorati, Francesco; Collet, Jean Philippe; Maisano, Francesco; Latib, Azeem; Huber, Kurt; Stella, Pieter R; Ten Berg, Jurrien M, Rationale and design of POPular-TAVI: antiPlatelet therapy fOr Patients undergoing Transcatheter Aortic Valve Implantation «American Heart Journal» , vol. 173 , 2016 , pp. 77-85

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