Rationale and design of non-antithrombotic therapy after transcatheter aortic valve implantation (NAPT) trial

Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, t...

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Bibliographic Details
Published in:Contemporary clinical trials 2023-11, Vol.134, p.107358-107358, Article 107358
Main Authors: Inohara, Taku, Otsuka, Toshiaki, Watanabe, Yusuke, Shirai, Shinichi, Tada, Norio, Yamanaka, Futoshi, Ueno, Hiroshi, Ohno, Yohei, Tabata, Minoru, Suzuyama, Hiroto, Asami, Masahiko, Yamawaki, Masahiro, Izumo, Masaki, Yamasaki, Kazumasa, Nishina, Hidetaka, Fuku, Yasushi, Mizutani, Kazuki, Yashima, Fumiaki, Yamamoto, Masanori, Hayashida, Kentaro
Format: Article
Language:English
Subjects:
Anticoagulation therapy
Antiplatelet therapy
Antithrombotic therapy
Aortic Valve Stenosis - drug therapy
Aortic Valve Stenosis - etiology
Aortic Valve Stenosis - surgery
Aspirin - therapeutic use
Humans
Platelet Aggregation Inhibitors - adverse effects
Prospective Studies
Transcatheter aortic valve implantation
Transcatheter Aortic Valve Replacement - adverse effects
Treatment Outcome
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Summary:Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2023.107358