An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention.
Humans
Percutaneous Coronary Intervention
/ adverse effects
Platelet Aggregation Inhibitors
/ adverse effects
Male
Time Factors
Female
Aspirin
/ administration & dosage
Aged
Middle Aged
Treatment Outcome
Hemorrhage
/ chemically induced
Dual Anti-Platelet Therapy
Risk Factors
Prasugrel Hydrochloride
/ administration & dosage
Everolimus
/ administration & dosage
Drug-Eluting Stents
Prosthesis Design
Drug Administration Schedule
Coronary Artery Disease
/ therapy
Coronary Thrombosis
/ etiology
Acute Coronary Syndrome
/ therapy
Chromium Alloys
Risk Assessment
Drug Therapy, Combination
antiplatelet therapy
complexity
coronary stent
percutaneous coronary intervention
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
13 May 2024
13 May 2024
Historique:
received:
11
12
2023
revised:
14
02
2024
accepted:
12
03
2024
medline:
16
5
2024
pubmed:
16
5
2024
entrez:
15
5
2024
Statut:
ppublish
Résumé
There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI). The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI. We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions. The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).
Sections du résumé
BACKGROUND
BACKGROUND
There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI).
OBJECTIVES
OBJECTIVE
The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI.
METHODS
METHODS
We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month.
RESULTS
RESULTS
Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions.
CONCLUSIONS
CONCLUSIONS
The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).
Identifiants
pubmed: 38749592
pii: S1936-8798(24)00580-6
doi: 10.1016/j.jcin.2024.03.017
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04609111']
Types de publication
Journal Article
Comparative Study
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1119-1130Investigateurs
Kenji Ando
(K)
Satoru Suwa
(S)
Tsuyoshi Isawa
(T)
Hiroyuki Takenaka
(H)
Tetsuya Ishikawa
(T)
Kohei Wakabayashi
(K)
Yuko Onishi
(Y)
Kiyoshi Hibi
(K)
Kazuya Kawai
(K)
Koh Ono
(K)
Ruka Yoshida
(R)
Hiroshi Suzuki
(H)
Gaku Nakazawa
(G)
Takanori Kusuyama
(T)
Itsuro Morishima
(I)
Hideo Tokuyama
(H)
Hiroki Sakamoto
(H)
Takanari Fujita
(T)
Mamoru Nanasato
(M)
Hideki Okayama
(H)
Toshihiro Tamura
(T)
Kando Kawahatsu
(K)
Fujio Hayashi
(F)
Masaharu Akao
(M)
Takeshi Serikawa
(T)
Kazushige Kadota
(K)
Yoshiki Hata
(Y)
Yoshihiro J Akashi
(YJ)
Shunzo Matsuoka
(S)
Hiroyuki Tanaka
(H)
Minoru Yamada
(M)
Tetsuzo Wakatsuki
(T)
Yoichi Nozaki
(Y)
Yoshio Kobayashi
(Y)
Ryuichi Kato
(R)
Yuji Ikari
(Y)
Tairo Kurita
(T)
Kazuaki Kaitani
(K)
Atsuhiko Sugimoto
(A)
Nobuhiko Ogata
(N)
Takafumi Yokomatsu
(T)
Hiroki Uehara
(H)
Tatsuki Doijiri
(T)
Ken Kozuma
(K)
Yasunori Nishida
(Y)
Junichi Yamaguchi
(J)
Yoshihiro Morino
(Y)
Takashi Tanigawa
(T)
Yukiko Nakano
(Y)
Noriko Makiguchi
(N)
Toshiyuki Noda
(T)
Nobuo Shiode
(N)
Koji Abe
(K)
Shichiro Abe
(S)
Isao Tabuchi
(I)
Shozo Ishihara
(S)
Makoto Kinoshita
(M)
Motoaki Higuchi
(M)
Tomofumi Takaya
(T)
Shin-Ichiro Miura
(SI)
Yoshinori Tsubakimoto
(Y)
Kenichi Tsujita
(K)
Koji Kumagai
(K)
Kengo Tanabe
(K)
Moriaki Inoko
(M)
Takuo Nakagami
(T)
Hirofumi Tomita
(H)
Masatsugu Nakano
(M)
Kazuhiko Yumoto
(K)
Takatoshi Wakeyama
(T)
Takeo Kaneko
(T)
Masayuki Doi
(M)
Informations de copyright
Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Funding Support and Author Disclosures This study was funded by Abbott Medical Japan. Dr Natsuaki has received honoraria from Abbott Medical Japan, Daiichi-Sankyo, Medtronic, Terumo, Japan Lifeline, Asahi Intecc, Bristol Myers Squibb, Otsuka, Amgen, Sanofi, Takeda, and Bayer. Dr Watanabe has received personal fees from Abbott Medical Japan during the conduct of the study as well as personal fees from Daiichi-Sankyo, Kowa, Abiomed, Bayer, Pfizer, Bristol Myers Squibb, and Otsuka outside the submitted work. Dr Morimoto has received lecturer fees from AstraZeneca, Bristol Myers Squibb, Daiichi-Sankyo, Japan Lifeline, Kowa, Pfizer, and Tsumura; has received manuscript fees from Bristol Myers Squibb and Pfizer; and has served on the Advisory Boards for Novartis and Teijin. Dr Suwa has received personal fees from Abbott Medical Japan and Daiichi-Sankyo outside the submitted work. Dr Kimura has received grants from Abbott Medical Japan and Boston Scientific; and has served on the Advisory Boards of Abbott Medical Japan and Terumo Japan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.