Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients With High Bleeding Risk
2019; Lippincott Williams & Wilkins; Volume: 140; Issue: 23 Linguagem: Inglês
10.1161/circulationaha.119.043613
ISSN1524-4539
AutoresHirotoshi Watanabe, Takenori Domei, Takeshi Morimoto, Masahiro Natsuaki, Hiroki Shiomi, Toshiaki Toyota, Masanobu Ohya, Satoru Suwa, Kensuke Takagi, Mamoru Nanasato, Yoshiki Hata, Masahiro Yagi, Nobuhiro Suematsu, Takafumi Yokomatsu, Itaru Takamisawa, Masayuki Doi, Toshiyuki Noda, Hideki Okayama, Yoshitane Seino, Tomohisa Tada, Hiroki Sakamoto, Kiyoshi Hibi, Mitsuru Abe, Kazuya Kawai, Kōichi Nakao, Kenji Andò, Kengo Tanabe, Yuji Ikari, Keiichi Igarashi Hanaoka, Yoshihiro Morino, Ken Kozuma, Kazushige Kadota, Yutaka Furukawa, Yoshihisa Nakagawa, Takeshi Kimura,
Tópico(s)Peripheral Artery Disease Management
ResumoHomeCirculationVol. 140, No. 23Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients With High Bleeding Risk Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBVery Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients With High Bleeding RiskInsight From the STOPDAPT-2 Trial Hirotoshi Watanabe, MD, Takenori Domei, MD, Takeshi Morimoto, MD, Masahiro Natsuaki, MD, Hiroki Shiomi, MD, Toshiaki Toyota, MD, Masanobu Ohya, MD, Satoru Suwa, MD, Kensuke Takagi, MD, Mamoru Nanasato, MD, Yoshiki Hata, MD, Masahiro Yagi, MD, Nobuhiro Suematsu, MD, Takafumi Yokomatsu, MD, Itaru Takamisawa, MD, Masayuki Doi, MD, Toshiyuki Noda, MD, Hideki Okayama, MD, Yoshitane Seino, MD, Tomohisa Tada, MD, Hiroki Sakamoto, MD, Kiyoshi Hibi, MD, Mitsuru Abe, MD, Kazuya Kawai, MD, Koichi Nakao, MD, Kenji Ando, MD, Kengo Tanabe, MD, Yuji Ikari, MD, Keiichi Igarashi Hanaoka, MD, Yoshihiro Morino, MD, Ken Kozuma, MD, Kazushige Kadota, MD, Yutaka Furukawa, MD, Yoshihisa Nakagawa, MD, Takeshi Kimura, MD and On behalf of the STOPDAPT-2 Investigators Hirotoshi WatanabeHirotoshi Watanabe Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (H.W., H. Shiomi, T.K.). , Takenori DomeiTakenori Domei Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan (T.D., K.A.). , Takeshi MorimotoTakeshi Morimoto Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T.M.). , Masahiro NatsuakiMasahiro Natsuaki Department of Cardiovascular Medicine, Saga University, Japan (M.N.). , Hiroki ShiomiHiroki Shiomi Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (H.W., H. Shiomi, T.K.). , Toshiaki ToyotaToshiaki Toyota Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Japan (T. Toyota, Y.F.). , Masanobu OhyaMasanobu Ohya Department of Cardiology, Kurashiki Central Hospital, Japan (M.O., K. Kadota). , Satoru SuwaSatoru Suwa Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan (S.S.). , Kensuke TakagiKensuke Takagi Department of Cardiology, Ogaki Municipal Hospital, Japan (K. Takagi). , Mamoru NanasatoMamoru Nanasato Department of Cardiology, Sakakibara Heart Institute, Fuchu, Japan (M.N., I.T.). , Yoshiki HataYoshiki Hata Department of Cardiology, Minamino Cardiovascular Hospital, Hachioji, Japan (Y.H.). , Masahiro YagiMasahiro Yagi Department of Cardiology, Sendai Cardiovascular Center, Japan (M.Y.). , Nobuhiro SuematsuNobuhiro Suematsu Department of Cardiology, Saiseikai Fukuoka General Hospital, Japan (N.S.). , Takafumi YokomatsuTakafumi Yokomatsu Department of Cardiology, Mitsubishi Kyoto Hospital, Kyoto, Japan (T.Y.). , Itaru TakamisawaItaru Takamisawa Department of Cardiology, Sakakibara Heart Institute, Fuchu, Japan (M.N., I.T.). , Masayuki DoiMasayuki Doi Department of Cardiology, Kagawa Prefectural Central Hospital, Takamatsu, Japan (M.D.). , Toshiyuki NodaToshiyuki Noda Department of Cardiology, Gifu Prefectural General Medical Center, Japan (T.N.). , Hideki OkayamaHideki Okayama Department of Cardiology, Ehime Prefectural Central Hospital, Matsuyama, Japan (H.O.). , Yoshitane SeinoYoshitane Seino Department of Cardiology, Hoshi General Hospital, Koriyama, Japan (Y.S.). , Tomohisa TadaTomohisa Tada Department of Cardiology, Shizuoka General Hospital, Japan (T. Tada, H. Sakamoto). , Hiroki SakamotoHiroki Sakamoto Department of Cardiology, Shizuoka General Hospital, Japan (T. Tada, H. Sakamoto). , Kiyoshi HibiKiyoshi Hibi Division of Cardiology, Yokohama City University Medical Center, Japan (K.H.). , Mitsuru AbeMitsuru Abe Department of Cardiology, National Hospital Organization Kyoto Medical Center, Japan (M.A.). , Kazuya KawaiKazuya Kawai Department of Cardiology, Chikamori Hospital, Kochi, Japan (K. Kawai). , Koichi NakaoKoichi Nakao Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Japan (K.N.). , Kenji AndoKenji Ando Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan (T.D., K.A.). , Kengo TanabeKengo Tanabe Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan (K. Tanabe). , Yuji IkariYuji Ikari Department of Cardiology, Tokai University Hospital, Isehara, Japan (Y.I.). , Keiichi Igarashi HanaokaKeiichi Igarashi Hanaoka Hanaoka Seishu Memorial Cardiovascular Clinic, Sapporo, Japan (K.I.H.). , Yoshihiro MorinoYoshihiro Morino Department of Cardiology, Iwate Medical University Hospital, Morioka, Japan (Y.M.). , Ken KozumaKen Kozuma Department of Cardiology, Teikyo University Hospital, Tokyo, Japan (K. Kozuma). , Kazushige KadotaKazushige Kadota Department of Cardiology, Kurashiki Central Hospital, Japan (M.O., K. Kadota). , Yutaka FurukawaYutaka Furukawa Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Japan (T. Toyota, Y.F.). , Yoshihisa NakagawaYoshihisa Nakagawa Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Japan (Y.N.). , Takeshi KimuraTakeshi Kimura Takeshi Kimura, MD, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507 Japan. Email E-mail Address: [email protected] Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (H.W., H. Shiomi, T.K.). and On behalf of the STOPDAPT-2 Investigators Originally published27 Sep 2019https://doi.org/10.1161/CIRCULATIONAHA.119.043613Circulation. 2019;140:1957–1959Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: September 27, 2019: Ahead of Print Optimal antithrombotic therapy after percutaneous coronary interventions in patients with high bleeding risk (HBR) is an important issue under active discussion. However, no previous study has compared different dual antiplatelet therapy (DAPT) duration in patients with HBR. Recently, we have reported the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent), suggesting the benefit of 1-month DAPT over 12-month DAPT with a reduction of bleeding events without an increase in cardiovascular events in an all-comer population.1 Very short DAPT might be beneficial, particularly in patients with HBR; therefore, we conducted a post hoc subgroup analysis that was based on the recently proposed Academic Research Consortium (ARC) HBR criteria.2STOPDAPT-2 is a physician-initiated, prospective, multicenter, open-label, adjudicator-blinded randomized clinical trial in Japan that was designed to assess the noninferiority of 1-month DAPT followed by clopidogrel monotherapy compared with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The Kyoto University Certified Review Board approved the study protocol, and written informed consent was obtained from all study patients. With the ARC HBR definitions,2 patients were divided into (1) an HBR group if they had at least 1 major criterion or 2 minor criteria and (2) a non-HBR group. Because some ARC HBR criteria were not captured, we used only the captured data for applying the criteria. In particular, malignancy was excluded from the criteria because we did not capture whether it was active.The primary end point of the STOPDAPT-2 was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, and bleeding defined as TIMI (Thrombolysis in Myocardial Infarction) major or minor criteria.3 The major secondary cardiovascular end point was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, and stroke. The major secondary bleeding end point was TIMI major or minor bleeding.The cumulative incidence was estimated with the Kaplan–Meier method, and hazard ratios were calculated with the Cox proportional hazard model. We calculated 95% CIs with Wald statistics. All reported P values were 2 tailed, and values of P<0.05 were considered statistically significant.Among the 3009 study patients, 1054 (35.0%) were in the HBR group (1-month DAPT, n=496; 12-month DAPT, n=558), and 1955 (65.0%) were in the non-HBR group (1-month DAPT, n=1004; 12-month DAPT, n=951). The ARC HBR major criteria such as severe anemia (8.7%) and end-stage chronic kidney disease (5.5%) were not common, whereas the ARC-HBR minor criteria, including age ≥75 years (31.5%) and moderate chronic kidney disease (29.4%), were more prevalent.Patients in the HBR group were older (75.8±8.6 years versus 64.8±9.7 years) and more often presented as stable coronary artery disease (70.6% versus 57.1%) than those in the non-HBR group. High-risk features of stent-driven recurrent ischemia from the 2017 European Society of Cardiology focused update on DAPT were present in 76.6% of patients in the HBR group and in 24.9% of patients in the non-HBR group.4 The patterns of DAPT discontinuation were similar between patients in the HBR and non-HBR groups, and baseline characteristics and medications were well balanced between the 1-month and 12-month DAPT groups.In patients in the HBR group, the 1-year rate of the primary end point trended to be lower in the 1-month DAPT group compared with the 12-month DAPT group (3.48% versus 5.98%; absolute difference, −2.50% [95% CI, −5.06 to 0.06]; hazard ratio, 0.57 [95% CI, 0.32–1.03]; P=0.06), and the absolute reduction in the event rate with 1-month DAPT was numerically greater in patients in the HBR group than in patients in the non-HBR group. The rate of the major secondary cardiovascular end point was not significantly different (3.07% versus 4.03%; hazard ratio, 0.77 [95% CI, 0.40–1.48]; P=0.43), whereas the rate of the major secondary bleeding end point was significantly lower in the 1-month DAPT group (0.41% versus 2.71%; hazard ratio, 0.15 [95% CI, 0.03–0.65]; P=0.01). There were no significant interactions between the HBR/non-HBR subgroups and the assigned DAPT groups on the primary and the 2 major secondary end points (Figure). In patients in the HBR group, the major bleeding rate at 1 year was remarkably low in the 1-month DAPT group (0.41%).One of the reasons for this very low bleeding rate in patients in the HBR group compared with previous studies5 might be the unique clopidogrel monotherapy after DAPT was stopped. Despite the high prevalence of patients with high-risk features for stent-driven ischemia among the patients in the HBR group, 1-month DAPT was not associated with an increase in cardiovascular event rates. Therefore, 1-month DAPT followed by clopidogrel monotherapy could be an important option in patients in the HBR group.This analysis has some limitations. Japanese patients compared with US or European patients are known to have lower ischemic and higher bleeding risks and are more often treated with intravascular imaging and clopidogrel or low-dose prasugrel. We should be cautious in extrapolating the present results outside Japan. The favorable results of 1-month DAPT in patients in the HBR group should be regarded as hypothesis generating for the underpowered analysis and the modified adoption of ARC HBR.In conclusion, the effects of 1-month versus 12-month DAPT were consistent in both HBR groups without any significant interactions. One-month DAPT provided a significant reduction in major bleeding without any increase in cardiovascular events over 12-month DAPT in patients in the HBR group, although the analysis was underpowered and needs confirmation in future studies.Download figureDownload PowerPointFigure. Effect of 1-month dual antiplatelet therapy (DAPT) vs 12-month DAPT at 1 year stratified by high bleeding risk (HBR) and non-HBR. Effects of 1-month vs 12-month DAPT for the primary and major secondary end points in the HBR and non-HBR subgroups. HBR was classified by Academic Research Consortium HBR definition with modification for some criteria not captured. Hazard ratios were not adjusted by any covariates.AcknowledgmentsThe authors appreciate the members of Research Institute for Production Development handling a series of large clinical trials performed by Kyoto University and the coinvestigators enrolling patients, collecting follow-up data, or adjudicating clinical events.Sources of FundingSTOPDAPT-2 was funded by Abbott Vascular Japan. The study sponsor is not involved in the implementation of the study, data collection, event fixation, and statistical analysis. However, approval of the study sponsor should be obtained for presentation in scientific meetings and submission of papers.DisclosuresDr Watanabe reported receipt of personal fees from Abbott Vascular Japan and Daiichi Sankyo. Dr Toyota reports personal fees from Abbott Vascular, Bayer yakuhin, Ltd, Sanofi KK, and Amgen Astellas BioPharma KK. Dr Yagi reports receipt of personal fees from Otsuka Pharmaceutical, Daiichi Sankyo, and Kowa Pharmaceuticals. Dr Hibi reports receipt of personal fees from Abbott Vascular. Dr Nakao reports receipt of personal fees from Sanofi, Bayer, Daiichi-Sankyo, and Boehringer Ingelheim. Dr Tanabe reports receipt of personal fees from Abbott Vascular, AstraZeneca, Sanofi, Daiichi Sankyo, Terumo, Boston Scientific, Japan Lifeline, Bayer, and Medtronic and advisory board membership for Abbott Vascular and Terumo Japan. Dr Morino reports receipt of personal fees from Abbott Vascular and advisory board membership for Abbott Vascular and Terumo Japan. Dr Kozuma reports receipt of grants and personal fees from Abbott Vascular and advisory board membership for Abbott Vascular and Terumo Japan. Dr Furukawa reports receipt of personal fees from Daiichi Sankyo, Bayer, and Sanofi. Dr Nakagawa reports advisory board membership for Abbott Vascular. Dr Kimura reports receipt of personal fees from Abbott Vascular, grants from Abbott Vascular and Boston Scientific, and advisory board membership for Abbott Vascular and Terumo Japan. The other authors report no conflicts.FootnotesThe full author list is available on page 1959https://www.ahajournals.org/journal/circData sharing: We will not make the data, methods used in the analysis, and materials used to conduct the research available to any researcher for purposes of reproducing the results or replicating the procedure.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02619760.Takeshi Kimura, MD, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507 Japan. Email [email protected]kyoto-u.ac.jpReferences1. Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, et al; STOPDAPT-2 Investigators. 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Saito Y, Kobayashi Y, Tanabe K and Ikari Y (2019) Antithrombotic therapy after percutaneous coronary intervention from the Japanese perspective, Cardiovascular Intervention and Therapeutics, 10.1007/s12928-019-00633-6, 35:1, (19-29), Online publication date: 1-Jan-2020. December 3, 2019Vol 140, Issue 23 Advertisement Article InformationMetrics © 2019 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.119.043613PMID: 31560216 Originally publishedSeptember 27, 2019 Keywordsplatelet aggregation inhibitorspercutaneous coronary interventionstentshemorrhagethrombosisPDF download Advertisement SubjectsPercutaneous Coronary InterventionRevascularizationStent
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