Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation

Nakamura, Masato; Iijima, Raisuke; Ako, Junya; Shinke, Toshiro; Okada, Hisayuki; Ito, Yoshiaki; Ando, Kenji; Anzai, Hitoshi; Tanaka, Hiroyuki; Ueda, Yasunori; Takiuchi, Shin; Nishida, Yasunori; Ohira, Hiroshi; Kawaguchi, Katsuhiro; Kadotani, Makoto; Niinuma, Hiroyuki; Omiya, Kazuto; Morita, Takashi; Zen, Kan; Yasaka, Yoshinori; Inoue, Kenji; Ishiwata, Sugao; Ochiai, Masahiko; Hamasaki, Toshimitsu; Yokoi, Hiroyoshi; Hara, Hidehiko; Yaita, Yoshinori; Takamisawa, Itaru; Yajima, Junji; Ishihara, Takayuki; Nakamura, Shigeru; Fujii, Kenshi; Ashida, Kazuhiro; Ōta, Hiroshi; Okutsu, Masaaki; Oshima, Masao; Kongoji, Ken; Jinno, Yasushi; Shutta, Ryu; Shiode, Nobuo; Oumi, Tetsuo; Doijiri, Tatsuki; Yokoi, Yoshiaki; Ogawa, Takayuki; Kimura, Keizo; Munemasa, Mitsuru; Mukawa, Hiroaki; Komiyama, Kanki; Suzuki, Takahiko; Inoue, Tatsuo; Ueno, Takayoshi; Sugano, Teruyasu; Yamashita, Jun; Yasumura, Yoshio; Kamiya, Hajime; Fujita, Hiroshi; Urasawa, Kazushi; Ono, Shiro; Ajioka, Masayoshi; Ando, Jiro; Mizuno, Koichi; Hanawa, Haruo; Tojo, Taiki; Maekawa, Yuichiro; Kawasaki, Terukazu; Okamura, Takayuki; Toyota, Fumitoshi; Hikichi, Yutaka; Michishita, Ichiro; Yagi, Takafumi; Kamihata, Hiroshi; Shindo, Naohisa; Ishizaka, Nobukazu; Ashikaga, Takashi; Ozaki, Yukio; Hara, Hisao; Sakamoto, Hiroshi; Kada, Kenji; Doi, Nobuhide; Honye, Junko; Takano, Hitoshi; Kawata, Masahito; Houzawa, Hidenori; Ozawa, Toru; Kikuchi, Arifumi; Kadota, Kazushige; Kijima, Yasufumi; Ikemoto, Tomokazu; Shimada, Yoshihisa; Yumoto, Kazuhiko; Kawajiri, Kenji; Nozaki, Yoichi; Sakakibara, Masayoshi; Tosaka, Atsushi; Noma, Shigetaka; Wakabayashi, Yasushi; Okada, Masaharu; Hirose, Mayumi; Takagi, Yuichiro; Takagi, Toshio; Miyauchi, Katsumi; Misu, Kazuhiko; Yasuda, Satoshi; Yoshikawa, Ryohei; Inoue, Ichiro; Yoshiyama, Minoru; Masuyama, Toru; Tomobuchi, Yoshiaki; Yamazaki, Seiji; Tanabe, Kengo; Wagatsuma, Kenji; Kato, Masayuki; Kawai, Kensuke; Hamazaki, Yuji; Yamagishi, Masakazu; Shibata, Yoshisato; Watanabe, Kentaro; Tachibana, Kunihide; Wada, Hiroshi; Ninomiya, Kenji; Suzuki, Hiroshi; Yoshioka, Jiro; Mori, Chisato; Sonoda, Masahiro; Kataoka, Toru; Terai, Hidenobu; Onishi, Yuko; Toma, Masanao; Serikawa, Takeshi; Otsuka, Yoritaka; Yano, Shoji; Ebisawa, Soichiro; Takashima, Hiroaki; Shimomura, Hideki; Kurumatani, Yoko; Shinjo, Samuel Katsuyuki; Uehara, Hiroki

doi:10.1016/j.jcin.2017.04.019

Cited by 94 publications

(96 citation statements)

References 24 publications

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“…Studies have shown that shorter DAPT length could be reasonable for BP‐DES. In the NIPPON study (biolimus BP‐DES), there was no significant increase in cardiovascular adverse events between the 6‐ and 18‐month DAPT . The I‐LOVE‐IT 2 study (sirolimus BP‐DES) showed no significant difference in TLF and total adverse events between the 6‐ and 12‐month DAPT groups .…”

Section: Discussionmentioning

confidence: 95%

“…In the NIPPON study (biolimus BP-DES), there was no significant increase in cardiovascular adverse events between the 6-and 18-month DAPT. 22 The I-LOVE-IT 2 study (sirolimus BP-DES) showed no significant difference in TLF and total adverse events between the 6-and 12-month DAPT groups. 23 The GLOBAL LEADERS study (biolimus BP-DES) compared 1-month DAPT, followed by ticagrelor monotherapy with standard 1-year DAPT, and found no difference between cardiovascular events and ST, 24 which also indicated the possibility of short-term DAPT.…”

Section: Clinical Outcomesmentioning

confidence: 93%

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Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Wang

Tao

et al. 2020

Cathet Cardio Intervent

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Objectives To analyze the 3‐year outcomes of the biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in CREDIT II AND III TRIALS. Background Though approved by CFDA, the long‐term safety and efficacy of EXCROSSAL is still unknown. Methods CREDIT II was a randomized trial comparing the EXCROSSAL versus EXCEL stents in patients with up to two de novo coronary lesions, and CREDIT III was a prospective, single‐arm study evaluating the efficacy and safety of EXCROSSAL in broad types of de novo coronary artery lesions. We pooled the 3‐year follow‐up data of the EXCROSSAL arm of the CREDIT II and CREDIT III Trials. The primary outcome was 3‐year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV‐MI), and clinically indicated target lesion revascularization (CI‐TLR). The patient‐oriented composite endpoint (PoCE) (all‐cause death, all MI, or any revascularization) and stent thrombosis (ST) were also analyzed. Results A total of 833 patients were included in this study. The incidence of TLF and PoCE in the 3‐year follow‐up were 7.6% and 12.5%, respectively. ST occurred in 0.6% of patients. In the subgroup analyses, TLF was significantly higher in small target vessels, multi‐lesion PCI, and multi‐vessel disease. Conclusions The 3‐year follow‐up analysis confirmed low rates of TLF and ST in EXCROSSAL, which is similar to the most widely used new generation durable polymer drug‐eluting stent.

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Section: Discussionmentioning

confidence: 95%

Section: Clinical Outcomesmentioning

confidence: 93%

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Wang

Tao

et al. 2020

Cathet Cardio Intervent

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“…To illustrate our methods, we perform an analysis of long-term follow-up of the NIPPON trial. 20 The study was designed to evaluate the noninferiority of the short-term DAPT (6 months) compared to long-term DAPT (18 months) in patients with drug eluting stents. The primary endpoint was time to the first occurrence of all-cause mortality, MI, stroke, or major bleed by 18 months.…”

Section: Examplementioning

confidence: 99%

Analysis of ordered composite endpoints

Follmann

Hamasaki

Evans

2019

Statistics in Medicine

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Composite endpoints are frequently used in clinical trials, but simple approaches, such as the time to first event, do not reflect any ordering among the endpoints. However, some endpoints, such as mortality, are worse than others. A variety of procedures have been proposed to reflect the severity of the individual endpoints such as pairwise ranking approaches, the win ratio, and the desirability of outcome ranking. When patients have different lengths of follow-up, however, ranking can be difficult and proposed methods do not naturally lead to regression approaches and require specialized software. This paper defines an ordering score O to operationalize the patient ranking implied by hierarchical endpoints. We show how differential right censoring of follow-up corresponds to multiple interval censoring of the ordering score allowing standard software for survival models to be used to calculate the nonparametric maximum likelihood estimators (NPMLEs) of different measures. Additionally, if one assumes that the ordering score is transformable to an exponential random variable, a semiparametric regression is obtained, which is equivalent to the proportional hazards model subject to multiple interval censoring. Standard software can be used for estimation. We show that the NPMLE can be poorly behaved compared to the simple estimators in staggered entry trials. We also show that the semiparametric estimator can be more efficient than simple estimators and explore how standard Cox regression maneuvers can be used to assess model fit, allow for flexible generalizations, and assess interactions of covariates with treatment. We analyze a trial of short versus long-term antiplatelet therapy using our methods. KEYWORDScomposite endpoints, DOOR, pairwise regression, probabilistic index model, win ratio INTRODUCTIONComposite endpoints are frequently used in clinical trials to provide a more comprehensive characterization of clinical outcomes than can be achieved by a single endpoint. In cardiovascular disease, the composite endpoint might include death, stroke, myocardial infarction (MI), major bleed, or revascularization. In trials of infections with drug resistant pathogens, death and kidney failure might be used while in trials of multiple sclerosis, death, relapse, or "substantial progression" might be used. Often, components of the endpoint are treated equally, for example, by using the time to occurrence of the first of any constituent endpoints.

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“…These trials were powered to look for difference in bleeding, and due to the low ischemic event rates, any conclusions drawn to qualify the efficacy would be inaccurate. More recently, NIPPON trial 56 was performed in Japan using bioabsorbable polymer-based DES. This trial tested for non-inferiority of 6-month DAPT vs. 18month DAPT, and randomized 3775 patients.…”

Section: Table 4 Comparative Features Of Randomized Controlled Trialsmentioning

confidence: 99%

Dual Antiplatelet Therapy (DAPT) in Coronary Artery Disease: A Daunting Dilemma

Chaturvedula¹,

Diver²,

Vashist³

2018

Preprint

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Percutaneous coronary intervention(PCI) with stenting for the treatment of acute coronary syndrome(ACS) is the contemporary standard of care. Such treatment is followed by Dual anti-platelet therapy(DAPT) comprising of aspirin and a P2Y12 inhibitor. The efficacy of this therapy has been well established but the optimal duration of DAPT remains elusive, and has thus far attracted a prodigious deal of scientific attention. Decision regarding DAPT duration can be challenging clinically in the modern era with the evolution of newer stents, more potent antiplatelet agents and novel anticoagulant drugs in addition to an older patient population with multiple comorbidities. Major societal guidelines have emphasized comprehensive assessment of ischemic and bleeding risk, in turn recommending individualization of DAPT duration, thus encouraging "shared decision making". The following review is aimed at critically evaluating the available evidence to help make these crucial clinical decisions regarding duration of DAPT and triple therapy.

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Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation

Cited by 94 publications

References 24 publications

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Analysis of ordered composite endpoints

Dual Antiplatelet Therapy (DAPT) in Coronary Artery Disease: A Daunting Dilemma

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