Evidence map›Paper›PMID 41444578›Full record

Trial reportBMC medicine2025

Three vs 12-month DAPT after implantation of biodegradable-polymer sirolimus-eluting coronary stent: a randomised clinical trial.

Hongbo Yang, Feng Zhang, Xiwen Zhang, Yanqing Wu, Zhixiong Zhong, Jian'an Wang, Yujie Zhou, Lang Hong, Wei Yang, Tingbo Jiang and 19 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03008083 (A Prospective Multi-center Open-label Controlled Trial of Comparison 3 vs 12 Months of Dual Anti-Platelet Therapy After Implantation of Firehawk Sirolimus Target- Eluting Stent in Patients With Stable Coronary Artery Disease), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03008083 phase4unknown statusnot on this map

A Prospective Multi-center Open-label Controlled Trial of Comparison 3 vs 12 Months of Dual Anti-Platelet Therapy After Implantation of Firehawk Sirolimus Target- Eluting Stent in Patients With Stable Coronary Artery Disease

TypeinterventionalSponsorShanghai MicroPort Medical (Group) Co., Ltd.Ran2019 to 2022Enrolled2,446ConditionsDrug-Eluting Stents, Percutaneous Coronary InterventionArms3 months DAPT, 12 months DAPT
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Hongbo Yang *Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital of Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 110015, China.
Feng Zhang *Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital of Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 110015, China. zhang.feng@zs-hospital.sh.cn.
Xiwen Zhang *Department of Cardiology, Huai'an First People's Hospital, Huai'an, China.
Yanqing WuDepartment of Cardiology, Second Affiliated Hospital of Nan Chang University, Nan Chang, China.
Zhixiong ZhongDepartment of Cardiology, Mei Zhou People's Hospital, Mei Zhou, China.
Jian'an WangDepartment of Cardiology, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Yujie ZhouDepartment of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing, China.
Lang HongDepartment of Cardiology, Jiangxi Provincial People's Hospital, Nan Chang, China.
Wei YangDepartment of Cardiology, The Fourth Hospital of Harbin Medical University, Harbin, China.
Tingbo JiangDepartment of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Jianjie ZouDepartment of Cardiology, The Hospital of Traditional Chinese Medicine and Western Medicine of Panzhihua, Panzhihua, China.
Zheng ZhangDepartment of Cardiology, The First Hospital of Lanzhou University, Lanzhou, China.
Yitong MaDepartment of Cardiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
Shangyu WenDepartment of Cardiology, Tianjin Fourth Central Hospital, Tianjin, China.
Zhongcai FanDepartment of Cardiology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
Dawen XuDepartment of Cardiology, Panzhihua Central Hospital, Panzhihua, China.
Hong JiangDepartment of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.
Jianhong TaoDepartment of Cardiology, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu, China.
Haojin RenDepartment of Cardiology, Wuhan Puren Hospital, Wuhan, China.
Yong XiaDepartment of Cardiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Yijie HuangDepartment of Cardiology, Xuzhou Central Hospital, Xuzhou, China.
Guidong XuDepartment of Cardiology, Suzhou Municipal Hospital, Suzhou, China.
Ruifen CaoShanghai MicroPort Medical (Group) Co., Ltd., Shanghai, China.
Ming ZhengShanghai MicroPort Medical (Group) Co., Ltd., Shanghai, China.
Juying QianDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital of Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 110015, China.
Dominic P FranceseSection of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Alexandra J LanskySection of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Junbo GeDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital of Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 110015, China. jbge@zs-hospital.sh.cn.
TARGET DAPT Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly discontinuation of dual antiplatelet therapy (DAPT) within 3 months after implantation of drug-eluting stents may reduce bleeding risk without increasing ischaemic events. This study aimed to assess whether 3-month DAPT is as safe as the conventional 12-month regimen in patients treated with Firehawk stents, which have demonstrated 99.9% reendothelialisation at 3 months by optical coherence tomography.

methodsFrom January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to a 3-month (n = 1222) or 12-month DAPT regimen (n = 1223) in this randomised, open-label, non-inferiority trial, patients from 36 centres in China who underwent percutaneous coronary intervention with Firehawk stents. The primary endpoint was a composite of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 18 months. The co-equal secondary endpoints were major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction and ischaemia-driven target lesion revascularisation, and major bleeding.

resultsFrom January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to 3-month (N = 1222) or 12-month DAPT regimen (N = 1223). Adherence to the protocol-defined DAPT duration was 71.0% and 95.5%, respectively. Rates of the primary endpoint were comparable between both groups (10.1% vs 10.9%). Non-inferiority of 3-month DAPT was established (absolute rate difference, - 0.76%; upper limit of 1-sided 97.5% CI, 1.70%; p non-inferiority = 0.0003, with a predefined non-inferiority margin of 3.5%). Rates of co-secondary endpoints showed no significant difference (both p > 0.05). Landmark analysis (3-18 months) showed significant lower rate of major bleeding (2.7% vs 4.4%; p = 0.03) with 3-month DAPT.

conclusionsIn patients treated with Firehawk stents, 3-month DAPT was non-inferior to 12-month DAPT for the primary composite endpoint of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding at 18 months.

trial registrationNCT03008083 (clinicaltrials.gov).

Indexed as

Absorbable ImplantsDrug-Eluting StentsDual Anti-Platelet TherapyPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsSirolimusAgedChinaFemaleHemorrhageHumansMaleMiddle AgedPolymersTime FactorsPlatelet Aggregation InhibitorsPolymersSirolimusBiodegradable polymerDrug-eluting stentDual antiplatelet therapyDurationNet adverse clinical and cerebral event

Identifiers

PMID41444578
PMCPMC12729390

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.