Evidence map›Paper›PMID 42541503›Full record

ArticleJACC. Asia2026

Paclitaxel-Coated Balloon for Coronary In-Stent Restenosis and De Novo Disease in Chinese Patients.

Tse-Min Lu, Hsu-Lung Jen, Hee Hwa Ho, Chiung Ray Lu, Cheng-Ting Tsai, Feng-Yu Kuo, Simon Cheung-Chi Lam, Ji-Hung Wang, Jack Livingston, Rafael Cavalcante and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in JACC. Asia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04085445 (Agent DCB Registry), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT04085445 completednot on this map

Agent DCB Registry

Typeobservational_patient_registrySponsorBoston Scientific CorporationRan2019 to 2024Enrolled500ConditionsChinese Patients Treated With Agent DCBArmsAgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

11 authors.

Tse-Min LuTaipei Veterans General Hospital, Taipei, Taiwan.
Hsu-Lung JenCheng Hsin General Hospital, Taipei, Taiwan.
Hee Hwa HoTan Tock Seng Hospital, Singapore.
Chiung Ray LuChina Medical University Hospital, Taichung, Taiwan.
Cheng-Ting TsaiMackay Memorial Hospital, Taipei, Taiwan.
Feng-Yu KuoKaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
Simon Cheung-Chi LamDepartment of Medicine, Queen Mary Hospital, Hong Kong SAR, China.
Ji-Hung WangHualien Tzu Chi Hospital, Hualien, Taiwan.
Jack LivingstonBoston Scientific Corporation, Marlborough, Massachusetts, USA.
Rafael CavalcanteBoston Scientific Corporation, Marlborough, Massachusetts, USA.
Hsien-Li KaoNational Taiwan University Hospital, Taipei, Taiwan. Electronic address: Hsienli_kao@yahoo.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDrug-coated balloons provide antiproliferative therapy without permanent implants and may benefit lesion subsets where drug-eluting stent performance is suboptimal.

objectivesThe authors aimed to evaluate safety and effectiveness of a paclitaxel-coated balloon in a real-world cohort of ethnically Chinese patients with in-stent restenosis (ISR) or de novo coronary artery disease.

methodsThis was a prospective, multicenter, single-arm registry across 9 sites in Taiwan, Hong Kong, and Singapore. Patients undergoing percutaneous coronary intervention with paclitaxel-coated balloon (AGENT, Boston Scientific Corp.) for ISR or de novo coronary artery disease were included. Primary endpoint was 12-month major adverse cardiac events (MACEs; cardiac death, myocardial infarction, or target vessel revascularization). Secondary endpoints included target lesion revascularization, target lesion thrombosis, and 9-month angiographic outcomes. Events adjudicated by independent clinical events committee; angiography analyzed by independent core laboratory.

resultsA total of 500 patients (mean age 65.6 ± 11.2) were enrolled. At 365 days (IQR: 354-379) after the index procedure, 13.9% (68 of 489) of patients experienced MACE. MACE rates were 16.3% (48 of 294) and 10.5% (20 of 191), in ISR and de novo patients, respectively. Cardiac death and myocardial infarction rates were 1.6% (8 of 489) and 2.0% (10 of 489), respectively; target vessel revascularization occurred in 11.7% (57 of 489). Angiographic follow-up was performed in 35% (175 of 500) of patients. The 12-month MACE was significantly higher in patients undergoing surveillance angiography compared to without (26.9% [47 of 175] vs 4.9% [15 of 305], P < 0.001), driven by increased target lesion revascularization.

conclusionsPaclitaxel-coated balloon was safe and effective in ethnically Chinese patients. Surveillance imaging significantly influenced revascularization rates, underscoring its impact on clinical decision-making. (An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients; NCT04085445).

Indexed as

Chinese populationde novo coronary diseasedrug-coated balloonin-stent restenosispaclitaxel-coated balloonpercutaneous coronary intervention

Identifiers

PMID42541503
PMCPMC13554778

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