Evidence map›Paper›PMID 32876814›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2021

Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study.

Ioannis Merinopoulos, Tharusha Gunawardena, Upul Wickramarachchi, Paul Richardson, Clint Maart, Sulfi Sreekumar, Chris Sawh, Trevor Wistow, Toomas Sarev, Alisdair Ryding and 4 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
4.7field-weighted citation impact, top 4% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Drug-Coated Balloons for Coronary Interventions: A Focused Review.Methodist DeBakey cardiovascular journal · 2025
    Review
  11. Review
  12. Article
  13. Safety aspects ofFrontiers in cardiovascular medicine · 2025
    Article
  14. Review
  15. Article
  16. Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
    Article
  17. Article
  18. Review
  19. Article
  20. 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

14 authors at 3 institutions in 1 country.

Ioannis MerinopoulosDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.ORCID http://orcid.org/0000-0002-2059-0357
Tharusha GunawardenaDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Upul WickramarachchiDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Paul RichardsonDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Clint MaartDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Sulfi SreekumarDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Chris SawhDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Trevor WistowDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Toomas SarevDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Alisdair RydingDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Tim GilbertDepartment of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Aris PerperoglouSchool of Mathematics, Statistics and Physics, Newcastle University, Newcastle Upon, UK.
Vassilios S Vassiliou *Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK. v.vassiliou@uea.ac.uk.
Simon C Eccleshall *Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
Norfolk and Norwich University Hospital · GBUniversity of East Anglia · GBNewcastle University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesWe aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI).

backgroundSafety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel.

methodsWe compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel second-generation drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan-Meier curves and Cox regression statistical models.

resultsWe present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES (p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis.

conclusionWe found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.

Indexed as

Coated Materials, BiocompatibleDrug-Eluting StentsAgedAngioplasty, Balloon, CoronaryCause of DeathCoronary AngiographyCoronary Artery DiseaseCoronary VesselsFemaleFollow-Up StudiesHumansMalePaclitaxelTime FactorsTreatment OutcomeUnited KingdomCoated Materials, BiocompatiblePaclitaxelDrug-coated balloonMortalityStable angina

Identifiers

PMID32876814
PMCPMC7862512
OpenAlexW3081893201

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.