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September 3, 2026Cardiology ResearchOpen Access

Regional Differences Between Drug-Coated Balloons and Drug-Eluting Stents in De Novo Coronary Disease

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Why the study?

Does drug-coated balloon compared to drug-eluting stent improve device-oriented composite outcomes in adults with de novo coronary artery disease?

Population

13 randomized trials pooling 4,673 adult patients with de novo coronary artery disease. Trials of in-stent…

Comparison

Drug-coated balloons vs Drug-eluting stents (first- or second-generation)

Design

Meta-analysis

Follow-up

6 months to 5 years

Key result

Drug-coated balloons and drug-eluting stents produced comparable overall rates of device-oriented composite outcomes (IRR 1.00) in de novo coronary artery disease.

Authors

GDGulshan Man Singh DangolQLQuang LeSMSajana Maharjan

Discussion

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Overview

Regional variation in DCB versus DES outcomes for dnCAD remains uncertain; leaves open whether geography or trial factors drive differences.

Key Points

  • To determine whether clinical outcomes comparing drug-coated balloons with drug-eluting stents for de novo coronary artery disease differ between Europe and Asia, and assess whether observed disparities reflect true geographic effects or trial-level confounding.
  • Searched PubMed, Embase, and Cochrane Central for randomized controlled trials comparing drug-coated balloons (DCBs) with drug-eluting stents (DESs) in de novo coronary artery disease (13 trials, N=4,673).
  • Pooled incidence rate ratios (IRRs) using DerSimonian-Laird random-effects models with Hartung-Knapp 95% confidence intervals for a harmonized device-oriented composite outcome (DOCO) across 12 trials (N=4,396).
  • Assessed regional subgroup interactions (Europe vs. Asia) alongside subgroup-aware leave-one-out sensitivity analyses, vessel size inclusion criteria, and comparator-DES generations.
  • DOCO did not differ overall between DCBs and DESs (IRR = 1.00; 95% CI, 0.70–1.44; I² = 49.1%), and secondary endpoints including cardiac death also showed no significant overall difference (IRR = 1.20; 95% CI, 0.94–1.52).
  • A nominally significant regional DOCO difference (Europe IRR = 0.83, 95% CI 0.44–1.57; Asia IRR = 1.48, 95% CI 1.04–2.11; subgroup P = 0.04) was not robust, losing significance in 8 of 12 leave-one-out iterations and upon omitting REC-CAGEFREE I (subgroup P = 0.46).

Study Design

Type

Meta-Analysis (n=4,673)

Structured PICO

Does drug-coated balloon compared to drug-eluting stent improve device-oriented composite outcomes in adults with de novo coronary artery disease?

P
Population
4,673 adults with de novo coronary artery disease from 13 randomized trials in Europe and Asia, followed for 6 months to 5 years.
I
Intervention
Drug-coated balloons (all 13 trials used paclitaxel-coated balloons)
C
Comparator
Drug-eluting stents (first- or second-generation)
O
Outcome
Harmonized device-oriented composite outcome (DOCO), defined per trial as major adverse cardiovascular events (MACEs), target-lesion failure (TLF), or device-oriented clinical endpoint (DoCE)composite

Main Result

Relative Risk: 1 (95% CI 0.7–1.44)

The apparent regional difference in outcomes between drug-coated balloons and drug-eluting stents for de novo coronary disease is driven by trial-level confounding rather than geography, highlighting the need for globally representative trials.

Limitations

  • Pooled and regional estimates were disproportionately influenced by a single trial (REC-CAGEFREE I).
  • All included trials were conducted in Europe or Asia, with no randomized data from other continents.
  • Aggregate data were used, requiring harmonization of composite endpoints across partially differing trial definitions.
  • Follow-up durations differed widely, requiring reconstruction of person-years which could introduce bias if event rates varied over time.
  • Univariable meta-regression was underpowered due to the small number of trials.
  • Antiplatelet regimens differed across trials and regions, potentially confounding the results.
  • Pooled and regional estimates were disproportionately influenced by a single trial (REC-CAGEFREE I)
  • All included trials were conducted in Europe or Asia, with no randomized data from other regions
  • Aggregate (not individual-patient) data were used, requiring harmonization of composite endpoints
  • Follow-up durations differed widely, requiring incidence-rate ratios under a constant-hazard assumption
  • Antiplatelet regimens differed across trials and regions and were unmeasured at the patient level

Cite This Study

Dangol et al. (2026) conducted a meta-analysis in De novo coronary artery disease (n=4,673). Drug-coated balloons vs. Drug-eluting stents was evaluated on Device-oriented composite outcome (DOCO) (IRR 1.00, 95% CI 0.70-1.44). Drug-coated balloons and drug-eluting stents produced comparable overall rates of device-oriented composite outcomes (IRR 1.00) in de novo coronary artery disease.

synapsesocial.com/papers/6a9934ea636c6408cfa7ca50https://doi.org/10.14740/cr2252
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