Evidence map›Paper›PMID 38958753›Full record

SynthesisClinical research in cardiology : official journal of the German Cardiac Society2025

Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.

Rodolfo Caminiti, Giampiero Vizzari, Alfonso Ielasi, Giampaolo Vetta, Antonio Parlavecchio, Domenico Giovanni Della Rocca, Carolina Montonati, Dario Pellegrini, Mariano Pellicano, Maurizio Tespili and 1 more

Abstract readSystematic ReviewMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Clinical research in cardiology : official journal of the German Cardiac Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

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

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

  1. Drug Coated Balloons Versus Drug-Eluting Stents in Patients With De Novo Coronary Artery Disease.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Pooled it
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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.

Rodolfo Caminiti *Unità Operativa Di Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Via Belgioioso 173, 20157, Milan, Italy.
Giampiero Vizzari *Cardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Alfonso IelasiUnità Operativa Di Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Via Belgioioso 173, 20157, Milan, Italy. alielasi@hotmail.com.
Giampaolo VettaCardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Antonio ParlavecchioCardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Domenico Giovanni Della RoccaHeart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, European Reference Networks Guard-Heart, Brussels, Belgium.
Carolina MontonatiUnità Operativa Di Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Via Belgioioso 173, 20157, Milan, Italy.
Dario PellegriniUnità Operativa Di Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Via Belgioioso 173, 20157, Milan, Italy.
Mariano PellicanoUnità Operativa Di Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Via Belgioioso 173, 20157, Milan, Italy.
Maurizio TespiliUnità Operativa Di Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Via Belgioioso 173, 20157, Milan, Italy.
Antonio MicariCardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDrug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting.

methodsA comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI).

resultsA total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006].

conclusionOur meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal-free" strategy in this subset of CAD.

Indexed as

Angioplasty, Balloon, CoronaryCoated Materials, BiocompatibleCoronary Artery DiseaseDrug-Eluting StentsHumansTreatment OutcomeCoated Materials, BiocompatibleAngioplastyCoronary artery diseaseDe novoDrug-coated balloonDrug-eluting stentLarge vessel disease

Identifiers

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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.