Evidence map›Paper›PMID 37930402›Full record

SynthesisClinical research in cardiology : official journal of the German Cardiac Society2024

Modified balloons to prepare severely calcified coronary lesions before stent implantation: a systematic review and meta-analysis of randomized trials.

Maria Scalamogna, Constantin Kuna, Felix Voll, Alp Aytekin, Shqipdona Lahu, Thorsten Kessler, Sebastian Kufner, Tobias Rheude, Hendrik B Sager, Erion Xhepa and 5 more

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Clinical research in cardiology : official journal of the German Cardiac Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

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

  1. Pooled it
  2. Review
  3. Review
  4. Calcium modifying dedicated balloons: a contemporary review.Frontiers in cardiovascular medicine · 2026
    Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Carotid artery stenting for heavily calcified lesions after plaque modification using scoring balloon angioplasty.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025
    Article
  11. Review
  12. 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

15 authors.

Maria Scalamogna *Klinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Constantin Kuna *Klinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Felix VollKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Alp AytekinKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Shqipdona LahuKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Thorsten KesslerKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Sebastian KufnerKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Tobias RheudeKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Hendrik B SagerKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Erion XhepaKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Jens WiebeKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Michael JonerKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Gjin NdrepepaKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Adnan KastratiKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.
Salvatore CasseseKlinik Für Herz- Und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany. cassese@dhm.mhn.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe performance of modified balloons (namely cutting or scoring balloons) to prepare severely calcified lesions in patients undergoing percutaneous coronary intervention (PCI) remains controversial. We investigated the clinical and imaging outcomes of patients undergoing PCI assigned to modified balloon therapy to prepare severely calcified coronary lesions before stent implantation.

methodsIn this meta-analysis, we aggregated the study-level data from trials enrolling invasively treated patients who were randomly assigned to modified balloon or control therapy to prepare severely calcified lesions before stenting. The primary outcome was major adverse cardiac events (MACE), including death, myocardial infarction (MI), and repeat revascularization. The secondary outcomes included the individual components of the primary outcome, coronary perforation and final minimal stent area (MSA) as measured by intracoronary imaging.

resultsA total of 648 participants in six trials were allocated to modified balloon therapy (n = 335) or control therapy (semi-compliant, non-compliant, or super high-pressure balloon, n = 313). The median follow-up was 11 months. Overall, MACE occurred in 8.96% of patients assigned to a modified balloon and 12.78% of patients assigned to control therapy [risk ratio = 0.70, 95% confidence interval (CI) 0.35-1.39; P = 0.24]. There was a significant treatment effect-by-modified balloon type interaction for the outcome MACE in patients assigned to cutting balloon compared with control therapy [RR = 0.40 (0.28-0.56), P for interaction (P

conclusionsIn patients treated with PCI for severely calcific coronary artery disease a strategy of lesion preparation with a modified balloon before stenting does not improve clinical or imaging outcomes compared with control therapy. The different performance of cutting and scoring balloons warrants further investigation.

Indexed as

Angioplasty, Balloon, CoronaryCoronary Artery DiseaseRandomized Controlled Trials as TopicStentsVascular CalcificationHumansPercutaneous Coronary InterventionSeverity of Illness IndexTreatment OutcomeCoronary artery diseaseMeta-analysisModified balloonsStent

Identifiers

PMID37930402
PMCPMC11219378

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.