Evidence map›Paper›PMID 36385601›Full record

ArticleCardiology journal2022

Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon.

Mehdi Madanchi, Giacomo M Cioffi, Adrian Attinger-Toller, Thomas Seiler, Sophie Somm, Tanja Koch, Gregorio Tersalvi, Mathias Wolfrum, Federico Moccetti, Stefan Toggweiler and 5 more

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Cardiology journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

NCT04988685 recruitingnot on this map

SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters

Typeobservational_patient_registrySponsorLuzerner KantonsspitalRan2021 to 2031Enrolled2,000ConditionsCoronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary ArteriosclerosisArmsSirolimus Eluting Balloon
NCT06373601 narecruitingnot on this mapstarted 2024, after this paper: background citation

Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.

TypeinterventionalSponsorFondazione Evidence per Attività e Ricerche Cardiovascolari ONLUSRan2024 to 2027Enrolled140ConditionsCoronary Artery Disease, Stenosis Coronary, Coronary Artery Lesion, Percutaneous Coronary InterventionArmssirolimus-eluting balloon (Selution), paclitaxel-eluting balloon (SeQuent Please Neo)
NCT07256249 recruitingnot on this mapstarted 2025, after this paper: background citation

Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry

Typeobservational_patient_registrySponsorFundación EPICRan2025 to 2027Enrolled960ConditionsCardiovascular DiseasesArmsSELUTION SLRTM sirolimus coated balloon
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. A novel sirolimus-coated balloon versus a paclitaxel-coated balloon for coronary artery disease: the SELSEQ registry.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  2. Review
  3. Clinical Efficacy and Safety of Selution SLRActa Cardiologica Sinica · 2025
    Article
  4. Article
  5. Review
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 at 4 institutions in 2 countries.

Mehdi MadanchiCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland. mehdi1369@hotmail.com.ORCID 0000-0001-6366-6211
Giacomo M CioffiCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Adrian Attinger-TollerCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Thomas SeilerCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Sophie SommCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Tanja KochCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Gregorio TersalviCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Mathias WolfrumCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Federico MoccettiCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Stefan ToggweilerCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Richard KobzaCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Molly B LevineDivision of Interventional Cardiology - MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Georgetown University, Washington, United States.
Hector M Garcia-GarciaDivision of Interventional Cardiology - MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Georgetown University, Washington, United States.
Matthias BossardCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Florim CuculiCardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Luzerner Kantonsspital · CHUniversity of Lucerne · CHMedStar Georgetown University Hospital · USResearch Network (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLimus-eluting stents have become the mainstay for percutaneous coronary intervention (PCI). However, even with the latest generation drug-eluting stent, in-stent restenosis and very late stent thrombosis remain a concern. The Selution SLR™ drug-coated balloon (DCB) is a novel sirolimus-coated balloon that provides a controlled release of the antiproliferative drug. Herein we evaluated its performance in a real-world patient cohort with complex coronary artery lesions.

methodsPatients undergoing PCI using the Selution SLR™ DCB were analyzed from the prospective SIROOP registry. We evaluated procedural success and clinical outcomes, including major adverse cardiovascular event (MACE), cardiac death, target vessel myocardial infarction and target lesion revascularization.

resultsFrom September 2020 to April 2021, we enrolled 78 patients (87 lesions) treated using a "DCB only" strategy. The mean age was 66.7 ± 10.4 years and 28 (36%) presented with an acute coronary syndrome. Almost all lesions were type B2/C 86 (99%) and 49 (63%) had moderate to severe calcifications. Procedural success was 100%. After a median follow-up of 11.2 months (interquartile range: 10.0-12.6), MACE occurred in 5 (6.8%) patients. No acute vessel closure was observed.

conclusionsIn complex coronary lesions, a "DCB only" strategy using the Selution SLR™ DCB is not just safe and feasible, but also seems to be associated with a low rate of MACE at 1-year follow-up. Our promising results warrant further evaluation in a dedicated comparative trial.

Indexed as

Coronary Artery DiseaseCoronary RestenosisDrug-Eluting StentsPercutaneous Coronary InterventionAgedCoronary AngiographyHumansMetalsMiddle AgedProspective StudiesSirolimusTreatment OutcomeMetalsSirolimuscomplex coronary lesionsdrug-coated balloonsdrug-eluting stentpercutaneous coronary interventionssirolimus

Identifiers

PMID36385601
PMCPMC9788730
OpenAlexW4309245501

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.