Evidence map›Paper›PMID 38483633›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2024

Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial.

Nader Mankerious, Gert Richardt, Abdelhakim Allali, Volker Geist, Adnan Kastrati, Mohamed El-Mawardy, Tobias Rheude, Dmitriy Sulimov, Ralph Toelg, Mohamed Abdel-Wahab

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyComparative Study
PubMed Publisher
In one paragraph

Trial report 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. It is linked to trial NCT02502851 (The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT02502851 nacompletednot on this map

The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions

TypeinterventionalSponsorSegeberger Kliniken GmbHRan2014 to 2019Enrolled200ConditionsCoronary Atherosclerosis Due to Severely Calcified Coronary LesionArmsRotational Atherectomy, Cutting/Scoring Balloon
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Network meta-analysis of treatment strategies for calcified coronary lesions.Cardiovascular intervention and therapeutics · 2026
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. Calcium modifying dedicated balloons: a contemporary review.Frontiers in cardiovascular medicine · 2026
    Review
  6. Article
  7. Article
  8. 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

10 authors at 7 institutions in 2 countries.

Nader MankeriousCardiology Department, Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany. nader.mankerious@gmail.com.ORCID http://orcid.org/0000-0003-4809-5371
Gert RichardtCardiology Department, Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany.
Abdelhakim AllaliCardiology Department, University Heart Center Lübeck, Lübeck, Germany.
Volker GeistCardiology Department, Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany.
Adnan KastratiCardiology Department, German Heart Center, Technical University of Munich, Munich, Germany.
Mohamed El-MawardyCardiology Department, DRK Kliniken Berlin Köpenick, Berlin, Germany.
Tobias RheudeCardiology Department, German Heart Center, Technical University of Munich, Munich, Germany.
Dmitriy SulimovCardiology Department, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Ralph ToelgCardiology Department, Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany.
Mohamed Abdel-WahabCardiology Department, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Deutsches Herzzentrum München · DELeipzig Heart Institute · DESegeberger Kliniken · DEChristian-Albrechts-Universität zu Kiel · DEDRK Kliniken Berlin · DEUniversity of Lübeck · DEZagazig University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation demonstrated higher procedural success and comparable rates of acute lumen gain and late lumen loss compared to modified balloons (MB) (scoring/cutting). We aimed to analyze the 5-year outcomes of both lesion preparation strategies.

methodsPREPARE-CALC randomly assigned 200 patients 1:1 to MB or RA, followed by SES implantation. The principal endpoint of the current analysis was target vessel failure (TVF) at 5 years.

resultsAt 5 years, MB had comparable rates of TVF to RA (19% vs. 21%, HR 1.14, 95% CI 0.60-2.16, p = 0.687). Subgroup analysis showed a lesion length treatment interaction, favoring MB for short lesions and RA for long ones (p for interaction = 0.042). Target lesion revascularization (TLR) was significantly less common with RA (12 vs. 3%, HR 0.28, 95% CI 0.08-0.98, p = 0.048). In a multivariate analysis, RA was independently protective against TLR (adj. HR 0.17, 95% CI 0.04-0.78, p = 0.022), while ostial lesions were associated with higher TLR independent of treatment strategy (adj. HR 11.3, 95% CI 2.98-42.6, p < 0.001).

conclusionIn patients with severely calcified coronary lesions, using MB or RA for lesion preparation followed by biodegradable polymer SES implantation was associated with comparable rates of TVF at 5 years. However, a significant reduction of TLR was observed after RA. PREPARE-CALC is the first randomized trial showing potential clinical advantages of RA over MB during long-term follow-up. CLINICAL

trial registrationURL: https://www. CLINICALTRIALS: gov . Unique identifier: NCT02502851.

Indexed as

Angioplasty, Balloon, CoronaryAtherectomy, CoronaryCoronary Artery DiseaseDrug-Eluting StentsVascular CalcificationAbsorbable ImplantsAgedCoronary AngiographyCoronary VesselsFemaleFollow-Up StudiesHumansMaleMiddle AgedTime FactorsTreatment OutcomeBiodegradable polymer sirolimus-eluting stentCalcified coronary lesionsModified balloonRotational atherectomy

Identifiers

PMID38483633
OpenAlexW4392809991

What OpenQuestion holds

Textmetadata
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.