Evidence map›Paper›PMID 34518287›Full record

Observational studyOpen heart2021

Long-term outcomes after treatment of in-stent restenosis using the Absorb everolimus-eluting bioresorbable scaffold.

Mehdi Madanchi, Giacomo Maria Cioffi, Adrian Attinger-Toller, Mathias Wolfrum, Federico Moccetti, Thomas Seiler, Luca Vercelli, Philipp Burkart, Stefan Toggweiler, Richard Kobza and 2 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Open heart, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06075602 (COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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.

NCT06075602 recruitingnot on this map

COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease

Typeobservational_patient_registrySponsorLuzerner KantonsspitalRan2021 to 2031Enrolled5,000ConditionsCoronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary ArteriosclerosisArmsImpact of current PCI techniques/ devices in complex coronary artery lesions
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Observational
  3. Review
  4. Review
  5. Bioabsorbable coronary stents - should they be buried?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Article
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Mehdi Madanchi *Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.ORCID 0000-0001-6366-6211
Giacomo Maria Cioffi *Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Adrian Attinger-TollerDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Mathias WolfrumDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Federico MoccettiDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Thomas SeilerDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Luca VercelliDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Philipp BurkartDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Stefan ToggweilerDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Richard KobzaDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Matthias BossardDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
Florim CuculiDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland florim.cuculi@luks.ch.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly studies evaluating the performance of bioresorbable scaffold (BRS) Absorb in in-stent restenosis (ISR) lesions indicated promising short-term to mid-term outcomes.

aimsTo evaluate long-term outcomes (up to 5 years) of patients with ISR treated with the Absorb BRS.

methodsWe did an observational analysis of long-term outcomes of patients treated for ISR using the Absorb BRS (Abbott Vascular, Santa Clara, California, USA) between 2013 and 2016 at the Heart Centre Luzern. The main outcomes included a device-oriented composite endpoint (DOCE), defined as composite of cardiac death, target vessel (TV) myocardial infarction and TV revascularisation, target lesion revascularisation and scaffold thrombosis (ScT).

resultsOverall, 118 ISR lesions were treated using totally 131 BRS among 89 patients and 31 (35%) presented with an acute coronary syndrome. The median follow-up time was 66.3 (IQR 52.3-77) months. A DOCE had occurred in 17% at 1 year, 27% at 2 years and 40% at 5 years of all patients treated for ISR using Absorb. ScTs were observed in six (8.4%) of the cohort at 5 years.

conclusionsTreatment of ISR using the everolimus-eluting BRS Absorb resulted in high rates of DOCE at 5 years. Interestingly, while event rates were low in the first year, there was a massive increase of DOCE between 1 and 5 years after scaffold implantation. With respect to its complexity, involving also a more unpredictable vascular healing process, current and future BRS should be used very restrictively for the treatment of ISR.

Indexed as

Absorbable ImplantsDrug-Eluting StentsRegistriesAgedCoronary AngiographyCoronary RestenosisEverolimusFemaleFollow-Up StudiesGraft Occlusion, VascularHumansImmunosuppressive AgentsMalePercutaneous Coronary InterventionPropensity ScoreRetrospective StudiesEverolimusImmunosuppressive Agentscardiac catheterisationcoronary angiographycoronary artery diseasepercutaneous coronary intervention

Identifiers

PMID34518287
PMCPMC8438862

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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.