Evidence map›Paper›PMID 26689707›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2016

Three-year efficacy and safety of new- versus early-generation drug-eluting stents for unprotected left main coronary artery disease insights from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 trials.

Salvatore Cassese, Sebastian Kufner, Erion Xhepa, Robert A Byrne, Johanna Kreutzer, Tareq Ibrahim, Klaus Tiroch, Marco Valgimigli, Ralph Tölg, Massimiliano Fusaro and 4 more

2 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

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

NCT00133237 phase4completednot on this map

Prospective, Randomized Trial of the Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent for the Treatment of Unprotected Left Main Coronary Artery Disease(ISAR-LEFT-MAIN)

TypeinterventionalSponsorDeutsches Herzzentrum MuenchenRan2005 to 2008Enrolled607ConditionsCoronary DiseaseArmsSirolimus-eluting stent, Paclitaxel-eluting stent
NCT00598637 phase4completednot on this map

Prospective Randomized Trial of Everolimus- and Zotarolimus-eluting Stents for Treatment of Unprotected Left Main Coronary Artery Disease: ISAR-LEFT-MAIN-2

TypeinterventionalSponsorDeutsches Herzzentrum MuenchenRan2007 to 2013Enrolled650ConditionsCoronary DiseaseArmsEverolimus-eluting stent (Xience), Zotarolimus-eluting stent (Endeavor Resolute)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents.Clinical research in cardiology : official journal of the German Cardiac Society · 2018
    Observational
  5. German contribution to development and innovations in the management of acute myocardial infarction and cardiogenic shock.Clinical research in cardiology : official journal of the German Cardiac Society · 2018
    Review
  6. Article
  7. Survival after percutaneous coronary intervention for chronic total occlusion.Clinical research in cardiology : official journal of the German Cardiac Society · 2016
    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

14 authors.

Salvatore CasseseDeutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Sebastian KufnerDeutsches Herzzentrum München, Technische Universität München, Munich, Germany. sebastian.kufner@gmx.de.ORCID http://orcid.org/0000-0002-8091-4552
Erion XhepaDeutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Robert A ByrneDeutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Johanna KreutzerDeutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Tareq Ibrahim1. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Lazarettstrasse 36, 80636, Munich, Germany.
Klaus TirochDepartment of Cardiology, Helios Klinikum Wuppertal, Universität Witten/Herdecke, Wuppertal, Germany.
Marco ValgimigliDepartment of Cardiology, Bern University Hospital, Bern, Switzerland.
Ralph TölgHerzzentrum der Segeberger Kliniken Gruppe, Bad Segeberg, Germany.
Massimiliano FusaroDeutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Heribert SchunkertDeutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Karl-Ludwig Laugwitz1. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Lazarettstrasse 36, 80636, Munich, Germany.
Julinda MehilliDepartment of Cardiology, Ludwig-Maximilians-Universität, Munich, Germany.
Adnan KastratiDeutsches Herzzentrum München, Technische Universität München, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn percutaneous coronary intervention (PCI) patients new-generation drug-eluting stent (DES) has reduced adverse events in comparison to early-generation DES. The aim of the current study was to investigate the long-term clinical efficacy and safety of new-generation DES versus early-generation DES for PCI of unprotected left main coronary artery (uLMCA) disease.

methodsThe patient-level data from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 randomized trials were pooled. The clinical outcomes of PCI patients assigned to new-generation DES (everolimus- or zotarolimus-eluting stent) versus early-generation DES (paclitaxel- or sirolimus-eluting stent) were studied. The primary endpoint was the composite of death, myocardial infarction (MI), target lesion revascularization and stroke (MACCE, major adverse cardiac and cerebrovascular event).

resultsIn total, 1257 patients were available. At 3 years, the risk of MACCE was comparable between patients assigned to new-generation DES or early-generation DES (28.2 versus 27.5 %, hazard ratio-HR 1.03, 95 % confidence intervals-CI 0.83-1.26; P = 0.86). Definite/probable stent thrombosis was low and comparable between new-generation DES and early-generation DES (0.8 versus 1.6 %, HR 0.52, 95 % CI 0.18-1.57; P = 0.25); in patients treated with new-generation DES no cases occurred beyond 30 days. Diabetes increased the risk of MACCE in patients treated with new-generation DES but not with early-generation DES (P interaction = 0.004).

conclusionsAt 3-year follow-up, a PCI with new-generation DES for uLMCA disease shows comparable efficacy to early-generation DES. Rates of stent thrombosis were low in both groups. Diabetes significantly impacts the risk of MACCE at 3 years in patients treated with new-generation DES for uLMCA disease. ClinicalTrials.gov Identifiers: NCT00133237; NCT00598637.

Indexed as

Drug-Eluting StentsAgedCardiovascular AgentsCoronary AngiographyCoronary Artery DiseaseEverolimusFemaleGermanyHumansItalyKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionProsthesis DesignCardiovascular AgentsEverolimusSirolimuszotarolimusDrug-eluting stentEverolimusLeft main coronary arteryPaclitaxelPercutaneous coronary interventionSirolimusZotarolimus

Identifiers

PMID26689707

What OpenQuestion holds

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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.