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22.12.2015 | Original Paper

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

verfasst von: Salvatore Cassese, Sebastian Kufner, Erion Xhepa, Robert A. Byrne, Johanna Kreutzer, Tareq Ibrahim, Klaus Tiroch, Marco Valgimigli, Ralph Tölg, Massimiliano Fusaro, Heribert Schunkert, Karl-Ludwig Laugwitz, Julinda Mehilli, Adnan Kastrati

Erschienen in: Clinical Research in Cardiology | Ausgabe 7/2016

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Abstract

Background

In 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.

Methods

The 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).

Results

In 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).

Conclusions

At 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.

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Titel: 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
verfasst von: Salvatore Cassese
Sebastian Kufner
Erion Xhepa
Robert A. Byrne
Johanna Kreutzer
Tareq Ibrahim
Klaus Tiroch
Marco Valgimigli
Ralph Tölg
Massimiliano Fusaro
Heribert Schunkert
Karl-Ludwig Laugwitz
Julinda Mehilli
Adnan Kastrati
Publikationsdatum: 22.12.2015
Verlag: Springer Berlin Heidelberg
Erschienen in: Clinical Research in Cardiology / Ausgabe 7/2016
Print ISSN: 1861-0684
Elektronische ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-015-0953-x

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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