TY - JOUR
T1 - 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
AU - Cassese, Salvatore
AU - Kufner, Sebastian
AU - Xhepa, Erion
AU - Byrne, Robert A.
AU - Kreutzer, Johanna
AU - Ibrahim, Tareq
AU - Tiroch, Klaus
AU - Valgimigli, Marco
AU - Tölg, Ralph
AU - Fusaro, Massimiliano
AU - Schunkert, Heribert
AU - Laugwitz, Karl Ludwig
AU - Mehilli, Julinda
AU - Kastrati, Adnan
N1 - Publisher Copyright:
© 2015, Springer-Verlag Berlin Heidelberg.
PY - 2016/7/1
Y1 - 2016/7/1
N2 - 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 (Pinteraction = 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.
AB - 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 (Pinteraction = 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.
KW - Drug-eluting stent
KW - Everolimus
KW - Left main coronary artery
KW - Paclitaxel
KW - Percutaneous coronary intervention
KW - Sirolimus
KW - Zotarolimus
UR - http://www.scopus.com/inward/record.url?scp=84975832686&partnerID=8YFLogxK
U2 - 10.1007/s00392-015-0953-x
DO - 10.1007/s00392-015-0953-x
M3 - Article
C2 - 26689707
AN - SCOPUS:84975832686
SN - 1861-0684
VL - 105
SP - 575
EP - 584
JO - Clinical research in cardiology : official journal of the German Cardiac Society
JF - Clinical research in cardiology : official journal of the German Cardiac Society
IS - 7
ER -