TY - JOUR
T1 - Short-term and long-term clinical impact of stent thrombosis and graft occlusion in the SYNTAX trial at 5 years
T2 - Synergy between percutaneous coronary intervention with taxus and cardiac surgery trial
AU - Farooq, Vasim
AU - Serruys, Patrick W.
AU - Zhang, Yaojun
AU - Mack, Michael
AU - Ståhle, Elisabeth
AU - Holmes, David R.
AU - Feldman, Ted
AU - Morice, Marie Claude
AU - Colombo, Antonio
AU - Bourantas, Christos V.
AU - De Vries, Ton
AU - Morel, Marie Angèle
AU - Dawkins, Keith D.
AU - Kappetein, Arie Pieter
AU - Mohr, Friedrich W.
N1 - Funding Information:
The SYNTAX trial was funded by Boston Scientific. Dr. Mack has served on the Speakers’ Bureau of Boston Scientific, Cordis, and Medtronic. Dr. Feldman has served on the Speakers’ Bureau of Boston Scientific; received grant support from Abbott Laboratories , Atritech, Boston Scientific , Edwards, and Evalve ; and served as a consultant for Abbott Laboratories, Boston Scientific , Coherex , Edwards, InterValve , Square One, and W. L. Gore and Associates . Dr. Morice’s institution has received a research grant from Boston Scientific. Dr. Dawkins is a full-time employee and stockholder of Boston Scientific. All other authors have reported that they have no relationships relevant to the content of this paper to disclose.
PY - 2013/12/24
Y1 - 2013/12/24
N2 - Objectives The aim of this study was to report the short-term and long-term clinical impact of stent thrombosis (ST) and graft occlusion (GO) in the final 5-year outcomes of the SYNTAX (SYNergy Between PCI With TAXUS and Cardiac Surgery) trial. Background The clinical effect of newer-generation drug-eluting stents and operative factors in complex coronary artery disease is uncertain. Methods The incidence of 5-year ST and GO, and their association with clinical outcomes, were analyzed in the randomized percutaneous coronary intervention and coronary artery bypass graft cohorts. ST and GO were defined by the SYNTAX protocol definitions (clinical presentation with acute coronary syndrome and angiographic/pathological evidence), the Academic Research Consortium (ARC) definition for ST, and the newly devised "ARC-like" definition of GO (i.e., definite, probable, or possible GO). Results At 5 years, 871 of 903 patients (96.5%) in the percutaneous coronary intervention cohort and 805 of 897 patients (89.7%) in the coronary artery bypass graft cohort completed follow-up. As compared with other vessel locations, protocol ST (72 lesions) occurred more frequently in the left main (14 of 72; 19%) and proximal coronary vasculature (37 of 72; 51%) and protocol GO (41 lesions) with grafts anastomosed to the distal right coronary artery (17 of 41; 42%). The incidence of 5-year ARC definite ST and ARC-like definite GO did not significantly differ (7% [n = 48] vs. 6% [n = 32], log rank p = 0.34); landmark analyses indicated significantly increased ARC definite ST within 30 days (3% [n = 19] vs. 1% [n = 6], log rank p = 0.033) but not >30 days to 5 years (4.2% [n = 29] vs. 4.5% [n = 26], log rank p = 0.78). At presentation, ARC definite ST (n = 48) and ARC-like definite GO (n = 32) were adjudicated to be linked to 4 (8%) and 0 deaths, respectively. At 5 years, ARC definite ST (n = 48) and ARC definite/probable ST (n = 75) were associated with 17 (17 of 48, 35.4%; median days to death: 0 days; interquartile range: 0 to 16 days; maximum: 321 days) and 31 (31 of 75, 41.3%; median: 0 days; interquartile range: 0 to 9 days; maximum: 721 days) cardiac deaths, respectively. At 5 years, ARC-like definite GO (n = 32) and ARC-like definite/probable GO (n = 53) were associated with 0 and 12 (12 of 52, 23.1%; median: 0 days; interquartile range: 0 to 14 days; maximum: 257 days) cardiac deaths, respectively. Conclusions Although the incidence of ST and GO was similar at 5 years, the clinical impact of ST appeared greater, with a negative impact on short-term to long-term mortality.
AB - Objectives The aim of this study was to report the short-term and long-term clinical impact of stent thrombosis (ST) and graft occlusion (GO) in the final 5-year outcomes of the SYNTAX (SYNergy Between PCI With TAXUS and Cardiac Surgery) trial. Background The clinical effect of newer-generation drug-eluting stents and operative factors in complex coronary artery disease is uncertain. Methods The incidence of 5-year ST and GO, and their association with clinical outcomes, were analyzed in the randomized percutaneous coronary intervention and coronary artery bypass graft cohorts. ST and GO were defined by the SYNTAX protocol definitions (clinical presentation with acute coronary syndrome and angiographic/pathological evidence), the Academic Research Consortium (ARC) definition for ST, and the newly devised "ARC-like" definition of GO (i.e., definite, probable, or possible GO). Results At 5 years, 871 of 903 patients (96.5%) in the percutaneous coronary intervention cohort and 805 of 897 patients (89.7%) in the coronary artery bypass graft cohort completed follow-up. As compared with other vessel locations, protocol ST (72 lesions) occurred more frequently in the left main (14 of 72; 19%) and proximal coronary vasculature (37 of 72; 51%) and protocol GO (41 lesions) with grafts anastomosed to the distal right coronary artery (17 of 41; 42%). The incidence of 5-year ARC definite ST and ARC-like definite GO did not significantly differ (7% [n = 48] vs. 6% [n = 32], log rank p = 0.34); landmark analyses indicated significantly increased ARC definite ST within 30 days (3% [n = 19] vs. 1% [n = 6], log rank p = 0.033) but not >30 days to 5 years (4.2% [n = 29] vs. 4.5% [n = 26], log rank p = 0.78). At presentation, ARC definite ST (n = 48) and ARC-like definite GO (n = 32) were adjudicated to be linked to 4 (8%) and 0 deaths, respectively. At 5 years, ARC definite ST (n = 48) and ARC definite/probable ST (n = 75) were associated with 17 (17 of 48, 35.4%; median days to death: 0 days; interquartile range: 0 to 16 days; maximum: 321 days) and 31 (31 of 75, 41.3%; median: 0 days; interquartile range: 0 to 9 days; maximum: 721 days) cardiac deaths, respectively. At 5 years, ARC-like definite GO (n = 32) and ARC-like definite/probable GO (n = 53) were associated with 0 and 12 (12 of 52, 23.1%; median: 0 days; interquartile range: 0 to 14 days; maximum: 257 days) cardiac deaths, respectively. Conclusions Although the incidence of ST and GO was similar at 5 years, the clinical impact of ST appeared greater, with a negative impact on short-term to long-term mortality.
KW - SYNTAX
KW - graft occlusion
KW - mortality
KW - stent thrombosis
UR - http://www.scopus.com/inward/record.url?scp=84890680363&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84890680363&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2013.07.106
DO - 10.1016/j.jacc.2013.07.106
M3 - Article
AN - SCOPUS:84890680363
VL - 62
SP - 2360
EP - 2369
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 25
ER -