TY - JOUR
T1 - 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
AU - Chandrasekhar, Jaya
AU - Baber, Usman
AU - Sartori, Samantha
AU - Aquino, Melissa B.
AU - Hájek, Petr
AU - Atzev, Borislav
AU - Hudec, Martin
AU - Kiam Ong, Tiong
AU - Mates, Martin
AU - Borisov, Borislav
AU - Warda, Hazem M.
AU - den Heijer, Peter
AU - Wojcik, Jaroslaw
AU - Iniguez, Andres
AU - Coufal, Zdeněk
AU - Khashaba, Ahmed
AU - Munawar, Muhammad
AU - Gerber, Robert T.
AU - Yan, Bryan P.
AU - Tejedor, Paula
AU - Kala, Petr
AU - Bang Liew, Houng
AU - Lee, Michael
AU - Kalkman, Deborah N.
AU - Dangas, George D.
AU - de Winter, Robbert J.
AU - MASCOT investigators
AU - Colombo, Antonio
AU - Mehran, Roxana
PY - 2020/12/1
Y1 - 2020/12/1
N2 - Background: The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. Objective: We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. Methods: MASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score ≤ 3 and intermediate-to-high (IHBR) for score > 3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results: The study included 56% (n = 1270) LBR and 44% (n = 1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p = 0.047) driven by cardiac death (1.7% vs. 0.7%, p = 0.029) with similar rates of MI (1.8% vs. 1.1%, p = 0.17), TLR (1.5% vs. 1.6%, p = 0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p = 0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p = 0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p < 0.01), driven by physician-guided discontinuation. Conclusions: Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.
AB - Background: The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. Objective: We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. Methods: MASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score ≤ 3 and intermediate-to-high (IHBR) for score > 3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results: The study included 56% (n = 1270) LBR and 44% (n = 1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p = 0.047) driven by cardiac death (1.7% vs. 0.7%, p = 0.029) with similar rates of MI (1.8% vs. 1.1%, p = 0.17), TLR (1.5% vs. 1.6%, p = 0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p = 0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p = 0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p < 0.01), driven by physician-guided discontinuation. Conclusions: Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.
KW - COMBO stent
KW - Dual therapy stent
KW - Endothelial progenitor cell capture
KW - NCT02183454
KW - PARIS bleeding risk score
UR - http://www.scopus.com/inward/record.url?scp=85090419361&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ijcha.2020.100605
DO - https://doi.org/10.1016/j.ijcha.2020.100605
M3 - Article
C2 - 32953969
SN - 2352-9067
VL - 31
JO - International journal of cardiology. Heart & vasculature
JF - International journal of cardiology. Heart & vasculature
M1 - 100605
ER -