TY - JOUR
T1 - Assessment of paclitaxel drug-coated balloon only angioplasty in STEMI
AU - Merinopoulos, Ioannis
AU - Gunawardena, Tharusha
AU - Corballis, Natasha
AU - Bhalraam, U.
AU - Reinhold, Johannes
AU - Wickramarachchi, Upul
AU - Maart, Clint
AU - Gilbert, Tim
AU - Richardson, Paul
AU - Sulfi, Sreekumar
AU - Sarev, Toomas
AU - Sawh, Chris
AU - Wistow, Trevor
AU - Ryding, Alisdair
AU - Mohamed, Mohamed O.
AU - Perperoglou, Aris
AU - Mamas, Mamas A.
AU - Vassiliou, Vassilios S.
AU - Eccleshall, Simon C.
PY - 2023/4/10
Y1 - 2023/4/10
N2 - Background: Primary percutaneous coronary intervention (pPCI) with drug-eluting stents (DES) has emerged as the standard of care, but stent-related events have persisted. Drug-coated balloon (DCB)–only angioplasty is an emerging technology, although it is not fully evaluated compared with DES in the context of pPCI. Objectives: The aim of this study was to investigate the safety of DCB-only angioplasty compared with second-generation DES in pPCI. Methods: All-cause mortality and net adverse cardiac events (cardiovascular mortality, acute coronary syndrome, ischemic stroke or transient ischemic attack, major bleeding, and unplanned target lesion revascularization [TLR]) were compared among all patients treated with DCBs only or with second-generation DES only for first presentation of ST-segment elevation myocardial infarction (STEMI) due to de novo disease between January 1, 2016, and November 15, 2019. Patients treated with both DCBs and DES were excluded. Data were analyzed using Cox regression models, Kaplan-Meier estimator plots and propensity score matching. Results: Among 1,139 patients with STEMI due to de novo disease, 452 were treated with DCBs and 687 with DES. After a median follow-up period of >3 years, all-cause mortality was 49 of 452 and 62 of 687 in the DCB and DES groups, respectively (P = 0.18). On multivariable Cox regression analysis, there was no difference in mortality between DCBs and DES in the full and propensity score–matched cohorts. Age, frailty risk, history of heart failure, and family history of ischemic heart disease remained significant independent predictors of mortality. There was no difference in any of the secondary endpoints, including unplanned TLR. Conclusions: DCB-only angioplasty appears safe compared with DES for STEMI in terms of all-cause mortality and all net adverse cardiac events, including unplanned TLR. DCB may be an efficacious and safe alternative to DES in selected patient groups. (Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty; NCT04482972)
AB - Background: Primary percutaneous coronary intervention (pPCI) with drug-eluting stents (DES) has emerged as the standard of care, but stent-related events have persisted. Drug-coated balloon (DCB)–only angioplasty is an emerging technology, although it is not fully evaluated compared with DES in the context of pPCI. Objectives: The aim of this study was to investigate the safety of DCB-only angioplasty compared with second-generation DES in pPCI. Methods: All-cause mortality and net adverse cardiac events (cardiovascular mortality, acute coronary syndrome, ischemic stroke or transient ischemic attack, major bleeding, and unplanned target lesion revascularization [TLR]) were compared among all patients treated with DCBs only or with second-generation DES only for first presentation of ST-segment elevation myocardial infarction (STEMI) due to de novo disease between January 1, 2016, and November 15, 2019. Patients treated with both DCBs and DES were excluded. Data were analyzed using Cox regression models, Kaplan-Meier estimator plots and propensity score matching. Results: Among 1,139 patients with STEMI due to de novo disease, 452 were treated with DCBs and 687 with DES. After a median follow-up period of >3 years, all-cause mortality was 49 of 452 and 62 of 687 in the DCB and DES groups, respectively (P = 0.18). On multivariable Cox regression analysis, there was no difference in mortality between DCBs and DES in the full and propensity score–matched cohorts. Age, frailty risk, history of heart failure, and family history of ischemic heart disease remained significant independent predictors of mortality. There was no difference in any of the secondary endpoints, including unplanned TLR. Conclusions: DCB-only angioplasty appears safe compared with DES for STEMI in terms of all-cause mortality and all net adverse cardiac events, including unplanned TLR. DCB may be an efficacious and safe alternative to DES in selected patient groups. (Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty; NCT04482972)
KW - DCB
KW - DES
KW - STEMI
UR - http://www.scopus.com/inward/record.url?scp=85151359493&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2023.01.380
DO - 10.1016/j.jcin.2023.01.380
M3 - Article
C2 - 37045498
AN - SCOPUS:85151359493
VL - 16
SP - 771
EP - 779
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 7
ER -