TY - JOUR
T1 - Clopidogrel or ticagrelor in acute coronary syndrome patients treated with newer-generation drug-eluting stents
T2 - CHANGE DAPT
AU - Zocca, Paolo
AU - van der Heijden, Liefke C.
AU - Kok, Marlies M.
AU - Löwik, Marije M.
AU - Hartmann, Marc
AU - Stoel, Martin G.
AU - Louwerenburg, Johannes W.
AU - de Man, Frits H.A.F.
AU - Linssen, Gerard C.M.
AU - Knottnerus, Iris L.
AU - Doggen, Carine J.M.
AU - van Houwelingen, Gert K.
AU - von Birgelen, Clemens
PY - 2017/11/1
Y1 - 2017/11/1
N2 - Aims: Acute coronary syndrome (ACS) guidelines have been changed, favouring more potent antiplatelet drugs. We aimed to evaluate the safety and efficacy of a ticagrelor- instead of a clopidogrel-based primary dual antiplatelet (DAPT) regimen in ACS patients treated with newer-generation drug-eluting stents (DES).Methods and results: CHANGE DAPT (clinicaltrials.gov: NCT03197298) assessed 2, 062 consecutive real-world ACS patients, treated by percutaneous coronary intervention (PCI), the primary composite endpoint being net adverse clinical and cerebral events (NACCE: all-cause death, any myocardial infarction, stroke or major bleeding). In the clopidogrel (CP; December 2012-April 2014) and ticagrelor periods (TP; May 2014-August 2015), 1, 009 and 1, 053 patients were treated, respectively. TP patients were somewhat older, underwent fewer transfemoral procedures, and received fewer glycoprotein IIb/IIIa inhibitors. In the TP, the one-year NACCE rate was higher (5.1% vs. 7.8%; HR 1.53 [95% CI: 1.08-2.17]; p=0.02). Assessment of non-inferiority (pre-specified margin: 2.7%) was inconclusive (risk difference: 2.64 [95% CI: 0.52-4.77]; pnon-inferiority=0.48). TP patients had more major bleeding (1.2% vs. 2.7%; p=0.02) while there was no benefit in ischaemic endpoints. Propensity score-adjusted multivariate analysis confirmed higher NACCE (adj. HR 1.75 [95% CI: 1.20-2.55]; p=0.003) and major bleeding risks during TP (adj. HR 2.75 [95% CI: 1.34-5.61]; p=0.01). Conclusions: In this observational study, the guideline-recommended ticagrelor-based primary DAPT regimen was associated with an increased event risk in consecutive ACS patients treated with newer-generation DES.
AB - Aims: Acute coronary syndrome (ACS) guidelines have been changed, favouring more potent antiplatelet drugs. We aimed to evaluate the safety and efficacy of a ticagrelor- instead of a clopidogrel-based primary dual antiplatelet (DAPT) regimen in ACS patients treated with newer-generation drug-eluting stents (DES).Methods and results: CHANGE DAPT (clinicaltrials.gov: NCT03197298) assessed 2, 062 consecutive real-world ACS patients, treated by percutaneous coronary intervention (PCI), the primary composite endpoint being net adverse clinical and cerebral events (NACCE: all-cause death, any myocardial infarction, stroke or major bleeding). In the clopidogrel (CP; December 2012-April 2014) and ticagrelor periods (TP; May 2014-August 2015), 1, 009 and 1, 053 patients were treated, respectively. TP patients were somewhat older, underwent fewer transfemoral procedures, and received fewer glycoprotein IIb/IIIa inhibitors. In the TP, the one-year NACCE rate was higher (5.1% vs. 7.8%; HR 1.53 [95% CI: 1.08-2.17]; p=0.02). Assessment of non-inferiority (pre-specified margin: 2.7%) was inconclusive (risk difference: 2.64 [95% CI: 0.52-4.77]; pnon-inferiority=0.48). TP patients had more major bleeding (1.2% vs. 2.7%; p=0.02) while there was no benefit in ischaemic endpoints. Propensity score-adjusted multivariate analysis confirmed higher NACCE (adj. HR 1.75 [95% CI: 1.20-2.55]; p=0.003) and major bleeding risks during TP (adj. HR 2.75 [95% CI: 1.34-5.61]; p=0.01). Conclusions: In this observational study, the guideline-recommended ticagrelor-based primary DAPT regimen was associated with an increased event risk in consecutive ACS patients treated with newer-generation DES.
KW - Acute coronary syndrome
KW - Adjunctive pharmacotherapy
KW - Drug-eluting stent
KW - Non-ST-elevation acute coronary syndrome
KW - ST-elevation myocardial infarction
UR - http://www.scopus.com/inward/record.url?scp=85036500069&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-17-00634
DO - 10.4244/EIJ-D-17-00634
M3 - Article
AN - SCOPUS:85036500069
VL - 13
SP - 1168
EP - 1176
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 10
ER -