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Clopidogrel or ticagrelor in acute coronary syndrome patients treated with newer-generation drug-eluting stents: CHANGE DAPT.

AbstractAIMS:
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.
AuthorsPaolo Zocca, Liefke C van der Heijden, Marlies M Kok, Marije M Löwik, Marc Hartmann, Martin G Stoel, J W Louwerenburg, Frits H A F de Man, Gerard C M Linssen, Iris L Knottnerus, Carine J M Doggen, K Gert van Houwelingen, Clemens von Birgelen
JournalEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 13 Issue 10 Pg. 1168-1176 (Nov 20 2017) ISSN: 1969-6213 [Electronic] France
PMID29151439 (Publication Type: Journal Article)
Chemical References
  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticagrelor
  • Adenosine
  • Ticlopidine
  • Aspirin
Topics
  • Acute Coronary Syndrome (therapy)
  • Adenosine (adverse effects, analogs & derivatives, therapeutic use)
  • Aged
  • Aged, 80 and over
  • Aspirin (therapeutic use)
  • Clopidogrel
  • Coronary Artery Disease (therapy)
  • Drug Therapy, Combination (methods)
  • Drug-Eluting Stents (adverse effects)
  • Female
  • Hemorrhage (chemically induced)
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction (etiology)
  • Percutaneous Coronary Intervention (methods)
  • Platelet Aggregation Inhibitors (therapeutic use)
  • Ticagrelor
  • Ticlopidine (adverse effects, analogs & derivatives, therapeutic use)

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