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Safety and Efficacy of Ticagrelor vs. Clopidogrel After DES
Study Questions:
What is the safety and efficacy of a ticagrelor- instead of a clopidogrel-based primary dual antiplatelet (DAPT) regimen in acute coronary syndrome (ACS) patients treated with newer-generation drug-eluting stents (DES)?
Methods:
The CHANGE DAPT (clinicaltrials.gov: NCT03197298) trial investigators assessed 2,062 consecutive real-world ACS patients, treated by percutaneous coronary intervention (PCI). The primary composite endpoint was net adverse clinical and cerebral events (NACCE: all-cause death, any myocardial infarction, stroke, or major bleeding) in the two treatment periods, clopidogrel period (CP) versus ticagrelor period (TP). To assess noninferiority, a NACCE rate of 6.5% was assumed in both periods (i.e., CP and TP), based on previous data.
Results:
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 1-year NACCE rate was higher (5.1% vs. 7.8%; hazard ratio [HR], 1.53; 95% confidence interval [CI], 1.08-2.17; p = 0.02). Assessment of noninferiority (prespecified margin: 2.7%) was inconclusive (risk difference, 2.64; 95% CI, 0.52-4.77; pnoninferiority = 0.48). TP patients had more major bleeding (1.2% vs. 2.7%; p = 0.02), while there was no benefit in ischemic 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 the TP (adj. HR, 2.75; 95% CI, 1.34-5.61; p = 0.01).
Conclusions:
The authors concluded that the ticagrelor-based primary DAPT regimen was associated with an increased event risk in consecutive ACS patients treated with newer-generation DES.
Perspective:
This observational study reports that patients treated during the TP had significantly higher rates of the primary endpoint NACCE as compared to CP patients. Furthermore, patients treated with ticagrelor during the TP had a significantly higher risk of major bleedings than patients treated with clopidogrel during the CP, while there was no difference in ischemic outcomes. This increased bleeding risk with ticagrelor should be balanced against benefits in reducing ischemic events, and DAPT therapy individualized based on bleeding versus ischemic risks. It is important to realize that not all patients may be better served with ticagrelor.
Keywords: Acute Coronary Syndrome, Adenosine, Drug-Eluting Stents, ESC Congress, ESC2017, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Platelet Glycoprotein GPIIb-IIIa Complex, Purinergic P2Y Receptor Antagonists, Risk, Stents, Stroke
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