Table 2

Trials of prolonged duration of antithrombotics

StudyNo. of patientsAgent usedFollow-up
duration
Efficacy endpointsSafety endpoint
PEGASUS
2015
ACS in previous 1–3 years with high ischaemia risk
21 162Aspirin+Ticagrelor 60mg two times a day vs
Aspirin+Ticagrelor 90mg two times a day
vs
Aspirin+placebo
33 monthsDeath/MI/stroke
Ticagrelor 90mg: 7.85%
60mg 7.77 %
Placebo: 9.04 %
P<0.001
TIMI major bleeding
90mg: 2.6%
60mg: 2.3%
Placebo:1.06%
THEMIS
2019
Stable CAD and type 2 diabetes, no history of previous MI/Stroke
19 220Ticagrelor (60 two times a day)+Aspirin
vs
Aspirin+placebo
39.9 monthsPrimary end point:
CV death/MI/stroke
Ticagrelor+Aspirin = 7.7%
Aspirin+placebo = 8.1%
p=0.038
TIMI major bleeding
Ticagrelor+Aspirin = 2.2%
Aspirin+placebo = 1.0%
P<0.001
THEMIS-PCI
2019
Subgroup of THEMIS patients who underwent PCI
11 154Ticagrelor (60 two times a day)+Aspirin
vs
Aspirin+placebo
Primary end point:
CV death/MI/stroke
Ticagrelor+Aspirin=7.3%
Aspirin+placebo=8.6%
P=0.013
TIMI major bleeding
Ticagrelor+Aspirin=2.0%
Aspirin+placebo=1.1%
P<0.001
Net clinical benefit: 15% reduction in Ticagrelor arm
DAPT
2014
ACS with high ischaemia risk
9961Aspirin+thienopyridine for 12 months
vs
Aspirin+thienopyridine for 30 months
30 monthsStent thrombosis,
0.4%–30 months
1.4%–12 months death/MI/stroke
4.3%–30 months
5.9%–12 months
P<0.001
Moderate–severe bleeding
30 months—2.5%
12 months—1.6%
P<0.001
COMPASS
2017
Stable atherosclerotic vascular disease
27 395Rivoraxaban 2.5 mg two times a day+Aspirin
vs
Rivoraxaban 5 mg two times a day
vs
Aspirin
23
months
Death/MI/Stroke
4.1% (Rivaroxaban+Aspirin)
4.9% Rivoraxaban
5.4% Aspirin
P<0.001 for (R+A) vs A
Major bleeding
3.1%—(Rivaroxaban+Aspirin)
1.9%—Aspirin
P<0.001
  • DAPT, dual antiplatelet therapy; TIMI, Thrombolysis in Myocardial Infarction.