. 2020 Jun 23;2020:3057168. doi: 10.1155/2020/3057168

Table 3.

Key efficacy and safety results.

Outcome	Study	Follow-up (months)	Interventions	N	N with event	% with event	Comparison HR (LCI; UCI)	N/100 p-yrs
CV death/MI/stroke	CHARISMA, NCT00050817 [1]	Median: 28	Clopidogrel 75 mg od+ASA 75-162 mg od	7802	534	6.80	0.93 (0.83; 1.05)	2.93^‡
	CHARISMA, NCT00050817 [1]	Median: 28	ASA 75-162 mg od	7801	573	7.30	Ref.	3.15‡
	COMPASS, NCT01776424 [15]	Mean: 23	Rivaroxaban 5 mg bid	9117	448	4.90	0.90 (0.79; 1.03)	2.60^{^}
			Rivaroxaban 2.5 mg bid+ASA 100 mg od	9152	379	4.10	0.76 (0.66; 0.86)	2.18^{^}
			ASA 100 mg od	9126	496	5.40	Ref.	2.88^{^}
	TRA 2°P–TIMI 50, NCT00526474 [20]	Median: 30	Vorapaxar 2.5 mg od	13225	1028	9.30^†	0.87 (0.80; 0.94)	3.11^‡
	TRA 2°P–TIMI 50, NCT00526474 [20]	Median: 30	Placebo	13224	1176	10.50†	Ref.	3.56^‡

CHD death/MI/IS/ALI	COMPASS, NCT01776424 [15]	Mean: 23	Rivaroxaban 5 mg bid	9117	397	4.40	0.88 (0.77; 1.01)	2.31^{^}
			Rivaroxaban 2.5 mg bid+ASA 100 mg od	9152	329	3.60	0.72 (0.63; 0.83)	1.89^{^}
			ASA 100 mg od	9126	450	4.90	Ref.	2.62^{^}

CV death/MI/IS/ALI	COMPASS, NCT01776424 [15]	Mean: 23	Rivaroxaban 5 mg bid	9117	453	5.00	0.88 (0.77; 0.99)	2.63^{^}
			Rivaroxaban 2.5 mg bid+ASA 100 mg od	9152	389	4.30	0.74 (0.65; 0.85)	2.24^{^}
			ASA 100 mg od	9126	516	5.70	Ref.	3.00^{^}

All-cause mortality	CAPRIE [19]	Mean: 22.9	Clopidogrel 75 mg od	9599	560	3.00^†	0.98 (0.87; 1.10)‡	3.18^‡
	CAPRIE [19]	Mean: 22.9	ASA 325 mg od	9586	571	3.10^†	Ref.	3.26^‡
	CHARISMA, NCT00050817 [1]	Median: 28	Clopidogrel 75 mg od+ASA 75-162 mg od	7802	371	4.80	0.99 (0.83; 1.14)	2.04^‡
	CHARISMA, NCT00050817 [1]	Median: 28	ASA 75-162 mg od	7801	374	4.80	Ref.	2.05^‡
	COMPASS, NCT01776424 [15]	Mean: 23	Rivaroxaban 5 mg bid	9117	366	4.00	0.97 (0.84; 1.12)	2.09^{^}
			Rivaroxaban 2.5 mg bid+ASA 100 mg od	9152	313	3.40	0.82 (0.71; 0.96)	1.78^{^}
			ASA 100 mg od	9126	378	4.10	Ref.	2.16^{^}
	TRA 2°P–TIMI 50, NCT00526474 [20]	Median: 30	Vorapaxar 2.5 mg od	13225	540	5.00^†	0.95 (0.85; 1.07)	1.63^‡
	TRA 2°P–TIMI 50, NCT00526474 [20]	Median: 30	Placebo	13224	565	5.30^†	Ref.	1.71^‡

CV death	CAPRIE [19]	Mean: 22.9	Clopidogrel 75 mg od	9599	350	1.90^†	0.92 (0.80; 1.07)^‡	1.98^‡
	CAPRIE [19]	Mean: 22.9	ASA 325 mg od	9586	378	2.06^†	Ref.	2.16‡
	CHARISMA, NCT00050817 [1]	Median: 28	Clopidogrel 75 mg od+ASA 75-162 mg od	7802	238	3.10	1.04 (0.87; 1.25)	1.31^‡
	CHARISMA, NCT00050817 [1]	Median: 28	ASA 75-162 mg od	7801	229	2.90	Ref.	1.26^‡
	COMPASS, NCT0177642 [15]	Mean: 23	Rivaroxaban 5 mg bid	9117	195	2.10	0.96 (0.79; 1.17)	1.11^{^}
			Rivaroxaban 2.5 mg bid+ASA 100 mg od	9152	160	1.70	0.78 (0.64; 0.96)	0.91^{^}
			ASA 100 mg od	9126	203	2.20	Ref.	1.16^{^}
	TRA 2°P–TIMI 50, NCT00526474 [20]	Median: 30	Vorapaxar 2.5 mg od	13225	285	2.70^†	0.89 (0.76; 1.04)	0.86^‡
	TRA 2°P–TIMI 50, NCT00526474 [20]	Median: 30	Placebo	13224	319	3.00^†	Ref.	0.96^‡

IS	CAPRIE [19]	Mean: 22.9	Clopidogrel 75 mg od	9553	315^‡	3.30^‡	0.95 (0.83; 1.08)^‡	1.79^‡
	CAPRIE [19]	Mean: 22.9	ASA 325 mg od	9546	338^‡	3.50^‡	Ref.	1.93^‡
	COMPASS, NCT01776424 [15]^	Mean: 23	Rivaroxaban 5 mg BID	9117	83	0.90	0.66 (0.50; 0.88)	0.48^{^}
			Rivaroxaban 2.5 mg BID+ASA 100 mg od	9152	64	0.70	0.51 (0.38; 0.69)	0.36^{^}
			ASA 100 mg od	9126	125	1.40	Ref.	0.72^{^}
	TRA 2°P–TIMI 50, NCT00526474 [20]	Median: 30	Vorapaxar 2.5 mg od	13225	250	2.20^†	0.85 (0.72; 1.01)	1.23^‡
	TRA 2°P–TIMI 50, NCT00526474 [20]	Median: 30	Placebo	13224	294	2.60^†	Ref.	1.79^‡

Major Adverse Limb Event (MALE)	COMPASS, NCT01776424 [15]	Mean: 23	Rivaroxaban 5 mg bid	9117	41	0.40	0.64 (0.43; 0.95)	0.23^{^}
			Rivaroxaban 2.5 mg bid+ASA 100 mg od	9152	34	0.40	0.53 (0.35; 0.80)	0.19^{^}
			ASA 100 mg od	9126	64	0.70	Ref.	0.37^{^}

Major bleedings	CAPRIE^∗ [19]	Mean: 22.9	Clopidogrel 75 mg od	9599	132	1.38	0.88 (0.70;1.12)^‡	0.75^‡
	CAPRIE^∗ [19]	Mean: 22.9	ASA 325 mg od	9586	149	1.55	Ref.	0.85^‡
	CHARISMA, NCT00050817^∗∗ [1]	Median: 28	Clopidogrel 75 mg od+ASA 75-162 mg od	7802	130	1.70	1.25 (0.97; 1.61)	0.71^‡
	CHARISMA, NCT00050817^∗∗ [1]	Median: 28	ASA 75-162 mg od	7801	104	1.30	Ref.	0.57^‡
	COMPASS, NCT01776424^∗∗∗ [15]	Mean: 23	Rivaroxaban 5 mg bid	9117	255	2.8	1.51 (1.25; 1.84)	1.48^{^}
			Rivaroxaban 2.5 mg bid+ASA 100 mg od	9152	288	3.1	1.70 (1.40; 2.05)	1.67^{^}
			ASA 100 mg od	9126	170	1.9	Ref.	0.98^{^}
	TRA 2°P–TIMI 50, NCT00526474^∗∗ [20]	Median: 30	Vorapaxar 2.5 mg od	13186	438	4.20^†	1.66 (1.43; 1.93)	1.33^‡
	TRA 2°P–TIMI 50, NCT00526474^∗∗ [20]		Placebo	13166	267	2.50^†	Ref.	0.81^‡
	TRA 2°P–TIMI 50, NCT00526474^∗∗∗∗ [20]		Vorapaxar 2.5 mg od	13186	298	2.90^†	1.44 (1.21; 1.72)	0.90^‡
	TRA 2°P–TIMI 50, NCT00526474^∗∗∗∗ [20]		Placebo	13166	209	1.90^†	Ref.	0.63^‡
	TRA 2°P–TIMI 50, NCT00526474^{∗∗∗∗∗} [20]		Vorapaxar 2.5 mg od	13186	624	5.90^†	1.57 (1.38; 1.78)	1.89^‡
	TRA 2°P–TIMI 50, NCT00526474^{∗∗∗∗∗} [20]		Placebo	13166	404	3.70^†	Ref.	1.23^‡

^∗Trial-specific criteria definition, ^∗∗GUSTO severe definition, ^∗∗∗Modified ISTH definition, ^∗∗∗∗TIMI major bleeding, ^{∗∗∗∗∗}ISTH definition, ^‡Calculated on the basis of available data, ^{^}Unpublished data extracted from CSR, ^†Kaplan-Meier estimate. ALI: acute limb ischaemia; ASA: acetylsalicylic acid; bid: bis in die = twice a day; CHD: coronary heart disease; CV: cardiovascular; GUSTO: Global Utilization of Streptokinase and Tpa for Occluded Arteries definition; HR: hazard ratio; IS: ischaemic stroke; ISTH: International Society on Thrombosis and Haemostasis classification; LCI: lower confidence interval; MI: myocardial infarction; od: once a day; p-yrs: Patients-years; Ref.: reference group; UCI: upper confidence interval.