The safety and efficacy of indobufen or aspirin combined with clopidogrel in patients with acute myocardial infarction after percutaneous coronary intervention

Figures & data

Figure 1. Patient enrollment.

AMI, acute myocardial infarction; DAPT, dual antiplatelet therapy; PCI, percutaneous coronary intervention; NSTEMI, non-ST segment elevation myocardial infarction; STEMI, ST segment elevation myocardial infarction; ARC-HBR, the Academic Research Consortium-High Bleeding Risk; PPI, proton pump inhibitor.

Table I. Clinical characteristics of patients.

	Unmatched patients			Propensity-Score Matched patients
Parameter	Aspirin (n = 1193)	Indobufen (n = 258)	P	Aspirin (n = 224)	Indobufen (n = 224)	P
Baseline characteristic
Age (years)	66 ± 12	73 ± 11	0.001	72 ± 10	72 ± 11	0.509
Male, n(%)	816 (68.4)	159 (61.6)	0.043	150 (67.0)	141 (62.9)	0.428
Previous MI, n(%)	155 (13.0)	36 (14.0)	0.755	31 (13.8)	29 (12.9)	0.890
Previous PCI, n(%)	186 (15.6)	54 (20.9)	0.045	37 (16.5)	43 (19.2)	0.537
Hypertension, n(%)	854 (71.6)	191 (74.0)	0.473	165 (73.7)	168 (75.0)	0.829
Diabetes, n(%)	462 (38.7)	103 (39.9)	0.774	93 (41.5)	89 (39.7)	0.773
Atrial fibrillation, n(%)	56 (4.69)	19 (7.36)	0.109	15 (6.70)	18 (8.04)	0.718
Chronic kidney disease,n(%)	218 (18.3)	97 (37.6)	0.001	85 (37.9)	80 (35.7)	0.695
Previous ischemic stroke,n(%)	216 (18.1)	51 (19.8)	0.592	54 (24.1)	46 (20.5)	0.427
Previous gastrointestinal bleeding, n(%)	12 (1.01)	22 (8.53)	0.001	4 (1.79)	7 (3.12)	0.541
Previous cerebral hemorrhage, n(%)	11 (0.92)	8 (3.10)	0.011	5 (2.23)	5 (2.23)	1.000
Smoke history, n(%)	507 (42.5)	90 (34.9)	0.029	80 (35.7)	82 (36.6)	0.922
HBR, n(%)	595 (49.9)	212 (82.2)	0.001	185 (82.6)	178 (79.5)	0.470
Clinical Indication of PCI
NSTEMI, n(%)	674 (56.5)	155 (60.1)	0.325	139 (62.1)	134 (59.8)	0.699
STEMI, n(%)	478 (40.1)	89 (34.5)	0.111	78 (34.8)	77 (34.4)	1.000
Medications
β-blockers, n(%)	735 (61.6)	139 (53.9)	0.026	126 (56.2)	126 (56.2)	1.000
ACEI or ARB, n(%)	170 (14.2)	16 (6.20)	0.001	26 (11.6)	15 (6.70)	0.101
PPI, n(%)	956 (80.1)	229 (88.8)	0.002	201 (89.7)	195 (87.1)	0.461
Statins, n(%)	1133 (95.0)	229 (88.8)	0.001	208 (92.9)	202 (90.2)	0.397
Laboratory results
LDLc (mmol/L)	3.04 ± 0.92	2.84 ± 0.93	0.002	2.94 ± 0.86	2.86 ± 0.92	0.357
CK-MB (ng/ml)	46.4 ± 63.4	44.6 ± 64.2	0.685	51.0 ± 74.6	45.9 ± 66.6	0.450
Interventional characteristics
Target lesion location
LM, n(%)	94 (7.88)	21 (8.14)	0.989	25 (11.2)	17 (7.59)	0.257
LAD, n(%)	1142 (95.7)	247 (95.7)	1.000	215 (96.0)	214 (95.5)	1.000
LCX, n(%)	979 (82.1)	221 (85.7)	0.196	192 (85.7)	189 (84.4)	0.791
RCA, n(%)	1084 (90.9)	237 (91.9)	0.698	204 (91.1)	204 (91.1)	1.000
Ramus, n(%)	40 (3.35)	14 (5.43)	0.157	7 (3.12)	13 (5.80)	0.253
Multi-vessel disease, n(%)	1117 (93.6)	245 (95.0)	0.506	208 (92.9)	212 (94.6)	0.558
No. of diseased vessels, mean (SD)	2.83 ± 0.67	2.94 ± 0.60	0.015	2.90 ± 0.71	2.91 ± 0.62	0.847
Implanted stents location
LM, n(%)	14 (1.17)	5 (1.94)	0.360	3 (1.34)	4 (1.79)	1.000
LAD, n(%)	464 (38.9)	75 (29.1)	0.004	81 (36.2)	68 (30.4)	0.229
LCX, n(%)	227 (19.0)	53 (20.5)	0.637	40 (17.9)	47 (21.0)	0.474
RCA, n(%)	425 (35.6)	91 (35.3)	0.971	80 (35.7)	79 (35.3)	1.000
Ramus, n(%)	5 (0.42)	1 (0.39)	1.000	0 (0.00)	1 (0.45)	1.000
No. of implanted stents, mean (SD)	1.42 ± 0.84	1.35 ± 0.96	0.268	1.34 ± 0.80	1.38 ± 0.97	0.589

previous MI, previous myocardial infarction; PCI, percutaneous coronary intervention; HBR, high bleeding risk; NSTEMI, non-ST segment elevation myocardial infarction; STEMI, ST segment elevation myocardial infarction; ACEI, angiotensin converting enzyme inhibitor; ARB, angiotensin receptor blocker; PPI, proton pump inhibitor; LDLc, low-density lipoprotein cholesterol; CK-MB, creatine kinase-MB Isoenzyme; LM, left main coronary artery; LAD, left anterior desending artery; LCX, left circumflex artery; RCA, right coronary artery.

Table II. One-year clinical endpoints in patients with AMI.

	Aspirin (n = 224)	Indobufen (n = 224)	Hazard ratio (95%CI)	P value
Primary endpoint
NACE	52 (23.20%)	58 (25.9%)	1.128 (0.776–1.639)	0.527
Secondary efficacy endpoint
MACCE	33 (14.7%)	45 (20.1%)	1.392 (0.893–2.170)	0.146
Cardiac Death	16 (7.14%)	25 (11.2%)	1.577 (0.855–2.909)	0.149
Recurrence of MI	9 (4.02%)	8 (3.57%)	0.888 (0.343–2.299)	0.807
Definite or probable ST	2 (0.89%)	1 (0.45%)	0.501 (0.052–4.814)	0.565
TLR	3 (1.34%)	5 (2.23%)	1.667 (0.417–6.663)	0.480
Ischemic stroke	8 (3.57%)	8 (3.57%)	1.001 (0.376–2.666)	0.999
Secondary safety endpoint
BARC type 2, 3 or 5 bleeding	23 (10.30%)	18 (8.04%)	0.779 (0.423–1.438)	0.427
BARC type 2 bleeding	19 (8.48%)	13 (5.80%)	0.681 (0.341–1.363)	0.284
BARC type 3 or 5 bleeding	4 (1.79%)	5 (2.23%)	1.245 (0.337–4.597)	0.744

Data are expressed as number of patients (percentage).

NACE, net adverse clinical event;

MACCE, major adverse cardiac and cerebral events;

MI, myocardial infarction;

TLR, target lesion revascularization;

BARC, Bleeding Academic Research Consortium.

Figure 2. Cumulative Kaplan-Meier curve estimates of NACE (A), MACCE (B), and BARC 2, 3, or 5 (C) at 1 year in patients with AMI.

NACE, net adverse clinical event; MACCE, major adverse cardiac and cerebral events; BARC, Bleeding Academic Research Consortium; HR, hazard ratio; CI, confidence interval.

Figure 3. 1-year Gastrointestinal symptoms in the patients with AMI.

Figure 4. Subgroup analyses for primary endpoints (NACE) of the patients with AMI.

NACE, net adverse clinical event; STEMI, ST segment elevation myocardial infarction; MI, myocardial infarction; PPI, proton pump inhibitor; HBR, high bleeding risk; HR, hazard ratio; CI, confidence interval.

Data availability statement

The datasets generated during and/or analyzed during the current study are not publicly available as the data also forms part of another ongoing study but are available from the corresponding author on reasonable request.