Skip to main content

Table 2 AEs, ADRs, thrombocytopenia and bleeding stratified by baseline criteria

From: Comprehensive safety profile evaluation of bivalirudin in Chinese ST-segment elevation myocardial infarction patients receiving percutaneous coronary intervention: a prospective, multicenter, intensive monitoring study

Items

AEs

P value

ADRs

P value

Thrombocytopenia

P value

Bleeding

P value

Age, no. (%)

 

0.041

 

0.168

 

0.282

 

0.236

  > 75 years

49 (22.9)

 

12 (5.6)

 

6 (2.8)

 

6 (2.8)

 

  ≤ 75 years

175 (17.0)

 

37 (3.6)

 

18 (1.7)

 

15 (1.5)

 

Gender, No. (%)

 

0.968

 

0.182

 

0.088

 

0.471

 Male

165 (18.0)

 

32 (3.5)

 

14 (1.5)

 

14 (1.5)

 

 Female

59 (17.9)

 

17 (5.2)

 

10 (3.0)

 

7 (2.1)

 

BMI, No. (%)

 

0.776

 

0.424

 

0.254

 

1.000

  > 28 kg/m2

20 (19.8)

 

2 (2.0)

 

0 (0.0)

 

1 (1.0)

 

  ≤ 28 kg/m2

195 (18.6)

 

44 (4.2)

 

23 (2.2)

 

18 (1.7)

 

History of diabetes mellitus, No. (%)

 

0.071

 

0.135

 

0.301

 

0.407

 Yes

55 (21.9)

 

14 (5.6)

 

7 (2.8)

 

6 (2.4)

 

 No

169 (17.0)

 

35 (3.5)

 

17 (1.7)

 

15 (1.5)

 

History of allergy, No. (%)

 

0.847

 

0.772

 

0.682

 

0.654

 Yes

15 (17.2)

 

4 (4.6)

 

2 (2.3)

 

2 (2.3)

 

 No

209 (18.1)

 

45 (3.9)

 

22 (1.9)

 

19 (1.6)

 

History of cardiac surgery, No. (%)

 

0.008

 

0.009

 

0.005

 

0.282

 Yes

19 (30.6)

 

7 (11.3)

 

5 (8.1)

 

2 (3.2)

 

 No

205 (17.3)

 

42 (3.6)

 

19 (1.6)

 

19 (1.6)

 

History of critical respiratory disease, No. (%)

 

 < 0.001

 

0.650

 

1.000

 

0.463

 Yes

16 (44.4)

 

2 (5.6)

 

0 (0.0)

 

1 (2.8)

 

 No

208 (17.2)

 

47 (3.9)

 

24 (2.0)

 

20 (1.7)

 

History of renal function impairment, No. (%)

 

0.043

 

0.009

 

0.065

 

0.051

 Yes

8 (36.4)

 

4 (18.2)

 

2 (9.1)

 

2 (9.1)

 

 No

216 (17.7)

 

45 (3.7)

 

22 (1.8)

 

19 (1.6)

 

CRUSADE risk stratification, No. (%)

 

0.075

 

 < 0.001

 

0.009

 

0.011

 Very low risk (≤ 20)

55 (16.8)

 

11 (3.4)

 

3 (0.9)

 

4 (1.2)

 

 Low risk (21–30)

56 (16.0)

 

3 (0.9)

 

2 (0.6)

 

1 (0.3)

 

 Moderate risk (31–40)

53 (19.1)

 

17 (6.1)

 

11 (4.0)

 

6 (2.2)

 

 High risk (41–50)

24 (15.3)

 

7 (4.5)

 

3 (1.9)

 

4 (2.5)

 

 Very high risk (> 50)

31 (27.4)

 

11 (9.7)

 

5 (4.4)

 

6 (5.3)

 

 Unknown

5 (26.3)

 

0 (0.0)

 

0 (0.0)

 

0 (0.0)

 

Operative timing, No. (%)

 

 < 0.001

 

0.749

 

0.004

 

0.033

 Elective operation

31 (10.1)

 

13 (4.2)

 

12 (3.9)

 

1 (0.3)

 

 Emergency operation

193 (20.6)

 

36 (3.8)

 

12 (1.3)

 

20 (2.1)

 

Types of coronary interventional therapy, No. (%)

 

0.101

 

0.640

 

0.958

 

0.965

 Stent implantation

207 (17.5)

 

48 (4.1)

 

23 (1.9)

 

20 (1.7)

 

 Balloon dilatation

16 (28.6)

 

1 (1.8)

 

1 (1.8)

 

1 (1.8)

 

 Thrombus aspiration

0 (0.0)

 

0 (0.0)

 

0 (0.0)

 

0 (0.0)

 

 Others

1 (25.0)

 

0 (0.0)

 

0 (0.0)

 

0 (0.0)

 

Types of stents, No. (%)

 

0.564

 

0.837

 

0.643

 

0.931

 Drug stent

202 (17.7)

 

47 (4.1)

 

23 (2.0)

 

19 (1.7)

 

 Bare stent

5 (11.9)

 

1 (2.4)

 

0 (0.0)

 

1 (2.4)

 

 Others

0 (0.0)

 

0 (0.0)

 

0 (0.0)

 

0 (0.0)

 

Arterial access, No. (%)

 

0.568

 

0.868

 

0.715

 

0.974

 Radial artery

215 (18.2)

 

46 (3.9)

 

22 (1.9)

 

20 (1.7)

 

 Femoral artery

9 (14.8)

 

3 (4.9)

 

2 (3.3)

 

1 (1.6)

 

 Brachial artery

0 (0.0)

 

0 (0.0)

 

0 (0.0

 

0 (0.0)

 

 Others

0 (0.0)

 

0 (0.0)

 

0 (0.0)

 

0 (0.0)

 

Culprit vessel, No. (%)

 

0.224

 

0.836

 

0.777

 

0.548

 Single

183 (17.4)

 

41 (3.9)

 

20 (1.9)

 

17 (1.6)

 

 Multiple

40 (21.1)

 

8 (4.2)

 

4 (2.1)

 

4 (2.1)

 

Administration of bivalirudin, No. (%)

 

0.112

 

0.355

 

0.408

 

0.830

 Preoperative or intraoperative

9 (20.5)

 

3 (6.8)

 

2 (4.5)

 

1 (2.3)

 

 Postoperative ≤ 4 h

193 (17.3)

 

41 (3.7)

 

20 (1.8)

 

18 (1.6)

 

 Postoperative > 4 h

22 (26.2)

 

5 (6.0)

 

2 (2.4)

 

2 (2.4)

 

Combined with GP IIb/IIIa inhibitors, no. (%)

 

 < 0.001

 

0.002

 

0.005

 

0.267

 Yes

192 (23.9)

 

42 (5.2)

 

22 (2.7)

 

16 (2.0)

 

 No

32 (7.3)

 

7 (1.6)

 

2 (0.5)

 

5 (1.1)

 
  1. The bold indicates items of statistical significance
  2. AEs, adverse events; ADRs, adverse drug reactions; BMI, body mass indexes; CRUSADE, Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines; GP, glycoprotein