Table 3 Primary and secondary endpoints.

From: Safety and efficacy of low-temperature RA-flush solution in patients with moderate-to-severe calcified lesions (LOTA-II): a randomized, double-blind, multicenter study

 

Room-temperature group (N = 66)

Low-temperature group (N = 66)

OR (95%CI)

P-value

Primary endpoint: myocardial injury based on the 4th UDMI (%)

 cTnI elevation

47 (71.2%)

31 (47.0%)

0.36 (0.17 ~ 0.74)

0.005

 CK-MB elevation

41 (62.1%)

19 (28.8%)

0.25 (0.12 ~ 0.51)

< 0.001

Secondary endpoints: RA related MI

 Type 4a MI of the 4th UDMI definition (%)

1 (1.5%)

0 (0.0%)

-

1.000

 “Clinical relevant MI” of SCAI definition (%)

    

 cTnI ≥ 70×URL

4 (6.1%)

0 (0.0%)

-

0.119

 CK-MB ≥ 10×URL

1 (1.5%)

0 (0.0%)

-

1.000

RA-related complications

 Transient slow/no flow (%)

23 (34.8%)

4 (6.1%)

0.12 (0.04 ~ 0.37)

< 0.001

 Transient coronary spasm (%)

17 (25.8%)

6 (9.1%)

0.29 (0.11 ~ 0.79)

0.012

 RA-related coronary perforation (%)

0 (0.0%)

0 (0.0%)

-

1.000

Clinical outcomes at the 1-year follow-up

 TVF

7 (10.6%)

2 (3.0%)

0.26 (0.05 ~ 1.32)

0.167

 Cardiac death

1 (1.5%)

1 (1.5%)

-

1.000

 TVMI

1 (1.5%)

0 (0.0%)

-

1.000

 Clinical driven TVR

7 (10.6%)

2 (3.0%)

0.26 (0.05 ~ 1.32)

0.167

  1. Values are expressed as the frequency (percentage) for categorical variables in the table. CK-MB creatine kinase isoenzyme, cTnI cardiac troponin I, MI myocardial infarction, RA rotational atherectomy, SCAI the Society for Cardiovascular Angiography and Interventions, TVF target-vessel failure, TVMI target-vessel-related MI, TVR target-vessel revascularization, 4th UDMI the fourth universal definition of myocardial infarction, URL upper reference limit, OR odds ratio.
Back to article page