Page 101 - GTM-3-4
P. 101

Global Translational Medicine                                              Prediction of in-stent restenosis



                                                                 To illustrate the results of the evaluation, Kaplan-Meier
                                                               curves were plotted on the survival function  graph
                                                               (with restenosis as the endpoint), where the x-axis is the
                                                               observation period (before the development or absence of
                                                               restenosis; defined in months). The log-rank test was used
                                                               to compare the time intervals before restenosis in groups
                                                               with or without a certain variable (e.g., stent type [DES
                                                               vs. BMS]), with the null hypothesis stating no differences
                                                               between the groups. The significance level for rejecting the
                                                               null hypothesis was P < 0.05.
                                                                 To  confirm  the  influence  of  potential  risk  predictors
                                                               identified in the first stage of the study on restenosis
                                                               development, we performed survival analysis using Cox
                                                               regression with multiple variables:
                                                               λ t () = λ t ⋅() exp ( β x +…+ β x +  β )   (II)
                                                                               1
                                                                i
                                                                      0
                                                                                          ki
                                                                                              0
                                                                                 i 1
                                                                                        k
                                                                 where λ (t) is the risk of restenosis in the i-th patient
                                                                        i
                                                               during the observation period  t;  λ (t) is the baseline
                                                                                             0
                                                               risk  of  restenosis  in  each  patient  by  default;  x ,…  x   is
                                                                                                          ki
                                                                                                     1i
                                                               the potential risk factor(s) of restenosis;  β ,…β  is the
                                                                                                   1
                                                                                                       k
                                                               coefficient(s) of the regressors identified in the first stage
            Figure 1. Retrospective analysis design            of the study and evaluated using the partial likelihood
                                                               method; and  β  is the intercept. The coefficients of the
                                                                           0
            requiring continuous glucocorticosteroids  and another   regressors in  the  Cox model were estimated  using the
            controller therapy; (vi) familial hypercholesterolemia; and   maximum partial likelihood method with the partial
            (vii) cancer that required chemotherapy and radiation   likelihood function according to the Efron and the Breslow
            therapy after percutaneous coronary intervention.  formulas. For both formulas (Equations I and II), the
                                                               Akaike and Schwartz information criteria values (AIC and
            2.3. Statistical analysis                          BIC) were calculated. The model was estimated using the
            Patients were divided into two groups based on the absence   Efron partial likelihood method, as it yielded lower Akaike
            (control group) or presence (restenosis group) of re-stenosis   and Schwartz information criteria values compared to the
            requiring repeat percutaneous coronary intervention.   Breslow method (for Breslow: AIC=3282.33, BIC=3313.58;
            The  restenosis  group  included  516  patients,  while  the   for Efron AIC=3280.96, BIC=3312.21). The form of the
            control group included patients without hemodynamically   partial likelihood function was selected based on the
            significant restenosis. The endpoints (death, acute   smallest information criteria values.
            myocardial infarction, acute cerebrovascular accident,   Statistical significance of risk predictors was tested
            repeat hospitalization, and repeat revascularization) were   according to the Wald test at a significance level of
            determined for all patients within 5 years. R Studio was   p < 0.05; the null hypothesis was the assumption that the
            used in packages (“survival,” “survMisc,” and “survminer”).   regressor coefficient = 0, that is, there was no impact of
            Single-  and multivariate survival analyses (e.g., Cox   the investigated factor on the risk of restenosis. The Wald
            regressions) and Kaplan-Meier analysis were performed.   statistic (Z ) was calculated as follows:
            The latter was used to estimate the differences in function   w
            S(t) before the development or absence of restenosis in   β
                                                                     ˆ
            different stent types:                             Z W  =  SE  β ( )                          (III)
                                                                         ˆ
             ( )
                                                                                                      ˆ
                                                                          ˆ
            St       [  (nj )  ]                        (I)      where  SE  β ()  is the estimated standard error  β .
                      nj
                     ( −+   )
                                                                 To assess the quality of the Cox model, the likelihood
              where n is the total number of observations; d is equal to   ratio (LR) test was performed with the null hypothesis of
                                                  j
            1 if the event occurred during the considered observation   no significance in the general model. The hypothesis was
            period or 0 – if the event was censored.           rejected in favor of the alternative at  P < 0.05. Harrell’s
            Volume 3 Issue 4 (2024)                         3                               doi: 10.36922/gtm.4957
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