One-year outcomes of a single bolus r-SAK before primary PCI for STEMI: Follow-up of the OPTIMA-5 study

Figure 1. Study flow chart. Abbreviations: NS, normal saline; r-SAK, recombinant staphylokinase.

Figure 2. Procedures of in vitro thrombolysis experiments. Abbreviations: CAD, coronary artery disease; CAG, coronary angiography; ELISA, enzyme-linked immunosorbent assay; FAPA, fibrin-agarose plate assay; OPTIMA-5, Optimal Management of Antithrombotic and Thrombolytic Agents-5 (OPTIMA-5); r-SAK, recombinant staphylokinase; STEMI, ST-elevation myocardial infarction.

Figure 3. Clinical outcomes of the r-SAK group vs. the NS group in OPTIMA-5 patients. The Kaplan–Meier curve (tested with the log-rank test) was used to evaluate the 1-year MACE incidence. The incidence of 1-year MACE in the r-SAK group was numerically lower than that in the NS group. Abbreviations: CI, confidence interval; HR, hazard ratio; MACE, major adverse cardiovascular events; NS, normal saline; r-SAK, recombinant staphylokinase.

Figure 4. Major adverse cardiovascular events in subgroup analysis. Subgroup analysis was performed using Cox proportional hazards regression, with results presented as HRs and 95% CIs. Abbreviations: HR, hazard ratio; CI, confidence interval; IRA, infarct-related artery; LAD, left anterior descending artery; LCX, left circumflex artery; n and N indicate the number of events and patients, respectively; NS, normal saline; RCA, right coronary artery; r-SAK, recombinant staphylokinase.

Figure 5. Variations of anti-r-SAK antibody levels in OPTIMA-5 patients. The comparisons of anti-r-SAK antibody titers between groups at each visit were performed using the unpaired t-test with Welch correction. ***P < 0.001 compared with the NS group. Abbreviations: NS, normal saline; r-SAK, recombinant staphylokinase.

Figure 6. In vitro thrombolysis rates at different anti-r-SAK antibody titers. A: Blood clots before and after in vitro thrombolysis. B: Variations of in vitro thrombolysis rates at different anti-r-SAK antibody titers. Thrombolysis rates grouped by antibody titers were compared using one-way ANOVA, and pairwise comparisons were performed using the least significant difference test method. The nonlinear regression model utilizing a logit transformation of thrombolysis rates was constructed to estimate the relationship between the anti-r-SAK antibody titers and thrombolysis rates. Bartlett's test and robust Levene's test were used to assess homoscedasticity, and the weighted least squares method was applied to account for heteroscedasticity. ****P < 0.0001. Abbreviations: ns, no significance; r-SAK, recombinant staphylokinase; No., number of patients.

Figure 7. Determination of r-SAK activity before and after in vitro thrombolysis. A: Images from the FAPA experiment, showing a standard well plate (left) and an experimental well plate (right). Diameter-log concentration curve (Diameter-lgC curve) was used for the quantitative analysis of r-SAK in FAPA. B: r-SAK activity at different anti-r-SAK antibody titers before and after in vitro thrombolysis. The r-SAK activity grouped by antibody titers was compared using one-way ANOVA, and pairwise comparisons were performed using the least significant difference test method. **P < 0.01. Abbreviations: r-SAK, recombinant staphylokinase; FAPA, fibrin-agarose plate assay; AU, activity unit.