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Aim of the study is to describe the impact of routine aspiration thrombectomy with PCI versus PCI alone in patients with STEMI. To study the post procedural outcomes post PCI TIMI flow and long term mortality.
Study population: patients with symptom onset < 12 hours and atleast 1mm ST elevation in 2 > contiguous limb leads or atleast 2 mm ST elevation in 2> contiguous precordial leads or LBBB are considered for PPCI. They are divided into 2 groups, PCI alone and PCI with thrombectomy group.
Study outcomes: The primary efficacy outcome was death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA class IV heart failure within 180 days. Key secondary outcome was cardiovascular deaths, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA class IV heart failure, stent thrombosis or target-vessel revascularization within 180 days.
Statistical analysis: Primary and secondary outcomes are analyzed by cox regression analysis and hazard ratios for the events were compared between two groups.
Kaplan meier estimates for the primary outcome was done in PCI alone and thrombectomy group within 180 days after the procedure.
In this study, 84 patients were included of whom 53 underwent PCI alone and 31 underwent thrombus aspiration plus PCI. The mean age was 57.3 ± 10 and 55.8 ± 11.2 in PCI alone and thrombectomy group respectively.The rate of the primary outcome in patients who underwent PCI for index STEMI was 18.8% in the PCI-alone group was 9.67% in the thrombectomy group (hazard ratio for the thrombectomy group as compared with PCI alone group was 1.94; 95% confidence interval [CI], 0.46 to 8.03; P = 0.36). The secondary outcome occurred in 33.96% of patients in PCI alone group and 25.8% of patients in thrombectomy group (hazard ratio 1.33; 95% CI 0.57- 3.05 with p value of 0.5).
Subgroup analysis of the study done for the occurrence of the primary outcome within 180 days, revealed that the patients with initial TIMI thrombus grade ≥ 3, anterior wall MI and symptom onset < 6hrs had a higher risk of mortality in PCI alone group when compared to thrombectomy group however it was not statistically significant. (HR 2.00; 95% CI 0.4-10; p=0.41, HR 2.5; 95% CI 0.5-11.7; p=0.25, HR 3.76; 95%CI 0.4-33.7; p=0.24 respectively). In our study, two patients suffered from stroke, one in each group. Kaplan meier analysis demonstrated that there was no statistically significant difference in time to death between the 2 groups over a period of 180 days.
In our study, patients who were undergoing primary PCI, there was 94% higher risk of death within 180 days in PCI alone group when compared to thrombectomy group. In patients with higher initial TIMI thrombus grade or anterior wall MI or symptom onset less than 6 hrs had higher risk of death with PCI alone as compared with thrombectomy. Our study demonstrates that thrombus aspiration followed by PCI yields better clinical outcomes in such cases.