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Prevention of hemorrhagic complications has emerged as a priority in patients undergoing PCI in addition to suppressing periprocedural ischemia. In patients with stable angina and NSTEMI, Bivalirudin has been shown to result in similar rates of composite ischemia as heparin plus Abciximab, while significantly reducing major bleeding. Does Bivalirudin cause less myocardial necrosis as evidenced by Troponin I and CKMB in STEMI undergoing primary PCI is unknown?
A prospective all comers' intention to treat patients was included in the study. The laboratory was blinded about the study drugs of the patients. The use of drugs was in the discretion of the operator and was decided upon the purchasing capacity of the patients. Study period was January 2013 to December 2015. The patients included with STEM I>20 mins and <24 hours in duration. Principal exclusion criteria were any contraindication to primary PCI and use of Bivalirudin or Abciximab. The study medications were UFH (5000 unit IV; subsequent boluses titrated to ACT 200-250 secs); Bivalirudin (Bolus 0.75 mg/kg IV, infusion 1.75 mg/kg/h); Abciximab (Bolus:.25 mg/kg and infusion: 0.125 mcg/kg/min); Antiplatelets: Aspirin 300 mg and Clopidogrel 600 mg or Prasugrel 60 mg pre-procedure. Troponin I and CKMB were measured as a biochemical marker of myocardial necrosis at pre-procedure. Just after the procedure, 8 hours, 16 hours and 24 hours post procedure.
Ninety-three patients (male 80, female 13) age ranges from 31 to 80 years (mean ±SD: 53.83 ± 11.52) were enrolled. Primary PCI was done in all cases. All patients got aspirin 300 mg and clopidogrel 600 mg or prasugrel 60 mg pre-procedure and Unfractionated heparin (5000 unit IV*; subsequent boluses titrated to ACT 200-250 secs) during the procedure. Bivalirudin was used in 69 (74.2%) and Abciximab in 24 (25.8%) of patients. Mean difference of Troponin I in Bivalirudin and Abciximab group at different times did not reveal statistical significance (Figure 1), but CK-MB level did better outcome (Figure 2).
In this small scale trial of patients with STEMI undergoing primary PCI in a single center compared Abciximab and Bivalirudin to prevent myocardial necrosis as evidenced by Troponin I and CKMB resulted in non-inferior outcome with Bivalirudin.