Purpose: To study the safety of giving protamin after coronary angioplasty to reverse heparin for immediate removal of the femoral sheath.
Material and Methods: After successful angioplasty, 100 patients were randomized to receive protamin and immediate sheath removal or to the control group with sheath removal after 3 h. Patients were followed for 30 days so that groin complications and coronary events could be compared. After 6 months, target vessel revascularization and death were recorded.
Results: The time to mobilization was significantly shorter in the protamin group compared to the control group; 6 versus 19 h. The protamin patients were more satisfied than the control patients, in particular during bed rest after compression. Puncture site complications were one (2%) and two (4%) pseudoaneurysms in the protamin group and the control group, respectively. Early angina and restenosis/reocclusion before 30 days were seen in 4 patients in the protamin group and in 1 in the control group. Adverse incidents between 30 days and 6 months were the same for both groups.
Conclusion: Protamin reversal improved patient comfort and reduced immobilization time. The cardiac safety concern observed requires the antiplatelet agent clopidogrel to be given before the procedure.
