Key result
Protamin reversal for immediate sheath removal after coronary angioplasty reduced immobilization time (6 vs 19 hours) with 2% vs 4% pseudoaneurysms, though early ischemic events were higher.
Why the study?
Does protamine reversal of heparin with immediate sheath removal improve safety and patient comfort compared to delayed sheath removal in patients after coronary angioplasty?
RCT (n=100)
randomized
Does protamine reversal of heparin with immediate sheath removal improve safety and patient comfort compared to delayed sheath removal in patients after coronary angioplasty?
Absolute Event Rate: 2% vs 4%
Protamine reversal for immediate sheath removal after coronary angioplasty reduces immobilization time and improves comfort, but may increase early ischemic events, suggesting a need for pre-procedural clopidogrel.
Permits earlier mobilization after angioplasty with protamine reversal; extends RCT evidence while cautioning on ischemic event trade-offs.
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.
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Lohne et al. (2004) conducted an RCT in coronary angioplasty (n=100). Protamin and immediate sheath removal vs. Sheath removal after 3 hours was evaluated on Puncture site complications (pseudoaneurysms). Protamin reversal for immediate sheath removal after coronary angioplasty reduced immobilization time (6 vs 19 hours) with 2% vs 4% pseudoaneurysms, though early ischemic events were higher.
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