INTRODUCTION: Despite recent technical improvements and device developments, post-percutaneous coronary intervention care in patients submitted to this procedure performed through the femoral approach remains almost unchanged. An earlier sheath removal and ambulation could help to cut costs, save health system resources and prevent patient discomfort. However, this approach has not yet been well assessed. OBJECTIVES: The main objective of this paper was to evaluate a strategy of post-procedure immediate sheath removal and early ambulation. METHODS: A randomised trial was conducted in 347 patients submitted topercutaneous coronary intervention that used a 6 French gauge arterial sheath. The intervention group (IG, n=172) had the arterial sheath removed immediately after the procedure and ambulated after 3 h of bed rest. The control group (CG, n=175) had the arterial sheath removed 4h after the end of the angioplasty and rested for an additional 6 h. The primary end point was the development of major vascular complications: hematoma>10 cm, pseudo-aneurism and arterial bleeding after or during ambulation. Secondary end points were minor vascular complications: hematoma<10 cm, vasovagal reactions after sheath removal, and assessment of patient's comfort during the peri-operative period. RESULTS: Baseline characteristics did not differ statistically between groups, as major bleeding (IG=1.7% vs. CG=0.6%; p=0.31). Regarding other vascular complications and vasovagal reactions, there were also no significant differences. Patients of IG had less pain (26% vs. 41%, p=0.004) than CG, but the frequency of urinary retention was the same in both groups. CONCLUSION: This study, although underpowered, indicates that immediate arterial sheath removal with early ambulation after PCI was not significantly associated with an increase in major vascular complications and was associated with increased patient comfort. Although further studies with larger samples are necessary to confirm these results, this study suggests that immediate arterial sheath removal with early ambulation may be an alternative for selected elective patients submitted to percutaneous coronary interventions and for those with difficulties to endure prolonged bed rest. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
RCT Entities:
INTRODUCTION: Despite recent technical improvements and device developments, post-percutaneous coronary intervention care in patients submitted to this procedure performed through the femoral approach remains almost unchanged. An earlier sheath removal and ambulation could help to cut costs, save health system resources and prevent patient discomfort. However, this approach has not yet been well assessed. OBJECTIVES: The main objective of this paper was to evaluate a strategy of post-procedure immediate sheath removal and early ambulation. METHODS: A randomised trial was conducted in 347 patients submitted to percutaneous coronary intervention that used a 6 French gauge arterial sheath. The intervention group (IG, n=172) had the arterial sheath removed immediately after the procedure and ambulated after 3 h of bed rest. The control group (CG, n=175) had the arterial sheath removed 4h after the end of the angioplasty and rested for an additional 6 h. The primary end point was the development of major vascular complications: hematoma>10 cm, pseudo-aneurism and arterial bleeding after or during ambulation. Secondary end points were minor vascular complications: hematoma<10 cm, vasovagal reactions after sheath removal, and assessment of patient's comfort during the peri-operative period. RESULTS: Baseline characteristics did not differ statistically between groups, as major bleeding (IG=1.7% vs. CG=0.6%; p=0.31). Regarding other vascular complications and vasovagal reactions, there were also no significant differences. Patients of IG had less pain (26% vs. 41%, p=0.004) than CG, but the frequency of urinary retention was the same in both groups. CONCLUSION: This study, although underpowered, indicates that immediate arterial sheath removal with early ambulation after PCI was not significantly associated with an increase in major vascular complications and was associated with increased patient comfort. Although further studies with larger samples are necessary to confirm these results, this study suggests that immediate arterial sheath removal with early ambulation may be an alternative for selected elective patients submitted to percutaneous coronary interventions and for those with difficulties to endure prolonged bed rest. Copyright (c) 2010 Elsevier Ltd. All rights reserved.