Abstract
BACKGROUND: Coronary artery disease (CAD) diagnosis and management have significantly advanced with percutaneous coronary intervention (PCI), yet the procedure remains associated with notable vascular complications in patients, with hematoma being one of the most common post-procedural adverse events. This study aimed to evaluate the effectiveness of cryotherapy in preventing and reducing hematoma formation at arterial puncture sites in patients undergoing PCI. METHODOLOGY: A randomized controlled trial was conducted at a tertiary care center in India, involving 70 patients undergoing PCI via the femoral approach. Patients were randomly divided into experimental and control groups. The experimental group received cryotherapy through ice pack application at two-minute intervals for 10 minutes immediately after sheath removal, while the control group followed the standard hospital protocol. Hematoma was assessed and graded by size, with measurements taken before and after intervention. RESULTS: The mean age of the patients in the control and experimental groups was 57.29 ± 10.03 years and 57.09 ± 9.67 years, respectively, with a marked male predominance of 57 (81.43%) across both groups. Before the intervention, 18 (51.43%) patients in the experimental group had no hematoma, while 9 (25.71%) patients experienced severe hematoma, and 4 (11.43%) patients had mild hematoma. After receiving cryotherapy, a total of 33 (94.29%) patients in the experimental group had no hematoma and only 2 (5.71%) of patients had mild hematoma. Hematoma reduction was significantly greater in the experimental group (95.35%, P = 0.0003) than in the control group (78.79%, P = 0.0023). Notably, body mass index (BMI) and antiplatelet drug use showed significant correlations with hematoma formation in the experimental group. CONCLUSIONS: Hence, cryotherapy can be effectively used for the prevention and management of hematoma after sheath removal in post-PCI patients.