Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients.

BACKGROUND: Arterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy. METHODS: ARISE is a national, multicenter, non-inferiority randomized clinical trial. Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device. The primary outcome is the occurrence of vascular complications at an arterial puncture site 30 days after the procedure, including major bleeding, retroperitoneal hematoma, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arterio-venous fistula, infection, limb ischemia, arterial occlusion, adjacent nerve injury or the need for vascular surgical repair. RESULTS: Enrollment was initiated in September 2012, and until October 2013 91 patients were included. The inclusion phase is expected to last until the second half of 2014. CONCLUSIONS: The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01653587.

Transulnar approach as an alternative access site for coronary invasive procedures after transradial approach failure.

BACKGROUND: Unsuccessful radial artery puncture, inability to advance the guide catheter to the ascending aorta, and inadequate guide catheter support represent mechanisms of transradial approach failure. With the rationale of sharing the same efficacy and safety promoted by radial access, the transulnar approach represents an alternative access site for percutaneous coronary procedures. METHODS: Between May 2007 and May 2012, 11,059 coronary invasive procedures were performed in a single institution: 10,108 by transradial approach (91.4%), 541 by transfemoral approach (4.9%), and 410 by transulnar approach (3.7%). Patients who underwent coronary procedures through transulnar access were included in a prospective registry of effectiveness and safety. RESULTS: Diagnostic procedures accounted for 71.8% of cases, and the right ulnar access was the most common route (88.9%). Procedure success was high (98.5%), with a crossover rate of 1.5% (6 cases), of which 5 were achieved through the contralateral radial access and 1 through femoral approach. Complications related to access site were low (3.9%), consisting mostly of minor bleeding due to subcutaneous hematomas. There were no cases of major bleeding, nerve injury, pseudoaneurysm, arteriovenous fistula, or necessity of vascular surgical repair. CONCLUSIONS: The transulnar approach represents an alternative to the transradial approach in selected cases when performed by radial-trained operators, sharing a high success rate and extremely low incidence of access-site complications.

Transulnar approach: the rationale from the radialist's view.

BACKGROUND: Radial access, besides providing greater comfort to the patient and reduction of hospital costs, promotes unequivocal reduction of vascular complications, with possible prognosis implication. A series of cases has shown that when its use is not suitable, ulnar access presents itself as a viable and effective alternative. OBJECTIVE: To evaluate the safety and effectiveness of ulnar approach in the performance of coronary procedures after failed attempt in obtaining radial access. METHODS AND RESULTS: From May 2007 to February 2009, 115 patients underwent 122 coronary procedures via ulnar access and were included in a prospective registry. The average age was 61.3 +/- 11.1 years, 67 (58%) were female and 36 (31%) were diabetic. Procedure success was achieved in 116 (95%) cases. There were no cases of major bleeding, transfusions or vascular repair surgery among the complications. There were hematomas in 4.9% of the cases, though mostly superficial, light to moderate spasms in 4% and asymptomatic ulnar artery occlusion, with no evidence of ischemia in 1.6%. CONCLUSIONS: The ulnar artery is a feasible and effective alternative approach to perform coronary procedures. When radial access is not available, it presents a similar safety profile with virtually no occurrence of hemorrhagic complications.