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Rapid Ambulation After Closure - RACE - Rapid Ambulation After Closure
Description:
The goal of the Rapid Ambulation After Closure (RACE) trial was to evaluate the safety and efficacy of the X-Press closure device compared to compression (manual or mechanically based) following diagnostic catheterization or percutaneous coronary intervention (PCI) via the femoral artery.
Hypothesis:
Use of the X-Press closure device will be associated with a reduction in median time to ambulation compared to compression following diagnostic catheterization or PCI via the femoral artery.
Study Design
Study Design:
Patients Screened: 628
Patients Enrolled: 393
Mean Follow Up: 14 days
Mean Patient Age: Mean age 63 years
Female: 24
Patient Populations:
Candidates for diagnostic or PCI procedures via a femoral sheath ≤6 Fr, age ≥18 years, and able to sign informed consent
Exclusions:
Pregnant or immunocompromised; repuncture at a site previously punctured within 48 hours; significant anemia; morbid obesity; participation in another Investigational Device Exemption or Investigational New Drug trial; baseline international normalized ratio >1.5; known bleeding disorder; platelet count <100,000 cells/ul;="" puncture="" tract="" angle="">55°; antegrade puncture; suspected posterior wall puncture or >1 arterial puncture; puncture site in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries on femoral arteriography; common femoral artery calcium on fluoroscopy; small femoral artery <4 cm;="" femoral="" artery="" stenosis="" resulting="" in="" vessel="" diameter=""><4 cm;="" pre-existing="" hematoma,="" pseudoaneurysm,="" or="" arteriovenous="" fistula;="" an="" activated="" clotting="" time="">400 seconds at the time of sheath removal; or planned continued anticoagulation following the catheterization procedure
Primary Endpoints:
Efficacy: median time to ambulation
Safety: major complications (vascular repair, ultrasound-guided compression, transfusion, or infection) at 14 days
Secondary Endpoints:
Time to hemostasis and treatment success
Drug/Procedures Used:
Patients were randomized in a 2:1 fashion to X-Press closure device (n=261) or manual or mechanically based compression (n=132). The X-Press suture system consists of a 6 Fr over-the-wire device, a guidewire, a suture pack containing a single strand of suture attached to two needles, and a knot pusher.
Principal Findings:
Diagnostic catheterization was performed in 34% of patients, and PCI in 66% of patients; 52% of PCI patients received glycoprotein (GP) IIb/IIIa inhibitors, and 90% received stents. There were eight device malfunctions in the X-Press arm.
The primary endpoint of median time to ambulation was significantly shorter in the X-Press arm compared with compression in patients undergoing diagnostic catheterization (2.2 vs. 6.2 hours; p<0.0001) and="" in="" patients="" undergoing="" pci="" (4.1="" vs.="" 14.7="" hours;=""><0.0001). time="" to="" hemostasis="" was="" also="" significantly="" shorter="" in="" the="" x-press="" arm="" patients="" undergoing="" diagnostic="" catheterization="" (9.0="" minutes="" vs.="" 49.5="" minutes;=""><0.0001) and="" in="" patients="" undergoing="" pci="" (10.0="" minutes="" vs.="" 269.5="" minutes;=""><0.0001). there="" was="" no="" difference="" in="" treatment="" success,="" defined="" as="" attainment="" of="" stable="" hemostasis="" the="" femoral="" arteriotomy="" (92.0%="" with="" x-press="" vs.="" 97.0%="" usual="" care,="" p="">
The primary safety endpoint of equivalence of major complications at 14 days did not differ in the overall population between the X-Press versus compression arm (0.4% vs. 2.3%, p=0.11) or in diagnostic catheterization patients (1.1% vs. 0%, p=1.0), but was lower in PCI patients (0% vs. 3.4%, p=0.037). GP IIb/IIIa inhibitor did not impact the frequency of major complications in either treatment group.
Interpretation:
Among patients undergoing diagnostic catheterization or PCI via the femoral artery, use of the X-Press closure device was associated with a reduction in the primary efficacy endpoint of median time to ambulation compared with manual or mechanically based compression. Additionally, major vascular complications were similar between treatment groups in patients undergoing diagnostic angiography, and were lower in the X-Press arm in patients undergoing PCI.
There have been several trials of closure devices. However, the present trial is the first to show a reduction in major vascular complications in patients undergoing PCI with a high use of GP IIb/IIIa inhibitors (52%).
References:
Sanborn TA, et al. Reduced vascular complications after percutaneous coronary interventions with a nonmechanical suture device: results from the randomized RACE study. Catheter Cardiovasc Interv 2004;61:327–332.
Keywords: Sutures, Walking, Hemostatic Techniques, Catheterization, Femoral Artery, Coronary Disease, Informed Consent, Platelet Membrane Glycoprotein IIb, Needles, Stents, Percutaneous Coronary Intervention
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