ST Elevation Myocardial Infarction treated by RADIAL or femoral approach - STEMI-RADIAL

Description:

Bleeding complications are a significant source of morbidity and mortality in patients undergoing cardiac catheterization. Two recent trials, RIVAL and RIFLE-STEACS, have compared outcomes between transfemoral and transradial access in patients presenting with ST-segment elevation myocardial infarction (STEMI). The current trial also sought to compare outcomes between transfemoral and transradial access in STEMI patients presenting to high-volume radial centers (where >80% primary percutaneous coronary interventions [PCIs] were performed radially).

Hypothesis:

Transradial access would be superior to transfemoral access in patients presenting with STEMI.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Age >18 years old with STEMI within 12 hours of symptom onset
  • Need for emergent coronary angiography
  • Patient has no contraindication to percutaneous arterial access by both and transfemoral route

    Number of enrollees: 707
    Duration of follow-up: 30 days
    Mean patient age: 62 years
    Percentage female: 23%

Primary Endpoints:

  • HORIZONS-AMI bleeding and access site complication (hematoma ≥15 cm)

Secondary Endpoints:

  • MACE (death, MI, stroke)
  • NACE (MACE + bleeding)
  • Crossover rates
  • Angiographic success
  • Contrast volume
  • Procedural and fluoroscopic times
  • ICU stay

Drug/Procedures Used:

Before arterial puncture for percutaneous access, all STEMI patients eligible for acute revascularization were randomized in a 1:1 ratio to radial or femoral access.

Concomitant Medications:

Glycoprotein IIb/IIIa inhibitors (45%), clopidogrel (99%), and aspiration thrombectomy (28%). Bivalirudin was not utilized in the trial.

Principal Findings:

A total of 707 patients were enrolled at four high-volume centers, 359 to transfemoral access and 348 to transradial access. Baseline characteristics were similar between the two arms. Rates of crossover were 3.7% for the transradial arm, and 0.6% for the transfemoral arm. About 21% had diabetes, and 7.2% had undergone prior PCI. The median ischemic time was 213 minutes. Approximately 50% had single-vessel disease, and 15% had three-vessel disease. An occlusive lesion (TIMI 0/1 flow) was noted in 65% of patients; 41% presented with an anterior MI. A 6F sheath was utilized in nearly three-fourths of the patients. Use of the vascular closure device in the femoral arm was low, at approximately 38%.

Overall, angiographic success was noted in 91% of patients. Total fluoroscopy time (7.9 vs. 8.0 minutes) and procedural time (49 vs. 49 minutes) were similar between the transradial and transfemoral arm, respectively. Total contrast volume (170 vs. 182 cc, p = 0.01) and mean length of intensive care unit (ICU) stay (2.5 vs. 3.0 days, p = 0.0016) were lower in the transradial arm.

The primary endpoint of 30-day bleeding and access site complications was significantly reduced in the transradial arm as compared with the transfemoral arm (1.4% vs. 7.2%, p = 0.0001). This was driven predominantly by a reduction in large hematomas >15% (0.6% vs. 5.3%) and hemoglobin drop ≥3 g/dl (0.9% vs. 2.8%), although gastrointestinal bleeding (0.3% vs. 1.1%) and vascular complications (0.3% vs. 0.8%) were also numerically lower in the transradial arm. Reduced bleeding also resulted in net adverse clinical events (NACE) at 30 days being significantly lower in the transradial arm as compared with the transfemoral arm (4.6% vs. 11.0%, p = 0.0028). Major adverse cardiac event (MACE) rates at 30 days were similar (3.5% vs. 4.2%, p = 0.7).

Interpretation:

The results of this trial indicate that transradial access is superior to transfemoral access in reducing bleeding and access site complications in patients undergoing primary PCI for STEMI. Contrast use and length of ICU stay were also lower with transradial access, whereas procedure and fluoroscopy times were similar. These results are similar to the RIVAL and RIFLE-STEACS trials, in which access site bleeding was significantly reduced in the transradial arm. As with these trials, a number of caveats exist. The learning curve associated with learning radial access must be recognized; recent data indicate that the curve is much steeper than previously described. All four centers in this trial were high-volume radial access centers; thus, in centers that do not utilize radial access routinely or preferentially, procedure times may increase substantially, and again negate some of the advantages of radial access.

In this trial, the majority of benefit was driven by a reduction in large hematomas. Although an important finding, using a more standard definition of bleeding such as BARC would have made comparison with other trials easier. Longer-term follow-up and data on intra-aortic balloon pump use/patients in cardiogenic shock are necessary. Given that the majority of benefit with radial access is driven by a reduction in access site bleeding and since bivalirudin was not utilized in this trial, future studies will also need to compare bleeding rates in STEMI patients who are treated with bivalirudin exclusively.

References:

Bernat I, Horak D, Stasek J, et al. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol 2014;63:964-72.

Presented by Dr. Ivo Bernat a at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2012), Miami, FL, October 26, 2012.

Clinical Topics: Anticoagulation Management, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Acute Heart Failure, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Fluoroscopy, Intensive Care Units, Myocardial Infarction, Follow-Up Studies, Cardiac Catheterization, Learning Curve, Hematoma, Hirudins, Percutaneous Coronary Intervention, Shock, Cardiogenic, Hemoglobins, Coronary Angiography, Peptide Fragments, Diabetes Mellitus


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