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Radial Versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome - RIFLE-STEACS
Description:
Bleeding complications are a significant source of morbidity and mortality in patients undergoing cardiac catheterization. Numerous studies, including the recently published large RIVAL trial, have compared outcomes between transfemoral and transradial access. The current trial sought to study if transradial access would be superior to transfemoral access in patients presenting with ST-segment elevation myocardial infarction (STEMI).
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 recent acute STEMI requiring emergent coronary angiography
Number of enrollees: 1,001
Duration of follow-up: 30 days
Exclusions:
- Contraindication to either radial or femoral vascular access (e.g., abnormal Allen’s test or known severe peripheral vascular disease)
- Recent stroke or transient ischemic attack (<4 weeks), irrespective of age
- International normalized ratio (INR) >2.0, or other severe bleeding diathesis
- Pregnant or breastfeeding
- Known allergies to: aspirin, clopidogrel and ticlopidine, heparin, IIb/IIIa inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated)
Primary Endpoints:
- 30-day NACE (cardiac death/MI/TLR/stroke/bleeding)
Secondary Endpoints:
- Length of hospital stay
- 1-year NACE
- Individual components of NACE at 30 days
- Individual components of NACE at 1 year
- Total procedural and fluoroscopic times for the index procedure
Drug/Procedures Used:
Procedural anticoagulation was achieved with preliminary administration of an unfractionated heparin bolus at a dose of 70 UI/kg, supplemented during the procedure to maintain an activated clotting time of ≥250 seconds. 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:
All patients were pretreated with aspirin and clopidogrel 300-600 mg. Bivalirudin (7.4%), glycoprotein IIb/IIIa inhibitors continued for ≥12 hours following PCI (68.6%).
Principal Findings:
A total of 1,001 patients were enrolled at four high-volume centers in Italy, 501 to transfemoral access and 500 to transradial access. Baseline characteristics were similar between the two arms. All participating interventionalists were high-volume operators (>150 PCIs/year), and were proficient in doing at least 50% of PCI cases by radial approach per year. Rates of crossover were 9.6% for the transradial arm, and 2.8% for the transfemoral arm. About 24% had diabetes, and the median left ventricular ejection fraction was 45%. The median ischemic time was 207 minutes, and 7.6% had undergone failed thrombolytic therapy. Median door-to-balloon times were similar between the radial and femoral arms (60 vs. 53 minutes, p = 0.175). About 54% had single-vessel disease, and 16% had three-vessel disease. An occlusive lesion (TIMI 0-1 flow) was noted in 72% of patients; the left anterior descending was the culprit vessel in about 47% of the patients. A drug-eluting stent was used in 24.3% of patients; direct stenting was utilized in 28.1% of patients.
The primary endpoint of net adverse clinical events (NACE) at 30 days was significantly lower in the transradial arm, as compared with the transfemoral arm (13.6% vs. 21.0%, p = 0.003). Both major adverse cardiac and cerebrovascular events (MACCE) at 30 days (7.2% vs. 11.4%, p = 0.029) and BARC (Bleeding Academic Research Consortium) bleeding (non-CABG) ≥2 (7.8% vs. 12.2%, p = 0.026) were significantly lower in the transradial arm at 30 days. The reduction in MACCE was driven predominantly by a reduction in cardiac death (5.2% vs. 9.2%, p = 0.02); other outcomes including MI (1.2% vs. 1.4%, p = 1.0), target lesion revascularization (TLR) (1.2% vs. 1.8%, p = 0.6), and cerebrovascular accident (0.8% vs. 0.6%, p = 0.73) were similar between the two arms. The reduction in bleeding was driven predominantly by a reduction in access site bleeding (2.6% vs. 6.8%, p = 0.002); no difference was noted in nonaccess site bleeding (5.2% vs. 5.4%, p = 1.0). Hospital stay was lower in patients in the transradial arm (5 vs. 6 days, p = -0.008).
Interpretation:
The results of this trial indicate that transradial access is superior to transfemoral access in patients undergoing primary percutaneous coronary intervention for STEMI. These results are similar to the RIVAL trial in that access site bleeding was significantly reduced in the transradial arm. On subgroup analysis in the RIVAL trial, the group with the largest benefit for ischemic outcomes was patients presenting with STEMI and, thus, mirrors the findings of this trial as well.
As with the RIVAL trial, a number of caveats exist. The learning curve associated with 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 and, in centers that do not utilize radial access routinely or preferentially, procedure times may increase substantially and negate some of the other advantages of radial access. Longer-term data are awaited.
References:
Romagnoli E, Biondi-Zoccai G, Sciahbasi A, et al. Radial Versus Femoral Randomized Investigation in ST-Segment Elevation Acute Coronary Syndrome: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) Study. J Am Coll Cardiol 2012;60:2481-9.
Presented by Dr. Enrico Romagnoli at the Transcatheter Cardiovascular Therapeutics Meeting (TCT 2011), San Francisco, CA, November 9, 2011.
Keywords: Thrombolytic Therapy, Acute Coronary Syndrome, Myocardial Infarction, Drug-Eluting Stents, Cardiac Catheterization, Ticlopidine, Hirudins, Percutaneous Coronary Intervention, Length of Stay, Punctures, Peptide Fragments, Stroke Volume, Diabetes Mellitus, Platelet Glycoprotein GPIIb-IIIa Complex
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