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RIVAL - Radial vs Femoral access for coronary intervention

Primary PCI

MACE

Is the Radial Approach better?

Meta-analyses of all comers to angiography =

  • no difference in MACE:
  • Radial: 222/7763 (2.9%) vs
  • Femoral: 260/7345 (3.5%)

ACS patients planned for an invasive strategy

  • Operative expertise in both approaches
  • Dual circulation of hand by Allens test
  • Without cardiogenic shock, Severe PVD, Previous IMA graft

Between '06 and '10 7021 patients were enrolled from 158 hospitals in 32 countries

  • 1:1 radomisation to Femoral vs Radial access with medical therapy as per the treating physician

0.9%

7.0%

But what about high risk patients?

Mortality

SCAAR registry (7):

  • 21,339 patients with STEMI
  • Adjusted one year risk of death:
  • OR: 0.78 (0.64 - 0.96)

Primary outcome = Death, MI, stroke, or Non-CABG related major bleeding within 30 days

Secondary outcomes: Major access site complications and PCI success

99.8% Angiogram

66.4% PCI

8.5% CABGs

Safety

RADIAL-STEMI (8)

Radial approach significantly reduces access site related major bleeding (4):

  • Meta-analyses before RIVAL: OR = 0.27
  • After RIVAL: OR= 0.51

Major bleeding is an independent predictor of mortality (5)

Access site bleeding accounts for around 50% of bleeding on long term follow up (6)

707 STEMI patients

1:1 randomisation to radial or femoral

Same medical therapy

  • 30-day bleeding and access-site complications were 80% less with radial approach
  • 1.4% vs 7.2%
  • MACE + Major bleeding = 4.6% vs 11%
  • ICU stay = 2.5 vs 3 days p=0.0016

Radiation exposure is related to operator experience and access route (2).

  • Fluroscopy time 7.8 mins vs 6.5 mins in RIVAL
  • No difference in higher volume centres

Feasibility

Primary outcome (Death, MI, stroke, major bleeding at 30 days):

  • 3.7% Radial approach
  • 4% Femoral approach

No significant difference in primary endpoints or components including Major Bleeding

  • Superficial, free of other anatomical structures
  • Easy to find, safe to compress post-procedure

  • Bleeding is easily noticed unlike femoral puncture site
  • Double blood supply to the hand

  • Conversion rate to femoral access 1.5% in high volume centres according to recent registries (4)

Secondary endpoints:

  • Major vascular complications: 1.4% vs 3.7%
  • HR: 0.37 (0.27-0.52)

Pre-specified subgroup analysis, Primary outcome:

  • STEMI: 3.1% vs 5.2%. HR 0.6 (0.38 - 0.94)
  • Highest tertile radial volume by centre:
  • 1.6% vs 3.2%. HR 0.49 (0.28-0.87)

References

1. Kiemeneij F, Laarman GJ. Percutaneous transradial artery approach for coronary Palmaz-Schatz stent implantation. Am Heart J. 1994;128:167-74.

2. Jolly SS, Yusuf S, Cairns J et al; RIVAL trial group. Radial versus femoral access for coronary angi- ography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011;377:1409-20.

3.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.

4. Hamon M, Pristipino C, Di Mario C, et al. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and working groups on acute cardiac care and thrombosis of the European Society of Cardiology. EuroIntervention 2013

5. Cayla G,Silvain J,Barthelemy O et al; ABOARD investigators. Trans-radial approach for catheterisation in non-ST segment elevation acute coronary syn- drome: an analysis of major bleeding complications in the ABOARD Study. Heart. 2011;97:887-91.

6. Verheugt FW, Steinhubl SR, Hamon M et al. Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. JACC Cardiovasc Interv. 2011;4:191-7.

7. Olivecrona GK, Lagerqvist B, Gotberg M et al. Lower Mortality with Transradial PCI Compared to Transfemoral PCI in 21,000 Patients with Acute Myocardial Infarction- Results from the SCAAR Database. EuroPCR 2011

8.Bernat I. STEMI-RADIAL: A prospective, randomized trial of radial vs. femoral access in patients with ST-Segment elevation myocardial infarction. TCT 2012; October 26, 2012; Miami, FL

SUMMARY

Bleeding

  • Clear mortality benefit in STEMI

  • Reduced mortality, MI and Stoke in high volume centers

  • Cause fewer access site complications

  • Allows more rapid ambulation

  • Provide greater post-procedural patient comfort

  • More cost effective

RIVAL major bleeding =

Fatal, ≥ 2 units PRBCs, causing hypotension needing vasopressors, caused severe disabling sequelae, intracranial and symptomatic, or drop in Hb ≥ 50g/L

  • no significant difference

ACUITY major Bleeding

  • RIVAL major bleeding plus
  • Large haematoma, pseudo-aneurysms requiring intervention
  • HR: 0.43 (0.32 - 0.57)
  • 1.9% vs 4.5%

Why perform Radial angiography?

Does the Radial Artery belong to the Interventionalist or the Surgeon?

ESC: "the radial artery should be the default access route for patients undergoing transcatheter coronary interventions"

Compared with Femoral access Radial angiography has been shown to:

  • Cause fewer access site complications
  • allow more rapid ambulation
  • provide greater post-procedural patient comfort
  • be more cost effective (1)

More recently the radial approach has been shown to:

  • Confer mortality benefits in STEMI
  • Cause reduced mortality, MI and Stoke in high volume centers (2, 3)

1948 Radner cutdown

1989 Campeau Percutaneous

1992 Kiemeneij PCI

RADIAL ACCESS ANGIOGRAPHY

DR RYAN SPENCER

Austin Health, Victoria, Australia

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