radial versus femoral approach for percutaneous coronary procedures: a meta-analysis of randomized...
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Radial versus Femoral Approach for Radial versus Femoral Approach for
Percutaneous Coronary Procedures: Percutaneous Coronary Procedures:
A Meta-analysis of Randomized A Meta-analysis of Randomized
TrialsTrials
6th EUROPEAN WORKSHOP ON TRANSRADIALAPPROACH FOR CORONARY DIAGNOSIS
AND INTERVENTIONSMassy Opera, Pairs, France, 23 June 2005
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INTRODUCTION
Since its introduction in 1989 for coronary angiography,1 and its improvement for percutaneous coronary interventions,2 the radial approach has gained progressive widespread diffusion, in all the world.
1. Campeau L. Cathet Cardiovasc Diagn, 19892. Kiemeneij F and Laarman GJ. Cathet Cardiovasc Diagn, 1992
In any case, the actual “gold-standard” for percutaneous coronary procedures remains the femoral access, mainly due to its easy feasibilty and the short-term learning curve.
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INTRODUCTION
The radial approach has been shown to
have several advantages:
3. Kiemeneij F, et al. ACCESS Trial. JACC, 1997
- a time-sparing hemostasis technique
- a lower incidence of local complications3
- avoidance of post-procedural bed-rest
- improved quality of life for patients4
4. Cooper CJ, et al. Am Heart J, 1999
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INTRODUCTION
Several randomized trials compared the transradial and the transfemoral approach for percutaneous coronary procedures.
However, as relatively small numbers of patients were included in each, they were underpowered to detect major differences between the two techniques in terms of safety and feasibility.
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INTRODUCTION
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INTRODUCTION
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INTRODUCTION
As systematic overviews and meta-analytic techniques may provide more precise effect estimates with greater statistical power, leading to more robust and generalized conclusions...
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AIM OF OUR REVIEW* Research* Retrieve* Evaluate* Combine
in a systematic way
all the randomized trials comparing transradial vs. transfemoral approach in percutaneous coronary diagnostic and interventional procedures.
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METHODS
Systematic Research MEDLINE, CENTRAL, mRCT
AHA, ACC, ESC, TCT 2000-2003 abstracts
Inclusion criteria Prospective comparison Randomized allocation
Intention-to-treat
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METHODS
- MACE: Death
MI
Stroke
Emergent PCI/CABG
- Local complications: Major bleeding
Pseudo-aneurysm
A-V fistula
Limb ischemia
Nerve damage
- Procedural Failure: Cross-over to a different access site Inability to perform the procedure
Primary End-points
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METHODS
- Procedural Time - Fluoroscopy Time
- Hospital Stay
Secondary End-points
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METHODS Binary outcomes comparison
Odds Ratios (95% Confidence Intervals) Random effect model
Continuous variables comparison Weighted mean difference (95% CI)
Random effect model
Heterogeneity
Cochran Q 2 test
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Included Studies
>3200
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MACE
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Local Complications
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Procedural Failure
Heterogeneity p = 0.38
Heterogeneity p = 0.73Overall effect p = 0.26
Overall effect p < 0.001
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Femoral Radial WMD (95% CI)
Procedural Time (min) 33.8 35 NS
Fluoroscopy Time (min) 7.8 8.9 1.1 (0.5-1.6)
Hospital Stay (days) 2.4 1.8 -0.5 (-0.3/-0.8)
Secondary End-points
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CONCLUSIONS
The transradial and the transfemoral approach are equivalent in terms of major safety, with a similar rate of MACE.
The transradial access virtually eliminates entry site local complications:
0.3% vs. 2.8% in transfemoral group5/1472 (!)
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CONCLUSIONS
However, the transradial approach is more technically demanding with a global procedural failure of around 7%.
Nonetheless, a clear ongoing trend toward equalization of the two procedures, in terms of procedural success, is evident through the years, probably due to technologic improvement of materials and increased operator experience.
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Many thanks to all the co-authors of this work:
Giuseppe G.L. Biondi-Zoccai, MDM. Luisa De Benedictis, MD
Stefano Rigattieri, MDMarco Turri, MD
Maurizio Anselmi, MDCorrado Vassanelli, MD
Piero Zardini, MDYves Louvard, MD
Martial Hamon, MD
This meta-analyisis is part of an ongoing training project of
(Center for Overview, Metaanalyisis and Evidence-based medicine Training)
Web-site: http://it.geocities.com/comet_milano/Home.htm
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Limits of the Radial Approach
• Non pathological Allen test– (? -> Louvard & Saito: no Allen test!)
• Thrombotic occlusion of the radial artery– 3-6% in trials with mandatory doppler
(Mann 1996, BRAFE Stent 1997, ACCESS 1997)
– 0-9% loss of radial pulse in the others
• Use of larger sheaths (7-8 F or more) for larger devices – bifurcation stenting, atherectomy, covered stents,
aspiration devices…
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Quality assessment
• statement of objectives• explicit inclusion and exclusion criteria• description of interventions• objective means of follow-up• description of adverse events• power analysis• description of statistical methods• multi-center design• discussion of withdrawals• details on medical therapy during procedure
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For further slides on these topics For further slides on these topics please feel free to visit the please feel free to visit the
metcardio.org website:metcardio.org website:
http://www.metcardio.org/slides.html