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

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.

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

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.

INTRODUCTION

INTRODUCTION

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...

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.

METHODS

Systematic Research MEDLINE, CENTRAL, mRCT

AHA, ACC, ESC, TCT 2000-2003 abstracts

Inclusion criteria Prospective comparison Randomized allocation

Intention-to-treat

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

METHODS

- Procedural Time - Fluoroscopy Time

- Hospital Stay

Secondary End-points

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

Included Studies

>3200

MACE

Local Complications

Procedural Failure

Heterogeneity p = 0.38

Heterogeneity p = 0.73Overall effect p = 0.26

Overall effect p < 0.001

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

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 (!)

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.

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

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…

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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