1. Radial versus Femoral Approach for Percutaneous Coronary Procedures: A Meta-analysis of Randomized Trials 6th EUROPEAN WORKSHOP ON TRANSRADIAL APPROACH FOR CORONARY DIAGNOSIS AND INTERVENTIONS Massy Opera, Pairs, France, 23 June 2005

2. 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, 1989 2. 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.

3. 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 complications 3 - avoidance of post-procedural bed-rest - improved quality of life for patients 4 4. Cooper CJ, et al. Am Heart J, 1999

4. 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.

5. INTRODUCTION

7. As systematic overviews and meta- analytic techniques may provide more precise effect estimates with greater statistical power, leading to more robust and generalized conclusions...

8. 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.

9. METHODS Systematic Research MEDLINE, CENTRAL, mRCT AHA, ACC, ESC, TCT 2000-2003 abstracts Inclusion criteria Prospective comparison Randomized allocation Intention-to-treat

10. 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

11. METHODS - Procedural Time - Fluoroscopy Time - Hospital Stay Secondary End-points

12. 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

13. Included Studies >3200

14. MACE

15. Local Complications

16. Procedural Failure Heterogeneity p = 0.38 Heterogeneity p = 0.73 Overall effect p = 0.26 Overall effect p < 0.001

17. Secondary End-points

18. 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 group 5/1472 (!)

19. 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.

20. Many thanks to all the co-authors of this work: Giuseppe G.L. Biondi-Zoccai, MD M. Luisa De Benedictis, MD Stefano Rigattieri, MD Marco Turri, MD Maurizio Anselmi, MD Corrado Vassanelli, MD Piero Zardini, MD Yves 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.htmhttp://it.geocities.com/comet_milano/Home.htm

22. 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…

25. 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

26. For further slides on these topics please feel free to visit the metcardio.org website: http://www.metcardio.org/slides.html http://www.metcardio.org/slides.html