Prof. Yasser Baghdady, MD Professor of Cardiology Cairo University Why Change to Radial? Prof. Yasser Baghdady, MD Professor of Cardiology Cairo University

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In Medicine We argue a lot… Always debating…. PCI vs Surgery Medical treatment vs PCI So inevitably we come to the question? Radial vs Femoral

A few years back…. We had little to argue about…. Femoral approach was well established The default in most interventional procedures Radial approach was used as a “bail out”

Conditions mandating Radial Access

Do we need to change? Do we have enough evidence of radial first, femoral as a “bail out” Or rather concept is not radial instead of femoral but rather radial as a “default”

When do we need to change? If radial approach is safer than femoral approach (safest should be the default) If radial approach is at least as efficacious as the femoral

Why Femoral?

The argument for the “femoral” approach The “3” distinct steps for radial approach: Arterial Access Negotiating the catheter into the ascending aorta Intubating the coronary arteries More: Difficult Time consuming Fail or be inadequate

The argument for the “femoral” approach Once the coronaries are engaged, the quality of the procedure is more likely to be compromised by inadequate support or visualization.

The argument for the “femoral” approach With proper training and experience (radial approach), most of these obstacles can be avoided. However, Larger learning curve A significant percentage of practitioners (esp. in low volume centres) may never reach the plateau of equivalency with the femoral approach.

The argument for the “femoral” approach Flexibility in terms of catheter sizes and procedures inherent in access to a large vessel are usually not available. Longer time and greater radiation exposure for the patient and the operator.

The argument for the “femoral” approach RIVAL Trial: Access site failure

Cross Over and Procedural Success Rates 94.1% of radial and 97.4% of femoral cohorts received respective treatment as allocated In 5.8% of radial and 2.3% of TF cohort the allocated access was attempted but failed. In 3 (0.1%) in the radial and 13 (0.3%) patients in the femoral groups the allocated access was not attempted % P<0.001 P=0.77 * *: TIMI <3 and/or % final stenosis >30%

Why Radial?

Risks and Complications of PCI PCI risk includes: Peri-procedural myocardial infarction Stent thrombosis Stroke Vascular complications especially bleeding Mortality

Risk of Complications Related to Underlying patient characteristics Anti-thrombotic therapy used Integrity of the arteriotomy Method of post-procedure haemostasis Clinical status: elective or emergency procedures

Among patients undergoing PCI 30-70% of bleeding complications are related to the vascular access

So what? Across the spectrum of clinical risk, post-procedural bleeding and vascular complications were considered minor. Now, multiple studies have shown significant association between bleeding and subsequent morbidity and mortality.

Bleeding is associated with Death and Ischemic Events HR 5.37 (3.97-7.26) N=34,146 OASIS Registry, OASIS 2, CURE trials HR 4.44 (3.16-6.24) Change colors HR 6.46 (3.54-11.79) Eikelboom JW et al. Circulation 2006;114(8):774-82.

Risk of Bleeding 26000 patients with ACS As bleeding increases, stepwise increase in risk of 30 day mortality, 30 day death or MI 6 months mortality Rao et al: Impact of bleeding severity on clincal outcomes among patients With acute coronary syndromes. Am J Cardiol 2005;96: 1200-6

Definitions Major Bleeding (CURRENT/ OASIS 7) Fatal > 2 units of Blood transfusion Hypotension requiring inotropes Leading to hemoglobin drop of ≥ 5 g/dl Requiring surgical intervention ICH or Intraocular bleeding leading to significant vision loss Major Vascular Access Site Complications Large hematoma Pseudoaneurysm requiring closure AV fistula Other vascular surgery related to the access site

Risk of Bleeding Not only MI and Mortality Bleeding increases: Stroke Stent thrombosis Blood transfusions which by themselves increase mortality Length of hospital stay and cost ($70 million in US, extra cost of bleeding)

So this is the reason For Why Radial..

Meta-analysis of 23 RCTs of Radial vs. Femoral (N=7030) Radial better Femoral better 1.0 PCI Procedure Failure Death Death, MI or stroke Major bleeding 1.31 (0.87-1.96) 0.74 (0.42-1.30) 0.71 (0.49-1.01) 0.27 (0.16-0.45) Jolly SS, et al. Am Heart J 2009;157:132-40.

Radial approach and Complex PCI Radial artery readily accommodates 6F and sheathless 7F techniques: no limitations to performing complex PCI (incl. LM, CTO)

So why does a radial approach decrease bleeding and vascular complications? Radial artery compared to femoral: More superficial Smaller in caliber Lacks any important adjacent structures or potential spaces (e.g. retroperitoneal space) Easily compressible

A randomized comparison of RadIal Vs A randomized comparison of RadIal Vs. femorAL access for coronary intervention in ACS (RIVAL) SS Jolly, S Yusuf, J Cairns, K Niemela, D Xavier, P Widimsky, A Budaj, M Niemela, V Valentin, BS Lewis, A Avezum, PG Steg, SV Rao, P Gao, R Afzal, CD Joyner, S Chrolavicius, SR Mehta on behalf of the RIVAL investigators

RIVAL Study Design Primary Outcome: Death, MI, stroke NSTE-ACS and STEMI (n=7021) Key Inclusion: Intact dual circulation of hand required Interventionalist experienced with both (minimum 50 radial procedures in last year) Randomization Radial Access (n=3507) Femoral Access (n=3514) Blinded Adjudication of Outcomes Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days Jolly SS et al. Am Heart J. 2011;161:254-60.

Primary and Secondary Outcomes Radial (n=3507) % Femoral (n=3514) % HR 95% CI P Primary Outcome Death, MI, Stroke, Non-CABG Major Bleed 3.7 4.0 0.92 0.72-1.17 0.50 Secondary Outcomes Death, MI, Stroke 3.2 0.98 0.77-1.28 0.90 Non-CABG Major Bleeding 0.7 0.9 0.73 0.43-1.23 0.23

Other Outcomes Radial (n=3507) % Femoral (n=3514) % HR 95% CI P Major Vascular Access Site Complications 1.4 3.7 0.37 0.27-0.52 <0.0001 Other Definitions of Major Bleeding TIMI Non-CABG Major Bleeding 0.5 1.00 0.53-1.89 ACUITY Non-CABG Major Bleeding* 1.9 4.5 0.43 0.32-0.57 * Post Hoc analysis

Other Outcomes Radial (n=3507) % Femoral (n=3514) % HR 95% CI P Death 1.3 1.5 0.86 0.58-1.29 0.47 MI 1.7 1.9 0.92 0.65-1.31 0.65 Stroke 0.6 0.4 1.43 0.72-2.83 0.30 Stent Thrombosis 0.7 1.2 0.63 0.34-1.17 0.14

Other Outcomes Radial (n=3507) Femoral (n=3514) P Access site Cross-over (%) 7.6 2.0 <0.0001 PCI Procedure duration (min) 35 34 0.62 Fluoroscopy time (min) 9.3 8.0 Persistent pain at access site >2 weeks (%) 2.6 3.1 0.22 Patient prefers assigned access site for next procedure (%) 90 49 Symptomatic radial occlusion requiring medical attention 0.2% in radial group

ACUITY TRIAL EuroIntervention. 2009 May;5(1):115-20. Choice of arterial access site and outcomes in patients with acute coronary syndromes managed with an early invasive strategy: the ACUITY trial. Hamon M1, Rasmussen LH, Manoukian SV, Cequier A, Lincoff MA, Rupprecht HJ, Gersh BJ, Mann T, Bertrand ME, Mehran R, Stone GW.

ACUITY TRIAL 13K + pts CONCLUSIONS: Transradial compared to femoral arterial access is associated with similar rates of composite ischaemia and with fewer major bleeding complications in patients with ACS managed invasively.

Results From The Minimizing Adverse Haemorrhagic Events By Transradial Access Site And Systemic Implementation of Angiox-MATRIX Access Program M. Valgimigli, MD, PhD Erasmus MC Rotterdam, The Netherlands on behalf of the MATRIX Group NCT01433627

NSTEACS or STEMI with invasive management MATRIX Access NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker 8,404 patients with ACS undergoing coronary angiography ± PCI from 11th Oct 2011 to 7th Nov 2014 1:1 Trans-Radial Access Trans-Femoral Access Q: Is TRI superior to TFI ? 1:1 Bivalirudin Mono-Tx Heparin ±GPI MATRIX Access) was a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with percutaneous coronary intervention with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention, if indicated 1:1 Stop Infusion Prolong≥ 6 hs infusion MATRIX Program registered at ClinicalTrials.gov, number NCT01433627 Am Heart J. 2014 Dec;168(6):838-45.e6.

MI and CVA endpoints: Any MI, STEMI, NSTEMI, unclassified MI and CVA endpoints: Any MI, STEMI, NSTEMI, unclassified*, stroke, TIA *: LBBB, paced rhythm or unavailability of interpretable ECG P=0.20 P=1.00 % % P=0.059 When looking into the individual components of both coprimary endpoints, overall MI or stroke or type thereof did not differ in the radial vs femoral group

Fatal and ST EPs: All-Cause, Cardiac, non-CV mortality, type of stent thrombosis RR:0.72 (0.53-0.99) P=0.045 % RR: 0.75 (0.54-1.04) P=0.08 P=0.69 % NNTB: 167

Bleeding endpoints: BARC, TIMI, GUSTO, access vs non-access related RR: 0.64 0.45-0.90 % P=0.20 RR: 0.78 0.53-1.14 P=0.08 RR: 0.72 0.50-1.04 P=0.0004 RR: 0.37 0.21-0.66 2.5% P=0.68 P=0.013 RR: 0.67 0.49-0.92 1.4% P=0.82 BARC 3 or 5 Major or minor moderate or severe

MATRIX: Radial PCI Reduces Major Bleeding, All-Cause Mortality in ACS Patients

STEMI RADIAL TRIAL

RIFLE STEACS (Radial Versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome) 1001 patients randomly assigned to TRA or TFA No difference in total ischaemic time, use GP IIb/IIIa inhibitors, thrombus aspiration or final TIMI flow

RIFLE STEACS

From: 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(24):2481-2489. doi:10.1016/j.jacc.2012.06.017 Figure Legend: Net adverse cardiac event (NACE) is the composite of cardiac death, myocardial infarction, target lesion revascularization, stroke, and bleeding. Date of download: 8/28/2016 Copyright © The American College of Cardiology. All rights reserved.

We now have….. Bleeding All cause mortality

Radial Approach and Patient Preference Patient Preference: Overwhelming

Summarize

Comparing Femoral & Radial Access

So even if you are not experienced…

Conclusion Deciding between 2 therapeutic strategies involves weighing the risks and benefits of each.

Conclusion If we take into account NNT for radial vs femoral access to prevent: One major attack of Bleeding: 1/68 Death: 1/136 to 1/167

Conclusion The bulk of evidence calls for radial access as the default access site. Femoral access should be used as a bailout strategy Compared with femoral the radial approach is: Safer Preferred by patients Associated with reduced mortality esp. in acute coronary syndrome. Lower hospital costs

ESC guidelines Radial Access for ACS: 1a recommendation