ΓΙΑΚΔΡΚΙΓΙΚΗ ΠΡΟΠΔΛΑΗ ΚΑΙ ΑΓΓΔΙΟΠΛΑΣΙΚΗ: ΤΜΒΟΤΛΔ ΚΑΙ ΜΤΣΙΚΑ ΓΙΔΝΔΡΓΔΙΑ ΠΡΩΣΟΓΔΝΟΤ ΓΙΑΓΔΡΜΙΚΗ ΣΔΦΑΝΙΑΙΑ ΠΑΡΔΜΒΑΗ ΑΠΟ ΣΗΝ ΚΔΡΚΙΓΙΚΗ ΑΡΣΗΡΙΑ Λάμπρος Κ. Μόσιαλος Γιεσθσντής Δπεμβατικός Καρδιολόγος ΓΝΘ «Παπαγεωργίοσ»
Patient characteristics 53 yo M presented to the ED with chest pain lasting 30 min. Heavy smoker ECG showed ST-e in II III avf V6 Given ASA, Prasugrel Radial access chosen
DIAGNOSTIC CorAngio Direct PPCI in RCA - TRA
DIAGNOSTIC CorAngio Direct PPCI in LAD - TRA
Patient characteristics 67 yo M with chest discomfort lasting 12 h NIDDM, Smoker ST-e in II III avf predominantly in III, ST-d in I avl V5 V6 Given ASA, Prasugrel Radial access.
Direct PPCI probable contribution Shortening of D2B time Prevention of artery spasm Reduced contrast administration Less fluoroscopy time More cost effective
TRA-PPCI in PAPAGEORGIOU CATH LAB 2012 2271 Overall cases 1585 Diagnostic 684 PCI. 553 TRA (81%) 109 Primary PCIs 81 TRA (74%)
KATANOMH PPCI ΜΔ ΒΑΗ ΣΗΝ ΟΓΟ ΠΡΟΠΔΛΑΗ
Why transradial approach for Primary PCI?
Mortality & Bleeding / Transfusion Doyle et al, JACC 2009; 53: 2019-27
SITES OF BLEEDING OVERALL NSTEMI STEMI JACC Vol. 55, No. 20, 2010 Transradial Approach for PCI May 18, 2010:2187 95
RIVAL Study: Subgroups: Primary Outcome Death, MI, Stroke or non-cabg major Bleed Overall Age <75 75 Gender Female Male BMI <25 25-35 >35 Radial PCI Volume by Operator 70 70-142.5 >142.5 Radial PCI Volume by Centre Lowest Tertile Middle Tertile Highest Tertile Diagnosis at presentation NSTE-ACS STEMI 0.25 Hazard Ratio (95% CI) 1.00 4.00 Radial better Femoral better p-value Interaction 0.786 0.356 0.637 0.536 0.021 0.025
Romagnoli et al. TCT 2011 RIFLE-STEACS study: Reduction in bleeding with TR access 30-day bleeding rate
STEMI RADIAL - results 30-day NACE p = 0.0028 11.0% 58% 4.6% p = 0.0001 7.2% 80% 1.4% 4.2% p = 0.7 3.5% Net Adverse Clinical Event (NACE) = MACE + major bleeding MACE = composite of death, myocardial infarction and stroke I Bernat TCT 2012
21 studies 8534 pts EuroIntervention 2012;8:501-510
Mortality in the TRA vs TFA EuroIntervention 201 2; 8:501-510
Ongoing Randomized Trials Comparing TRA-TFA RADIAL-CABG : 128 pts Diagnostic-PCI STEMI-RADIAL : 700 pts Acute MI SAFARI-STEMI : 1274 pts Acute MI MATRIX : 6800 pts ACS SAFE-PCI for WOMEN : 3000 pts Diagnostic-PCI ClinicalTrials.gov
LEARNING CURVE JACC Vol. 55, No. 20, 2010 Transradial Approach for PCI May 18, 2010:2187 95
LEARNING CURVE Procedural Failure for TRA 10% in the first 50 cases 3-4% after other 500 <1% only after 1000 Louvard Y. Am J Cardiol 2004 94:1177-80
CONCLUSIONS TRA is specially effective in high risk populations like old patients, AMI, patients treated with powerful anticoagulant or antiplatelet drugs. Modern interventional cardiologist should adopt TRA as first choise. The effectiveness of radial procedures might be linked to operator s expertise and a center s volume
ΕΥΦΑΡΙΣΤΩ
Meta-analysis 1:- Radial vs Femoral Agostoni et al, JACC 2004; 44: 349-56
Meta-analysis 2: Radial vs Femoral 23 studies included spanning 1993 2007 Major Bleeding: Radial: 0.5% (13 / 2390 pts) Femoral: 2.3% (48 / 2068 pts) OR: 0.27 (95% CI 0.16 0.45, p < 0.001) Trend towards reduced composite of death / MI / stroke OR: 0.71 (95% CI 0.49 1.01, p = 0.058) Trend towards reduced mortality OR 0.74 (95% CI 0.42 1.30, p = 0.29) Jolly et al, Am Heart J 2009; 157: 132-40)
MORTAL Study Access Site Odds Ratios (adjusted for baseline characteristics) for receiving a transfusion based on Radial vs Femoral access: 0.59 (95% CI 0.48 to 0.73), p < 0.001 Adjusted OR for mortality: TRA v TFA 30 day: 0.71 (95% CI 0.61 to 0.82) p < 0.001 1 year: 0.83 (95% CI 0.71 to 0.98) P < 0.001 If only non-transfused procedures analyzed, difference in mortality non-significant Supports hypothesis that mortality difference closely linked with need for transfusion Chase et al, Heart 2008; 94: 1019-1025
RIVAL (RadIal Vs femoral access for PCI) Study Design NSTE-ACS and STEMI (n=7021) Randomization 3831 (45%) pts were sub-study of OASIS-7 Trial Key Inclusion: Intact dual circulation of hand required Interventionalist experienced with both (minimum 50 radial procedures in last year) 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 S et al. published online Lancet April 4, 2011
RIVAL TRIAL Primary and Secondary Outcomes at 30 days Radial (n=3507) Femoral (n=3514) % p=0.50 3.7 4.0 p=0.90 3.2 3.2 Death, MI, Stroke, or non CABG Bleeding Death, MI or Stroke Jolly S published online at thelancet.com April 4, 2011
Cumulative analysis of major adverse cardiac events. EuroIntervention 201 2; 8:501-510
PCI and Bleeding
RIVIERA Study: Death / MI Montelescot et al, Int J Card 2008; 129(3): 379-387
RIVIERA Study: Bleeding Montelescot et al, Int J Card 2008; 129(3): 379-387
RADIAL APPROACH PENETRATION 60% in France 20% in Europe 1.5% in USA Louvard Y Ann Cardiol Angeiol (Paris) 2009;58:327-32
Choice of Site and Arterial Access The strongest multivariate predictors of femoral vascular complication during PCIs were: Age > 70 years Female sex Body surface area <1.6 m2 Renal failure or creatinine > 2mg/dl Emergent procedures Larger sheath sizes/iapb use Anticoagulation regimen: IIb/IIIa inhibitors and preprocedural use of thienopyridines Piper WD AHL 2003
Meta-analysis of Bleeding in ACS Hamon et al, EuroIntervention 2007; 3: 400-408
PROCERURAL and CLINICAL OUTCOMES after TRA PCI JACC Vol. 55, No. 20, 2010 Transradial Approach for PCI May 18, 2010:2187 95
MORTAL Study British Columbia Cardiac Registry used to evaluate patients who had undergone PCI from 1999-2005 Cross-referenced with Central Transfusion Registry to identify patients transfused within 10 days of PCI Objective: To determine association of arterial access site (radial vs femoral) with transfusion and mortality Chase et al, Heart 2008; 94: 1019-1025
RIVAL Study: Conclusions Overall Trans-radial approach was similar to Trans-femoral approach in terms of MACE with lower vascular complications in the radial group TRI had advantage over TFI in STEMI pts in having lower MACE and even lower mortality, perhaps largely driven by lower vascular/bleeding complications Radial approach had higher access site crossover without compromising PCI procedural success and was associated with higher radiation exposure The effectiveness of radial procedures might be linked to operator s expertise and a center s volume Jolly S et al. published online Lancet April 4, 2011
Radial PCI in STEMI - MACE Azmendi et al, Am J Card 2010; 106(2): 148-154
Major Femoral Bleeding Post-PCI Doyle et al, JACC Interventions 2008 ; 1: 202-9
Bleeding rates reduced with Bivalirudin, but are still 5% in STEMI Stone G, et al, NEJM 2008;358 : 2218-30
First Randomized Comparison of Elective PCI via TRA-TBA-TFA
First prospective multi-center randomized AMI-TRI trial Catheterization and Cardiovascular Interventions 59:26 33 (2003)
Meta-analysis in STEMI Patients MORTALITY MAJOR BLEEDING ACCESS SITE COMPLICATION MACE Mamas A. Heart 2012;98:303-311