Diapositiva 1 - American College of Cardiology

Diapositiva 1 - American College of Cardiology

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 I, Marco Valgimigli, have received: Institutional research grant from Medtronic and The Medicines Company/Terumo (current study) honoraria for lectures/advisory board from Merck, Correvio, Astra Zeneca, The Medicines Company, St Jude, Abbott Vascular, Alvimedica and Terumo. Background Compared with the femoral, the radial artery is more superficial and has a smaller calibre. This characteristic makes access site haemostasis more predictable, but the procedure itself technically demanding Previous studies have come to differing conclusions with regards to the role of radial access in reducing adverse outcomes in patients with ACS It remains unclear whether avoiding access site bleeding and vascular complications through routine transradial intervention improves outcomes in unselected patients with ACS undergoing invasive management MATRIX Access NSTEACS NSTEACS or or STEMI

STEMI with with invasive invasive management management Aspirin+P2Y12 Aspirin+P2Y12 blocker blocker 1:1 Trans-Radial Access Trans-Femoral Access Q: Is TRI superior to TFI ? 1:1 Bivalirudin Heparin Mono-Tx GPI 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.

Study Organization and Sites Sponsor Gruppo Italiano Studi Emodinamica Grant suppliers: The Medicines Company and Terumo Principal Investigator: Marco Valgimigli, MD, PhD Study Director: Maria Salomone. MD, PhD 78 Sites across 4 EU countries recruited patients National Coordinating Investigators and CROs Paolo Calabr, MD, PhD, Italy; Trial Form Support Arnoud W J vant Hof, MD, The Netherlands; Trial Form Support Manel Sabate, MD, PhD, Spain; FLS-Research Support Elmir Omerovic, MD, PhD, Sweden; Gothia Forum Clinical Event Committee P. Vranckx, Chair S. Leonardi Co-Chair P. Tricoci Statistical Committee (CTU) P.Jni, MD, Chair M. Rothenbhler Dik Heg Data Mng E. Frigoli, Eustrategy Project Leader Committee Members Executive Committee Marco Valgimigl, (PI and Chair), Andrea Gagnor; Paolo Calabr, Paolo Rubartelli, Stefano Garducci, Giuseppe And, Andrea Santarelli, Mario Galli; Roberto Garbo; Ezio Bramucci; Salvatore Ierna, Carlo Briguori, Bernardo Cortese; Ugo Limbruno, Roberto Violini; Patrizia Presbitero; Nicoletta de Cesare; Paolo Sganzerla; Arturo Ausiello; Paolo Tosi;

Gennaro Sardella; Manel Sabate; Salvatore Brugaletta. Steering Committee Giovanni Saccone; Pietro Vandoni, Antonio Zingarelli; Armando Liso; Stefano Rigattieri, Emilio Di Lorenzo, Carlo Vigna; Cataldo Palmieri; Camillo Falcone, Raffaele De Caterina, Marcello Caputo; Giovanni Esposito; Alessandro Lupi; Pietro Mazzarotto, Fernando Varbella; Tiziana Zaro; Marco Nazzaro; Sunil V. Rao, Arnoud WJ vant Hof; Elmir Omerovic. MATRIX Access 8,404 patients with ACS undergoing coronary angiography PCI from 11th Oct 2011 to 7th Nov 2014 Operator Eligibility Criteria: Interventional cardiologist expertise in TRI and TFI including at least 75 transradial coronary interventions and at least 50% of interventions performed via radial route in the year preceding site initiation 8,404 Am Heart J. 2014 Dec;168(6):838-45.e6. Cumulative enrollment by month Complete follow-up to 30 days available in 4183 (99.7%) of radial and 4191 (996%) of femoral cohorts 8,404 Patient Eligibility UA/NSTEMI New or worsening ischaemia, occurring at rest or with minimal activity within 7 days AND At least 2 high-risk criteria: Age > 60 High Tp T I or CKMB ECG changes

suggesting ischemia STEMI Chest pain for >20 min with ST-segment elevation 1 mm in two or more contiguous leads, or with a new left LBBB or true posterior myocardial infarction AND Admission <12 hs OR Between 12 and 24 hs with evidence of continuing ischemia or lysis Of note: Cardiogenic shock, severe PVD and prior CABG were eligible Endpoints The MATRIX Access program had two pre-specified primary superiority endpoints at 30 days: MACE: composite of death, MI and stroke NACE: composite of death, MI or stroke and major bleeding (BARC 3 or 5) For both the RR was assumed in the range of 0.70 with a background event rate of 6% and 9%, respectively. With an alpha error set at 2.5%, 3,400 patients per group would provide study power greater than 90% and 99% for MACE and NACE, respectively. Major 2 EPs: each component of the co-primary endpoints, any bleeding according to BARC, TIMI and GUSTO scales and stent thrombosis Baseline Characteristics Radial (N=4,197) Age (years) 6712

Age 75 ys (%) 28.3 Male (%) 74.5 BMI (kg/m2) 27.14.1 Previous CVA (%) 4.6 PAD (%) 8.1 8.8 Renal failure (%) 1.1 Previous PCI (%) 13.9 Previous radial access (%) Killip > 1 (%) 9.6 STEMI (%) 47.7 NSTEMI (%) 46.5 UA (%) 5.8 6.4 Enoxaparin (%) 16.3 Fondaparinux (%) 10.2 UFH (%) 29.5 Femoral (N=4,207) 6712 29.3 72.4 27.14.1 5.5 1.4

2.8 14.7 2.0 9.7 47.8 45.9 17.5 11.1 29.4 Procedural Characteristics Radial (N=4,197) PCI attempted (%) CABG (%) 3.7 Medical Tx (%) 11.7 Medications in the Lab Clopidogrel (%) Ticagrelor/prasugrel (%) GP IIb/IIIa inhibitors (%) UFH (%) 49.9 Bivalirudin (%) 40.1 IABP (%) 1.9 Treated vessel(%) LMCA 4.6 LAD 50.3 Multivessel PCI (%) Stent lenght (mm) Femoral (N=4,207) 80.3

79.8 3.7 11.9 6.4 17.1 13.7 6.0 16.3 12.4 45.5 40.7 2.3 3.5 49.2 13.7 31.8 13.7 31.4 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% Primary EP: MACE 10.3% 8.8% 15% significant reduction at nominal 5% alpha which is however NOT significant at the pre-specificed alpha of 2.5% Femoral Radial Primary EP: NACE 11.7% 9.8% Rate Ratio 0.83; 95% CI, 0.73 to 0.96; p=0.0092 NNTB: 53 Femoral Radial 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 Fatal and ST EPs: All-Cause, Cardiac, non-CV mortality, type of stent thrombosis Mortality RR:0.72 RR: 0.75 (0.53-0.99) (0.54-1.04) P=0.045 % P=0.08 NNTB: 167 Stent Thrombosis P=0.66 % P=0.69 Bleeding endpoints: BARC, TIMI, GUSTO, access vs non-access related P=0.0098 RR: 0.64 % 0.45-0.90 P=0.08 RR: 0.72 0.50-1.04 P=0.0004 RR: 0.37 0.21-0.66

P=0.20 RR: 0.78 2.5% 0.53-1.14 P=0.68 P=0.013 RR: 0.67 1.4% 0.49-0.92 P=0.82 BARC 3 or 5 Major or minor moderate or severe NACE: Subgroup Analysis P-VALUES HAZARD RATIO (95% CI) Superiority Low (247-544) Centres annual Intermediate (548-991) volume of PCI High (1000-1950) Centres Proportion of radial PCI

Low (14.9-64.4%) Intermediate (65.4-79.0%) High (80.0-98.0%) STEMI NSTE-ACS (tp) ACS type NSTE-ACS (tp+) 75 <75 Age Interaction 0.75 (0.60-0.94) 1.04 (0.82-1.32) 0.75 (0.58-0.97) 0.011 0.76 0.025 0.89 1.01 (0.79-1.29) 0.95 (0.75 -1.22) 0.64 (0.51-0.80) 0.95 0.71 <0.001 0.0048 0.86 (0.68-1.08)

0.58 (0.33-1.03) 0.85 (0.71-1.02) 0.19 0.059 0.07 0.44 0.88 (0.70-1.09) 0.23 0.023 0.62 0.82 (0.68-0.97) 0.012 0.72 (0.56-0.93) Women o Sex interaction between access and anticoagulant use in a post0.18 0.16 (0.76-1.05) oc analysis Men of the subgroup of 7,213 patients 0.89 randomized to bivalirudin 0.86 (0.73-1.02) 25 or BMI unfractionated heparin for the two co-primary outcomes, 0.09 all-cause 0.53

0.038 0.79 (0.63-0.99) <25 mortality, or BARC 3 or 5 bleeding 0.07 0.06 0.94 0.45 0.08 0.43 0.86 (0.70-1.07) 0.01 0.18 0.51 0.91 (0.64-1.30) 0.83 (0.71-0.96) 0.60 0.012 0.64 Ticagrelor or prasugrel Yes No 0.83 (0.68-1.02) Diabetes

Yes No 0.91 (0.71-1.17) GFR 60 <60 0.78 (0.65-0.94) History of PVD Yes No Rardial Better 0.84 (0.70-1.01) 0.80 (0.68-0.94) 0.25 0.50 1 2 Femoral Better Subgroup Analysis P-VALUES Mortality Centres Proportion

of radial PCI ACS type HAZARD RATIO (95% CI) Superiority Low (14.9-64.4%) 1.28 (0.71-2.32) 0.41 Intermediate (65.479.0%) High (80.0-98.0%) 0.69 (0.40 -1.19) 0.18 0.48 (0.28-0.81) 0.006 STEMI 0.87 (0.59-1.29) 0.49 NSTE-ACS (tp) Centres Proportion of radial PCI ACS type 0.49 (0.28-0.87) 0.25

0.50 0.012 2 1 Low (14.9-64.4%) 0.90 (0.54-1.50) 0.68 Intermediate (65.479.0%) High (80.0-98.0%) 0.57 (0.31 -1.03) 0.06 0.56 (0.32-0.97) 0.035 STEMI 0.62 (0.41-0.94) 0.022 NSTE-ACS (tp) 1.66 (0.28-10.0) 0.58 NSTE-ACS (tp+)

0.70 (0.42-1.17) 0.17 Radial Better 0.0157 0.10 NSTE-ACS (tp+) Bleeding Interaction 0.25 0.50 1 2 4 Femoral Better 0.20 0.54 Updated Meta-analysis 19,328 ACS patients being randomly allocated to radial or femoral access Heterogenity SUBGROUP Non-CABG major bleeds Death, myocardial infarction or

stroke Death Myocardial Infarction Stroke Risk Ratio (95%CI) P Value I2 P Value Pre-Rival RIVAL Post-RIVAL MATRI C X ombined 0.41 (0.22-0.76) 0.73 (0.43-1.23) 0.39 (0.23-0.67) 0.68 (0.49-0.92) 0.58 (0.46-0.72) <0.0001 0% Pre-Rival RIVAL Post-RIVAL MATRI C

X ombined 0.82 (0.52-1.29) 0.98 (0.76-1.27) 0.67 (0.48-0.93) 0.86 (0.76-0.98) 0.86 (0.77-0.95) 0.5 1 0.0051 0% Pre-Rival RIVAL Post-RIVAL MATRI Combined X 0.77 (0.46-1.28) 0.86 (0.58-1.29) 0.58 (0.39-0.87) 0.73 (0.53-0.99) 0.72 (0.60-0.88) 0.9 7 0.0011 0% Pre-Rival RIVAL Post-RIVAL MATRI

Combined X 0.73 (0.12-4.47) 0.92 (0.65-1.31) 0.85 (0.39-1.90) 0.91 (0.78-1.06) 0.91 (0.79-1.04) 1.0 0 0% Pre-Rival RIVAL Post-RIVAL MATRI C X ombined 0.26 (0.06-1.23) 1.43 (0.72-2.83) 1.40 (0.45-4.40) 1.00 (0.50-2.00) 1.05 (0.69-1.60) 0.1 6 0.8 8 0.8 0 0% 0.7

5 Rardial Better 0.25 0.50 1 2 4 Femoral Better Summary Among patients with an ACS, with or without ST-segment elevation who underwent invasive management, the use of radial access for coronary angiography PCI reduced the rate of net adverse clinical events, with a number needed to treat for benefit of 53 Differences between groups were driven by reductions in BARC major bleeding unrelated to CABG and all-cause mortality with radial access. Our results, in conjunction with the updated metaanalysis, suggest that radial approach should become the default access for patients with ACS undergoing invasive management MATRIX Access Program http://dx.doi.org/10.1016/S0140-6736(15)60507-4

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