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Transradial Access Site and Angiox-MATRIX Access Program in ACS Patients: Results from the MATRIX Study

This study evaluates the role of transradial access and systemic implementation of Angiox-MATRIX Access Program in reducing adverse outcomes in ACS patients undergoing invasive management. Results show the superiority of transradial access and the program in improving outcomes.

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Transradial Access Site and Angiox-MATRIX Access Program in ACS Patients: Results from the MATRIX Study

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  1. 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

  2. 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, Alvimedicaand Terumo.

  3. 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

  4. MATRIX Access NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker 1:1 Trans-Radial Access Trans-Femoral Access Q: Is TRI superior to TFI ? 1:1 Heparin ±GPI Bivalirudin Mono-Tx 1:1 Stop Infusion Prolong≥ 6 hs infusion Am Heart J. 2014 Dec;168(6):838-45.e6. MATRIX Program registered at ClinicalTrials.gov, number NCT01433627

  5. Study Organization and Sites Sponsor GruppoItalianoStudiEmodinamica 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 Calabrò, MD, PhD, Italy; Trial Form Support Arnoud W J van‘t Hof, MD, TheNetherlands; Trial Form Support Manel Sabate’, MD, PhD, Spain;FLS-Research Support Elmir Omerovic, MD, PhD, Sweden; Gothia Forum Clinical Event Committee Statistical Committee (CTU) Data Mng P. Vranckx, Chair S. Leonardi Co-Chair P. Tricoci P.Jüni, MD, Chair M. Rothenbühler Dik Heg E. Frigoli, Eustrategy Project Leader

  6. Committee Members Executive Committee Marco Valgimigl, (PI and Chair), Andrea Gagnor; Paolo Calabrò, Paolo Rubartelli, Stefano Garducci, Giuseppe Andò, 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 van‘t Hof; Elmir Omerovic.

  7. 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. 8,404 Cumulative enrollment by month Complete follow-up to 30 days available in 4183 (99.7%) of radial and 4191 (99·6%) of femoral cohorts

  8. 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 CK-MB 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

  9. 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

  10. Baseline Characteristics Radial (N=4,197) Femoral(N=4,207) Age (years) 67±12 67±12 Age ≥ 75 ys (%) 28.3 29.3 Male (%) 74.5 72.4 BMI (kg/m2) 27.1±4.1 27.1±4.1 Previous CVA (%) 4.6 5.5 PAD (%) 8.1 8.8 Renal failure (%) 1.1 1.4 Previous PCI (%) 13.9 14.7 Previous radial access (%) 2.8 2.0 Killip > 1 (%) 9.6 9.7 STEMI (%)47.7 47.8 NSTEMI (%)46.5 45.9 UA (%) 5.8 6.4 Enoxaparin (%)16.3 17.5 Fondaparinux (%)10.2 11.1 UFH (%)29.5 29.4

  11. Procedural Characteristics Radial (N=4,197)Femoral(N=4,207) PCI attempted (%)80.3 79.8 CABG (%) 3.7 3.7 Medical Tx(%) 11.7 11.9 Medications in the Lab Clopidogrel(%) 6.4 6.0 Ticagrelor/prasugrel(%)17.1 16.3 GP IIb/IIIa inhibitors (%) 13.7 12.4 UFH (%)49.9 45.5 Bivalirudin(%)40.1 40.7 IABP (%)1.9 2.3 Treated vessel(%) LMCA 4.6 3.5 LAD 50.3 49.2 Multivessel PCI (%)13.7 13.7 Stent lenght (mm)31.8 31.4

  12. Cross Over and Procedural SuccessRates 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%

  13. 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

  14. Primary EP: NACE 11.7% 9.8% Rate Ratio 0.83; 95% CI, 0.73 to 0.96; p=0.0092 Femoral NNTB: 53 Radial

  15. 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

  16. Fatal and ST EPs: All-Cause, Cardiac, non-CV mortality, type of stent thrombosis Mortality Stent Thrombosis P=0.66 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

  17. 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=0.20 RR: 0.78 0.53-1.14 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

  18. NACE: Subgroup Analysis P-VALUES HAZARD RATIO (95% CI) Superiority Interaction Low (247-544) 0.75 (0.60-0.94) 0.011 Centre’s annual volume of PCI Intermediate (548-991) 1.04 (0.82-1.32) 0.76 0.89 High (1000-1950) 0.025 0.75 (0.58-0.97) Low (14.9-64.4%) Centre’s Proportion of radial PCI 1.01 (0.79-1.29) 0.95 Intermediate (65.4-79.0%) 0.0048 0.71 0.95 (0.75 -1.22) High (80.0-98.0%) <0.001 0.64 (0.51-0.80) STEMI 0.86 (0.68-1.08) 0.19 NSTE-ACS (tp–) ACS type 0.059 0.58 (0.33-1.03) 0.44 0.07 0.85 (0.71-1.02) NSTE-ACS (tp+) ≥75 0.23 0.88 (0.70-1.09) Age 0.62 <75 0.023 0.82 (0.68-0.97) No interaction between access and anticoagulant use in a post- hoc analysis of the subgroup of 7,213 patients randomized to bivalirudin or unfractionated heparin for the two co-primary outcomes, all-cause mortality, or BARC 3 or 5 bleeding Women 0.012 0.72 (0.56-0.93) Sex 0.18 0.16 0.89 (0.76-1.05) Men 0.09 0.86 (0.73-1.02) ≥25 BMI 0.53 0.038 0.79 (0.63-0.99) <25 0.07 0.83 (0.68-1.02) Ticagrelor or prasugrel Yes 0.94 0.06 No 0.84 (0.70-1.01) Yes 0.45 0.91 (0.71-1.17) Diabetes 0.43 No 0.08 0.80 (0.68-0.94) ≥60 0.78 (0.65-0.94) 0.01 GFR 0.51 <60 0.86 (0.70-1.07) 0.18 History of PVD 0.60 0.91 (0.64-1.30) Yes 0.64 0.012 No 0.83 (0.71-0.96) 0.50 2 0.25 1 Femoral Better Rardial Better

  19. Subgroup Analysis P-VALUES Mortality HAZARD RATIO (95% CI) Superiority Interaction 1.28 (0.71-2.32) 0.41 Low (14.9-64.4%) Centre’s Proportion of radial PCI Intermediate (65.4-79.0%) 0.0157 0.69 (0.40 -1.19) 0.18 High (80.0-98.0%) 0.48 (0.28-0.81) 0.006 STEMI 0.87 (0.59-1.29) 0.49 NSTE-ACS (tp–) ACS type 0.10 NSTE-ACS (tp+) 0.49 (0.28-0.87) 0.012 2 0.50 0.25 1 Bleeding 0.90 (0.54-1.50) 0.68 Low (14.9-64.4%) Centre’s Proportion of radial PCI Intermediate (65.4-79.0%) 0.06 0.57 (0.31 -1.03) 0.20 High (80.0-98.0%) 0.035 0.56 (0.32-0.97) 0.62 (0.41-0.94) 0.022 STEMI 0.58 0.54 1.66 (0.28-10.0) ACS type NSTE-ACS (tp–) 0.70 (0.42-1.17) 0.17 NSTE-ACS (tp+) 4 2 0.25 0.50 1 Femoral Better Radial Better

  20. Updated Meta-analysis 19,328 ACS patients being randomly allocated to radial or femoral access Heterogenity SUBGROUP Risk Ratio (95%CI) P Value P Value I2 Non-CABG major bleeds 0.41 (0.22-0.76) Pre-Rival 0.73 (0.43-1.23) RIVAL Post-RIVAL 0.39 (0.23-0.67) MATRIX 0.68 (0.49-0.92) Combined 0.58 (0.46-0.72) <0.0001 0% 0.51 Death, myocardial infarction or stroke 0.82 (0.52-1.29) Pre-Rival 0.98 (0.76-1.27) RIVAL 0.67 (0.48-0.93) Post-RIVAL 0.86 (0.76-0.98) MATRIX Combined 0.86 (0.77-0.95) 0.0051 0% 0.97 Death 0.77 (0.46-1.28) Pre-Rival 0.86 (0.58-1.29) RIVAL 0.58 (0.39-0.87) Post-RIVAL 0.73 (0.53-0.99) MATRIX 0.72 (0.60-0.88) 0.0011 1.00 Combined 0% Myocardial Infarction Pre-Rival 0.73 (0.12-4.47) 0.92 (0.65-1.31) RIVAL Post-RIVAL 0.85 (0.39-1.90) MATRIX 0.91 (0.78-1.06) Combined 0.91 (0.79-1.04) 0.16 0% 0.88 0.26 (0.06-1.23) Pre-Rival Stroke 1.43 (0.72-2.83) RIVAL 1.40 (0.45-4.40) Post-RIVAL 1.00 (0.50-2.00) MATRIX 1.05 (0.69-1.60) 0.80 0.75 Combined 0% 2 0.50 4 0.25 1 Rardial Better Femoral Better

  21. 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 meta-analysis, suggest that radial approach should become the default access for patients with ACS undergoing invasive management

  22. MATRIX Access Program http://dx.doi.org/10.1016/S0140-6736(15)60507-4

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