1 / 24

M. Valgimigli, MD, PhD Swiss Cardiovascular Center Bern , Inselspital, Bern, Switzerland

Results From The Minimizing Adverse Haemorrhagic Events By Transradial Access Site And Systemic Implementation of Angiox- MATRIX Treatment Duration Program. M. Valgimigli, MD, PhD Swiss Cardiovascular Center Bern , Inselspital, Bern, Switzerland on behalf of the MATRIX Group. NCT01433627.

benitar
Download Presentation

M. Valgimigli, MD, PhD Swiss Cardiovascular Center Bern , Inselspital, Bern, Switzerland

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Results From The Minimizing Adverse Haemorrhagic Events By Transradial Access Site And Systemic Implementation of Angiox-MATRIX Treatment Duration Program M. Valgimigli, MD, PhD Swiss Cardiovascular Center Bern, Inselspital, Bern, Switzerland on behalf of the MATRIX Group NCT01433627

  2. Declaration of Interest I, Marco Valgimigli, Served as a speaker, or advisor or consultant for: The Medicines Company and Terumo

  3. Background The most effective anti-thrombotic regimen for preventing ischemic complications, while limiting bleeding risk, in patients with acute coronary syndromes undergoing invasive management remains unresolved Bivalirudin decreases bleeding events as compared to UFH±GPI but it also increases the hazard of stent thrombosis Whether prolonging bivalirudin after PCI mitigates ischemic without increasing bleeding risks is unknown

  4. Objectives To determine whether the use of bivalirudin during intervention followed by a post-PCI infusion of ≥4 hours, as compared to no post-PCI infusion, reduces net adverse cardiovascular events (NACE), defined as the composite of death, MI, stroke, major bleeding, urgent TVR and ST To determine the impact of post-PCI bivalirudin on each component of the primary endpoint In a broadly inclusive ACS population undergoing invasive management via randomly assigned radial or femoral access

  5. MATRIX Program NCT01433627 NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker 1:1 Trans-Radial Access Trans-Femoral Access ACCESS Lancet. 2015; 385(9986):2465-76 1:1 Heparin ±GPI Bivalirudin Mono-Tx ANTITHROMBIN TYPE 1:1 ACC 2015, oral presentation Stop Infusion Prolong≥ 4 hs infusion TREATMENT DURATION http://www.cardiostudy.it/matrix

  6. Study Organization and Sites Sponsor Italian Society of Interventional Cardiology 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

  7. 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, Peter Jüni 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.

  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. STEMI UA/NSTEMI Access Site Randomization * Diagnostic Catheterisation Medical tx or CABG planned PCI Planned Anti-ThrombinType/DurationRandomization * Do notrandomise for anti-thrombin PCI No PCI PrimaryendpointsCohort for Anti-thrombinComparison Primary Endpoints cohort for Acces Site Comparison *: stratified by presenting syndrome and type of P2Y12i

  10. MATRIX Recruiting timelines: Anti-thrombin program First Recruited patient: 11th Oct 2011 Last Recruited patient: 7th Nov 2014 7,213 Cumulative enrollment by month Complete follow-up information at 30 days available in all but 13 patients per group

  11. MATRIX Patient Flow Chart: Treatment Duration program 7213pts included in the Anti-thrombin program 3603 allocated to UFH 3610pts included in the Treatment Duration Study 1799Post-PCI Bivalirudin 93.3% receivedallocatedIntervention 1811No post-PCI Bivalirudin 96.8% receivedallocatedintervention 13 No post-discharge FUP 1790 (99.4%) Complete 30-day information 1807 (99.8%) Complete 30-day information

  12. Post-PCI Bivalirudin Rx Regimens and temporal distribution Bivalirudin could be administered at*: the full PCI dose (1.75mg/kg/h) for up to 4 hours or the reduced dose of 0.25 mg/Kg/h for at least 6 hours *: with the choice between those two regimens made at the discretion of the treating physicians Full PCI regimen 34.4% Infusion duration: 264’ Reduced regimen 59% Infusion duration: 433’ N=119 (6.6%) receiving no post-PCI bivalirudin in the post-PCI bivalirudin arm

  13. Baseline Characteristics Post-PCI No post-PCI Bivalirudin(N=1,799) Bivalirudin (N=1,811) Age (years) 65.4±12.1 65.5±11.7 Age ≥ 75 ys (%) 25.7 24.5 Male (%) 75.1 76.2 Previous CVA (%) 5.8 4.3 PAD (%) 9.3 7.1 Cardiac Arrest (%) 2.0 2.4 Killip > 1 (%) 8.8 9.8 STEMI (%)55.9 55.5 NSTEMI (%)40.1 39.3 UA (%) 4.0% 5.1% Pre-LAB P2Y12i (%)83.1 83.8 Clopidogrel 46.4 47.7 Ticagrelor/prasugrel 36.7 36.1 Enoxaparin (%)14.3 15.6 Fondaparinux (%)9.6 9.2 UFH (%)32.9 31.8

  14. index procedure Procedural Characteristics Post-PCI No post-PCI Bivalirudin (N=1,799) Bivalirudin (N=1,811) PCI attempted (%) 94.0 94.3 CABG (%) 0.6 0.7 Medical Tx (%) 4.4 3.7 Medications in the Lab (%) Clopidogrel 7.5 5.8 Ticagrelor/prasugrel 18.6 20.9 Gp IIb/IIIa inhibitors* 3.6 5.5§ LMCA treated (%) 4.5 4.9 Multi-vessel PCI (%)15 14.9 Total stent length (mm)32±20 32±21 At least 1 implanted DES (%)66.3 67.9 At least 1 Complex lesion (%)52 52 Post dilatation (%) 43.1 46.3 Success in all Tx lesion (%)93.3 92.0 §: p<0.05 *: restricted to bailout conditions

  15. Treatment Duration Study Primary EP: NACE 11.9% 11.0% No post-PCI bivalirudin Post-PCI bivalirudin RR: 0.91; 95% CI: 0.74-1.11; P=0.34

  16. 1 EP ComponentsDeath, MI, Stroke, urg. TVR, ST and BARC 3 or 5 % P=0.99 0.85 0.51–1.42 1.49 0.85–2.60 0.53 0.30–0.96 1.78 0.90–3.53 0.86 0.29–2.56 P=0.53 P=0.16 P=0.03 P=0.09 P=0.79

  17. Stent ThrombosisDefinite and Definite or Probable % P=0.99 1.38 0.76–2.50 4.37 1.24–15.35 P=0.29 1.89 0.80–4.46 1.01 0.42–2.43 1.01 0.43–2.33 P=0.14 P=0.01 P=0.99 P=0.99

  18. BleedingBARC, TIMI and GUSTO definitions % 1.46 1.05–2.03 P=0.99 P=0.02 0.25 0.10–0.61 0.65 0.32–1.31 0.39 0.18–0.85 1.38 0.56–3.45 P=0.001 P=0.23 P=0.01 P=0.48

  19. Bleeding Location BARC 3 or 5 in Patients on Bivalirudin According to Post-PCI Treatment Duration No. of Bleeding

  20. Exploratory Analysis*Ischemic and Bleeding EPs according to bivalirudin regimen in the post-PCI bivalirudin arm % 14.7 * The choice of post-PCI bivalirudin regimen was at discretion of the investigator

  21. Composite Outcome: Subgroup Analysis P-VALUES RATE RATIO (95% CI) Superiority Interaction Low (247-544) 0.99 (0.72-1.36) 0.95 Centre’s annual volume of PCI Intermediate (548-991) 0.75 (0.51-1.10) 1.14 0.77 High (1000-1950) 0.75 0.94 (0.65-1.36) STEMI 0.96 (0.69-1.33) 0.79 NSTE-ACS (tp–) ACS type 0.09 2.10 (0.86-5.11) 0.10 0.11 0.80 (0.60-1.05) NSTE-ACS (tp+) ≥75 0.75 0.95 (0.69-1.31) Age 0.65 <75 0.26 0.86 (0.66-1.12) Women 0.74 1.06 (0.74-1.53) Sex 0.28 0.15 0.84 (0.66-1.07) Men 0.61 0.94 (0.72-1.21) ≥25 BMI 0.72 0.40 0.87 (0.62-1.21) <25 0.15 0.80 (0.59-1.08) Ticagrelor or prasugrel Yes 0.27 0.97 No 1.00 (0.76-1.32) Yes 0.94 1.01 (0.70-1.46) Diabetes 0.48 No 0.25 0.87 (0.68-1.11) ≥60 0.85 (0.64-1.12) 0.24 GFR 0.79 <60 0.90 (0.65-1.24) 0.51 History of PVD 0.75 1.09 (0.63-1.89) Yes 0.42 0.17 No 0.86 (0.69-1.07) Access site 0.07 0.77 (0.58-1.02) Femoral 0.11 0.62 Radial 1.08 (0.80-1.45) 1 2 4 0.50 Favours Post-PCI Bivalirudin Favours NO Post-PCI Bivalirudin

  22. Summary The post-PCI infusion of bivalirudin for at least 4 hours after the intervention did not decrease the composite outcome of ischemic and bleeding events, including stent thrombosis. This finding was consistent across subgroups, including access site. Post-PCI bivalirudin infusion was safe and associated to lower risk of major bleeding according to BARC 3/5 or GUSTO scales.

  23. Summary At exploratory analysis, the post-PCI 0.25 mg/kg/h bivalirudin regimen was associated to higher, whereas the 1.75 mg/kg/h full regimen to lower ischemic and bleeding risks compared to no post-PCI bivalirudin.

More Related