M. Valgimigli, MD, PhD Swiss Cardiovascular Center Bern, Inselspital, Bern, Switzerland on behalf of the MATRIX Group NCT

Transcription

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 NCT

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

3 Background Bivalirudin reduces bleeding events as compared to UFH±GPI but it concomitntaly increases stent thrombosis risk Bivalirudin label allows continuation of the drug after PCI at either low (0.25 mg/kg/h) or full (1.75 mg/kg/h) regimen Whether prolonging bivalirudin after PCI mitigates ischemic without increasing bleeding risks is unknown due to lack of properly powered RCTs

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, is associated with reduction in net adverse cardiovascular events (NACE), defined as the composite of death, MI, stroke, major bleeding, urgent TVR and stent thrombosis To determine the impact of post-pci bivalirudin infusion on each components of the primary endpoint In a broadly inclusive ACS population undergoing invasive management via randomly assigned radial or femoral access

5 MATRIX Program NCT NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker 1:1 Trans-Radial Access Trans-Femoral Access 1:1 Lancet. 2015; 385(9986): Bivalirudin Mono-Tx 1:1 Heparin ±GPI ACC 2015, oral presentation Stop Infusion Prolong 4 hs infusion

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, 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.Jüni, MD, Chair M. Rothenbühler Dik Heg Data Mng E. Frigoli, Eustrategy Project Leader

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

8 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

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

10 1 EP Components Death, MI, Stroke, urg. TVR, ST and BARC 3 or 5 % Post-PCI Biv no Post-PCI Biv P= P= P=0.16 P=0.09 P= P= Death MI Stroke Urg TVR ST BARC 3 or 5

11 Stent Thrombosis Definite and Definite or Probable % P= Post-PCI Biv P= P= no Post-PCI Biv P= P= P= Definite Acute Definite Subacute Def o Prob Overall Def or Prob Acute Def or Prob Subacute

12 Bleeding BARC, TIMI and GUSTO definitions % P= Post-PCI Biv P=0.99 no Post-PCI Biv P= P= BARC 2 BARC 3/5 AR BARC 3/5 NAR TIMI GUSTO P= P=

13 % Explorative Analysis* Ischemic and Bleeding EPs according to bivalirudin regimen in the post-pci bivalirudin arm Post-PCI Biv 1.75 Post-PCI Biv no Post-PCI Biv NACE (1 EP) Death Definite ST Acute ST Subacute ST BARC 3 or 5 * The choice of post-pci bivalirudin regimen was at discretion of the investigator

14 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.

15