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The GRACIA – 2 Trial ( GR upo de A nálisis de la C ardiopatía I squémica A guda)

The GRACIA – 2 Trial ( GR upo de A nálisis de la C ardiopatía I squémica A guda). Randomised trial comparing Primary PCI versus Facilitated Intervention (TNK + Stenting) in patients with STEMI . Francisco F. Avilés (on behalf on the GRACIA group). GRACIA – 2 BACKGROUND.

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The GRACIA – 2 Trial ( GR upo de A nálisis de la C ardiopatía I squémica A guda)

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  1. The GRACIA – 2 Trial(GRupo de Análisis de la Cardiopatía Isquémica Aguda) Randomised trial comparing Primary PCI versus Facilitated Intervention (TNK + Stenting) in patients with STEMI Francisco F. Avilés(on behalf on the GRACIA group)

  2. GRACIA – 2 BACKGROUND • Less than 50% of pts with STEMI achieve optimal arterial reopening plus effective myocardial reperfusion because of the still limited use, availability and efficacy of current therapies • Thrombolysis is widely available and easily applicable, but strongly limited by reopening failure and reocclusion • Primary PCI is highly effective, but available for less than 20% of pts with STEMI in Europe (Euro Heart Survey ACS). Few pts receive primary PCI within 2 hours of onset (6% in the PAMI trial)

  3. GRACIA – 2 RATIONALE FOR FACILITATION (pharmacological reperfusion therapy + early planned PCI) • Pharmacological reopening prolongs time-window for definitive mechanical repair of the culprit artery (PCI more available) • TIMI 3 flow before primary PCI increases technical success and benefits prognosis by enhancing myocardial salvage and preserving LV function1,2,3 • Unlike in previous attempts4, in the era of stents and modern antiplatelets, early posthrombolysis PCI seems to be feasible, safe and beneficial (PACT3, SPEED5, GRACIA – 16) (1) Stone GW. Circulation 2001; (2) Lundergan CF. Am Heart J 2002; (3) Ross AM. JACC1999; (4) Hermann HC. JACC 2000; (4) Simoons ML. Lancet 1998; (6) Aviles FF. Eur Heart J 2003

  4. GRACIA – 2 • HYPOTHESIS In pts with STEMI, the strategy of performing immediate thrombolysis followed by routine early catheterization and appropriate intervention is as available as thrombolysis and as effective as primary PCI

  5. GRACIA – 2 • PURPOSE To compare the safety and efficacy of optimal primary PCI versus a combined reperfusion strategy designed to be easily applicable and widely available

  6. “OPTIMALPRIMARY PCI”(N=108) “FACILITATEDINTERVENTION”(N=104) AMI / ST+(<12 hours) < 180 min Immediately RANDOMISATION TNK + Enoxaparin 3 – 12 hours DIRECT PTCA – IRA** (stent / abciximab) ADEQUATE REVASCULARIZATION*(stent / CABG) 6 deaths 3 deaths N = 103 N = 102 GRACIA-2 CLINICAL AND ANGIOGRAPHIC FOLLOW- UP AT 6 WEEKS & 6 MONTHS (*) Adequate revascularization: revascularization of culprit artery or non-culprit arteries with severe stenosis threateninglarge areas of myocardium (**) IRA: Infarct Related Artery

  7. GRACIA – 2 • CO – PRIMARY ENDPOINTS • Infarct size(area under the CK-MB mass curve and cTnT release curve) • Myocardial reperfusion (% of pts with complete ∑STe resolution at 1, 3 and 6 hours) • LV angiographic evolution at 6 weeks (volumes, LVEF, Wall Motion Index)

  8. GRACIA-2 • SECONDARY ENDPOINTS • Combined incidence of death, non-fatal myocardial infarction, or ischaemia-driven revascularization at 6 weeks and 6 months • Incidence of bleeding complications and non-cardiac events at 6 weeks and 6 months

  9. GRACIA – 2 Recruitment 212 patients July 2002 – March 2003 15 Centres (Spain & Portugal) H. Clínico-Universitario, Valladolid (FF Avilés) H. P. Del Río Hortega, Valladolid (J Blanco, JJ Sanz) H. Río Carrión, Palencia (J López Mesa) H. Juan Canalejo, A Coruña (A Castro, N Vázquez) H. Meixoeiro (MEDTEC), Vigo (J Golicolea) H. Miguel Servet, Zaragoza (I Calvo) Complejo Hospitalario, León (F Fernández V) H. Clínico de San Carlos, Madrid (R A Hernández) H. Virgen de la Salud, Toledo (J Moreu) H. U. Virgen del Rocío, Sevilla (L Díaz de la Llera) H. U. V. de la Victoria, Málaga (J Alonso B) H. Rafael Méndez, Lorca-Murcia (S. Nicolás) H. C. U. Valencia (J Sanchís) H. Los Arcos, San Javier-Murcia (F.Martinez) H. Fernando Fonseca, Amadora, Portugal (P. Abreu)

  10. GRACIA – 2 • MAIN SPONSORS • Spanish Ministry of Health* • Guidant** • Lilly** (*) Cooperative Network for Cardiovascular Research [Instituto de Salud Carlos III]; (**) Unrestricted grant

  11. GRACIA – 2 Baseline Clinical

  12. Primary Facilitated GRACIA – 2 Adjunctive medical treatment 97% 91% 89% 87% 85% p = 0.001 79% 75% 67% 68% 64% 66% 23% Thienopyridines B - Blockers Aspirin ACE Inh. Statins Abciximab

  13. Primary Facilitated GRACIA – 2 Time intervals (mean) p = 0.001 9.06+4.19 hh p = 0.001 p = 0.82 Hours 5.89+3.7 hh 4.19+9.06 hh 3.18+1.9 hh 3.20+2.05 hh 1.08+3.7 hh

  14. Facilitated (9.1+4.2 hh from onset) Primary (4.2+9.1 hh from onset) GRACIA – 2 Baseline culprit artery flowTIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)1 p=0.008 p=0.005 73% p=0.034 59% p=0.047 30.6+20.5 23% 20.9+13.0 14% 15% 8% (1) Gibson CM et al. Circulation 1996

  15. (P=0.82) 47% 45% 44% 44% (P=0.37) (P=0.08) (P=0.01) 11% 5% 2% 0% Primary Facilitated GRACIA – 2 Baseline Angiography CAD extension(vessels with >50% QCAstenosis) IRA location

  16. GRACIA – 2 Angiography (culprit lesion)

  17. p = 0.19 89% 83% p = 0.02 p = 0.07 p = 0.64 20% 16% 9% 8% 3% 1% CABG NOMECHANICALINTERVENTION* CULPRITPCI ASSOCIATEDNON-CULPRIT PCI Primary Facilitated GRACIA – 2 Final treatment (*) Conservative treatment due to non-significant CAD or CAD unsuitable for revascularization

  18. P= 0.03 P= 0.83 P= 0.19 Percentage of pts with “Complete”* ∑STe Recovery Primary Facilitated GRACIA – 2 ST – Segment Elevation Recovery (*) [Schroeder R. JACC 1994]: > 70% reduction of the pre-reperfusion total deviation (∑STe)

  19. cTnT release CK-MB mass 300 4,5 Primary 253,92 4,15 4,17 229,12 Facilitated 3,36 229,94 3,19 3,06 211,06 2,98 171,91 160,87 ng/dl 2,61 2,23 106,11 Primary 58,56 91,68 35,03 Facilitated 15,51 56,96 21,96 12,42 0,59 27,57 34,62 17,62 hours 0,19 20,08 days 0 0.0 0 12 24 0 1 2 3 4 48 GRACIA – 2 Infarct size

  20. GRACIA – 2LV evolution at 6 weeks

  21. ** ** ** p = NS ** ** ** ** Combinedclinical endpoint*(10.5%) Death(4.5%) Re-infarction(1.5%) Surgery(1%) Ischaemiadriven PCI(6.5%) Re-admission(4.5%) Primary Facilitated GRACIA – 26-week clinical outcome Cardiac Events (*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization

  22. p=0.45 p=0.97 p=0.99 IntracranialHaemorrhage(ICH) MajorComplications (ICH included)* AnyComplication Primary Facilitated GRACIA – 26-week clinical outcome Bleeding & vascular complications (*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed surgery / transfusion

  23. GRACIA – 2 CONCLUSIONS • Catheterization plus adequate revascularization within 3 – 12 hours of immediate facilitation with TNK seems to be as safe as optimal primary PCI (stent & GP IIb/IIIa inhibitors) • These results suggest that both strategies are similarly effective in restoring myocardial perfusion, preserving left ventricular size & function and beneficing clinical outcome • If this equivalence is confirmed in large studies clinically focused, the proportion of patients with STEAMI who can benefit from early PCI could increase dramatically

  24. GRACIA – 2 Hospital stay p = 0.22 7.4±5.6 6.4±3.3 Days PRIMARY FACILITATED

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