Reunion Anual Madeira 2015 Estudios en Cardiología Intervencionista desde el último Congreso FARMACOLOGÍA
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Este documento resume varios estudios recientes en cardiología intervencionista y farmacología. Resume los hallazgos clave de los estudios Montalescot, Italic Trial, ISAR SAFE y DAPT Trial sobre la duración óptima de la terapia antiplaquetaria dual después de la colocación de stents. También resume los resultados del estudio MATRIX sobre la eficacia y seguridad de la bivalirudina versus heparina no fraccionada. Además, menciona varios estudios en curso sobre el pretratamiento, oxígeno en
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Similar a Reunion Anual Madeira 2015 Estudios en Cardiología Intervencionista desde el último Congreso FARMACOLOGÍA (20)
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Reunion Anual Madeira 2015 Estudios en Cardiología Intervencionista desde el último Congreso FARMACOLOGÍA
- 1. Estudios en Cardiología Intervencionista desde el último Congreso FARMACOLOGÍA Dr. Juan Miguel Ruiz Nodar Hemodinámica y Cardiología Intervencionista Hospital General Universitario de Alicante Madeira. 11 de junio de 2015
- 2. Conflicto de intereses He recibido ayudas para Investigación o pagos por Cursos o Conferencias de: Abbott AstraZeneca Daichi Fundación Gent x Gent Lilly Medtronic St.Jude
- 3. Guías de revascularización coronaria 2014 Guías de revascularización miocárdica. EHT (29 agosto 2014) doi:10.1093/eurheartj/ehu278
- 4. Pretratamiento Duración DAG Bivalirudina Otros fármacos Farmacología
- 5. Montalescot. N Engl J Med 2014; 371:1016-1027
- 6. Montalescot. N Engl J Med 2014; 371:1016-1027
- 7. Objetivo Primario Montalescot. N Engl J Med 2014; 371:1016-1027
- 8. Objetivo Primario: subgrupos Montalescot. N Engl J Med 2014; 371:1016-1027
- 9. Trombosis definitiva Montalescot. N Engl J Med 2014; 371:1016-1027
- 10. Sangrados no relacionados con CCV en el ATLANTIC (definición PLATO) Montalescot. N Engl J Med 2014; 371:1016-1027
- 11. Pretratamiento Duración DAG Bivalirudina Otros fármacos Farmacología
- 12. ¿Debemos acortar o prolongar la DAPT? < 6 meses >12 meses No diferencias en eventos hemorrágicos e isquemicos entre 6 y 12 meses Similares resultados clínicos entre 6 y 12 meses La DPAT a 30 meses reduce la trombosis del stent y eventos cardiovasculares
- 13. Italic Trial N=1800 6 vs 24 meses de DAPT 10.1016/j.jacc.2014.11.008
- 14. ISAR SAFE N=4000 6 vs 12 meses de DAPT Schulz-Schupke. Europ Heart J 2015;36:1252–63
- 15. DAPT Trial Mauri L. N Engl J Med 2014; 371:2155-2166
- 16. ¿Sigue importando el tipo de DES? Mauri L. N Engl J Med 2014; 371:2155-2166
- 21. J Am Coll Cardiol. 2015;65(21):2359-2360. doi:10.1016/j.jacc.2015.03.547 Dudas sobre los diseños de “no inferioridad”
- 22. Pretratamiento Duración DAG Bivalirudina Otros fármacos Farmacología
- 23. Guías de revascularización miocárdica. EHT (29 agosto 2014) doi:10.1093/eurheartj/ehu278 Guías de revascularización coronaria 2014
- 24. Navarese et al. J Am Coll Cardiol Intv. 2015;8:201-13
- 26. End point Bivalirudin (%) UFH (%) 95% CI P value MACE 10.3 10.9 0.81-1.10 0.45 NACE 11.2 12.4 0.78-1.103 0.122 BARC 3 or 5 bleed 1.4 2.5 0.39-0.78 0.001 All-cause death 1.7 2.3 0.51-0.99 0.042 Definite stent thrombosis 1.0 0.6 1.00-2.93 0.048 MATRIX: Co-Primary End Points and Key Secondary End Points Valgimigli ACC, marzo 2105
- 28. NAG • AVOID • Oxígeno en el IAM Bendavia • EMBRACE STEMI • Lesión de reperfusión REG-1 • REGULATE-PCI • REG 1 vs Bivalirudina en PCI Metoprolol • METOCARD •Metoprolol antes de la pPCI
- 33. Pizarro, Ibañez et al. J Am Coll Cardiol 2014;63:2356–62
- 35. Gracias
Notas del editor
- 1800 randomizados a los 6 meses a 6 vs 24 meses
- No diferencias en eventos isquemicos pero tampoco reducción de los hemorragicos Y cuando no hay aumento de eventos hemorrágicos es que son poblaciones de bajo riesgo
- Comprehensive Meta-Analysis of Safety and Efficacy of Bivalirudin Versus Heparin With or Without Routine Glycoprotein IIb/IIIa Inhibitors in Patients With Acute Coronary Syndrome Eliano Pio Navarese, MD, PhD∗; Volker Schulze, MD†; Felicita Andreotti, MD, PhD‡; Mariusz Kowalewski, MD‡; Michalina Kołodziejczak, MD‡; David E. Kandzari, MD#; Tienush Rassaf, MD, PhD†; Bartosz Gorny, MD‡; Maximilian Brockmeyer, MD†; Christian Meyer, MD, PhD†; Sergio Berti, MD∗; Jacek Kubica, MD, PhD‡; Malte Kelm, MD†; Marco Valgimigli, MD, PhD†† [+-] Author Information∗ Invasive Cardiology, National Research Council Institute of Clinical Physiology, Pisa, Italy † Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany ‡ Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network, Poland and Germany # Piedmont Heart Institute, Atlanta, Georgia †† Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands J Am Coll Cardiol Intv. 2015;8(1_PB):201-213. doi:10.1016/j.jcin.2014.10.003 Published online Article Figures Tables References Supplemental Materials text A A A Abstract Objectives The aim of this meta-analysis was to compare the 30-day safety and efficacy of bivalirudin with those of heparin with or without routine administration of a glycoprotein IIb/IIIa inhibitor (GPI) in patients with acute coronary syndrome (ACS). Background Bivalirudin has been a mainstay of anticoagulation in patients with ACS compared with heparin. The extent to which trial results have been affected by the coadministration of heparin with a GPI, however, remains unclear. Methods A total of 13 randomized, controlled trials involving 24,605 patients were included. Results There was no significant difference in 30-day mortality or myocardial infarction rate with bivalirudin compared with heparin with or without routine GPI administration. A reduction of 30-day major bleeding was observed with bivalirudin compared with heparin that was significant when GPI was routinely administered (odds ratio [OR]: 0.52, 95% confidence interval [CI]: 0.45 to 0.60), p < 0.001) but not with provisionally administered GPI (OR: 0.66, 95% CI: 0.33 to 1.32; p = 0.24). The occurrence of stent thrombosis (ST) at 30 days was significantly increased with bivalirudin compared with heparin plus routinely administered GPI (OR: 1.67, 95% CI: 1.13 to 2.45, p = 0.02), but not compared with heparin plus provisionally administered GPI (OR: 2.08, 95% CI: 0.35 to 12.32, p = 0.42). The rate of acute ST (≤24 h), however, was almost 4.5-fold higher with bivalirudin compared with heparin with or without GPI, whereas the rate of subacute ST (24 h to 30 days) did not differ significantly. Conclusions Overall, bivalirudin in ACS patients is associated with a significant reduction of major bleeding compared with heparin plus routinely administered GPI, but with a marked increase in ST rates compared with heparin with or without GPI
- Comprehensive Meta-Analysis of Safety and Efficacy of Bivalirudin Versus Heparin With or Without Routine Glycoprotein IIb/IIIa Inhibitors in Patients With Acute Coronary Syndrome Eliano Pio Navarese, MD, PhD∗; Volker Schulze, MD†; Felicita Andreotti, MD, PhD‡; Mariusz Kowalewski, MD‡; Michalina Kołodziejczak, MD‡; David E. Kandzari, MD#; Tienush Rassaf, MD, PhD†; Bartosz Gorny, MD‡; Maximilian Brockmeyer, MD†; Christian Meyer, MD, PhD†; Sergio Berti, MD∗; Jacek Kubica, MD, PhD‡; Malte Kelm, MD†; Marco Valgimigli, MD, PhD†† [+-] Author Information∗ Invasive Cardiology, National Research Council Institute of Clinical Physiology, Pisa, Italy † Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany ‡ Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network, Poland and Germany # Piedmont Heart Institute, Atlanta, Georgia †† Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands J Am Coll Cardiol Intv. 2015;8(1_PB):201-213. doi:10.1016/j.jcin.2014.10.003 Published online Article Figures Tables References Supplemental Materials text A A A Abstract Objectives The aim of this meta-analysis was to compare the 30-day safety and efficacy of bivalirudin with those of heparin with or without routine administration of a glycoprotein IIb/IIIa inhibitor (GPI) in patients with acute coronary syndrome (ACS). Background Bivalirudin has been a mainstay of anticoagulation in patients with ACS compared with heparin. The extent to which trial results have been affected by the coadministration of heparin with a GPI, however, remains unclear. Methods A total of 13 randomized, controlled trials involving 24,605 patients were included. Results There was no significant difference in 30-day mortality or myocardial infarction rate with bivalirudin compared with heparin with or without routine GPI administration. A reduction of 30-day major bleeding was observed with bivalirudin compared with heparin that was significant when GPI was routinely administered (odds ratio [OR]: 0.52, 95% confidence interval [CI]: 0.45 to 0.60), p < 0.001) but not with provisionally administered GPI (OR: 0.66, 95% CI: 0.33 to 1.32; p = 0.24). The occurrence of stent thrombosis (ST) at 30 days was significantly increased with bivalirudin compared with heparin plus routinely administered GPI (OR: 1.67, 95% CI: 1.13 to 2.45, p = 0.02), but not compared with heparin plus provisionally administered GPI (OR: 2.08, 95% CI: 0.35 to 12.32, p = 0.42). The rate of acute ST (≤24 h), however, was almost 4.5-fold higher with bivalirudin compared with heparin with or without GPI, whereas the rate of subacute ST (24 h to 30 days) did not differ significantly. Conclusions Overall, bivalirudin in ACS patients is associated with a significant reduction of major bleeding compared with heparin plus routinely administered GPI, but with a marked increase in ST rates compared with heparin with or without GPI
- The MATRIX antithrombin analysis addressed the question of whether bivalirudin with bailout GP IIb/IIIa inhibitor (GPI) use was superior to UFH with planned or bailout GPI use in reducing MACE or NACE. The superiority of the newer agent, bivalirudin, first established in STEMI patients in the HORIZONS and EUROMAX trials, was called into question last year with the results from the single-centre HEAT-PPCI trial. In all, 3610 patients were randomized to a bivalirudin strategy and 3603 randomized to a UFH-based strategy. In MATRIX, for both co-primary end points, MACE and NACE, bivalirudin was not statistically superior to UFH at 30 days. Valgimigli speculated that this may have been due to the higher-than-expected rate of MI (including periprocedural MI) in both groups at 8.5%. Several secondary end points, however, favoured bivalirudin including major bleeding (1.4% vs. 2.5%, p=0.001) and all-cause death (1.7% vs. 2.3%, p=0.042). Definite stent thrombosis, however, was more common in the bivalirudin-treated patients (1.0% vs. 0.6%, p=0.048). Bivalirudin in MATRIX was dosed according to drug labelling, which included a prolonged infusion by operator discretion, Valgimigli said. UFH was given pre-admission to approximately one-third of both patient groups, which Valgimigli pointed out was guideline recommended. UFH dose during PCI was 70-100 units per kg in patients not receiving GPIs and at 50-70 units per kg in patients receiving GPIs. GPIs were ultimately given periprocedurally to 4.6% of the bivalirudin group and 25.8% of the UFH group. Valgimigli was careful to stress that both co-primary end points in the MATRIX antithrombin analysis were neutral, but highlighted the benefits of bivalirudin in reducing deaths (driven by CV fatalities) and bleeding events. The number needed to treat to prevent one death, he noted, was 150.
- Rapid Onset of Action Predictable Dose-Response High Anti-Thrombotic Efficacy Quick Reversibility or Titratability
- In patients with anterior Killip class II STEMI undergoing pPCI, early IV metoprolol before reperfusion resulted in higher long-term LVEF, reduced incidence of severe LV systolic dysfunction and ICD indications, and fewer heart failure admissions. (Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The METOCARD-CNIC Trial; NCT01311700) (J Am Coll Cardiol 2014;63:2356–62)