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A modern thrombolysis service is superior to primary angioplasty

A modern thrombolysis service is superior to primary angioplasty. Rob Henderson Consultant Cardiologist Trent Cardiac Centre Nottingham. Responses to a request to defend thrombolysis at BCIS Autumn meeting. Thanks…..but NO!.

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A modern thrombolysis service is superior to primary angioplasty

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  1. A modern thrombolysis service is superior to primary angioplasty Rob Henderson Consultant Cardiologist Trent Cardiac Centre Nottingham

  2. Responses to a request to defend thrombolysis at BCIS Autumn meeting Thanks…..but NO!

  3. Responses to a request to defend thrombolysis at BCIS Autumn meeting Yes……but can I take the other side?

  4. Fibrinolytic Therapy Triallists35 Day Outcome in 58 600 patients 16 per 1000 lives saved Lancet 1994:343;311

  5. Thrombolysis equivalence trials‘ceiling’ of benefit? 30 d mortality

  6. Thrombosaurus Rex EXTINCTOPLASE ? Courtesy Bob Wilcox

  7. % Patients PCI NEJM 1993;335:1313 Patency of infarct-related artery

  8. Keeley et al, 2003 OR 0.70, 95% CI 0.59-083, P<0.0001

  9. Quantitative review of 23 trials of primary angioplasty versus thrombolysis (n=7739) Short-term clinical outcomes Keeley, Lancet 2003;361:13

  10. Keeley meta-analysis of 23 trialsSome limitations… • Suboptimal lytic strategies • symptom onset to drug ≈ 3 hrs • streptokinase in 8 trials • Inclusion of SHOCK trial (only 63% lysis) • End-points not defined, no blinded validation • Most trials (15) had fewer than 200 patients • Double counting of fatal stroke • 2% excess major bleeding in PPCI group

  11. Keeley meta-analysis: proof of concept?

  12. OR 0.81, 95% CI 0.64-1.02, P=0.07

  13. NRMI-2: Primary angioplasty versus thrombolysisReal life registry P<0.0001 Presentation to alteplase 42 min Presentation to balloon 111 min Tiefenbrunn, JACC 1998;31:1240

  14. Problem with primary PCI……

  15. Reperfusion therapy Time is muscle is survival

  16. 80 60 40 20 0 3 6 9 12 15 18 21 24 Thrombolysis: the ‘golden hour’ Absolute reduction in 35 day mortality per 1000 patients treated Lives saved per 1000 treated patients 0 Treatment delay (h) FTT data - closed circles Smaller trials - open circles Boersma, Lancet 1996;348:771

  17. 12 10 8 6 4 2 0 0 60 120 180 240 300 360 Time delay from symptom onset to primary PCI: every minute counts 6 RCTs of primary PCI by the Zwolle group 1994-2001 (1791 STEMI patients) One year mortality (%) RR 1.08 for every 30 min delay 95% CI 1.01-1.16, p<0.0001 Ischaemic time (mins) De Luca, Circulation 2004;109:1223

  18. 15 10 Absolute benefit of PCI in 4-6 week mortality (%) 5 0 -5 PCI-related time delay (mins) 0 20 40 60 80 100 23 trials of PCI versus thrombolysis (n=7419) Mean delay 39.5 min (SD 22.1) For every 10 min delay there is 0.94% decrease in mortality benefit, p=0.006. No benefit if delay>62mins Circles reflect trial sample size Blue line: weighted meta-regression Nallamothu, Am J Cardiol 2003;92:824

  19. Relationship between time of day and time to reperfusion Regular hours = weekdays 7am to 5pm 67.9% lysis and 54.2% PPCI were treated off hours NRMI registry 1999-2002 Magid, JAMA 2005;294:803

  20. Main cause of delay to treatment

  21. TIME Delays to treatment in AMI Patient education Pre-hospital intervention (lytics, IIbIIIa etc) Logistics Interhospital transfer

  22. 14 12 10 % mortality pre-hospital thrombolysis 8 6 4 2 0 % mortality in-hospital thrombolysis 0 2 4 6 8 10 12 14 Meta-analysis of 6 trials ofpre-hospital thrombolysis (n=6436) Time from symptoms (SE) to thrombolysis: 104 (7) min for pre-hospital 162 (16) mins for in-hospital (Urokinase, anistreplase, t-PA) For all cause in-hospital mortality OR 0.83 95% CI 0.70-0.98 Morrison, JAMA 2000;283:2686

  23. Comparison of primary PCI and prehospital thrombolysis in acute MI (CAPTIM n=840) Events at 30 days P=0.61 P=0.29 Planned 1200 patients Symptoms to lysis 130 min Symptoms to balloon 190 min Bonnefoy, Lancet 2002;360:825

  24. Pre-hospital thrombolysis vs primary PCIFrench Nationwide USIC 2000 registry (n=1922) Age-adjusted survival (%) 100 Pre-hospital lysis 94% 95 In-hospital lysis 89% 90 Primary PCI 89% % 85 80 No reperfusion 79% P<0.0001 75 0 180 360 days Danchin et al, Circulation 2004;110:1909

  25. 100 90 Prehospital lysis 75% % Survival 80 70 In-hospital lysis 64% 60 4 0 1 2 3 5 Years Grampion region early anistreplase trial Delaying thrombolysis by 1 hour results in 43 additional deaths per 1000 lives over 5 years Rawles, J Am Coll Cardiol 1997;30:1181

  26. Time from symptom onset to treatment in recent trials Time from symptom onset to treatment (mins)

  27. Onset of pain to needle timeEast Midlands Ambulance Service Median symptom onset to needle 93 minutes N=117 EMAS PHT audit 04/05

  28. Pre-hospital thrombolysis in the UK(27 of 31 ambulance services participating) 2877 patients treated Ambulance Service Association and Joint Royal Colleges Ambulance Liaison committee http://www.asancep.org.uk/thromb%20update%20August05.doc

  29. Dr Curzen liaises with Hampshire Ambulance Service Trust At July 05 HAST had treated 8 patients with pre-hospital lysis

  30. Primary PCI - providing a UK service? • In 2004 there were 3447 STEMI interventions • This morning Peter Ludman estimated number of STEMIs requiring reperfusion at 30000 • Provision of nationwide PPCI service is not feasible in the short term!

  31. What would you want…? • You develop central chest pain…. • The paramedic arrives and does an ECG…. • The ECG is faxed to the local CCU who confirm evolving anterior myocardial infarction

  32. What would you want…? • The local DGH is 30 mins away.…and the door to balloon time is 30 mins • The local PCI unit is 45 mins away…. and the door to balloon time is 90 mins • The paramedic is clutching a syringe of lytic... The choice is yours!

  33. Conclusions • For foreseeable future thrombolysis will remain the default reperfusion strategy in most UK hospitals • Pre-hospital thrombolysis saves lives and is only practical strategy for timely delivery of reperfusion therapy • The NHS should fully implement a national programme of pre-hospital thrombolysis (with rescue PCI as necessary) targeting symptom-onset to drug times less than 120 minutes • Primary PCI programmes are costly, potentially delay treatment, and disturb our sleep!

  34. My opponent has a tendency to overestimate size!(and treatment effect)

  35. National Infarct Angioplasty Pilot (NIAP) • 3 of 6 pilot sites are not running 24/7 • At 1 centre median door to balloon times were >90 mins for 5 consecutive months

  36. Introduction of Primary PCIat a NIAP centre …..careful case selection?

  37. Comparison of angioplasty and prehospital thrombolysis in acute MI (CAPTIM n=840) Mortality at 30 days N=460 N=374 Interaction test HR 4.19, 95%CI 1.03-17.0, p=0.045 Steg, Circulation 2003;108:2851

  38. Meta-analysis in cardiologyHypothesis-generating or definitive research?

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