20 years of Primary PCI for STEMI:
Czech experience and evolution of networks.
Petr Widimsky
Charles University Prague &
U...
How to reperfuse the obstructed route ?
Before 1985: no routine treatment available
1986-1993: dissolving the clot (thromb...
Geoff Hartzler (USA) 1982
1st primary PCI
Felix Zijlstra & Zwolle Group (NL) 1988-93
1st randomized trial on primary PCI
O...
„1st Zwolle trial“ (NEJM 1993):
PCI superior to TL for patients directly admitted to PCI centers.
SK
(n=72)
P-PCI
(n=70)
p...
1990 cup of coffee in Rotterdam
1993-4 PCI training in Zwolle
1995 end of thrombolysis in Prague
1997-9 the PRAGUE-1 study...
Thrombolysis
(50% success rates
7% reocclusion risk)
Primary PCI
(90% success rates
3% reocclusion risk)
Modern therapy of...
Reperfusion methods in STEMI:
Primary PCI:
•90% success rate
•8% death /re-MI /stroke
•3% reinfarctions
•1% strokes
•3-7% ...
LIMI + PRAGUE-1
(Metaanalysis from: F. Vermeer, Heart 1999; 82:
426-31; P. Widimský, Eur Heart J 2000; 21: 823-31)
13
11
7...
0
2
4
6
8
10
12
ASSENT4 (2005) PRAGUE1 (1999)
Facilit.PCI
Prim.PCI
F. v/d Werf 2000: Routine transport of STEMI pts. to
PC...
PRAGUE-2: 30-days outcomes
Eur Heart J. 2003 Jan;24(1):94-104
10
6,80
15,2
8,4
0
2
4
6
8
10
12
14
16
Mortality +/re-MI/str...
Metaanalysis of 23 studies TL vs. PCI
(Keeley et al., Lancet 2003; 361: 13-20)
9
7 7
3
2
1
14
8
0
2
4
6
8
10
12
14
Mortali...
Czech Republic:
Experience with primary PCI
and STEMI networks
Čas lék čes 1983; 122: 694-6.
Dec. 20, 1982
Real-life STEMI mortality in various hospital types
Czech Republic 1995
29
17 17
8
0
5
10
15
20
25
30
In-hospital mortalit...
Change of reperfusion strategy in University Hospital „Vinohrady“
Prague: October 5, 1995 thrombolysis declared non-lege a...
5-leté přežívání po PCI
5-leté přežívání po trombolýze
STEMI guidelies of the Czech Society of Cardiology
PCIPCIPCIPain-ECG
3-12
hours
TLPCIPCIPain-ECG
< 3 hours
ECG-PCI
> 90 mi...
….. The world first guidelines declaring p-
PCI as first treatment option !
• 2002 Czech Society of Cardiology
• 2003 Euro...
Evolution of PCI rates in the Czech R.
320
1829
9270
16338
21676
22545
21624
0
5000
10000
15000
20000
25000
1990 1995 2000...
P-PCI networks Czech Rep.
During 1999 – 2005 period the implementation of the „PRAGUE“ trials results
completely abolished mortality differences bet...
Stent for Life
≥600 p-PCI / million / year
400-599 p-PCI / million / year
200-399 p-PCI / million / year
<200 p-PCI / million / year
Data...
SFL prokázal, že národní strategie léčby infarktu trombolýzou vede k
tomu, že 46% nemocných s infarktem de facto není vůbe...
And what about
Non-STEMI ?
Špaček R. et al.: VINO Study.
Eur Heart J. 2002 Feb;23(3):230-8.
30days 6months
Invasive
Conserv
7.5%
13.4%
1.6%
3.1%
p<0....
•Unstable angina is disappearing in the current era of hs-Tn…..
•…..We can expect, that patients with coronary artery dise...
Hot topics in
acute PCI for AMI
Dr Adeel Shahzad
Dr Rod Stables (PI)
Liverpool Heart and Chest Hospital
Liverpool, UK
How Effective are
Antithrombotic The...
Bivalirudin Heparin
GPI Bailout GPI Universal
ACUITY 9 % 97 %
ISAR REACT 4 0 % 100 %
HORIZONS 7 % 98 %
EUROMAX 9 % 70 %
↑ ...
• Single centre RCT
• Trial recruitment: Feb 2012 - Nov 2013 22 months
• Bivalirudin v Unfractionated Heparin
• STEMI pati...
• Dual oral anti-platelet therapy pre-procedure
• Heparin: 70 units/kg body weight pre-procedure
• Bivalirudin: Bolus 0.75...
Assigned to Heparin 914
Included in analysis 907
915 Assigned to Bivalirudin
905 Included in analysis
Consent not availabl...
Characteristic Bivalirudin (%) Heparin (%)
P2Y12 use - Any 99.6 99.5
- Clopidogrel 11.8 10.0
- Prasugrel 27.3 27.6
- Ticag...
Bivalirudin Heparin
n % % n
MACE 79 8.7 % v 5.7 % 52
Absolute risk increase = 3.0% (95% CI 0.6, 5.4)
Relative risk = 1.52 ...
Event curve shows first event experienced
Bivalirudin Heparin
n % % n
Death 46 5.1 % v 4.3 % 39
CVA 15 1.6% v 1.2% 11
Reinfarction 24 2.7% v 0.9% 8
TLR 24 2.7% v 0....
Bivalirudin Heparin
n % % n
Definite 23 3.3 % v 0.7 % 5
Probable 1 0.1 % v 0.1 % 1
Acute 20 2.9 % v 0.9 % 6
Subacute 4 0.6...
Bivalirudin Heparin
n % % n
Major Bleed 32 3.5 % v 3.1 % 28
Relative risk = 1.15 (95% CI 0.7 - 1.9) P=0.59
Major Bleed BAR...
• A unique study with 100% recruitment of eligible patients
Use of heparin rather than bivalirudin
• Reduced rate of major...
• 1. Bivalirudin is better drug and despite its price is cost-
effective.
• 2. Bivalirudin is better drug, but heparin is ...
After infarct artery PCI, patients were
randomized to (A) no further PCI procedures
or (B) immediate preventive PCI in non...
What was known before PRAMI: evidence
and guidelines
Ph.Gabriel Steg
DHU-FIRE, Hôpital Bichat, Assistance Publique – Hôpit...
Worse Prognosis in Patients with MVD vs SVD After
Primary PCI
57
Parodi et al. Heart 2005;91:1541-44
Consecutive Patients ...
After ACS, as many recurrent events are related to “non
culprit” and “culprit” lesions
Findings from the PROSPECT study:
M...
Complete vs Incomplete Revasc in DES Era: An
analysis from the NY State Database
Death Death/MI
Adjusted HR 1.23, P=0.01 A...
APEX-AMI: Multivessel PCI during initial
Procedure Associated with Increased Death
61Toma M, Buller CE et al. Eur Heart J ...
Non-IRA Revascularization routinely after Primary PCI –
a Meta Analysis
Bainey K, Mehta SR, Welsh R, AHJ 2013
Same-sitting...
Steg PG, James SK et al. Eur Heart J 2012
ESC STEMI guidelines
3.5.4.9 Revascularization strategy for ST-segment elevation myocardial infarction
with multivessel di...
ESC STEMI guidelines
Summary of indications for imaging and stress testing
Steg PG, James SK et al. Eur Heart J 2012
Bioresorbable vascular scaffolds
in acute STEMI
(PRAGUE-19 study)
Petr Widimský, Viktor Kočka, Martin Malý*,
Libor Lisa, T...
Inclusion criteria Exclusion criteria - clinical Exclusion criteria - angiographic
STEMI <24 hours from
symptom onset
Kill...
BVS vs. other stent: cardiac death / myocardial
infarction / TVR.
Number of patients available for follow-up in BVS/Contro...
Procedural result and BVS feasibility
• 85 BVS successfully implanted to 76/79 patients
• In 3 pts. BVS could not be deliv...
Why BVS was not implanted to 75%
STEMI patients (n = 235)
12%
37%
17%
13%
9%
1%
5%
2% 4%
Reasons for exclusion PCI without...
BVS group – overall outcomes (n=76)
follow-up: 21 pts. >1 year, 52 pts. >6 months, 70 pts. >1 month
• Overall mortality: 1...
Endothelization at 1 month
Endothelization at 6 months
Conclusions
• BVS implantation in acute STEMI is feasible and safe.
• With the currently available size spectrum and expir...
Three young females (37-46 years)
with acute stroke (NIHSS 12-17)
and full neurologic recovery within 48 hours
45-years mother from 3 children
11:30 sudden loss of consciousness, hemiplegia
12:30 CT scan
13:00 transfemoral angiograph...
Functional outcomes
Favourable outcome (mRs ≤2) in 48%. Mean mRs among survivors
treated within <120 minutes was 1.17 !
Our results are similar / better when compared to
endovascular treatment arms in the 3 largest
randomized trials (NEJM Mar...
PRAGUE trials overview
• PRAGUE-1: p-PCI vs. TL vs. facil.
PCI in STEMI (transport)
• P-2: p-PCI vs. TL in STEMI
(transpor...
Hot Line / Late Breaking Clinical Trials
presentations from the PRAGUE Study Group
• 1999 ESC: PRAGUE-1
• 2000 ESC: VINO
•...
Ke stažení v PDF verzi:
www.kardio-cz.cz
The goal of modern cardiology:
To keep the routes open !
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. P...
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20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. Petr Widimsky

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Conferencia magistral "20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto" del Dr. Petr Widimsky durante la XXV Reunión Anual de la Sección de Hemodinámica y Cardiología Intervencionista (SHCI) de 2014 en Córdoba.

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20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto. - Dr. Petr Widimsky

  1. 1. 20 years of Primary PCI for STEMI: Czech experience and evolution of networks. Petr Widimsky Charles University Prague & University Hospital Kralovske Vinohrady, Prague Czech Republic
  2. 2. How to reperfuse the obstructed route ? Before 1985: no routine treatment available 1986-1993: dissolving the clot (thrombolysis) in 25% of all STEMIs 1993-2002: reperfusion & revascularization (p-PCI) for 50% of STEMIs (locals only) After 2002: reperfusion & revascularization (p-PCI) for all STEMIs (transport)
  3. 3. Geoff Hartzler (USA) 1982 1st primary PCI Felix Zijlstra & Zwolle Group (NL) 1988-93 1st randomized trial on primary PCI Otto Klein (CZ) 1929 1st diagnostic cardiac catheterization Andreas Gruntzig (CH) 1977 1st PTCA
  4. 4. „1st Zwolle trial“ (NEJM 1993): PCI superior to TL for patients directly admitted to PCI centers. SK (n=72) P-PCI (n=70) p value IRA recanalization 68% 91% 0,02 Discharge EF 45% 51% 0,004 Re-MI 13% 0% 0,003 Post-MI angina 19% 6% 0,001
  5. 5. 1990 cup of coffee in Rotterdam 1993-4 PCI training in Zwolle 1995 end of thrombolysis in Prague 1997-9 the PRAGUE-1 study 2002 Czech STEMI guidelines 2008 Stent for Life
  6. 6. Thrombolysis (50% success rates 7% reocclusion risk) Primary PCI (90% success rates 3% reocclusion risk) Modern therapy of AMI: Thrombus removal, Flow restoration
  7. 7. Reperfusion methods in STEMI: Primary PCI: •90% success rate •8% death /re-MI /stroke •3% reinfarctions •1% strokes •3-7% mortality in trials •5-9% mortality in registries Thrombolysis: •50% success rate •14% death /re-MI /stroke •7% reinfarctions •2% strokes •6-9% mortality in trials •10-17% mortality in registries
  8. 8. LIMI + PRAGUE-1 (Metaanalysis from: F. Vermeer, Heart 1999; 82: 426-31; P. Widimský, Eur Heart J 2000; 21: 823-31) 13 11 7 20 14 8 2 4 1 0 2 4 6 8 10 12 14 16 18 20 Mortality +/reMI Stroke Thrombolysis Both PrimPTCA % N = 524
  9. 9. 0 2 4 6 8 10 12 ASSENT4 (2005) PRAGUE1 (1999) Facilit.PCI Prim.PCI F. v/d Werf 2000: Routine transport of STEMI pts. to PCI centers is not acceptable (EHJ 2000, editorial k PRAGUE) F. v/d Werf 2006: ASSENT-4 (Lancet 2006; 367: 569–78)  37%  42%
  10. 10. PRAGUE-2: 30-days outcomes Eur Heart J. 2003 Jan;24(1):94-104 10 6,80 15,2 8,4 0 2 4 6 8 10 12 14 16 Mortality +/re-MI/stroke TL PCI P = 0,12 P < 0,003
  11. 11. Metaanalysis of 23 studies TL vs. PCI (Keeley et al., Lancet 2003; 361: 13-20) 9 7 7 3 2 1 14 8 0 2 4 6 8 10 12 14 Mortality Re-MI Stroke Comb.end- point TL PCI % n=7739
  12. 12. Czech Republic: Experience with primary PCI and STEMI networks
  13. 13. Čas lék čes 1983; 122: 694-6. Dec. 20, 1982
  14. 14. Real-life STEMI mortality in various hospital types Czech Republic 1995 29 17 17 8 0 5 10 15 20 25 30 In-hospital mortality No cardiologist on duty Cardiologist day- hours Cardiologist 24/7, but no PCI Cardiologist + PCI 24/7
  15. 15. Change of reperfusion strategy in University Hospital „Vinohrady“ Prague: October 5, 1995 thrombolysis declared non-lege artis 0 2 4 6 8 10 12 Mortalita STEMI 1994 1996
  16. 16. 5-leté přežívání po PCI 5-leté přežívání po trombolýze
  17. 17. STEMI guidelies of the Czech Society of Cardiology PCIPCIPCIPain-ECG 3-12 hours TLPCIPCIPain-ECG < 3 hours ECG-PCI > 90 min. ECG-PCI 30-90 min. ECG-PCI < 30 min. STEMI (Cor et Vasa 2002; 44: K123-143)
  18. 18. ….. The world first guidelines declaring p- PCI as first treatment option ! • 2002 Czech Society of Cardiology • 2003 European Society of Cardiology • 2004 American College of Cardiology / AHA
  19. 19. Evolution of PCI rates in the Czech R. 320 1829 9270 16338 21676 22545 21624 0 5000 10000 15000 20000 25000 1990 1995 2000 2002 2004 2009 2013 PCI/rok/ČR PCI/rok/ČR PRAGUE-1 1999 PRAGUE-2 2002
  20. 20. P-PCI networks Czech Rep.
  21. 21. During 1999 – 2005 period the implementation of the „PRAGUE“ trials results completely abolished mortality differences between hospital types 8 18 0 5 10 15 20 In-hospital mortality Tertiary PCI centers Hospitals without cath-lab 6,8 6,9 0 5 10 15 20 In-hospital mortality Tertiary PCI centers Hospitals without cath-lab
  22. 22. Stent for Life
  23. 23. ≥600 p-PCI / million / year 400-599 p-PCI / million / year 200-399 p-PCI / million / year <200 p-PCI / million / year Data not known Annual Incidence of Primary PCIs
  24. 24. SFL prokázal, že národní strategie léčby infarktu trombolýzou vede k tomu, že 46% nemocných s infarktem de facto není vůbec léčeno. Národní strategie léčby infarktu primární PCI (CZ, NL) sníží tento počet na pouhých 7%. 7 46 0 5 10 15 20 25 30 35 40 45 50 No reperfusion used NL + CZ Countries with thrombolysis dominance % from all STEMI
  25. 25. And what about Non-STEMI ?
  26. 26. Špaček R. et al.: VINO Study. Eur Heart J. 2002 Feb;23(3):230-8. 30days 6months Invasive Conserv 7.5% 13.4% 1.6% 3.1% p<0.05
  27. 27. •Unstable angina is disappearing in the current era of hs-Tn….. •…..We can expect, that patients with coronary artery disease will again (as many years ago) be classified as having either (a) angina pectoris or (b) acute myocardial infarction. •A requiem is a choral musical work that is performed at the funeral of a great personage or at the close of an important era. Has not the time arrived to prepare a requiem for unstable angina ? (Circulation. 2013;127:2452-2457.)
  28. 28. Hot topics in acute PCI for AMI
  29. 29. Dr Adeel Shahzad Dr Rod Stables (PI) Liverpool Heart and Chest Hospital Liverpool, UK How Effective are Antithrombotic Therapies in PPCI
  30. 30. Bivalirudin Heparin GPI Bailout GPI Universal ACUITY 9 % 97 % ISAR REACT 4 0 % 100 % HORIZONS 7 % 98 % EUROMAX 9 % 70 % ↑ bleeding with ↑ GPI use
  31. 31. • Single centre RCT • Trial recruitment: Feb 2012 - Nov 2013 22 months • Bivalirudin v Unfractionated Heparin • STEMI patients • Randomised at presentation • Acute phase management with Primary PCI • Philosophy for clinical teams: • Assess ‘Every Patient - Every Time’
  32. 32. • Dual oral anti-platelet therapy pre-procedure • Heparin: 70 units/kg body weight pre-procedure • Bivalirudin: Bolus 0.75 mg/kg Infusion 1.75 mg/kg/hr - procedure duration • GPI - Abciximab • Selective (‘bailout’) use in both groups • ESC guideline indications
  33. 33. Assigned to Heparin 914 Included in analysis 907 915 Assigned to Bivalirudin 905 Included in analysis Consent not available in surviving patients Consent not available in surviving patients 7 10 Received allocated Rx 900 Received no study drug 14 Treatment cross-over 0 LMWH pre-procedure 3 907 Received allocated Rx 7 Received no study drug 1 Treatment cross-over 4 LMWH pre-procedure
  34. 34. Characteristic Bivalirudin (%) Heparin (%) P2Y12 use - Any 99.6 99.5 - Clopidogrel 11.8 10.0 - Prasugrel 27.3 27.6 - Ticagrelor 61.2 62.7 GPI use 13.5 15.5 Radial arterial access 80.3 82.0 PCI performed 83.0 81.6
  35. 35. Bivalirudin Heparin n % % n MACE 79 8.7 % v 5.7 % 52 Absolute risk increase = 3.0% (95% CI 0.6, 5.4) Relative risk = 1.52 (95% CI 1.1 – 2.1) P=0.01
  36. 36. Event curve shows first event experienced
  37. 37. Bivalirudin Heparin n % % n Death 46 5.1 % v 4.3 % 39 CVA 15 1.6% v 1.2% 11 Reinfarction 24 2.7% v 0.9% 8 TLR 24 2.7% v 0.7% 6 Any MACE 79 8.7 % v 5.7 % 52
  38. 38. Bivalirudin Heparin n % % n Definite 23 3.3 % v 0.7 % 5 Probable 1 0.1 % v 0.1 % 1 Acute 20 2.9 % v 0.9 % 6 Subacute 4 0.6% v 0% 0 ARC definite or probable stent thrombosis events
  39. 39. Bivalirudin Heparin n % % n Major Bleed 32 3.5 % v 3.1 % 28 Relative risk = 1.15 (95% CI 0.7 - 1.9) P=0.59 Major Bleed BARC grade 3-5
  40. 40. • A unique study with 100% recruitment of eligible patients Use of heparin rather than bivalirudin • Reduced rate of major adverse events (NNT = 33) • Fewer stent thromboses and reinfarction events • Consistent effect across pre-specified subgroups • No increase in bleeding complications • Potential for substantial saving in drug costs
  41. 41. • 1. Bivalirudin is better drug and despite its price is cost- effective. • 2. Bivalirudin is better drug, but heparin is more cost- effective. • 3. Bivalirudin is just an expensive alternative to heparin (both drugs are equally effective) • 4. Heparin is better and bivalirudin should be abandoned.
  42. 42. After infarct artery PCI, patients were randomized to (A) no further PCI procedures or (B) immediate preventive PCI in noninfarct arteries with more than 50% DS (preventive PCI). Staged PCI in patients without angina was discouraged.
  43. 43. What was known before PRAMI: evidence and guidelines Ph.Gabriel Steg DHU-FIRE, Hôpital Bichat, Assistance Publique – Hôpitaux de Paris, Université Paris – Diderot, INSERM U-698, Paris, France, French Alliance for Cardiovascular clinical Trials and Imperial College, Royal Brompton Hospital, London, UK
  44. 44. Worse Prognosis in Patients with MVD vs SVD After Primary PCI 57 Parodi et al. Heart 2005;91:1541-44 Consecutive Patients Undergoing Primary PCI in a High Volume Center (N=1009) n=511 n=498
  45. 45. After ACS, as many recurrent events are related to “non culprit” and “culprit” lesions Findings from the PROSPECT study: MACE after Successful, Uncomplicated PCI in 697 Patients with ACS Stone GW et al. N Engl J Med 2011;364:226-235
  46. 46. Complete vs Incomplete Revasc in DES Era: An analysis from the NY State Database Death Death/MI Adjusted HR 1.23, P=0.01 Adjusted HR 1.27 P=0.002 Hannan et al. JACC Intv 2009;2:17-25
  47. 47. APEX-AMI: Multivessel PCI during initial Procedure Associated with Increased Death 61Toma M, Buller CE et al. Eur Heart J 2010; 31:1701-7.
  48. 48. Non-IRA Revascularization routinely after Primary PCI – a Meta Analysis Bainey K, Mehta SR, Welsh R, AHJ 2013 Same-sitting: favours culprit-only Staged: favours routine revasc
  49. 49. Steg PG, James SK et al. Eur Heart J 2012
  50. 50. ESC STEMI guidelines 3.5.4.9 Revascularization strategy for ST-segment elevation myocardial infarction with multivessel disease Apart from patients in cardiogenic shock, and in patients with continuous ischaemia after opening the supposed culprit lesion, performing PCI of non-culprit vessels in the acute setting is generally discouraged. The best strategy for STEMI patients with multivessel disease, who underwent primary PCI of the infarct-related artery in the acute phase with remaining multivessel disease, is still not well established. Among the possible strategies, two that are frequently used are either a conservative approach—which uses medical therapy after primary PCI, and revascularization of other arteries only if there are symptoms or evidence of ischaemia in provocative tests—or a staged revascularization approach, using PCI or coronary bypass surgery of non-infarct arteries several days or weeks after primary PCI, often after confirmation of the stenosis severity with measurements of fractional flow reserve. A multidisciplinary approach is often needed, including a heart team and appropriate informed consent of the patient. In STEMI patients with multivessel disease initially treated with primary or post-thrombolysis culprit-artery PCI and confirmed presence of ischaemia in non-infarcted territories, staged revascularization may be performed before discharge or in the days to weeks after initial PCI Steg PG, James SK et al. Eur Heart J 2012
  51. 51. ESC STEMI guidelines Summary of indications for imaging and stress testing Steg PG, James SK et al. Eur Heart J 2012
  52. 52. Bioresorbable vascular scaffolds in acute STEMI (PRAGUE-19 study) Petr Widimský, Viktor Kočka, Martin Malý*, Libor Lisa, Tomáš Buděšínský, Petr Toušek University Hospital Kralovske Vinohrady and *Central Military Hospital Prague, Czech Republic
  53. 53. Inclusion criteria Exclusion criteria - clinical Exclusion criteria - angiographic STEMI <24 hours from symptom onset Killip III-IV class (i.e. high likelihood of death within BVS absorbtion time) Infarct artery reference diameter <2,3 mm or >3,7 mm (i.e. not suitable for currently available BVS sizes) Signed written informed consent Any other disease with probable prognosis <3 years Lesion lenth >24 mm (i.e. precluding single BVS implantation) Indication for oral anticoagulation (e.g. atrial fibrillation) Extensive infarct artery calcifications or severe tortuosity Contraindication to prolonged DAPT or high likelihood of non-compliance to DAPT STEMI caused by in-stent restenosis or stent thrombosis No stent: not needed (POBA, thrombus aspiration etc.) or not possible (failed PCI or failed stent delivery) 79/311 (25.4%) pts fullfilled the prespecified inclusion / exclusion criteria for BVS implantation
  54. 54. BVS vs. other stent: cardiac death / myocardial infarction / TVR. Number of patients available for follow-up in BVS/Control group is 40/57 at discharge, 36/48 at 1 month and 17/25 at 6 months.
  55. 55. Procedural result and BVS feasibility • 85 BVS successfully implanted to 76/79 patients • In 3 pts. BVS could not be delivered to LCX (BMS 2x succeeded, 1x failed) • 72/76 BVS patients had ideal result (TIMI-3 flow, no residual stenosis, no angiographically visible dissection) • 4/76 patients had TIMI-2 flow
  56. 56. Why BVS was not implanted to 75% STEMI patients (n = 235) 12% 37% 17% 13% 9% 1% 5% 2% 4% Reasons for exclusion PCI without stent Too large artery (≥3,7 mm) Killip III-IV Artery calcifications or tortuosity BVS size not on stock Stent thrombosis as culprit lesion Expected non-compliance to DAPT Other illness with short prognosis Oral anticoagulation 37% more STEMI pts. might receive BVS if size 4,0 mm would be available
  57. 57. BVS group – overall outcomes (n=76) follow-up: 21 pts. >1 year, 52 pts. >6 months, 70 pts. >1 month • Overall mortality: 1/76 = 1.3% (1 patient with anterior STEMI treated 18 hours after symptom onset died due to septal rupture occurring 4 hours after P-PCI) • Reinfarction (up to 16 months post PCI): 1/76 = 1.3% (1 BVS thrombosis 3 days after stopping ticagrelor, 10 days after hospital discharge) • Stent thrombosis: 1/76 = 1.3% • Stroke (up to 16 months post PCI): 3/76 = 3.9% (1 ICB after elective neurointervention 95 days post PCI, 1 TIA during elective re-CAG 47 days post PCI, 1 spontaneous TIA 10 days after p-PCI) • Clinical restenosis (up to 10 months post PCI): 0 = 0%
  58. 58. Endothelization at 1 month
  59. 59. Endothelization at 6 months
  60. 60. Conclusions • BVS implantation in acute STEMI is feasible and safe. • With the currently available size spectrum and expiration times BVS can be used in 25-35% of STEMI patients. Availability of 4,0 mm size would substantially increase this proportion. • OCT can be used safely to control BVS implantation in STEMI. • The study will elucidate the role of CT angiography for long- term BVS patency assessment • Long-term follow-up will elucidate the future role of BVS in STEMI.
  61. 61. Three young females (37-46 years) with acute stroke (NIHSS 12-17) and full neurologic recovery within 48 hours
  62. 62. 45-years mother from 3 children 11:30 sudden loss of consciousness, hemiplegia 12:30 CT scan 13:00 transfemoral angiography 13:30 thrombectomy (Solitaire) 13:45 conscious, speaking 16:00 moving (photo) Next morning willing to go home (mRS 0)
  63. 63. Functional outcomes Favourable outcome (mRs ≤2) in 48%. Mean mRs among survivors treated within <120 minutes was 1.17 !
  64. 64. Our results are similar / better when compared to endovascular treatment arms in the 3 largest randomized trials (NEJM March 2013) 21,7 19,1 18,8 14,4 52 59 81 58 0 10 20 30 40 50 60 70 80 90 PRAGUE-16 IMS-III trial MR Rescue trial SYNTHESIS trial Mortality Death/ severe invalidity MeanmRS at 90 days *SYNTHESIS included pts. with small strokes (NIHSS ≥2) * * MR-Rescue included pts. with NIHSS ≥6 * * *
  65. 65. PRAGUE trials overview • PRAGUE-1: p-PCI vs. TL vs. facil. PCI in STEMI (transport) • P-2: p-PCI vs. TL in STEMI (transport) • P-3: p-PCI for late-presenting STEMI • P-4: off-pump vs. on-pump CABG for all-comers • P-5: 24-hour discharge after STEMI • P-6: off-pump vs. on-pump CABG for high risk pts. • P-7: abciximab in cardiogenic shock • P-8: clopidogrel pretreatment before PCI • P-9: ischemic mitral regurgitation • P-10: trimetazidine in heart failure • P-11: platelet activity in CABG • P-12: surgical MAZE • P-13: multivessel PCI in STEMI • P-14: perioperative bleeding and ischemia in non-cardiac surgery • P-15: renal denervation • P-16: acute stroke intervention • P-17: anticoagulant + antiplatelet therapy after PCI in pts with atrial fibrillation • P-18: ticagrelor vs. prasugrel in STEMI • P-19: bioresorbable vascular scaffolds in STEMI Published Unpublished (failed) Ongoing
  66. 66. Hot Line / Late Breaking Clinical Trials presentations from the PRAGUE Study Group • 1999 ESC: PRAGUE-1 • 2000 ESC: VINO • 2002 ESC: PRAGUE-2 (30-day outcomes) • 2002 ESC: PRAGUE-4 (early surgical outcomes) • 2002 TCT: PRAGUE-2 • 2004 ACC: PRAGUE-4 (1-year CAG outcomes) • 2006 WCC: PRAGUE-2 (5-yers f-u) • 2007 ESC: PRAGUE-8 • 2009 ESC: PRAGUE-7 • 2012 ESC: PRAGUE-12 • 2013 ACC: PRAGUE-6 • 2013 EuroPCR: PRAGUE-19 • 2013 ESC: PRAGUE-14 • 2014 EuroPCR: PRAGUE-16
  67. 67. Ke stažení v PDF verzi: www.kardio-cz.cz
  68. 68. The goal of modern cardiology: To keep the routes open !

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