Your SlideShare is downloading. ×
0
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Zelizko M
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Zelizko M

739

Published on

Transradial Access is the Best Access for Percutaneous Coronary Intervention in Acute Coronary Syndrome with ST Elevation: Results from the RIVAL Trial, SCAAR Registry and Czech NRKI Registry

Transradial Access is the Best Access for Percutaneous Coronary Intervention in Acute Coronary Syndrome with ST Elevation: Results from the RIVAL Trial, SCAAR Registry and Czech NRKI Registry

0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
739
On Slideshare
0
From Embeds
0
Number of Embeds
3
Actions
Shares
0
Downloads
0
Comments
0
Likes
1
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. Rencontres Interventionnelles - Transradial Approach Prague, Czech Republic, Thursday 29th & Friday 30th September 2011TRA is the best access for PCI in ACSwith ST elevation: results from the RIVAL trial,SCAAR registry and Czech NRKI registry Michael ZELIZKO IKEM, PRAGUE
  • 2. STEMI and TRA: historical studies TRA: less bleeding, shorter lenght of stay, higher access failure Studies: small or non randomized, most cases by single physician.Vorobcsuk A. et al, Am Heart J 2009;158:814-21
  • 3. RIVAL trial: radial vs femoral access for coronaryangiography and intervention in pts. with ACS
  • 4. RIVAL trial99,8% coronary angiogram, 66% PCI, 8,5% CABG
  • 5. RIVAL trial
  • 6. RIVAL trial
  • 7. RIVAL trial: subgroup analysis
  • 8. RIVAL trial: STEMI vs NSTEACS subanalysis
  • 9. RIVAL trial summary
  • 10. SCAAR registry: transradial PCI cuts mortality in STEMIEnd point TFA TRA Adjusted OR p30-day mortality 4,4% 3,2% 0,57 0,001One-year mortality 7,3% 6,2% 0,78 0,018Serious bleeding 2,2% 1% 0,43 0,001Hospital stay /days/ 5,2 4,8 - 0,001 SCAAR registry STEMI procedures between 2005-2010, n=25 374 pts, Pts with prior CABG, cardiogenic shock, IABP, warfarin were excluded final study cohort 21 339 pts TRA increased from12% to 50% Comments: Bivalirudin use higher in TRA Pts with crossover from TRA to TFA excluded from analysis
  • 11. NRKI – National (Czech) registry for cardiovascularinterventions (analysis 2005 – 2009)NRKI Interventions (N=99 065) Patients (N=86 554) Lesions (N=137 876) All records of PCI 2005-2009 N=99 065 (100.0%) N=60 (0.1%) Incomplete date of PCI or death N=127 (0.1%) Duplicate records Records from 3 hospitals with incomplete N=4 476 (4.5%) records in 2008 and 2009 Records with missing entry of essential N=6 098 (6.2%) items about PCI Records with missing entry of essential N=379 (0.4%) items about treatment of lesions Complete records of PCI 2005-2009 N=87 925 (88.8%)
  • 12. Primary PCI in STEMI (1/2005-12/2009): TRA (n=2060) and TFA (n=19457) TFA TRA Others Number of PCI TRA and TFA in TRA and TFA in 0 1000 2000 3000 4000 5000 2005 - 2009 2008 and 2009 (without cardiogenic shocks) 2005 N=92 N=3781 N=3887 N=14 18.6 9.9 %For patients %with STEMI 2006 N=4220 N=166 N=4401 N=15 N=20 162 2007 N=4053 N=346 N=4408 N=9 2008 N=3439 N=456 N=3899 N=4 81.4 90.1 % 2009 N=2630 % N=929 N=3567 N=8 Number of PCI 0 1000 2000 3000 4000 5000 TRA and TFA in TRA and TFA in 2005 - 2009 2008 and 2009 N=4018 2005 N=97 N=4131 N=16 17.9 For patients with STEMI 9.6 N=4483 % 2006 N=173 % N=21 517 N=4671 N=15 N=4375 2007 N=369 N=4753 N=9 N=3685 2008 N=467 N=4159 N=7 82.1 90.4 N=2836 % 2009 N=958 % N=3803 N=9
  • 13. Cardiogenic shock (before PCI) in STEMI: TRA (3.6% patients) and TFA (6.5% patients)Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI(N=20112) without cardiogenic shocks (N=1349) with cardiogenic shocks 5.6% 9.9% TFA TRA 90.1 94.4 % % Mortality at 30th day (%) Mortality at 30th day (%) 0% 10% 20% 30% 40% 50% 0% 10% 20% 30% 40% 50% N=18123 5 .0 % N=1274 4 7 .8 % N=1989 2 .8 % N=75 3 3 .3 %
  • 14. Age and gender of patients no difference between TRA vs TFAPatients with TFA or TRA and STEMI Patients with TFA or TRA(N=20112) without cardiogenic shocks Number of patients and STEMI (N=21461) Number of patients 0 5000 10000 15000 0 5000 10000 15000 N=12630 TFA N=13492 Men N=1417 Men N=1466 TRA N=5493 N=5905Women N=572 Women N=598 >90 >90 80-90 80-90 Age of patients Age of patients 70-80 70-80 60-70 60-70 50-60 50-60 40-50 40-50 <40 <40 800 600 400 200 0 200 800 600 400 200 0 200 Number of patients Number of patients Age Age Total Men Women Total Men WomenMean ± SD Mean ± SD Total 63.6 ± 12.1 61.1 ± 11.5 69.2 ± 11.6 Total 63.8 ± 12.1 61.3 ± 11.5 69.5 ± 11.5 Femoral 63.6 ± 12.1 61.1 ± 11.5 69.4 ± 11.5 Femoral 62.8 ± 12.1 61.0 ± 11.6 67.3 ± 12.3 Radial 62.7 ± 12.1 60.9 ± 11.6 67.1 ± 12.2 Radial 63.7 ± 12.1 61.3 ± 11.5 69.3 ± 11.6 p1 0.001* 0.528 <0.001* p1 <0.001* 0.228 <0.001* 1 statistical significance of Kruskal-Wallis test *statistically significant
  • 15. TRA patients – better LVEF, less 3VD, less LMCA and bypass as IRA and compared to TFA Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI TFA without cardiogenic shock (N=20112) 0% 20% 40% 60% 80% 100% 0% 20% (N=21461) 40% 60% 80% 100% Anamnesis TRA 1 5 .0 % 1 6 .0 % IM 1 5 .0 % 1 5 .0 % 1 9 .0 % 1 9 .0 % DM 1 9 .0 % 1 9 .0 % 5 .0 % 5 .0 % CMP 5 .0 % 5 .0 % 2 .0 % 2 .0 % CABG 1 .0 % * 1 .0 % * 9 .0 % 9 .0 % previous PCI 9 .0 % 9 .0 % Diseased vessel 3 .0 % 3 .0 % Stem ACS 3 .0 % 3 .0 % 4 2 .0 % 4 1 .0 % 1VD 4 3 .0 % 4 1 .0 % 3 0 .0 % 3 0 .0 % 2VD 3 4 .0 % * 3 4 .0 % * 2 6 .0 % 2 8 .0 % 3VD 2 2 .0 % * 2 3 .0 % * Ejection fraction 2 0 .0 % 1 9 .0 % > 50% 2 4 .0 % * 2 3 .0 % * 2 1 .0 % 2 0 .0 % 30-50% 1 5 .0 % * 1 6 .0 % * 3 .0 % 4 .0 % <30% 2 .0 % * 2 .0 % * Character of operation 8 2 .0 % 8 2 .0 % Emergent 8 7 .0 % * * 8 6 .0 % 0 .0 % 1 7 .0 % Elective 0 .0 % 1 4 .0 % * 1 7 .0 % 0 .0 % Ad hoc 1 3 .0 % * 0 .0 % Segment 1 .0 % 2 .0 % LMCA 0 .0 % 1 .0 % * 4 4 .4 % RIA - RD 4 3 .4 % 4 4 .8 % 4 3 .7 % 1 6 .3 % 1 6 .7 % RC - RMS 1 6 .6 % 1 7 .0 %* Statistically significant 4 2 .7 %difference between TFA ACD 4 3 .1 % 4 2 .1 % 4 3 .1 %and TRA; tested by 0 .9 %Fisher’s exact test Bypass 0 .3 % * 0 .9 % 0 .3 % *
  • 16. TRA patients – more frequent use of GPI, DES and thromboaspiration, but less IABP compared to TFA Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI TFA without cardiogenic shock (N=20112) (N=21461) Type of lesion 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% A TRA 3 .0 % 3 .0 % 3 .0 % 3 .0 % B1 1 7 .0 % 1 7 .0 % 1 7 .0 % 1 7 .0 % B2 4 0 .0 % 3 6 .0 % * 4 0 .0 % 3 6 .0 % * C 4 7 .0 % 4 9 .0 % 4 7 .0 % 5 0 .0 % R 0 .0 % 0 .0 % 0 .0 % 0 .0 % ISR 2 .0 % 2 .0 % 2 .0 % 2 .0 % Length of lesion < 10mm 1 4 .0 % 1 2 .0 % * 1 4 .0 % 1 2 .0 % * 11-20mm 6 0 .0 % 6 5 .0 % * 6 0 .0 % 6 5 .0 % * >20mm 3 5 .0 % 3 0 .0 % * 3 6 .0 % 3 0 .0 % * Stenosis before 100% 6 1 .7 % Yes 6 1 .4 % 6 2 .4 % 6 1 .9 % Timi flow before >3 2 2 .6 % Yes 1 9 .8 % * 2 2 .3 % 1 9 .6 % * Thrombus 7 6 .0 % Yes 8 3 .0 % * 7 7 .0 % 8 3 .0 % * Type of stent 5 .0 % 5 .0 % DES 7 .0 % * 7 .0 % * Others 92.1% 9 3 .9 %* 91.6% 9 3 .8 % * Indication of stents 4 7 .2 % direct stenting 4 3 .7 % * 4 6 .0 % 4 4 .0 % * 4 9 .8 % others 5 4 .7 % * 5 0 .4 % 5 5 .0 % * Other operations 1 6 .3 % Inhibitors IIb/IIIa 2 2 .3 % * 1 7 .2 % 2 2 .8 % ** Statistically significant 0 .6 %difference between TFA IABP 0 .2 % * 2 .4 % 0 .8 % *and TRA; tested by 7 .9 % 8 .0 %Fisher’s exact test Thromboaspiration 1 8 .1 % * 1 8 .1 % *
  • 17. TRA vs TFA: no difference in number of treated lesions per procedure TFA Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI without cardiogenic shock (N=20112) (N=21461) TRA N=15803 N=14858 18000 18000 16000 16000 Number of PCI 14000 14000 12000 12000 10000 10000 8000 8000 N=3012 6000 6000 N=2760 N=1724 N=1775 4000 4000 N=514 N=456 N=247 N=225 N=48 N=37 N=67 N=35 2000 N=5 2000 N=5 0 0 Number of treated lesions per PCI Number of treated lesions per PCI Median Median Mean ± SD Min - Max Mean ± SD Min - Max (5th;95th perc.) (5th;95th perc.) Total 1.2 ± 0.5 1(1;2) 1-6 Total 1.2 ± 0.5 1(1;2) 1-6Femoral 1.2 ± 0.5 1(1;2) 1–6 Femoral 1.2 ± 0.5 1(1;2) 1-6 Radial 1.2 ± 0.4 1(1;2) 1-5 Radial 1.2 ± 0.4 1(1;2) 1-5
  • 18. Mortality at 30th day: TRA better than TFA even after exclusion of cardiogenic shock Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI TFA without cardiogenic shock (N=20112) 0% 10% 20% 30% 40% (N=21461) Anamnesis 0% 10% 20% 30% 40% TRA 7 .2 % 1 2 .5 % IM 6 .1 % 7 .6 % * 8 .3 % 1 2 .5 % DM 5 .1 % * 6 .8 % * 1 0 .9 % 1 4 .9 % CMP 4 .3 % * 6 .9 % * 5 .2 % 9 .1 % CABG 1 1 .1 % 1 0 .0 % 4 .6 % 7 .8 % previous PCI 3 .9 % 4 .4 % Diseased vessels 9 .0 % 2 1 .8 % Stem ACS 9 .3 % 1 7 .5 % 3 .5 % 4 .6 % 1VD 1 .3 % * 1 .5 % * 4 .8 % 6 .9 % 2VD 3 .2 % 4 .1 % * 7 .3 % 1 2 .9 % 3VD 5 .1 % 7 .7 % * Ejection fraction 1 .8 % 2 .0 % > 50% 1 .0 % 1 .0 % 5 .9 % 7 .4 % 30-50% 4 .2 % 5 .3 % 1 8 .4 % 3 3 .3 % <30% 2 6 .7 % 2 7 .5 % Character of operation 5 .0 % 7 .9 % Emergent 2 .7 % * 3 .7 % * 2 .6 % 7 .4 % Elective 0 .0 % 5 .0 % 4 .9 % 4 .9 % Ad hoc 3 .0 % 0 .0 % Segment 1 6 .7 % 3 9 .9 % LMCA 1 1 .1 % 2 5 .0 % 6 .0 % 9 .3 % RIA - RD 3 .9 % * 5 .1 % * RC - RMS 4 .7 % 2 .4 % ALL ø 4.7% 5 .1 % 8 .4 % * ALL ø 7.4%* Statistically significant 4 .0 % TFA ø 5.0% 5 .9 % TFA ø 7.8%difference between TFA ACD 1 .9 % * 3 .3 % *and TRA; tested by 6 .3 % TRA ø 2.8% 9 .8 % TRA ø 3.9%ML chi-squared test Bypass 0 .0 % 0 .0 %
  • 19. Mortality at 30th day: increase of mortality in complex lesions, absence of TIMI 3 flow before PCI, need of IABP Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMITFA without cardiogenic shock (N=20112) 0% 20% 40% 60% (N=21461) Type of lesionTRA A 12 .7 % .7 % B1 23.7 %.4 % * B2 1 .5 %4 .7 % * * C 3 .7 % % 6 .0 * * R 0 .0 % 8 .3 % ISR 3 .2.2 % 5 % Length of lesion < 10mm 5 .1 % 1 .2 % * * 11-20mm 4 .3 % 2 .3 % * * >20mm 6 .3 % 4 .3 % * Stenosis before 100% 5 .8 % Yes 3 .6 % * * Timi flow before >3 4 .0 % Yes 1 .5 % * * Thrombus 5 .0 % Yes 3 .2 % * * Type of stent 3 .1 % DES 0 .7 % * others 2 .6 % 4.5% * * Indication of stents 3 .2 % direct stenting 1 .8 % ALL ø 4.7% * * 5 .7 % ALL ø 7.4% others 3 .6 % TFA ø 5.0% * * TFA ø 7.8% Others operation TRA ø 2.8% TRA ø 3.9% 6 .0 % Inhibitors IIb/IIIa 4 .1 % * 3 6 .3 % IABP 2 5 .0 % 6 .3 % Thromboaspiration 2 .8 % * *
  • 20. Survival of patients after 30th day after admission Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI without cardiogenic shock (N=19 810) (N=19 875) Log-rank test Log-rank test p=0.452 p=0.407 TFA TRA TFA TRASurvival Survival 95% CI 95% CI 95% CI 95% CI 1 year 95.4 (95.1; 95.7) 96.1 (95.2; 97.0) 1 year 95.1 (94.7;95.1) 95.9 (95.0;96.8) 3 year 90.3 (89.8; 90.8) 91.0 (89.2; 92.8) 3 year 90.0 (89.5;90.5) 90.7 (88.9;92.5) 5 year 86.6 (85.9; 87.3) 83.4 (78.4; 88.4) 5 year 86.3 (85.6;87.0) 83.3 (78.4;88.2)
  • 21. NRKI registry summary•  Data from the Czech National registry for cardiovascular interventions (2005-2009) were analyzed with focus on differences between access for PCI (TRA vs. TFA) and presence of cardiogenic shock•  Statistically significant differences between TRA and TFA were found both for their basic characteristics and mortality of patients•  Differences between TRA and TFA in mortality at 30th day after admission were found for patients with STEMI with/without cardiogenic shock (TRA had lower mortality at 30th day after admission then TFA)•  For long-term survival differences between TRA and TFA were not found both for patients with STEMI with/without cardiogenic shock•  Due to large sample size the statistical significance of results should be interpreted in context of their clinical significance
  • 22. Implications for TRA in STEMI•  TRA shoud be default access for all STEMI patients –  Lower mortality at 30 day, same mortality at 1 year –  Better early results of TRA can be partially explained by → lower risk profile → different pharmacological regimen → more experienced PCI operators –  TRA reduce vascular complications and access site bleeding… –  …small or no difference in large bleeding (non CABG, gastrointestinal, genitourinary, intracranial)•  Pts in profound cardiogenic shock (pulseless) are excluded from trials, but they contibute substantially to the mortality of all STEMI•  Operators should be high volume and trained in both accesses
  • 23. STEMI – RADIAL ST Elevation Myocardial Infarction treated by RADIAL or femoral approach 700 patients with STEMI <12 hours reffering to the cathlab for pPCI (24/7)•  randomization 1:1 (electronically by www.fnplzen.cz/radial with password for each investigator)•  intention to treat analysis•  primary endpoint - bleeding and access site complications at 30 days•  secondary endpoints - MACE - primary access site failure - angiographical procedure success - contrast media consumption - procedural and flouroscopic times - duration of hospital/ICU stay - TVR/TLR - any new hospitalizationStudy start date - October 2009End of enrollment - December 2011Principal investigator – Ivo Bernat, Pilsen Country: Czech Republic Centers: University Hospital Pilsen, University Hospital Hradec Kralove, Nemocnice Na Homolce, Prague, Regional Hospital Liberec

×