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Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
Varenne O - AIMRADIAL 2013 - SPASM 3 study
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Varenne O - AIMRADIAL 2013 - SPASM 3 study

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How to prevent radial artery spasm during PCI? Results of the SPASM 3 study

How to prevent radial artery spasm during PCI? Results of the SPASM 3 study

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  • 1. How to prevent radial artery spasm during PCI ? Results of the SPASM 3 Study Rosencher J, Chaïb A, Barbou F, Arnould MA, Huber A, Salengro E, Jégou A, Allouch P, Zuily S, Mihoub F, Varenne O. Hôpital Cochin, Hôpital du Val de Grace Paris, France
  • 2. • Conflicts of interest: – The SPASM 3 study received a grant from Abbott Vascular
  • 3. Radial Artery Spasm The major limitation of TRA. Frequent (arround 20%). Catheter movements are painfull. Limitation of catheter movements Could lead to vascular effraction.
  • 4. SPASM1 Study p<0.001 Patients with spasm (%) 25 20 p<0.001 22 15 p<0.004 15,3 10 7,5 5 0 placebo molsidomine verapamil n=198 n=203 n=200 Varenne O et al. Catheter Cardiovasc Interv. 2006;68:231-5
  • 5. SPASM2 Study Interrupted Study: 110 Pts included Patients with radial spasm % 14 12 12.8 10 9.7 8 6 7.9 4 2 0 n=38 Verapamil 2.5mg n=39 Verapamil 5mg n=31 Verapamil 2.5mg + Molsidomine 1mg
  • 6. SPASM3 • 2012, due to verapamil global production disruption • Prospective RCT to evaluate the efficacy and safety of two alternative vasodilators to verapamil 2.5mg: – diltiazem 5mg, and – isosorbide dinitrate 1 mg Rosencher J et al, Catheter Cardiovasc Interv. 2013 Aug 27, epub
  • 7. Material and Methods 731 pts coronary angiography or PCI TRA access Diltiazem 5mg n=252 ISDN 1mg n=244 Verapamil 2.5mg n=235 Occurrence of RAS Rosencher J et al, Catheter Cardiovasc Interv. 2013 Aug 27, epub
  • 8. Material and Methods • Primary endpoint: Radial artery spasm – occurrence of a severe RAS signification limitation of the catheter movement perceived by the operator with mild to severe pain in the forearm of the patient • Secondary endpoints : – – – – – – occurrence of a severe RAS (catheter blockage), severe pain in the arm (≥ 8/10) need for morphine chlorydrate injection need for midazolam injection crossover to the contralateral radial or femoral artery safety events (heart rate and arterial pressure) Rosencher J et al, Catheter Cardiovasc Interv. 2013 Aug 27, epub
  • 9. TOTAL DILTIAZEM VERAPAMIL ISDN ( n= 731) (n =252) (n=235) (n=244) Age, years 63.7 (12.2) 64.0 (12.3) 63.1 (12.3) 64.0 (12.1) 0.59 Male gender 528 (72.3) 175 (69.7) 175 (74.5) 178 (73.0) 0.49 Size, cm 170.5 (8.5) 170.7 (7.9) 170.6 (8.8) 170.2 (9.0) 0.93 Weight, kg 77.3 (15.5) 77.6 (15.6) 77.7 (16.8) 76.7 (14.2) 0.91 Diabetes mellitus 100 (20.8) 31 (18.5) 31 (19.6) 38 (24.4) 0.39 34 (4.7) 14 (5.6) 10 (4.3) 10 (4.1) 0.70 Arterial sheath 5F 532 (72.8) 174 (69.0) 174 (74.0) 184 (75.4) 0.25 Successful access at first attempt 597 (81.7) 205 (81.4) 188 (80.0) 204 (83.6) 0.59 Left radial access 480 (65.7) 174 (69.1) 154 (65.5) 152 (62.3) 0.29 2.4 (1.0) 2.4 (0.9) 2.5 (1.1) 2.3 (0.9) 0.13 214 (29.4) 80 (31.8) 64 (27.4) 70 (28.8) 0.56 Emergency Nb of catheters Angioplasty P value
  • 10. SPASM3 Study p<0.001 30 Patients with spasm (%) p<0.001 25 26,6 p=ns 20 15 17,2 16,2 ISDN verapamil 10 5 0 diltiazem n=203 n=200 n=198 Rosencher J et al, Catheter Cardiovasc Interv. 2013 Aug 27, epub
  • 11. Efficacy endpoints TOTAL DILTIAZEM VERAPAMIL ISDN P value (N= 731) (N =252) (N=235) (N=244) RAS 147 (20.1) 67 (26.6) 38 (16.2) 42 (17.2) 0.006 Severe RAS 51 (7.0) 24 (9.5) 12 (5.1) 15 (6.2) 0.13 Pain evaluation / 10 1.2 (2.0) 1.2 (2.1) 1.4 (2.2) 1.1 (1.8) 0.18 Severe pain 17 (2.3) 7 (2.8) 3 (1.3) 7 (2.9) 0.43 Vascular rupture 1 (0.1) 0 (0) 1 (0.4) 0 (0) 0.35 Access site crossover 16 (2.2) 8 (3.2) 5 (2.1) 3 (1.2) 0.33 Crossover due to RAS 11 (1.5) 4 (1.6) 4 (1.7) 3 (1.2) 0.90 Morphine use 20 (2.7) 5 (2.0) 3 (1.3) 12 (4.9) 0.03 Midazolam use 85 (11.6) 39 (15.5) 27 (11.5) 19 (7.8) 0.03
  • 12. Independent predictors of RAS OR CI95% Male Gender 0.54 0.36 0.79 Emergency Procedure 4.05 1.97 8.32 Successful access at first attempt 0.55 0.35 0.85 Diltiazem use 1.76 1.21 2.57 Rosencher J et al, Catheter Cardiovasc Interv. 2013 Aug 27, epub
  • 13. Conclusions • Verapamil 2.5 mg and ISDN 1mg are more effective than diltiazem to prevent RAS • Diltiazem was an independent predictive factor of occurrence of RAS, with female gender, failure to puncture at first attempt, and emergency procedures • Verapamil 2.5 mg or ISDN 1mg can be recommended to prevent RAS during transradial procedures Rosencher J et al, Catheter Cardiovasc Interv. 2013 Aug 27, epub

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