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

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