Randomized clinical trial comparing transradial catheterization with or without spasmolytic drugs

1. Randomized Clinical Trial Comparing
Transradial Catheterization With or
Without Spasmolytic Drugs
Roberto Léo da Silva, MD
On behalf of LSC Luciano; DM Moreira; L Waldrich; L Panata; LEKS
Thiago; LC Giuliano; AP Trombetta; RS Conceição; T Fattah
Instituto de Cardiologia de Santa Catarina; Florianópolis
BRAZIL
clinicaltrials.gov Identifier: NCT02343276
4th Advanced International Masterclass
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Potential conflicts of interest
Speaker's name: Roberto Léo da Silva
• I do not have any potential conflict of interest
• This study was an independent and investigator-
driven study which did not receive funding by
any pharmaceutical or device company

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Background
• Catheterization by radial access has proved to be safe
and comfortable for the patients, as well as cost-
effective.
• Nevertheless, radial access requires more skilled labor
and it is technically more complex.
• Radial artery spasm. Frequency varies between 3 and
22%.
• Therefore, intra-arterial vasodilators have been used to
avoid it prophylactically.

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Radial Spasm
• Definition: wide variety.
• Patient’s comfort
• Operator’s difficulty
• Objective measure:
• Automatic pullback device (Kiemineij 2001)
• Image methods

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Radial Spasm
• Patient’s comfort:
• Visual Analogue Scale
• Operator’s difficulty:
• Procedure duration
• Radiation exposure

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Study Aim
• To compare the incidence of radial spasm
with and without the use of prophylactic
Nitroglycerin.

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Methodology
• Randomized, double-blind, placebo-controlled, single
centre study, conducted between January and August
2015.
• Randomization to Nitroglycerin or placebo after sheath
insertion. All patients received heparin 5000 units.
• Nitroglycerin
• 200 µg diluted with 0,9% saline to 10 ml
• Placebo
• 10 ml 0,9% saline alone

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Inclusion Criteria
• Aged 18 or over;
• Indication for cardiac catheterization;
• Suitable candidates for transradial approach.
Exclusion Criteria
• Primary angioplasty due to AMI;
• Intubated patients;
• Complications during procedure (cardiac arrest, pulmonary
edema, cardiogenic shock, stroke).
• Prior inclusion in this trial.

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Primary End Point
• Pain assessment using visual analogue scale.
Secondary End Points
• Procedure duration;
• Radiation exposure.

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Power Calculation & Sample Size
• Primary Endpoint: pain assessment
• Expected: 25,54 ± 25,73*
• Relative reduction in the primary endpoint: 30%
• Two-sided alpha level of 0∙05
• Power of 85%
• Sample Size:
• 328 patients
* The expected pain for radial catheterization was based on result from previous study conducted
to evaluate pain assessment using visual analogue scale.

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Baseline Characteristics
Nitroglycerin (n = 164) Placebo (n = 164)
Age (years), mean ± SD 60,93 ± 11,90 59,79 ± 11,15
Male, % 64,6 64,6
Weight (kg), mean ± SD 76,59 ± 17,14 76,61 ± 15,73
Height (m), mean ± SD 1,64 ± 0,09 1,65 ± 0,09
Body mass index, mean 28,47 28,13
Previous radial cath., % 17,7 15,9
p-value: >0,05

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Procedure Data
Values are % Nitroglycerin (n = 164) Placebo (n = 164)
Arterial sheath size
5 F
6 F
34,8
65,2
39,6
60,4
Radial punctures
attempts, mean ± SD 1,27 ± 0,71 1,22 ± 0,63
Needle radial puncture
One piece steel
Two piece
Angiocath®
11,6
88,4
9,1
90,9
Number of catheters,
mean ± SD 2,24 ± 1,03 2,09 ± 0,88
Procedure
Diagnostic
Therapeutic
Both
74,4
7,3
18,3
72,0
9,8
18,3p-value: >0,05

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Primary & Secondary Endpoints
Nitroglycerin (n=164) Placebo (n = 164) p-value
Pain assessment
(mm), mean ± SD
median
24,74 ± 26,0
19,00
24,75 ± 23,1
20,00
0,724
Procedure
duration (min),
mean ± SD
median
21,36 ± 13,57
17,40
22,24 ± 12,31
17,91
0,234
Radiation
exposure (mGy),
mean ± SD
median
655,61 ± 441,64
538,45
660,92 ± 433,25
548,75
0,635

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Operator’s Impression
Nitroglycerin (n=164) Placebo (n = 164)
0: neither pain or
resistance
59 (36,0%) 51 (31,1%)
1: without resistence
but with pain
92 (56,1%) 75 (45,7%)
2: small limitation of
catheters
movements
9 (5,5%) 23 (14,0%)
3: medium limitation
of cath. movements
4 (2,4%) 13 (7,9%)
4: severe limitation
of movements
0 (0%) 2 (1,2%)
p-value: 0,004

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Medication & Crossover
Nitroglycerin (n=164) Placebo (n = 164) p-value
Analgesic 5 (3,0%) 8 (4,9%) 0,418
Nitrate 5 (3,0%) 16 (9,8%) 0,013
Crossover* 1 (0,6%) 2 (1,2%) 0,562
* 1 crossover in Placebo group was due to anatomic variation. Others were due to spasm.

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Limitations
• Procedures were conducted in a single, high-volume
centre.
• All, but one operator, had high experience with radial
access.
• Although not powered to evaluate adverse effects
related to intra-arterial application of Nitroglycerin, we
had no complication.

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Conclusions
• Our data indicate that prophylactic use of
Nitroglycerin offers no advantage in terms of
comfort to patient during cardiac catheterization
by transradial approach.
• Although there is difference in subjective
operator's impression favoring the prophylactic
use of Nitroglycerin, objective measures of
difficulty show no difference.

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Conclusions
• Therefore, the prophylactic use of Nitroglycerin
may not necessarily be required in transradial
procedures.

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