The frequency of radial artery occlusion was compared between patients receiving 4Fr versus 6Fr transradial coronary interventions (TRIs) in an open-label randomized trial ( ClinicalTrials.gov identifier: NCT00815997 ). The primary outcome measure was radial artery occlusion on the day after TRI. The secondary outcome measures were the procedural success, major advanced cardiac events, access site–related complications, procedural times, fluoroscopy times, and contrast dye usage. A total of 160 patients were included. The procedure was successful in 79 of 80 patients (99%) in both groups. Whereas the 4Fr group showed no access site–related complications, the 6Fr developed 5 (6%), including 3 radial artery occlusions and 2 bleedings (1 radial artery perforation and 1 massive hematoma; p = 0.02). Although the radial artery occlusion rate was lower in the 4Fr versus the 6Fr groups, the difference was not significant (0% vs 4%, p = 0.08). The mean hemostasis time was significantly shorter in the 4Fr than in the 6Fr groups (237 ± 105 vs 320 ± 238 minutes, p = 0.007). In conclusion, these findings suggest that 4Fr TRI may become a less invasive alternative to 6Fr TRI in treating coronary artery diseases.
Since Gruentzig completed the first human percutaneous coronary balloon angioplasty in 1977, angioplasty equipment has become progressively miniaturized. In the early years, 9Fr and 10Fr guiding catheters were used. Now, a 4Fr guiding catheter is available for minimally invasive coronary intervention. Although not previously studied, the small profile of the 4Fr guiding catheter may reduce complications associated with vascular access. The hypothesis underlying this study was that using a 4Fr guiding catheter would have a lower rate of radial artery occlusion compared with the use of 6Fr guiding catheter. Hence, we undertook an open-label randomized trial to compare the incidence of radial artery occlusion when either 4Fr or 6Fr guiding catheters were used in transradial coronary interventions (TRIs).
Methods
The Novel Angioplasty USIng Coronary Accessor (NAUSICA) trial ( ClinicalTrials.gov identifier: NCT00815997 ) was a prospective, open-label, multicenter randomized trial involving patients with coronary artery diseases who were undergoing TRI. The trial was designed by the principal investigator and the executive committee and managed by the International TRI Network, a nonprofit organization. The principal investigator had unrestricted access to the data after the database was locked, decided whether the study’s findings should be submitted for publication, prepared the manuscript, and vouched for the integrity of the data.
The study was conducted at 19 institutions across Asia. Every patient who was undergoing stent implantation through the transradial route and who was aged >18 years was eligible for the study. The prerequisites for TRI were a sufficiently pulsating radial artery and the presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia based on Allen test. Angiographic exclusion criteria were lesions associated with the large side branches requiring wire protection or application of the kissing balloon technique and the intended use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which are not compatible with the use of a 4Fr guiding catheter. In addition, patients requiring stents that were not compatible with a 4Fr guiding catheter were excluded. The study was approved by the institutional review board or ethics committee at each participating hospital, and all patients gave written informed consent.
Eligible patients were randomly assigned in a 1:1 ratio to undergo TRI using the 4Fr guiding catheter (KIWAMI, Heartrail II; Terumo, Tokyo, Japan; 4Fr TRI group) or the 6Fr guiding catheter (6Fr TRI group). A computer-based random generator system performed the randomization. The primary end point was radial artery occlusion the day after TRI, defined as the absence of a radial pulse confirmed by a reverse Allen test. Secondary end points were the success of the procedures, onset of major adverse cardiac events, access site–related complications, procedural times, and contrast dye usage. Procedural success was defined as a postprocedural residual stenosis of <20% and a Thrombolysis In Myocardial Infarction grade 3 angiographic flow without major adverse cardiac events during in-hospital follow-up. Major adverse cardiac event was defined as cardiac death, Q-wave myocardial infarction, and target lesion revascularization. Access site–related complications were defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery, which were considered to be major if they were associated with a vascular repair or a blood transfusion.
The procedure was conducted by physicians who were expert in TRI. The sizes of the guiding catheters and the introducer sheaths used were randomized. If the TRI using the randomized size of the guiding catheter and introducer sheath failed, crossover to use the other size of guiding catheter and/or introducer sheath or to use other puncture sites (i.e., brachial or femoral puncture) was allowed. The sheath was removed immediately after withdrawal of the guiding catheter. Hemostasis of the radial puncture site was achieved using a TR Band pressure bandage (Terumo), a Tometa-Kun compression system (Zeon Medical, Tokyo, Japan), a Stepty-P elastic bandage (Nichiban, Tokyo, Japan), or manual compression followed by the application of gauze and a tourniquet. In all instances, puncture site compression was released 4 hours after the procedure. If bleeding from the puncture site continued, radial compression was resumed and continued until complete hemostasis was achieved.
The trial was powered to show the noninferiority of 4Fr TRI compared with 6Fr TRI in achieving the primary end point of radial artery patency, with a 2-sided α level of 0.05. Assuming a radial artery occlusion rate of 1% in the 4Fr and 6% in the 6Fr groups, with a noninferiority margin, δ, of 5%, and with 60 patients assigned to each group, we calculated that the trial would have a 90% power to show the noninferiority of 4Fr TRI in achieving the primary efficacy end point. Taking into account the dropout rate, the final sample size was determined to be 80 patients in each group. Data were analyzed on an intention-to-treat basis. Categorical variables were compared using the chi-square test, and continuous variables, which are expressed as the mean ± SD, were compared using unpaired Student t tests, using the StatView application (SAS Institute Inc., Cary, North Carolina). Statistical significance was defined as a p value of <0.05.
Results
The present study comprised a total of 160 patients divided into 2 groups, those who underwent 4Fr TRI and those who underwent 6Fr TRI. The patients’ demographic and clinical data are provided in Table 1 . No significant differences were found between the patient groups for any of the demographic criteria, including age, gender, co-morbidities, and lesion types. In both groups, type A or B1 lesions accounted for >70% of the cases.
| Variable | 4-Fr TRI (n = 80) | 6-Fr TRI (n = 80) |
|---|---|---|
| Age (years) | 68 ± 11 | 68 ± 11 |
| Male gender | 63 (79%) | 64 (80%) |
| Diabetes mellitus | 20 (25%) | 28 (35%) |
| Hypertension | 44 (55%) | 50 (63%) |
| Dyslipidemia | 40 (50%) | 44 (55%) |
| Smoker | 21 (26%) | 25 (31%) |
| Cerebrovascular disease | 5 (6%) | 7 (9%) |
| Previous coronary bypass surgery | 5 (6%) | 5 (6%) |
| Multivessel disease | 29 (36%) | 34 (43%) |
| Lesion AHA/ACC type | ||
| A | 38 (48%) | 35 (44%) |
| B1 | 23 (29%) | 22 (28%) |
| B2 | 13 (16%) | 14 (18%) |
| C | 6 (8%) | 9 (11%) |
Table 2 presents the procedural characteristics for each patient group. The reason for the crossover from the 4Fr to the 6Fr guiding catheter was poor support by the 4Fr guiding catheter in all 3 instances. In 1 patient, the balloon catheter failed to cross the lesion even after crossover to the 6Fr guiding catheter and despite using the Tornus catheter and mother-child techniques. Crossover from the 6Fr to the 4Fr guiding was observed in 1 patient because of radial spasm. The difference between the crossover rates to the alternative guiding catheter was not significant.
| Variable | 4-Fr TRI (n = 80) | 6-Fr TRI (n = 80) | p Value |
|---|---|---|---|
| Guiding catheter crossover | 3 (4%) | 1 (1%) | NS |
| Access-site crossover | 1 (1%) | 2 (3%) | NS |
| Procedural success | 79 (99%) | 79 (99%) | NS |
| Procedure time (minutes) | 37 ± 21 | 37 ± 22 | NS |
| Fluoroscopy time (minutes) | 13 ± 9 | 12 ± 11 | NS |
| Contrast dye volume (mL) | 87 ± 45 | 101 ± 68 | NS |
| Hemostasis time (minutes) | 237 ± 105 | 320 ± 238 | 0.007 |
| Access-site-related complications | 0 (0%) | 5 (6%) | 0.02 |
| Radial artery occlusion | 0 (0%) | 3 (4%) | 0.08 |
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