03 Wainstein aimradial20170922 Compression device
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This randomized clinical trial compared the TR Band hemostasis device to pressure dressing in 600 patients undergoing transradial coronary procedures. The study found that the incidence of radial artery occlusion was low and similar between the two hemostasis techniques at discharge and 30 days. While the TR Band was associated with a longer additional hemostasis time and more minor bleeding, there was no significant difference between the groups in successful hemostasis, need for additional hemostasis, hematoma formation, or pain. Peripheral vascular disease was identified as an independent predictor of radial artery occlusion.
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03 Wainstein aimradial20170922 Compression device
- 1. Comparision of 2 Hemostasis Techniques After Transradial Coronary Procedures: Randomized Clinical Trial Rodrigo V. Wainstein, MD, PhD Federal University of Rio Grande do Sul Medicine School - Cardiology Division rwainstein@hcpa.edu.br HEMOTEC-Radial
- 2. Disclosures • I have no conflict of interest to declare
- 3. Background • Radial artery occlusion (RAO) has been reported to occur in up to 30% of patients undergoing transradial approach (TRA) procedures • RAO may result from arterial spasm, endothelial injury, thrombus formation, and/or neointimal hyperplasia • Low profile equipment, adequate anticoagulation and patent hemostasis are the most important measures to prevent RAO • The influence of different hemostasis devices and protocols on RAO is still controversial
- 4. RCT, n=790 Rathore S et al. Catheter Cardiovasc Interv. 2010. 4-6meses A randomized comparison of TR band and radistop hemostatic compression devices after transradial coronary intervention Angio ± PCI, 6Fr
- 5. A comparison of 2 devices for radial artery hemostasis after transradial coronary intervention Dai N et al. J Cardiovasc Nurs. 2015. RCT, n=600, PCI, 6Fr
- 6. Randomized Comparison of 3 Hemostasis Techniques After Transradial Coronary Intervention Cong X et al. J Cardiovasc Nurs. 2016. Pressure Dressing TR Band Work Angio± PCI, 6FrAngio± PCI, 6Fr RCT, n=1650
- 9. Hypothesis • Radial artery hemostasis with TR Band© reduces the risk of radial artery occlusion when compared to pressure dressing with elastic bandage in patients undergoing transradial diagnostic and therapeutic cardiac procedures.
- 10. Study Design Comparision of 2 Hemostasis Techniques After Transradial Coronary Procedures: Randomized Clinical Trial – HEMOTEC-Radial •Randomized Clinical Trial •Single Center •Blinded outcome evaluation •Registered at:
- 11. Study Site • Hospital de Clínicas de Porto Alegre • Large tertiary center • University Hospital • Internationally accredited (JNC)
- 12. Eligible Patients (n=1,794) Excluded (n=1,194) •Femoral (n=805) •Right heart Cath (n=100) •Left radial (n=16) •Brachial/Ulnar (n=9) •Logistics (n=264) Randomized (n=600) TR Band © •Received TR Band (n=301) Pressure Dressing (PD) •Received PD (n=299) 301 Analysed (100%) Enrollment Allocation Analysis 299 Analysed (100%) Flowchart Nov, 2015 - Oct, 2016.
- 13. Eligible Patients (n=1,794) Excluded (n=1,194) •Femoral (n=805) •Right heart Cath (n=100) •Left radial (n=16) •Brachial/Ulnar (n=9) •Logistics (n=264) Randomized (n=600) TR Band © •Received TR Band (n=301) Pressure Dressing (PD) •Received PD (n=299) 301 Analysed (100%) Enrollment Allocation Analysis 299 Analysed (100%) Flowchart F/U: 30 days n=101 (30%) n=100 (30%) Nov, 2015 - Oct, 2016.
- 14. Study Population Inclusion Criteria •≥ 18 years old •Submitted to cath or PCI •Type A, B or C on Barbeau test •Writen informed consent signed Barbeau Test Exclusion Criteria •Radial artery occlusion on reverse Barbeau test •Arterial access other than right radial •Unable to sign informed consent form •Logistics (off-hours, non trained staff)
- 15. Outcomes Primary outcome •Radial artery occlusion (reverse Barbeau test) : • at discharge • in 30 days Secondary outcomes •Additional hemostasis time with original device (>150min for TR band© and >120min for pressure dressing) •Succesful hemostasis with original device •Failed hemostasis with original device (need for digital compression) •Additional hemostasis time with digital compression •Minor bleeding •Hematoma (EASY classification) •Pain/Pain scale ( 0-10)
- 16. Methods Sample size calculation •Estimated 7% difference of RAO between groups •Power 80% •Level of significance of 5% ( p<0.05) •Losses 20% •n= 600 Randomization •On line randomization •Followed CONSORT recommendations •Sealed opaque sequentially numbered envelopes
- 17. Regular Dressing reverse Barbeau Test TR Band© Procedure 6Fr sheath Device withdrawn Randomization/ Allocation Study Protocol 120+30min Barbeau Test
- 18. Regular Dressing Regular Dressing reverse Barbeau Test TR Band© Pressure Dressing Procedure 6Fr sheath Device withdrawn Randomization/ Allocation Study Protocol 120min120+30min Barbeau Test
- 19. Sample (n=600) TR Band© (n=301) Dressing (n=299) Age (years) 63 ± 10 63 ± 10 63 ± 10 Sex (male) 344 (57%) 161 (53%) 183 (61%) BMI (kg/m2 ) 29 ± 5 29 ± 5 28 ± 5 Wrist Circunference (cm) 17.7 (12-23) 17.7 (12-23) 17.9 (14.5-23) Systolic Pressure, mmHg 143 ± 27 143 ± 27 145 ± 28 Diastolic Pressure, mmHg 79 ± 13 79 ± 13 81 ± 12 BASELINE CHARACTERISTICS Data shown in n(%) – Mean ± SD Results
- 20. Sample (n=600) TR Band© (n=301) Dressing (n=299) Diabetes 242 (40%) 131 (44%) 111 (37%) Previous MI 126 (21%) 64 (21%) 62 (21%) PVD 20 (3%) 13 (4%) 7 (2%) Active smoker 103 (17%) 50 (17%) 53 (18%) Antiplatelets 457 (76%) 227 (75%) 230 (77%) PVD: peripheral vascular disease Data shown in n(%) BASELINE CHARACTERISTICS Results
- 21. Sample (n=600) TR Band© (n=301) Dressing (n=299) Diagnostic Angiogram 496 (82%) 243 (81%) 253 (85%) PCI 40 (17%) 22 (7%) 18 (6%) Angio + PCI 64 (11%) 36 (12%) 28 (9%) Previous radial access 108 (18%) 55 (18%) 53 (17%) 5Fr catheter 318 (53%) 154 (51%) 164 (55%) Number of catheters 2 ± 1 2 ± 1 2 ± 1 Abciximab 10 (2%) 5 (2%) 5 (2%) Heparin dose (UI) 5314 ± 2091 5313 ± 2135 5315 ± 2050 Vasoespasm 46 (8%) 25 (8%) 21 (7%) BASELINE CHARACTERISTICS Data shown in n(%) – Mean ± SD Results
- 22. 8% 6% 20 40 TR Band Pressure Dressing Incidence of RAO at discharge P = 0.53 Primary Outcomes
- 23. 5% 6% 20 40 TR Band Pressure Dressing Incidence of RAO in 30 days P = 0.86 Primary Outcomes
- 24. 89.5% 87% 50% 100% TR Band Pressure Dressing Successful hemostasis P = 0.18 Secondary Outcomes
- 25. Sample (N=600) TR Band© (N=301) Dressing (N=299) P Additional hemostasis 144(24) 85(28) 59(20) 0.02 Additonal hemostasis time 20[10-40] 30[15-48] 15[10-35] 0.04 Failed hemostasis 75(13) 32(11) 43(15) 0.18 Digital compression time 10[5-15] 10[5-15] 10[5-20] 0.69 Secondary Outcomes Data shown in n(%) – Median [IQR] - Time (minute)
- 26. Sample (n=600) TR Band© (n=301) Dressing (n=299) p Minor bleeding 107 (18%) 67 (22%) 40 (13%) 0.006 Hematoma (EASY) 53 (9%) 20 (7%) 33 (11%) 0.080 Type I (≤5cm) 35 (6%) 13 (4%) 22 (7%) Type 2 (≤10cm) 12 (2%) 4 (1%) 8 (3%) 0.230 Type 3 (≥10cm) 5 (1%) 2 (0.7%) 3 (1%) Pain complaint 76 (13%) 36 (12%) 40 (13%) 0.690 Pain scale 5 ± 2 5 ± 2 5 ± 2 0.958 Secondary Outcomes Data shown in n(%) – Mean ± SD
- 27. Baseline Characteristic R2 p Systolic pressure (mmHg) -102 0.013 Antiplatelets -0.087 0.033 Statins -0.106 0.009 PVD 0.92 0.024 Wrist Circunference (cm) 0.005 0.903 BMI (kg/m2 ) 0.010 0.805 TR Band -0.031 0.443 Predictors of RAO PVD: peripheral vascular disease UNIVARIATE ANALYSIS
- 28. Baseline Characteristic OR IC95% Systolic pressure (mmHg) 0.98 0.97-0.99 PVD 4.99 1.50-16.55 Antiplatelets 1.64 0.77-3.49 Statins 2.03 0.98-4.20 TR Band 1.15 0.61-2.18 PVD: peripheral vascular disease Predictors of RAO MULTIVARIATE ANALYSIS
- 29. • Small sample size • Single center • Lack of patent hemostasis Limitations
- 30. • Small sample size Largest trial comparing TR Band vs PD; adequate power. • Single center Large volume center, experienced staff • Lack of patent hemostasis Pragmatic hemostasis protocol (ALAP) Limitations
- 31. Conclusions • Incidence of RAO was low and similar to previous trials • TR Band and Pressure Dressing were equivalent regarding to: – RAO at discharge and 30 days – Successful hemostasis rate – Incidence of hematoma and pain – Need for additional hemostasis with digital compression • Minor local bleeding was more commom with TR Band • Additional hemostasis time was longer with TR Band
- 32. Comparision of 2 Hemostasis Techniques After Transradial Coronary Procedures: Randomized Clinical Trial Rodrigo V. Wainstein, MD, PhD Federal University of Rio Grande do Sul Medicine School -Cardiology Division rwainstein@hcpa.edu.br HEMOTEC-Radial
Editor's Notes
- Good morning Mr Chairman, members of the panel and audience. It’s a great honor to present the Hemotec Radial on behalf of my coleagues in Brazil
- Several trials regarding radial hemostasis have been published in the last 10y. In this trial, Rathore compared the Radistop device with the TR Band in 800 patients and found that time taken to achieve hemostasis was a bit lower in the radistop group, nevertheless the total hemostasis time was much longer than what is currently recommended in both groups ( around 5h). RAO incidence was also similar in both groups: around 9% at discharge and 8-6% in the 30day F/U Incidência OAR Imediata: 9,6% vs 8,9 % p=0,892 4-6 meses: 8 % vs 5,6 % p=0,273 Conforto There was a significantly higher incidence of radial artery occlusion in patients with a smaller wrist circumference, patients who expe- rienced radial artery spasm during the procedure and patients with no heparin administration during the pro- cedure.
- In this other trial the TR Band was compared to a Chitosan based pad. Compression time was again significantly longer with TR Band ( 3h with the TR Band and 2h with the Chitosan pad). Moreover, oozing from the puncture site and RAO assessed in 24h and 30 days were also more commom in the TR Band group Desenvolvidos por ENFEREMEIRO Incidência OAR GI vs GC: 24h: 5,4% vs 11.7% (p&lt;0,05) 30 dias: 5% vs 10 % (p&lt;0,05) ICP, 6F A total of 526 patients received the ultrasound examination 30 days after the procedure, 260 patients in the CD group and 266 patients in the CS group.
- However, this larger trial enrolled almost 1700 patients and compared 3 hemostasis devices (regular pressure dressing, TR Band and a rotacional compression pad) and it showed different results from the others. Time taken to achieve hemostasis was significantly longer with the pressure dressing than the other two devices. Moreover, the incidence of early RAO (24h) and late RAO (30d) were also higher with pressure dressing. Incidência OAR: PD, PCD, PCD 24h: 15.6%, 5.8%, 4.5% 30 dias: 12%, 2.7%, 2.1%
- So, as I mentioned before hemostasis devices and protocols are very heterogeneous and there is no consesus regarding which one is better. Therefore, we aimed to investigate specifically if the TR Band is superior to a regular pressure dressing with elastic bandage which has been used for many years in low income contries
- So, as I mentioned before radial hemostasis devices and protocols are very heterogeneous and there is no consesus regarding which one is better. Therefore, we aimed to investigate specifically if the TR Band is superior to a pressure dressing with elastic bandage which has been used for many years in low income contries
- So our hypothesis is :
- It is a randomized clinical trial , performed in a single center, with blinded outcome evaluation and the trial was registred in the clinicaltrial,gov web site
- Our study site was the Hospital de Clinicas de Porto alegre, a large tertiary center located in the extreme south of Brazil. It is affiliated to the Federal University of Rio Grande do Sul and is internationally accredited by the JNC
- 1794 patients were eligible to the study. The patients were prospectively enrolled from nov 2015 to october 2016. 1194 patients were excluded, mainly the patients done from transfemoral approach, those who undewent RHC and due to logistic reasons. Therefore, 600 were randomized. 301 allocated to the TR Band group and 299 patients allocated to the PD group. There were no losses for the primary outcome analysis, both at discharge of the recovery room and in a pre-specified 30 days F/U perfomed in 30% of the sample
- 1794 patients were eligible to the study. The patients were prospectively enrolled from nov 2015 to october 2016. 1194 patients were excluded, mainly patients done from transfemoral approach, those who undewent RHC and due to logistic reasons. Therefore, 600 were randomized. 301 allocated to the TR Band group and 299 patients allocated to the PD group. There were no losses for the primary outcome analysis, both at discharge of the recovery room and in a pre-specified 30 days F/U perfomed in 30% of the sample
- The primary outcome was radial artery oclusion assessed by reverse barbeau test at discharge and in 30 days. Secondary outcomes were..
- Sample size was calculated estimating a 7% difference of RAO between groups, with a power of 80%, level of significance of 5% and estimated losses of 20%. Patients were randomized on line, following the consort recomendations and sealed opaque sequentially numbered envelopes were used
- Eligible patients were submitted to a Barbeau test. The procedure was done from the right radial with a 6Fr sheat. After finished the procedure the patient was randomized and allocated to one of the groups. The TR Band protocol consisted of inflating the device up to 15cc, retrieving the sheath and slowly deflating until blood is seen in the puncure site then 1 or 2cc was added again to secure hemostasis and this pressure was kept for 2h. Then the device was again slowly deflated 1-2cc evey 10 min in the next 30 min. After removing the device, the reverse Barbeau test was perfomed and recorded by a blinded investigator
- The pressure dressing with elastic bandage was fixed by a experienced nurse with enough pressure to prevent bleeding and secure hand perfusion. The device was removed after 2h and the reverse barbeau test was perfomed and recorded by a blided investigator
- Regarding the results, patient baseline characteristics were well balanced between the two groups and there were no statiscally differences between them. Mean age was 63yo and aproximately 60% were male
- Diabetes was present in approximately 40%, peripheral vascular disease in 3%, around 17% were active smokers and antiplateles were being used by almost 80% of the patients
- The vast majority of the patients underwent diagnostic angiogram. Aproximately 20% had been submitted to a previous coronary procedure from the right radial artery, 5Fr catheters were used in half the patients, mean heparin dose was 5 thousand units and vasoespasm occured in 8% of the patients
- Regarding the primary outcome, the incidence of RAO at discharge of the recovery room was similar between the groups. 8% in the TR Band group and 6% in pressure dressing group Chi-square.
- As I mentioned before, an additional pre-especified F/U with 30% of the sample was performed in 30 days and continued to show that the incidence of RAO was similar between groups. Interestingly, as reported previously, there was some recanalization of the radial artery in the TR Band group Chi-square (Pearson)
- As you can see, success in radial hemostasis with original device was around 90% and also similar between groups Chi-square (Pearson)
- Regarding the other secondary outcomes, TR Band was associated with more need for additional hemostasis (28% X 20%) with a p value of 0.02 and additional hemostasis time was also longer with TR Band (median 30min x 15 min) with a p value of 0.04. Failed hemostasis and need for digital compression was similar between groups Chi-square and frequencies
- Minor local bleeding, which was defined as persistent oozing from the puncture site with hematoma formation was also more commom with the TR Band ( 22% x 13%. Incidence of hematoma assessed with the Easy criteria and pain were similar between the groups
- On univariate analysis, systolic pressure, antiplatelets and statins were found protect against RAO and peripheral vascular disease was found to be a predictor of RAO
- On multivariate analysis, however, only systolic pressure was found to be an independent predictor of RAO prevention
- We do have to acknowledge some limitations of this randomized trial. It had a relatively small sample sized
- We do have to acknolowdge some limitations of this randomized trial. It had a relatively small sample sized, however it has adequate power and it is largest head to head comparison TR Band with pressure dressing. Also, it is was conducted in a single center, but with large volume and experienced staff, at last, patent hemostasis was not part of the protocol, nevertheless we perfomed a pragmatic hemostasis protocol keeping pressure as low as possible to prevent bleeding and secure hand perfusion
- Therefore, we conclude that in our trial:
- Good morning Mr Chairman, members of the table and audience. It’s a great honor to present the Hemotec Radial on behalf of my coleagues in Brazil