Effects of topical medications on radial artery spasm in patients undergoing transradial coronary procedures: a systematic review protocol

Transcription

1 Effects of topical medications on radial artery spasm in patients undergoing transradial coronary procedures: a systematic review protocol Elizabeth Curtis 1,2 Ritin Fernandez 2,3 Astin Lee 4 1 Western Sydney University, Sydney, Australia, 2 University of Wollongong, Wollongong, Australia, 3 Centre for Evidence Based Initiatives in Health Care: a Joanna Briggs Institute Centre of Excellence, Australia, and 4 Department of Cardiology, The Wollongong Hospital, Wollongong, Australia Review objective: The objective is to identify the effectiveness of topical medications in reducing radial artery spasm in patients undergoing transradial coronary procedures. Keywords Angioplasty; coronary angiogram; radial artery; spasm; transradial Background P ercutaneous coronary procedures are the current gold standard utilized internationally for the diagnosis and/or treatment of coronary artery disease. 1,2 Percutaneous coronary procedures, traditionally carried out via the femoral artery, are now increasingly being performed via the brachial and radial arteries. 3,4 Initially, the femoral artery was the preferred option as it provided a large access point; however, this requires the patient to remain lying flat for an extended period of time during and after the procedure to restore hemostasis. 4,5 The anatomical location of the femoral artery can result in severe complications when removing the sheath and applying pressure to restore hemostasis, while the extended period of recovery time lying flat can often lead to lower back pain for the patient. 4,5 The transfemoral approach has also been associated with a number of complications including bleeding (particularly retroperitoneal hemorrhage), hematoma, pseudoaneurysm, nerve damage, arteriovenous fistulae, stroke and death. 6 In a metaanalysis of radial versus femoral catheterization for primary angioplasty where antiplatelet and thrombolytics are routinely used, the radial approach was associated with a significant (P < 0.001) reduction in mortality (5.2 versus 10.3%, OR (odds ratio) 0.42, 95% confidence interval [95% CI] 0.37, 0.48) and major bleeding Correspondence: Elizabeth Curtis, e.curtis@westernsydney.edu.au There is no conflict of interest in this project. DOI: /JBISRIR complications (1.9 versus 4.7%, OR 0.38, 95% CI 0.31, 0.47, P < ). 6 Over the last 20 years, there has been a global increase in the number of proceduralists performing percutaneous coronary procedures via the transradial approach. This increase can be attributed to the lower amount of complications in comparison to the femoral approach. 7 Campeau 8 initially recommended the radial approach for undertaking percutaneous diagnostic procedures due to its anatomic location and absence from major veins or nerves, resulting in the potential to reduce the rate of complications such as nerve damage and arteriovenous fistulae. Since then, the radial approach has also been documented as an option for undertaking percutaneous interventional procedures Despite the significant reduction in severe complications and the increase in popularity of the radial approach for percutaneous coronary procedures, concerns remain regarding the rates of procedural success. Procedural failure commonly occurs as a result of inability to cannulate the radial artery due to radial artery spasm (RAS), 12 causing severe limitations in the ability of the operator to manipulate the guide wires and catheters along the tortuous pathways of the arteries. 6,13 As a result, the operator may be required to cross over to an alternate access site to gain vascular access, which can, potentially, increase time and radiation exposure in the cardiac catheter laboratory. The radial artery is a type III limb artery and, as a result, is more easily prone to spasm in comparison to larger arteries. 14 The decreased diameter of the radial artery also presents a challenge JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 2

2 in relation to the size of the catheter that can be used. The literature suggests that catheter size and number of attempts at gaining access can have an impact on the level of trauma to the artery, leading to radial artery occlusion, hemorrhage, radial artery dissection, vasospasm, pseudoaneurysm, pain and thrombosis of the vessel. 12 The incidence of RAS has also been associated with an increase in the patient s experience of pain during cannulation of the radial artery. 7 A study that aimed to identify variables associated with RAS during transradial percutaneous coronary procedures found that 90% of patients who experienced severe pain during radial artery catheterization also experienced RAS during the procedure. 7 Various intra-arterial, intravenous and topical medications have been used to reduce the occurrence of vasospasm. Although the need for a prophylaxis to reduce the occurrence of RAS has previously been agreed upon by experts, 15 a specific medication or spasmolytic cocktail and method of administration has yet to be agreed upon. 16 Intravenous or intraarterial medications commonly utilized include calcium channel blockers and nitrates. 12,15-26 The use of topical nitroglycerine and lidocaine has been suggested in the literature to have an impact on the reduction in RAS incidents by causing vasodilation and increasing the radial artery diameter. 25 However, the evidence from the literature remains contradictory. Two studies assessing the effectiveness of topical nitroglycerine and lidocaine 12,26 reported a statistical significant (P < and P ¼ 0.005) increase in the diameter of the radial artery but no statistical significant decrease in the incidence of RAS, with RAS occurring in 25% of patients in both the placebo and treatment groups. 26 In contrast, other studies have reported a reduction in RAS incidents in patients receiving topical medications. 25,27 Given the controversy that surrounds the use of topical medications, a systematic review will be conducted to identify the effectiveness of topical medications on the incidence of RAS in patients having transradial coronary procedures. Kristic and Lukenda 13 carried out a review of trials assessing the effect of premedications on RAS. However, this did not include topical medications. Currently, there are no systematic reviews of randomized and quasi-randomized controlled trials addressing the effect of topical medications on RAS during percutaneous coronary procedures. Inclusion criteria Types of participants The current review will consider studies that include participants aged 18 years and over undergoing nonemergent transradial coronary procedures. Types of intervention(s)/phenomena of interest The current review will consider studies that use topical medications prior to commencing transradial coronary approaches to reduce RAS. Specific comparisons will be made between: Topical medication compared to no treatment Topical medication compared to placebo Topical medications compared to other medications. Outcomes The current review will consider studies that include the following outcomes: RAS as assessed by angiography, ultrasound to visualize RAS or resistance felt by the operator while manipulating the catheter. 15 Secondary outcomes will include a change in radial artery diameter measured by angiography or ultrasound and side effects of medications. Types of studies The current review will consider randomized and quasi-randomized controlled trials. Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE, EMBASE and Scopus will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe an article. A second search using all identified keywords and index terms will then be undertaken across all included databases. The key terms used will be transradial coronary procedures, coronary angio, premedication, lidocaine, nitroglycerine, Eutectic Mixture of Local Anesthetics, topical, artery spasm, radial. Third, the reference list of all identified reports and articles will be searched for additional studies. Studies published in English between 1989 to present will be considered for inclusion in this review. This date was selected as, prior to 1989, no studies on transradial percutaneous coronary procedures had been published. 8,13 JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 3

3 The databases to be searched include: MEDLINE, EMBASE, Scopus, Cochrane Central Register of Controlled Trial and clinicaltrials.gov. The search for unpublished studies will include: dissertation abstracts international, ProQuest dissertations & theses and MedNar. Assessment of methodological quality Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer. Data extraction Quantitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Data extraction will be carried out by one of the authors and checked by a second. In the event of missing information, the corresponding author will be contacted and clarification will be attempted. Data synthesis Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (WMDs) (for continuous data), and their 95% CIs will be calculated for analysis. Clinical heterogeneity will be assessed by considering the populations, interventions and outcomes between the studies. Statistical heterogeneity will be investigated by calculating the I 2 statistic, and if this indicates a high level of heterogeneity (75-100%) among the trials included in an analysis, a random effects meta-analysis will be preferred for the overall summary. Fixed effects meta-analysis will be used for combining study data if the trials are judged to be sufficiently similar. Analysis of continuous data will be undertaken using the mean and standard deviation values to derive WMDs and their 95% CIs. Where synthesis is inappropriate, a narrative overview will be undertaken. References 1. Mohandes M, Colomer I, De Castro R, Guarinos J, Rojas S, Fernández F, et al. Safety of diagnostic coronary angiogram by radial approach in patients on chronic anticoagulation therapy with coumarin derivatives. Int Cardiovasc Res J 2012;6(2): Aroney C, Aylward P, Kelly A-M, Chew D, Clune E. Guidelines for the management of acute coronary syndromes Med J Aust 2006;184:S Schueler A, Black SR, Shay N. Management of transradial access for coronary angiography. J Cardiovasc Nurs 2013;28(5): Mullin M. Transradial approach versus transfemoral approach for coronary angiography and coronary angioplasty. Crit Care Nurs Q 2014;37(2): Lunden M, Bengtson A, Lundgren S. Hours during and after coronary intervention and angiography. Clin Nurs Res 2006;15(4): De Luca G, Schaffer A, Wirianta J, Suryapranata H. Comprehensive meta-analysis of radial vs femoral approach in primary angioplasty for STEMI. Int J Cardiol 2013;168(3): Ruiz-Salmeron RJ, Mora R, Velez-Gimon M, Ortiz J, Fernandez C, Vidal B, et al. Radial artery spasm in transradial cardiac catheterization. Assessment of factors related to its occurrence, and of its consequences during follow-up. Rev Esp Cardiol 2005;58(5): Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989; 16(1): Kiemeneij F, Vajifdar BU, Eccleshall SC, Laarman G, Slagboom T, van der Wieken R. Evaluation of a spasmolytic cocktail to prevent radial artery spasm during coronary procedures. Catheter Cardiovasc Interv 2003;58(3): Caputo RP, Tremmel JA, Rao S, Gilchrist IC, Pyne C, Pancholy S, et al. Transradial arterial access for coronary and peripheral procedures: Executive summary by the transradial committee of the SCAI. Catheter Cardiovasc Interv 2011; 78(6): Rao SV, Tremmel JA, Gilchrist IC, Shah PB, Gulati R, Shroff AR, et al. Best practices for transradial angiography and intervention: A consensus statement from the society for cardiovascular angiography and intervention s transradial working group. Catheter Cardiovasc Interv 2014; 83(2): Majure D, Hallaux M, Yeghiazarians Y, Boyle A. Topical nitroglycerin and lidocaine locally vasodilate the radial JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 4

4 artery without affecting systemic blood pressure: a dosefinding phase I study. J Crit Care 2012;27(5): Kristic I, Lukenda J. Radial artery spasm during transradial coronary procedures. J Invasive Cardiol 2011;23(12): He G-W, Yang C-Q. Comparison among arterial grafts and coronary artery: an attempt at functional classification. J Thorac Cardiovasc Surg 1995;109(4): Hizoh I, Majoros Z, Major L, Gulyas Z, Szabo G, Kerecsen G, et al. Need for prophylactic application of verapamil in transradial coronary procedures: a randomized trial. The VITRIOL (is Verapamil In TransRadial Interventions OmittabLe?) trial. J Am Heart Assoc 2014;3(2):e Hamon M, Pristipino C, Di Mario C, Nolan J, Ludwig J, Tubaro M, et al. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology. Eurointervention 2013;8(11): Kim SH, Kim EJ, Cheon WS, Kim M-K, Park WJ, Cho G-Y, et al. Comparative study of nicorandil and a spasmolytic cocktail in preventing radial artery spasm during transradial coronary angiography. Inter J Cardiol 2007;120(3): Rosencher J, Chaib A, Barbou F, Arnould MA, Huber A, Salengro E, et al. How to limit radial artery spasm during percutaneous coronary interventions: the spasmolytic agents to avoid spasm during transradial percutaneous coronary interventions (SPASM3) study. Catheter Cardiovasc Interv 2014;84(5): Chen C-W, Lin C-L, Lin T-K, Lin C-D. A simple and effective regimen for prevention of radial artery spasm during coronary catheterization. Cardiology 2006;105(1): Byrne J, Spence M, Haegeli L, Fretz E, Della Siega A, Williams M, et al. Magnesium sulphate during transradial cardiac catheterization: a new use for an old drug? J Invasive Cardiol 2008;20(10): Ruiz-Salmerón RJ, Mora R, Masotti M, Betriu A. Assessment of the efficacy of phentolamine to prevent radial artery spasm during cardiac catheterization procedures: a randomized study comparing phentolamine vs. verapamil. Catheter Cardiovasc Interv 2005;66(2): Varenne O, Jegou A, Cohen R, Empana JP, Salengro E, Ohanessian A, et al. Prevention of arterial spasm during percutaneous coronary interventions through radial artery: the SPASM study. Catheter Cardiovasc Interv 2006; 68(2): Mont Alverne Filho JR, Assad JA, Zago Ado C, da Costa RL, Pierre AG, Saleh MH, et al. Comparative study of the use of diltiazem as an antispasmodic drug in coronary angiography via the transradial approach. Arq Bras Cardiol 2003;81(1):59 63; Dharma S, Shah S, Radadiya R, Vyas C, Pancholy S, Patel T. Nitroglycerin plus diltiazem versus nitroglycerin alone for spasm prophylaxis with transradial approach. J Invasive Cardiol 2012;24(3): Youn YJ, Kim W-T, Lee J-W, Ahn S-G, Ahn M-S, Kim J-Y, et al. Eutectic mixture of local anesthesia cream can reduce both the radial pain and sympathetic response during transradial coronary angiography. Korean Circ J 2011;41(12): Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, et al. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol 2013;168(3): Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J 2009;157(1): JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 5

5 Appendix I: Appraisal instrument MAStARI appraisal instrument JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 6

6 Appendix II: Data extraction instrument MAStARI data extraction instrument JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 7

7 JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 8