Background

The use of percutaneous coronary procedures for the diagnosis and management of coronary artery disease has increased steadily in the past decade.1 Percutaneous coronary procedures include coronary angiography as well as coronary interventions. Percutaneous coronary procedures require the introduction of arterial sheaths to access the vascular system.2 Due to its large diameter, the femoral artery has, in the past, been the preferred route of access for arterial sheath insertion.3 However, obtaining hemostasis following femoral artery sheath removal has been challenging, resulting in severe pain or discomfort for the patient, increased length of hospital stay and re-admission to hospital.4 In addition, vascular complications such as hematoma, bleeding at the site, retroperitoneal bleeding, pseudo-aneurysm and arteriovenous fistula-fistula creation have been reported in patients who have received percutaneous procedures via the femoral approach.3,5,6

Over the past two decades, technological advances have resulted in trans-radial access for percutaneous coronary procedures7 becoming the preferred access route, and it is being increasingly used for emergent and elective coronary procedures.8,9 In contrast to the femoral approach, where hospital stays can range over several days, the radial approach has resulted in shorter periods of hospitalization and a reduction in vascular complications.10 In addition, significant reduction in 30-day mortality has been demonstrated with the radial compared to the femoral approach.11

Despite the benefits, the risks associated with the trans-radial approach are significant, therefore requiring expert care in negotiating the peri-procedural period. Due to the smaller diameter of the artery, radial artery occlusion (RAO) is a complication that occurs in the first 24 hours following sheath removal.12,13 It is purported that sheath insertion causes local endothelial injury and cessation of blood flow in the radial artery, thus causing arterial thrombosis leading to RAO.14 If left untreated, this complication can cause hand ischemia. In addition, the occurrence of RAO prohibits future trans-radial access for percutaneous procedures. Age, gender, anti-coagulation therapy, repeated interventional cardiology procedures15,16 and strategies for achieving vascular site hemostasis can all impact on RAO.

Observational studies have demonstrated that compression and closure methods for obtaining hemostasis post arterial sheath removal are causative factors for RAO. The commonly used compression and closure methods are manual compression, mechanical compression17 and synthetic pad impregnated with a pro-coagulant agent such as Kaolin.18 Tourniquets are widely used with good results and low complication rates.14,19 However, the disadvantage of tourniquets is the application of pressure across the whole wrist and not just at the site of arterial access which can cause ulnar artery compression20 resulting in increased patient discomfort. In addition, venous congestion of the hand has been reported if the tourniquet is applied for a prolonged period.21 Pneumatic compression devices such as the TR Band (Terumo, Japan) and RADI Stop (RADI, Uppsala, Sweden)22,23 have been developed to deliver pressure at the puncture site rather than the whole wrist with sustained arterial and venous residual flow. These devices enhance patient comfort and can be kept in place for a prolonged period of time to achieve hemostasis.22,23 Various other mechanical devices have been developed and used with varying results.

Clinical trials have reported varying results relating to RAO for different compression methods. A search of the Cochrane Database of Systematic Reviews, the JBI Database of Systematic Reviews and Implementation Reports, MEDLINE and DARE databases was performed and no current or in progress systematic review on this topic was identified. Therefore, the aim of this review is to systematically review the literature and identify the best available evidence relating to the effects of various methods used to achieve hemostasis on RAO rates in adult patients following the radial artery approach for percutaneous coronary procedures.

Inclusion criteria

Types of participants

The current review will consider studies that include adult patients (18 years and above) who have had a percutaneous coronary procedure via the radial artery.

Types of interventions

The interventions will include manual compression, hemostatic dressings and pneumatic compression. The comparator will include patients treated with traditional methods, including tourniquets and elastic, bandages or one of the interventions.

Outcomes

The primary outcome of interest is the incidence of RAO assessed using objective measures such as the Allens test, Doppler ultrasound or through angiographic evidence at the time of discharge and persistent occlusion at the time of follow-up.

Secondary outcomes include vascular complications, such as:

* Local small hematoma and large hematoma

* Time taken to achieve hemostasis

* Failure of closure device (active bleeding)

Types of studies

The current review will consider any randomized controlled trials (RCTs); in the absence of RCTs quazi-RCTs will be considered for inclusion in the review.

Search strategy

The search strategy will aim to find both published and unpublished studies as old as possible. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe each article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Third, the reference list of all identified reports and articles will be searched for additional studies. No date or language restrictions will be applied, and studies will be searched without a date limit.

Initial keywords to be used will be radial artery, radial sheath, cardiovascular, hemostasis, bleeding, compression, closure device, occlusion.

The databases to be searched include CINAHL, EMBASE, PUBMED and Cochrane Central Register of Controlled Trials.

The search for unpublished studies will include, Clinicaltrials.govanzctr.org.au, WorldCat, ProQuest and Mednar.

Assessment of methodological quality

Quantitative 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). Data extraction from the included trials will be undertaken and summarized independently by two reviewers. The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. If any data are missing from the trial report, attempts will be made to obtain them by contacting the authors.

Data synthesis

All calculations will be made using Review Manager 5.2 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012). All results will be subject to double data entry. Clinical heterogeneity will be assessed by considering the populations, interventions and outcomes between the studies. Statistical heterogeneity will be investigated by calculating the I² statistic,24 and if this indicates a high level of heterogeneity among the trials included in an analysis, a random effects meta-analysis will be preferred for the overall summary. Where high levels of heterogeneity are found, they will be explored by the pre-specified sub-group analyses and by sensitivity analyses excluding the trials most susceptible to bias based on the quality assessment. Fixed effects meta-analysis will be used for combining study data if the trials are judged to be sufficiently similar. Relative risks and 95% confidence intervals (CIs) will be calculated for dichotomous data. Analysis of continuous data will be undertaken using the mean and standard deviation values to derive weighted mean differences and their 95% CIs. Where synthesis is inappropriate a narrative overview will be undertaken.

Appendix I: Appraisal instruments

Appendix II: Data extraction instruments

References