Complex Large-Bore Radial percutaneous coronary intervention: rationale of the COLOR trial study protocol

IntroductionThe radial artery has become the standard access site for percutaneous coronary intervention (PCI) in stable coronary artery disease and acute coronary syndrome, because of less access site related bleeding complications. Patients with complex coronary lesions are under-represented in randomised trials comparing radial with femoral access with regard to safety and efficacy. The femoral artery is currently the most applied access site in patients with complex coronary lesions, especially when large bore guiding catheters are required. With slender technology, transradial PCI may be increasingly applied in patients with complex coronary lesions when large bore guiding catheters are mandatory and might be a safer alternative as compared with the transfemoral approach.Methods and analysisA total of 388 patients undergoing complex PCI will be randomised to radial 7 French access with Terumo Glidesheath Slender (Terumo, Japan) or femoral 7 French access as comparator. The primary outcome is the incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Procedural success and major adverse cardiovascular events up to 1 month will also be compared between both groups.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting center (‘Medisch Ethische Toetsing Commissie Isala Zwolle’, ‘Commissie voor medische ethiek ZNA’, ‘Comité Medische Ethiek Ziekenhuis Oost-Limburg’, ‘Comité d’éthique CHU-Charleroi-ISPPC’, ‘Commission cantonale d'éthique de la recherche CCER-Republique et Canton de Geneve’, ‘Ethik Kommission de Ärztekammer Nordrhein’ and ‘Riverside Research Ethics Committee’). The trial outcomes will be published in peer-reviewed journals of the concerned literature.Trial registration numberNCT03846752.

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Nursing interventions to decrease bleeding at the femoral access site after percutaneous coronary intervention. SANDBAG Nursing Coordinators. Standards of Angioplasty Nursing Techniques to Diminish Bleeding Around the Groin

American Journal of Critical Care ◽

10.4037/ajcc1999.8.5.303 ◽

1999 ◽

Vol 8 (5) ◽

pp. 303-313 ◽

Cited By ~ 18

Author(s):

NB Juran ◽

CL Rouse ◽

DD Smith ◽

MA O'Brien ◽

SA DeLuca ◽

...

Keyword(s):

Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

Standards Of Care ◽

Bleeding Complications ◽

Severe Bleeding ◽

Nursing Interventions ◽

Access Site ◽

Femoral Access ◽

Percutaneous Coronary ◽

Coronary Procedures

BACKGROUND: This trial is the first prospective, multicenter clinical nursing trial conducted to measure the effect of nursing interventions on bleeding at the femoral access site after percutaneous coronary intervention with or without a potent antiplatelet agent given along with heparin and aspirin. OBJECTIVE: To measure the relationship between nursing interventions and complications at the arterial access site in patients undergoing percutaneous coronary interventions and to recommend a standard of care to minimize bleeding complications. METHODS: In a descriptive, correlational 4010-patient study, nursing care interventions after coronary procedures were measured. Observed standards of care were assessed, and regression techniques were used to evaluate nursing interventions and the effect of the interventions on bleeding at the access site after percutaneous coronary procedures. RESULTS: Several significant correlations between nursing interventions and the occurrences of moderate to severe bleeding at the access site were found; however, most interventions had little effect. The most significant factors in decreasing complications at the access site were early removal of the arterial sheath, the type of pressure mechanism used to achieve arterial hemostasis, staffing allocation, and the person and method used to remove the sheath. CONCLUSION: Many nursing interventions after percutaneous coronary intervention have become routine in the absence of clinical outcome data. Most nursing interventions aimed at decreasing bleeding at the vascular access site increase nursing workload but do not significantly affect bleeding in the groin. These results underscore the importance of continued clinical research studies to validate nursing practice on the basis of patients' outcomes.

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Acceptance and safety of femoral versus radial access for percutaneous coronary intervention (PCI): results from a large monitor-controlled German registry (QuIK)

BMC Cardiovascular Disorders ◽

10.1186/s12872-021-02283-0 ◽

2022 ◽

Vol 22 (1) ◽

Author(s):

Jörg Reifart ◽

Stefan Göhring ◽

Alexander Albrecht ◽

Winfried Haerer ◽

Benny Levenson ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

Bleeding Complications ◽

Access Site ◽

Femoral Access ◽

Radial Approach ◽

Radial Access ◽

Invasive Cardiology ◽

Percutaneous Coronary

Abstract Background In 2015 and 2018, European Society of Cardiology guidelines for percutaneous coronary intervention (PCI) favoring radial access over femoral access were published. These recommendations were based on randomized trials suggesting that patients treated radially experienced reduced bleeding complications and all-cause mortality. We aimed to assess acceptance and results of radial access in a real-world scenario by analyzing all PCI cases in the Quality Assurance in Invasive Cardiology (QuIK) registry. Methods The QuIK registry prospectively collects data on all diagnostic and interventional coronary procedures from 148 private practice cardiology centers in Germany. Major adverse cardiac and cerebrovascular events (MACE) were defined as myocardial infarction, stroke, or death during hospitalization. Results From 2012 to 2018, 189,917 patients underwent PCI via either access method. The rate of radial approach steadily increased from 13 to 49%. The groups did not differ significantly with respect to age or extent of coronary disease. Femoral approach was significantly more common in patients with ST elevation myocardial infarction and cardiogenic shock. Overall, there were significant differences in MACE (radial 0.12%; femoral 0.24%; p < 0.0009) and access site complications (radial 0.2%; femoral 0.8% (p < 0.0009). Conclusion Our data reveals an increase in use of radial access in recent years in Germany. The radial approach emerged as favorable regarding MACE in non-myocardial infarction patients, as well as favorable regarding access site complication regardless of indication for percutaneous intervention.

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Assessment Framework for Recognizing Clinical Deterioration in Patients With ACS Undergoing PCI

Critical Care Nurse ◽

10.4037/ccn2021904 ◽

2021 ◽

Vol 41 (4) ◽

pp. 18-28

Author(s):

Kevin White ◽

Judy Currey ◽

Julie Considine

Keyword(s):

Percutaneous Coronary Intervention ◽

Acute Coronary Syndrome ◽

Signs And Symptoms ◽

Coronary Artery Occlusion ◽

Coronary Intervention ◽

Clinical Deterioration ◽

Access Site ◽

Mortality And Morbidity ◽

Coronary Syndrome ◽

Percutaneous Coronary

Topic Patients with acute coronary syndrome undergoing primary percutaneous coronary intervention are at risk of clinical deterioration that results in similar general signs and symptoms regardless of its cause. However, specific causes and forms of clinical deterioration are associated with key differences in assessment findings. Focused clinical assessments using a modified primary survey enable nurses to rapidly identify the cause and form of clinical deterioration, facilitating targeted treatment. Clinical Relevance Clinical deterioration during percutaneous coronary intervention is associated with increased mortality and morbidity. Previous studies identified nursing inconsistencies when recognizing clinical deterioration, with inconsistent collection of cues and prioritization of cues related to cardiac performance over more sensitive indicators of clinical deterioration. Purpose of Paper To describe a framework to help nurses optimize physiological cue collection to improve recognition of clinical deterioration during periprocedural care of patients undergoing percutaneous coronary intervention for unstable acute coronary syndrome. Content Covered Literature analysis revealed 7 forms of clinical deterioration in patients undergoing percutaneous coronary intervention: coronary artery occlusion, stroke, ventricular rupture, valvular insufficiency, lethal cardiac arrhythmias, access-site and non–access-site bleeding, and anaphylaxis. Evidence for the pathophysiology, incidence, severity, and clinical features of each form of clinical deterioration is identified. A framework is proposed to help nurses conduct highly focused patient assessments, enabling prompt recognition of and response to the specific forms of clinical deterioration that occur in patients undergoing percutaneous coronary intervention.

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