The Relationship Between Patient Characteristics and Access Site Complications Post PCI: A Cross-Sectional Study

1.1. Objectives

This study aims to:

(1) Determine the incidence of access site complications post-PCI in two tertiary hospitals in the United Arab Emirates.

(2) Identify patient and procedural associations between patient characteristics and access site complications post-PCI.

2.1. Study Design

A prospective cross-sectional correlational design was employed to examine the relationship between patient characteristics and access-site complications following PCI. The study was conducted between January and December 2023 in two tertiary-care hospitals in the United Arab Emirates.

2.2. Study Variables

2.3. Setting

The study was conducted at two tertiary care centers in the UAE where PCI is routinely performed. One center included a 10-bed Cardiac Intensive Care Unit (CICU), and the other had a 22-bed Intensive Care Unit (ICU) that also accommodated cardiac patients. The two sites include advanced interventional cardiology service providers and catheterization labs that perform a high volume of diagnostic and therapeutic interventions (e.g., percutaneous coronary intervention [PCI]).

2.4. Sampling and Sample Size

Convenience sampling was used to recruit eligible patients undergoing PCI who provided informed consent.

Inclusion criteria were:

(1) Patients aged 18 years and older.

(2) Patients can provide informed consent.

(3) Can read and write English

Exclusion criteria were:

(1) Patients undergoing non-PCI procedures.

(2) Patients with vascular complications prior to PCI.

Sample size was estimated using G * Power 3.1.9.4 for a Chi-square test of association, assuming a small-to-medium effect size (Cohen’s w = 0.20), an alpha of 0.05 (two-tailed), and a power of 0.80. The required sample size was calculated as n = 199. To ensure an adequate sample size and account for potential data loss, the study enrolled 200 participants.

2.5. Data Collection

The Access Site Complication Observation Sheet was adapted from previously published observational studies and registry frameworks that have examined vascular complications following PCI (AL-Momani and AbuRuz, 2019 [11], Hetrodt et al., 2021 [13], Kwok et al., 2021 [22]). The tool included:

• Demographic data: age, gender, BMI, comorbidities
• Procedural data: number of punctures and puncture site.
• Complications: puncture site-bleeding, hematoma, oozing, ecchymosis.

Assessments were conducted at three time points:

Time-1: immediately after sheath removal.

Time-2: six hours after sheath removal.

Time-3: 24 hours after sheath removal post-procedure.

The access site was inspected, palpated for tenderness or rigidity, and peripheral pulses were assessed. Any complications were recorded by the first author using standardized criteria. Measurements were taken using an electronic weight scale, a flexible ruler; height was obtained from patient records.

During data collection, puncture sites were carefully observed for potential complications. Oozing was assessed by placing sterile gauze on the site; if the blood stain on the gauze measured less than 3×3 cm², using a disposable ruler for accuracy, it was recorded as oozing but not classified as bleeding (Sabo et al., 2008 [19]). Ecchymosis was identified by visual inspection for skin discoloration and confirmed by gentle palpation for pain or swelling; the affected area was measured in centimeters (Cosman et al., 2011 [14]). Bleeding was documented when the pressure dressing became saturated with blood or when a drop in hemoglobin of more than 2 g/dL from baseline was observed (Sabo et al., 2008 [19]). Hematoma was evaluated by palpating the swelling around the puncture site and measuring its diameter with a ruler or measuring tape, then categorized as small (<5 cm) or large (>5 cm) (Merriweather and Sulzbach-Hoke, 2012 [23]).

2.6. Data Analysis

All analyses were conducted using SPSS version 21. Descriptive statistics (frequencies and percentages) were used to summarize participant characteristics and to report the incidence of complications (research question 1). Chi-square tests were applied to assess associations between patient/procedural characteristics and complications (research question 2). A p-value of <0.05 was considered statistically significant.

2.7. Ethical Considerations

Ethical approval was obtained from the University of Sharjah (REC-22-01-22-01-S), the University Hospital of Sharjah (UHS-HERC-121-24012023), and the Ministry of Health and Prevention, Research Ethics Committees (MOHAP/DXB-REC/ S.O-J /No. 92/ 2022), before initiating the study. Written informed consent was obtained from each participant. Participation was voluntary, with the right to withdraw at any point without consequences. Confidentiality and anonymity were strictly maintained. The study procedures conformed to the ethical principles outlined in the Declaration of Helsinki for research involving human subjects, and the Sex and Gender Equity in Research (SAGER) Guidelines were followed.

3.1. Participants' Descriptive Data

A total of 211 patients underwent PCI and were included in the analysis. Most were male (74.0%), and 26.0% were female. By age, 18–39 years comprised 36.0% (n=76), 40–59 years 39.7% (n=84), 60–79 years 22.7% (n=48), and ≥80 years 1.4% (n=3). The radial approach was used in 144 cases and the femoral approach in 67. With respect to comorbidities, 77.3% had at least one (e.g., diabetes, hypertension, peripheral vascular disease) Table 1.

3.2. Post-PCI Complications

3.3. Ecchymosis

Ecchymosis increased from immediately post-procedure to 6 hours, then plateaued at 24 hours. Age remained significantly associated at all time points (p < 0.001), peaking in the 60–79-year group (38.9% immediate → 47.4% at six h → 46.5% at 24 h). Females consistently had higher rates than males (immediate: p = 0.013; 6 h: p < 0.001; 24 h: p < 0.001). This gender difference may be explained by smaller arterial caliber and higher sheath-to-artery ratios, thinner vascular walls, lower baseline haemoglobin, and variations in platelet reactivity and vascular responses to antithrombotic therapy, which predispose females to greater access-site bleeding (O’Donoghue and Sarma, 2020 [24], Anderson et al., 2024 [25]). Notably, the effect was evident immediately and persisted for more than 6 hours, indicating that it is not a transient phenomenon but a sustained risk factor during the first 24 hours post-procedure. Comorbidities and BMI were not associated (all p > 0.35). The access site was not initially related, but it reached borderline significance at 24 hours (p = 0.050), with higher ecchymosis noted after femoral access Table 3.

3.4. Bleeding

Immediately after sheath removal, age (p = 0.004) and gender (p < 0.001) were significant; bleeding was most frequent in the 40–59-year age group and in females. The higher bleeding risk observed in women at this stage may be attributed to smaller vessel caliber, higher sheath-to-artery ratios, thinner vascular walls, and differences in vascular reactivity and platelet response, which increase susceptibility to early access-site complications (Merriweather and Sulzbach-Hoke, 2012 [24]). Once hemostasis was achieved and the pressure dressing was maintained, these differences diminished, explaining why age and gender were no longer significant at 6 and 24 hours (all p > 0.30). At 6 hours and 24 hours, age and gender were no longer significant (all p > 0.30). Comorbidities and BMI were not associated at any time point (all p > 0.21). Access site remained a consistent predictor at all time points-higher with femoral access (immediate p < 0.001; 6 h p = 0.007; 24 h p = 0.011) Table 4.

3.5. Oozing

Gender was significantly associated with oozing at 0 hours (p = 0.001), 6 hours (p < 0.001), and 24 hours (p = 0.001), with females consistently higher. Access site was also significant immediately (p = 0.004) and at 6 hours (p = 0.001), favoring radial over femoral; at 24 hours, the association approached significance (p = 0.057). Age, comorbidities, and BMI showed no significant associations (all p > 0.14) Table 5.

3.6. Hematoma

Across immediate, 6 hours, and 24 hours, access site was the principal determinant of hematoma, with femoral access consistently higher than radial (immediate p = 0.036; 6 h p = 0.002; 24 h p = 0.001). Age, gender, comorbidities, and BMI were not significantly associated at any time point (all p > 0.10) Table 6.

Taken together, the analyses identified female sex and femoral access as the most consistent risk markers for early post-PCI site-related events. Older age was strongly associated with overall complications and progression of ecchymosis, whereas comorbidities and BMI showed no measurable associations in this cohort. The robustness of the access-site signal across bleeding and hematoma at all time points underscores the procedural contribution to risk. It supports preferential radial access where feasible, alongside enhanced surveillance and nursing care for female and older patients.

Because the overweight and obese subgroups were small, they were combined for stability in BMI analyses. All reported p-values were two-sided with α = 0.05. No imputation was required; there was no missing outcome data.

4.1. Age as a Contributing Factor

Advancing age was associated with higher rates of ecchymosis, particularly in the 60–79-year group. This is consistent with Sabo et al. (2008) [19], who attributed increased bruising in older adults to vascular fragility, and with Wu et al. (2015) [20], who reported a marked increase in access-site complications in patients aged 70 years or older. Interestingly, bleeding was more pronounced in the 40–59 age group immediately after sheath removal (Sabo et al., 2008 [19], Wu et al., 2015 [20]). This differs from the ecchymosis pattern but is supported by Al-Momani and AbuRuz (2019), who emphasized the role of age and elevated systolic blood pressure in groin complications (AL-Momani and AbuRuz, 2019 [11]). Unlike studies showing a steady increase in bleeding with age, our results implicated that this increase is noted in middle-aged patients, which may reflect stronger antithrombotic use (following local protocols), and earlier mobilization in this group; by 6–24 hours, the age effect had faded, similar to reports from settings with rigorous post-haemostasis monitoring. For nursing care, these findings suggest the value of age-adapted interventions such as extended compression, delayed ambulation, and more frequent vascular assessments.

4.2. Gender Differences

Women are over one-quarter of the cohort, but more than half of all reported complications. Moreover, it is in line with global evidence that reported a higher risk of bleeding and vascular complications in women who undergo PCI compared to men (Spirito et al., 2021 [12], Peerwani et al., 2023 [18]). However, our study had a relatively small number of female participants, which limits its strength and indicates caution in interpretations. Small sample sizes can sometimes exaggerate associations, and the male-female imbalance in this sample may have had a greater effect.

Nevertheless, the result is in agreement with established explanations. Women generally have smaller vessel caliber, higher sheath-to-artery ratios, and differences in vascular structure and hormonal influences that may increase their vulnerability to bleeding complications after PCI (Spirito et al., 2021 [12]). Importantly, this does not mean that monitoring is needed only for female patients. A more balanced approach is to ensure all patients receive vigilant surveillance after PCI, with particular attention to those at higher risk-such as women, older adults, and patients with multiple comorbidities. This strategy ensures that complications in men are not overlooked, while recognizing that female patients may benefit from closer early observation, thoughtful access-site selection, and tailored education on promptly recognizing warning signs. For nursing practice, this highlights the importance of consistent access-site assessment and complication-prevention strategies for every patient, while applying additional vigilance to high-risk groups. Compared with the literature, our study found that gender differences are similar but concentrated in the earliest post-procedural window, consistent with hypotheses related to sheath-to-artery ratio, haemostasis technique, and mobility practices; standardizing compression protocols and reassessment intervals may narrow this gap without reducing overall vigilance.

An unexpected finding in this study was that immediate bleeding was more frequent among patients aged 40–59 years. Several factors explain this result. Middle-aged patients in this cohort were more likely to present with acute coronary syndromes, undergo PCI, and receive aggressive antithrombotic or anticoagulant therapy, which can increase bleeding risk in patients. In contrast, elderly patients may have been managed with more conservative dosing or procedural approaches, reflecting clinicians’ awareness of their heightened bleeding vulnerability. This pattern suggests that bleeding risk is not determined by age alone but may also be influenced by case mix, procedural complexity, and medication practices. Future studies with larger, stratified samples are needed to confirm these associations and clarify whether middle-aged patients carry unique risk profiles in specific clinical contexts.

4.3. Access Site as a Determinant

The choice of access site is strongly associated with the incidence of complications (AL-Momani and AbuRuz, 2019 [11]). Bleeding, hematoma, and oozing were significantly associated with femoral access at all time points, consistent with the findings of Rana et al. (2021) [16]. Radial access, on the other hand, is less risky and is frequently recommended as the preferred option when clinically possible. From a nursing perspective, patients with femoral access require prolonged immobilization, increased assessment frequency, and rapid identification of bleeding or hematoma formation. This is consistent with previous studies associating female sex, age, and hypertension with higher complication risks (AL-Momani and AbuRuz, 2019 [11], Sabo et al., 2008 [19]).

4.4. Comorbidities and BMI

Contrary to some prior studies, comorbidities such as diabetes and hypertension were not significantly linked to the presence of complications. Similarly, BMI showed no association with post-PCI complications. Al-Momani and AbuRuz (2019) suggested these factors could contribute to risk; however, standardized procedural protocols and consistent nursing care in the current setting might have reduced their impact (AL-Momani and AbuRuz, 2019 [11]). This indicates that good evidence-based nursing practices may have significant potential to reduce underlying baseline risks. The absence of this effect may also reflect on improved chronic-disease control, a relatively small high-risk subgroup, and protocolized peri-procedural pathways that control variability; collectively, these factors can reduce associations detected in less standardized environments.

4.5. Nursing Implications

The findings of this study emphasize the need for nursing care to address the risk factors for patient- and procedure-related vascular access complications. The study showed that older age, female gender, and femoral access were associated with higher rates of bleeding, ecchymosis, and oozing. Data from these studies, for instance, is also consistent with evidence from earlier studies suggesting that targeted preventive strategies are needed for patients identified as high-risk. Incorporating risk stratification into the standard nursing assessment can enhance surveillance and the rapid identification of complications. In reality, this implies improving post-treatment care regimens by reinforcing haemostasis, ensuring adequate immobilization, and maintaining regular access-site monitoring. Other options for high-risk patients may include reinforced pressure dressings, prolonged observation, and a structured patient education program on the signs of clinical deterioration. Embedding these strategies into nursing procedural protocols and continuing professional development may improve safety, reduce morbidity from complications, and enhance recovery and patient satisfaction.