Arterial closure devices (ACDs) provide immediate hemostasis, improve comfort, and allow early ambulation after percutaneous coronary intervention (PCI). The aim of this study was to evaluate ACD utilization and post-PCI major bleeding in an unselected cohort. Patients receiving ACDs were propensity matched to those with manual compression to evaluate a primary end point of National Cardiovascular Data Registry (NCDR) major bleeding and a secondary end point of major bleeding stratified by previously developed NCDR bleeding risk categories. Bleeding events that required transfusion, prolonged hospital stays, and/or decreases in hemoglobin ≥3.0 g/dl were included. Length of stay, defined as days after PCI until discharge, was also evaluated. Secondary analysis of bleeding and complication rates between ACD types (suture vs collagen plug) was performed. Five thousand four hundred twenty-one patients underwent PCI, and 2,324 patients (43%) were included in the final propensity matching: 1,162 with ACDs and 1,162 manual compression patients. Major bleeding was reduced in ACD patients compared to those with manual compression (2.4% vs 5.2%, p <0.001), and NCDR high-risk patients receiving ACDs had the greatest reduction in major bleeds (3.1% vs 10.3%, p <0.001). Length of stay (1.9 ± 1.9 vs 2.3 ± 5.3 days, p = 0.007) and pseudoaneurysms (0.3% vs 1.1%, p = 0.028) were decreased in ACD patients. Suture-based devices revealed a lower composite event rate than collagen-plug ACDs (1.4% vs 3.4%, p = 0.048). In conclusion, ACD use is associated with reductions in NCDR major bleeding, length of stay, and pseudoaneurysms in PCI patients.
Arterial closure devices (ACDs) reduce time to hemostasis, allow earlier ambulation, and improve comfort compared to manual compression (MC) after coronary angiography and percutaneous coronary intervention (PCI). Data are conflicting regarding vascular complications with ACDs. Some investigators have reported reduced vascular complications with ACD use. Available ACD devices are suture-mediated closure, collagen-based plugs, and nitinol clips. Variable results with each device have further confounded the assessment of ACD effects on vascular complications. Some studies have demonstrate benefit with 1 device and increasing complications with others. In the present study, we evaluated complications in post-PCI patients receiving ACDs compared to MC at a single center. Patients were stratified by bleeding risk category to evaluate for incremental benefit of ACDs in patients with varying risks of major bleeding after PCI.
Methods
All patients who underwent PCI via femoral access were enrolled from 4 centers within the Saint Luke’s Health System (Mid America Heart Institute, Saint Luke’s South Hospital, Saint Luke’s East Hospital, and Saint Luke’s North Hospital) in Kansas City, Missouri, from January 1, 2006, to June 30, 2009. National Cardiovascular Data Registry (NCDR) definitions were used, and data were collected in a prospective registry. Trained nurses input data, and any required adjudication of events is performed by interventional cardiologists. Currently, all PCI patients are evaluated with femoral angiography to consider ACD use. In the absence of contraindications (non-common femoral artery insertion, sticks above the inferior epigastric artery, small arteries, and the presence of significant calcification), all the interventional cardiologists use ACDs. The MC protocol is standardized and requires an activated clotting time <160 seconds or a 2-hour wait after bivalirudin use. Patients may ambulate 4 hours after MC and 2 hours after ACD.
In-laboratory deaths and patients with cardiogenic shock were excluded. Propensity matching was used to form 2 groups: those with ACDs after PCI and those with hemostasis by MC. The primary end point was the comparison of NCDR major bleeding rates between the ACD and MC groups. As a secondary analysis, patients were further stratified into previously developed bleeding risk categories to assess the effects of ACDs on the basis of individualized bleeding risk. Major bleeding rates were compared between ACD and MC groups within each category. Additional secondary analyses comparing ACD types (suture vs collagen plug) and each ACD type versus MC were performed.
The definition of myocardial infarction was new ST-segment elevation or Q waves in ≥2 contiguous electrocardiographic leads, new left bundle branch block, or creatine kinase-MB >3 times the upper limit of normal. Urgent target vessel revascularization was defined as any unplanned revascularization of the target vessel. Bleeding was defined as occurring at the access site during or after PCI until discharge, which may be external or a hematoma >10 cm for femoral access. All bleeding events that required transfusion, prolonged hospital stays, and/or decreases in hemoglobin ≥3.0 g/dl were included in the primary end point. Bleeding was further categorized by access site or non–access site. Retroperitoneal, gastrointestinal, genitourinary, and other or unknown sites were also included, as was pseudoaneurysm formation. Other or unknown sites included any bleeding from sites not previously specified or potentially reflecting occult bleeds that were not clinically evident. Shock was defined as hypotension requiring inotropes and/or intra-aortic balloon pump to maintain systolic blood pressure >80 mm Hg and/or cardiac index >1.8. Congestive heart failure was defined as paroxysmal nocturnal dyspnea and/or fatigue, dyspnea due to heart failure, chest x-ray with pulmonary congestion or edema, or dyspnea treated with medical therapy for heart failure. Stroke was defined as a central neurologic deficit persisting for >72 hours, and renal failure was defined as an increase of serum creatinine to >2.0 mg/dl and 2 times the baseline level or a new requirement for dialysis. Death was all-cause mortality during the index hospitalization. Baseline covariates were analyzed using Student’s t tests for continuous variables and chi-square or Fisher’s exact tests for categorical variables. To adequately balance characteristics between ACDs and MC, a propensity score was developed using nonparsimonious logistic regression conditioned on 18 clinical covariates: bivalirudin use, body mass index, age, gender, diabetes, previous myocardial infarction, previous congestive heart failure, renal failure, cerebrovascular disease, peripheral vascular disease, chronic lung disease, hypertension, previous coronary bypass surgery, previous PCI, ST-segment elevation myocardial infarction, non–ST-segment elevation myocardial infarction, sheath size, and tobacco use at presentation.
By creating a propensity score for ACDs, we followed a valid method to balance a large number of potential confounders equally across 2 observational cohorts of patients. A 1:1 match was performed using a nearest neighbor match within a caliper of 1/5 the standard deviation of the logit of the propensity model. The standardized difference was used to determine adequacy of the match using the value of 10 as the cutoff to determine balance. To determine the effect of ACDs on the primary end point of major bleeding, a conditional logistic regression model was used stratified by matched pair. All statistical analyses were performed by the Saint Luke’s Mid America Heart Institute Department of Biostatistics using SAS version 9.2 (SAS Institute Inc., Cary, North Carolina).
Results
A total of 5,421 patients underwent PCI during the study period. A final 2,324 were included in the propensity matching: 1,162 patients receiving ACDs were matched to 1,162 who had hemostasis via MC. During the period studied, there was a significant increase in ACD use from 2.9% in 2006 to 70% in 2009. Over time, there was more use of suture-mediated closure, but individual preferences drove the decision making for each physician. Individual rates of ACD use ranged from 22% to 50%. Of the 8 physicians who contributed 99.9% of cases, all perform closure. Operators’ individual totals ranged from 301 to 1,041 cases over the 3.5 years studied (average 175 cases/year).
Baseline characteristics were well matched ( Table 1 ). All variables in the propensity model had standardized differences <10, indicating excellent balance. Current smoking, chronic lung disease, and diabetes mellitus were common. More than 2/3 of included patients presented with acute coronary syndromes, with no significant difference noted between the ACD and MC groups. Procedural variables were also similar ( Table 2 ). Bivalirudin was used as the anticoagulation strategy in 1/4 of patients. Almost half of the cases in each group were performed using 6Fr guiding catheters. Most patients in the 2 groups underwent single-vessel PCI, and the left anterior descending coronary artery was the most common target vessel. There were few left main coronary artery or bypass graft PCIs included.
| Variable | ACD | MC | p Value |
|---|---|---|---|
| (n = 1,162) | (n = 1,162) | ||
| Age (years) | 63.7 ± 12.6 | 63.3 ± 12.7 | 0.46 |
| Men | 69.4% | 68.6% | 0.65 |
| Body mass index (kg/m 2 ) | 30.2 ± 6.4 | 30.2 ± 6.4 | 0.78 |
| Diabetes mellitus | 32.0% | 33.0% | 0.63 |
| Previous myocardial infarction | 32.7% | 33.0% | 0.86 |
| Previous heart failure | 9.2% | 8.8% | 0.72 |
| Previous renal failure | 3.5% | 4.4% | 0.29 |
| Peripheral vascular disease | 9.6% | 9.0% | 0.62 |
| Chronic lung disease | 16.9% | 16.8% | 0.96 |
| Hypertension | 78.9% | 80.0% | 0.50 |
| Current smoker | 26.6% | 28.8% | 0.39 |
| Previous PCI | 38.9% | 39.2% | 0.87 |
| Previous coronary artery bypass grafting | 15.5% | 15.7% | 0.91 |
| Current heart failure | 5.8% | 7.7% | 0.06 |
| Acute coronary syndromes | 67.9% | 67.9% | 0.99 |
| Variable | ACD | MC | p Value |
|---|---|---|---|
| (n = 1,162) | (n = 1,162) | ||
| Bivalirudin use | 25.6% | 25.5% | 0.96 |
| Clopidogrel use | 96.0% | 95.9% | 0.80 |
| Aspirin use | 99.1% | 98.0% | 0.06 |
| Warfarin use | 1.8% | 1.9% | 0.42 |
| Sheath size (≤6Fr) | 44.7% | 44.6% | 0.97 |
| Target coronary artery | |||
| Left circumflex | 28.1% | 27.7% | 0.82 |
| Left anterior descending | 44.2% | 46.9% | 0.20 |
| Right | 40.2% | 38.8% | 0.50 |
| Left main | 1.8% | 2.1% | 0.65 |
| Vein graft | 5.6% | 6.7% | 0.26 |
| Single vessel intervention | 80.6% | 78.2% | 0.15 |
Major bleeding occurred less frequently in the ACD group, as listed in Table 3 (adjusted odds ratio 0.46, 95% confidence interval 0.29 to 0.72, p = 0.006). Bleeding at the arterial entry site and other or unknown sites was less frequent with ACDs, as was the incidence of pseudoaneurysm formation. The relative contribution of each bleeding site to the overall bleeding rate is presented in Figure 1 . This demonstrates decreased access site bleeding or pseudoaneurysm formation with ACDs. The major secondary end point assessed patients in bleeding risk categories ( Figure 2 ). Overall, the average predicted bleeding risk was similar between groups (2.3% for ACDs vs 2.4% for MC, p = 0.57). Approximately half of the patients (n = 1,170) were at moderate risk (1% to 3%) for major bleeding, with the remaining patients evenly distributed between the high-risk (>3%, n = 584) and low-risk (<1%, n = 570) groups. High-risk patients receiving ACDs had a 70% lower rate of major bleeds compared to MC patients (p <0.001). Low- and moderate-risk patients demonstrated a consistent benefit (61% and 34% relative risk reduction, respectively, p = NS).
| Post-PCI Complication | ACD | MC | p Value |
|---|---|---|---|
| (n = 1,162) | (n = 1,162) | ||
| Myocardial infarction | 6.5% | 5.9% | 0.55 |
| Cardiogenic shock | 0.4% | 0.8% | 0.28 |
| Congestive heart failure | 2.0% | 3.3% | 0.052 |
| Stroke | 0.0% | 0.5% | 0.03 |
| Renal failure | 0.3% | 0.3% | 1.00 |
| Major bleeding complications | 2.4% | 5.2% | <0.001 |
| Entry site | 0.6% | 1.7% | 0.012 |
| Retroperitoneal | 0.4% | 0.9% | 0.20 |
| Gastrointestinal | 0.4% | 0.7% | 0.40 |
| Genital/urinary | 0.3% | 0.3% | 1.00 |
| Other/unknown | 0.8% | 1.8% | 0.03 |
| Pseudoaneurysm | 0.3% | 1.1% | 0.03 |
| In-hospital mortality | 0.3% | 0.9% | 0.07 |
| Length of stay (days) | 1.9 ± 1.9 | 2.3 ± 5.3 | 0.007 |
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