2
Materials and methods
This is a single-institution (two hospitals), prospective, randomized study. Patients undergoing diagnostic coronary angiography (n = 5627) were screened from October 2011 to April 2014. Patients were stratified on the basis of their initial clinical presentation. This included patients with SA and unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) with a troponin T < 1 ng/mL.
Based on inclusion ( Table 1 ) and exclusion criteria ( Table 2 ), 493 eligible patients consented prior to coronary angiography; 103 patients met inclusion criteria immediately after PCI and 100 patients were randomized four hours after uncomplicated PCI ( Fig. 1 ). Patients received an oral loading dose of clopidogrel (300–600 mg) as pre-treatment or immediately after stent implantation and were anticoagulated with bivalirudin (0.75 mg/kg intravenous loading dose and 1.75 mg/kg/h infusion for the duration of the PCI) or heparin (70 units/kg intravenous loading dose and additional doses to an activated clotting time goal of ~ 250 s) ( Table 3 ). Common femoral angiography was performed at the end of the procedure via the side arm of the sheath. Hemostasis of the femoral-arteriotomy access site was facilitated by deployment of a hemostatic closure device (StarClose® or ProGlide®, Abbott Vascular, Temecula, CA). The ultimate choice of closure device used was at the discretion of the interventional cardiologist.
Table 1
General inclusion criteria.
|
Patients undergoing single and multivessel stenting of type A, B, and C de novo lesion(s) for the treatment of stable angina, unstable angina or non-ST-elevation myocardial infarction with a troponin T of < 1 ng/mL. |
Patients treated with P2Y12 inhibitor oral loading dose, either as a pre-treatment or immediately after stenting, and recommended to be continued daily. |
Patients anticoagulated with intravenous heparin or bivalirudin during the procedure and stopped immediately after procedure completion. |
Arterial access via the femoral artery (sheath size 5, 6, 7 or 8 Fr) and an arteriotomy site suitable for hemostatic device closure (puncture in the common femoral artery at least 5 mm from femoral artery bifurcation). |
Thrombolysis In Myocardial Infarction III coronary flow upon completion of the intervention. |
Left ventricular ejection fraction ≥ 30%. |
Patients who live less than an hour away from the hospital. |
Table 2
General exclusion criteria.
|
Age < 30 or > 80 years |
Acute ST-elevation myocardial infarction (STEMI) |
Non-STEMI with documented troponin T > 1 ng/mL at presentation to the catheterization laboratory |
Severe valvular heart disease |
Cardiogenic shock or hemodynamic instability |
Any contraindication to anticoagulation |
Pregnancy |
Patients with bleeding diathesis, including thrombocytopenia (platelets < 100,000), thrombasthenia, Von Willebrand’s disease, or anemia (hemoglobin < 10 mg/dl, hematocrit < 30) or coagulopathy |
Patients with a creatinine > 1.5 mg/ml not on hemodialysis |
Patients with an international normalized ratio (INR) > 1.5 |
Patients unable to consent or follow-up |
Patients with inadequate social or home support (homeless, lives alone, etc.) |
Patients with cancer or autoimmune disease with life expectancy of < 1 year |
|
|
Patients who received a IIb/IIIa inhibitor or thrombolytics within 24 h of the procedure |
Patients who received low molecular weight heparin within 12 h of the procedure |
Patients on or planned coumadin therapy post angioplasty |
|
|
Treatment of > 2 lesions in > 2 vessels |
Major site branch occlusion |
Target lesion is a total occlusion, located in the left main coronary artery or a vein graft with friable lesions |
Significant left main diameter stenosis (> 50%) |
Intra-coronary thrombus |
Dissection type C–F not stented |
Target lesion is > 55 mm in length, heavily calcified, or with visible thrombus |
|
|
Closure device non-deployment (including morbidly obese patients) |
Uncontrolled hypertension (> 160 mm Hg systolic) |
Target artery closed (with any method) within 48 h of study closure |
Ipsilateral arterial puncture |
Patients with hematoma, pseudoaneurysm, or arteriovenous fistula present prior to sheath removal |
Patients with severe common femoral calcification visualized by fluoroscopy |
Patients with small femoral arteries (< 5 mm in diameter) |
Patients with femoral artery stenosis > 50% |
Patients with brachial or radial puncture sites |
Patients with puncture sites in vascular grafts |
Patients with antegrade punctures |
Table 3
Comparison of management and clinical outcomes.
|
Medical treatment |
Glycoprotein IIb/IIIa inhibitor |
0 |
0 |
1.0 |
Bivalirudin |
33 (66%) |
33 (66%) |
1.0 |
Heparin |
17 (34%) |
17 (34%) |
1.0 |
Aspirin |
49 (98%) |
49 (98%) |
1.0 |
Clopidogrel |
50 (100%) |
50 (100%) |
1.0 |
ACEI/ARB |
40 (80%) |
43 (86%) |
0.34 |
β-Blocker |
40 (80%) |
47 (94%) |
0.10 |
Ca 2 + channel blocker |
10 (20%) |
8 (16%) |
0.40 |
Statin |
44 (88%) |
44 (88%) |
0.47 |
Hospital outcomes |
Days in telemetry unit |
0.24 ± 0.64 |
0.91 ± 0.52 |
< 0.0001 |
Length of hospital stay (days) |
0.78 ± 3.02 |
1.53 ± 0.96 |
0.10 |
In-hospital mortality |
0 |
0 |
1.0 |
Vascular complication |
0 |
0 |
1.0 |
Long-term outcome |
Repeat percutaneous coronary intervention |
0 |
1 (2%) |
0.52 |
ACEI/ARB, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker.
If the stenting procedure was performed without complications and the closure device was successfully deployed, the patient was observed for four hours. If there were no complications, the electrocardiogram remained unchanged, and the patient was asymptomatic, with stable vital signs, and able to ambulate, he/she was then enrolled in the study (n = 100) and randomized to either the SD (n = 50) or the DD (n = 50) group. Patients were not considered enrolled until they were successfully randomized. During the observation period, patients received risk factor modification education and were informed about continued pharmacotherapy, especially dual antiplatelet therapy.
Patients in the SD group were discharged from the hospital six hours after hemostatic closure device deployment, only if they remained stable. Patients in the DD group were discharged from the hospital at the discretion of the attending cardiologist no sooner than 24 h after PCI. Patients with an indication for extended hospital stay were not discharged from the hospital regardless of randomization.
Detailed screening information was recorded to track the number of patients screened and consented, and included the reason for screening failure (exclusion criteria, procedure-related complications, closure device failure, access complication, chest pain, arrhythmias, hemodynamic instability, etc.) ( Tables 4 and 5 ).
Table 4
Exclusion criteria breakdown (n = 1987).
|
Off-hour (weekdays 3 pm to 6 am) |
724 |
Weekends |
201 |
|
|
Age 30 years |
7 |
Age 80 |
106 |
Acute ST-elevation myocardial infarction (STEMI) |
158 |
NSTEMI + troponin T > 1 ng/mL |
50 |
Cardiogenic shock |
47 |
Severe valvular heart disease |
79 |
Anemia |
183 |
Creatinine > 1.5 mg/dl and not on dialysis |
94 |
Living > 60 min away from hospital |
158 |
Homeless |
6 |
|
|
IIb/IIa inhibitor |
51 |
Low molecular weight heparin |
0 |
|
|
Left main stenosis (> 50%) |
18 |
Total occlusion (left main) |
1 |
Total occlusion (vein graft) |
1 |
Lesion > 55 mm, heavily calcified or visible thrombus |
14 |
Bifurcated lesion |
8 |
> 2 lesions in > 2 vessels |
68 |
|
|
No closure device |
4 |
Prior pseudoanuerysm or arteriovenous fistula |
2 |
Peripheral vascular disease |
4 |
Brachial or radial puncture sites |
3 |
Table 5
Screen failure breakdown details.
|
Patients undergoing single and multivessel stenting of type A, B, C lesions |
14 |
Thrombolysis In Myocardial Infarction III coronary flow upon completion of the intervention |
2 |
Left ventricular ejection fraction ≥ 30% |
6 |
Patients who live < 60 min away from the hospital |
3 |
Total |
25 |
|
|
Acute ST-elevation myocardial infarction (STEMI) |
1 |
Cardiogenic shock or hemodynamic instability |
2 |
Patients with bleeding diathesis, thrombocytopenia, Von Willebrand’s disease, or anemia |
2 |
Patients with a creatinine > 1.5 mg/ml not on chronic hemodialysis |
1 |
Patients with an international normalized ratio (INR) > 1.5 |
1 |
Patients who live > 60 min away from the hospital |
1 |
Patients with inadequate social or home support |
1 |
Total |
9 |
|
|
Patients who received a IIb/IIIa inhibitor or thrombolytics within 24 h of the procedure Total |
1 |
Total |
1 |
|
|
Significant left main diameter stenosis |
6 |
Target lesion is a total occlusion, located in the left main coronary artery or a vein graft with friable lesions |
27 |
Suboptimal stent result |
1 |
Target lesion is > 55 mm in length, heavily calcified, or with visible thrombus |
27 |
Bifurcated lesions |
1 |
Dissection type C–F not stented |
3 |
Intracoronary thrombus |
3 |
Treatment of > 2 lesions in > 2 vessels |
1 |
|
|
Closure device non-deployment |
2 |
Ipsilateral arterial puncture |
1 |
Patients with hematoma |
2 |
Patients with brachial or radial puncture sites |
1 |
|
|
Stented lesion |
227 |
Successful closure using StarClose or Perclose as hemostatic closure device |
51 |
|
|
No complications |
1 |
No new electrocardiogram changes suggesting of ischemia and/or arrhythmia |
1 |
Free of chest pain |
1 |
Grand total |
393 |
The primary end point was major adverse cardiac events (MACE) defined as a composite of events at 30 days, including death from any cause, myocardial infarction (MI), unplanned coronary revascularization, or vascular complication. MI was defined based on clinical presentation, troponin elevation and ECG. PCI-related, procedural MI was defined as a troponin increase > 3 times the upper limit of normal. Vascular complication was defined as the cumulative occurrence of intracranial or intraocular bleeding, hemorrhage at the access site requiring intervention, hematoma with a diameter > 5 cm, a reduction in hemoglobin > 4 g per deciliter without an overt bleeding source, or ≥ 3 g per deciliter with a source and vascular injury requiring repair (defined as any vascular injury requiring open surgery or ultrasound guided intervention), or transfusion of a blood product.
The secondary end points at 30 days included major bleeding not related to coronary artery bypass surgery (CABG) and recurrent hospitalization. The safety end point was a composite of major bleeding or vascular complication. Patients were followed through the hospital course: at 24–72 h, 7–14 days post-discharge in the clinic, and at 30–45 days via telephone contact or office visit. Follow-up at one year was performed via telephone contact, office visit, or medical record review. Patient satisfaction surveys were conducted at pre-specified intervals at 30–45 days after discharge. To estimate potential savings, an allocated model of hospital costs was used, and the unit cost for the interventional cardiac procedure was estimated. This cost model was estimated based on current Medicare hospital rates and based on an allocation model. Prices per unit were based on actual costs or estimated based on current hospital cost. This cost model was specific for the University of Southern California Hospital and LA County Hospital .
2.1
Statistical analysis
Categorical variables were reported as numbers and frequencies and were compared using chi-square statistics or Fisher exact test. Continuous variables were reported as mean ± standard deviation. For continuous data, measurement differences were compared using the Student’s t-test; while the Mann–Whitney U test was used for the nonparametric continuous data. One-way analysis of variance and a post hoc multiple comparisons test (Scheffe) were used for comparison of continuous data between the SD and DD patient groups. A two-tailed probability value of < 0.05 was considered statistically significant.
2.2
Patient satisfaction analysis
Patient satisfaction surveys were provided in person or via telephone interviews 24–72 h, 7–14 days, and 30–45 days after the procedure. We formulated specific questions to assess the patient’s experience, quality characteristics, satisfaction, comfort and convenience with the procedure, and transition to regular activities. Patient response rates were compared using the chi-square test. Patient satisfaction scores were standardized to a scale of 0 to 5, (0 = no response; 5 = very satisfied or strongly agree). The Student’s t-test was used to compare continuous variables, such as length of stay, opinion on treatment procedure, pain management skills, and health knowledge ( Table 6 ) ( Addendum 1 ).
Table 6
Patient satisfaction score table.
|
|
LOS |
3.43 ± 0.06 |
3.5 ± 0.04 |
0.37 |
3.47 ± 0.04 |
3.45 ± 0.04 |
0.72 |
3.5 ± 0.3 |
3.41 ± 0.05 |
0.12 |
Pain |
4.52 ± 0.07 |
4.36 ± 0.07 |
0.09 |
4.43 ± 0.07 |
4.38 ± 0.06 |
0.56 |
4.52 ± 0.06 |
4.37 ± 0.07 |
0.12 |
Procedure |
4.47 ± 0.07 |
4.26 ± 0.08 |
0.06 |
4.26 ± 0.07 |
4.3 ± 0.08 |
0.58 |
4.47 ± 0.09 |
4.48 ± 0.07 |
0.95 |
Knowledge |
4.49 ± 0.07 |
4.37 ± 0.07 |
0.21 |
4.26 ± 0.07 |
4.39 ± 0.08 |
0.26 |
4.43 ± 0.07 |
4.41 ± 0.08 |
0.85 |
LOS, length of stay.
