A prospective multicenter registry was performed in the setting of standard clinical practice with the participation of 3 tertiary centers with extensive experience in radial access, understood as 85% or more of the procedures being performed via this access route per year. Each center had implemented a PCI outpatient program. The registry included patients undergoing outpatient PCI between January 2013 and September 2015 in each participating hospital. Patient data from each center were included in a shared database. The researchers from each participating hospital prospectively reviewed clinical events. The ethics committee of the hospital that sponsored the registry evaluated and approved the study and performed data analysis. All patients were informed of their inclusion in the study.

Table 1 shows the registry inclusion and exclusion criteria. All patients meeting these criteria were eligible for same-day discharge. Table 1 also shows the criteria for admission after PCI. Patients who were admitted formed a second analysis group to characterize the reasons for and predictors of admission. The main study group comprised patients who underwent same-day admission and discharge after 4 to 12hours of surveillance according to the protocol and standard practice of each center. All patients underwent elective PCI (scheduled or ad hoc) using radial or ulnar access for stable coronary disease of 1 or more vessels. Before PCI, all patients should receive antiplatelet therapy with at least aspirin and clopidogrel or another P2Y12 inhibitor and could receive the loading dose of the second antiplatelet agent in the cardiac catheterization laboratory. Medical staff reassessed the patients before discharge and by telephone or in person at 24 hours and 30 days. If there were vascular access complications (hematoma), the patients were reassessed in person. The computerized medical records of each patient were also reviewed in the event of complications or prespecified adverse events. Figure shows the study flow chart.

Figure.

Study flow chart. COA, chronic oral anticoagulation; CTO, chronic total occlusion; GFR, glomerular filtration rate; HF, heart failure; LMCA, left main coronary artery; PCI, percutaneous coronary intervention; SIHD, stable ischemic heart disease; SP, study period. * Absence of caregiver at home, inability to understand the procedure, or home far from health resources (>60min).

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The main aim of the study was to assess feasibility and short-term safety from the end of the procedure to discharge and at 24hours and 30 days.

Elective outpatient PCI: scheduled outpatient procedure or immediately after diagnosis (ad hoc), with discharge within 12 hours after an observation period.

Seven analysis groups were established to assess reasons for admission: suboptimal angiographic result, clinical instability (eg, angina, periprocedural complications, recurrent chest pain, arrhythmias, syncope), patient or family refusal, vascular access complications, radial-to-femoral crossover, excess of contrast agent (> 300mL), and miscellaneous other reasons.

Qualitative variables are expressed as frequency and percentage and were analyzed using the parametric chi-square test or the Fisher exact test (nonparametric) when needed according to the distribution of the variable analyzed. Quantitative variables are expressed as mean ± standard deviation or median [interquartile range] according to the distribution of the variable. The normality of the distribution of the variables was assessed using the Kolmogorov-Smirnov test and they were compared using the Student t test. The medians of time were analyzed using the nonparametric Mann-Whitney U test. A P value of < 0.05 was used as a cutoff for statistical significance for a 95% confidence interval (95%CI). Variables associated with admission were determined using univariable analysis. Independent predictors of admission were identified using logistic regression analysis, after the inclusion of variables with a P value < 0.1 in the univariable analysis. All analyses were conducted using the SPSS 17.0 software package for Windows (SPSS Inc., Chicago, Illinois, United States).

Table 2 shows the baseline characteristics of the 723 patients finally included in the study and their comparison according to early discharge or admission. The mean age of the population was 66.6±10.5 years, 76% were male, and there was a high percentage of diabetes (37.5%). The most frequent characteristics of the patients were a history of peripheral artery disease and a high baseline creatinine level. Table 3 shows the procedural characteristics. Patients were admitted more frequently after unscheduled procedures, longer and more complex procedures, or those requiring multivessel revascularization.

During the study period, a total of 16 672 cardiac catheterization procedures and 6980 PCI procedures were performed in 3 hospitals, 1788 (25.6%) of which were performed in the setting of stable ischemic heart disease. In total, 40.5% of these patients met the inclusion criteria. A total of 190 (26.3%) patients were admitted after PCI. Of the 533 (73.7%) patients who were discharged home, 128 (23.6%) lived in a municipality without a hospital. In predischarge assessment, 8 patients (1.5%) had vascular complications without need for admission; 7 with moderate hematoma and 1 with radial occlusion at discharge without digital ischemia.

The Figure shows the different reasons for admission and the percentage of patients admitted for each one. Median length of stay was 1 [1-2] days.

Univariable analysis showed that predictors of admission were peripheral vascular disease, high baseline creatinine levels, and ad hoc multivessel procedures. Multivariable analysis showed that these variables were also independent predictors of admission. However, a history of previous catheterization using the same access route was a protective factor (Table 4).

Table 5 shows clinical events and recorded complications. The primary safety endpoint (major adverse cardiovascular events) was reached in 0.19% of patients at 24hours and in 0.57% at 30 days. No deaths were recorded at 24hours or at 30 days. At 24hours, 1 patient needed readmission (major bleeding unrelated to vascular access, due to a 4g/dL decrease in hemoglobin caused by rectal bleeding) and 2 needed medical care in the emergency room. Both patients had chest pain, which ruled out an ischemic origin. At 30 days, 8 patients were readmitted and another 12 were treated in the emergency room. Three major adverse cardiovascular events were recorded: 1 patient had a definite subacute stent thrombosis that developed into non—ST-segment acute myocardial infarction, 1 patient had unstable angina that needed PCI on a vessel other than the target vessel, and 1 patient had a minor stroke 5 days after PCI. The other patients admitted at 30 days did not need another angiographic reassessment and were admitted for various reasons such as chest pain or decompensated heart failure. Regarding minor complications, 1.8% of hematomas were recorded at 24hours and 1.3% at 30 days, without the need for surgical intervention or admission and without major bleeding.

Currently, a vast number of medical and surgical procedures are safely performed on an outpatient basis.10 It should be noted that an overnight stay in hospital is associated with a 0.5% risk of an adverse drug reaction or up to a 1.6% risk of infection.11 In 2009, the Society of Cardiovascular Angiography and Interventions/American College of Cardiology published a consensus document12 which established the recommendations for outpatient PCI. Similar criteria were used in this registry. However, there are no recommendations in the European revascularization guidelines.13

Patients with stable ischemic heart disease account for more than 25% of the activity of cardiac catheterization laboratories: of these, up to 40.5% could benefit from the application of the type of outpatient PCI programs described above. The data also show that most of the eligible patients (74%) are discharged. In total, PCI procedures comprise around 10% of all cardiac catheterization laboratory activity, which in numerical terms represents an increase in the availability of beds and can produce overall cost savings without compromising patient safety.14,15

The feasibility of outpatient PCI is determined by ischemic and hemorrhagic risk factors.

Although the risk of ischemic complications appears to be more closely associated with procedural outcomes than with the type of target lesion and target vessel,16,17 acute stent thrombosis, which is probably the most dreaded complication, is clearly associated with various factors such as acute coronary syndrome or PCI in complex lesions.18–20 Some studies have included patients with acute coronary syndrome21 (25% in the EASY study22), with a higher rate of major adverse cardiovascular events than the total rate. However, complex lesions were not included in previous studies. Future research could address outpatient PCI for more complex lesions, given the current improvements in materials and increasingly experienced operators.

Hemorrhagic risk mainly depends on the vascular access route. In this regard, radial access is clearly superior to femoral access.24,25 The EPOS study26 found a vascular complications rate of 6.1% within 24 hours in patients discharged the same day after transfemoral PCI using manual compression for hemostasis. Similarly, although the largest registry of same-day discharge after PCI (98% femoral access)27 found a low rate of vascular complications, the rate was 3 times higher in discharged patients (0.75% vs 0.25%, P< .001) despite vascular closure devices being used more frequently in this group and being used in more than 50% of patients in both groups. Although the systematic use of vascular closure devices can reduce complications (0.8% in the study by Antonsen et al.28), it also increases costs. No major vascular complications were recorded in the present registry. The only documented major bleeding episode was unrelated to vascular access. Approximately 1.5% of patients had hematomas > 5cm, all of which were superficial and did not need treatment other than standard compression bandages and local measures. The low event rate is in line with the findings of previously published studies and meta-analyses,21,23,27 in which the rate was around 1% at 24 hours and 30 days.21

Regarding length of stay after PCI, major complications usually occur within 4 to 6 hours or 24 hours after the procedure.16 Thus, careful patient selection after 4 to 12 hours of surveillance, possibly in dedicated “radial lounge”,29 appears to be both sufficient and safe.

Finally, when these programs are implemented, certain comorbidities should be taken into account, such as chronic kidney failure, severe left systolic ventricular dysfunction, or oral anticoagulation therapy, as well as certain social conditions, such as distance to a hospital with emergency services and family or caregiver support in the first 24 hours after PCI.

Several limitations of this registry should be taken into account. On the one hand, the data were obtained from 3 hospitals each with their own outpatient PCI programs, rather than having a program in common. On the other hand, common inclusion and exclusion criteria were established for the registry. In addition, data from the 3 hospitals were collected in a shared database. Because we did not conduct a systematic survey of patient acceptance and opinion, it cannot be concluded from this study that outpatient PCI is more comfortable for patients, although previous studies15 have confirmed their acceptance. Patient follow-up was not always conducted in person; thus, some vascular complications, although not severe ones, may have been underestimated. The potential intervention bias inherent to prospective registries is another limitation. Finally, although a cost analysis was not conducted, previous studies suggest savings of up to 50% per procedure.14