Anemia is an independent predictor of bleeding complications and poor clinical outcomes after percutaneous coronary intervention. Percutaneous coronary transradial intervention (TRI) is better than percutaneous coronary transfemoral intervention (TFI) in terms of reducing bleeding complications that can affect the prognosis. This study aims to investigate the clinical outcomes between TRI and TFI for patients with anemia. We analyzed periprocedure complications, in-hospital mortality, and major adverse cardiac events for one year in the Korean TRI registry from January 2013 to April 2014. Patients with chronic kidney disease for whom TFI is preferred were excluded. Anemia was defined as hemoglobin <13 g/dl for men and <12 g/dl for women. A total of 1,279 patients were finally enrolled. Of these, 348 patients had anemia. Among them, 253 patients (72.7%) underwent TRI and 95 patients (27.3%) underwent TFI. There were no significant differences of baseline demographic characteristics between the TRI and TFI groups, except for the incidence of dyslipidemia (TRI 23.7% vs TFI 12.6%, p = 0.023). Multivariate logistic regression analysis revealed lower incidence of composite severe bleeding complications (hazard ratio 0.34, 95% CI 0.12 to 0.99, p = 0.049) and lower incidence of in-hospital mortality than TFI group (hazard ratio 0.74, 95% CI 0.62 to 0.88, p = 0.042). In conclusion, this study suggests that the TRI for patients with anemia may be translated into better prognosis in terms of lower rates of bleeding complications and in-hospital mortality.
Percutaneous coronary intervention (PCI) has been suggested as a representative strategy for treating ischemic heart disease. The femoral and radial arteries are commonly used sites for vascular access. Percutaneous coronary transfemoral intervention (TFI) has been the dominant procedure for several decades. More recently, percutaneous coronary transradial intervention (TRI) has increased in popularity because of its comparative feasibility and safety. TRI is associated with a lower rate of access-site complications and bleeding than TFI. Anemia is an independent risk factor of mortality and poor clinical outcomes after PCI. If TRI also reduces bleeding complications, the approach for patients with anemia could be better than the TFI. Clinical profiles of patients with anemia receiving PCI are unclear. This study was undertaken to investigate the clinical outcomes and compare TRI with the TFI for patients with the anemia through a 1-year follow-up.
Methods
The Korean TRI registry is an open, prospective, observational, and multicenter on-line registry of coronary angiogram and/or PCI data, regardless of the approach (TFI or TRI). The registry protocols were verified and approved by the institutional review board of each participating center.
A total of 1,279 patients from 21 centers around South Korea were enrolled from January 2013 to April 2014. Patients who underwent PCI for acute coronary syndrome (ACS) were selected. Patients whose recorded data including demographic features, angiographic findings, procedure details, and level of hemoglobin (Hb) were invalid or incomplete were excluded. We excluded the patients who had needed to switch access site during procedure, which might confuse the results of impact on anemia. A total of 389 patients with anemia were chosen by World Health Organization criteria, which defines anemia as Hb <13 g/dl in men and <12 g/dl in women. Subjects with chronic kidney disease preferentially receive TFI to preserve the radial artery for the upcoming hemodialysis. These subjects were also excluded. Finally, a total of 348 patients were enrolled.
Demographic data and baseline clinical characteristics including age, gender, and cardiovascular risk factors were identified. The cardiovascular risk factors included hypertension, diabetes mellitus, dyslipidemia, smoking status, past history of ischemic heart disease, cerebrovascular disease, and peripheral vascular disease. Initial vital signs including systolic blood pressure, diastolic blood pressure, and heart rate were measured. Blood samples for baseline laboratory tests were collected at admission or before PCI. The diagnosis was established from patients’ symptoms, electrocardiogram findings, and cardiac markers by attending physicians and/or cardiologists, based on current clinical guidelines. During the index PCI, the interventional cardiologists had made some important decisions about vascular access site, using balloon predilatation, and intracoronary stents. Preprocedure and postprocedure coronary flow in the target vessel was graded according to the classification used in the Thrombolysis In Myocardial Infarction (TIMI) trials. All patients were treated with optimal medications recommended by the evidence-based guidelines during hospitalization and after discharge.
Rates of in-hospital mortality, any bleeding and access-site complications, and major adverse cardiac events (MACE; defined as the composite of cardiac death, noncardiac death, myocardial infarction), and repeated PCI (target lesion or target vessel revascularization, or non–target vessel revascularization) were determined. Bleeding complications included patients with occurrence of Bleeding Academic Research Consortium bleeding type ≥2. Access-site complication was defined as the composite of pseudoanuerysm, hematoma, or arteriovenous fistula related with the puncture site. Cardiac death was defined as death because of pump failure, arrhythmia, or mechanical complications including ventricular septal rupture and free wall rupture. Follow-up data were obtained by reviewing the medical records and/or telephone interview with patients. All data were entered into an electronic web-based case report form.
For discrete variables, differences were expressed as counts and percentages, and differences between groups were analyzed using the chi-square (or Fisher’s exact) test as appropriate. For continuous variables, differences between groups were evaluated using the unpaired t test or Mann–Whitney rank-sum test. Cumulative 1-year MACE-free survival curves according to the method of vascular approach were constructed from Kaplan–Meier survival analysis and compared using log-rank test. Multivariate logistic regression analyses were performed using all available variables that could be of potential relevance to determine the impact of the vascular access on clinical outcomes. Variables including the initial clinical characteristics, angiographic findings, and procedural findings were first analyzed by the univariate logistic regression analysis. From this analysis, a multivariate logistic regression model was constructed using variables that were clinically significant (p <0.05). In addition, the variables proposed in the Can Rapid risk stratification of Unstable angina patients Suppress Adverse outcomes with Early implementation bleeding risk scoring system guidelines of the American College of Cardiology/American Heart Association (ACC/AHA) were also included. Hazard ratios and 95% CIs were identified. All the analyses were 2-tailed with clinical significance defined as p <0.05. Statistical analyses were performed with SPSS 21.0 for Windows (SPSS-PC, Chicago, Illinois).
Results
The TRI group comprised 253 patients (72.7%) and the TFI group 95 patients (27.3%). Baseline characteristics are listed in Table 1 . There were no significant differences of age, gender, and cardiovascular risk factors between the TRI group and the TFI group, except for the incidence of dyslipidemia. The patients in the TRI group tended to have higher systolic blood pressure and diastolic blood pressure. The patients who diagnosed as myocardial infarction underwent TFI more frequently than TRI.
| Variables | TRI group (n=253) | TFI group (n=95) | P value |
|---|---|---|---|
| Age (years) | 70.9±10 | 70.9±9.8 | 0.989 |
| Men | 148 (58.5%) | 63 (66.3%) | 0.184 |
| Women | 105 (41.5%) | 32 (33.7%) | 0.184 |
| Hypertension | 171 (67.6%) | 55 (57.9%) | 0.091 |
| Diabetes mellitus | 106 (41.9%) | 41 (43.2%) | 0.832 |
| Smoker | 92 (36.4%) | 36 (37.9%) | 0.792 |
| Dyslipidemia | 60 (23.7%) | 12 (12.6%) | 0.023 |
| Prior myocardial infarction | 25 (9.9%) | 6 (6.3%) | 0.298 |
| Previous PCI | 66 (26.1%) | 16 (16.8%) | 0.070 |
| Prior coronary bypass | 1 (0.4%) | 1 (1.1%) | 0.470 |
| Cerebrovascular disease | 26 (10.3%) | 12 (12.6%) | 0.530 |
| Peripheral vascular disease | 7 (2.8%) | 7 (7.4%) | 0.052 |
| Systolic blood pressure (mmHg) | 126.6±21.7 | 119.5±28.9 | 0.031 |
| Diastolic blood pressure (mmHg) | 72.8±12.9 | 67.1±19.5 | 0.009 |
| Heart rate (beats/minute) | 76.2±17.3 | 75.2±25.6 | 0.729 |
| Diagnosis | |||
| Myocardial infarction | 73 (28.9%) | 48 (50.5%) | <0.001 |
| Unstable angina pectoris | 180 (71.1%) | 47 (49.5%) | <0.001 |
Periprocedure anticoagulation and medications are listed in Table 2 . There was no significant difference regarding the use of antiplatelet agents, such as aspirin and clopidogrel, between the TRI and the TFI group. The overall rate of administration of periprocedure anticoagulation was similar between the 2 groups. The patients in the TFI group were more frequently treated with low-molecular weight heparin. The TRI and the TFI groups were similar in the initial level of Hb at presentation. The TFI group had lower level of nadir Hb than the TRI group. There were no significant differences in the cardiac markers, creatinine, HbA1c, total cholesterol, triglyceride, high-density lipoprotein, low-density lipoprotein, high-sensitivity C-reactive protein, and N-terminal pro B-type natriuretic peptide between the 2 groups.
| Variables | TRI group (n=253) | TFI group (n=95) | P value |
|---|---|---|---|
| Hemoglobin (g/dL) | |||
| At presentation | 11.3±1.3 | 11.1±1.5 | 0.236 |
| Change | 0.6±1.1 | 1.1±2.2 | <0.001 |
| At nadir | 10.6±1.4 | 10±2.1 | 0.033 |
| Troponin I (ng/ml) | 7.4±65.6 | 8.6±26.6 | 0.896 |
| CK-MB (ng/ml) | 18.1±55 | 21.4±49.9 | 0.620 |
| Creatinine (mg/dL) | 1.1±1.3 | 1.0±0.4 | 0.430 |
| HbA1c (%) | 6.7±1.4 | 6.6±1.5 | 0.945 |
| Total cholesterol (mg/dL) | 157.6±42.5 | 160.3±55.3 | 0.638 |
| Triglyceride (mg/dL) | 123.5±80.9 | 110.1±77.1 | 0.185 |
| HDL-cholesterol (mg/dL) | 41.7±11.6 | 39.9±12.5 | 0.238 |
| LDL-cholesterol (mg/dL) | 97.4±35.8 | 111.5±73.1 | 0.091 |
| hs-CRP (mg/dL) | 2.3±5.6 | 8.8±36.2 | 0.212 |
| NT-proBNP (pg/ml) | 1593.8±4602.7 | 2065.5±2711.2 | 0.567 |
| Aspirin | 175 (69.2%) | 69 (72.6%) | 0.530 |
| Clopidogrel | 198 (78.3%) | 70 (73.7%) | 0.366 |
| Dual antiplatelet therapy | 169 (66.8%) | 67 (70.5%) | 0.507 |
| Unfractioned heparin | 242 (95.7%) | 84 (88.4%) | 0.014 |
| Low-molecular weight heparin | 94 (37.2%) | 52 (54.7%) | 0.003 |
| Glycoprotein IIb/IIIa inhibitor | 18 (7.1%) | 9 (9.5%) | 0.464 |
The TRI and TFI groups showed similar total procedure time, fluoroscopic time, and amount of contrast media ( Table 3 ). The puncture time of patients in the TRI group was shorter than that of the TFI group. As expected, the TFI group used larger diameter of sheath than the TRI group. In the TRI group, the left anterior descending artery was involved more frequently, whereas the right coronary artery was involved more frequently in the TFI group. The patients underwent TRI showed a lesser percentage of ACC/AHA lesion type C and the preprocedure TIMI flow 0. There were no significant differences from the vascular access, in aspect of incidence of multivessel disease, intracoronary stenting, and the implanted stent profile. The successful rate of PCI was higher in the TRI group than that in the TFI group.
| Variables | TRI group (n=253) | TFI group (n=95) | P value |
|---|---|---|---|
| Total Procedure time (min) | 45.1±30.2 | 44.2±27.1 | 0.793 |
| Puncture time | 1.8±2.7 | 2.6±3.9 | 0.048 |
| CAG time | 11.2±17.5 | 11.5±8.8 | 0.869 |
| PCI time | 31.8±25.8 | 30.8±26.9 | 0.749 |
| Fluoroscopic time (min) | |||
| During CAG | 3.2±7 | 3.2±2.6 | 0.995 |
| During PCI | 12.4±15.9 | 13.6±9.7 | 0.725 |
| Use of contrast media (ml) | |||
| During CAG | 67.6±18.1 | 71.2±23 | 0.324 |
| During PCI | 127.1±80.7 | 130.6±73.9 | 0.804 |
| Sheath size (Fr) | 5.8±1.1 | 6.7±0.9 | <0.001 |
| Multi-vessel disease | 87 (34.4%) | 29 (30.5%) | 0.496 |
| Target coronary artery (%) | |||
| Left anterior descending | 128 (50.6%) | 34 (35.8%) | 0.014 |
| Left circumflex | 40 (15.8%) | 12 (12.6%) | 0.459 |
| Right | 77 (30.4%) | 42 (44.2%) | 0.016 |
| Left main | 8 (3.2%) | 7 (7.4%) | 0.085 |
| ACC/AHA types (%) | |||
| Type A | 4 (1.6%) | 1 (1%) | 0.712 |
| Type B1/B2 | 249 (98.4%) | 77 (81.1%) | <0.001 |
| Type C | 0 (0%) | 17 (17.9%) | <0.001 |
| Pre-procedure TIMI flow 0 | 33 (13.1%) | 36 (37.9%) | <0.001 |
| Pre-procedure TIMI flow 3 | 249 (99.6%) | 90 (95.7%) | 0.008 |
| Intracoronary stenting | 229 (90.5%) | 85 (89.5%) | 0.771 |
| Stent length (mm) | 24.6±8.1 | 23.5±8.4 | 0.796 |
| Stent diameter (mm) | 3±0.4 | 3±0.4 | 0.301 |
| Successful PCI | 252 (99.6%) | 90 (94.7%) | 0.002 |
Table 4 presents data on in-hospital mortality, complications, and cumulative clinical outcomes after 1 year. There was no significant difference in composite of complications between the both groups. The patients in the TRI group showed lower rates of bleeding and access-site complications, in comparison with those in the TFI group. The rates of cardiac death, noncardiac death, myocardial infarction, repeat PCI, and MACE were not different at 12 months, whether or not the TRI was performed. In the multivariate logistic regression analyses, the rates of the bleeding complications and the in-hospital death were lower in the TRI group than in the TFI group ( Table 5 ).
| Variables | TRI group (n=253) | TFI group (n=95) | P value |
|---|---|---|---|
| Complications | . | . | . |
| Bleeding complications | 8 (3.2%) | 8 (8.4%) | 0.037 |
| Access site complications | 3 (1.2%) | 7 (7.4%) | 0.002 |
| In-hospital death | 3 (1.2%) | 5 (5.3%) | 0.024 |
| Twelve-month follow-up | |||
| Cardiac death | 9 (3.6%) | 4 (4.2%) | 0.775 |
| Non-cardiac death | 3 (1.2%) | 4 (4.2%) | 0.073 |
| Myocardial infarction | 1 (0.4%) | 0 (0%) | 0.539 |
| Repeat percutaneous coronary intervention | 10 (4%) | 1 (1.1%) | 0.168 |
| Major adverse cardiac events | 23 (9.1%) | 9 (9.5%) | 0.226 |
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