The outcomes of second-generation drug-eluting stent (DES) are unknown in patients on maintenance hemodialysis (HD) although HD has been reported as a strong predictor of adverse outcome after the first-generation DES implantation. The OUCH-PRO Study is a prospective multicenter single-arm registry design to study clinical and angiographic outcomes after everolimus-eluting stent (EES). Patients who underwent maintenance HD were prospectively enrolled at the time of elective coronary intervention using EES. Quantitative coronary angiography was performed in an independent core laboratory. The primary end point was the occurrence of target vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), and target vessel revascularization at 1 year. A total of 123 patients were enrolled and 161 EES were implanted. The TVF rate at 1 year was 18% (4% cardiac death, 0% MI, 17% target vessel revascularization). No stent thrombosis was documented. Other clinical events at 1 year were 3% noncardiac death, 3% stroke, and 9% non–target-vessel revascularization. Late lumen loss in stent was 0.37 ± 0.63 mm at 8 months. In conclusion, EES had a high TVF rate and great late lumen loss in patients on HD compared with previous huge EES data in non-HD patients.
Cardiovascular disease is a major cause of mortality in patients on hemodialysis (HD). Bypass surgery has superior long-term outcome to percutaneous coronary intervention (PCI) using bare metal stents (BMS) in dialysis patients. Although drug-eluting stents (DES) are associated with lower event rates than BMS, outcomes of the first-generation DES are reported to be disappointing in dialysis patients. Big registry studies of sirolimus-eluting stent (SES) have shown that dialysis was the strongest predictor of adverse outcome. SES for patients on dialysis showed that the target vessel failure (TVF) rate at 1 year was as high as 25%, despite the TVF at 1 year was <10% in nondialysis patients. The second-generation DES has better long-term outcome than the first-generation DES. It is necessary to evaluate the second-generation DES, everolimus-eluting stent (EES), in the group of patients on HD.
Methods
The OUtCome in Hemodialysis with PROmus stent Study (OUCH-PRO) is a prospective multicenter registry study targeting the outcome of EES implantation in patients undergoing maintenance HD. Inclusion criteria were end-stage renal disease requiring HD, age ≥21 years, and elective percutaneous coronary intervention (PCI) with EES. Exclusion criteria were a history of survival after an episode of sudden death, cardiogenic shock, emergency PCI, ST-segment elevation myocardial infarction, intolerance to antiplatelet drugs, coronary stenting within 6 months, in-stent restenosis after DES implantation, myocardial infarction within 30 days, severe valvular heart disease, critical limb ischemia, patients waiting for renal transplantation, and total occlusion of the target vessel. All patients received information about the inclusion and exclusion criteria for the study and gave written informed consent.
All PCI procedures were carried out at the discretion of the operator and with the objective of achieving optimal results, although in elective situations, the use of EES (Promus or Xience) was mandatory. BMS could be used only to facilitate bailout in cases where EES caused edge dissection. Use of other DESs was prohibited; however, rotablator could be used when necessary. Use of intravascular ultrasound to confirm optimal stent expansion was encouraged.
Follow-up was started from the date of the PCI. Planned staged PCI procedures were not considered as adverse events. The “target lesion” was defined at the time of the initial PCI. Follow-up clinical data were collected at 1, 8, and 12 months, and follow-up coronary angiography was performed at 8 months. Maintenance HD was performed 3 times a week using a high-performance membrane.
In the presence of Thrombosis in Myocardial Infarction (TIMI) grade 3 flow, angiographic success was defined as the achievement of a minimum stenosis diameter reduction to <50%. Overall procedural success was defined as the presence of angiographic success plus absence of a major complication and procedural failure as either lack of angiographic success or occurrence of a major complication.
All the angiographic data were transmitted to the independent core laboratory (Japan Cardiocore, Tokyo, Japan) and assessed by experts blinded to patient data. Quantitative coronary angiography (QCA) was carried out in an independent core laboratory using CAAS 5.4 (Pie Medical Imaging, Maastricht, The Netherlands).
The primary end point of the study was occurrence of TVF, defined as cardiac death, MI in the target vessel, and the requirement for TVR within the first year after PCI. MACE was defined as death, MI, repeat PCI, or coronary artery bypass graft (CABG) surgery. Deaths were classified as cardiac or noncardiac. Sudden death due to an unknown cause was classified as a cardiac death. Repeat PCI was categorized as target lesion, target vessel, or nontarget vessel revascularization according to whether the index lesion or artery was involved. Stent thrombosis was categorized as definite, probable, or possible according to the Academic Research Consortium definition.
The target case number for this registry was set at 120 for 12 months of follow-up, which was the same number as the OUCH study. Continuous variables were expressed as mean ± standard deviation and were compared with the Student unpaired t test. Categorical variables were expressed as counts and percentages, and the chi-square test was used for comparison. Cumulative 1-year adverse event rates were estimated according to the Kaplan–Meier method. Logistic regression analysis was performed to detect predictors of the primary end point. All analyses were performed with the SAS 9.2 system. This trial is registered with UMIN with number UMIN000006684.
Results
A total of 123 patients who fulfilled the inclusion criteria were enrolled from September 2011 to October 2012. A total of 161 target lesions were present in these 123 patients. Clinical follow-up was available in 98% of patients at 12 months, and angiographic follow-up was available in 87% of the survivors (98 of 113).
Overall, mean age of patients was 67 years; 75% were men, 85% had hypertension; and 67% had diabetes ( Table 1 ). Dual-antiplatelet therapy (DAPT) was prescribed for 90% and triple antiplatelet therapy was for 10%. Lesion characteristics and coronary intervention procedures are provided in Table 2 . PCI was successful for 100% cases with 71% intravascular ultrasound guidance. Transfemoral approach was 100% because transradial approach is considered as contraindication for patients on HD.
| Patient number | 123 |
| Male gender | 75% |
| Age (years) | 67 ± 10 |
| Height (cm) | 161 ± 9 |
| Weight (kg) | 59 ± 11 |
| Body mass index (kg/m 2 ) | 22.7 ± 3.3 |
| Hypertension | 85% |
| Dyslipidemia | 48% |
| Current smoking | 37% |
| Peripheral artery disease | 22% |
| Cerebrovascular disease | 7% |
| Family history of CAD | 7% |
| Diabetes mellitus | 67% |
| Reason of renal failure | |
| Diabetic nephropathy | 64% |
| Non-diabetic nephropathy | 36% |
| Duration of hemodialysis (years) | 5.9 ± 5.8 |
| Diagnosis | |
| Stable angina | 48% |
| CCS Class 1 | 32% |
| CCS Class 2 | 14% |
| CCS Class 3 | 2% |
| Unstable angina | 14% |
| Asymptomatic ischemia | 38% |
| Prior myocardial infarction | 17% |
| Prior PCI | 23% |
| Prior CABG | 5% |
| Number of diseased vessels | |
| 1 | 51% |
| 2 | 33% |
| 3 | 16% |
| Non-protected left main disease | 4% |
| Ejection fraction | 56 ± 11% |
| Ejection fraction < 50% | 24% |
| Baseline Antiplatelet therapy | |
| Dual antiplatelet therapy | 111 (90%) |
| Aspirin + Clopidogrel | 100 |
| Aspirin + Ticlopidine | 8 |
| Aspirin + Cilostazol | 3 |
| Triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) | 12 (10%) |
| Baseline medications | |
| Statin | 33% |
| Angiotensin converting enzyme Inhibitor | 7% |
| Angiotensin receptor blocker | 51% |
| Beta blocker | 28% |
| Insulin | 24% |
| Sevelamer | 11% |
| Baseline blood data | |
| Hemoglobin (g/dL) | 10.9 ± 2.5 |
| Calcium (mg/dL) | 8.8 ± 0.8 |
| Phosphate (mg/dL) | 4.9 ± 3.1 |
| BNP (pg/mL) | 492 ± 751 |
| hsCRP (mg/dL) | 0.54 ± 1.23 |
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