No data are available comparing the long-term outcome of sirolimus-eluting stents (SESs) versus paclitaxel-eluting stents (PESs) in patients with moderate to severe renal insufficiency. The incidence of major adverse cardiac events (MACE), including death, myocardial infarction, and target vessel revascularization, during long-term follow-up were studied in patients with a glomerular filtration rate of <60 ml/min/1.73 m 2 , as measured by the Modification of Diet in Renal Disease (MDRD) study equation, who also underwent percutaneous coronary intervention with drug-eluting stents. Of 428 patients studied, PESs were placed in 287 patients and SESs in 141 patients. Stepwise Cox regression analyses were performed to identify significant independent risk factors for MACE. At 47 ± 19 months of follow-up, MACE had occurred in 49 (17%) of 287 patients in the PES group (mean age 71 ± 11 years, 55% men) and in 31 (22%) of 141 patients in the SES group (mean age 71 ± 12 years, 53% men). No significant difference was found in the MACE rate between the PES and SES groups. This persisted even after controlling for stent length, lesion complexity, and other co-morbidities. Also, all-cause mortality was not significantly different between the PES and SES groups (7.1% vs 8.5%, respectively). In conclusion, during long-term follow-up of patients with moderate to severe renal insufficiency, the rates of MACE and all-cause mortality were similar in the PES and SES groups.
Coronary artery disease is the predominant cause of mortality in patients with chronic kidney disease (CKD). Previous studies have demonstrated a greater incidence of major adverse cardiac events (MACE) in patients with CKD after percutaneous coronary interventions. Randomized trials have shown that drug-eluting stents (DESs) substantially reduce MACE primarily by decreasing in-stent restenosis ; however, most of these studies excluded patients with CKD. In the present study, we compared sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) with regard to long-term MACE in patients with a glomerular filtration rate of <60 ml/min/1.73 m 2 .
Methods
We retrospectively studied 428 consecutive patients with moderate to severe renal insufficiency from January 2003 to December 2005, who had undergone single-vessel percutaneous coronary intervention with a DES at our institution. Moderate to severe renal insufficiency was defined as a glomerular filtration rate of <60 mL/min/1.73 m 2 . All patients with acute renal failure, requiring dialysis, or with a renal transplant were excluded from the present study. The glomerular filtration rate was calculated using the Modification of Diet in Renal Disease (MDRD) study equation within 24 hours of percutaneous coronary intervention.
Of 428 patients, PESs were used in 287 patients and SESs in 141 patients. The angiographic and procedural success rates were similar in the SES- and PES-treated patients. Also, the in-hospital outcomes were not different between the SES- and PES-treated patients.
We collected data on demographics and the baseline characteristics of age, gender, race, body mass index, hypertension, diabetes mellitus, dyslipidemia, current smoking, and current medications. Diabetes mellitus was defined as a previous diagnosis, the use of diet or antidiabetic medicines, or a fasting venous blood glucose level of ≥126 mg/dl on 2 occasions in previously untreated patients. Patients who had received medications for hypertension or those with a systolic blood pressure of ≥140 mm Hg or diastolic blood pressure of ≥90 mm Hg and not taking concurrent antihypertensive therapy were classified as having hypertension. Hypertension in patients with diabetes was defined as a systolic blood pressure of ≥130 mm Hg or a diastolic blood pressure of ≥80 mm Hg. Dyslipidemia was defined as a serum total cholesterol level of ≥200 mg/dl, low-density lipoprotein cholesterol level of ≥100 mg/dl, high-density lipoprotein level of ≤40 mg/dl, triglycerides of ≥150 mg/dl, or if the patient was taking any lipid-lowering drugs. Patients who had smoked within the previous 1 year of entry into the study were deemed current smokers.
We also collected data on the angiographic and procedural variables, including the number of coronary arteries with ≥50% stenosis, the vessel stented (left anterior descending, left circumflex, right coronary artery, vein graft, or arterial graft), the lesion complexity (A, B, or C), length of the stented segment, target vessel diameter, and use of glycoprotein IIb/IIIa inhibitors during the procedure.
The primary outcome of interest was MACE, which was a composite of death, nonfatal myocardial infarction, and target vessel revascularization. The primary outcome MACE was compared in the PES and SES groups. We also studied death, myocardial infarction, and target vessel revascularization individually. The mean duration of follow-up was 49 ± 21 months in the SES group and 46 ± 18 months in the PES group. Follow-up data were obtained for all 428 patients in the study by frequent office visits to the cardiologist and from the Social Security Death Index.
All statistical analyses were performed using a Statistical Analysis Systems, version 9, software package (SAS Institute, Cary, North Carolina). Descriptive statistics included the mean and SD for continuous measurements and proportions for categorical ones. We applied 2-sample t tests and chi-square tests to test the equality of the means and proportions between the PES and SES groups. The association between DES and the MACE was tested using logistic regression models, controlling for other covariates at each step. Purposeful selection methods were used during that process to evaluate the significance and confounding effects of the covariates. The covariates considered for the final model for the outcome of interest included the variables of age, gender, race, stent length, target vessel diameter, indications for percutaneous coronary intervention, coronary artery disease burden, lesion complexity, previous coronary artery bypass surgery, smoking, hypertension, diabetes, dyslipidemia, body mass index, and use of drugs, including aspirin, clopidogrel, thrombolytics, glycoprotein IIb/IIIa inhibitors, β blockers, statins, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. The goodness of fit of the models was evaluated using the Pearson goodness of fit statistic and c statistic (area under the receiver operating characteristic curve). All associations less than the α level of 0.05 were considered significant.
Results
Table 1 lists the demographics and baseline characteristics in the SES and PES groups. The baseline characteristics and lesion characteristics were similar in both groups. As listed in Table 1 , the antiplatelet drugs aspirin and clopidogrel were taken by 99% to 100% of all patients. β Blockers were taken by 94% of patients and statins by 97% to 98% of patients. Glycoprotein IIb/IIIa inhibitors were used by 6% to 8% of the patients.
| Variable | SES (n = 141) | PES (n = 287) | p Value |
|---|---|---|---|
| Age (years) | 71 ± 12 | 71 ± 11 | 0.53 |
| Gender | |||
| Men | 75 (53%) | 157 (55%) | |
| Women | 66 (47%) | 130 (45%) | 0.84 |
| Race | |||
| White | 121 (86%) | 249 (87%) | |
| Nonwhite | 20 (14%) | 38 (13%) | 0.77 |
| Indication | |||
| Unstable angina pectoris | 62 (44%) | 129 (45%) | 0.92 |
| Positive stress test | 44 (31%) | 104 (36%) | 0.33 |
| Acute myocardial infarction | 35 (25%) | 54 (19%) | 0.097 |
| Body mass index (kg/m 2 ) | 28 ± 6 | 29 ± 6 | 0.62 |
| Body mass index ≥30 kg/m 2 | 50 (35%) | 100 (35%) | 0.91 |
| Glomerular filtration rate (ml/min/1.73 m 2 ) | 45 ± 14 | 46 ± 13 | 0.43 |
| Hypertension | 135 (96%) | 265 (92%) | 0.22 |
| Diabetes mellitus | 69 (49%) | 130 (45%) | 0.61 |
| Dyslipidemia ⁎ | 136 (96%) | 280 (98%) | 0.54 |
| Smoker | 41 (29%) | 73 (25%) | 0.42 |
| Aspirin use | 139 (99%) | 285 (99%) | 0.60 |
| Clopidogrel use | 141 (100%) | 286 (100%) | 1.0 |
| β-Blocker use | 133 (94%) | 271 (94%) | 1.0 |
| Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use | 57 (40%) | 120 (42%) | 0.83 |
| Statin use | 136 (96%) | 280 (98%) | 0.54 |
| Glycoprotein IIb/IIIa inhibitor use | 9 (6%) | 22 (8%) | 0.70 |
| Thrombolytic use | 17 (12%) | 29 (10%) | 0.62 |
| Previous coronary bypass | 30 (21%) | 64 (22%) | 0.90 |
| No. of coronary arteries involved | |||
| 1 | 44 (31%) | 102 (36%) | 0.39 |
| 2 | 50 (35%) | 100 (35%) | 0.91 |
| 3 | 47 (33%) | 85 (30%) | 0.44 |
| Complexity of stented lesion | |||
| A | 74 (52%) | 143 (50%) | 0.61 |
| B | 46 (33%) | 108 (38%) | 0.34 |
| C | 21 (15%) | 36 (13%) | 0.55 |
| Left ventricular ejection fraction | |||
| >50% | 78 (55%) | 166 (58%) | 0.68 |
| <30% | 5 (4%) | 17 (6%) | 0.36 |
| 30–50% | 58 (41%) | 104 (36%) | 0.34 |
| Stented coronary artery | |||
| Left anterior descending | 62 (44%) | 114 (40%) | 0.41 |
| Left circumflex | 32 (23%) | 78 (27%) | 0.35 |
| Right | 35 (25%) | 84 (30%) | 0.36 |
| Vein graft | 12 (9%) | 11 (4%) | 0.07 |
| Length of stented segment (mm) | 25 ± 11 | 25 ± 15 | 0.98 |
| Target vessel diameter (mm) | 3 ± 0.4 | 3 ± 0.4 | 0.63 |
| Follow-up duration (months) | 49 ± 21 | 46 ± 18 | 0.22 |
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