Summary
Background
It is unknown whether the efficacy and safety of drug-eluting stents (DES) apply in patients with chronic renal failure (CRF).
Aims
To compare DES with bare metal stents (BMS) for percutaneous coronary intervention (PCI) in CRF patients.
Patients and methods
Consecutive patients treated by PCI were allocated to four groups according to type of stent used (DES versus BMS) and creatinine clearance (CrCl). CRF was defined as CrCl less than 60 mL/minute. Cardiovascular death, major adverse cardiac events (MACE, defined as cardiovascular death, myocardial infarction, stroke and target lesion revascularization [TLR]), TLR and definite stent thrombosis (ST) were recorded at 1 year.
Results
We note that 1376 consecutive patients underwent PCI with stent within 18 months: 534 (39%) and 492 (36%) patients without CRF and 224 (16%) and 126 (9%) patients with CRF were treated with BMS and DES, respectively. In the entire cohort, patients treated with DES had a higher restenosis risk profile. BMS were predominantly (87%) used for ST-segment elevation myocardial infarction. At 1 year, 6.2% had cardiovascular death, 15.8% MACE, 7.3% TLR and 1.5% ST. Cardiovascular death and MACE occurred less frequently in DES groups. The TLR rate was not significantly different in the CRF groups (BMS 9.8% vs DES 7.1%; P = 0.44). No excess of ST was observed in the DES groups and use of DES was independently associated with absence of MACE and TLR.
Conclusions
In patients with CRF, DES appear to be at least as effective as BMS — despite a higher restenosis risk profile — with no excess of ST at 1 year.
Résumé
Context
Peu de données sont disponibles sur l’efficacité et la sécurité des stents actifs (DES) chez les patients avec insuffisance rénale (CRF).
Objectif Comparer DES et stents nus (BMS) lors de l’angioplastie coronaire (PCI) chez les patients avec CRF.
Patients et méthodes
Une série consécutive de patients traités par PCI ont été répartis en quatre groupes selon le stent utilisé (DES ou BMS), et la clairance de la créatinine (CrCl). CRF était défini par une CrCl inférieure à 60 mL/min. Les décès cardiovasculaire (CV), revascularisation de la lésion cible (TLR), thrombose certaine de stent (ST), événement cardiaque majeur (MACE) incluant décès CV, infarctus, accident vasculaire cérébral et TLR ont été analysés à un an.
Résultats
On note que 1376 patients consécutifs ont été traités par PCI en 18 mois : 534 (39 %), 492 (36 %), 224 (16 %) et 126 (9 %) patients ont été répartis dans les groupes BMS, DES, BMS CRF et DES CRF. Les patients traités par DES avaient un plus haut risque de resténose. Le BMS était préférentiellement utilisé en phase aiguë d’infarctus. À un an, le taux de décès CV était de 6,2 %, avec 15,8 % de MACE, 7,3 % de TLR et 1,1 % de ST. Les décès CV et MACE étaient moins fréquents dans les groupes avec DES. Dans le groupe avec CRF, le taux de TLR était comparable avec BMS et DES (9,8 % vs 7,1 % ; p = 0,44). Il n’a pas été observé d’excès de ST avec le DES, et l’utilisation de DES était associée de manière indépendante à un moindre risque de MACE et TLR.
Conclusion
Chez les patients avec CRF, le DES apparaît au moins aussi efficace que le BMS, malgré un profil plus à risque de resténose, sans excès de ST à un an.
Background
Patients with chronic renal failure (CRF) carry the risk of severe coronary artery disease, with cardiovascular death accounting for almost 50% of the total mortality in this population . Outcomes after percutaneous coronary intervention (PCI) — with balloon or bare metal stents (BMS) — remain poor compared with in patients with normal renal function , with no prognostic benefit demonstrated with this revascularization strategy . Some authors report an increased rate of silent in-stent restenosis in CRF patients, which could partly explain these adverse outcomes .
Drug-eluting stents (DES) dramatically decrease the rates of in-stent restenosis and subsequent target lesion revascularization (TLR) compared with BMS in the general population . However, little is known about the subset of patients with CRF.
The purpose of the present study was to assess the efficacy and safety of DES (vs BMS) in the contemporary practice of PCI (elective or urgent) in a consecutive, non-selected population of patients with CRF.
Patients and methods
Patient population
All patients treated by PCI with at least one stent in our institution were included between August 2007 and January 2009. This was an “all-comers”, prospective, single-centre registry. Patients treated by balloon angioplasty without subsequent stent implantation ( n = 68) were excluded. During the 1-year follow-up period, new PCIs were counted as outcomes ( n = 124). Clinical and angiographical data were prospectively entered into the web-based “Middle Care” database.
Aspirin and clopidogrel pretreatment or loading dose (300 to 900 mg) was given before PCI. Periprocedural 0.9% saline intravenous perfusion (100 mL/hour) was achieved 12 hours before and after PCI, except in patients with congestive heart failure. All patients — except those previously treated by vitamin K antagonists — received intravenous low molecular weight heparin during PCI. The use of glycoprotein IIb/IIIa inhibitors was left to the operators’ discretion; they were mostly used in cases of primary PCI for ongoing stent thrombosis (ST)-segment elevation myocardial infarction, in high-risk acute coronary syndrome patients or in bail-out situations. PCI was performed according to standard guidelines, mostly by the radial approach, using five or six French sheaths with systematic stent implantation (unless inappropriate). The usual aspirin maintenance dose was 75 mg/day while the daily clopidogrel dose was 75 to 150 mg. Dual antiplatelet therapy was maintained for 12 months in cases of acute coronary syndrome or DES implantation and could be switched to single antithrombotic therapy after 1 month in cases of BMS implantation in a non-urgent setting.
Patient assessments
Patients were allocated to four patient groups according to the stent used (BMS versus DES) and renal function (CRF vs NO CRF). Chronic renal failure was defined as creatinine clearance (CrCl) less than 60 mL/minute calculated with the Cockroft formula. Patients treated with both DES and BMS were allocated to the DES groups.
Death was defined as death from any cause. Cardiovascular death was defined as death from cardiovascular cause or sudden death without extracardiovascular cause. Myocardial infarction was defined as recurrent chest pain and/or electrocardiogram changes with at least one of the following criteria: creatine kinase and troponin I ≥ 2 times the upper limit of normal with an increase of more than 50% of the prior value; and the appearance of a new left bundle-branch block or new Q waves. Stroke was defined as an acute neurological deficit lasting for more than 24 hours, classified by neurological evaluation. Clinical TLR was defined as new revascularization of the treated lesion mandated by clinical symptoms or documented ischaemia. Major adverse cardiac events (MACE) were defined as the composite of cardiovascular death, myocardial infarction, stroke and TLR. Stent thrombosis (ST) was defined as definite ST according to the American Research Consortium criteria .
Cardiovascular events
The primary endpoint was the rate of MACE and the secondary endpoint was the rate of TLR at 1 year. The safety endpoint was the rate of ST at 1 year. One-year clinical outcomes were obtained by medical consultation, from the rehospitalization medical report or by telephone call.
Statistical analyses
Categorical variables are expressed as numbers and percentages (%); continuous variables are expressed as means ± standard deviations. Univariate analyses were performed using the chi-square test for categorical variables and Student’s t test for continuous variables. Kaplan-Meier curves were drawn using GraphPad Prism (version 5.01 for Windows; GraphPad Software, San Diego, CA, USA). Multivariable analyses were performed using a multiple logistic regression model. The statistical analyses were performed with Statview software (version 5.0; SAS Institute Inc., Cary, NC, USA).
Results
Baseline characteristics
Among the 1376 consecutive patients who underwent PCI with stent implantation in our institution, 534 (39%), 492 (36%), 224 (16%) and 126 (9%) patients were allocated to the NO CRF-BMS, NO CRF-DES, CRF-BMS and CRF-DES groups, respectively.
Baseline clinical and procedural characteristics according to renal function and stent type are shown in Table 1 .
| CRF-BMS ( n = 224; 16%) | CRF-DES ( n = 126; 9%) | NO CRF-BMS ( n = 534; 39%) | NO CRF-DES ( n = 492; 36%) | P | |
|---|---|---|---|---|---|
| Age (years) | 75 ± 11 | 72 ± 11 | 62 ± 12 | 61 ± 11 | < 0.0001 |
| Women | 76 (34) | 39 (31) | 93 (17) | 77 (16) | < 0.0001 |
| BMI | 25 ± 4 | 24 ± 4 | 27 ± 5 | 27 ± 4 | < 0.0001 |
| Diabetes | 57 (25) | 40 (32) | 123 (23) | 145 (30) | 0.056 |
| Dyslipidaemia | 121 (54) | 81 (64) | 271 (51) | 331 (67) | < 0.0001 |
| Current smoker | 28 (13) | 15 (12) | 210 (39) | 149 (30) | < 0.0001 |
| Hypertension | 146 (65) | 98 (78) | 280 (53) | 272 (55) | < 0.0001 |
| Hx of CAD | 16 (7) | 17 (13) | 91 (17) | 110 (22) | < 0.0001 |
| Prior MI | 42 (19) | 27 (21) | 86 (16) | 124 (25) | 0.004 |
| Prior PCI | 44 (20) | 57 (45) | 78 (15) | 182 (37) | < 0.0001 |
| Prior CABG | 22 (10) | 11 (9) | 33 (6) | 40 (8) | 0.325 |
| Prior stroke | 25 (11) | 7 (6) | 32 (6) | 16 (3) | 0.0005 |
| Creatinine | 157 ± 137 | 162 ± 141 | 78 ± 18 | 78 ± 17 | < 0.0001 |
| CrCl | 42 ± 13 | 42 ± 14 | 98 ± 32 | 100 ± 31 | < 0.0001 |
| Dialysis | 22 (10) | 16 (15) | – | – | – |
| ACS | 67 (30) | 50 (41) | 151 (29) | 174 (36) | 0.010 |
| AMI | 59 (27) | 1 (1) | 189 (36) | 37 (8) | < 0.0001 |
| Cardiogenic shock | 25 (11) | 1 (8) | 18 (3) | 1 (0) | < 0.0001 |
| Out-of-hospital cardiac arrest | 9 (4) | 1 (1) | 9 (2) | 1 (0) | 0.001 |
| Radial access | 169 (82) | 90 (81) | 425 (88) | 403 (90) | 0.009 |
| Multivessel disease | 143 (64) | 72 (57) | 253 (48) | 297 (61) | < 0.0001 |
| LM | 19 (8) | 7 (6) | 14 (3) | 21 (4) | 0.004 |
| LAD | 163 (73) | 82 (65) | 318 (59) | 337 (68) | 0.001 |
| Circ | 102 (46) | 54 (43) | 214 (40) | 219 (45) | 0.410 |
| RCA | 127 (57) | 67 (53) | 289 (54) | 248 (50) | 0.417 |
| Graft | 61 (27) | 27 (21) | 95 (18) | 121 (25) | 0.011 |
| Number of stents/patient | 1.6 ± 0.9 | 1.7 ± 0.9 | 1.5 ± 0.8 | 1.7 ± 1.0 | 0.002 |
| Total stent length/patient | 25 ± 18 | 27 ± 17 | 23 ± 14 | 28 ± 19 | < 0.0001 |
| Average stent diameter/patient | 2.9 ± 0.4 | 2.7 ± 0.4 | 3.0 ± 1.0 | 2.8 ± 0.8 | 0.006 |
| Cypher© | – | 38 (30) | – | 174 (35) | 0.273 |
| Taxus© | – | 47 (37) | – | 174 (35) | 0.686 |
| Endeavor© | – | 46 (37) | – | 201 (41) | 0.375 |
| Other DES | – | 12 (10) | – | 30 (6) | 0.173 |
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