Abstract
Objective
The aim of this study was to compare the safety and efficacy of the everolimus-eluting stents (EES) with the paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) for the treatment of bare-metal in-stent restenosis.
Background
The optimal treatment for bare-metal in-stent restenosis remains controversial.
Methods
The study cohort comprised 322 consecutive patients (543 lesions) who presented with bare-metal in-stent restenosis to our institution and underwent coronary artery stent implantation with EES (114 patients; 181 lesions), PES (65 patients; 116 lesions) and SES (143 patients; 246 lesions). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, MI, or TLR at 1-year.
Results
The three groups were well matched for the conventional risk factors except for age and chronic kidney disease. The 1-year analyzed clinical parameters were similar in the three groups: death (EES = 3.5%, PES = 4.6%, SES = 4.2%; p = 0.94), MI (EES = 3.5%, PES = 6.3%, SES = 2.1%; p = 0.31), TLR (EES = 9.8%, PES = 9.5%, SES = 5.7%; p = 0.42), TVR (EES = 14.3%, PES = 11.1%, SES = 11.3%; p = 0.74), definite ST (EES = 0.9%, PES = 3.1%, SES = 3.5%; p = 0.38) and MACE (EES = 14.0%, PES = 15.4%, SES = 10.5%; p = 0.54). Male gender (hazard ratio = 0.47; 95% confidence interval = 0.25–0.88) and number of treated lesions (hazard ratio = 1.47; 95% confidence interval = 1.06–2.05) were found to be independent predictors of MACE.
Conclusion
The results of the present study indicate that EES may provide similar safety and efficacy as first generation DES for the treatment of patients presenting with bare-metal in-stent restenosis.
1
Introduction
In-stent restenosis (ISR) following percutaneous coronary intervention (PCI) has continued to remain a challenging issue in interventional cardiology. Although drug-eluting stents (DES) have dramatically reduced the rates of ISR and target lesion revascularization (TLR) associated with bare-metal stents (BMS), BMS-ISR remains problematic, particularly in patients in whom the use of DES is contraindicated such as those with expected lack of adherence or inability to tolerate an extended course of dual antiplatelet therapy . Although a number of strategies for BMS-ISR are currently available, including cutting balloons, scoring balloons, drug-coated balloons (DCBs), DES, vascular brachytherapy, and bioabsobable stents, the optimal therapeutic strategy for the treatment of BMS-ISR remains to be determined .
Recent trials have demonstrated the clinical superiority of EES to first-generation DES in a variety of coronary lesion subsets . However, whether EES provide superior clinical outcomes in the context of BMS-ISR remains to be determined. The aim of this study was therefore to compare the 1-year safety and efficacy of EES with first generation DES in the treatment of BMS-ISR.
2
Methods
This single-center, retrospective study comprised 322 consecutive patients (543 lesions) who had undergone coronary artery stent implantation with EES (XienceV; Abbott Vascular, Santa Clara, CA, or PROMUS; Boston Scientific Corporation, Natick, MA) (114 patients, 181 lesions), PES (TAXUS-Express; Boston Scientific) (65 patients, 116 lesions) and SES (Cypher; Cordis Corporation, Miami Lakes, FL) (143 patients, 246 lesions) for BMS-ISR at the MedStar Washington Hospital Center from January 2007 to December 2011. Patients presenting with ST-elevation myocardial infarction (MI), stent thrombosis (ST) or cardiogenic shock secondary to BMS-ISR were excluded. All patients provided written informed consent for the percutaneous coronary intervention procedure. The study complied with the Declaration of Helsinki for investigation in human beings and was approved by the institutional ethics committee of the MedStar Washington Hospital Center. The procedures were performed according to standard clinical guidelines. In all cases, the interventional strategy as well as the type of stent, use of adjunctive devices and pharmacotherapy, was at the discretion of the operating interventional cardiologist. All patients received aspirin 325 mg pre-procedure and were recommended to continue this regime indefinitely. In addition clopidogrel 75 mg daily following a 300-mg or 600-mg loading dose was commenced pre-procedurally and continued for 12 months. Follow-up data at 30 days, 6-months and 12 months were obtained by telephone contact, mailed questionnaire or outpatient review.
The primary end point of this analysis was major adverse cardiac events (MACE), defined as the composite of death, Q-wave myocardial infarction, or target lesion revascularization (TLR). The secondary end points were repeat revascularization, including TLR and target vessel revascularization (TVR) and definite stent thrombosis (ST).
ISR was defined as ≥ 50% luminal stenosis within the stent segment or stent edge. Repeat restenotic lesion was defined as any lesion that had previously been treated with balloon angioplasty (including cutting balloon) or vascular brachytherapy following BMS-ISR. Q-wave MI was defined as evidence of new Q-waves on the electrocardiogram at the time of MI; the latter being defined as a total creatinine kinase increase ≥ 2 × the upper limit of normal and/or creatinine kinase (MB fraction) ≥ 20 ng/ml together with symptoms and/or ischemic electrocardiogram changes. Angiographic success was defined as post-procedural stenosis ≤ 30% and thrombolysis in myocardial infarction flow grade 3. TLR was defined as ischemia-driven percutaneous or surgical repeat intervention in the stent or within 5 mm proximal or distal to the stent. TVR was defined as percutaneous or surgical revascularization of the stented epicardial vessel. ST was defined in accordance with the Academic Research Consortium definitions as definite, probable, or possible.
Statistical analysis was performed using SAS version 9.2 (SAS institute Inc., Cary, North Carolina). Continuous variables and categorical variables were expressed as mean ± standard deviation and percentages, respectively. Analyses of difference among the 3 drug-eluting stent were performed using analysis of variance for continuous variables, and chi-square test or Fisher exact test for categorical variables. Multivariable analyses were performed using univariate and multivariate Cox Regression analysis, evaluating predictors of MACE. The variables were selected on the basis of overall clinical relevance, with particular attention paid to clinical and procedural factors that would make MACE more likely. Variables with a p value ≤ 0.10 on univariate analysis were entered into the multivariate Cox regression to adjust for baseline differences. One-year MACE-free rate was performed using the Kaplan–Meier method, and differences in parameters were assessed using the log-rank test. The results of the multivariate analysis are expressed as hazard ratio (HR) with 95% confidence interval (CI). A p value < 0.05 was considered statistically significant.
2
Methods
This single-center, retrospective study comprised 322 consecutive patients (543 lesions) who had undergone coronary artery stent implantation with EES (XienceV; Abbott Vascular, Santa Clara, CA, or PROMUS; Boston Scientific Corporation, Natick, MA) (114 patients, 181 lesions), PES (TAXUS-Express; Boston Scientific) (65 patients, 116 lesions) and SES (Cypher; Cordis Corporation, Miami Lakes, FL) (143 patients, 246 lesions) for BMS-ISR at the MedStar Washington Hospital Center from January 2007 to December 2011. Patients presenting with ST-elevation myocardial infarction (MI), stent thrombosis (ST) or cardiogenic shock secondary to BMS-ISR were excluded. All patients provided written informed consent for the percutaneous coronary intervention procedure. The study complied with the Declaration of Helsinki for investigation in human beings and was approved by the institutional ethics committee of the MedStar Washington Hospital Center. The procedures were performed according to standard clinical guidelines. In all cases, the interventional strategy as well as the type of stent, use of adjunctive devices and pharmacotherapy, was at the discretion of the operating interventional cardiologist. All patients received aspirin 325 mg pre-procedure and were recommended to continue this regime indefinitely. In addition clopidogrel 75 mg daily following a 300-mg or 600-mg loading dose was commenced pre-procedurally and continued for 12 months. Follow-up data at 30 days, 6-months and 12 months were obtained by telephone contact, mailed questionnaire or outpatient review.
The primary end point of this analysis was major adverse cardiac events (MACE), defined as the composite of death, Q-wave myocardial infarction, or target lesion revascularization (TLR). The secondary end points were repeat revascularization, including TLR and target vessel revascularization (TVR) and definite stent thrombosis (ST).
ISR was defined as ≥ 50% luminal stenosis within the stent segment or stent edge. Repeat restenotic lesion was defined as any lesion that had previously been treated with balloon angioplasty (including cutting balloon) or vascular brachytherapy following BMS-ISR. Q-wave MI was defined as evidence of new Q-waves on the electrocardiogram at the time of MI; the latter being defined as a total creatinine kinase increase ≥ 2 × the upper limit of normal and/or creatinine kinase (MB fraction) ≥ 20 ng/ml together with symptoms and/or ischemic electrocardiogram changes. Angiographic success was defined as post-procedural stenosis ≤ 30% and thrombolysis in myocardial infarction flow grade 3. TLR was defined as ischemia-driven percutaneous or surgical repeat intervention in the stent or within 5 mm proximal or distal to the stent. TVR was defined as percutaneous or surgical revascularization of the stented epicardial vessel. ST was defined in accordance with the Academic Research Consortium definitions as definite, probable, or possible.
Statistical analysis was performed using SAS version 9.2 (SAS institute Inc., Cary, North Carolina). Continuous variables and categorical variables were expressed as mean ± standard deviation and percentages, respectively. Analyses of difference among the 3 drug-eluting stent were performed using analysis of variance for continuous variables, and chi-square test or Fisher exact test for categorical variables. Multivariable analyses were performed using univariate and multivariate Cox Regression analysis, evaluating predictors of MACE. The variables were selected on the basis of overall clinical relevance, with particular attention paid to clinical and procedural factors that would make MACE more likely. Variables with a p value ≤ 0.10 on univariate analysis were entered into the multivariate Cox regression to adjust for baseline differences. One-year MACE-free rate was performed using the Kaplan–Meier method, and differences in parameters were assessed using the log-rank test. The results of the multivariate analysis are expressed as hazard ratio (HR) with 95% confidence interval (CI). A p value < 0.05 was considered statistically significant.
3
Results
The baseline characteristics and procedural indication of the patients are summarized in Table 1 . The three groups were well matched for the conventional risk factors for coronary artery disease and their clinical presentations, except for age (EES: 65.9 ± 11.3, PES: 61.3 ± 11.5, SES: 65.4 ± 11.2; p = 0.024) and chronic kidney disease (EES = 25.7%, PES = 6.3%, SES = 15.4%; p = 0.003).
| EES (n = 114) | PES (n = 65) | SES (n = 143) | p-value | |
|---|---|---|---|---|
| Age (yrs) | 65.9 ± 11.3 | 61.3 ± 11.5 | 65.4 ± 11.2 | 0.024 |
| Male gender | 78 (68.4) | 48 (75.0) | 100 (69.9) | 0.64 |
| Body mass index (kg/m 2 ) | 30.3 ± 6.2 | 30.8 ± 5.0 | 30.1 ± 6.9 | 0.79 |
| Hypertension | 107 (93.9) | 60 (93.8) | 131 (91.6) | 0.75 |
| Diabetes mellitus | 52 (46.0) | 25 (39.7) | 53 (37.6) | 0.39 |
| Hyperlipidemia | 110 (96.5) | 57 (89.1) | 136 (95.8) | 0.078 |
| Chronic kidney disease | 29 (25.7) | 4 (6.3) | 22 (15.4) | 0.003 |
| Smoking | 68 (59.6) | 40 (62.5) | 83 (58.0) | 0.83 |
| History of MI | 68 (61.8) | 31 (54.4) | 63 (48.1) | 0.10 |
| History of CABG | 41 (36.3) | 22 (34.4) | 37 (26.4) | 0.21 |
| LV ejection fraction | 0.48 ± 0.14 | 0.45 ± 0.14 | 0.48 ± 0.15 | 0.61 |
| Procedure indication | ||||
| Stable angina | 36 (31.6) | 17 (26.6) | 48 (33.6) | 0.60 |
| Unstable angina | 64 (56.1) | 45 (70.3) | 83 (58.0) | 0.15 |
| MI this admission | 9 (7.9) | 0 (0.0) | 7 (4.9) | 0.067 |
| Number of diseased vessels | 1.8 ± 0.9 | 2.0 ± 0.9 | 1.8 ± 0.9 | 0.63 |
The angiographic and procedural characteristics are summarized in Table 2 . The three cohorts differed in the target vessel intervened upon, the location of the target lesion, the pre-TLR diameter stenosis, the length of stents used, as well as the use of cutting balloons and intravascular ultrasound.
| EES (n = 181) | PES (n = 116) | SES (n = 246) | p value | |
|---|---|---|---|---|
| Lesion location | ||||
| Right coronary artery | 56 (30.9) | 48 (41.4) | 88 (35.8) | 0.18 |
| Left anterior descending | 59 (32.6) | 30 (25.9) | 86 (35.0) | 0.22 |
| Left circumflex | 46 (25.4) | 17 (14.7) | 49 (19.9) | 0.07 |
| Saphenous vein graft | 15 (8.3) | 19 (16.4) | 16 (6.5) | 0.009 |
| Lesion location | ||||
| Ostial | 5 (2.8) | 5 (4.4) | 16 (6.6) | 0.19 |
| Proximal | 41 (22.7) | 39 (34.2) | 107 (43.9) | < 0.001 |
| Mid | 77 (42.5) | 48 (42.1) | 86 (35.2) | 0.24 |
| Distal | 55 (30.4) | 21 (18.4) | 28 (11.5) | < 0.001 |
| Repeat restenotic lesion | 53 (29.4) | 50 (43.1) | 85 (34.6) | 0.06 |
| Number of treated lesions | 1.6 ± 0.8 | 1.8 ± 0.9 | 1.7 ± 0.7 | 0.28 |
| Treatment details | ||||
| Pre-TLR diameter stenosis (mm) | 0.85 ± 0.10 | 0.83 ± 0.09 | 0.82 ± 0.12 | 0.04 |
| Post-TLR diameter stenosis (mm) | 0.05 ± 0.13 | 0.04 ± 0.15 | 0.03 ± 0.08 | 0.27 |
| Pre-balloon dilatation | 128 (70.7) | 72 (62.1) | 162 (65.9) | 0.29 |
| Cutting balloon | 10 (5.5) | 17 (14.7) | 35 (14.2) | 0.009 |
| Rotational atherectomy | 3 (1.7) | 0 (0.0) | 1 (0.4) | 0.27 |
| Brachytherapy | 2 (1.1) | 3 (2.6) | 2 (0.8) | 0.38 |
| Stent diameter of secondary stent (mm) | 3.0 ± 0.4 | 3.1 ± 0.3 | 3.1 ± 0.8 | 0.40 |
| Stent length of secondary stent (mm) | 19.1 ± 5.8 | 19.7 ± 6.6 | 21.7 ± 6.2 | 0.002 |
| Number of implanted stents | 1.6 ± 0.8 | 1.8 ± 0.9 | 1.6 ± 0.8 | 0.28 |
| IVUS guided PCI | 96 (53.0) | 82 (72.6) | 159 (65.7) | 0.002 |
| Angiographical success | 178 (98.3) | 113 (97.4) | 242 (99.6) | 0.18 |
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