Abstract
Background
It has been reported that sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) have been more effective than bare‐metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there might be differences between these two drug‐eluting stents in terms of efficacy and safety in the setting of acute ST‐segment elevation myocardial infarction (STEMI).
Hypothesis
The aim of the present study was to compare SES with PES in patients with acute STEMI undergoing primary percutaneous coronary intervention (PCI).
Methods
The published research was scanned by formal searches of electronic databases (PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials) from January 2001 to February 2010. Internet‐based sources of information on the results of clinical trials in cardiology were also searched.
Results
A total of 4 randomized trials were included in the present meta‐analysis, involving 1105 patients (550 in the SES group, 555 in the PES group). SES were significantly more effective in the reduction of angiographic binary (≥50%) restenosis (4.0% vs 9.6%, odds ratio 0.38, 95% confidence interval 0.19 to 0.74, P = 0.004) compared to PES. The differences between SES and PES were not statistically significant with respect to target vessel revascularization (TVR), stent thrombosis, cardiac death, and myocardial infarction.
Conclusions
SES are superior to PES in reducing the incidence of restenosis in patients undergoing primary PCI for STEMI, with nonsignificant differences in terms of TVR, cardiac death, myocardial infarction, and stent thrombosis. Copyright © 2010 Wiley Periodicals, Inc.
The authors have no funding, financial relationships, or conflicts of interest to disclose.
Introduction
Primary angioplasty has become the standard of care for acute ST‐segment elevation myocardial infarction (STEMI); however, its long‐term success is limited by the occurrence of restenosis.1,2 The introduction of drug‐eluting stents (DES) has greatly alleviated this problem,3 and their use in coronary intervention has markedly increased. DES decreases angiographic and clinical measurements of restenosis compared with bare metal stents4,5 in elective patients and those with STEMI. A meta‐analysis in a broad population has shown that sirolimus‐eluting stents (SES) are superior to paclitaxel‐eluting stents (PES) in terms of late loss and target lesion revascularization (TLR).6 However, the relative efficacy and safety of SES and PES in STEMI patients remains unclear. We therefore performed a meta‐analysis of randomized trials to compare SES with PES in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI.
Methods
Literature Search and Study Selection
The published research was scanned by formal searches of electronic databases (PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials) from January 2001 to February 2010. All randomized trials involving comparisons of SES and PES in patients with STEMI were examined using the following key words: “myocardial infarction,” “sirolimus,” “paclitaxel,” and “stent.” Internet‐based sources of information on the results of clinical trials in cardiology (http://www.cardiosource.com/clinicaltrials, http://www.theheart.org, http://www.clinicaltrialresults. com, and http://www.tctmd.com) were also searched. Additional data sources included conference proceedings from the American College of Cardiology, American Heart Association, and European Society of Cardiology meetings. We also identified relevant reviews and editorials from major medical journals published within the last year and assessed for possible information on trials of interest. All studies meeting the requirements, regardless of the language or form of publication, were considered eligible for this meta‐analysis. When there were multiple reports from the same trial, we used the most complete and/or recently reported data.
Randomized clinical trials evaluating outcome after SES vs PES implantation for STEMI were reviewed; specific trials enrolling patients with STEMI or trials reporting outcome analyses of the subpopulation of STEMI patients were selected for analysis. All studies had to report results at a follow‐up duration of ≥ 6 months after the index procedure.
Definitions and Endpoints
The primary outcome of interest was target vessel revascularization (TVR), which was defined as either surgical or percutaneous reintervention of a lesion in the same epicardial vessel as index procedure. Other clinical outcomes of interest were cardiac death, myocardial infarction, and stent thrombosis. We accepted the individual protocol definitions of clinical events and did not attempt to retrospectively recategorize them. The angiographic outcome of interest was binary (≥50%) restenosis.
Data Extraction
Two investigators (YL and WL) independently extracted data on patient and study characteristics, outcomes, and study quality for each trial using a standardized protocol and reporting form. Disagreements were resolved by consensus with a third reviewer (ZW). Absolute numbers were recalculated when percentages were reported.
Statistical Analysis
All analyses were performed according to intention‐to‐treat data using Review Manager (RevMan) version 5.0.16.0 (Cochrane Information Management System, http://www.cc‐ims.net/). The Mantel‐Haenszel method for fixed effects and the DerSimonian‐Laird method for random effects were used to estimate pooled odds ratios (ORs). We tested heterogeneity of the included studies with Q statistics and extent of inconsistency between results with I 2 statistics. In the absence of heterogeneity between studies, the Mantel‐Haenszel and DerSimonian‐Laird methods produce very similar results. We report fixed effects estimates, because fixed effects are more robust in meta‐analysis calculations when there are small numbers of events. Possibility of publication bias was assessed by funnel plot analysis. Data are presented as ORs with 95% confidence intervals (CIs), with 2‐tailed P values and statistical significance set at a P value < 0.05 (2‐tailed).
Results
Search Results and Study Characteristics
The initial search yielded 531 results, of which 6 reports of 4 trials (2 prospective randomized clinical trials7, 8, 9 and 2 subgroups of 2 randomized clinical trials10, 11, 12) met our inclusion criteria. The studies included a total of 1105 patients undergoing primary PCI for STEMI, of whom 550 were in SES and 555 were in PES. The main characteristics of these trials are listed in Table 1, and baseline characteristics of enrolled patients in the individual trials are listed in Table 2.
Table 1.
Main Characteristics of the Trials Included in the Meta‐analysis
| Study | Trial Name (Year of Publication) | Study Site | No. of Centers | No. of Enrolled Patients | Primary End Points | Minimal Length of Thienopyridine Therapy in the SES/PES Groups (m) | Angiographic Follow‐Up (m) | Clinical Follow‐Up (y) |
|---|---|---|---|---|---|---|---|---|
| Lee et al7, Kim et al8 | PROSIT (2008, 2009) | Korea | 3 | 308 (154 SES, 154 PES) | Major adverse cardiac events | 6/6 | 6 | 3 |
| Di Lorenzo et al10 | PASEO (2009) | Italy | 1 | 270 (90 SES, 90 PES, 90 BMS) | Target lesion revascularization | 6/6 | NA | 4.3a |
| Juwana et al 9 | NA (2009) | The Netherlands | 1 | 397 (196 SES, 201 PES) | Late lumen loss | 6/6 | 9 | 1 |
| Lee et al11,12 | ZEST‐AMI (2008, 2009) | Korea | 12 | 328 (110 SES, 110 PES, 108 ZES) | Major adverse cardiac events | 12/12 | 8 | 1 |
Abbreviations: BMS, bare metal stents; NA, no information available; PASEO, PaclitAxel or Sirolimus‐Eluting Stent Versus Bare Metal Stent in Primary Angioplasty; PES, paclitaxel‐eluting stents; PROSIT, Prospective Randomized Trial of Sirolimus‐ Versus Paclitaxel‐Eluting Stents for the Treatment of Acute ST‐Elevation Myocardial Infarction; SES, sirolimus‐eluting stents; ZES, zotarolimus‐eluting stents; ZEST‐AMI, Zotarolimus‐Eluting Stent Versus Sirolimus‐Eluting Stent Versus Paclitaxel‐Eluting Stent for Acute Myocardial Infarction Patients.
Expressed as median.
Table 2.
Baseline Clinical and Angiographic Characteristics of the Study Populations
| Variablea | PROSIT7,8 | PASEO10 | Juwana et al9 | ZEST‐AMI11,12 | ||||
|---|---|---|---|---|---|---|---|---|
| SES (n=154) | PES (n=154) | SES (n=90) | PES (n=90) | SES (n=196) | PES (n= 201) | SES (n=110) | PES (n=110) | |
| Age (y) | 60 ± 11 | 60 ± 12 | 62 ± 15 | 63 ± 15 | 61 ± 12 | 61 ± 11 | 57.8 ± 11.3 | 59.3 ± 11.2 |
| Men, no. (%) | 117 (76.0) | 118 (76.6) | 64 (71.1) | 62 (68.9) | 135 (69) | 149 (74) | 95 (86.4) | 91 (82.7) |
| Hypertension, no. (%) | 70 (45.5) | 63 (40.9) | 25 (27.8) | 24 (26.7) | 53 (27) | 66 (33) | 42 (38.2) | 51 (53.6) |
| Hypercholesterolemia, no. (%) | 45 (29.2) | 35 (22.7) | NA | NA | 37 (19) | 38 (19) | 45 (40.9) | 51 (46.4) |
| Diabetes mellitus, no. (%) | 34 (22.1) | 44 (28.6) | 25 (27.8) | 21 (23.3) | 21 (10.7) | 13 (6.5) | 29 (26.4) | 26 (23.6) |
| Current smoking, no. (%) | 95 (61.7) | 86 (55.8) | 22 (24.4) | 22 (24.4) | 98 (50) | 111 (55) | 62 (56.4) | 68 (61.8) |
| Previous myocardial infarction, no. (%) | NA | NA | 14 (15.6) | 13 (14.4) | 12 (6.1) | 12 (6.0) | NA | NA |
| Previous percutaneous coronary intervention, no. (%) | NA | NA | 6 (6.7) | 3 (3.3) | 13 (6.6) | 12 (6.0) | 1 (0.9) | 2 (1.8) |
| Previous coronary artery bypass graft, no. (%) | NA | NA | 5 (5.6) | 7 (7.8) | 2 (1.0) | 3 (1.5) | NA | NA |
| Center ventricular ejection fraction (%) | 51.6 ± 10.1 | 51.2 ± 10.9 | NA | NA | NA | NA | 51.9 ± 10.3 | 49.7 ± 10.3 |
| Door‐to‐balloon time (m) | 65 (50– 81)b | 65 (55– 85)b | 45.2 ± 16.9 | 43.2 ± 14.2 | 87.0 ± 79.2 | 76.0 ± 58.8 | ||
| Glycoprotein IIb/IIIa inhibitor use, no. (%) | 14 (9.1) | 20 (13.0) | 90 (100) | 90 (100) | 55 (28) | 66 (33) | 23 (20.9) | 22 (20.0) |
| Thrombectomy devices, no. (%) | 44 (29.6) | 55 (35.7) | 4 (4.4) | 4 (4.4) | 2 (1.0) | 3 (1.5) | 6 (5.7) | 5 (4.8) |
| Infarct related artery, no. (%) | ||||||||
| Center anterior descending coronary | 75 (48.7) | 80 (51.9) | 48 (53.3) | 46 (51.1) | 86 (44) | 82 (41) | 50 (45.5) | 50 (45.5) |
| Right coronary | 55 (35.7) | 55 (35.7) | 21 (23.3) | 21 (23.3) | 80 (41) | 84 (42) | 46 (41.8) | 41 (37.3) |
| Center circumflex coronary, no. (%) | 22 (14.3) | 17 (11.0) | 21 (23.3) | 23 (25.6) | 29 (14.8) | 34 (16.9) | 14 (12.7) | 19 (17.3) |
| Center main coronary, no. (%) | 2 (1.3) | 2 (1.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Preprocedural TIMI flow grade, no. (%) | ||||||||
| 0 | 103 (66.9) | 98 (63.6) | 71 (78.9)c | 70 (77.8)c | NA | NA | 62 (56.4) | 65 (59.1) |
| 1 | 12 (7.8) | 22 (14.3) | NA | NA | 12 (10.9) | 13 (11.8) | ||
| 2 | 27 (17.5) | 23 (14.9) | 8 (8.9) | 9 (10) | NA | NA | 19 (17.3) | 18 (16.4) |
| 3 | 12 (7.8) | 11 (7.1) | 11 (12.2) | 11 (12.2) | NA | NA | 17 (15.5) | 14 (12.7) |
Abbreviations: NA, no information available; PASEO, PaclitAxel or Sirolimus‐Eluting Stent Versus Bare Metal Stent in Primary Angioplasty; PROSIT, Prospective Randomized Trial of Sirolimus‐ Versus Paclitaxel‐Eluting Stents for the Treatment of Acute ST‐Elevation Myocardial Infarction; TIMI, thrombolysis in myocardial infarction. ZEST‐AMI, Zotarolimus‐Eluting Stent Versus Sirolimus‐Eluting Stent Versus Paclitaxel‐Eluting Stent for Acute Myocardial Infarction Patients.
The definitions of all variables were according to the prespecified protocols of the individual studies included.
Expressed as median (interquartile range).
Expressed as preprocedural TIMI flow grade 0∼1.
TVR
TVR, the primary outcome of interest, was needed in 29 of 550 patients (5.3%) in the SES group vs 42 of 555 patients (7.6%) in the PES group. There was a trend toward reduction in TVR for those patients who received SES (OR 0.68; 95% CI, 0.42–1.11; P = 0.12) (Figure 1). There was no significant heterogeneity between trials (P = 0.79).
Figure 1.
Odds ratios of target vessel revascularization associated with sirolimus‐eluting stents (SES) vs paclitaxel‐eluting stents (PES) in patients with acute ST‐segment elevation myocardial infarction. Abbreviations: CI, confidence interval.
Angiographic Restenosis
SES were significantly more effective in the reduction of angiographic binary restenosis than PES (Figure 2). The incidence of angiographic restenosis was 4.0% in patients treated with SES and 9.6% in those treated with PES. The pooled OR in favor of SES was 0.38 (95% CI, 0.19–0.74; P = 0.004) by the fixed‐effects model. There was no significant heterogeneity between trials (P = 0.48). We did not find publication bias on visual examination of the funnel plot or by Egger's regression method.13 The omission of individual trials from the analysis did not have any relevant influence on the overall results of the analysis. One study did not report angiographic restenosis rates and was not included in the analysis.10
Figure 2.
Odds ratios of angiographic restenosis associated with sirolimus‐eluting stents (SES) vs paclitaxel‐eluting stents (PES) in patients with acute ST‐segment elevation myocardial infarction. Abbreviations: CI, confidence interval.
Stent Thrombosis, Cardiac Death, and Myocardial Infarction
Patients treated with SES and PES did not differ significantly with respect to other outcomes of interest. There were 17 cases (3.1%) of stent thrombosis reported among 550 patients who received SES and 18 cases (3.2%) among 555 patients who received PES (OR 0.95; 95% CI, 0.48–1.86; P = 0.88; P = 0.83 for heterogeneity) (Figure 3). Cardiac death occurred in 22 of 550 patients (4.0%) who underwent SES implantation and 23 of 555 patients (4.1%) who underwent PES implantation (OR 0.96; 95% CI, 0.53–1.74; P = 0.90; P = 0.47 for heterogeneity). Myocardial infarctions were reported in 21 patients (3.8%) in the SES group and 20 (3.6%) in the PES group (OR 1.06; 95% CI, 0.57–1.97; P = 0.86; P = 0.67 for heterogeneity).
Figure 3.
Odds ratios of stent thrombosis associated with sirolimus‐eluting stents (SES) vs paclitaxel‐eluting stents (PES) in patients with acute ST‐segment elevation myocardial infarction. Abbreviations: CI, confidence interval.
Discussion
Despite SES showing better angiographic and clinical outcomes than PES in head‐to‐head comparison and meta‐analysis of randomized studies, these excluded patients with STEMI.14, 15, 16 Therefore, it has not been confirmed whether the superiority of SES to PES, documented in elective patients with various lesion subsets, also extends to patients presenting with STEMI. This meta‐analysis compared clinical outcomes of SES with those of PES in the STEMI setting.
In our study, there was a trend toward favoring SES in a reduction of TVR over PES (5.3% vs 7.6%; OR 0.68; 95% CI, 0.42–1.11; P = 0.12). The better clinical efficacy of SES was angiographically demonstrated by a 62% reduction in the odds of angiographic restenosis. Such superiority of SES over PES found in our meta‐analysis might be explained by the greater reduction of late luminal loss with SES, uniformly demonstrated by angiographic follow‐up data in most studies included.7,9,11 Previous meta‐analyses have shown that patients receiving SES had a significantly lower risk for restenosis and/or TLR compared to those receiving PES in a broad population.6,14 Our results demonstrate that such benefits of SES might be extrapolated to patients with STEMI. However, we found no significant difference between SES and PES in patients with acute STEMI with respect to cardiac death, myocardial infarction, or stent thrombosis. The reduction in angiographic restenosis with SES was not associated with a similar reduction in risk for mortality, myocardial infarction, or stent thrombosis.
SES and PES are the most widely used DES to date. In light of stent thrombosis, there have been great concerns about the long‐term safety of DES associated with late stent thrombosis.17,18 The primary stenting for STEMI was associated with a higher risk of stent thrombosis in registry data,19,20 even though meta‐analysis of randomized trials has not shown an increased risk of stent thrombosis in the DES group compared with bare metal stents (BMS) in the primary PCI.21 Delayed healing characterized by persistent fibrin deposition, poorer endothelialization, and local hypersensitivity reaction are some of the mechanisms put forward for the explanation of the late occurrence of thrombosis‐related events with DES.22 There have been reports that these phenomena are more pronounced with PES than SES, at least in the presence of overlapping stents.23 In this meta‐analysis of 4 randomized trials, we found no difference in rates of stent thrombosis between SES and PES at ≥ 12 months follow‐up. The rate of stent thrombosis was 3.1% in the SES group and 3.2% in the PES group in our study. This is much higher than the previously reported rates of stent thrombosis in selected patients in 8 pivotal DES randomized trials, which showed rates of cumulative stent thrombosis to be 1.5% for SES and 1.8% for PES at 4 years, and 0.6% and 0.9% for SES and PES, respectively, at 1 year.24 Our results support the view that STEMI was a significant independent predictor of stent thrombosis.25
Our study has several potential limitations. First, 3 of the 4 trials included in this meta‐analysis had a protocol‐mandated follow‐up angiography. This might exaggerate the risk of the oculostenotic reflex and lead to an increase in the number of reinterventions, although no significant interaction could be found between this study design feature and treatment effect. Second, all trials were open‐label trials due to the impossibility of blinding completely different devices coming from 2 different manufacturers. Although all reported events went through a blind adjudication process, these limitations might have had an impact on the evaluation of at least 1 of the events of interest, the TVR. Third, the number of eligible trials was relatively small, which might limit the power to detect publication bias. And the total number of patients also was not large, limiting the ability to detect meaningful differences in safety end points.
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