Background Concerns have emerged regarding a higher risk of stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Our objective was to perform a meta-analysis using individual patient data to evaluate the long-term safety and effectiveness of DES compared with bare-metal stents (BMS) in patients undergoing primary percutaneous coronary intervention for STEMI.
Data Sources Formal searches of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2000 to June 2011.
Study Selection We examined all completed randomized trials of DES for STEMI.
Data Extraction Individual patient data.
Data Synthesis Individual patient data were obtained from 11 of 13 trials identified, including a total of 6298 patients (3980 [63.2%] randomized to DES [99% sirolimus-eluting or paclitaxel-eluting stents] and 2318 [36.8%] randomized to BMS). At long-term follow-up (mean [SD], 1201 [440] days), DES implantation significantly reduced the occurrence of target-vessel revascularization (12.7% vs 20.1%; hazard ratio [95% CI], 0.57 [0.50-0.66]; P < .001, P value for heterogeneity, .20), without any significant difference in terms of mortality, reinfarction, and stent thrombosis. However, DES implantation was associated with an increased risk of very late stent thrombosis and reinfarction.
Conclusions The present pooled patient-level meta-analysis demonstrates that among patients with STEMI undergoing primary percutaneous coronary intervention, sirolimus-eluting and paclitaxel-eluting stents compared with BMS are associated with a significant reduction in target-vessel revascularization at long-term follow-up. Although there were no differences in cumulative mortality, reinfarction, or stent thrombosis, the incidence of very late reinfarction and stent thrombosis was increased with these DES.
The early administration of pharmacological and/or mechanical reperfusion therapies1,2 and improvements in antiplatelet and anticoagulation agents3-6 have greatly contributed to the reduction in mortality achieved over the last 2 decades in patients with ST-segment elevation myocardial infarction (STEMI). In randomized trials, bare-metal stents (BMS) have been shown to reduce target-vessel revascularization (TVR) in STEMI, with rates of death and/or reinfarction comparable to balloon angioplasty.7-9 However, these benefits may not be as profound in unselected patients with STEMI.8
Drug-eluting stents (DES) have shown a further significant reduction in restenosis and TVR in patients without acute coronary syndromes compared with BMS.10-14 Initial meta-analyses showed the efficacy and safety of DES at short-term follow-up in the setting of STEMI,15-17 with no safety issues. However, concerns have emerged regarding a potentially higher risk of stent thrombosis (ST) with DES18,19 that might be even more pronounced among patients with STEMI, as suggested by a prospective registry.20-22 Therefore, the aim of the Drug-Eluting Stents in Primary Angioplasty (DESERT) Cooperation was to perform a pooled patient-level meta-analysis of randomized trials to evaluate the risks and benefits of DES compared with BMS in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI.
Eligibility and search strategy
To identify all completed, randomized trials comparing DES vs BMS in primary PCI for STEMI, we scanned the literature by formal searches of electronic databases (MEDLINE and CENTRAL) and the scientific session abstracts in Circulation,Journal of College of Cardiology, European Heart Journal, and American Journal of Cardiology from January 2000 to June 2011. Furthermore, oral presentations and/or expert slide presentations were included (searched on the Transcatheter Cardiovascular Therapeutics (TCT) [ http://www.tctmd.com], EuroPCR [ http://www.europcr.com], American College of Cardiology (ACC) [ http://www.acc.org], American Hospital Association (AHA) [ http://www.aha.org], and European Society of Cardiology (ESC) [ http://www.escardio.org] websites from January 2000 to June 2011). The following keywords were used: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, BMS, sirolimus-eluting stent (SES), Cypher (Cordis Corporation), paclitaxel-eluting stent (PES), Taxus (Boston Scientific Corporation). Inclusion criteria were (1) randomized treatment allocation, (2) follow-up data of more than 1 year, and (3) availability of complete clinical data. Exclusion criteria were (1) follow-up data in less than 90% of patients, (2) ongoing studies or irretrievable data, (3) trials with overall small sample size (<50 patients), and (4) investigators' unwillingness to provide individual patient data. No language restrictions were enforced. All principal investigators were contacted and invited to provide individual patient data, which were transferred without patient identifiers to the Eastern Piedmont University, Novara, Italy. The dataset was checked for completeness and consistency and compared with the results from any publications. Queries were resolved by direct correspondence with the responsible study investigator. Data were managed according to the intention-to-treat principle.
The primary end point for the present study was mortality, whereas secondary end points were reinfarction, TVR, and ST (definite or probable according to Academic Research Consortium [ARC] definitions) at long-term follow-up.
Statistical analysis was performed using the Review Manager 4.27 freeware package (Cochrane Collaboration), SPSS 15.0 statistical package (SPSS Inc), and the R statistical software (version 2.11.0; R Foundation for Statistical Computing). Continuous data were expressed as mean (SD) and categorical data as percentage. The pooled odds ratio for categorical variables was calculated by using the Mantel-Haenszel method, whereas a weighted mean difference was used for continuous variables.23 Data were pooled by fixed-effect method with generic inverse variance weight. The weight of the individual studies was measured as the inverse of the estimated variance of the log hazard ratio (HR) obtained with Cox proportional hazard analysis. Heterogeneity across trials was assessed by the I2 statistic. We additionally performed survival analyses with the use of Cox regression analysis stratified according to trial.5 The proportionality hazards assumption in Cox regression models was tested by using the Score test and Schoenfeld residuals. In case the proportionality assumption was not met, we used a Cox model with time-varying regression coefficients (piecewise time-constant coefficients).24 This means that the entire study period was split in a certain number of time intervals, and the effect of DES (HR) estimated within each of these intervals. The choice of the time intervals was based on estimates of fully time-dependent regression. Kaplan-Meier survival curves are presented with event rates reported as estimated probabilities. Results were considered statistically significant at P < .05 (2-sided), and Bonferroni correction was used to adjust for multiple testing. The study was performed in compliance with the Quality of Reporting of Meta-analyses (QUOROM) guidelines.25
Eligible studies and baseline characteristics
A total of 16 randomized trials6,26-40 were initially identified. Two trials were excluded because of inclusion of both STEMI and non-STEMI patients.29,31 Three other trials were excluded because of small sample size28 or investigator unwillingness to provide individual patient data34,40 (Figure 1). Therefore 11 trials were finally included in the meta-analysis, in which 6298 patients were randomized, including 3980 patients (63.2%) assigned to the DES group and 2318 patients (36.8%) assigned to the BMS group. Characteristics of the included trials are given in Table 1. The length of clinical follow-up varied between 3 and 6 years.
In the Paclitaxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO)33 and Basel Stent Kosten-Effektivitäts in Acute Myocardial Infarction (BASKET-AMI)27 trials, patients were randomized at a ratio of 1:1:1 to BMS, SES, or PES. Routine angiographic follow-up was performed in the randomized study of Sirolimus-Eluting Stent vs Conventional Stent in Acute Myocardial Infarction (SESAMI),35 the prospective randomized controlled trial to evaluate the efficacy of drug-eluting stents vs bare-metal stents for the treatment of acute myocardial infarction (MISSION! Intervention Study),37 and the Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction (DEDICATION) study,36 as well as in a subgroup of patients in the Trial to Assess the Use of Cypher Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty (TYPHOON).39 In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial,6 patients underwent both a pharmacology randomization (bivalirudin or unfractionated heparin plus a glycoprotein IIb-IIIa inhibitor, with a 1:1 randomization ratio) and a stent randomization (Taxus vs Express [Boston Scientific Corporation], with a 3:1 randomization ratio). Baseline characteristics are reported in Table 2; there were no significant differences observed between the 2 groups.
The DES used were SES in 26.7%, PES in 72.3%, and zotarolimus-eluting stents (Endeavor; Medtronic) in 1.0% of patients. No significant differences in baseline characteristics were observed between the 2 groups (Table 2). However, a significantly higher percentage of patients in the DES group were receiving dual antiplatelet therapy (aspirin and clopidogrel) during 3-year follow-up compared with the BMS group (Table 3).
At long-term follow-up (mean [SD], 1201 [440] days), a total of 432 patients had died. No significant difference in mortality was observed with DES compared with BMS implantation (8.5% vs 10.2%, respectively; HR, 0.85 [95% CI, 0.70-1.04]; P = .11, P value for heterogeneity, .28) (Figure 1). Similar results were observed with Cox regression analysis stratified according to trial, where the proportionality of hazards was met (P = .46). There were no differences in cardiac mortality between DES and BMS implantation (data available from 9 trials including 5846 patients) (5.7% vs 6.8%, respectively; HR, 0.84 [95% CI, 0.65-1.09]; P = .19, P value for heterogeneity, .20).
Reinfarction was observed in a total of 350 patients. As shown in Figure 2, no significant difference in reinfarction was observed between DES and BMS implantation (9.4% vs 5.9%, respectively; HR, 1.12 [95% CI, 0.88-1.41]; P = .36, P value for heterogeneity, .37). However, the assumption of proportionality of hazards was not met (P = .01), and therefore we additionally used a Cox model with time-varying regression coefficients (piecewise time-constant coefficients). In fact, as given in Table 4, the HR changed across time, suggesting that at long-term follow-up (after 2 years from the beginning of the study) the reinfarction rate increased significantly for the DES group compared with the BMS group (HR, 2.06 [95% CI, 1.22-3.49]; P = .03).
Stent thrombosis, according to the ARC definition, was observed in a total of 267 patients (219 definite and 48 probable). As shown in Figure 3, the long-term rate of ST was not significantly different between DES and BMS implantation (5.8% vs 4.3% respectively; HR, 1.13 [95% CI, 0.86-1.47]; P = .38, P value for heterogeneity, .94). However, the assumption of proportionality of hazards was not met (P = .04), and therefore we additionally used a Cox model with time-varying regression coefficients (piecewise time-constant coefficients). In fact, as given in Table 4, the HR changed across time, suggesting that at long-term follow-up (after 2 years from the beginning of the study), the rate of ST increased significantly for the DES group compared with the BMS group (HR, 2.81 [95% CI, 1.28-6.19]; P = .04).
Target-Vessel Revascularization
A total of 837 patients underwent a repeated intervention of the target vessel. As shown in Figure 4, DES use significantly reduced the occurrence of TVR compared with BMS use (12.7% vs 20.1%, respectively; HR, 0.57 [95% CI, 0.50-0.66]; P < .001, P value for heterogeneity, .20) (number needed to treat = 12.2 [95% CI, 10.3-15.4]. Similar results were observed with Cox regression analysis stratified according to trial, where the proportionality of hazards was met (P = .07). Similar findings were observed in terms of target lesion revascularization (data available in 5072 patients from 7 trials) (10.1% [DES] vs 17.9% [BMS]; HR, 0.54 [95% CI, 0.45-0.64]; P < .001, P value for heterogeneity, .10) (number needed to treat, 11.7 [95% CI, 10.1-15.2]).
The present study represents, to our knowledge, the first meta-analysis reporting on long-term clinical outcome (mean [SD], 3.3 [1.2] years) of DES in the setting of primary PCI for STEMI based on individual patient-level data. The principal finding from our study is that among patients with STEMI undergoing primary PCI, compared with BMS, SES and PES are associated with significant and sustained reductions in TVR, without significant differences in ST, reinfarction, or death. Reductions in TVR were noted with DES in both the early and very late periods. However, we observed a significantly higher occurrence of very late reinfarction and ST with these DES compared with BMS.
Early after its introduction, stenting had been avoided in the setting of STEMI because of concerns that implantation of a metallic device within a thrombotic environment such as that of a plaque disruption resulting in myocardial infarction might predispose to ST with resultant vessel occlusion. Vigorous anticoagulation—necessary to avoid ST—exposed the patient to the risks of bleeding and vascular complications.41 However, following improvements in stent deployment techniques and advances in antiplatelet therapy,4-6,42,43 numerous studies and randomized trials demonstrated the safety and efficacy of BMS in the setting of STEMI.7-9,44-46 Previous meta-analyses in patients undergoing primary PCI have shown the benefits of stenting compared with balloon angioplasty alone in terms of reducing TVR, though no definite impact on death or reinfarction was present.9 However, restenosis rates after BMS implantation, in patients with STEMI are still high, especially in unselected patients with complex lesion morphology.47 Several initial randomized trials have shown that, among patients without acute coronary syndromes, DES implantation is associated with a significant reduction in restenosis and TVR.10-14 However, concerns emerged regarding an increased risk of very late ST associated with DES implantation.18-22 As most episodes of ST result in myocardial infarction, the increased rate of very late ST with DES implantation may have an impact on mortality, particularly after primary PCI in STEMI, since reinfarction is a major determinant of mortality.47,48
In a recent prospective multicenter primary PCI registry (PREMIER [Prospective Registry Evaluating Myocardial Infarction: Events and Recovery]), the use of DES rather than BMS was associated with a high risk of mortality within the first 6 months (presumably due to ST) in cases of early discontinuation of dual antiplatelet therapy.20,21 In this regard it may be difficult to forecast future long-term patient medication compliance at the time of intervention for STEMI.18
Several meta-analyses have been conducted in many settings on long-term follow-up data, showing contrasting results in terms of higher ST with DES,49-54 in particular in STEMI. However, in this specific setting, no concern has emerged so far in almost all the randomized trials, potentially because of underpowering.
The results of the present study, based on individual patients' data, provide strong evidence of the beneficial effects of SES and PES during primary PCI in STEMI. With follow-up as late as 6 years, a robust and sustained decrease in TVR was noted with use of these DES. Although the rates of late reinfarction and ST progressively increased, with the difference becoming statistically significant after 2 years in patients receiving SES and PES, the HR for mortality, while not significantly different between DES and BMS, favored DES.
The increase in very late reinfarction and ST in the DES group bears discussion. Similarly to our data, in a large report of patients with stable coronary artery disease undergoing elective stent implantation, PES has been associated with an increased rate of very late myocardial infarction (>1 year) compared with BMS.55 However, both experiences have also found no significant differences in survival between the BMS and DES groups, potentially because of the beneficial effects from preventing restenosis.56 The lower mortality with DES use, despite the higher rates of late reinfarction and ST, may also be explained by the time-related prognostic impact of in-stent thrombosis. In fact, both early and late ST carry a worst prognostic on survival compared with very late in-stent thrombosis.57
Recent studies have shown that newer-generation DES (with thinner, fracture-resistant stent struts, and novel biocompatible polymers) are associated with significantly improved clinical outcomes and reduced ST rates.58-60 Future randomized trials are needed to evaluate the safety and efficacy of these DES in the setting of primary PCI in STEMI, especially coupled with the benefits from more potent and/or prolonged dual antiplatelet therapy.61,62
There are some limitations to this study. The patients enrolled in the current randomized trials were highly selected, with few patients having cardiogenic shock. Thus the conclusion of this meta-analysis cannot be extended to all patients undergoing primary PCI for STEMI. We were not able to obtain individual data from 2 randomized trials, including 920 patients.34,40 However, the inclusion of these 2 studies would have certainly not changed our conclusions, especially in terms of mortality. Availability of costs at discharge and at follow-up would have further improved our results. However, these data were not routinely collected in almost all trials. Approximately 5.5% of patients (n = 346) were lost to follow-up within the first 2 years (most of them [61%] from the TYPHOON study). In fact, long-term follow-up was not an end point in some of the included studies. However, the results did not change after the exclusion of these patients (data not shown). Even though clinically relevant, exact information on adherence/compliance to the prescription of dual antiplatelet therapy was not routinely collected.
Our study was certainly underpowered to show a statistically significant difference in mortality between the groups. In fact, based on the 3-year results (0.8% absolute mortality reduction), with a significance level (α) of .05 and a statistical power of 0.8, we would have needed a population of 30 130 (19 084 with DES and 11 226 with BMS) to reach this end point.
Finally, the results of the current analysis apply only to Cypher (SES) and Taxus (PES), as substantial randomized studies in STEMI have not yet been performed with newer DES. However, the huge number of patients treated worldwide with first-generation DES in the setting of STEMI in the last few years certainly support the high clinical relevance of our findings at long-term follow-up, especially concerning the potential prolongation of dual antiplatelet therapy.
In conclusion, the present meta-analysis, based on pooled patient-level data from 11 trials with 6270 randomized patients, shows that among selected patients with STEMI undergoing primary PCI, compared with BMS, SES and PES, are associated with a significant reduction in TVR and target-lesion revascularization at long-term follow-up. Despite a slightly higher rate of very late reinfarction and ST with SES and PES compared with BMS, there were no significant differences in overall or very late mortality, with the point estimate favoring DES in all periods.
Correspondence: Giuseppe De Luca, MD, PhD, Division of Cardiology, Ospedale “Maggiore della Carità,” Eastern Piedmont University, C.so Mazzini 18, 24100 Novara, Italy (giuseppe.deluca@maggioreosp.novara.it).
Accepted for Publication: February 13, 2012.
Author Contributions: Dr De Luca had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: De Luca, Kelbæk, Pasceri, and Stone. Acquisition of data: De Luca, Dirksen, Spaulding, Kelbæk, Schalij, Thuesen, van der Hoeven, Vink, Kaiser, Kaiser, Musto, Chechi, Spaziani, Díaz de la Llera, Pasceri, Di Lorenzo, and Violini. Analysis and interpretation of data: De Luca, Dirksen, Spaulding, Kelbæk, van der Hoeven, Vink, Díaz de la Llera, Cortese, Suryapranata, and Stone. Drafting of the manuscript: De Luca. Critical revision of the manuscript for important intellectual content: Dirksen, Spaulding, Kelbæk, Schalij, Thuesen, van der Hoeven, Vink, Kaiser, Kaiser, Musto, Chechi, Spaziani, Díaz de la Llera, Pasceri, Di Lorenzo, Violini, Cortese, Suryapranata, and Stone. Statistical analysis: De Luca, Spaulding, and Cortese. Obtained funding: Spaulding and Thuesen. Administrative, technical, and material support: Dirksen, Spaulding, Kelbæk, Schalij, Thuesen, van der Hoeven, Vink, and Pasceri. Study supervision: Dirksen, Spaulding, Musto, Chechi, Spaziani, Díaz de la Llera, Pasceri, Di Lorenzo, Violini, Suryapranata, and Stone.
Financial Disclosure: The Department of Cardiology, Leiden University Medical Center (Dr Schalij), receives research grants from Boston Scientific, Medtronic, and Biotronik. Dr Kaiser is on the advisory board at Ely Lilly and received research/travel support from Abbott Vascular. Dr Stone is a consultant to Abbott Vascular, Boston Scientific, Medtronic.
1.Zijlstra F, Hoorntje JC, de Boer MJ,
et al. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction.
N Engl J Med. 1999;341(19):1413-141910547403
PubMedGoogle ScholarCrossref 2.Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials.
Lancet. 2003;361(9351):13-2012517460
PubMedGoogle ScholarCrossref 3.Bhatt DL, Bertrand ME, Berger PB,
et al. Meta-analysis of randomized and registry comparisons of ticlopidine with clopidogrel after stenting.
J Am Coll Cardiol. 2002;39(1):9-1411755280
PubMedGoogle ScholarCrossref 4.De Luca G, Suryapranata H, Stone GW,
et al. Abciximab as adjunctive therapy to reperfusion in acute ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.
JAMA. 2005;293(14):1759-176515827315
PubMedGoogle ScholarCrossref 5.De Luca G, Gibson CM, Bellandi F,
et al. Early glycoprotein IIb-IIIa inhibitors in primary angioplasty (EGYPT) cooperation: an individual patient data meta-analysis.
Heart. 2008;94(12):1548-155818474534
PubMedGoogle ScholarCrossref 6.Stone GW, Witzenbichler B, Guagliumi G,
et al; HORIZONS-AMI Trial Investigators. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial.
Lancet. 2011;377(9784):2193-220421665265
PubMedGoogle ScholarCrossref 7.Stone GW, Grines CL, Cox DA,
et al; Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) Investigators. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction.
N Engl J Med. 2002;346(13):957-96611919304
PubMedGoogle ScholarCrossref 8.Suryapranata H, De Luca G, van 't Hof AW,
et al. Is routine stenting for acute myocardial infarction superior to balloon angioplasty? a randomised comparison in a large cohort of unselected patients.
Heart. 2005;91(5):641-64515831652
PubMedGoogle ScholarCrossref 9.De Luca G, Suryapranata H, Stone GW,
et al. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials.
Int J Cardiol. 2008;126(1):37-4417544528
PubMedGoogle ScholarCrossref 10.Moses JW, Leon MB, Popma JJ,
et al; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a nativecoronary artery.
N Engl J Med. 2003;349(14):1315-132314523139
PubMedGoogle ScholarCrossref 11.Stone GW, Ellis SG, Cox DA,
et al; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.
N Engl J Med. 2004;350(3):221-23114724301
PubMedGoogle ScholarCrossref 12.Ardissino D, Cavallini C, Bramucci E,
et al; SES-SMART Investigators. Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial.
JAMA. 2004;292(22):2727-273415585732
PubMedGoogle ScholarCrossref 13.Colombo A, Moses JW, Morice MC,
et al. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions.
Circulation. 2004;109(10):1244-124914981005
PubMedGoogle ScholarCrossref 14.Roiron C, Sanchez P, Bouzamondo A, Lechat P, Montalescot G. Drug eluting stents: an updated meta-analysis of randomised controlled trials.
Heart. 2006;92(5):641-64916216853
PubMedGoogle ScholarCrossref 15.De Luca G, Stone GW, Suryapranata H,
et al. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.
Int J Cardiol. 2009;133(2):213-22218394731
PubMedGoogle ScholarCrossref 16.De Luca G, Valgimigli M, Spaulding C,
et al. Short and long-term benefits of sirolimus-eluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.
J Thromb Thrombolysis. 2009;28(2):200-21019190859
PubMedGoogle ScholarCrossref 17.Dibra A, Tiroch K, Schulz S,
et al. Drug-eluting stents in acute myocardial infarction: updated meta-analysis of randomized trials.
Clin Res Cardiol. 2010;99(6):345-35720221617
PubMedGoogle ScholarCrossref 18. McFadden EP, Stabile E, Regar E,
et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy.
Lancet. 2004;364(9444):1519-152115500897
PubMedGoogle ScholarCrossref 19.Iakovou I, Schmidt T, Bonizzoni E,
et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents.
JAMA. 2005;293(17):2126-213015870416
PubMedGoogle ScholarCrossref 20.Spertus JA, Kettelkamp R, Vance C,
et al. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry.
Circulation. 2006;113(24):2803-280916769908
PubMedGoogle ScholarCrossref 21.Kernis SJ, Cohen D, Rein K. Clinical outcome associated with use of drug-eluting stents compared with bare metal stent for primary percutaneous intervention [abstract].
Am J Cardiol. 2005;96:(suppl 7A)
47H
Google Scholar 22.Daemen J, Tanimoto S, García-García HM,
et al. Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries).
Am J Cardiol. 2007;99(8):1027-103217437722
PubMedGoogle ScholarCrossref 25.Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement: quality of reporting of meta-analyses.
Lancet. 1999;354(9193):1896-190010584742
PubMedGoogle ScholarCrossref 26.Pasceri V, Granatelli A, Pristipino C. A randomized trial of a rapamycin-eluting stent in acute myocardial infarction: preliminary results [abstract].
Am J Cardiol. 2003;92:(suppl 6A)
1L14499360
PubMedGoogle Scholar 27.Pittl U, Kaiser C, Brunner-La Rocca HP.BASKET Investigators. Safety and efficacy of drug eluting stents vs bare metal stents in primary angioplasty of patients with acute ST-elevation myocardial infarction—a prospective randomized study [abstract].
Eur Heart J. 2006;27:(abstract suppl)
650
Google Scholar 28.Sardella G, Paroli M, Mancone M. Impact of paclitaxel-eluting stent implantation in patients with STEMI on anti-inflammatory IL-10-producing T regulatory 1 (Tr1) cells [abstract].
Eur Heart J. 2006;27:(abstract suppl)
831
Google Scholar 30.Chechi T, Vittori G, Biondi Zoccai GG,
et al. Single-center randomized evaluation of paclitaxel-eluting versus conventional stent in acute myocardial infarction (SELECTION).
J Interv Cardiol. 2007;20(4):282-29117680858
PubMedGoogle ScholarCrossref 32.Díaz de la Llera LS, Ballesteros S, Nevado J,
et al. Sirolimus-eluting stents compared with standard stents in the treatment of patients with primary angioplasty.
Am Heart J. 2007;154(1):164.e1-164.e617584571
PubMedGoogle ScholarCrossref 33.Di Lorenzo E, Sauro R, Varricchio A,
et al. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial.
Am Heart J. 2009;158(4):e43-e5019781402
PubMedGoogle ScholarCrossref 34.Tebaldi M, Arcozzi C, Campo G, Percoco G, Ferrari R, Valgimigli M.STRATEGY Investigators. The 5-year clinical outcomes after a randomized comparison of sirolimus-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction.
J Am Coll Cardiol. 2009;54(20):1900-190119892243
PubMedGoogle ScholarCrossref 35.Violini R, Musto C, De Felice F,
et al. Maintenance of long-term clinical benefit with sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction 3-year results of the SESAMI (sirolimus-eluting stent versus bare-metal stent in acute myocardial infarction) trial.
J Am Coll Cardiol. 2010;55(8):810-81420170821
PubMedGoogle ScholarCrossref 36.Kaltoft A, Kelbaek H, Thuesen L,
et al. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial.
J Am Coll Cardiol. 2010;56(8):641-64520688033
PubMedGoogle ScholarCrossref 37.Atary JZ, van der Hoeven BL, Liem SS,
et al. Three-year outcome of sirolimus-eluting versus bare-metal stents for the treatment of ST-segment elevation myocardial infarction (from the MISSION! Intervention Study).
Am J Cardiol. 2010;106(1):4-1220609639
PubMedGoogle ScholarCrossref 38.Vink MA, Dirksen MT, Suttorp MJ,
et al. 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial.
JACC Cardiovasc Interv. 2011;4(1):24-2921251625
PubMedGoogle ScholarCrossref 39.Spaulding C, Teiger E, Commeau P,
et al. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty).
JACC Cardiovasc Interv. 2011;4(1):14-2321251624
PubMedGoogle ScholarCrossref 40.Valgimigli M, Campo G, Gambetti S,
et al; MULTIcentre evaluation of Single high-dose bolus TiRofiban vs Abciximab with sirolimus eluting sTEnt or Bare Metal Stent in Acute Myocardial Infarction studY (MULTISTRATEGY) investigators. Three-year follow-up of the MULTIcentre evaluation of Single high-dose Bolus TiRofiban versus Abciximab with Sirolimus-eluting STEnt or Bare-Metal Stent in Acute Myocardial Infarction StudY (MULTISTRATEGY) [published online August 24, 2011].
Int J Cardiol21864917
PubMedGoogle Scholar 41.George BS, Voorhees WD III, Roubin GS,
et al. Multicenter investigation of coronary stenting to treat acute or threatened closure after percutaneous transluminal coronary angioplasty: clinical and angiographic outcomes.
J Am Coll Cardiol. 1993;22(1):135-1438509533
PubMedGoogle ScholarCrossref 42.Schömig A, Neumann FJ, Kastrati A,
et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents.
N Engl J Med. 1996;334(17):1084-10898598866
PubMedGoogle ScholarCrossref 43.EPISTENT Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade.
Lancet. 1998;352(9122):87-929672272
PubMedGoogle ScholarCrossref 44.Suryapranata H, van 't Hof AW, Hoorntje JC, de Boer MJ, Zijlstra F. Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction.
Circulation. 1998;97(25):2502-25059657469
PubMedGoogle ScholarCrossref 45.Antoniucci D, Santoro GM, Bolognese L, Valenti R, Trapani M, Fazzini PF. A clinical trial comparing primary stenting of the infarct-related artery with optimal primary angioplasty for acute myocardial infarction: results from the Florence Randomized Elective Stenting in Acute Coronary Occlusions (FRESCO) trial.
J Am Coll Cardiol. 1998;31(6):1234-12399581713
PubMedGoogle ScholarCrossref 46.Grines CL, Cox DA, Stone GW,
et al; Stent Primary Angioplasty in Myocardial Infarction Study Group. Coronary angioplasty with or without stent implantation for acute myocardial infarction.
N Engl J Med. 1999;341(26):1949-195610607811
PubMedGoogle ScholarCrossref 47.Gibson CM, Karha J, Murphy SA,
et al; TIMI Study Group. Early and long-term clinical outcomes associated with reinfarction following fibrinolytic administration in the Thrombolysis in Myocardial Infarction trials.
J Am Coll Cardiol. 2003;42(1):7-1612849652
PubMedGoogle ScholarCrossref 48.De Luca G, Ernst N, van 't Hof AW,
et al. Predictors and clinical implications of early reinfarction after primary angioplasty for ST-segment elevation myocardial infarction.
Am Heart J. 2006;151(6):1256-125916781232
PubMedGoogle ScholarCrossref 49.Stettler C, Wandel S, Allemann S,
et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis.
Lancet. 2007;370(9591):937-94817869634
PubMedGoogle ScholarCrossref 50.Hakeem A, Helmy T, Munsif S,
et al. Safety and efficacy of drug eluting stents compared with bare metal stents for saphenous vein graft interventions: a comprehensive meta-analysis of randomized trials and observational studies comprising 7,994 patients.
Catheter Cardiovasc Interv. 2011;77(3):343-35521328679
PubMedGoogle ScholarCrossref 51.Cortese B, Bertoletti A, De Matteis S, Danzi GB, Kastrati A. Drug-eluting stents perform better than bare metal stents in small coronary vessels: a meta-analysis of randomised and observational clinical studies with mid-term follow up [published online May 13, 2011].
Int J Cardiol21570728
PubMedGoogle Scholar 52.Ma J, Yang W, Singh M, Peng T, Fang N, Wei M. Meta-analysis of long-term outcomes of drug-eluting stent implantations for chronic total coronary occlusions.
Heart Lung. 2011;40(3):e32-e4021419488
PubMedGoogle ScholarCrossref 53.Piccolo R, Cassese S, Galasso G, De Rosa R, D’Anna C, Piscione F. Long-term safety and efficacy of drug-eluting stents in patients with acute myocardial infarction: a meta-analysis of randomized trials.
Atherosclerosis. 2011;217(1):149-15721477802
PubMedGoogle ScholarCrossref 54.Wallace EL, Abdel-Latif A, Charnigo R, Moliterno DJ, Brodie B, Matnani R, Ziada KM. Meta-analysis of long-term outcomes for drug-eluting stents versus bare-metal stents in primary percutaneous coronary interventions for ST-segment elevation myocardial infarction [published online January 3, 2012].
Am J Cardiol22221949
PubMedGoogle Scholar 55.Stone GW, Ellis SG, Colombo A,
et al. Long-term safety and efficacy of paclitaxel-eluting stents final 5-year analysis from the TAXUS Clinical Trial Program.
JACC Cardiovasc Interv. 2011;4(5):530-54221596326
PubMedGoogle ScholarCrossref 56.Stone GW, Ellis SG, Colombo A,
et al. Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation.
Circulation. 2007;115(22):2842-284717515458
PubMedGoogle ScholarCrossref 57.Kereiakes DJ, Smits PC, Kedhi E,
et al. Predictors of death or myocardial infarction, ischaemic-driven revascularisation, and major adverse cardiovascular events following everolimus-eluting or paclitaxel-eluting stent deployment: pooled analysis from the SPIRIT II, III, IV and COMPARE trials.
EuroIntervention. 2011;7(1):74-8321550906
PubMedGoogle ScholarCrossref 58.Kimura T, Morimoto T, Kozuma K,
et al; RESTART Investigators. Comparisons of baseline demographics, clinical presentation, and long-term outcome among patients with early, late, and very late stent thrombosis of sirolimus-eluting stents: observations from the Registry of Stent Thrombosis for Review and Reevaluation (RESTART).
Circulation. 2010;122(1):52-6120566955
PubMedGoogle ScholarCrossref 59.Windecker S, Serruys PW, Wandel S,
et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial.
Lancet. 2008;372(9644):1163-117318765162
PubMedGoogle ScholarCrossref 60.Navarese EP, Kubica J, Castriota F,
et al. Safety and efficacy of biodegradable vs. durable polymer drug-eluting stents: evidence from a meta-analysis of randomised trials.
EuroIntervention. 2011;7(8):985-99422116195
PubMedGoogle ScholarCrossref 61.Wallentin L, Becker RC, Budaj A,
et al; PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes.
N Engl J Med. 2009;361(11):1045-105719717846
PubMedGoogle ScholarCrossref 62.Wiviott SD, Braunwald E, McCabe CH,
et al; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes.
N Engl J Med. 2007;357(20):2001-201517982182
PubMedGoogle ScholarCrossref