The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial
Emilio Di Lorenzo, MD, PhD*,*,
Giuseppe De Luca, MD, PhD , ,
Rosario Sauro, MD*,
Attilio Varricchio, MD, PhD*,
Michele Capasso, MD*,
Tonino Lanzillo, MD*,
Fiore Manganelli, MD*,
Ciro Mariello, MD*,
Francesco Siano, MD*,
Maria Rosaria Pagliuca, MD*,
Giovanni Stanco, MD*,
Giuseppe Rosato, MD*
* Division of Cardiology, Ospedale "S.G. Moscati," Avellino, Italy
Division of Cardiology, Ospedale "Maggiore della Carità,", Eastern Piedmont University, Novara, Italy
Centro di Biotecnologie per la Ricerca Medica Applicata (BRMA), Eastern Piedmont University, Novara, Italy
 |
Abstract
|
|---|
Objectives: The aim of this study was to evaluate the benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in patients undergoing primary angioplasty.
Background: Recent concerns have emerged on the potential higher risk of stent thrombosis after drug-eluting stent implantation, especially among ST-segment elevation myocardial infarction (STEMI) patients.
Methods: We randomly assigned STEMI patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation to BMS, PES, or SES. The primary study end point was target lesion revascularization at 1-year follow-up. All patients were reviewed at our outpatient clinic or by telephone interview at 6, 12, and 24 months.
Results: From October 2003 to December 2005, 270 STEMI patients undergoing primary angioplasty were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). No patient was lost to follow-up. As compared with BMS (14.4%), both PES (4.4%, p = 0.023) and SES (3.3%, p = 0.016) were associated with a significant reduction in target lesion revascularization at 1-year follow-up. At 2-year follow-up no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared with BMS, both PES and SES were associated with significant benefits in major adverse cardiac events (PES: 16.7%, p = 0.015; SES: 15.6%, p = 0.009, respectively).
Conclusions: This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of target lesion revascularization up to the 2-year follow-up. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered for STEMI patients undergoing primary angioplasty. (PaclitAxel or Sirolimus-Eluting Stent versus Bare Metal Stent in Primary Angioplasty [PASEO] Randomized Trial; NCT00759850)
Key Words: percutaneous coronary intervention • ST-segment elevation myocardial infarction • drug-eluting stents
|
Abbreviations and Acronyms
| | BMS = bare-metal stent(s) | | DES = drug-eluting stent(s) | | PCI = percutaneous coronary intervention | | PES = paclitaxel-eluting stent(s) | | SES = sirolimus-eluting stent(s) | | STEMI = ST-segment elevation myocardial infarction | | TLR = target lesion revascularization | | TVR = target vessel revascularization |
|
Primary percutaneous coronary intervention (PCI), when performed expeditiously and expertly, has been shown to be superior to thrombolytic therapy in the treatment of patients with ST-segment elevation myocardial infarction (STEMI) (1). Although, as compared with balloon angioplasty, stent implantation has reduced the occurrence of restenosis in selected STEMI patients (2,3), the outcome of bare-metal stents (BMS) seem to be worse in unselected patients with a rate of target vessel revascularization (TVR) up to 20% (4,5). Several randomized trials have shown that drug-eluting stents (DES), compared with BMS, are associated with a significant reduction in restenosis and TVR in elective patients (6–10). However, recent concerns have emerged on the potential higher risk of stent thrombosis with DES (11–14) that might be even more pronounced among STEMI patients, as suggested by a prospective registry (15). The aim of the current study was to evaluate the benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) as compared with the benefits of BMS in patients undergoing primary angioplasty for STEMI.
|
Methods
|
|---|
The PASEO (PaclitAxel or Sirolimus-Eluting Stent versus Bare Metal Stent in Primary Angioplasty) trial was a prospective, single-center, randomized trial evaluating the benefits of SES or PES as compared with BMS implantation in patients undergoing primary angioplasty for acute STEMI. Individuals eligible for enrollment were patients presenting with STEMI who fulfilled all the following inclusion criteria: 1) chest pain for more than 30 min; 2) ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle branch block; 3) hospital admission within 12 h from symptoms onset. Exclusion criteria included: 1) active internal bleeding or a history of bleeding diathesis within the previous 30 days; 2) history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation or aneurysm; 3) known allergy to sirolimus, paclitaxel, heparin, aspirin, or clopidogrel; 4) history of stroke within 30 days or any history of hemorrhagic stroke; 5) major surgical procedure or severe physical trauma within the previous month; 6) history, symptoms, or findings suggestive of aortic dissection; 7) thrombolytic/fibrinolytic therapy within 24 h; 8) history of thrombocytopenia; 9) hemorrhagic retinopathy; 10) patients on warfarin or acenocoumarol with international normalized ratio >2; and 11) pregnancy. Previous gastrointestinal ulcer or gastrointestinal bleeding were not exclusion criteria. A vessel size <2.25 mm was the only angiographic exclusion criteria.
The institutional review board of the Ospedale "S.G. Moscati" (Avellino, Italy) approved the protocol in 2003, and all patients gave written informed consent.
Open-label randomization was performed in the catheterization laboratory after initial angiography by the treating physician when eligibility criteria were met. A 1:1:1 computer-generated random sequence, without blocking or stratification, was used. Sealed envelopes indicated the treatment group to which the patients were assigned: SES, PES, or BMS.
Medications.
In the coronary care unit, all patients received 70 U/kg intravenous bolus of unfractionated heparin plus 1000 U/h infusion (to maintain an activated clotting time of at least 200 s), aspirin intravenously (500 mg), and clopidogrel (300-mg loading dose). All patients received upstream glycoprotein IIb/IIIa inhibitors as a routine adjunctive therapy before primary PCI. Post-interventional antiplatelet therapy for all patients included in the 3 study groups consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for 6 months).
Angioplasty procedure.
Stenting procedures were performed according to standard techniques. The number, size, and length of stents (based on online quantitative angiographic analyses), and the type of BMS to be implanted, were left to the operator's discretion. In cases of DES implantation, it was recommended to cover the entire length of the lesion with additional coverage of 5 mm proximal and distal to the lesion. The use of intravascular ultrasound, adjunctive thrombectomy devices, distal protection devices, and intra-aortic balloon pump were left to the operator's discretion.
Angiographic analysis.
Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 coronary flow in the treated vessel and a residual stenosis less than 30% were the criteria used to define a successful PCI. Offline quantitative coronary angiography (Integris Allura, Philips, Best, the Netherlands) were performed by 2 experienced technicians who were unaware of treatment assignment with the averaging scores if they were not in agreement. The target lesion was defined as the stented segment plus the 5-mm segments immediately proximal and distal to the stent.
Data collection and follow-up.
All patients were reviewed at our outpatient clinic or by telephone interview at 6, 12, and 24 months. A stress test was performed at 6 to 8 months and subsequently yearly. For patients who died during follow-up, hospital records and necropsy data were reviewed when possible. No patient was lost to follow-up.
Study end points and definitions.
The primary end point was target lesion revascularization (TLR) at 1-year follow-up. Secondary end points were: 1) cumulative combined incidence of death and/or recurrent MI at 2-year follow-up; 2) cumulative incidence of in-stent thrombosis (assessed according to Academic Research Consortium's definition [16]) at 2-year follow-up; and 3) major adverse cardiac events (combined death and/or recurrent MI and/or TLR) at 2-year follow-up. All deaths were considered cardiac unless an unequivocal noncardiac cause could be identified. Recurrent MI was defined as recurrence of anginal symptoms with typical electrocardiographic changes and increase above the upper limit of normal of creatine kinase-myocardial band or troponin. The indication for a second intervention had to be substantiated by symptoms or by electrocardiographic or scintigraphic evidence of ischemia at rest or during exercise. Subsequent revascularization of other coronary arteries did not constitute an end point. All events were reviewed by 2 cardiologists blinded to treatment assignment.
Statistical analysis.
Statistical analysis was performed using SPSS version 15.0 (SPSS Inc., Chicago, Illinois). Continuous data were expressed as mean (SD) and categorical data as percentages. Data were analyzed according to intention-to-treat analysis (SES vs. BMS and PES vs. BMS). The analysis of variance or the Mann-Whitney U test were appropriately used for continuous variables. (Normal distribution was assessed by the Kolmogorov-Smirnov test.) The chi-square test or Fisher exact test was used for categorical variables The difference in event rates between groups during the follow-up period was assessed by the Kaplan-Meier method with the log-rank test. A probability value of p < 0.025 (with Bonferroni correction) was considered significant.
Sample Size Calculation
According to recent reports (4,5), we estimated a rate of TLR at 1 year of 20% in the BMS group. With an anticipated 2-sided test for differences in independent binomial proportions at the 2.5% significance level (with Bonferroni correction) with a power of 80%, 89 patients were necessary to detect a reduction in a primary end point of 80% (from 20% to 4%) with DES (PES and SES, respectively). The number of patients was extended to 90 per group.
|
Results
|
|---|
Patient population.
From October 1, 2003, to December 31, 2005, 270 patients with STEMI undergoing primary angioplasty and stent implantation were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90) treatment. A trial flow diagram is shown in Figure 1. As reported in Tables 1 and 2, no difference was observed in terms of baseline demographic, clinical, and angiographic characteristics among the groups.
View larger version (11K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 1 Study Flow Chart
The figure shows how patients were assigned to specific stent treatment groups. BMS = bare-metal stent(s); PES = paclitaxel-eluting stent(s); pts = patients; SES = sirolimus-eluting stent(s); STEMI = ST-segment elevation myocardial infarction.
|
|
Procedural results.
As shown in Table 2, no difference was observed in terms of angiographic and procedural characteristics. Almost 50% of patients underwent PCI of left anterior descending artery. All patients received upstream glycoprotein IIb/IIIa inhibitors. Procedural success was obtained in 93% to 95% of patients. A direct stenting strategy was adopted in 24% to 29% of patients. In the PES group, we observed a higher number of stents per patient (1.28 ± 0.56 vs. 1.11 ± 0.35, p = 0.036).
Clinical outcome at 1-year follow-up.
Follow-up data were available for all patients. Almost all patients stopped clopidogrel therapy at 6-month follow-up (Table 3). As reported in Table 4, at 1-year follow-up, no difference was observed in terms of death (6 deaths in BMS patients due to: heart failure [n = 3], sudden death [n = 1], reinfarction [n = 1], cardiac surgery [n = 1]; 4 deaths in PES patients due to: sudden death [n = 2], reinfarction [n = 2]; 3 deaths in SES patients due to: sudden death [n = 2], reinfarction [n = 1]), reinfarction, and combined death and/or reinfarction. One stent thrombosis was documented in both the BMS (1.1%) and PES (1.1%) groups, both of them within 30 days from primary PCI, whereas no case of stent thrombosis was observed after 30 days. As compared with BMS (14.4%), both PES (4.4%, hazard ratio [HR] [95% confidence interval (CI)]: 0.29 [0.095 to 0.89], p = 0.023) and SES (3.3%, HR [95% CI]: 0.21 [0.06 to 0.75], p = 0.016) were associated with a significant reduction in TLR (primary study end point). Finally, as compared with BMS (24.4%), both PES and SES were associated with significant benefits in major adverse cardiac events (PES: 11.1%, HR [95% CI]: 0.42 [0.2 to 0.9], p = 0.02; SES: 11.1%, HR [95% CI]: 0.42 [0.2 to 0.89], p = 0.02).
Clinical outcome at 2-year follow-up.
Follow-up data were available in all patients. As reported in Table 4, at 2-year follow-up, no difference was observed in terms of death (Fig. 2) (9 deaths in BMS patients due to: heart failure [n = 4], sudden death [n = 2], cardiac surgery [n = 1], reinfarction [n = 2]; 6 deaths in PES patients due to: sudden death [n = 2], reinfarction [n = 2]; cardiogenic shock [n = 2]; 5 deaths in SES patients due to: sudden death [n = 2], reinfarction [n = 2], noncardiac death [n = 1]), reinfarction (Fig. 3), and combined death and/or reinfarction (secondary study end point) (PES: 12.2%, HR [95% CI]: 0.63 [0.29 to 1.34], p = 0.17; SES: 11.1%, HR [95% CI]: 0.57 [0.26 to 1.23], p = 0.27), as compared with BMS (18.3%) (Fig. 4). No additional case of in-stent thrombosis was observed up to 2-year follow-up. As compared with BMS (17.8%), both PES (5.6%, HR [95% CI]: 0.29 [0.11 to 0.8], p = 0.01) and SES (4.4%, HR [95% CI]: 0.23 [0.076 to 0.68], p = 0.004) were associated with a significant reduction in TLR (Fig. 5). Finally, as compared with BMS (32.2%), both PES and SES were associated with significant benefits in overall MACE (secondary study end point) (PES: 16.7%, HR [95% CI]: 0.47 [0.25 to 0.88], p = 0.015; SES: 15.6%, HR [95% CI]: 0.44 [0.23 to 0.83], p = 0.005) (Fig. 6).
View larger version (13K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 3 Kaplan-Meier Event-Free Survival Curves for Reinfarction Comparing BMS, PES, and SES
Kaplan-Meier event-free survival curves for reinfarction comparing BMS with PES (p = 0.34) and SES (p = 0.58). Abbreviations as in Figure 1.
|
|
View larger version (15K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 4 Kaplan-Meier Event-Free Survival Curves (for Death and/or Reinfarction) Comparing BMS, PES, and SES
Kaplan-Meier event-free survival curves (for death and/or reinfarction) comparing BMS with PES (p = 0.44) and SES (p = 0.29). Abbreviations as in Figure 1.
|
|
View larger version (14K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 5 Kaplan-Meier Event-Free Survival Curves for TLR Comparing BMS, PES, and SES
Kaplan-Meier event-free survival curves for target lesion revascularization (TLR) comparing BMS with PES (p = 0.02) and SES (p = 0.008). Abbreviations as in Figure 1.
|
|
View larger version (16K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 6 Kaplan-Meier Event-Free Survival Curves for MACE Comparing BMS, PES, and SES
Kaplan-Meier event-free survival curves for major adverse cardiac events (MACE) comparing BMS with PES (p = 0.03) and SES (p = 0.018). Abbreviations as in Figure 1.
|
|
|
Discussion
|
|---|
To the best of our knowledge, this is the first randomized study evaluating the benefits and safety of both PES and SES versus BMS in patients undergoing primary angioplasty for STEMI at long-term follow-up (2 years). The main finding of the current study is that PES and SES are safer and more effective than BMS, mainly due to a reduction in TLR.
After the initial safety concerns, numerous studies and randomized trials have demonstrated the safety and efficacy of stenting in the setting of STEMI (3).
A recent comprehensive meta-analysis in patients undergoing primary PCI has shown the benefits of stenting compared with balloon angioplasty alone in terms of reducing TVR, though no definite affect on death and reinfarction was present (3). However, restenosis rates after BMS in STEMI patients are still high, especially in unselected patients with complex lesion morphology (4,5). Several randomized trials have shown that, among elective patients, DES are associated with a significant reduction in restenosis and TVR (6–10). However, recent concerns have emerged regarding an increased risk of late thrombosis stent associated with DES (12–15). As most episodes of stent thrombosis result in MI, this increase with DES may impact mortality, particularly after primary angioplasty, as reinfarction is a major determinant of survival (17). In a recent prospective multicenter primary angioplasty registry (PREMIER [Prospective Registry Evaluating Myocardial Infarction Events and Recovery]), the use of DES rather than BMS was associated with higher risk of mortality within the first 6 months (presumably due to higher stent thrombosis), particularly in the case of early discontinuation of double oral antiplatelet therapy (18). In fact, unlike with elective patients, it may be difficult to forecast future long-term patients' compliance at the time of intervention among STEMI patients (18).
Several randomized trials have been conducted so far in STEMI (19–35). Valgimigli et al. (19) compared SES plus tirofiban with the bare-metal Bx Velocity (Cordis Corp., Bridgewater, New Jersey) plus abciximab in 175 STEMI patients. At 8-month follow-up, SES was associated with a significant reduction in TVR (7% vs. 20%, p = 0.01), with a similar outcome in terms of death (2% vs. 3%, p = NS), reinfarction (1% vs. 3%, p = NS), and stent thrombosis (0% vs. 2%, p = NS). Similar benefits have been observed in the larger MULTISTRATEGY (Multicentre Evaluation of Single High-Dose Bolus Tirofiban versus Abciximab with Sirolimus-Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study) trial (32). The benefits from SES in terms of reducing clinical and angiographic restenosis without an increase in death or MI have been confirmed in subsequent moderate-sized randomized trials such as the TYPHOON (Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Angioplasty), SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction), and MISSION trials (21,22,27).
In the PASSION (Paclitaxel-Eluting Stent versus Conventional Stent in ST-Segment Elevation Myocardial Infarction) trial (20), Laarman et al. compared PES versus Express (Boston Scientific, Natick, Massachusetts) stents in 619 STEMI patients. Despite the safety of PES in terms of death (4.6% vs. 6.5%, p = NS) and stent thrombosis (1% vs. 1%, p = NS) at 1-year follow-up, as compared with BMS, only a weak trend was present toward a reduction in TLR (5.3% vs. 7.8%, p = NS). The relatively less favorable outcomes of PES in this trial compared with the outcomes of SES in the previous trials may relate either to the less marked reduction of neointimal hyperplasia with paclitaxel versus sirolimus, or a better outcome with the control stents in the PASSION trial compared with the Bx Velocity stents in the SES trials. Also of note, routine angiographic follow-up was not performed in the PASSION trial. In fact, several reports have demonstrated that routine angiographic follow-up is associated with a larger rate of TVR, even in the era of DES (36). Similar findings have been observed in the recently conducted large HORIZONS AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial (32), including more than 3,000 STEMI patients, that have shown significant benefits in terms of TLR with Taxus (Boston Scientific) stents as compared with BMS (4.5% vs. 7.5%, respectively), with similar outcome in terms of death and reinfarction.
However, almost all currently available trials have provided relatively short-term follow-up data (not longer than 12 months), whereas late stent thrombosis has been described up to 1 to 2 years after clopidogrel discontinuation.
The STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent vs. Abciximab and Bare-Metal Stent in Myocardial Infarction) trial is the only trial published so far with 2-year follow-up data, showing long-term safety and benefits of SES as compared with BMS (33).
In our study, including a larger population, we demonstrated the long-term safety and benefits of both SES and PES as compared with BMS. Of relevance, unlike the vast majority of randomized trials so far conducted, in our trial, the superiority of SES and PES was observed without use of routine angiographic follow-up.
Large randomized trials, with longer follow-up data are certainly needed to further investigate the long-term safety of DES in primary angioplasty. In this regard, important information is expected to be derived from the HORIZONS-AMI trial (34).
Study limitations.
Due to a relatively late randomization strategy (after initial angiography), patients have for the most part been selected, and thus the conclusion of this trial cannot be extended to all patients undergoing primary angioplasty for STEMI. Even though small vessels (2.25 to 2.5 mm) were not excluded, our patient population had a relatively larger (3.1 mm) mean reference diameters than were included in previous randomized trials. Furthermore, to avoid any bias due to length of clopidogrel prescription, we preferred to prescribe clopidogrel up to 6 months in BMS patients as well.
Despite long-term follow-up data, due to the relatively small sample size, this trial cannot provide definite conclusions on DES safety in terms of death and reinfarction that will be hopefully provided by large randomized trials.
|
Conclusions
|
|---|
This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 2-year follow-up. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered for use for STEMI patients undergoing primary angioplasty.
|
Footnotes
|
|---|
Drs. Di Lorenzo and De Luca contributed equally to this study.
* Reprint requests and correspondence: Dr. Emilio Di Lorenzo, Division of Cardiology, Laboratory of Cardiac Catheterization and Interventional Cardiology, S.G. Moscati Hospital, Via Otranto, 83100 Avellino, Italy (Email: emidilorenzo{at}tin.it).
Manuscript received February 12, 2009;
accepted March 17, 2009.
|
REFERENCES
|
|---|
- 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;361:13-20.[CrossRef][Web of Science][Medline]
- 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;346:957-966.[CrossRef][Web of Science][Medline]
- 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;126:37-44.[CrossRef][Web of Science][Medline]
- Antoniucci D, Migliorini A, Parodi G, et al. Abciximab-supported infarct artery stent implantation for acute myocardial infarction and long-term survival: a prospective, multicenter, randomized trial comparing infarct artery stenting plus abciximab with stenting alone Circulation 2004;109:1704-1706.[Abstract/Free Full Text]
- 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;91:641-645.[Abstract/Free Full Text]
- Moses JW, Leon MB, Popma JJ, et al. SIRIUS Investigators Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery N Engl J Med 2003;349:1315-1323.[CrossRef][Web of Science][Medline]
- 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;350:221-231.[CrossRef][Web of Science][Medline]
- 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;292:2727-2734.[Abstract/Free Full Text]
- Colombo A, Moses JW, Morice MC, et al. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions Circulation 2004;109:1244-1249.[Abstract/Free Full Text]
- Roiron C, Sanchez P, Bouzamondo A, Lechat P, Montalescot G. Drug eluting stents: an updated meta-analysis of randomised controlled trials Heart 2006;92:641-649.[Abstract/Free Full Text]
- Schömig A, Dibra A, Windecker S, et al. A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease J Am Coll Cardiol 2007;50:1373-1380.[Abstract/Free Full Text]
- McFadden EP, Stabile E, Regar E, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy Lancet 2004;364:1519-1521.[CrossRef][Web of Science][Medline]
- Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents JAMA 2005;293:2126-2130.[Abstract/Free Full Text]
- Lagerqvist B, James SK, Stenestrand U, et al. SCAAR Study Group Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden N Engl J Med 2007;356:1009-1019.[CrossRef][Medline]
- Kernis SJ, Cohen D, Rein K. Clinical outcome associated with use of drug-eluting stents compared with bare metal stent for primary percutaneous intervention (abstr) Am J Cardiol 2005;96(Suppl 7A):47H.
- Cutlip DE, Windecker S, Mehran R, et al. Academic Research Consortium Clinical end points in coronary stent trials: a case for standardized definitions Circulation 2007;115:2344-2351.[Abstract/Free Full Text]
- 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;151:1256-1259.[CrossRef][Web of Science][Medline]
- 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;113:2803-2809.[Abstract/Free Full Text]
- Valgimigli M, Campo G, Percoco G, 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 Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial JAMA 2005;293:2109-2117.[Abstract/Free Full Text]
- Laarman GJ, Suttorp MJ, Dirksen MT, et al. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention N Engl J Med 2006;355:1105-1113.[CrossRef][Medline]
- Spaulding C, Henry P, Teiger E, et al. TYPHOON Investigators Sirolimus-eluting versus uncoated stents in acute myocardial infarction N Engl J Med 2006;355:1093-1104.[CrossRef][Medline]
- Menichelli M, Parma A, Pucci E, et al. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI) J Am Coll Cardiol 2007;49:1924-1930.[Abstract/Free Full Text]
- Pittl U, Kaiser C, Brunner-La Rocca HP, et al. BASKET Investigators Safety and efficacy of drug eluting stents versus bare metal stents in primary angioplasty of patients with acute ST-elevation myocardial infarction—a prospective randomized study (abstr) Eur Heart J 2006;27(Suppl):650.
- 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 (abstr) Eur Heart J 2006;27(Suppl):831.
- Pasceri V, Granatelli A, Pristipino C. A randomized trial of a rapamycin-eluting stent in acute myocardial infarction: preliminary results Am J Cardiol 2003;92(Suppl 6A):1L.[Medline]
- Tierala I. The Helsinki Area Acute Myocardial Infarction treatment re-evaluation—should the patient get a drug-eluting or a normal stent (HAAMU-STENT) study http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1453095 2003Accesssed November 7, 2007.
- van der Hoeven BL, Liem SS, Jukema JW, et al. Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome results from the MISSION! Intervention Study J Am Coll Cardiol 2008;51:618-626.[Abstract/Free Full Text]
- 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;154:164.e1-164.e6.[CrossRef][Medline]
- 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;20:282-291.[CrossRef][Medline]
- Kelbaek H, Theusen L, Helqvist S, et al. Drug-eluting vs. bare metal stents in patients with ST-segment elevation myocardial infarction: eight-month follow-up in the drug-elution and distal protection in acute myocardial infarction (DEDICATION) trial Circulation 2008;118:1155-1162.[Abstract/Free Full Text]
- Karjalainen PP, Ylitalo A, Niemala M, et al. Titanium-nitride-oxide coated stents versus paclitaxel-eluting stents in acute myocardial infarction: a 12-month follow-up report from the TITAX AMI trial EuroIntervention 2008;4:234-241.[Medline]
- Valgimigli M, Campo G, Percoco G, 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 Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial JAMA 2008;299:1788-1799.[Abstract/Free Full Text]
- Valgimigli M, Campo G, Arcozzi C, et al. Two-year clinical follow-up after sirolimus-eluting versus bare-metal stent implantation assisted by systematic glycoprotein IIb/IIIa Inhibitor Infusion in patients with myocardial infarction: results from the STRATEGY study J Am Coll Cardiol 2007;50:138-145.[Abstract/Free Full Text]
- Stone GW, Lansky A, Pocock SJ, et al. Paclitaxel-eluting stent versus bare-metal stents in acute myocardial infarction N Engl J Med 2008;360:1846-1858.
- Kastrati A, Dibra A, Spaulding C, et al. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction Eur Heart J 2007;28:2706-2713.[Abstract/Free Full Text]
- Pinto DS, Stone GW, Ellis SG, et al. TAXUS-IV Investigators Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: results from the TAXUS-IV trial J Am Coll Cardiol 2006;48:32-36.[Abstract/Free Full Text]
This article has been cited by other articles:
|
|
|
|
 
S. Garg and P. W. Serruys
Coronary Stents: Current Status
J. Am. Coll. Cardiol.,
August 31, 2010;
56(10_Suppl_S):
S1 - S42.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol.,
May 18, 2010;
55(20):
2272 - 2286.
[Full Text]
[PDF]
|
|
|
|
Top
Abstract
Methods