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Doi:10.1016/s0140-6736(09)62127-9

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Second-generation everolimus-eluting and
paclitaxel-eluting stents in real-life practice (COMPARE):
a randomised trial

Elvin Kedhi, Kaiyum Sheik Joesoef, Eugene McFadden, Jochem Wassing, Carlos van Mieghem, Dick Goedhart, Pieter Cornelis Smits Summary
Background Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of
Published Online
restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and effi

cacy of the January 8, 2010
second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice.
Department of Cardiology,
Methods We randomly assigned 1800 consecutive patients (aged 18–85 years) undergoing percutaneous coronary Maasstad Ziekenhuis,
intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint Rotterdam, Netherlands
was a composite of safety and effi

cacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) (E Kedhi MD, K S Joesoef MD,
within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The E McFadden MD, J Wassing MD,
trial is registered with ClinicalTrials.gov, number NCT01016041.
P C Smits MD); and Cardialysis,
Rotterdam, Netherlands

Findings Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the (D Goedhart PhD)
everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0·69 [95% CI Correspondence to:
0·50–0·95], p value for superiority=0·02). The diff erence was attributable to a lower rate of stent thrombosis (6 [<1%] Dr Pieter Cornelis Smits,
vs
23 [3%], 0·26 [0·11–0–64], p=0·002), myocardial infarction (25 [3%] vs 48 [5%], 0·52 [0·33–0·84], p=0·007), and Maasstad Ziekenhuis, Groene
target vessel revascularisation (21 [ 2%] vs 54 [6%], 0·39 [0·24–0·64], p=0·0001). Cardiac death, non-fatal myocardial Hilledijk 315, 3075 EA
infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus Rotterdam, Netherlands
74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0·005.
smitsp@maasstadziekenhuis.nl
Interpretation The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected
patients in terms of safety and effi

cacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no
longer be used in everyday clinical practice.
Funding Unrestricted grants from Abbott Vascular and Boston Scientifi c.
Introduction
Compared with the currently available fi rst-generation On the basis of results from randomised trials with drug-eluting stents, second-generation drug-eluting strict inclusion and exclusion criteria, fi rst-generation stents have been designed with the goal of improving drug-eluting stents, coated with sirolimus or paclitaxel, cacy, and device performance. Everolimus, a were approved for clinical use in patients with coronary semisynthetic sirolimus analogue, is released from a thin artery disease.1–3 Early experience with use of fi rst- coating of a biocompatible fl uoropolymer on an open generation stents in patients in real-life practice showed cell, thin-strut, cobalt-chromium frame. A signifi cant that benefi t, in terms of the need for reintervention, reduction in serious adverse cardiac events was noted in was most apparent in those with high risk of restenosis.4 patients with the everolimus-eluting stent compared with Widespread use of fi rst-generation drug-eluting stents those who had the fi rst-generation paclitaxel-eluting has drawn attention to several unresolved issues stent.8 This fi rst-generation stent has been superseded in that are clinically relevant. First, although the risk is Europe by the new-generation paclitaxel-eluting stent small, stent thrombosis is unpredictable, continues since September, 2005. Whether such diff erences persist to increase with time, and has serious clinical with a new-generation paclitaxel-eluting stent that consequences.5,6 Second, the deliverability of fi rst- consists of the same polymer but has a diff erent stent generation drug-eluting stents could be improved. platform is not known.
Third, although these stents are more eff ective than are We therefore compared the safety and effi bare metal stents in patients at high risk of restenosis, the second-generation everolimus-eluting and pacli taxel-the need for reintervention is still a problem in patients eluting stents in unselected patients in real-life practice.
with severe coronary disease, as shown in a randomised
study in which individuals with complex coronary Methods
disease were given percutaneous treatment with the Study design and patients
fi rst-generation paclitaxel-eluting stent or coronary Consecutive patients (aged 18–85 years) referred to the
artery bypass surgery.7
Maasstad Ziekenhuis for elective or emergent www.thelancet.com Published online January 8, 2010 DOI:10.1016/S0140-6736(09)62127-9
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other coronary-device trials; and inability to provide 1800 patients enrolled and randomly assigned* All patients provided written informed consent. The study complied with the Declaration of Helsinki for investigation in human beings, and was approved by the insti tutional ethics committee of the Maasstad Zieken-huis, Rotterdam, the Netherlands, and the Dutch Central Committee on Research Involving Human Subjects.
Randomisation and masking
The allocation schedule was based on computer-generated random numbers. The statistician involved in the design of the study generated the randomisation list. Patients were assigned in a one-to-one ratio to a polymer- 897 analysed according to intention to treat 903 analysed according to intention to treat based, everolimus-eluting stent (Xience V, Abbott Vascular, Santa Clara, CA, USA) or a polymer-based, Figure 1: Trial profi le
paclitaxel-eluting stent (Taxus Liberté, Boston Scientifi c, *We have no reliable data for patients assessed for eligibility.
Natick, MA, USA), using sealed, opaque, sequentially numbered allocation envelopes after passage of the Everolimus-eluting stent Paclitaxel-eluting stent
guide wire. The patients knew they had been randomly assigned in a trial of drug-eluting stents, but did not know which stent they had been allocated.
Procedures
Staged procedures were permitted and the same stent type, allocated at initial randomisation, was used. Everolimus-eluting stents were available in diameters of 2·25 mm, 2·50 mm, 3·00 mm, 3·50 mm, and 4·00 mm, and in lengths of 8 mm, 12 mm, 15 mm, 18 mm, 23 mm, Family history of coronary artery disease and 28 mm. Paclitaxel-eluting stents were available in diameters of 2·25 mm, 2·50 mm, 3·00 mm, 3·50 mm, History of percutaneous coronary intervention and 4·00 mm, and in lengths of 8 mm, 12 mm, 16 mm, History of coronary artery bypass grafting Percutaneous coronary intervention was done according to standard techniques. Crossover to another stent was allowed in the event of an inability to insert the assigned device. Technical details, such as the decision to stent Non-ST-segment elevation myocardial infarction without balloon predilatation, use of adjunctive tech- ST-segment elevation myocardial infarction niques such as rotational atherectomy, and decision to postdilate the stent, were at the discretion of the operator. Off -line quantitative coronary angiography analysis for Number of lesions treated per patient (SD) the baseline data was done with an automated edge-detection system (CAAS, version 1.1, Pie Medical Imaging, Maastricht, Netherlands). The analyses were Data are number (%), unless otherwise indicated. Percentages have been rounded. *Defi ned as treatment with diet or drugs for previously diagnosed diabetes. †Defi ned as serum creatinine greater than 130 μmol/L or patient on dialysis.
All patients not on dual antiplatelet drugs were given aspirin (300 mg) and clopidogrel (300 mg or 600 mg) Table 1: Baseline characteristics
before the procedure. The high dose of clopidogrel was given to patients undergoing primary percutaneous percutaneous coronary intervention, were eligible to intervention for ST-segment elevation myocardial participate in the study. There were no limitations about infarction. An initial bolus of unfractionated heparin the number of lesions or vessels, location of lesions, or (70–100 IU/kg) was given to all patients, and additional their length. Exclusion criteria were contraindica- boluses were given to achieve and maintain an activated tions or expected non-adherence to dual antiplatelet clotting time of more than 250 s, which was checked drugs in the 12 months after the procedure; planned every 30 min. The use of bivaluridin or low-major surgery within 30 days; inability or refusal to molecular-weight heparin was not allowed. The use of comply with follow-up procedures; participation in glycoprotein IIb/IIIa antagonists was at the discretion of www.thelancet.com Published online January 8, 2010 DOI:10.1016/S0140-6736(09)62127-9
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the operator. A 12-lead electrocardiograph was done Everolimus-eluting stent
Paclitaxel-eluting stent
before and after the procedure; before discharge; and at (1286 lesions)
(1294 lesions)
1 month, 6 months, and 12 months follow-up. Post- procedural measurements of cardiac biomarkers were obtained systematically only in patients in whom procedural complications, such as side-branch closure, residual dissection, or no refl ow, occurred or when patients had chest pain or electrocardiographic changes after the procedure. At the time of discharge, all patients were given aspirin (100 mg once a day) for an indefi nite period, as well as clopidogrel (75 mg per day) for Outcomes and data management
The prespecifi ed primary endpoint was a composite of all-cause mortality, non-fatal myocardial infarction, and target vessel revascularisation within 12 months. The secondary endpoints were a composite of major adverse cardiac events (cardiac death, non-fatal myocardial infarction, and clinically justifi ed target lesion revas- isation within 12 months of follow-up), and a composite of all-cause mortality, non-fatal myocardial infarction, and target vessel revascularisation at 3 years and 5 years. All deaths were regarded as cardiac unless an unequivocal non-cardiac cause was established. Periprocedural myocardial infarction, in patients Data are number (%). Percentages have been rounded. ACC=American College of Cardiology. AHA=American Heart without infarction at baseline, was defi ned as any Association. TIMI=thrombolysis in myocardial infarction.
elevation in concentrations of creatine kinase to more than double normal value, with elevated values of a Table 2: Baseline lesion characteristics
confi rmatory cardiac biomarker (creatine kinase-MB fraction or troponin). Spontaneous infarction was defi ned as a typical rise and fall in concentrations of Everolimus-eluting
Paclitaxel-eluting
stent (1286 lesions)
stent (1294 lesions)
troponin or creatinine kinase-MB with at least one of the following: ischaemic symptoms, development of pathological Q waves, ischaemic electro cardiographic changes, or pathological fi ndings of an acute myo- cardial infarction.9 Target lesion revasc ular isa tion was defi ned as revascularisation for a stenosis within the Postprocedure stenosis (lumen diameter, %) stent or within the 5-mm borders adjacent to the Postprocedure minimum lumen diameter (mm) stent. Revascularisation of the target lesion and vessel was regarded as clinically justifi ed if the stenosis of any target lesion or vessel was at least 50% of vessel diameter on the basis of quantitative coronary angiography in the presence of objective evidence of ischaemia on non-invasive or invasive testing or Data are median (IQR) or number (%), unless otherwise indicated. Data for quantitative coronary angiography (QCA) symptoms, or if the stenosis was at least 70% of are presented only for lesions with matched views for QCA before and after procedure (1977 lesions).
vessel diameter even in the absence of ischaemic signs or symptoms. Table 3: Quantitative coronary angiography and procedural results
Stent thrombosis was defi ned according to the de- nitions provided by the Academic Research 12 months to check for adverse events and establish Consortium.10 Adverse events were assessed in the current antiplatelet drugs. Data were stored in our hospital, and at 1 month and 12 months. Data were institution. Data processing and adjudication of adverse gathered by study monitors who visited the hospitals in events were done by an independent contract research which follow-up was undertaken, reviewed the clinical organisation and core lab (Cardialysis, Rotterdam, notes, and collected the protocol-mandated electro- Netherlands). An independent data and safety cardiographs. Furthermore, medical questionnaires monitoring board reviewed the data after interim were posted to all patients at 1 month, 6 months, and analyses with formal stopping rules. www.thelancet.com Published online January 8, 2010 DOI:10.1016/S0140-6736(09)62127-9
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Everolimus-eluting
Paclitaxel-eluting
Relative risk
stent (n=897)
stent (n=903)
Events at 30 days
All-cause mortality or myocardial infarction Target vessel revascularisation (clinically justifi ed) Target lesion revascularisation (clinically justifi ed) Stent thrombosis (defi nite and probable) Acute stent thrombosis (on date of procedure) Subacute stent thrombosis (1–30 days after procedure) Early stent thrombosis (0–30 days after procedure) Statistical analysis
was regarded as signifi cant. Analyses were done with On the basis of results from the T-SEARCH registry,4 and SIRTAX11 and SPIRIT II trials,12 we assumed an The trial is registered with ClinicalTrials.gov, number incidence of the primary endpoint of 9% in the evero- limus-eluting stent group and 14% in the paclitaxel-
eluting stent group. Enrolment of 1800 patients would Role of the funding source
provide the study with a statistical power of 85% to The sponsors had no involvement in the design, conduct,
detect this diff erence with a two-sided signifi cance level or analysis of the study. The corresponding author had
of 0·05, allowing for 3–4% of patients lost to follow-up.
full access to all the data in the study, and had full All analyses were done according to the intention-to- responsibility for the decision to submit for publication.
treat principle. Patients were censored from the
Kaplan-Meier plots when they reached any component Results
of the composite endpoint. Categorical variables were Figure 1 shows the trial profi le. 1800 patients were enrolled
assessed with use of χ² or Fisher’s exact tests, whereas between February, 2007, and September, 2008. Five (<1%)
continuous variables were assessed with the Wilcoxon were not given the designated stent. Staged procedures
rank-sum test.
were done in 191 (21%) patients in the everolimus-eluting The time to the primary endpoint was assessed stent group and in 172 (19%) patients in the paclitaxel-eluting according to the method of Kaplan-Meier, and the stent group (p=0·23). Three were lost to follow-up. The log-rank test was applied to compare the incidence of groups had similar baseline clinical (table 1), angiographic the endpoint between groups. Relative risks with 95% (table 2), and procedural characteristics (table 3). CIs, were calculated with the log-binomial method.13 Most patients presented with an acute coronary The Kaplan-Meier curves were drawn with the syndrome (table 1); the subtype of acute coronary guidelines provided by Pocock and colleagues.14 All p syndrome was equally distributed in the two groups; 74% values were two-sided, and a p value of less than 0·05 of lesions were complex (type B2 or C; table 2). The www.thelancet.com Published online January 8, 2010 DOI:10.1016/S0140-6736(09)62127-9
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Everolimus-eluting
Paclitaxel-eluting
Relative risk
stent (n=897)
stent (n=903)
Events at 12 months
All-cause mortality or myocardial infarction Target vessel revascularisation (clinically justifi ed) Target lesion revascularisation (clinically justifi ed) Stent thrombosis (defi nite and probable) Late stent thrombosis (30 days to 1 year after procedure) Data are number (%). Percentages have been rounded. *The 1·00 upper limit of 95% CI was 0·998, and p value was 0·047.
Table 4: Clinical events during follow-up
median total stent length per lesion, compared with signifi cant diff previous studies, and the number of stents per lesion (table 4; fi gure 3A). The rate of defi nite and probable were high; the number of stents was slightly, but stent thrombosis for up to 1 year remained signifi cantly signifi cantly, higher in the everolimus-eluting stent lower in the everolimus-eluting stent group compared group because of a shorter available maximum stent with the paclitaxel-eluting stent group (table 4). There length (table 3). Postprocedural cardiac biomarkers were were more late-stent thromboses in the paclitaxel-eluting assessed in 364 (41%) patients in the everolimus-eluting stent group than in the everolimus-eluting stent group at stent group and in 338 (37%) in the paclitaxel-eluting 1 year but the diff erence was not signifi cant (fi gure 3B).
stent group (p=0·17).
The rate of target vessel revascularisation was Table 4 shows the major adverse cardiac events during signifi cantly lower in patients who had everolimus-eluting follow-up. The primary endpoint occurred in fewer stents. This diff erence between the groups was already patients in the everolimus-eluting stent group than in apparent at 30 days, and remained signifi cant at the paclitaxel-eluting stent group (table 4; fi gure 2A). The diff erence resulted from a lower rate of myocardial The main secondary endpoint occurred in fewer infarction and of target vessel revascularisation at patients in the everolimus-eluting stent group than in 12 months in patients with everolimus-eluting stents, the paclitaxel-eluting stent group (table 4).
whereas all-cause mortality did not diff er between the We did an exploratory stratifi ed analysis of the primary gure 2B–D). Periprocedural myocardial endpoint that was not prespecifi ed in the protocol infarction occurred in 15 (2%) patients in the everolimus- (fi gure 4). The outcome of the primary endpoint was eluting stent group and 19 (2%) patients in the consistent across all but two subgroups—ie, patients paclitaxel-eluting stent group (p=0·49). The lower rate of with diabetes (n=325) and those with long lesions non-fatal myocardial infarction during 12 months in (n=553). CIs were wide and the results of a test of patients given everolimus-eluting stents refl ects a interaction were not signifi cant.
www.thelancet.com Published online January 8, 2010 DOI:10.1016/S0140-6736(09)62127-9
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Number at risk
Number at risk
Figure 2: Kaplan-Meier cumulative events curves at 12 months for primary endpoint (A), mortality (B), myocardial infarction (C), and target vessel revascularisation (D)
Compliance with aspirin and clopidogrel was 809 infarction was signifi cantly reduced in the evero li mus- (91%) in the everolimus-eluting stent group versus eluting stent group. This reduction was already apparent 829 (92%) in the paclitaxel-eluting stent group at at 1 month. The signifi cantly lower rate of myocardial 1 month; 805 (91%) and 815 (91%), respectively, at infarction at 30 days with the everolimus stent was 6 months; and 611 (70%) in the everolimus-eluting stent attributable to a signifi cantly lower rate of early stent group and 625 (70%) in the paclitaxel-eluting stent group thrombosis because there was no signifi cant diff erence between the groups in the rate of periprocedural myocardial infarction.
Discussion
Use of the paclitaxel-eluting stent was associated with The use of second-generation everolimus-eluting stents, a higher rate of early stent thrombosis in the unselected compared with paclitaxel-eluting stents, was associated population we studied than that reported in previous with a signifi cant reduction in the risk of major adverse randomised trials in selected patient populations.8,12 A cardiac events at 1 year. This diff erence was a result of large proportion of the unselected patients enrolled had reduction in the rate of myocardial infarction, a safety high-risk clinical or angiographic characteristics. Since component of the primary endpoint, and reduction in the proportion of patients with such high-risk repeat revascularisation of the target vessel.
characteristics did not diff er signifi cantly between Rates of all-cause or cardiac mortality did not diff er groups, diff erences between the devices—stent design, between the two groups; however the rate of myo cardial polymer coating, or the drug used—are the most www.thelancet.com Published online January 8, 2010 DOI:10.1016/S0140-6736(09)62127-9
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plausible explanations for the high rate of stent thrombosis with the paclitaxel stent. By contrast, the rate of stent thrombosis with the everolimus-eluting stent in our study was similar to that reported in the randomised trials of selected populations that led to The signifi cant diff erence in stent thrombosis at 12 months between the two groups was mainly attributable to early stent thrombosis. Because the groups did not diff er in terms of baseline characteristics, preprocedural and postprocedural antiplatelet and antithrombotic drugs, or procedural technique, we believe that the noted diff erence in early stent thrombosis rates relate to diff erences between the two devices that become apparent in an unselected population. An open-cell, thin-strut stent frame mounted on a semicompliant balloon might result in better apposition Number at risk
and less side-branch compromise than would a closed-cell, thick-strut device on a non-compliant balloon. The thinner layer of polymer on the everolimus-eluting stent might also play a part. Preclinical data have shown that the everolimus -eluting stent has more rapid and more extensive re-endo- thelialisation than has the second-generation paclitaxel- eluting stent.15 Numerically more stent thromboses were noted in the paclitaxel-eluting stent group than in the everolimus-eluting stent group between 1–12 months. The absolute numbers were small and the diff erences were not signifi cant. However, defi nitive conclusions about late stent thrombosis must await the prespecifi ed analyses at 3 years and 5 years because results from several studies have shown a predictable, continued, risk of stent thrombosis with time, particularly with paclitaxel-eluting stents.6 As with safety, a signifi cant diff erence in effi also noted with the everolimus-eluting stent. Both target vessel and target lesion revascularisation were Number at risk
signifi cantly reduced in the everolimus-eluting stent group compared with the paclitaxel-eluting stent group.
This diff erence was already evident at 30 days and Figure 3: Kaplan-Meier event curves at 12 months for stent thrombosis (A) and late stent thrombosis (B)
continued to increase up to 1 year, with similar relative
risk ratios at 30 days and at 12 months, consistent with reported in registries that also enrolled unselected
a continued treatment eff ect. Up to 30 days, the populations—namely, the X-Search study16 and the
diff
erence in revascularisation between groups Spirit V registry (E Grube, Helios Heart Centre, personal was related to the lower rate of stent thrombosis in communication).
the everolimus-eluting stent group than in the Since the test for interaction was not signifi cant, the paclitaxel-eluting stent group. At 12 months, the post-hoc exploratory subgroup analyses we did do diff erence suggested a signifi cantly lower rate of not allow us to infer whether the superiority of the clinically justifi ed reinterventions for restenosis and everolimus-eluting stent diff ers between subgroups. lower rate of stent thrombosis in the everolimus-eluting How ever, in a similar analysis done in the SPIRIT IV trial (G Stone, New York-Presbyterian Hospital, The lower rate of reintervention might relate to the Columbia University Medical Center, personal com- more potent reduction in neointimal hyperplasia with munication), the superiority of everolimus-eluting the everolimus-eluting stent than with the paclitaxel- compared with paclitaxel-eluting stents was less apparent in patients with diabetes. This fi nding can The rate of major adverse cardiac events with the only be regarded as exploratory. Patients with diabetes everolimus-eluting stent in our trial is similar to the rates under going per cutaneous coronary intervention have www.thelancet.com Published online January 8, 2010 DOI:10.1016/S0140-6736(09)62127-9
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Major adverse cardiac events in subgroups
Relative risk (95% CI)
p value for
interaction

No proximal left anterior coronary artery treated Proximal left anterior coronary artery treated 56/897 (6%)
82/903 (9%)
0·69 (0·50–0·95)
Figure 4: Subgroup analysis
Data are n/N (%). Percentages have been rounded.
poorer outcomes overall than do those without diabetes even when treated with drug-eluting stents. However, with the outcome of previous studies of selected patient results from previous studies have consistently cohorts in which everolimus-eluting and paclitaxel-eluting suggested that stents eluting limus derivatives might stents were compared8,12 and with the results of an all-comer off er an advantage over paclitaxel-eluting stents in registry in which the everolimus-eluting stent was patients with diabetes.17,18 compared with the fi rst-generation paclitaxel-eluting Enrolment of unselected patients and the entirely stent.16 clinical follow-up were the strengths of our study. In conclusion, we have shown that the everolimus-eluting more, we studied the second-generation Xience V stent is better than the second-generation paclitaxel-eluting stent whereas the fi rst-generation paclitaxel-eluting Taxus Liberté stent in treatment of paclitaxel-eluting stent was used in previous patients in real-life practice in terms of safety and effi On the basis of our results, we suggest that paclitaxel-eluting There are some limitations to our investigation. The stents should no longer be used in everyday clinical trial was done in one, high-volume, tertiary centre in practice.
which implantation of drug-eluting stents was the Contributors
default strategy for coronary intervention, and therefore EK wrote the fi rst draft of the report, and was responsible for the study at
the results might not be applicable in other settings. Maasstad Ziekenhuis. EM participated in drafting and revising the report.
Consistent with usual clinical practice in our institution,
JW was responsible for data entry. PCS designed the study, and wrote the protocol. EK, KSJ, EM, CVM, and PCS participated in data gathering. KSJ, systematic sampling of cardiac biomarkers was not EM, and DG did the data analysis. DG and PCS interpreted the data. KSJ,
done for all patients, and is unlikely to have aff ected the JW, CVM, DG, and PCS participated in writing the report.
outcome because the proportion of patients who had Confl icts of interest
biomarkers measured did not diff er signifi cantly EM has received honoraria or expenses from Abbot Vascular, Medtronic,
between groups. In the Spirit III trial,8 more Cordis, and Boston Scientifi c; and has been on speakers’ bureaus for
Medtronic. The other authors declare that they have no confl icts of interest.
postprocedure infarctions were noted in the paclitaxel-
eluting stent group than in the everolimus-eluting stent Acknowledgments
The Research Foundation received unrestricted research grants from Abbott group, whereas no signifi cant diff erence was noted Vascular and Boston Scientifi c. We gratefully acknowledge the help of the in the rate of periprocedural infarctions between groups research nurses, technicians, and medical staff in Maasstad Ziekenhuis and referring hospitals whose cooperation made this study possible.
www.thelancet.com Published online January 8, 2010 DOI:10.1016/S0140-6736(09)62127-9
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References
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