Paclitaxel-Eluting versus Uncoated Stents in Primary Percutaneous Coronary Intervention
Gerrit J. Laarman, M.D., Ph.D., Maarten J. Suttorp, M.D., Ph.D., Maurits T. Dirksen, M.D., Loek van Heerebeek, M.D., Ferdinand Kiemeneij, M.D., Ph.D., Ton Slagboom, M.D., L. Ron van der Wieken, M.D., Jan G.P. Tijssen, Ph.D., Benno J. Rensing, M.D., Ph.D., and Mark Patterson, M.R.C.P.
Background Drug-eluting coronary-artery stents have been shownto decrease restenosis and therefore the likelihood that additionalprocedures will be required after percutaneous coronary intervention(PCI). We evaluated the use of a drug-eluting stent in patientsundergoing PCI for acute myocardial infarction with ST-segmentelevation.
Methods We randomly assigned 619 patients presenting with anacute myocardial infarction with ST-segment elevation to receiveeither a paclitaxel-eluting stent or an uncoated stent. Theprimary end point was a composite of death from cardiac causes,recurrent myocardial infarction, or target-lesion revascularizationat 1 year.
Results Baseline clinical and angiographic characteristics inboth groups were well matched. There was a trend toward a lowerrate of serious adverse events in the paclitaxel-stent groupthan in the uncoated-stent group (8.8% vs. 12.8%; adjusted relativerisk, 0.63; 95% confidence interval, 0.37 to 1.07; P=0.09).A nonsignificant trend was also detected in favor of the paclitaxel-stentgroup, as compared with the uncoated-stent group, in the rateof death from cardiac causes or recurrent myocardial infarction(5.5% vs. 7.2%, P=0.40) and in the rate of target-lesion revascularization(5.3% vs. 7.8%, P=0.23). The incidence of stent thrombosis during1 year of follow-up was the same in both groups (1.0%).
Conclusions Although the use of paclitaxel-eluting stents inacute myocardial infarction with ST-segment elevation reducedthe incidence of serious adverse cardiac events at 1 year by4.0 percentage points, as compared with uncoated stents, thedifference was not statistically significant. (Current ControlledTrials number, ISRCTN65027270
[controlled-trials.com]
.)
Primary percutaneous coronary intervention (PCI) is now consideredthe optimal approach to the management of myocardial infarctionwith ST-segment elevation when the procedure is performed expeditiouslyand at a high-volume center.1,2,3,4,5 Stent implantation isassociated with an improvement in both early and late outcomes,as compared with balloon angioplasty alone, predominantly asa result of a reduction in target-vessel revascularization.6,7Furthermore, drug-eluting stents have been shown to reduce in-stentrestenosis (and therefore the need for repeated intervention)in a number of subgroups of patients.8,9 Retrospective studiesand one small, randomized trial have suggested that the useof drug-eluting stents is also beneficial in the setting ofprimary PCI.10,11,12,13 We aimed to determine whether paclitaxel-elutingstents are superior to uncoated stents in the setting of primaryPCI in terms of the rate of serious adverse cardiac events at1 year.
Methods
Study Design
Our prospective, single-blind, randomized study, called thePaclitaxel-Eluting Stent versus Conventional Stent in MyocardialInfarction with ST-Segment Elevation (PASSION) trial, was performedat two centers in the Netherlands (Onze Lieve Vrouwe Gasthuisin Amsterdam and St. Antonius Hospital in Nieuwegein). The trialwas entirely funded by the Department of Interventional Cardiologyat Onze Lieve Vrouwe Gasthuis and was approved by the ethicscommittees at both institutions. All study participants providedoral informed consent, which was documented in the patients'clinical records. This approach to informed consent was explicitlyapproved by the ethics committee at each center.
Enrollment of Patients
We enrolled patients who were between the ages of 18 and 80years if they had had an acute myocardial infarction with ST-segmentelevation (>20 minutes of chest pain and at least 1 mm ofST-segment elevation in at least two contiguous leads or a newleft bundle-branch block), reperfusion was expected to be achievedwithin 6 hours after the onset of symptoms, and the native coronaryartery was considered to be suitable for primary PCI with stentimplantation. We excluded patients if they had received thrombolytictherapy; the infarction was caused by in-stent thrombosis orrestenosis; there was a contraindication to aspirin, clopidogrel,or both; patients were participating in another clinical trial;cardiogenic shock was evident before randomization; the neurologicoutcome after resuscitation was uncertain; they had undergoneintubation, ventilation, or both; there was known intracranialdisease; or the estimated life expectancy was less than 6 months.
Procedures
We administered aspirin (at a dose of 100 to 500 mg) and clopidogrel(300 mg) when patients first arrived at the hospital. A glycoproteinIIb/IIIa receptor blocker was administered at the discretionof the operator. A bolus of 10,000 IU of unfractionated heparinwas administered before the procedure.
Coronary angiography was performed through either the radialor the femoral artery. The target segment was filmed in at leasttwo orthogonal planes after the intracoronary administrationof 100 to 200 µg of nitroglycerin; quantitative coronaryangiography was then performed. The use of thrombectomy devicesand predilatation balloons was at the operators' discretion.
As soon as the length and diameter of the stent had been chosen,patients were randomly assigned to receive either a paclitaxel-elutingstent (Taxus Express2, Boston Scientific) or an uncoated stent(Express2 or Liberté, Boston Scientific) in a 1:1 ratio,with the use of permuted blocks of 50. Assignment to study groupswas performed with the use of sealed envelopes. Patients, referringphysicians, investigators responsible for obtaining follow-upinformation, and interventionalists performing repeated procedureswere all unaware of treatment assignments.
Stents were deployed with a minimum pressure of 12 atm. If dissectionor incomplete coverage of the lesion occurred, additional stentsof the same type as the assigned stent were used. Final angiographywas performed to obtain views similar to those obtained beforethe procedure. Epicardial blood flow in the infarct-relatedartery before and after stent implantation was determined accordingto the Thrombolysis in Myocardial Infarction (TIMI) classification.14
Follow-up
We prescribed 80 to 100 mg of aspirin daily for life and 75mg of clopidogrel daily for at least 6 months. During each patient'shospital stay, we recorded all adverse events; during follow-upvisits at 30 days and at 12 months, we recorded all seriousadverse cardiac events (death from cardiac or noncardiac causes,recurrent myocardial infarction, revascularization of the targetlesion or target vessel, and coronary-artery bypass grafting[CABG]), as well as interventions to nontarget vessels.
Study End Points and Definitions
Drs. Laarman and Suttorp adjudicated all end points of the studyin a blinded fashion. The primary end point was the first occurrenceof a serious adverse cardiac event at 12 months, including deathfrom cardiac causes, recurrent myocardial infarction requiringhospitalization, and ischemia-driven revascularization of atarget lesion. The secondary end points of the study were revascularizationof a target lesion and a composite of death from cardiac causesor recurrent myocardial infarction.
All deaths were considered to have been from cardiac causesunless a noncardiac cause could be identified. Recurrent myocardialinfarction was defined by the development of either pathologicalQ waves lasting at least 0.4 second in at least two contiguousleads or an increase in the creatine kinase level to more thantwice the upper limit of normal with an elevation of the creatinekinase MB isoenzyme. A creatine kinase level of more than fivetimes the upper limit of normal was required for the diagnosisof myocardial infarction after bypass surgery. Patients whostill had an elevation in cardiac enzymes received a diagnosisof reinfarction if there was an increase of at least 50% fromthe previous measurement.
Revascularization of the target lesion was defined as ischemia-drivenPCI of the target lesion owing to restenosis or reocclusionwithin the stent or in the adjacent 5 mm of the distal or proximalsegments and included CABG involving the infarct-related artery.Stent thrombosis was defined by the angiographic documentationof either vessel occlusion or thrombus formation within, oradjacent to, the stented segment. Stent thrombosis was categorizedas acute (occurring within 24 hours after the procedure), subacute(occurring 1 to 30 days after the procedure), or late (occurringmore than 30 days after the procedure).
Statistical Analysis
We calculated that a total of 262 patients would be requiredin each group, using a two-sided test for differences in independentbinomial proportions with an alpha level of 0.05, for the studyto have a statistical power of 90% to detect a reduction inthe primary end point from an anticipated event rate of 21.7%in the uncoated-stent group to 10.9% in the paclitaxel-stentgroup, a relative reduction of approximately 50%. This assumptionwas based on the results of the TAXUS-II trial of the TaxusExpress2 paclitaxel-eluting stent.15 Given the differences inthe nature and design of that study and our study (primary vs.elective PCI and no angiographic follow-up), 10% was added tothe number of patients. Allowing for attrition, the requiredstudy population was determined to be 620 patients.
Baseline data are presented as proportions or mean (±SD)values and were compared with the use of Student's t-test orthe Wilcoxon rank-sum test for continuous variables and withFisher's exact test for categorical variables. A two-sided Pvalue of less than 0.05 was considered to indicate statisticalsignificance.
We estimated the cumulative incidence rates of the primary andsecondary end points at 1 year with the Kaplan–Meier method.16Data on patients who were lost to follow-up were censored atthe time of the last contact. Relative risks were calculatedby dividing the Kaplan–Meier estimated rate of an eventat 1 year in the paclitaxel-stent group by the rate in the uncoated-stentgroup. The 95% confidence interval (CI) for the relative riskwas calculated with the use of the standard errors from theKaplan–Meier curve. The significance of differences inrates of the end points between treatment groups was assessedby the log-rank test. A Cox proportional-hazards model was usedto adjust for baseline variables for calculation of an adjustedrelative risk for the primary end point.
Results
Baseline Characteristics and Procedural Results
We screened 1037 patients who had myocardial infarction withST-segment elevation at the two sites between March 28, 2003,and December 31, 2004. Of these patients, 619 were enrolledin the study; 310 were randomly assigned to the paclitaxel-stentgroup and 309 to the uncoated-stent group. The most common reasonsfor exclusion from the trial were an anticipated delay of morethan 6 hours between the onset of symptoms and reperfusion,coronary anatomy that was not suitable for stent implantation,cardiogenic shock, and mechanical ventilation.
The baseline clinical characteristics of both groups were wellmatched (Table 1). The mean age was 61 years; 75.9% of the patientswere men. The prevalence of diabetes mellitus was low (11.0%).All patients received aspirin and clopidogrel before percutaneouscoronary intervention. The time from the onset of symptoms tothe first balloon inflation was approximately 3 hours in bothgroups.
The baseline angiographic characteristics are shown in Table 2.Approximately half the patients had multivessel disease, andin 50.1% of the cases, the left anterior descending coronaryartery was the infarct-related artery. TIMI flow grade 2 or3 was present in 29.3% of patients in the paclitaxel-stent groupand in 28.4% in the uncoated-stent group. The majority of patientshad an estimated lesion length between 10 mm and 19 mm. Themean reference diameter was 3.13±0.43 mm in the paclitaxel-stentgroup and 3.20±0.47 mm in the uncoated-stent group.
The procedural characteristics were also well matched (Table 3).The average length of stents was 19 mm in both groups. GlycoproteinIIb/IIIa receptor blockers were used in three quarters of bothgroups (abciximab in all cases). TIMI grade 3 flow was establishedin 93.2% of patients in the paclitaxel-stent group, as comparedwith 96.1% of patients in the uncoated-stent group. The sizesof infarcts, reflected by the mean peak value of the creatinekinase MB isoenzyme, were similar (193±183 in the paclitaxel-stentgroup and 210±186 in the uncoated-stent group).
Events during the first 30 days after the intervention are shownin Table 4 and in Tables 1 through 9 of the Supplementary Appendix(available with the full text of this article at www.nejm.org).No significant differences were found between the two treatmentgroups. The cumulative incidence of serious adverse cardiacevents at 30 days was 4.2% in the paclitaxel-stent group and6.5% in the uncoated-stent group (P=0.21). Acute stent thrombosis(within 24 hours) occurred in one patient (0.3%) in the paclitaxel-stentgroup. Subacute stent thrombosis occurred in one patient (0.3%)in the paclitaxel-stent group and in three patients (1.0%) inthe uncoated-stent group.
A total of 97.4% of patients in the paclitaxel-stent group and98.1% of those in the uncoated-stent group underwent completeclinical follow-up. Events during the first year after the interventionare shown in Table 4 and in Tables 10 through 18 of the Supplementary Appendix.The cumulative incidence of the primary end point was 8.8% inthe paclitaxel-stent group and 12.8% in the uncoated-stent group(relative risk, 0.69; 95% CI, 0.43 to 1.10; P=0.12) (Figure 1and Table 4). Multivariate adjustment (which incorporated allthe variables in Table 1, Table 2, and Table 3) did not substantiallyalter the estimate of the relative risk (relative risk, 0.63;95% CI, 0.37 to 1.07; P=0.09). The secondary end points arealso shown in Table 4. Although trends were observed in favorof the paclitaxel-stent group, none of these differences weresignificant.
Figure 1. Composite Primary End Point of Death from Cardiac Causes, Recurrent Myocardial Infarction, or Target-Lesion Revascularization at 1 Year.
The cumulative incidence of the primary end point of serious adverse cardiac events was 8.8% in the paclitaxel-stent group and 12.8% in the uncoated-stent group (relative risk, 0.69; 95% CI, 0.43 to 1.10; P=0.12 by the log-rank test).
Late stent thrombosis occurred in one patient (0.3%) in thepaclitaxel-stent group and in none in the uncoated-stent group,a difference that was not significant. Clopidogrel was usedfor a median of 9 months (interquartile range, 6 to 12) in bothgroups; nine patients discontinued clopidogrel prematurely.None of these patients had a thrombotic event. The six patientswith stent thrombosis were all compliant with the specifiedregimen at the time of the event.
Discussion
Our study compared paclitaxel-eluting coronary-artery stentswith uncoated stents for primary PCI during acute myocardialinfarction with ST-segment elevation. The cumulative incidenceof the primary end point — a composite of death from cardiaccauses, recurrent myocardial infarction, and target-lesion revascularizationat 12 months — was 8.8% in the paclitaxel-stent groupand 12.8% in the uncoated-stent group. The adjusted risk ratiowas 0.63, which was not statistically significant. There wasalso a trend in favor of the paclitaxel-stent group in the ratesof individual adverse events, but no single end point reachedstatistical significance. In contrast, trials comparing thesetwo types of stents in elective PCI have consistently showeda significant benefit associated with the use of paclitaxel-elutingstents.8,9
There are a number of possible explanations for the differencebetween the results of this trial and those of previous studies.First, the trial power may have been insufficient. Event ratesin the uncoated-stent group were much lower than those anticipatedin our power calculations. The point estimate of the differencein the primary end point, if accurate, is clinically significant;a larger trial could have demonstrated statistical significance.However, the estimated relative reduction of serious adversecardiac events by 31% is considerably smaller than that observedin previous trials with drug-eluting stents. This finding hasconsequences for the cost–benefit profile of these stentsfor the indication of primary PCI.8,9,10,11,12,13 Second, thestudy design did not include angiographic follow-up. Recurrentstenosis observed during routine follow-up angiography couldhave led to reintervention without symptoms or objective evidenceof ischemia, thus increasing the event rate. In addition, afterPCI for myocardial infarction, restenosis may have developedin some patients in the absence of ischemic symptoms, owingeither to partial infarction or to a defective warning system.Third, there may have been a difference in response to vascularinjury in the setting of primary PCI, as compared with thatof more elective procedures. The literature, however, showsthat angiographic and clinical restenosis after primary PCIremains an important issue.6,7 Fourth, the study was performedin patients with relatively large infarct-related arteries inwhich there was a decreased risk of restenosis. Finally, continuingimprovements in the design of stents and the lower thicknessof struts may have been responsible for lower rates of restenosisin the uncoated-stent group than in those reported previously.
The results of our study also differ from a series of retrospectiveanalyses and one small, randomized trial evaluating the implantationof drug-eluting stents for myocardial infarction with ST-segmentelevation.10,11,12,13 Subgroup analysis of patients undergoingPCI with sirolimus-eluting stents for myocardial infarctionin the Thoraxcenter Research Registry showed that the rate ofserious adverse cardiac events at 300 days was reduced from17.0% to 9.4% (P=0.02).11 This pattern was repeated in a retrospectiveanalysis from the Washington Hospital Center using the samestent type.12 In the Single High-Dose Bolus Tirofiban and Sirolimus-ElutingStent vs. Abciximab and Bare-Metal Stent in Myocardial Infarction(STRATEGY) trial involving 175 patients, the rate of death,reinfarction, or target-vessel revascularization at 8 monthswas reduced from 32% with an uncoated stent to 18% with a sirolimus-elutingstent.13 These event rates are among the highest reported forany trial of PCI, and the reasons for the high event rates arenot entirely clear, although most of the patients in the STRATEGYtrial underwent routine follow-up angiography and the mean reference-vesseldiameter was considerably smaller than that in our trial. Anadditional feature of the STRATEGY trial was that by design,a different glycoprotein IIb/IIIa inhibitor was used in thetwo study groups, which confounded the interpretation of thecomparison between the two types of stents.
We did not observe a difference in the rates of stent thrombosisbetween our two study groups, although the definition of stentthrombosis was conservative (since angiographic documentationwas required). Acute or subacute stent thrombosis occurred intwo patients (0.6%) in the paclitaxel-stent group and threepatients (1.0%) in the uncoated-stent group. This incidenceis low, given the thrombotic environment at the time of stentplacement, the potential for suboptimal stent deployment inthe setting of PCI for acute myocardial infarction, and decreasedblood flow in a vessel that supplies infarcted myocardium. Ina recent retrospective study from the Thoraxcenter, the incidenceof stent thrombosis at 1 month (which was also defined on thebasis of angiography) after primary PCI with the use of a paclitaxel-elutingstent was 2.9%.17 We also found no evidence of an increase inthe rate of late stent thrombosis, a topic that has recentlycaused concern.18
In this issue of the Journal, a report on the Trial to Assessthe Use of the Cypher Stent in Acute Myocardial Infarction Treatedwith Balloon Angioplasty (TYPHOON) by Spaulding et al.19 comparessirolimus-eluting stents with uncoated stents in primary PCIamong 712 patients. The investigators report a significant differencein the primary end point (the composite of death from cardiaccauses, recurrent infarction, and target-vessel revascularizationat 1 year) in favor of sirolimus-eluting stents, as comparedwith uncoated stents (7.3% vs. 14.3%, P=0.004). Differencesbetween the two trials — including the type of drug-elutingstent used, the study design (routine follow-up angiographywas performed in a subgroup of patients in TYPHOON), primaryend points, and inclusion and exclusion criteria — makeit difficult to compare the outcomes of our trial with thoseof TYPHOON. It is worth noting, however, that the event ratesin the two groups of patients in TYPHOON are not markedly differentfrom those in our analysis.
In conclusion, our study did not show a significant benefitassociated with the use of paclitaxel-eluting stents in primaryPCI for acute myocardial infarction with ST-segment elevation,as compared with uncoated stents with the same design.
Dr. Laarman reports having served on the advisory board of BostonScientific and having received lecture fees from Cordis, Johnson& Johnson, and Medtronic; Dr. Dirksen, lecture fees fromBoston Scientific; Dr. Kiemeneij, lecture fees from Terumo Medicaland Cordis, Johnson & Johnson, and royalties from BostonScientific; and Dr. Slagboom, consulting fees from Biotronikand lecture fees from Cordis, Johnson & Johnson. No otherpotential conflict of interest relevant to this article wasreported.
We are indebted to Marian Viergever, Femmy Bosman, and MikeBosschaert for providing indispensable administrative support.
Source Information
From the Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam (G.J.L., M.T.D., L.H., F.K., T.S., L.R.W., M.P.); the Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein (M.J.S., B.J.R.); and the Department of Cardiology, Academic Medical Center, Amsterdam (J.G.P.T.) — all in the Netherlands.
Address reprint requests to Dr. Laarman at the Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Oosterpark 9, 1090 HM Amsterdam, the Netherlands, or at g.j.laarman{at}olvg.nl.
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Drug-Eluting Stents in Primary PCI
Alfonso F., Jneid H., Maree A. O., Palacios I. F., Valgimigli M., Percoco G., Bolognese L., Spaulding C., Henry P., Teiger E., Laarman G. J., Van de Werf F.
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355:2483-2486, Dec 7, 2006.
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