Published online before print January 26, 2009, doi: 10.1161/CIRCULATIONAHA.108.803528
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(Circulation. 2009;119:680-686.)
© 2009 American Heart Association, Inc.
Interventional Cardiology |
Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents
Two-Year Clinical Follow-Up From the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SPIRIT) III Trial
From the Columbia University Medical Center and Cardiovascular Research Foundation, New York, NY (G.W.S.); St Joseph Medical Center, Towson, Md (M.M.); Wake Medical Center, Raleigh, NC (W.N.); St Patrick Hospital, Missoula, Mont (M.S.); The Heart Center of Indiana, Indianapolis (J.B.H.); Presbyterian Hospital, Charlotte, NC (J.W.); EMH Regional Medical Center, Elyria, Ohio (N.F.); St Joseph’s Hospital Health Center, Syracuse, NY (R.C.); Jewish Hospital, Louisville, Ky (N.X.); Wake Forest University Baptist Medical Center, Winston-Salem, NC (R.A.); Miriam Hospital, Providence, RI (P.G.); Abbott Vascular, Santa Clara, Calif (R.M.W., K.S.); Harvard Clinical Research Institute, Boston, Mass (D.E.C.); and Duke Clinical Research Institute, Durham, NC (J.L.P.).
Correspondence to Gregg W. Stone, MD, Columbia University Medical Center, Cardiovascular Research Foundation, 111 E 59th St, 11th Floor, New York, NY 10022. E-mail gs2184{at}columbia.edu
Received July 1, 2008; accepted November 7, 2008.
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Abstract |
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Background— In the prospective randomized Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, an everolimus-eluting stent (EES) compared with a widely used paclitaxel-eluting stent (PES) resulted in a statistically significant reduction in angiographic in-segment late loss at 8 months and noninferior rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 1 year. The safety and efficacy of EES after 1 year have not been reported.
Methods and Results— A total of 1002 patients with up to 2 de novo native coronary artery lesions (reference vessel diameter, 2.5 to 3.75 mm; lesion length 
28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for 
6 months. Between 1 and 2 years, patients treated with EES compared with PES tended to have fewer episodes of protocol-defined stent thrombosis (0.2% versus 1.0%; P=0.10) and myocardial infarctions (0.5% versus 1.7%; P=0.12), with similar rates of cardiac death (0.3% versus 0.3%; P=1.0) and target vessel revascularization (2.9% versus 3.0%; P=1.0). As a result, at the completion of the 2-year follow-up, treatment with EES compared with PES resulted in a significant 32% reduction in target vessel failure (10.7% versus 15.4%; hazard ratio, 0.68; 95% confidence interval, 0.48 to 0.98; P=0.04) and a 45% reduction in major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization; 7.3% versus 12.8%; hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.83; P=0.004). Among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months, stent thrombosis subsequently developed in 0.4% of EES patients versus 2.6% of PES patients (P=0.10).
Conclusions— Patients treated with EES rather than PES experienced significantly improved event-free survival at a 2-year follow-up in the SPIRIT III trial, with continued divergence of the hazard curves for target vessel failure and major adverse cardiac events between 1 and 2 years evident. The encouraging trends toward fewer stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and after 1 year in all patients treated with EES rather than PES deserve further study.
Key Words: angioplasty • restenosis • stents • thrombosis
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Introduction |
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Compared with bare metal stents, both polymer-based paclitaxel-eluting stents (PES) and sirolimus-eluting stents have been shown to significantly reduce angiographic restenosis and recurrent ischemia necessitating repeat percutaneous coronary intervention and coronary artery bypass graft surgery.1–3 However, the rates of primary stent thrombosis (thrombosis attributable to the stent itself as opposed to events occurring after treatment of restenosis) are increased with both PES and sirolimus-eluting stents compared with their bare metal counterparts, a difference that emerges >1 year after stent implantation.3 With the goal of further enhancing the safety and efficacy of DES, an everolimus-eluting stent (EES) has been designed in which the antiproliferative agent is released from a thin (7.8 µm), nonadhesive, durable, biocompatible fluoropolymer coated onto a low-profile (0.0032-in strut thickness), flexible cobalt chromium stent. In a 14-day rabbit iliac model, endothelialization over the stent struts was more rapid with the EES than with stents eluting sirolimus, zotarolimus, or paclitaxel.4 Whether these experimental observations translate into improved safety in humans is unknown.
Editorial p 653
Clinical Perspective p 686
In the pivotal Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, patients with noncomplex coronary artery disease were randomized to treatment with a widely used PES or the EES. Angiographic follow-up at 8 months demonstrated a significant reduction in the primary angiographic end point of in-segment late loss with the EES compared with the PES; at 1 year, EES was noninferior to PES for the coprimary clinical end point of target vessel failure (TVF) but resulted in a significant reduction in major adverse cardiac events (MACE).5 Longer-term follow-up is required to determine whether these benefits are sustained and to assess the late safety profile of the EES. The present study reports the 2-year clinical outcomes from the SPIRIT III trial.
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Methods |
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Protocol Entry Criteria and Randomization
The design of the SPIRIT III trial has previously been described.5 In brief, SPIRIT III was a prospective, multicenter, randomized, single-blind, controlled clinical trial in which 1002 patients with either 1 or 2 de novo native coronary artery lesions (maximum, 1 lesion per epicardial coronary artery) were randomized in a 2:1 ratio to receive the EES (Xience V, Abbott Vascular, Santa Clara, Calif) or the PES (TAXUS EXPRESS2, Boston Scientific, Natick, Mass). Patients were enrolled who were
18 years of age with stable or unstable angina or inducible ischemia undergoing percutaneous coronary intervention. Major clinical exclusion criteria included percutaneous coronary intervention in the target vessel before or planned within 9 months after the index procedure or in a nontarget vessel within 90 days before or planned within 9 months afterward; acute or recent myocardial infarction (MI); left ventricular ejection fraction <30%; use of long-term anticoagulation, recent major bleed, hemorrhagic diathesis, or objection to blood transfusions; contraindications or allergy to any of the study medications, components of the study stents, or iodinated contrast that could not be premedicated; elective surgery planned within 9 months after the procedure necessitating discontinuation of the antiplatelet agent; platelet count <100 000 or >700 000 cells/mm3, white blood cell count <3000 cells/mm3, serum creatinine >2.5 mg/dL, dialysis, or liver disease; stroke or transient ischemic attack within 6 months; comorbid conditions limiting life expectancy to <1 year or that could affect protocol compliance; and participation in another investigational study that has not yet reached its primary end point. The study was approved by the institutional review board at each participating center, and consecutive eligible patients signed written informed consent.
By visual assessment, all study lesions had a diameter stenosis of 50% and <100%, with a reference vessel diameter of 2.5 to 3.75 mm and lesion length of 28 mm. Angiographic exclusion criteria included ostial or left main lesions; bifurcation lesions with the side branch either >50% stenosed or >2 mm in diameter or requiring predilatation; excessive proximal tortuosity, lesion angulation or calcification, or thrombus; lesion located within a bypass graft conduit; or the presence of lesions with >40% stenosis within the target vessel or a likelihood that additional percutaneous coronary intervention would be required within 9 months.
After confirmation of angiographic eligibility, telephone randomization was performed in randomly alternating blocks of 3 and 6 patients with an automated voice response system stratified by the presence of diabetes, planned dual-vessel treatment, and study site. Although the operators were by necessity unblinded during the stent implant procedure, the patient and staff involved in follow-up assessments remained blinded throughout the follow-up period, with a standardized follow-up interview script used to reduce bias. Protocol-specified angiographic follow-up was performed at 240±28 days in 436 patients as previously described.5 Clinical follow-up was performed at 1 month, 6 months, 9 months, and 1 year and then yearly through 5 years.
Medication Administration and Clinical Follow-Up
Procedural anticoagulation was achieved with either unfractionated heparin or bivalirudin as per standard of care, with glycoprotein IIb/IIIa inhibitors used per operator discretion. Patients were administered 300 mg aspirin before catheterization. A 300-mg oral dose of clopidogrel was recommended before the procedure and was required in all cases within 1 hour after stent implantation. The protocol recommended use of aspirin 80 mg daily indefinitely and clopidogrel 75 mg daily for a minimum of 6 months; a longer duration of clopidogrel use was permitted at the discretion of the treating physicians. Other medications were prescribed as per standard of care. Clinical follow-up was scheduled at 30±7, 180±14, 240±28, 270±14, and 365±28 days and then yearly (±28 days) through 5 years.
Data Management
Independent study monitors verified 100% of case report form data onsite. An independent committee blinded to treatment allocation adjudicated all MACE after review of original source documentation. A second clinical events committee blinded to randomization performed a post hoc adjudication of stent thrombosis using the Academic Research Consortium (ARC) definitions.6 Independent core angiographic and intravascular ultrasound laboratory analyses were performed by technicians blinded to treatment assignment and clinical outcomes using validated methods as previously described.7,8 A Data Safety and Monitoring Committee periodically reviewed blinded safety data, each time recommending that the study continue without modification.
Clinical End Points and Definitions
The primary clinical end point of the SPIRIT III trial was TVF, consisting of the composite of cardiac death, MI, or ischemia-driven target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery. Secondary end points included MACE, defined as the composite of cardiac death, MI, or ischemia-driven target lesion revascularization (TLR), as well as the individual components of TVF and MACE and stent thrombosis. Target vessel (or lesion) revascularization was considered to be ischemia driven if associated with a positive functional study, a target vessel (or lesion) diameter stenosis 50% by core laboratory quantitative analysis with ischemic symptoms, or a target vessel (or lesion) diameter stenosis 70% with or without documented ischemia. MI was defined as either the development of new pathological Q waves 0.4 seconds in duration in 2 contiguous leads or an elevation of creatine phosphokinase levels to >2.0 times normal with positive creatine phosphokinase-MB. Stent thrombosis was prospectively defined by protocol as an acute coronary syndrome with angiographic evidence of thrombus within or adjacent to a previously treated target lesion or, in the absence of angiography, any unexplained death or acute MI with ST-segment elevation or new Q waves in the distribution of the target lesion occurring within 30 days after the procedure. Definite or probable stent thrombosis also was adjudicated in a post hoc analysis with the ARC definitions.6
Statistical Methods
Categorical variables were compared by the Fisher exact test. Continuous variables are presented as mean±SD and were compared by t test. All analyses are by intention to treat using all patients randomized in the study, regardless of the treatment actually received. However, patients lost to follow-up in whom no event had occurred before the follow-up windows were not included in the denominator for calculations of binary end points. Time-to-event hazard curves also were constructed with Kaplan–Meier estimates and compared by log-rank test. A 2-sided value of 
=0.05 was used for all statistical tests to define significance. All statistical analyses were performed by SAS version 9.1.3 (SAS Institute, Cary, NC).
The authors had full access to and take full responsibility for the integrity of the data. All authors have read and agree to the manuscript as written.
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Results |
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Patients and Medications
A total of 1002 patients were enrolled at 75 US sites in the SPIRIT III trial between June 22, 2005, and March 15, 2006, and were randomized to receive EES (n=669) or PES (n=333). Baseline clinical and angiographic characteristics were well matched between the groups (Table 1). As also shown in Table 1, aspirin use was high in both groups throughout the 2-year study period, whereas thienopyridine use declined progressively over time, so that 60.9% of patients were taking either clopidogrel or ticlopidine at the end of 2 years.
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Clinical Outcomes at 2 Years
Clinical follow-up was available at 2 years in 951 patients (94.9%), including 642 EES patients and 309 PES patients. Table 2 reports the binomial rates of the major clinical end points at 2 years, and Figure 1 displays the Kaplan–Meier hazard event curves. At 1 year, no significant differences were found in the rates of TVF between the EES and PES groups (8.3% versus 10.8%; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.48 to 1.10; P=0.13). As seen in Figure 1 and Table 3, however, between 1 and 2 years, TVF events occurred more frequently in the PES group than in the EES group, so that by the end of the 2-year follow-up period, treatment with EES compared with PES resulted in a significant 32% reduction in the rate of TVF (10.7% versus 15.4%; HR, 0.68; 95% CI, 0.48 to 0.98; P=0.04). As also seen in Figure 1 and Table 3, MACE occurred more frequently in PES- compared with EES-treated patients between 1 and 2 years, so that by at the end of the 2-year follow-up period, patients treated with EES rather than PES had a significant 45% reduction in MACE (7.3% versus 12.8%; HR, 0.55; 95% CI, 0.36 to 0.83; P=0.004).
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Between 1 and 2 years of follow-up, treatment with EES compared with PES resulted in a trend toward fewer MIs, with nonsignificantly different interval rates of all-cause death, cardiac death, TLR, and TVR (Table 3). The 2-year composite rate of cardiac death or MI thus tended to be reduced in patients treated with EES compared with PES as a result of fewer periprocedural MIs and the trend toward fewer late MIs with EES (Figure 1). A strong trend also was present toward a 40% reduction in the composite rate of all-cause death or MI in patients treated with EES compared with PES (4.8% versus 8.1%; relative risk [RR], 0.60; 95% CI, 0.36 to 0.99; P=0.055). As also seen in Figure 1, a trend was present toward less TLR at 2 years in patients treated with EES rather than PES (4.3% versus 6.9%; HR, 0.60; 95% CI, 0.35 to 1.04; P=0.07).
Stent Thrombosis
As seen in Table 4, at the end of the 2-year follow-up period, stent thrombosis according to the prespecified protocol definition occurred in 1.0% of EES patients and 1.7% of PES patients (RR, 0.58; 95% CI, 0.18 to 1.87; P=0.35). The protocol-defined rates of stent thrombosis were comparable between the 2 groups within 1 year of randomization, whereas stent thrombosis between 1 and 2 years occurred in 0.2% of EES patients and in 1.0% of PES patients (RR, 0.16; 95% CI, 0.02 to 1.53; P=0.10). Similar trends were present when the post hoc ARC definitions of definite or probable stent thrombosis were used (Table 4).
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As shown in Figure 2, the 2-year rates of stent thrombosis according to the prespecified protocol definition were comparable among EES and PES patients who never discontinued a thienopyridine during the follow-up period (0.6% in both groups). In patients who discontinued clopidogrel or ticlopidine before 6 months, the rate of subsequent stent thrombosis after thienopyridine discontinuation through the end of the 2-year follow-up period was increased compared with patients who never discontinued a thienopyridine but similar in the EES and PES groups (2.8% and 2.9%, respectively). In contrast, among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months and before 2 years, stent thrombosis subsequently developed after thienopyridine discontinuation in 1 of 244 EES patients (0.4%) and in 3 of 116 PES patients (2.6%; P=0.10; Figures 2 and 3
).
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One patient who developed acute stent thrombosis (on day 0) in whom clopidogrel was subsequently discontinued on day 178 (and in whom stent thrombosis did not thereafter occur). |
Discussion |
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In the pivotal prospective, randomized SPIRIT III trial, patients randomized to EES rather than PES experienced fewer periprocedural MIs and less angiographic late loss at 8 months with fewer subsequent TLR procedures between 6 and 12 months, resulting in a significant reduction in MACE and noninferior rates of TVF with the EES at 9 months and 1 year.5 The present report demonstrates that between 1 and 2 years of follow-up after stent implantation, the advantages of the EES compared with the PES continue to accrue, with fewer episodes of very late stent thrombosis and MI occurring in patients having received the EES. As a result, the hazard curves for TVF and MACE between 1 and 2 years continued to diverge, so that at the end of the 2-year follow-up period, patients treated with the EES rather than PES had a significant 32% reduction in the rate of the primary clinical end point of TVF (10.7% versus 15.4%; HR, 0.68; 95% CI, 0.48 to 0.98; P=0.04) and a 45% reduction in MACE (7.3% versus 12.8%; HR, 0.55; 95% CI, 0.36 to 0.83; P=0.004), attributable to fewer MIs and less recurrent ischemia necessitating repeat TLR procedures through 2 years.
The present results with the EES are consistent with the clinical results from the smaller SPIRIT II trial, in which 300 patients in Europe and Asia Pacific were randomized 3:1 to EES versus PES.9 At the 2-year follow-up in SPIRIT II, treatment with EES compared with PES was associated with a nonsignificant 40% reduction in MACE (6.6% versus 11.0%; P=0.31), similar to the significant 45% reduction present in the larger SPIRIT III trial.10 Of potential concern in SPIRIT II, however, was the observation that among 97 EES patients who underwent routine follow-up angiography at both 6 months and 2 years, in-stent late loss significantly increased over time, whereas no such incremental late loss was noted in 35 PES patients.10 However, in the larger SPIRIT III trial, in which angiographic follow-up beyond 1 year was not performed, the absolute reduction in ischemia-driven TLR with the EES compared with PES present at 1 year was preserved at 2 years. Specifically, in SPIRIT III, ischemia-driven TLR was required between 1 and 2 years in 1.4% and 1.7% of EES and PES patients, respectively. This finding confirms and extends the results from SPIRIT II in which no late catch-up was evident in either the differences in in-segment binary restenosis or TLR between 6 and 24 months, both of which favored EES compared with PES. Thus, both SPIRIT studies have demonstrated that the early reduction in clinical restenosis (TLR) with EES compared with PES is sustained through 2 years, although longer-term follow-up is required to assess the late durability of the clinical advantages of the EES.
Use of both PES and sirolimus-eluting stents has been associated with increased rates of primary stent thrombosis compared with bare metal stents, a difference that emerges only after 1 year of follow-up.3 In this regard, it is noteworthy that in the present randomized trial, the rates of stent thrombosis were comparable between the PES and EES within the first year after implantation; after 1 year, however, trends were present for fewer stent thrombosis episodes with the EES than with the PES when assessed by either the prespecified protocol definition (0.2% versus 1.0%, respectively) or the post hoc ARC definitions (0.3% versus 1.0%, respectively). Moreover, although numerous studies have demonstrated that premature clopidogrel discontinuation (within 6 months after stent implantation, the duration of dual antiplatelet therapy required in the protocol) is a major risk factor for stent thrombosis,11,12 some13 but not all14 prior studies have found that prolonged thienopyridine administration (beyond 6 months) is protective against subsequent composite death or MI in sirolimus-eluting stent and PES patients. In the present study, thienopyridine discontinuation within the first 6 months was associated with a nearly 5-fold increase in the rates of thrombosis with both EES and PES, consistent with these earlier studies.11,12 Thienopyridine discontinuation for the first time after 6 months, however, was associated with a greater rate of subsequent stent thrombosis with the PES than with the EES (2.6% versus 0.4%), although given the relatively low rates of stent thrombosis, this difference did not reach statistical significance (P=0.10). Moreover, the duration between thienopyridine discontinuation after 6 months and subsequent stent thrombosis in PES-treated patients ranged from 73 to 135 days; as such, no definite conclusions can be drawn as to whether late thienopyridine discontinuation was causally related to subsequent stent thrombosis in these patients or whether stent thrombosis might have been prevented if dual antiplatelet therapy had not been interrupted. Thus, although the trends toward fewer subsequent stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and in all patients after 1 year treated with EES rather than PES are encouraging and consistent with the more rapid endothelialization expected with thin-strut stents15 and with the EES in particular,4 larger studies are required to confirm these observations.
In addition to the need for longer-term follow-up, other limitations of the SPIRIT III trial should be acknowledged. The events and their timing examined in the present analysis were secondary end points; thus, the findings should be considered hypothesis generating. Logistic considerations precluded blinding the operator to stent type, although the patients, follow-up study coordinators, and clinical events committee and core laboratory personnel were blinded and review of original source documents for clinical event adjudication was required. Routine angiographic follow-up was performed in 43.5% of patients at 8 months, potentially biasing subsequent clinical treatment decisions.16 However, this would not be expected to affect event rates between 1 and 2 years as described in the present report. The duration of dual antiplatelet therapy was not randomized, so the analysis of stent thrombosis rates according to dual antiplatelet use should not be considered definitive. Approximately 5% of patients were lost to follow-up at 2 years, warranting additional caution in the interpretation of differences in low-frequency safety events. Finally, the results of the present trial cannot be extended to higher-risk patients and lesion types excluded from enrollment.
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Conclusions |
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At the 2-year follow-up of the SPIRIT III trial, patients treated with EES rather than PES experienced significantly improved event-free survival, with statistically significant 32% and 45% reductions, respectively, in TVF and MACE as a result of fewer MIs and ischemic TLR procedures. The magnitude of the reduction in TLR with EES compared with PES at 1 year remains robust at 2 years, with no late catch-up apparent. The encouraging trends toward fewer subsequent stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and in all patients after 1 year treated with EES rather than PES are potentially important and deserve further study.
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Acknowledgments |
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Sources of Funding
This trial was sponsored and funded by Abbott Vascular, Santa Clara, Calif. The sponsors were involved in study design and in data collection, analysis, and interpretation, along with the principal investigator and steering committees.5 The corresponding author had full access to all the data in the study. The manuscript was prepared by the corresponding author and revised by all coauthors. The authors controlled the decision to submit the paper for publication. The sponsor was provided the opportunity for a nonbinding review of the manuscript before its submission.
Disclosures
Dr Stone reports having received research support from Abbott Vascular and Boston Scientific Corp and honoraria from Medtronic. Dr Hermiller reports serving as a consultant for Abbott Vascular and Boston Scientific Corp. Dr Applegate reports having received research support from Cordis and serving as a consultant for Abbott Vascular. Dr Gordon reports having received research support from Abbott Vascular and Boston Scientific Corp. Drs White and Sudhir are full-time employees of and own stock and/or options in Abbott Vascular. Dr Petersen reports having received research grants from Cordis Corp, Conor MedSystems, and Abbott Vascular. The other authors report no conflicts.
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References |
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Footnotes |
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Clinical trial registration information—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180479.
The names of the investigators, institutions, and research organizations participating in the SPIRIT III Trial appear in the Appendix of Reference 5.
Guest Editor for this article was Eric R. Bates, MD.
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 S. Windecker and P. Juni The Drug-Eluting Stent Saga Circulation, February 10, 2009; 119(5): 653 - 656. [Full Text] [PDF]
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