Published online before print September 3, 2008, doi: 10.1161/CIRCINTERVENTIONS.108.787762
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Original Articles |
Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
Long-Term Outcome After Bare Metal and Drug-Eluting Stent Implantation
From the Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands.
Correspondence to Patrick W. Serruys, MD, PhD, Thoraxcenter, Ba-583, ‘s Gravendijkwal 230, 3015 CE Rotterdam, Netherlands. E-mail p.w.j.c.serruys{at}erasmusmc.nl
Received April 22, 2008; accepted August 18, 2008.
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Abstract |
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Background— Primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction with bare metal stents (BMS) is well established, while randomized trials suggest equivalent safety and reduced repeat revascularization with drug-eluting stents (DES) in this setting. However, long-term data on DES in PPCI is lacking, especially in those ineligible for inclusion in randomized trials. Our aim was to investigate the long-term outcomes of unselected patients undergoing PPCI with BMS and DES.
Methods and Results— We analyzed all patients (n=1738) undergoing PPCI for a de novo lesion in our institution from 2000 to 2005. Patients from 3 sequential consecutive cohorts of BMS (n=531), sirolimus-eluting (SES, n=185) or paclitaxel-eluting stents (PES, n=1022) were included. The median duration of follow-up was 1185 days (interquartile range, 746 to 1675). There were no differences in all-cause mortality or repeat revascularization between DES and BMS, although there was a nonsignificant trend toward improved survival with SES compared with both BMS (propensity score-adjusted hazard ratio, 0.63; [95%CI, 0.33 to 1.18]) and PES (hazard ratio, 0.71; [95% CI, 0.40 to 1.26]). SES were associated with lower rates of the composite end point of all-cause death, nonfatal myocardial infarction, or target vessel revascularization (hazard ratio, 0.62; 95%CI, 0.40 to 0.96) when compared with PES. Very late stent thrombosis only occurred in the DES groups.
Conclusions— Although DES are not associated with an increase in adverse events compared with BMS when used for PPCI, neither DES reduced repeat revascularizations. Appropriately powered randomized trials with hard clinical end points and an "all-comer" design are required to further assess the benefit of DES in PPCI.
Key Words: angioplasty • mortality • myocardial infarction • stents
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Introduction |
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Primary percutaneous coronary intervention (PPCI) with stent implantation is the preferred modality for treating patients with ST-elevation myocardial infarction (STEMI).1 However, the role of drug-eluting stents (DES) in these patients is less well established, because these patients were excluded from the pivotal randomized trials comparing DES with bare metal stents (BMS).2–4 Although there have been randomized trials evaluating DES in STEMI patients, these trials included relatively small numbers of patients with the majority only reporting 1-year follow-up.5–9 The extent of registry data are similarly limited.10–13 Data from 4 meta-analyses demonstrate a significant benefit in terms of repeat revascularization, with no difference in mortality or stent thrombosis rates between DES and BMS.14–17 With the paucity of long-term data, concerns remain about the potential risk for late adverse events, particularly as acute coronary syndromes at the time of PCI is a predictor of stent thrombosis.18,19 Our aim was to investigate the long-term clinical outcomes of unselected patients (including those with cardiogenic shock) treated with bare metal and DES at a single academic medical center.
Editorial see p 87
Clinical Perspective see p 103
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Methods |
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Between January 2000 and December 2005, 1738 consecutive patients presenting with STEMI underwent PPCI for a de novo lesion with a single stent type as their standard treatment. During this time period, PPCI was the default strategy for all patients with STEMI presenting within 6 hours of symptom onset. The patients are transferred directly to our cath laboratory either by the ambulance service or by local emergency departments, thus minimizing any potential delays in call- and door-balloon times. Initially, all patients were treated with BMS, but on April 16, 2002, our institution adopted the use of sirolimus-eluting stents (SES: Cypher; Cordis, Warren, N.J.) as the default strategy for all coronary interventions. On February 16, 2003, SES was replaced by paclitaxel-eluting stents (PES: Taxus; Boston Scientific, Natick, Mass.) as the default stent. This single-center registry, therefore, consists of 3 sequential groups of consecutive patients: BMS (n=531; January 2000 to April 2002), SES (n=185; April 2002 to February 2003), and PES (n=1022; February 2003 to December 2005) (Figure 1). All patients undergoing PPCI were enrolled, including those in cardiogenic shock. The only exclusion criteria were the implantation of more than one different stent type during the index procedure or PCI for a previously stented lesion.
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All procedures were performed following standard procedural guidelines at the time.20 The use of glycoprotein 2b/3a inhibitors or adjunctive devices was left up to the operator’s discretion. Angiographic success was defined as residual stenosis <30% by visual estimation and thrombolysis in MI grade 3 flow. All patients were advised to maintain lifelong aspirin. Hypercholesterolemia was defined as fasting total cholesterol >5 mmol/L (193 mg/dL) or the use of lipid-lowering therapy. Hypertension was defined as blood pressure >140/90 mm[ths]Hg or the use of antihypertensive medications. Renal impairment was defined as a serum creatinine >150 µmol/L (1.7 mg/dL).
The primary end point was all-cause mortality. Secondary end points included MI, target vessel revascularization (TVR), target lesion revascularization (TLR), definite stent thrombosis, and the composites of all-cause death or nonfatal MI and major adverse clinical end points (defined as all-cause death, nonfatal MI, or TVR). MI included reinfarction (defined as recurrence of symptoms together with ST-elevation or new left bundle branch block and an increase in cardiac enzymes following stable or decreasing values) or spontaneous MI (diagnosed by a rise in creatine kinase-MB fraction of 3 times the upper limit of normal together with symptoms and either new ST-elevation or left bundle branch block). Stent thrombosis was adjudicated in accordance with the Academic Research Consortium classification of definite stent thrombosis.21 The timing of stent thrombosis was categorized into early (within 30 days after implantation), late (between 30 days and 1 year), or very late (>1 year).
Follow-up survival data for all patients were obtained annually from municipal civil registries. A questionnaire was subsequently sent to all living patients with specific enquiries about repeat hospital admission and adverse events. As the principal regional cardiac center, repeat revascularizations are normally performed at our institution and recorded prospectively in our database. For patients who suffered an adverse event at another center, medical records from the other institutions were systematically reviewed. General practitioners and patients were contacted as necessary if further information was required. The protocol was approved by the hospital ethics committee and is in accordance with the Declaration of Helsinki. Written informed consent was obtained from every patient. 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.
Statistical Analysis
Categorical variables are presented as percentages and were compared by Pearson 
2 test or Fisher exact test. Continuous variables are presented as mean±standard deviation and were compared by means of the F test for analysis of variance and the Bonferroni method, using a 2-sided probability value of <0.0167 (0.05/3) to indicate statistical significance. The cumulative incidence of adverse events was estimated according to the Kaplan-Meier method, and curves were compared using the log-rank test. Patients lost to follow-up were considered at risk until the date of last contact, at which point they were censored. Separate Cox multivariable regression analyses were performed for each paired treatment comparison. Stent type was forced into forward stepwise models using all the 34 variables listed in Tables 1 and 2
. Variables with a significance of P<0.1 were entered into the next step; the final results are presented as adjusted hazard ratios (HR) with 95% CI. To account for baseline differences in the 3 cohorts, individual propensity scores for each paired treatment comparison were calculated by logistic regression using all significantly different pretreatment variables in Tables 1 and 2.22 Stent type and the appropriate propensity scores were then forced into separate forward stepwise Cox multivariable regression analyses using the variables in Tables 1 and 2 as above to obtain propensity score-adjusted HRs. Further, Cox multivariable analyses were performed to identify independent predictors of adverse clinical events. All statistical analyses were performed using SPSS for windows version 12.0.1 (SPSS Inc., Chicago, Ill.).
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Results |
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Fifty-six patients (3.2%) were lost to follow-up. The overall mean duration of clinical follow-up was 1185 days (interquartile range [IQR], 746 to 1675). Because of the sequential nature of the 3 consecutive patient cohorts, there were significant differences (P<0.001) in the duration of follow-up for each stent type: BMS median 2132 days (IQR, 1588 to 2350), SES 1516 days (IQR, 1406 to 1643) and PES 884 days (IQR, 558 to 1209). Baseline demographics are shown in Table 1, whereas angiographic and procedural details are described in Table 2. There were significant baseline differences between the groups: in particular, the patients were older in the DES groups, although in the SES group this did not reach statistical significance.
Angiographic success rates were similar among the 3 cohorts (overall 95.4%). The total stented length was higher, and the mean stent diameter was smaller in the DES groups. The recommended duration of clopidogrel and the use of statins and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers at discharge from hospital progressively increased.
Clinical event rates after 3 years follow-up, together with HR adjusted both by conventional Cox multivariable regression analysis and propensity score-adjustment, are shown in Table 3.
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From the Kaplan-Meier estimates, there were no statistically significant differences between the 3 groups in terms of all-cause mortality, MI, TLR, or TVR (Figure 2a through 2c). The SES group had a significantly lower rate of the composite end point of all-cause mortality, nonfatal MI, or TVR compared with BMS (logrank P=0.04) and demonstrated a trend toward superiority over PES (logrank P=0.09) (Figure 2d). SES also exhibited a trend toward lower rates of the composite of all-cause death or nonfatal MI when compared with BMS (logrank P=0.07), whereas PES showed a trend toward increased rates of definite stent thrombosis (logrank P=0.07) (Figure 2e and 2f).
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Although there was a trend toward improved survival with SES compared with both BMS and PES, this was not statistically significant with conventional multivariable adjustment or after propensity score adjustment (Table 3). Any differences between the 3 groups in terms of TVR or TLR did not reach statistical significance. There were no differences in overall, early, or late stent thrombosis rates, although there were no cases of very late stent thrombosis in the BMS group versus 2.7% in SES (P=0.001; Fisher exact test) and 0.9% in PES (P=0.03; Fisher exact test). SES had a trend toward increased rates of very late stent thrombosis.
The multivariable predictors of mortality are shown in Table 4. Independent predictors of other clinical events are shown in Table 5, and those for composite end points in Table 6. The use of particular stent types did not predict any adverse event. Renal impairment, increasing age, previous MI, and the number of diseased vessels were independent predictors of all-cause mortality and both composite end points. Treatment of the right coronary artery (RCA) or the use of β-blockers at the time of discharge independently predicted improved outcome. Although patients with cardiogenic shock did have higher 3-year mortality than hemodynamically stable patients (overall 44.9% versus 11.9%, P<0.001; BMS 26.1% versus 16.0%, P=0.24; SES 45.8% versus 6.2%, P<0.001; PES 52.9% versus 10.7%, P<0.001), this was not an independent predictor of outcome after multivariable adjustment.
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Discussion |
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Our results provide some evidence as to the long-term safety of DES in a large cohort of patients undergoing PPCI. The use of DES in this setting has been questioned since firstly, delayed healing may predispose these and other patients to late and very late stent thrombosis with potentially fatal clinical repercussions.23,24 Secondly, eventual resolution of any thrombus trapped between the stent and vessel wall at the time of implantation may result in late acquired malapposition, which is another potential risk factor for stent thrombosis.25,26 Finally, adverse effects on endothelial function and vasomotion may also contribute.27–30 Although existing data suggest that DES are safe and reduce repeat revascularization in patients undergoing PPCI, long-term data are lacking: the majority of randomized trials have reported only 1-year follow-up, although some data are available up to 2 years.14,31 The Massachusetts registry has reported 2-year data on 1221 propensity score-matched pairs of DES and BMS patients, which showed reductions in mortality and repeat revascularization with DES.32 The New York State Registry also found a reduction in mortality with DES.33 We have found that after a median of 1185 days (IQR, 746 to 1675) follow-up, there were no differences in any clinical end point including all-cause mortality and repeat revascularizations between both DES types and BMS. In fact, compared with BMS, there was a trend toward improved survival and the composites of all-cause death or nonfatal MI and all-cause death, nonfatal MI or TVR with SES. The relatively smaller numbers in our SES cohort may explain why this difference did not reach statistical significance. When examining PES, we were unable to demonstrate benefits over BMS in terms of any of the clinical end points. Furthermore, after propensity score adjustment, PES had higher rates of the composite of all-cause death or nonfatal MI and all-cause-death, nonfatal MI, or TVR when compared with SES. Our results for the PES cohort are consistent with the randomized paclitaxel-eluting stent versus conventional stent in myocardial infarction with ST-segment elevation (PASSION) trial comparing PES with BMS, which found no significant difference in any of the clinical end points with PES.8
The lack of benefit in terms of repeat revascularization with both types of DES is surprising. Published randomized trials of DES in STEMI patients have demonstrated a consistent reduction in repeat revascularization with the use of SES,6,7,9,34 although this benefit did not reach statistical significance in a randomized trial comparing PES with BMS.8 All of these trials found no difference in mortality with DES. Recent meta-analyses of randomized-controlled trials demonstrated a consistent benefit with DES in terms of reducing repeat revascularization with a risk reduction of approximately 60%.14–17 Analysis of our data revealed a trend toward decreased TLR with both types of DES (conventional HR, 0.64; 95% CI, 0.30 to 1.35 and propensity score-adjusted HR, 0.54; 95% CI, 0.22 to 1.32 for SES; and conventional HR, 0.67; 95% CI, 0.40 to 1.12 and propensity score-adjusted HR, 0.82; 95% CI, 0.50 to 1.33 for PES), which was not statistically significant. Our patients, however, differed from those in the randomized trials: for example, the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON) study excluded patients with excessive tortuosity or calcification, ostial or multiple lesions, massive thrombus in the infarct-related artery, bifurcations, or left main coronary artery (LMCA) disease.9 Restrictions on the maximum lesion length permitted in the TYPHOON study (30 mm) meant that the mean stented length was 22.1 and 20.3 mm for SES and BMS in TYPHOON, compared with the overall mean length of 32 mm in our patients. Part of the explanation may be that in our patients, the DES groups had longer and smaller diameter stents implanted than the BMS group; both of these features increase the relative risk of restenosis. Another reason for a lack of benefit with regards to repeat revascularization in our study is the very low TLR and TVR rates for our BMS patients: for example, the TLR rate in our BMS cohort was remarkably low at 6.0% after 3 years, compared with approximately 13% after 1 year in the meta-analysis by Kastrati et al.17 One potential explanation for this is that our patients did not undergo routine angiographic follow-up, which may partly explain the higher revascularization rates in some randomized trials: for example, the 1-year TVR rate of 13.4% in the BMS group of the TYPHOON study and 13.2% in the MISSION! Intervention study (both with routine angiographic follow-up) appears excessive when compared with our 3-year BMS TVR rate of 8.0% and the 1-year TLR rate of 7.8% found in the PASSION study, where patients did not undergo routine angiographic follow-up.6,8,9 Furthermore, ST-elevation MI is often the consequence of plaque rupture in the proximal segments of coronary arteries, hence the lumen tends to be larger and the absolute risk of restenosis is lower. The all-comer Basel Stent Kosten Effektivitäts Trial found that patients with vessel diameter 
3.0 mm derived no clinical benefit from DES as opposed to BMS implantation.35 Another possibility is that the balance between neointimal suppression and late acquired malapposition with DES may even out clinical event rates. Close inspection of the survival curves suggests that there might be late catch-up in repeat revascularization in the SES group.
Although current guidelines recommend 12 months of dual antiplatelet therapy after DES implantation, the duration of clopidogrel given to our patients was based on the protocols from the pivotal DES randomized-controlled trials2,4; therefore, initially patients treated with SES were routinely given 3 months clopidogrel, except for complex cases (bifurcations, multiple stents) who were given 6 months. All PES patients were routinely given 6 months. Although the multivariable analysis adjusted for the recommended duration of clopidogrel, it is possible that the differences in dual antiplatelet therapy may have affected the results due to the shorter duration given to the SES group.
In summary, DES are not associated with increased overall 3-year adverse events when used for PPCI. However, given the cost difference compared with BMS, our results do not support the use of PES in patients with STEMI as these stents confer no clinical benefit over BMS. SES, however, are associated with a trend toward improved mortality compared with PES and BMS, although this did not reach statistical significance. Very late stent thrombosis only occurred in the DES cohorts, and ongoing follow-up is required to assess this continued risk.
Appropriately powered randomized trials with an "all-comer" design, hard clinical end points, and long-term follow-up are required to further assess the role of DES in the treatment of patients with STEMI. Routine intravascular ultrasound after stent implantation coupled with angiographic and intravascular ultrasound follow-up, which although increasing the rate of repeat revascularization due to the oculostenotic reflex, may nevertheless shed some light onto the mechanistic reasons why PES do not appear to reduce adverse clinical events in these patients.
Limitations
The patients included in the study are all from a single institution and were not randomized. Nevertheless, these unselected patients represent real-world practice, whereas patients enrolled in clinical trials are carefully selected. Furthermore, although there are significant differences between the historical cohorts, the use of single stent types at any one time period eliminates some bias, for example, treating higher risk patients with DES. We have attempted to account for differences between the cohorts in terms of baseline demographics by using a propensity score, although we acknowledge that each statistical method has limitations and there is no consensus method for adjusting for these differences, and there may be other potential confounding features that we have not accounted for. Unfortunately, time to reperfusion, LV function, and data relating stent thrombosis to antiplatelet therapy are unavailable.
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Acknowledgments |
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We acknowledge the senior cardiologists involved in the PCI procedures: E. McFadden, MD, PhD; P.J. de Feyter, MD, PhD; P.P.T. de Jaegere, MD, PhD; S.H. Hofma, MD, PhD; E. Regar, MD, PhD; G. Sianos, MD, PhD; P.C. Smits, MD, PhD; M.J. van der Ent, MD, PhD; W.J. van der Giessen, MD, PhD; C.A. van Mieghem, MD. We also acknowledge the contribution of Dick Goedhart, PhD, for his statistical advice.
Disclosures
All authors have approved the final manuscript, which has not been published and is not under consideration elsewhere.
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CLINICAL PERSPECTIVE
Primary percutaneous coronary intervention (PPCI) is the optimal treatment for ST-elevation myocardial infarction. Randomized trials suggest equivalent safety and reduced repeat revascularization with drug-eluting stents (DES) when compared with bare metal stents (BMS) in this setting. However, long-term data on DES in PPCI is lacking. We therefore investigated the long-term outcomes of all patients undergoing PPCI with BMS and DES (n=1738) for a de novo lesion in our institution from 2000 to 2005. Patients from 3 sequential consecutive cohorts of BMS (n=531), sirolimus-eluting (SES, n=185), or paclitaxel-eluting stents (PES, n=1022) were included and followed for a median of 1185 days. There were no differences in all-cause mortality or repeat revascularization between DES and BMS, although there was a nonsignificant trend towards improved survival with SES compared with both BMS (propensity score-adjusted hazard ratios HR, 0.63; 95% CI, 0.33–1.18) and PES (HR, 0.71; 95% CI, 0.40–1.26). SES were associated with lower rates of composite major adverse cardiac events when compared with PES (HR, 0.62; 95% CI, 0.40–0.96). Very late stent thrombosis only occurred in the DES groups. In summary, we found that although DES were not associated with an increase in adverse events compared with BMS when used for PPCI, they did not reduce the need for repeat revascularizations, a finding which conflicts from previously reported studies. We conclude that appropriately powered randomized trials with hard clinical end points and an "all-comer" design are required to further assess the benefit of DES in PPCI.
Circ Cardiovasc Interv 2008 1: 87-89.
Circ Cardiovasc Interv 2008 1: 103-110.
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