EXPEDITED REVIEW
Early outcome after sirolimus-eluting stent implantation in patients with acute coronary syndromes
Insights from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry
Pedro A. Lemos, MD*,
Chi-hang Lee, MBBS, MRCP*,
Muzaffer Degertekin, MD*,
Francesco Saia, MD*,
Kengo Tanabe, MD*,
Chourmouzios A. Arampatzis, MD*,
Angela Hoye, MB ChB, MRCP*,
Marco van Duuren*,
Giorgios Sianos, MD*,
Pieter C. Smits, MD, PhD*,
Pim de Feyter, MD, PhD*,
Willem J. van der Giessen, MD, PhD*,
Ron T. van Domburg, PhD* and
Patrick W. Serruys, MD, PhD, FESC, FACC*,*
* Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
Manuscript received February 12, 2003;
revised manuscript received March 15, 2003,
accepted March 20, 2003.
* Reprint requests and correspondence: Prof. Patrick W. Serruys, Thoraxcenter, Bd 406, Dr. Molewaterplein 40, NL-3015 GD Rotterdam, Netherlands.
p.w.j.c.serruys{at}erasmusmc.nl
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Abstract
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OBJECTIVES: This study evaluated the early outcomes of patients with acute coronary syndromes (ACS) treated with sirolimus-eluting stents (SES).
BACKGROUND: The safety of SES implantation in patients with a high risk for early thrombotic complications is currently unknown.
METHODS: Sirolimus-eluting stents have been utilized as the device of choice for all percutaneous procedures in our institution, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. After four months of enrollment, 198 patients with ACS had been treated exclusively with SES (64% of those treated in the period) and were compared with a control group composed of 301 consecutive patients treated with bare stents in the same time period immediately before this study. The incidence of major adverse cardiac events (MACE) during the first month was evaluated (death, nonfatal myocardial infarction [MI], or re-intervention).
RESULTS: Compared with control patients, patients treated with SES had more primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01). The 30-day MACE rate was similar between both groups (SES 6.1% vs. control patients 6.6%; p = 0.8), with most complications occurring during the first week. Stent thrombosis occurred in 0.5% of SES patients and in 1.7% of control patients (p = 0.4). In multivariate analysis, SES utilization did not influence the incidence of MACE (odds ratio 1.0 [95% confidence interval: 0.4 to 2.2]; p = 0.97).
CONCLUSIONS: Sirolimus-eluting stent implantation for patients with ACS is safe, with early outcomes comparable with bare metal stents.
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Abbreviations and Acronyms
| | ACS | | acute coronary syndromes | | CI | | confidence interval | | MACE | | major adverse cardiac events | | MI | | myocardial infarction | | OR | | odds ratio | | RESEARCH | | Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital registry | | SES | | sirolimus-eluting stent | | TIMI | | Thrombolysis In Myocardial Infarction |
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Percutaneous intervention has been increasingly demonstrated to reduce the risk of adverse events in patients with acute coronary syndromes (ACS) (1,2). Several technical and medical advancements have contributed to improve the results of angioplasty in this population. However, patients with acute coronary disease still present a higher risk for early events than chronic stable patients, possibly owing to an increased propensity for thrombotic complications in the first days after the intervention (3–5).
Sirolimus-eluting stent (SES) implantation has been demonstrated to virtually abolish in-stent restenosis in elective patients with relatively simple lesions (6,7). Notably, the reduction of in-stent restenosis with SES was achieved without compromising the high acute success rates currently accomplished with bare stents. However, the impact of SES in unselected complex cases is presently not known. Sirolimus has been reported to decrease endothelial function in vitro (8) and to affect platelet physiology (9–11). Moreover, impaired local vascular healing with delayed endothelization and late fibrin persistence has not been ruled out after SES implantation (12,13). Therefore, evaluation of the safety of SES in patients with increased risk for early thrombotic events is warranted.
The aim of this study was to investigate the impact of SES implantation on the occurrence of early adverse events (30 days) in a consecutive series of unselected patients with ACS enrolled in the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry.
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Methods
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The RESEARCH registry.
The SES (Cypher; Johnson & Johnson-Cordis unit, Cordis Europa NV, Roden, the Netherlands) received Conformité Européenne mark approval in April 2002, since then being commercially available for routine use in Europe. From April 16, 2002, it has been our policy to utilize the SES as the device of choice for every percutaneous coronary intervention performed in our institution, as part of the RESEARCH registry. The RESEARCH is a single-center registry conducted with the aim of evaluating the impact of SES implantation in the "real world" of interventional cardiology. All consecutive procedures were included, without any specific anatomical or clinical restriction. Additionally, a control group was formed by all patients treated with percutaneous interventions in the period immediately before this study. Therefore, the control and the RESEARCH groups are constituted by two sequential cohorts, primarily defined by the interventional strategy applied (conventional bare stent or SES implantation, respectively).
All procedures were performed according to standard interventional techniques except by the utilization of SES as the device of choice during the RESEARCH period (at the initiation of the RESEARCH registry, SES were available in diameters from 2.25 to 3.00 mm and lengths of 8, 18, and 33 mm). Glycoprotein IIb/IIIa inhibitors were given at the discretion of the operator.
The postprocedural antiplatelet regimen consisted of aspirin lifelong and clopidogrel 75 mg/day for one month (control group and patients treated with bare stent only) or three months (patients treated with SES). Prolonged clopidogrel prescription (six months) was recommended for patients treated with SES and at least one of the following characteristics: multiple SES (>3 stents), total stented length >36 mm, chronic total occlusion, bifurcations, and in-stent restenosis.
During the RESEARCH period, according to the actual SES utilization, three subgroups were a priori expected: 1) patients treated only with SES; 2) patients in whom both a SES and a non-SES device were utilized at the index procedure; and 3) patients treated without implantation of any SES. The specific reasons for nonutilization of SES were registered on a lesion-per-lesion basis.
The RESEARCH registry was designed with the primary objective of evaluating the effectiveness of SES implantation compared with the control population. Effectiveness in both groups was measured by the survival time during which patients remain free of major adverse cardiac events (MACE) after one year of follow-up. Additionally, the following secondary objectives have also been predefined: 1) short-term (30-day) safety in patients with ACS; 2) survival free of MACE at six-month follow-up; 3) cost-effectiveness analysis at six months and one year; 4) anginal status and medication usage at six months and one year; and 5) quality of life and work status at six months and one year.
In the present study, we report on the 30-day outcomes of patients with ACS treated with SES implantation compared with the control population. This study protocol was approved by the local ethics committee and is in accordance with the principles of Good Clinical Practice for Trials of Medicinal Products in the European Community and the Declaration of Helsinki. Written, informed consent was given by every patient.
ACS substudy: patient population.
In the present report, we evaluated the 30-day outcomes of all 198 consecutive patients with unstable angina or acute myocardial infarction (MI) treated exclusively with SES during the first four months of the RESEARCH registry (from April 16, 2002 to August 15, 2002). This group represents 64% of all procedures performed in patients with ACS in the period (n = 311 patients). Patients receiving both bare stents and SES in the same procedure (32 patients; 10%) and those treated without SES implantation (81 patients; 26%) were not included in the present analysis. Among patients not included, nonutilization of SES was due to unavailability of an appropriate SES size (diameter or length) in 73% of cases, inclusion in another study in 5%, and impossibility to cross the lesion with the SES in 1%. In the remaining 21% of cases, SES was not utilized owing to a variety conditions related to the operator’s personal choice or other "medical/technical issues" (for instance, balloon dilation instead of stent implantation in a small coronary branch, mechanical thrombectomy without stent implantation for vessels with a high thrombotic burden, or heparin-coated stents owing to contraindication for antiplatelet therapy). A control group was comprised of 301 consecutive patients with ACS treated with bare stent implantation during the last four months (from December 16, 2001 to April 15, 2002) before the initiation of the RESEARCH registry (94% of all patients treated in the period). Patients with unstable angina were categorized according to the Braunwald classification (14). Procedures performed in the first 24 h of an acute MI were classified as rescue or primary angioplasty, if preceded or not by (failed) intravenous thrombolysis, respectively. Patients treated after 24 h but before discharge of an episode of MI were classified as post-MI unstable angina (Braunwald class C).
End point definitions and follow-up.
Major adverse cardiac events were defined as: 1) death; 2) nonfatal MI; or 3) repeat target lesion revascularization or target vessel revascularization. A definite diagnosis of MI required an increase in the creatine kinase level to more than twice the upper normal limit with an increased level of creatine kinase-MB (7). Target lesion revascularization was defined as any surgical or percutaneous re-intervention motivated by a significant luminal narrowing within the stent or in the 5-mm distal or proximal peristent segments. Target vessel revascularization was defined as any re-intervention driven by lesions located in the treated vessel even beyond the target lesion limits. Additionally, we analyzed the incidence of stent thrombosis, defined as any angiographically documented thrombotic occlusion (Thrombolysis In Myocardial Infarction [TIMI] flow grade 0 or 1) or flow-limiting thrombus (TIMI flow grade 1 or 2) occurring after the procedure (after removal of the guiding catheter) in an artery treated with angiographic success (TIMI flow grade 3 immediately after stent placement and percent in-lesion diameter stenosis  30%).
All procedures were performed in a tertiary cardiology center. As ruled by the local medical system organization, the majority of hospitalized patients treated in this tertiary facility were referred from other peripheral hospitals, to which they were discharged shortly after the procedure unless a periprocedural complication occurred and/or specialized surveillance was required. In total, patients have been referred from a group of 14 local hospitals. Postprocedure medical care was performed at the discretion of the site of origin. Cardiac enzymes were measured serially after the procedure for all in-hospital patients maintained in our hospital. In most of the peripheral hospitals, cardiac markers were not collected routinely, unless a postprocedure MI was suspected. For elective outpatient cases, it has been our practice to discharge the patients after a mean period of observation of 3 ± 1 h (unpublished data), provided no postprocedural complications had occurred (access site hemostasis was routinely performed with a femoral closure device whenever possible). As a result of these policies for in- and outpatient cases, serial cardiac markers were not available only for patients in whom the likelihood of postprocedure MI was judged to be low. Such policy has been supported by evidence from studies with large population cohorts showing that minor asymptomatic enzymatic elevation has no impact on either short- or long-term prognosis (15,16) and, therefore, is highly unlikely to influence the postprocedural medical conduct.
In-hospital outcome information was obtained by means of an electronic clinical database for patients maintained in our hospital after the procedure and by review of the hospital records for those discharged to secondary hospitals. During the follow-up, recordings of all repeat interventions (surgical and percutaneous) and re-hospitalizations were prospectively collected in a dedicated database. Long-term survival status was assessed by written inquiries to the Municipal Civil Registries at 30 days, 6 months, and 1 year after the procedures. Questionnaires were sent at six months and one year to all living patients with information regarding postdischarge anginal status, medication usage, and the occurrence of clinical events. Furthermore, a psychological questionnaire was sent and included forms with the Short Form-36 quality of life (17), the Hospital Anxiety and Depression Scale (18), and the Type D personality score (19). The referring physician and institutions as well as the general practitioners were directly approached whenever necessary for additional information. For patients who went abroad, an effort was made to contact the local civil registries of their new residencies. Patients lost to follow-up were considered at risk until the date of last contact, at which point they were censored.
Data management and statistical analysis.
All consecutive procedures were included in the control group and in the RESEARCH, utilizing a dynamic registry design as previously described by Rothman and Greenland (20). For each patient, the time until the first MACE was computed (person-time). Any eventual repeat percutaneous intervention acts then as a new index procedure, and the person-time contributes again to the cohort. Therefore, a patient can contribute to one, two, or more person-time. This design is of particular interest in a study like the RESEARCH, which intends to evaluate two consecutive cohorts treated with coronary angioplasty. If re-entry is not allowed, the second group (in the present case, treatment with SES) is consequently emptied from cases with treatment for restenotic lesions. This design, therefore, permits the inclusion of patients with in-stent restenosis in both study periods, allowing the evaluation of the impact of each particular re-intervention on the subsequent outcomes. In view of the small applicability of this concept (person-time analysis) for short-term evaluations, no calculations with person-time units were performed in the current ACS substudy.
Discrete variables were presented as percentages and compared with Fisher exact tests. Continuous variables were presented by their means and standard deviations and compared with Student t test or one-way analysis of variance. Cumulative survival and MACE-free survival were calculated according to the Kaplan-Meier method. The log-rank test was used to compare survival and MACE-free survival among the different groups. Multivariate independent predictors of 30-day outcomes were evaluated by logistic regression. All baseline and procedural characteristics presented in Table 1 were tested, and a final multivariate model was constructed by backward deletion of the least significant variables. All tests were two-tailed, and a p value of <0.05 was considered as significant.
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Table 1 Baseline and Procedural Characteristics of Patients Treated With Bare Stents Versus Patients Treated With Sirolimus-Eluting Stents
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Results
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Baseline and procedural characteristics.
Clinical and procedural characteristics of the 499 patients included in the present report are summarized in Table 1. As compared with the control patients, patients treated with SES had more frequently primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01) (Table 1). Also, peak creatine kinase-MB was lower for acute MI patients treated with SES (217 ± 236 U/l vs. 317 ± 256 U/l; p = 0.04) (Table 1). Procedural angiographic success was achieved in all attempted lesions in a similar proportion of cases in the SES and the control groups (96% vs. 97%, respectively, p = 0.48) (Table 1).
30-day outcome.
The 30-day outcomes of the SES and control groups are shown in Table 2. Complete follow-up information was available for all patients in the SES group and for all except one patient in the control group (99.7%). There were no differences in the incidence of adverse events between patients treated with bare stents and those treated with SES (30-day MACE rate 6.1% vs. 6.6%, respectively; p = 0.8 by log-rank test), with most complications occurring in the first week after the procedure (Fig. 1). Stent thrombosis occurred in one patient (0.5%) in the SES group and in five patients (1.7%) in the control group (p = 0.4) (Table 2). We performed a multivariate analysis to determine independent predictors of MACE at 30 days. Figure 2 shows the four significant predictors of 30-day MACE identified in the final model. The presence of multivessel disease (odds ratio [OR] 4.4 [95% confidence interval {CI}: 1.8 to 10.8]; p < 0.01), cardiogenic shock (OR 3.9 [95% CI: 1.2 to 12.8]; p = 0.02), and acute MI at presentation (OR 3.3 [95% CI: 1.4 to 7.6]; p < 0.01) were associated with an increased risk of MACE, while right coronary angioplasty (OR 0.4 [95% CI: 0.2 to 0.9]; p = 0.04) was related to a decrease in the odds of early adverse events. When forced into the model, SES utilization (OR 1.0 [95% CI: 0.4 to 2.2]; p = 0.97) did not predict the occurrence of adverse events, with virtually no influence on the predictive strength of the model (Fig. 3).
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Table 2 Incidence of Adverse Events at 30 Days in Patients Treated With Bare Stents Versus Patients Treated With Sirolimus-Eluting Stents
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Figure 1 Cumulative major adverse cardiac events (MACE) rate (death, nonfatal myocardial infarction, or re-intervention) during the first month for control patients (bare stent) and patients treated with sirolimus-eluting stents (SES). Note that >50% of events occurred during the first week in both groups.
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Figure 2 Multivariate independent predictors of 30-day major adverse cardiac events (MACE) rate (death, nonfatal myocardial infarction, and re-intervention) derived from the final logistic regression model. The odds ratios (OR) are shown on logarithmic scale together with their 95% confidence interval (CI).
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Figure 3 Comparison of the strength (chi-square values) for the prediction of 30-day major adverse cardiac events (MACE) rate (death, nonfatal myocardial infarction, and re-intervention) of multivariate models. Model 1 is the final model selected in the logistic regression analysis and included the variables displayed in Figure 2. The forced inclusion of sirolimus-eluting stent (SES) utilization (Model 2) did not enhance the predictive strength of the model, as reflected by the negligible change in the chi-square values.
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Discussion
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In this study, we analyze for the first time the impact of SES implantation on the early outcomes of patients with ACS. Compared with conventional bare stents, utilization of SES in unselected patients with acute MI or unstable angina was observed to be safe at 30 days, with similar rates of procedural success and early adverse events.
Patients treated with SES differed in some aspects from patients in the control group. Control patients presented more rescue angioplasty for failed thrombolysis (instead of primary angioplasty), which could have increased the risk of events in this group. Conversely, SES patients were more frequently treated for bifurcation lesions, a well-known risk factor for periprocedural complications (21,22). Moreover, glycoprotein IIb/IIIa inhibitors were less commonly used in patients treated with SES, which may have exposed these patients to a higher procedural risk (23). It seems unlikely that the lower utilization of glycoprotein IIb/IIIa blockers in this group could be explained by a lower risk profile perceived during the procedure because both the control and SES populations were equally composed predominantly of patients with acute MI or high-grade unstable angina, with no significant difference in their diabetic status. Nevertheless, after adjusting for baseline and procedural differences, the type of stent used, either bare or SES, was not significantly associated with the occurrence of early adverse events.
Recently, sirolimus has been reported to reduce endothelium-dependent relaxation in vitro in a porcine model, although the authors did not rule out an effect of the drug vehicle (8). Additionally, sirolimus has been reported to increase platelet aggregation and secretion in transplant recipients (11). However, recent studies have demonstrated that this drug efficiently blocks the synthesis of Bcl-3, a regulatory protein expressed when platelets adhere to collagen via integrin  IIbß3 (9,10,24). Regardless of these contradictory laboratory findings, SES was not associated with clinically relevant device-related complications in our series, with no modification of the risk profile for procedural failure or event occurrence.
Patients treated with SES presented a similar timing of postprocedural complications compared with control patients, with most events occurring in the first days after the procedure, a typical pattern previously reported after bare stent implantation (4,5). In this context, a relatively delayed hazardous effect of the drug leading to an increase in "late" thrombotic complications after the first week was not observed in our patients.
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Study limitations
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The present investigation suffers from the inherent limitations of a nonrandomized trial, which explains some unbalance in the baseline characteristics among the treatment groups. However, the study population is representative of the "real world" of interventional cardiology, with findings more readily applicable to daily clinical practice. Postprocedure cardiac markers were not collected routinely for all patients (available for 42% of control patients and 46% of patients in the SES subgroup [p = NS]). This was justified by the fact that high-grade enzymatic elevations, those with proven prognostic impact (15,16), rarely occur "unnoticed" in asymptomatic patients. When comparing patients with and without postprocedure enzymes collected, the 30-day death rate was 7.1% versus 0% (p < 0.001) and the re-intervention rate was 4.7% versus 0% (p < 0.001), reflecting the low-risk nature of patients for whom cardiac markers were not measured. Similarly, the relatively low frequency of utilization of glycoprotein IIb/IIIa inhibitors in our study reflects the current practice of administration of these drugs in several countries worldwide (25). Risk stratification was based mainly on clinical characteristics. Although laboratorial tests are known to add important prognostic information, the validated Braunwald classification for unstable angina applied in the present study provides a powerful clinical tool for individual risk assessment (14).
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Conclusions
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Sirolimus-eluting stent implantation for patients with ACS was safe, with early outcomes comparable to conventional bare metal stents. Maintenance of the excellent short-term results already achieved with the current techniques is crucial for the validation of SES as a useful strategy in the treatment of complex cases, such as those commonly found in daily practice. Further evaluation in the context of randomized trials is warranted to confirm the results observed in the present study.
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S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al.
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A. T.L. Ong, P. W. Serruys, J. Aoki, A. Hoye, C. A.G. van Mieghem, G. A. Rodriguez-Granillo, M. Valgimigli, K. Sonnenschein, E. Regar, M. van der Ent, et al.
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R. T. van Domburg, P. A. Lemos, J. J.M. Takkenberg, T. K.K. Liu, L. A. van Herwerden, C. A. Arampatzis, P. C. Smits, J. Daemen, A. C. Venema, P. W. Serruys, et al.
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A. T.L. Ong, A. Hoye, J. Aoki, C. A.G. van Mieghem, G. A. Rodriguez Granillo, K. Sonnenschein, E. Regar, E. P. McFadden, G. Sianos, W. J. van der Giessen, et al.
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P. A. Lemos, N. Mercado, R. T. van Domburg, R. E. Kuntz, W. W. O'Neill, and P. W. Serruys
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R. Waksman, A. E. Ajani, A. D. Pichard, R. Torguson, E. Pinnow, D. Canos, L. F. Satler, K. M. Kent, P. Kuchulakanti, C. Pappas, et al.
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S. S. Pedersen, P. A. Lemos, P. R. van Vooren, T. K.K. Liu, J. Daemen, R. A.M. Erdman, P. C. Smits, P. W.J.C. Serruys, and R. T. van Domburg
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P W Serruys, P A Lemos, and B A van Hout
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P. A. Lemos, P. W. Serruys, R. T. van Domburg, F. Saia, C. A. Arampatzis, A. Hoye, M. Degertekin, K. Tanabe, J. Daemen, T. K.K. Liu, et al.
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F. Saia, P. A. Lemos, C.-H. Lee, C. A. Arampatzis, A. Hoye, M. Degertekin, K. Tanabe, G. Sianos, P. C. Smits, E. McFadden, et al.
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A. M. Taylor and C. A. McNamara
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S. B. Choi
CYPHER coronary stents and risk of thrombosis
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Do Sirolimus-Eluting Stents Also Benefit ACS Patients?
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P. A. Lemos, F. Saia, J. M.R. Ligthart, C. A. Arampatzis, G. Sianos, K. Tanabe, A. Hoye, M. Degertekin, J. Daemen, E. McFadden, et al.
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Circulation,
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[Abstract]
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Early Outcomes with Sirolimus-Eluting Stents
Journal Watch (General),
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P. A. Lemos, P. W. Serruys, and J. E. Sousa
Drug-Eluting Stents: Cost Versus Clinical Benefit
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Abstract
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