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(Circulation. 2001;103:1967.)
© 2001 American Heart Association, Inc.

Clinical Investigation and Reports

Stent Thrombosis in the Modern Era

A Pooled Analysis of Multicenter Coronary Stent Clinical Trials

Donald E. Cutlip, MD; Donald S. Baim, MD; Kalon K. L. Ho, MD, MSc; Jeffrey J. Popma, MD; Alexandra J. Lansky, MD; David J. Cohen, MD; Joseph P. Carrozza, Jr, MD; Manish S. Chauhan, MD; Orlando Rodriguez, MD; Richard E. Kuntz, MD, MSc

From the University of Rochester Medical Center, Rochester, NY (D.E.C.); Beth Israel Deaconess Medical Center, Boston, Mass (D.E.C., K.K.L.H., D.J.C., J.P.C., M.S.C., O.R.); Brigham and Women’s Hospital, Boston, Mass (D.S.B., J.J.P., R.E.K.); and Cardiology Research Foundation, Lenox-Hill Hospital, New York, NY (A.J.L.).

	Abstract

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Background—There are limited studies of stent thrombosis in the modern era of second-generation stents, high-pressure deployment, and current antithrombotic regimens.

Methods and Results—Six recently completed coronary stent trials and associated nonrandomized registries that enrolled 6186 patients (6219 treated vessels) treated with 1 coronary stent followed by antiplatelet therapy with aspirin and ticlopidine were pooled for this analysis. Within 30 days, clinical stent thrombosis developed in 53 patients (0.9%). The variables most significantly associated with the probability of stent thrombosis were persistent dissection NHLBI grade B or higher after stenting (OR, 3.7; 95% CI, 1.9 to 7.7), total stent length (OR, 1.3; 95% CI, 1.2 to 1.5 per 10 mm), and final minimal lumen diameter within the stent (OR, 0.4; 95% CI, 0.2 to 0.7 per 1 mm). Stent thrombosis was documented by angiography in 45 patients (0.7%). Clinical consequences of angiographic stent thrombosis included 64.4% incidence of death or myocardial infarction at the time of stent thrombosis and 8.9% 6-month mortality.

Conclusions—Stent thrombosis occurred in <1.0% of patients undergoing stenting of native coronary artery lesions and receiving routine antiplatelet therapy with aspirin plus ticlopidine. Procedure-related variables of persistent dissection, total stent length, and final lumen diameter were significantly associated with the probability of stent thrombosis. Continued efforts to eliminate this complication are warranted given the serious clinical consequences.

Key Words: stents • thrombosis • myocardial infarction

	Introduction

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Randomized clinical trials have shown excellent acute angiographic results and significantly lower rates of angiographic and clinical restenosis for the Palmaz-Schatz stent compared with balloon angioplasty.^{1 2 3 4} These studies also showed a reduction in the previously alarmingly high rates of stent thrombosis from 20%^{5 6 7} to 3.5%, although this was achieved at the cost of aggressive anticoagulation with an associated high rate of bleeding complications.^{1 2} More recently, studies using either routine high-pressure postdilation stenting or intravascular ultrasound guidance and antiplatelet therapy with aspirin and ticlopidine have reported reduced rates of stent thrombosis of 0.5% to 1.9% without an associated increased bleeding risk.^{8 9 10 11 12 13 14 15}

Detailed analyses of stent thrombosis from studies using exclusive modern stenting techniques and antiplatelet therapy have been limited,^{12 13} and no data are available regarding the second-generation stents that now account for essentially all coronary stent procedures. The purpose of this study was to analyze the frequency, timing, clinical outcomes, and predictors of stent thrombosis in a pooled population of 6186 patients who received stents as part of 6 recently completed randomized trials and associated nonrandomized registries.

	Methods

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Study Design
From September 1995 to March 1999, 6 major clinical trials of coronary stenting were coordinated by the Cardiovascular Data Analysis Center (Boston, Mass) using similar inclusion criteria and study protocols (Table 1). Stent thrombosis was a prespecified end point for each study.

View this table: [in this window] [in a new window]   Table 1. Summary of Coronary Stent Trials Included in This Analysis

Study Patients and Stenting Protocol
All patients treated within the 6 clinical trials who received 1 coronary stent and who were treated with aspirin and ticlopidine after the stent procedure were eligible for this analysis. The protocol for each study included routine high-pressure (12 atm) postdilation. Aspirin 325 mg daily and ticlopidine 250 mg twice daily for 4 weeks was the standard postprocedure antithrombotic regimen. Use of glycoprotein IIb/IIIa inhibitors was discouraged in all of the studies; they were used at the discretion of the investigator in 7.6% of patients overall.

Clinical End Points and Definitions
Clinical stent thrombosis was defined as any of the following within 30 days of the procedure: angiographic documentation of stent occlusion, unexplained sudden death when the stent was not known to be patent, myocardial infarction, or urgent target lesion revascularization within 30 days of the procedure. Angiographic stent thrombosis required angiographic documentation of stent occlusion. Clinical end points included all-cause mortality and recurrent myocardial infarction. Myocardial infarction was defined as Q-wave myocardial infarction (development of new regional pathological Q waves as determined by the ECG core laboratory) or non–Q-wave myocardial infarction (defined as total creatine kinase >2 times or creatine kinase-MB >3 times the upper limit of normal). Coronary luminal dimensions were calculated as previously described.¹⁶ The Clinical End Points Committee adjudicated all events. Coronary dissections before and after stent placement were defined as types A through F with the NHLBI classification.

Statistical Analysis
Continuous variables were examined with Student’s t tests. Binary and polychotomous variables were examined with Fisher’s exact and ² tests. Survival estimates were computed by use of Kaplan-Meier methods and compared through log-rank tests. Predictors of clinical stent thrombosis were analyzed with multivariable logistic regression models.¹⁷ All statistical analyses were performed with SAS for Windows (version 6.12, SAS Institute).

	Results

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Comparison of Patients With and Without Stent Thrombosis
Overall, 53 patients (0.9%; 95% CI, 0.6 to 1.1) suffered clinical stent thrombosis. Comparisons of clinical and angiographic baseline characteristics between patients with and without clinical stent thrombosis are shown in Tables 2 and 3, respectively. Short-term procedural results are shown in Table 4.

View this table: [in this window] [in a new window]   Table 2. Baseline Clinical Characteristics

View this table: [in this window] [in a new window]   Table 3. Baseline Angiographic Findings

View this table: [in this window] [in a new window]   Table 4. Short-Term Procedural Data

Manifestations and Clinical Outcomes of Stent Thrombosis
Of the 53 clinical stent thrombosis events, 45 were confirmed by angiography. Most stent thrombosis events occurred within the first 2 days of the procedure (the Figure). Stent thrombosis events occurring >1 week after the stent procedure were rare, with only 2 of 53 clinical stent thrombosis events after day 8 and no angiographically documented stent thromboses after day 5.

View larger version (14K): [in this window] [in a new window]   Figure 1. Survival curves (Kaplan-Meier method) showing incidence of clinical stent thrombosis and angiographic stent thrombosis during 30-day follow-up.

Clinical outcomes at 30 days and 6 months are shown in Table 5. The 6-month mortality for either definition of stent thrombosis was significantly higher than the 1.2% observed in the overall pooled population.

View this table: [in this window] [in a new window]   Table 5. Timing and Clinical Outcomes After Stent Thrombosis

Multivariable Modeling and Predictors of Stent Thrombosis
Observed frequencies of clinical stent thrombosis and results of logistic regression models are shown in Table 6. Of note, unstable angina presentation (OR, 1.1; 95% CI, 0.6 to 1.9), discretionary use of glycoprotein IIb/IIIa inhibitors (OR, 1.4; 95% CI, 0.6 to 3.3), nonrandomized versus randomized status (OR, 1.6; 95% CI, 0.7 to 3.8), and specific stent type were not significantly associated with the probability of clinical stent thrombosis. Stenting for threatened or abrupt closure was a significant univariate predictor but was no longer significant after adjustment for stent length, final lumen diameter, and the presence of residual dissection. Only 2 (0.2%) of the 1281 vessels meeting criteria for an "optimal" stent developed stent thrombosis.

View this table: [in this window] [in a new window]   Table 6. Predictors of Clinical Stent Thrombosis

	Discussion

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Prior registries^{12 13} and several randomized trials^{11 14 15 18} have shown the dramatic reduction in stent thrombosis afforded by the use of aspirin and ticlopidine after successful high-pressure stent implantation. The large sample size of our study allows a reliable estimate of the true stent thrombosis risk and analysis of the factors that may influence this risk.

In addition to a marked reduction in the incidence of stent thrombosis, our results also show a significant impact on the timing of stent thrombosis compared with older studies using aggressive anticoagulation protocols. The median time to occurrence was 1 day with virtual elimination of events after day 2 compared with a median time to occurrence of 4 to 5 days and frequent events 2 to 3 weeks after stent implantation reported in earlier series.^{1 19 20 21 22} The observed lesser efficacy of ticlopidine in the first 2 days may reflect imperfect results that were "doomed to thrombose." The other explanation, however, which would be consistent with the known pharmacokinetics of ticlopidine, is that the lack of protection in this early period is due largely to its delayed onset of action.

Clinical consequences of stent thrombosis in the present series were dire. Angiographically documented stent thrombosis was associated with a mortality rate of 6.7% at 30 days and 8.9% at 6 months compared with a mortality rate of 1.0% at 6 months in patients who did not experience stent thrombosis. For clinically defined stent thrombosis events, the associated 6-month mortality was 20.8%. These findings are consistent with the disastrous consequences of stent thrombosis reported in early studies^{1 6 19 21 23 24} and are somewhat surprising because stent thrombosis events in our study patients were much more likely to occur while patients were still hospitalized. This is consistent, however, with a report by Hasdai et al²⁵ that showed poor clinical outcomes despite prompt restoration of blood flow after stent thrombosis. The recent registry reports by Moussa et al¹³ and Karrillon et al¹² with ticlopidine therapy and modern stent implantation techniques also reported high 30-day mortality rates of 26% and 24%, respectively.

The most significant predictors of stent thrombosis included persistent dissection NHLBI grade B or higher after stenting, longer stent length, and final minimal lumen diameter within the stent. Multiple stents and longer stents should be used then only when needed to cover significant extrastent stenosis or dissection rather than for convenience or purely cosmetic indications. The importance of obtaining a large postprocedural lumen in the prevention of acute thrombosis is also underscored.²⁶

Interestingly, stenting for threatened or abrupt closure and the presence of significant prestent dissections were not independent predictors of stent thrombosis in this series. This is contrary to several other studies.^{12 24 27} It should be noted, however, that earlier experience with stenting for abrupt or threatened closure may have included a higher frequency of true "bailout" indications than in the present series. The absence of unstable angina as a risk factor is also somewhat surprising and may reflect the exclusion of patients with suspected acute myocardial infarction or angiographic evidence of thrombus from the clinical trials that were pooled for this analysis or represent an extension of the protective benefits of aspirin and ticlopidine to this subgroup of patients. Finally, low ejection fraction, which has been reported to be a risk factor in other studies,¹³ may not have been significant in our study largely because patients with markedly reduced ejection fraction were excluded from the trials included in this analysis. The low risk of stent thrombosis for patients with "optimal" stenting in our study may have implications for future outpatient stenting protocols.

Study Limitations
This pooled analysis has several limitations. First, because the data are pooled from several clinical trials, this analysis does not have the power of a single randomized trial using a random assignment of antithrombotic regimens and stent design. Second, the analysis is unavoidably limited to the antithrombotic regimens then in effect. The effect of pretreatment or shorter poststent courses of ticlopidine or newer oral antiplatelet agents such as clopidogrel cannot be determined. Likewise, the use of platelet IIb/IIIa inhibitors was too infrequent to determine the effect on the frequency of stent thrombosis. On the basis of the proven benefits of these agents to reduce acute ischemic complications after stenting,²⁸ such adjunctive treatment would seem reasonable, especially in patients having 1 of the risk factors for stent thrombosis identified in this study. Third, it cannot be excluded that clinical events adjudicated as clinical stent thrombosis were in fact due to other causes. Similarly, in the absence of complete 30-day angiographic follow-up, cases of silent stent thrombosis cannot be excluded. Finally, the conclusions drawn from the selected clinical trials may not be generalizable to the broader populations treated in daily practice. More specifically, conclusions from the multivariable model are limited to statistical associations within this sample. Causal assertions should not be made before the model is validated in a test sample.

	Footnotes

 
Reprint requests to Donald E. Cutlip, MD, Harvard Clinical Research Institute, 900 Commonwealth Ave, Boston, MA 02215.

Received November 14, 2000; revision received January 10, 2001; accepted January 19, 2001.

	References

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