(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
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.).
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionReferences |
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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
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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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.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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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.
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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).
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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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.
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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.
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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.
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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.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Prior registries12 13 and several randomized trials11 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 studies1 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.
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Footnotes |
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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.
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References |
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K. F. von Tiehl, M. J. Price, R. Valencia, K. J. Ludington, P. S. Teirstein, and R. A. Simon Clopidogrel Desensitization After Drug-Eluting Stent Placement J. Am. Coll. Cardiol., November 20, 2007; 50(21): 2039 - 2043. [Abstract] [Full Text] [PDF]
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B. Doyle, C. S. Rihal, C. J. O'Sullivan, R. J. Lennon, H. J. Wiste, M. Bell, J. Bresnahan, and D. R. Holmes Jr Outcomes of Stent Thrombosis and Restenosis During Extended Follow-Up of Patients Treated With Bare-Metal Coronary Stents Circulation, November 20, 2007; 116(21): 2391 - 2398. [Abstract] [Full Text] [PDF]
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L. A. Fleisher, J. A. Beckman, K. A. Brown, H. Calkins, E. L. Chaikof, K. E. Fleischmann, W. K. Freeman, J. B. Froehlich, E. K. Kasper, J. R. Kersten, et al. ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) Circulation, October 23, 2007; 116(17): e418 - e500. [Full Text] [PDF]
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C. L. Grines, R. O. Bonow, D. E. Casey Jr, T. J. Gardner, P. B. Lockhart, D. J. Moliterno, P. O'Gara, and P. Whitlow Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: A Science Advisory From the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, With Representation From the American College of Physicians J. Am. Coll. Cardiol., February 13, 2007; 49(6): 734 - 739. [Abstract] [Full Text] [PDF]
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C. L. Grines, R. O. Bonow, D. E. Casey Jr, T. J. Gardner, P. B. Lockhart, D. J. Moliterno, P. O'Gara, and P. Whitlow Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: A Science Advisory From the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, With Representation From the American College of Physicians Circulation, February 13, 2007; 115(6): 813 - 818. [Abstract] [Full Text] [PDF]
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