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Acute Myocardial Infarction: Safety of Cardiac MR Imaging after Percutaneous Revascularization with Stents¹

¹ From the Cardiovascular Magnetic Resonance Center (M.R.P., T.S.E.A., M.D.E., R.M.J., R.J.K.) and Clinical Research Institute (M.R.P., D.E.K., E.F.H., L.K.S., M.H.S.), Duke University Medical Center, 2400 Pratt St, Durham, NC 27705. Received May 1, 2005; revision requested July 6; revision received July 27; accepted August 29; final version accepted November 4. M.R.P. supported in part by an American College of Cardiology/Merck Research Fellowship Award. T.S.E.A. supported in part by a Sarnoff Fellowship Award. R.M.J. supported in part by National Institutes of Health (NIH) grant R01-HL63268. R.J.K. supported in part by NIH grant R01-HL64726. Address correspondence to M.R.P. (e-mail: patel017{at}mc.duke.edu).

	ABSTRACT

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Purpose: To retrospectively determine the safety of cardiac magnetic resonance (MR) imaging performed early (<14 days) after coronary stent implantation in patients with acute myocardial infarction (AMI).

Materials and Methods: This HIPPA-compliant study was approved by the institutional review board; the informed consent requirement was waived. Consecutive patients with AMI who underwent cardiac MR imaging (study group) shortly after stent implantation (median, 3 days) were compared with control subjects who did not undergo MR imaging and were matched for clinical factors and angiographic extent of coronary disease. A 1.5-T MR imager was used to evaluate cine function, perfusion, and viability. Rates of death, nonfatal myocardial infarction, or revascularization 30 days and 6 months after stent implantation were compared with ² analysis.

Results: The study group consisted of 66 patients (median age, 56 years; 17 women) with 97 stents, 38 (39%) of which were drug eluting. The control group included 124 patients (median age, 58 years; 23% women) with 197 stents, 21 (10.7%) of which were drug eluting. There was no significant (P = .13) difference in the combined end point of death, nonfatal myocardial infarction, or revascularization between the study (2.0% [95% confidence interval: 0.0%, 4.5%]) and control (6.5% [95% confidence interval: 1.6%, 11.3%]) groups at 30-day follow-up. The event-free survival rate at 6-month follow-up was 91% in the study group and 83.7% in the control group (P = .18). Considering the end points separately, there was no difference in the event rate at 30-day or 6-month follow-up between groups. No adverse cardiovascular events occurred in patients with drug-eluting stents who underwent MR imaging.

Conclusion: Cardiac MR imaging performed shortly after AMI and percutaneous revascularization with bare metal or drug-eluting stents appears safe. The risk of adverse cardiovascular events is low and similar to that in patients who do not undergo MR imaging.

© RSNA, 2006

	INTRODUCTION

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Manufacturers' instructions for use of weakly ferromagnetic coronary stents advise that magnetic resonance (MR) imaging should not be performed sooner than 8 weeks after stent implantation. This recommendation is based on the concept that the risk of stent displacement is minimized if complete endothelialization has occurred at the site of stent implantation; endothelialization should occur by 8 weeks after stent placement (1–3). However, no data exist to support the notion that endothelialization prevents stent displacement or that stent movement can occur before endothelialization. Alternatively, studies with animal models involving a variety of commercially available coronary stents have demonstrated no evidence of displacement, distortion, or substantial warming of coronary stents with standard MR imaging protocols (4,5). Nevertheless, it is possible that minute motion or heating of coronary stents may predispose patients to early stent thrombosis, and there is little information regarding the safety of MR imaging performed shortly (<8 weeks) after stent implantation. Moreover, little information regarding safety has been obtained in patients with stents who undergo cardiac MR imaging, which includes application of high-energy pulse sequences such as steady-state free precession techniques; limited safety information has been obtained in patients with acute myocardial infarction (AMI) (6); and, to our knowledge, no safety information has been obtained in patients who have undergone drug-eluting stent implantation. These issues may be particularly relevant in patients with drug-eluting stents because endothelialization may be delayed in these patients (7,8).

Advances in cardiac MR imaging techniques have improved the ability of physicians to assess patients with AMI. In particular, delayed enhancement techniques allow precise delineation of the presence, location, and extent of necrotic regions in patients with AMI (9,10). These techniques, in combination with cine MR imaging, can also be used to predict reversible myocardial dysfunction in patients undergoing revascularization procedures (11). The use of cardiac MR imaging findings as a measure of infarction size and a surrogate for clinical outcomes in clinical trials has increased partly due to these advances and is balanced only by uncertainty regarding the safety of MR imaging shortly after coronary stent implantation. For these reasons, data concerning the safety of cardiac MR imaging shortly after stent placement in patients with AMI would be valuable for both clinical and research purposes. Thus, the purpose of our study was to retrospectively determine the safety of cardiac MR imaging performed shortly (<14 days) after coronary stent implantation in patients with AMI.

	MATERIALS AND METHODS

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Patients
Study group.—Consecutive patients with AMI who were referred for cardiac MR imaging between January 2002 and May 2004 and had undergone coronary stent implantation within the previous 14 days were identified. Patients with ST segment-elevation myocardial infarction and those with non–ST segment-elevation myocardial infarction were included. Baseline clinical variables (clinical characteristics, cardiac risk factors, and physical examination findings) and procedural characteristics were collected by independent personnel (E.F.H., L.K.S.) from the Duke cardiovascular data bank. This retrospective study was approved by the institutional review board and compliant with the Health Insurance Portability and Accountability Act; the informed consent requirement was waived.

Control group.—Patients with AMI who underwent coronary stent implantation between January 2001 and December 2002 but did not undergo cardiac MR imaging were identified by searching the Duke cardiovascular data bank. This data bank includes the demographic, procedural, and outcome data. The median time between stent placement and cardiac MR imaging was 3 days in the study group. Thus, to reduce bias associated with early deaths that may have occurred before patients were able to undergo cardiac MR imaging, only those patients who were alive 4 days after stent implantation were included in the control group. Control subjects were matched to patients in the MR imaging group for the following characteristics: age, sex, myocardial infarction type (ST segment-elevation myocardial infarction vs non–ST segment-elevation myocardial infarction), presence of diabetes, and extent of coronary artery disease (single-vessel vs multivessel disease).

Outcomes
Patients were followed up for death from any cause, nonfatal myocardial infarction, or repeat coronary revascularization. End point acquisition was obtained with mailed questionnaires, telephone interviews, and a search of the National Death Index. All deaths were reviewed by two independent reviewers from the Duke cardiovascular data bank. A Health Insurance Portability and Accountability Act release was obtained from patients, and hospital records were reviewed to determine the occurrence of myocardial infarction. Electrocardiographic findings and serum cardiac markers, as well as discharge summaries, were examined in this assessment. The rates of events were assessed 30 days and 6 months after admission for the index event.

Procedures
Cardiac MR imaging.—Cardiac MR imaging was performed with a 1.5-T Sonata (Siemens, Erlangen, Germany) imager and a phased-array coil. Cardiac MR imaging consisted of cine, perfusion, and viability examinations. Cine images were acquired in multiple short-axis planes (at 1-cm intervals throughout the entire left ventricle) and in two or three long-axis planes with a steady-state free precession sequence and a flip angle of 60°–70°. Perfusion imaging was performed with a gradient-recalled-echo sequence and a flip angle of 10°–15°. Viability images were acquired with both a single-shot inversion-recovery steady-state free precession sequence with a flip angle of 45° and a breath-hold segmented gradient-recalled-echo sequence with a flip angle of 20°. Prior to perfusion and viability imaging, the gadolinium-enhanced contrast agent gadoversetamide (OptiMARK; Mallinckrodt, St Louis, Mo) was administered intravenously via an antecubital vein (total dose, 0.15 mmol per kilogram of body weight). Patients were monitored with electrocardiography and closed-circuit video by a physician during every examination.

Cardiac catheterization.—Baseline characteristics are shown in Table 1. Cardiac catheterization and coronary angiography were performed with standard techniques, and data were retrospectively obtained from procedure reports. Stenotic lesions were graded subjectively by visual consensus of at least two experienced observers on an ordinal scale of 0%, 25%, 50%, 75%, 95%, or 100%. For patients with significant coronary artery disease (>50% stenosis), the disease extent was characterized as either single vessel or multivessel. Coronary stent implantation and type (either bare metal or drug-eluting stent) were at the discretion of the clinical team. Left ventricular ejection fraction was measured with planimetry on the left ventriculogram in all patients. All patients underwent aspirin and thienopyridine therapy for at least 4 weeks after stent placement.

Statistical Analysis
To test for differences in patient characteristics between the MR imaging and control groups, we used a Wilcoxon two-sample test for continuous variables and a ² test for categorical variables. Logistic regression models were examined to assess the association between patient characteristics, including whether patients underwent cardiac MR imaging, and clinical outcomes at 30-day follow-up for the composite end point, which included death, nonfatal myocardial infarction, or revascularization. Kaplan-Meier event-free survival curves were developed for both the MR imaging group and the control group at 6-month follow-up. The log-rank test was used to assess differences between the groups.

	RESULTS

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Baseline Characteristics
Cardiac MR imaging was performed in 66 patients with AMI; a total of 97 stents were implanted in this group (38 [39%] were drug-eluting stents). The median time MR imaging was performed was 3 days (25th percentile, 1 day; 75th percentile, 4 days) after stent implantation. The control group consisted of 124 patients with AMI who were alive 4 days after stent implantation; a total of 197 stents were implanted in this group (21 [10.7%] were drug-eluting stents). The prevalence of each of the cardiac risk factors (Table 2) was similar in the two groups. Furthermore, there were no significant differences between the physical examination and laboratory findings at admission.

Cardiac Catheterization
Patients in the study group and those in the control group had a similar left ventricular ejection fraction (51% vs 52%, respectively; P > .99) and a similar rate of multivessel disease (41% vs 40%, respectively; P = .85) (Table 2). The average number of stents placed in patients in the study group was 1.5 (Fig 1), which was similar to the average number of stents placed in patients in the control group (1.6 stents, P = .18). The total length of stents per patient was also similar (23 mm in the study group vs 24 mm in the control group, P = .95). Drug-eluting stents were more prevalent in the MR imaging group (39% vs 10.7%, P < .001).

View larger version (162K): [in this window] [in a new window] [Download PPT slide]   Figure 1a: (a) Short- and (b) long-axis cardiac MR images obtained in a patient with a coronary stent. Note the stent in the proximal left anterior descending coronary artery (white arrow) and the areas of scar tissue from an anterior myocardial infarction (black arrow).

View larger version (163K): [in this window] [in a new window] [Download PPT slide]   Figure 1b: (a) Short- and (b) long-axis cardiac MR images obtained in a patient with a coronary stent. Note the stent in the proximal left anterior descending coronary artery (white arrow) and the areas of scar tissue from an anterior myocardial infarction (black arrow).

View larger version (9K): [in this window] [in a new window] [Download PPT slide]   Figure 2: Kaplan-Meier event-free estimates of death, revascularization, or nonfatal myocardial infarction.

	DISCUSSION

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These data add to the available literature pertaining to the safety of MR imaging in patients with coronary stents. Currently available stents are nonferromagnetic or weakly ferromagnetic, as defined by the absence of deflection or the presence of minimal deflection, respectively, from the vertical plane caused by the magnetic field (12,13). Manufacturers of nonferromagnetic stents (ie, cobalt-, nitinol-, tantalum-, or platinum-based stents) state in the package insert that these stents are safe for MR imaging (13,14). In current clinical practice, however, weakly ferromagnetic stents are implanted in the majority of patients, as demonstrated in this study. (Of the 97 implanted stents, 91 were weakly ferromagnetic.) Manufacturers of weakly ferromagnetic bare-metal stents generally state in the package insert that MR imaging should not be performed until complete endothelialization has occurred (8 weeks after stent implantation) to prevent migration (15,16). The two Food and Drug Administration–approved drug-eluting stents are also weakly ferromagnetic (316 low-carbon stainless steel).

For the pacliltaxel stent, the package insert states that the stent does not migrate in bench testing with a field strength of 3 T but that this product has not been evaluated for heating in the MR imaging environment (17). For the sirolimus stent, the manufacturer simply states that because of reduced neointimal formation associated with this stent, the period of vulnerability may be longer; however, there is currently insufficient information to provide a specific recommendation (18). Indeed, there are limited safety data for patients undergoing MR imaging early after coronary stent implantation.

We are aware of only two previous studies in which the safety of performing MR imaging less than 8 weeks after stent implantation was evaluated. The study by Gerber et al (19) involved 111 patients in whom MR imaging was performed a median of 18 days after stent implantation. In that study, low rates of adverse cardiac events due to stent thrombosis were observed at 30-day follow-up, and the researchers concluded that "postponing MR imaging does not appear to be necessary" (19). However, patients with AMI were not evaluated, patients who underwent cardiac MR imaging were not included, and there was no control group. In the other study, 13 patients underwent cardiac MR imaging an average of 3 days after coronary stent placement for treatment of AMI (6). For comparison purposes, 17 patients who did not undergo MR imaging also were examined. During the follow-up period, there was one instance of in-stent restenosis in the MR imaging group; this rate of restenosis was similar to that in the control group. However, since the study was performed in 2000, patients with drug-eluting stents were not included and cardiac MR imaging did not involve high-energy steady-state free precession cine sequences. We believe our study is the largest to date in which the safety of cardiac MR imaging was evaluated early after stent implantation in patients with AMI and the first in which patients with drug-eluting stents were evaluated.

The use of drug-eluting stents in clinical practice has been rapidly adopted and includes the use of these stents in patients with AMI. This is important because of the theoretical risk associated with delayed stent endothelialization. In fact, reports of subacute and delayed stent thrombosis with drug-eluting stents (20–22) have led to careful long-term evaluation of risks associated with drug-eluting stents and recommendations for prolonged thienopyridine therapy (7,8,23). In our study, there were no clinical events in any of the patients with drug-eluting stents who underwent MR imaging at either 30-day or 6-month follow-up.

These safety data have important clinical implications. The routine use of cardiac MR imaging in the acute and subacute settings continues to grow as the number of sites capable of performing cardiac MR imaging increases and the known applications of this modality expand. Presently, there are data that suggest that cardiac MR imaging may be an optimal technique for use in the evaluation of a number of important parameters in the acute or subacute setting, including the assessment of infarct size (9,10,24), microvascular obstruction (25), myocardial salvage (26,27), and postprocedural damage from percutaneous coronary interventions (27). More recently, cardiac MR imaging has also been used to assess the efficacy of new experimental therapies such as the intracoronary infusion of autologous bone marrow cells in patients after AMI (28,29).

A limitation of the current study was the fact that patients did not undergo routine angiography at 30-day follow-up to exclude subclinical stent thrombosis or restenosis. However, the incidence of subclinical stent thrombosis is rare, and the clinical importance of subclinical stent thrombosis is unknown. Furthermore, in our study, extending the clinical follow-up to 6 months allowed us to verify that there was no difference in adverse events between the groups. The sample size for the study limited our ability to generate adjusted comparisons. However, with our approach for case-control matching, we attempted to select patients with similar cardiac risk factors for comparisons. The patients in this study underwent cardiac MR imaging with a 1.5-T MR imager, and our findings cannot be extrapolated to MR imagers with higher field strengths, to stents made with materials different from those tested in the current study, or to all pulse sequences that may be used.

In summary, we found the rates of death, nonfatal myocardial infarction, or revascularization at both 30-day and 6-month follow-up to be similar between patients with AMI who underwent early cardiac MR imaging and patients with AMI who did not undergo MR imaging. We conclude that cardiac MR imaging performed shortly after AMI and implantation of either bare metal or drug-eluting stents appears to be safe for the stent types and pulse sequences we tested with a clinical imager and a 1.5-T field strength.

	ADVANCES IN KNOWLEDGE

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• Cardiac MR imaging performed early (<14 days) after an acute myocardial infarction has been treated with bare metal or drug-eluting stents appears to be safe.
  
• The risk of adverse cardiac events in patients who underwent cardiac MR imaging after stent implantation for treatment of an acute myocardial infarction was low and similar to the risk of adverse cardiac events in patients who did not undergo MR imaging.
  

	FOOTNOTES

 

Abbreviations: AMI = acute myocardial infarction

Authors stated no financial relationship to disclose.

Author contributions: Guarantors of integrity of entire study, M.R.P., R.J.K.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, M.R.P., R.M.J., R.J.K.; clinical studies, M.R.P., T.S.E.A., D.E.K., M.H.S., M.D.E., R.M.J., R.J.K.; statistical analysis, T.S.E.A., E.F.H., L.K.S., R.M.J.; and manuscript editing, M.R.P., T.S.E.A., D.E.K., L.K.S., M.H.S., M.D.E., R.M.J., R.J.K.

	References

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