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(Circulation. 2004;110:3411-3417.)
© 2004 American Heart Association, Inc.

Cardiovascular Surgery

Neuropsychological Outcome After Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting

Results From the Stent or Surgery (SoS) Trial

Peter Währborg, MD, PhD; Jean E. Booth, BSc, MSc; Tim Clayton, BSc, MSc; Fiona Nugara, BSc; John Pepper, MB, BChir, FRCS, MChir; William S. Weintraub, MD; Ulrich Sigwart, MD, FESC, FRCP; Rod H. Stables, MA, DM, FRCP, for the SoS Neuropsychology Substudy Investigators

From Sahlgrenska University Hospital, Gothenburg, Sweden (P.W.); Royal Brompton Hospital, London, UK (J.E.B., F.N., J.P.); London School of Hygiene and Tropical Medicine, London, UK (T.C.); Emory University School of Medicine, Atlanta, Ga (W.S.W.); University of Geneva, Geneva, Switzerland (U.S.); and Cardiothoracic Centre, Liverpool, UK (R.H.S.).

Correspondence to Peter Währborg, MD PhD, Department of Cardiology, Sahlgrenska University Hospital, S-413 45 Göteborg. Sweden. E-mail peter.wahrborg{at}hjl.gu.se

Received April 19, 2004; revision received September 1, 2004; accepted September 10, 2004.

	Abstract

Top Abstract Introduction Methods Results Discussion Appendix References

 
Background— Coronary artery bypass surgery (CABG) has been associated with a range of neurological and neuropsychological complications from stroke to cognitive problems such as memory and problem solving disturbance. However, little is known about the impact of percutaneous coronary intervention (PCI) on neuropsychological outcome.

Methods and Results— In the Stent or Surgery Trial (SoS), 988 patients were randomized in equal proportions between PCI supported by stent implantation and CABG. As a substudy of this trial, we undertook an evaluation of neurological and neuropsychological outcomes after intervention. A clinical examination and neuropsychological assessment consisting of 5 tests (Digit Span Forwards and Backwards, Visual Reproduction, Bourdon, and Block Design) were performed at baseline and 6 and 12 months after the procedure. A total of 145 patients were included in the substudy analysis: 77 in the PCI group and 68 in the CABG group. One patient in the PCI arm had a stroke. There was no significant difference between treatment groups at 6 and 12 months for any of the 5 tests. The mean change from baseline was also similar in both groups.

Conclusions— We were not able to demonstrate an important and significant difference in neuropsychological outcome in patients treated with different revascularization strategies. This important finding needs to be examined in further research.

Key Words: angioplasty • cognition • bypass, coronary artery • neuropsychology • stents

	Introduction

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The spectrum of neurological complications after coronary artery bypass surgery (CABG) ranges from stroke to cognitive problems such as memory and problem solving disturbance. The reported rate of stroke and reversible ischemic neurological deficits after CABG is low^1,2 but increases in the elderly.^3,4 Numerous studies have reported early deterioration in cognitive function after CABG^5–13 and at longer follow-up of 5 years.¹⁴ Cardiopulmonary bypass is thought to be a major contributor to cognitive decline.

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Percutaneous coronary intervention (PCI) is an alternative coronary revascularization therapy that avoids the need for bypass and should have little or no impact on cognitive function. A nonrandomized comparison of PCI with CABG reported that PCI is not associated with short-term cognitive decline.¹⁵ In the Bypass Angioplasty Revascularization Investigation (BARI), a comparison of cognitive function 5 years after randomization to PCI and CABG, the cognitive function was similar in both arms.¹⁶ In the Stent or Surgery Trial (SoS), patients were randomized to PCI with stent implantation or CABG procedure. As part of this trial, we performed a prospectively designed substudy to evaluate neuropsychological function in patients allocated to PCI or CABG.

	Methods

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In SoS, 988 patients were randomized to PCI supported by stent or CABG.¹⁷ The trial protocol has been published previously.¹⁸ Patients were eligible if they had multivessel coronary artery disease and if both the surgeon and interventionist accepted the patient for coronary revascularization. Equivalent revascularization was encouraged but not mandatory. Interventionists were permitted to use any commercially available stent. There were no protocol restrictions with regard to anesthesia, equipment, technique, or adjunctive medication schedules. Operators were required to perform procedures according to current local best practice. The trial was carried out in accordance with the Declaration of Helsinki and was approved by local ethics committee in each participating center. Patients gave their written informed consent to participate.

The prospectively designed neuropsychological substudy was performed at 11 centers in the United Kingdom (7), Germany (2), and Sweden (2). A list of centers and psychologists is presented in the Appendix. Consecutive patients randomized into SoS were eligible for inclusion in the substudy. Psychologists performed a neuropsychological evaluation at baseline and 6 and 12 months after the coronary revascularization procedure. The evaluation consisted of a clinical examination and a neuropsychological assessment.

The incidence of cerebrovascular accident was recorded and adjudicated by members of the clinical events committee. We recorded medications known to interfere with neuropsychological functions, including hypnotics, sedatives, neuroleptics, anxiolytics, antidepressants, and ß-blockers. The neuropsychological assessment was performed in accordance with the statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery.¹⁹ A series of 5 neuropsychological tests were administered: Digit Span Forwards and Backwards, Visual Reproduction, Bourdon, and Block Design. All of the tests have been reported to be sensitive to change after CABG.^20,21 Because the trial was multinational, verbal and language skills were not studied.

The digit span subtest of the Wechsler Adult Intelligence Scale–Revised (WAIS-R) and the Wechsler Memory Scale–Revised (WMS-R) were used to assess attention and short-term memory.^22,23 In the forward test, subjects are required to repeat a series of digits in the order that they were orally presented to the patient. In a second independent test, the patient is required to repeat the digits in reverse order (backward). The percentage of the maximum score possible is presented. A higher score indicates better attention and memory.

The Visual Reproduction I (immediate recall) from the WMS-R was used to test visual recognition and retention.²³ The patient looks at a geometric design and is then asked to draw it from memory. The drawings are scored for accuracy according to detailed criteria given in the test manual. The higher the score is, the better the visual reproduction and short-term memory are; the maximum possible score is 41.

The Bourdon letter cancellation test, from Cronholm and Molander, was used to assess sustained attention and vigilance and visuomotor skills.²⁴ In this test, the patient is presented with 35 rows of letters put together like words that are abstract or nonsense. In the nonsense words, 160 lower-case d’s are found. The task is to strike out all d’s with a pencil as fast and carefully as possible. The number of missed d’s is counted, with a low score indicating better attention and vigilance. The stanine scale is the standardized format of the Bourdon test. The raw points in the Bourdon test are transformed to this scale and are based on the normal (Gauss) distribution in the norm group: 1 (4%), 2 (7%), 3 (12%), 4 (17%), 5 (20%), 6 (17%), 7 (12%), 8 (7%), and 9 (4%). For the stanine, a higher score indicates better attention and vigilance.

The Block Design from the WAIS-R was used to examine visuospatial function.²² This test uses a set of 9 cards containing designs in red and white and a set of identical 1-in blocks with sides painted red, white, and red and white combined. The patient is shown one design at a time that he or she must reproduce by choosing and assembling the proper blocks. The score is based on the correct design and the time taken to complete the task. The maximum score is 51; a high score indicates a better visuospatial function.

Statistical Analysis
A sample size of 150 patients was chosen prospectively and provides 80% power to detect a difference 0.5 SD for each test score between patients treated with CABG and PCI. All patients with a baseline examination and at least 1 follow-up examination were included in the analysis to allow for adjustment of baseline score and to allow calculation of the individual change in score. All analyses were by intention to treat using standard methods. Correlations were performed for each test between baseline and 6 months and between baseline and 12 months. Treatment comparisons for each neuropsychological test at 6 and 12 months were based on mean differences adjusted for the baseline results with ANCOVA. To assess whether there were important changes from baseline, within-treatment differences were calculated, together with the corresponding SE for each test. In addition, for each neuropsychological test, the SD for both treatment groups was calculated from the baseline scores. The proportions of patients in each group that remained unchanged, improved, or worsened by >1 SD from baseline were calculated and compared by use of ² tests for trend. This method has been recommended to determine an individual clinical change in cognitive function.²⁵ Analyses were performed with standard statistical tests and Stata 7 software (Stat Corp).

Role of Funding Source
The study design, data management, data analysis, and reporting were independent of the funding organization.

	Results

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In the main study, a total of 500 patients were randomized to CABG and 488 to PCI. The clinical results have been published with a median follow-up of 2 years; all patients were followed up for at least 1 year.¹⁷ The rate of repeated revascularization was 21% in the PCI group compared with 6% in the CABG group (P<0.001). The incidence of death or Q-wave myocardial infarction was similar in patients treated with PCI and CABG (9% versus 10%, respectively; P=0.80). All-cause mortality was significantly lower in patients managed with CABG than in the PCI group (2% versus 5%, respectively; P=0.01).

The neuropsychological substudy profile is shown in the Figure. In the 11 participating centers, a total of 313 patients were randomized into the main study. Of these patients, 55 in the CABG group and 58 in the PCI group were not enrolled into the substudy because they were randomized before the start of the substudy or because recruitment for the substudy was completed. Another 33 patients in the CABG group and 14 in the PCI group were excluded. The reasons are shown in the Figure. The main reason related to problems with availability of the psychologist. We included 153 patients in the neuropsychological substudy: 83 from the PCI group and 70 from the CABG group. Of these, 8 patients who were alive at the end of the substudy had no follow-up evaluations and were excluded from analysis. Therefore, 145 patients (PCI, n=77; CABG, n=68) were included in the analysis and are reported. In the PCI group, follow-up evaluation was completed on 71 patients at 6 months and on 66 patients at 12 months. There were 4 deaths in the PCI group; 2 of the patients who died had no follow-up evaluation. One patient in the PCI arm suffered a stroke after the 6-month assessment but before the 12-month assessment. This patient completed all assessments. In the CABG group, follow-up evaluation was performed on 64 patients at 6 and 12 months. Thirteen patients in the PCI group and 8 patients in CABG group had only 1 follow-up evaluation.

View larger version (27K): [in this window] [in a new window]   Neuropsychological study profile.

Baseline characteristics are shown in Table 1. Although there are small differences in specific characteristics, these differences probably represent the play of chance because of the small numbers in each group. The mean age was 63 years, and there were slightly more men in the PCI group. The medications that may affect cognitive function are shown in Table 2. Recorded use is low in both groups, except for ß-blockers, which were used more in the PCI group compared with the CABG group at 6 months, although this difference is reduced by 12 months.

View this table: [in this window] [in a new window]   TABLE 1. Characteristics of Patients With Baseline and at Least 1 Follow-Up Assessment or Who Died Before the 6-Month Follow-Up

View this table: [in this window] [in a new window]   TABLE 2. Medications That Act on the Central Nervous System at Follow-Up by Treatment Group

Baseline results for the different cognitive tests, shown in Table 3, are similar between groups. Correlations for each test between baseline and 6 months ranged from 0.67 to 0.85 and between baseline and 12 months ranged from 0.64 to 0.80. In Table 4, the mean score and the change from baseline to 6 and 12 months are shown. A comparison of the difference in the mean scores at 6 and 12 months between the 2 treatment groups after adjustment for baseline is also shown, with a positive difference indicating a benefit of PCI. At 6 and 12 months, the magnitude of the mean change from baseline for each test is small and similar in both groups. The mean difference and 95% CIs are shown, and there is no significant difference between the 2 groups for any of the tests at 6 and 12 months. This is also the case after adjustment for ß-blocker use at follow-up.

View this table: [in this window] [in a new window]   TABLE 3. Neuropsychological Examination at Baseline by Treatment Group

View this table: [in this window] [in a new window]   TABLE 4. Neuropsychological Examination Change From Baseline to 6 and 12 Months

In Table 5, the proportion of patients whose results remain unchanged, improved, or worsened by 1 SD from the mean baseline values is shown at 6 and 12 months. Most patients remained unchanged by the above criteria. The proportion of patients who either improved or worsened by 1 SD was small and similar in both treatment groups. There was a tendency for more patients to improve their score for all tests except the Digit Span Forwards, in which a similarly low number of patients improved or worsened. No significant difference was found between the 2 groups.

View this table: [in this window] [in a new window]   TABLE 5. Neuropsychological Examination Differences at 6 and 12 Months of at Least 1 SD From Baseline

	Discussion

Top Abstract Introduction Methods Results Discussion Appendix References

 
CABG is associated with neuropsychological dysfunction in a proportion of patients after surgical procedure. We were not able to demonstrate a significant difference in neuropsychological outcome at 6 and 12 months in patients randomized to CABG or PCI with stent implantation. Few patients in each group showed a change of 1 SD, which is regarded as clinically significant. These findings were unexpected and are of particular interest because they are in contrast to other reports.

We are unable to exclude a difference in cognitive function between the 2 groups earlier than 6 months because this was the first time period at which we performed testing. In a conference report on neuropsychological evaluation after CABG, Murkin and colleagues¹⁹ recommend testing at 3 months after procedure because by this time the patient should have physically recovered and any cognitive impairment is likely to be permanent. A systematic review of 6 CABG studies with a control group with a total of 505 patients reported cognitive deterioration in 22% of patients at 2 months.²⁶ However, there is evidence to support reversibility of early cognitive dysfunction after CABG.²⁷ Surgeons and patients may be willing to accept a degree of cognitive dysfunction if it is transient over a few weeks.

Testing at 6 months allows the demonstration of problems that are likely to be irreversible. In a longitudinal study of 261 CABG patients, Newman and colleagues¹⁴ reported cognitive decline at 6 months and then 5 years. A decline in cognitive function was defined as a drop of 1 SD in scores of 1 of the 4 domains of cognitive function. At 6 months, 24% of patients had worsened, which was higher than reported in our study. At 5 years of follow-up, the cognitive dysfunction rate had almost doubled to 42%; however, it is not possible to exclude other causative factors besides CABG. This study is limited by the lack of a control group. The BARI trial had a design similar to that of SoS. The post hoc neurological assessment performed at 5 years of follow-up in 125 patients reported no difference in cognitive function.¹⁶ A limitation of this study was the lack of a baseline evaluation.

An important consideration is the sensitivity of the tests to detect a cognitive difference after revascularization. The battery of tests we used had all been reported to be valid and sensitive in CABG patients. However, we cannot discount a learning effect as demonstrated by the tendency for more patients to improve than to worsen for most of the tests. All neuropsychological tests may be subject to a learning effect, but a small effect is desirable because a large learning effect may mask deterioration in cognitive function.

The patients enrolled in the neuropsychological substudy may have been at low risk for poor neuropsychological outcome. Age has been reported to affect neuropsychological outcome in patients having cardiac surgery.²⁵ The mean age in our study was 63 years, which is similar to other studies assessing cognitive function after CABG and PCI.^14,16 We found no difference when adjustment for age was made. ß-Blockers have been suggested to have neuropsychological side effects²⁸ and have been shown to have a negative impact on perceptual motor functioning.²⁹ This is more noticeable in patients taking additional medication or in patients with neurological deficits.³⁰ We found that ß-blockers were prescribed more frequently in the PCI arm at follow-up, which is consistent with reports from other studies comparing PCI and CABG.³¹ However, when we adjusted for ß-blocker use, we found no difference in test results.

This study has some limitations. Our ability to detect a small significant difference in cognitive function between patients in the CABG and PCI group was limited by the relatively small sample size. The stroke rate at 1 year after PCI or CABG was low as expected, and we were underpowered to detect a meaningful difference between the treatment groups. We attempted to recruit consecutive patients enrolled in the main SoS study into the neuropsychological substudy. Forty-seven patients were not enrolled, most commonly because the psychologist was unavailable. Although the number of excluded patients is higher in the CABG group, this is probably a random effect resulting from the relatively small sample size. Eight patients recruited into the neuropsychology substudy were alive at the end of the substudy but did not undergo follow-up testing. In the CABG group, 1 patient moved to another country, and another patient refused follow-up. In the PCI group, 1 patient moved to another country, 2 patients were unwell, 1 patient refused, and 2 patients had scheduling problems with the psychologist.

In summary, we were not able to demonstrate an important and significant difference in neuropsychological outcome in patients treated with different revascularization strategies. This important finding needs to be examined in further research.

	Appendix

Top Abstract Introduction Methods Results Discussion Appendix References

 
Central Coordination and Data Management
Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London, UK: Jean Booth, Fiona Nugara, Pauline Dooley, Julian Collinson, Marrianne Stuteville, Nicola Delahunty, Andrew Wright, Marcus D. Flather, Matthew Forster.

Statistical Analysis
London School of Hygiene and Tropical Medicine, London, UK: Tim Clayton.

Participating Centers and Psychologists in the Substudy
Royal Brompton Hospital, UK: M. Puckey, F. Carrol, N. Hirsch; Cardiothoracic Centre, UK: C. Groom, C. Hallas, E.W. Thornton; Hull and East Yorkshire Cardiothoracic Centre, UK: G. Gibson; Kings’ College Hospital, UK: A. Rowe; St George’s Hospital, UK: R. Greenhalgh, M. Puckey, F. Carroll; University Hospital of Wales, UK: B. McLackland; Guy’s & St Thomas’ Hospital, UK: M. Puckey; Sahlgrenska University Hospital, Sweden: P. Währborg; Regionsjukhuset, Sweden: L. Ele; University Giessen, Germany: H. Kanwisher; University GHS Essen: V. Schmidkte.

	Acknowledgments

 
SoS was supported by funding from a consortium of stent manufacturers: Bard (now Medtronic), Guidant ACS, and Schneider (now Boston Scientific). The study design, data management analysis, and reporting were independent of the funding organizations.

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