CREST QOL Substudy: Early Advantage with Carotid Stenting Disappears Long-Term

Download this article's Factoid in PDF (& PPT for Gold Subscribers)


Patients who receive carotid artery stenting (CAS) have fewer physical limitations and less pain in the weeks after the procedure compared with those who undergo endarterectomy (CEA). But the health-related quality of life (QOL) differences diminish over time and are gone by 1 year, according to a prespecified substudy from the CREST trial published in the October 4, 2011, issue of the Journal of the American College of Cardiology.

For the main CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) report, 2,502 symptomatic and asymptomatic patients with significant carotid stenosis (≥ 50% on angiography) were randomized to CAS (n = 1,262) or CEA (n = 1,240). There was no difference between the treatment groups in rates of the primary composite endpoint of death, MI, or stroke. However, periprocedural stroke was more common with CAS, while periprocedural MI was more frequent with CEA.

For the current analysis, investigators led by David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart and Vascular Institute (Kansas City, MO), explored the recovery patterns of the 2 treatment groups, assessing QOL at baseline as well as at 2 weeks and 1 month after the procedure, and 1 year after randomization.

Early Differences Favor CAS

At baseline, overall health status scores on the Medical Outcomes Study Short-Form 36 (SF-36) were similar for the 2 arms. At 2 weeks, CAS patients had better scores for 5 of the 8 areas measured by the SF-36 questionnaire (all P ≤ 0.01), with physical role limitations showing the greatest difference between the groups. But by 1 month, only 3 of the 8 areas on the SF-36 favored the CAS group, and at1 year no differences between the treatment arms remained.

With regard to disease-specific measures, assessed by a different method, at 2 weeks CAS patients reported less difficulty eating/swallowing or driving and less impairment from headaches and neck pain than CEA patients. However, CAS patients reported greater difficulty walking and more leg pain. By 1-month follow-up, CAS patients continued to show advantages in eating/swallowing and impairment from headaches and neck pain but more limitations due to leg pain. By 1 year follow-up, all disease-specific differences had disappeared.  

Pain was measured on a scale of 0 to 10. Although the CAS and CEA groups started on a level playing field (mean 3.1 and 3.0, respectively), at 2 weeks, CAS patients reported lower pain scores than CEA patients (mean 2.9 vs. 3.1; P < 0.01). However, by 1 month this difference had disappeared and at 1 year the pain scores were identical (3.0). A similar pattern was seen in the need for pain medication.

Stroke, MI Have Different Long-term Effects

In addition, exploratory analyses estimated the impact of periprocedural events on health at 1 year. Patients who experienced a stroke reported worse health-related QOL scores on the SF-36 evaluation compared with those who did not have a stroke. In contrast, periprocedural MI was associated with worse general health perception at 1 year but no differences in any other health status domains. Cranial nerve palsy, a potential complication associated with surgery, did not appear to have a sustained impact on health-related QOL. 

According to the authors, these data show a “strong and consistent” impairment in health-related QOL among patients who suffered a periprocedural stroke but minimal or no long-term impairment in health status among those who experienced a periprocedural MI or cranial nerve palsy. This is not surprising, they say, since most studies have found persistent disability in 15% to 30% of patients who survive a stroke, whereas most MI patients, unless the infarct was large and associated with clinical heart failure or protracted recovery, have a health status comparable to the general population after recovery.

On the other hand, the lack of association between cranial nerve palsy and QOL was unexpected, the investigators say. However, they acknowledge, the effects of the nerve injury can be quite variable. Another possibility is that the SF-36 questionnaire may have been insensitive to the degree of disability caused by palsy in the CREST population.

Despite comparable 1-year QOL outcomes for the 2 procedures, “some patients may favor 1 or the other approach to carotid revascularization according to their individual values and preferences,” Dr. Cohen and colleagues observe. “Given the greater impact of stroke on late health status and the fact that stroke prevention is the principal indication for carotid revascularization, many patients may prefer CEA over CAS, because CEA minimizes the risk of such events. Conversely, patients at very low risk of periprocedural stroke (eg, younger, asymptomatic patients) may consider the more rapid recovery and lesser health status impairment during the first month after revascularization to be a compelling argument for CAS.”

Stroke Prevention Should Take Precedence

Christopher K. Zarins, MD, of Stanford University School of Medicine (Stanford, CA), put the emphasis squarely on stroke risk. “The CREST study has been portrayed as showing that [stenting and endarterectomy] are equal because of the [similarity of the] composite primary endpoint,” he told TCTMD in a telephone interview. But although composite endpoints are understandable from a trialist’s standpoint, they often obscure what is clinically relevant, he argued. And for procedures aimed at preventing stroke, the primary endpoint should center on stroke.

Moreover, for patients who need prophylactic intervention, the “number-one concern in deciding between stenting and surgery often is: Which of the 2 is better at preventing stroke?” Dr. Zarins said, adding that some go so far as to declare they would rather die from the procedure than live with a stroke.

According to all the data, it is clear that endarterectomy is superior in that regard, he indicated.

The CREST substudy further demonstrates that “stroke makes a difference a year later, whereas [surgery-associated complications] like neck pain, cranial nerve injury, and MI, while they may come into play periprocedurally, don’t make any difference a year later,” he said.

“You can argue about what a ‘disabling stroke’ is, but in this study it’s [defined by] the patient’s perception and quality of life,” Dr. Zarins added. “Even if the doctor classified a stroke as nondisabling, a year later the patient was still having a problem.”

Assessing the Therapy, not Just the Complication 

William A. Gray, MD, of Columbia University Medical Center (New York, NY), drew a decidedly different conclusion from the data. 

The main CREST study included estimates of the effect of stroke and MI on health status at 1 year, finding that major stroke had a substantial impact, minor stroke a much smaller impact, and MI smaller still, he observed. “At the time, people who had issues with carotid stenting said, ‘Well, there are more minor strokes with stenting, so it must not impart as good a quality of life.’ But [that inference] is not correct,” he commented, adding that this study helps clarify the issue because it evaluates patients’ health-related QOL based on the treatment received rather than the events experienced.

The current data, which are consistent with those from the earlier SAPPHIRE randomized trial, show that in the early phase the SF-36 indices favor stenting because it avoids an incision and the resulting physical limitations, although by 1 year these metrics are equalized, Dr. Gray said.

In CREST, rates of major stroke were similar between the therapies, with a few excess minor strokes in the stenting group and a few excess MIs in the endarterectomy group, he continued, adding that at 1 year, stroke had a greater impact on patients’ lives than MI. But, Dr. Gray stressed, “there were so few events in both of the arms that stenting did not drive the quality of life. The only thing that drove the quality of life was incisional pain.”

He agreed that the biggest issue for most patients is not to be disabled by stroke. “I tell them they have a roughly 1 in 100 chance of having a stroke with stenting compared with surgery,” Dr. Gray said. “Often it’s a minor stroke that resolves without affecting quality of life. On the other hand, with surgery they have a similar chance of having an MI, which [studies have shown] affects mortality [risk]. And in the short term, their quality of life will be [diminished].”

Another downside of surgery—not mentioned in this paper—is that access-site complications requiring an operation are 3 times more frequent than with stenting, Dr. Gray added.

“When you add it all up, stenting starts to look pretty good, especially in asymptomatic patients,” he concluded.

Resolving a Paradox 

In an accompanying editorial, Daniel B. Mark, MD, MPH, and colleagues of Duke University College of Medicine (Durham, NC), observe that “as the difference between treatments in rates of major morbid outcomes gets smaller and smaller, the importance of understanding the patient’s experience of the different treatments becomes greater.”

They acknowledge that at first glance, the 2 major findings—early QOL differences between the therapies disappear by 12 months but stroke has a greater 1-year impact than MI—might seem at odds, they write. “The resolution is found by focusing on the absolute number of excess perioperative strokes caused by stenting: 18 per 1,000. Even assuming that all 18 [are major] …, such a small number has an imperceptible effect on the population mean QOL values. Thus, our evaluation of the QOL data supports the view of the choice between stenting and CEA as a toss-up.”

This means that for the clinician there is no ‘wrong decision,’ the editorialists say. “In the end, patients need a balanced presentation of risks and benefits framed in a neutral way,” they conclude. “Knowledge of local experience (procedure volumes and complication rates) can be particularly helpful.”

 


Sources:
1. Cohen DJ, Stolker JM, Wang K, et al. Health-related quality of life after carotid stenting versus carotid endarterectomy. Results from CREST (Carotid Revascularization Endarterectomy versus Stenting Trial). J Am Coll Cardiol. 2011;58:1557-1565.

2. Mark DB, Patel MR, Anstrom KJ. Trade-offs and Toss-ups: Making revascularization decisions in carotid artery disease. J Am Coll Cardiol. 2011;58:1566-1568.

 

  • Dr. Cohen reports receiving research support and consulting and speaking fees from multiple device and pharmaceutical companies.
  • Drs. Mark and Zarins report no relevant conflicts of interest.
  • Dr. Gray reports having served as an investigator for CREST.

 

Related Stories:

CREST QOL Substudy: Early Advantage with Carotid Stenting Disappears Long-Term

Patients who receive carotid artery stenting (CAS) have fewer physical limitations and less pain in the weeks after the procedure compared with those who undergo endarterectomy (CEA). But the health related quality of life (QOL) differences diminish over time and
Disclosures
  • The study was supported by the National Institutes of Health with supplemental funding from Abbott Vascular Solutions.

Comments