Endovascular surges over surgery for patients hospitalized for CLI

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A promising future for CLI treatment?

Many of the unanswered questions regarding the optimal approach to CLI are being addressed by the National Heart, Lung, and Blood Institute–sponsored, multicenter, randomized BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial. The BEST-CLI trial will hopefully be completed in 2017. Until that time, clinicians will continue to rely on the best available data to guide revascularization strategies for the management of CLI.

Consistent with prior investigations, Dr. Agarwal et al. demonstrated a significant reduction in the proportion of patients undergoing surgical revascularization with a concomitant rise in endovascular revascularization during the same time period. This was accompanied by a steady decline in the incidence of in-hospital mortality and major amputation. Endovascular therapy was associated with a shorter mean length of stay and reduced hospital costs, despite a similar rate of in-hospital major amputation. As the authors correctly point out, the decreasing amputation and mortality rates cannot be directly attributable to a rise in endovascular therapy, as these studies cannot provide causal conclusions. Numerous other factors can influence mortality and amputation rates, including better medical care, aggressive risk factor modification, and appropriate wound care. Still, these associations are powerful and hypothesis generating, and they warrant further investigation.

Whether the improving CLI outcomes can be explained by the growth of these endovascular therapies is yet to be proved. We await the results of the landmark BEST-CLI trial to provide clarity regarding this issue and to further clarify the future role of surgical versus endovascular revascularization.

Dr. John R. Laird and Dr. Gagan D. Singh of the University of California, Davis Medical Center, Sacramento, and Dr. Ehrin J. Armstrong of the University of Colorado, Denver, made their comments in an invited editorial published online in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2016.02.041). Dr. Laird has served as a consultant or advisory board member for Bard Peripheral Vascular, Boston Scientific, Cordis, Medtronic, and Abbott Vascular; and has received research support from WL Gore. Dr. Armstrong has served as a consultant or advisory board member for Abbott Vascular, Boston Scientific, Medtronic, Merck, and Spectranetics. Dr. Singh reported that he has no relevant disclosures.




Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.

In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.

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The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].

Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.

A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).

Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).

Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.

Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.

In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.

“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.

The authors reported that they had no relevant disclosures.

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