Author + information
- Femi Philip, MD∗ ()
- ↵∗Cardiovascular Medicine, University of California, Davis, 4860 Y Street, Suite 2820, Sacramento, California 95817
We read with much interest the recent paper and editorial by Iida et al. (1) and Menard (2), respectively, in JACC: Cardiovascular Interventions assessing the mid-term outcomes after endovascular therapy in a prospective multicenter (A Prospective, Multi-Center, Three Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia [OLIVE]) registry in 314 patients with chronic limb ischemia (CLI). At 3 years, amputation-free survival, freedom from major adverse limb events, and wound-free survival rates were 55.2%, 84.0%, and 49.6%, respectively. Wound recurrence rate was at 3 years was 43.9%. After multivariable analysis, age (hazard ratio [HR]: 1.43, p = 0.001), body mass index 18.5 (HR: 2.17, p = 0.001), dialysis (HR: 2.91, p < 0.001), and Rutherford 6 (HR: 1.64, p = 0.047) were identified as predictors of 3-year major amputation or death. Statin use (HR: 0.28, p = 0.02), Rutherford 6 (HR: 2.40, p = 0.02), straight-line flow to the foot (HR: 0.27, p = 0.001), and heart failure (HR: 1.96, p = 0.04) were identified as 3-year major adverse limb event predictors. Finally, CLI due to isolated, below-the-knee lesion was a wound recurrence predictor (HR: 4.28, p = 0.001). Three-year survival, freedom from major amputation, and reintervention rates were 63.0%, 87.9%, and 43.2%, respectively.
The authors should be commended for writing this important and timely paper, especially as the research in CLI has reoriented towards optimizing long-term patient outcomes. Long-term patient outcomes beyond limb salvage are critical because large registry studies in peripheral artery disease have shown that suboptimal medical management increases the risk of cardiovascular death, stroke, and myocardial infarction by up to 7-fold at 3 years (3). In this regard, it is striking that in the OLIVE registry, despite a very high incidence of established vascular disease (100%) and cardiovascular disease (21% to 46%), only 26% are on statin therapy, 40% on clopidogrel, and/or 50% on cliostazol. Additionally, there are no data presented on whether the statin use or blood pressure control had been optimized and reached the targets set by the TransAtlantic Inter-Society Consensus (TASC) II guidelines (4). However, the authors should be congratulated for reporting on the degree of optimal medical therapy in their patient subset. In fact, most of the recent prospective studies have focused primarily on endovascular device use/techniques to optimize limb outcomes and have not quantified whether patients received guideline-based optimal medical therapy before or after endovascular intervention (1).
These observations suggest a persistent deficit in the quality of medical care in CLI and have profound implications. First, population-based interventions that improve medical therapy for CLI may have a large impact both on amputation-free survival and reducing the risk of cardiovascular mortality and myocardial infarction. Second, the addition of an optimal medical treatment metric in the assessment of endovascular and/or surgical interventions on CLI will allow for uniform comparisons between different treatment strategies. Furthermore, it is known that the costs of inpatient care in the year before amputation in patients with CLI is more than $20,000 per patient. This cost varies by 2-fold across hospital referral regions in the United States; much of this difference in cost is driven by the use of revascularization treatments and not related to patient or amputation care. Additionally, there is little evidence that higher spending on vascular care (primarily endovascular care) in the year prior lowers amputation rates. The quality of baseline medical therapy will be important in assessing and comparing the overall quality and cost of vascular care provided by institutions and individual providers (5). This is axiomatic in light of the environment in which medicine is practiced today with the creation of accountable care organizations and increasing patient/payer scrutiny.
Please note: The author has reported that he has no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
- Iida O.,
- Nakamura M.,
- Yamauchi Y.,
- et al.
- Menard M.T.
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- et al.