Author + information
- Yoshitaka Kumada, MD, PhD,
- Hideki Ishii, MD, PhD∗ (, )
- Toru Aoyama, MD, PhD,
- Daisuke Kamoi, MD,
- Takashi Sakakibara, MD,
- Norio Umemoto, MD,
- Susumu Suzuki, MD,
- Hiroshi Takahashi, BSc and
- Toyoaki Murohara, MD, PhD
- ↵∗Department of Cardiovascular Surgery, Matsunami General Hospital, 185-1 Tashiro, Kasamatsu, Gifu 501-6062, Japan AND Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Although lower limb revascularization has been commonly performed to treat critical limb ischemia (CLI) in patients with chronic kidney disease, the clinical outcomes such as limb salvage or survival rate have been reportedly poorer compared with those without chronic kidney disease after both bypass surgery and endovascular therapy (EVT) (1,2). On the other hand, it remains unclear which procedure should be optimized to treat CLI. The BASIL (Bypass Versus Angioplasty in Severe Ischemia of the Leg) trial (3) revealed that the outcomes after 2 procedures were broadly similar in the general population. However, there have been limited data regarding such comparison in patients on hemodialysis (HD). We investigated long-term clinical outcomes after bypass surgery or EVT in HD patients with CLI due to infrainguinal disease.
Follow-up study of a retrospective chart review conducted among 566 consecutive HD patients with 613 limbs electively undergoing infrainguinal revascularization to treat CLI at Nagoya Kyoritsu Hospital (Nagoya, Japan) and Matsunami General Hospital (Kasamatsu, Japan). Of them, 234 patients with 248 limbs underwent bypass surgery, and 332 patients with 365 limbs underwent EVT based on the decision of which procedure to perform made primarily by each patient or their physicians. Patients were routinely followed up at discharge and 1, 3, and 6 months for 1 year, then at yearly intervals using duplex scans. We collected data on amputation-free survival defined as freedom from amputation above the ankle or any-cause death (4) and incidence of revascularization. Kaplan-Meier analysis with the log-rank test was performed to compare the outcomes after 2 procedures. To adjust the differences of the characteristics between the 2 groups, a propensity score analysis was also performed. The score was then incorporated into a Cox proportional hazards model as a covariate. The study protocol was approved by the institutional ethics committees.
Tissue loss and infrapopliteal disease were more frequently seen in the bypass group than in the EVT group (89.7% vs. 55.1%; p < 0.0001 and 57.3% vs. 27.1%; p < 0.0001, respectively). Serum C-reactive protein levels were also significantly higher in the bypass group (median 22.0 mg/l vs. 7.0 mg/l; p < 0.0001). During the follow-up period, 61 major amputations (10.6%) and 171 deaths (30.2%) occurred. The cumulative incidence rate of amputation or death at 5 and 8 years were 48.6% and 52.9% in the bypass group, and 52.9% and 64.2% in the EVT group, respectively (p = 0.30) (Figure 1A). The propensity score-adjusted hazard ratio was 1.14 (95% confidence interval 0.83 to 1.58; p = 0.41).
The cumulative incidence rate of mortality at 5 and 8 years were also 39.4% and 45.9% in the bypass group, and 49.1% and 61.4% in the EVT group, respectively (p = 0.64) (Figure 1B). The incidence rate of revascularization was lower in the bypass group than in the EVT group (18.1% vs. 47.7% at 5 years and 21.5% vs. 51.7% at 8 years; p < 0.0001).
In the study, the rates of amputation-free survival were broadly comparable between the 2 procedure groups in HD patients although bypass surgery had lower rates of any revascularization compared with EVT. These results were mostly similar to finding in general population previously reported (3). However, the 2 procedures were assigned in a nonrandomized manner in the present study, and there might be too many chances for bias in the data assignments. Hence, we conducted propensity score adjustment to minimize the characteristics differences, but there may still be residual confounding, especially in that the definition of CLI might potentially be misclassified because we only referenced Fontaine classification on the chart review. In addition, these results may only be generalizable in Japanese HD patients because they reportedly have a better prognosis, compared with those in the United States and Europe (5). Further validation and replication is needed.
Please note: Dr. Ishii has received lecture fees from Astellas Pharma, AstraZeneca, Daiichi-Sankyo Pharma, and MSD. Dr. Murohara has received lecture fees from Bayer Pharmaceutical, Daiichi-Sankyo, Dainippon Sumitomo Pharma, Kowa, MSD, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Novartis Pharma, Pfizer Japan, Sanofi, and Takeda Pharmaceutical; and unrestricted research grants for the Department of Cardiology, Nagoya University Graduate School of Medicine, from Astellas Pharma, Daiichi-Sankyo, Dainippon Sumitomo Pharma, Kowa, MSD, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Novartis Pharma, Otsuka Pharma, Pfizer Japan, Sanofi, Takeda Pharmaceutical, and Teijin Pharma. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation