A multicenter phase II trial of preoperative chemoradiotherapy with S-1 plus oxaliplatin and bevacizumab for locally advanced rectal cancer.

BACKGROUND: We clarified the safety and efficacy of preoperative chemoradiotherapy for locally advanced rectal cancer using a multidrug regimen (S-1 + oxaliplatin + bevacizumab). METHODS: This multicenter phase II trial involved 47 patients with locally advanced rectal cancer. All patients received S-1 orally (80 mg/m2/day on days 1-5, 8-12, 15-19, and 22-26) and infusions of oxaliplatin (50 mg/m2 on days 1, 8, 15, and 22) and bevacizumab (5 mg/kg on days 1 and 15). The total radiation dose was 40 Gy delivered in daily fractions of 2 Gy via the four-field technique. The primary endpoint was the pathological complete response rate. The secondary endpoints were safety (incidence of adverse events) and clinical response, relapse-free survival, overall survival, local recurrence, R0 resection, downstaging, and treatment completion rates. RESULTS: All 47 patients received chemoradiotherapy, and 44 patients underwent curative resection. Two patients refused surgery and selected a watch-and-wait strategy. The pathological complete response rate was 18.2% in patients who underwent curative resection. The clinical response rate was 91.3% in 46 patients. Concerning hematotoxicity, there was one grade 4 adverse event (2.1%) and seven grade 3 events (14.9%). Diarrhea was the most frequent non-hematotoxic event, and the grade 3 event rate was 25.5%. CONCLUSIONS: Although preoperative chemoradiotherapy for patients with locally advanced rectal cancer using the S-1 + oxaliplatin + bevacizumab regimen did not achieve the expected pathological complete response rate, this regimen led to an improved clinical response rate.

Propensity score-matched study of laparoscopic and open surgery for colorectal cancer in rural hospitals.

BACKGROUND AND AIM: Various randomized clinical studies have suggested that short- and long-term outcomes of laparoscopic surgery (LAP) for colorectal cancer are comparable with those of open surgery (OP). However, these studies were performed in high-volume hospitals. The aim of the present study was to compare the outcomes of LAP versus OP for colorectal cancer in rural hospitals. METHODS: This was a multicenter retrospective propensity score-matched case-control study of patients who underwent colorectal surgery from January 2004 to April 2009 in 10 hospitals in Japan. All patients underwent curative surgery for pathologically diagnosed stage II or III colorectal cancer. The primary end point was 5-year overall survival (OS). The secondary end points were disease-free survival (DFS) and postoperative complications. RESULTS: In total, 319 patients who underwent LAP and 1020 patients who underwent OP were balanced to 261 pairs. There was no significant difference in the OS and DFS between two groups. The operation time was significantly shorter for OP than for LAP. Blood loss was significantly lower in LAP than in OP. There was no difference in intraoperative morbidity between the two groups. The postoperative morbidity was significantly lower in LAP than in OP. The hospital stay was significantly shorter in LAP than in OP. There was no significant difference in 90-day postoperative mortality. CONCLUSIONS: Laparoscopic surgery may be a feasible option for colorectal cancer in rural hospitals.

[Neuroendovascular Treatment for Cerebral Embolism in a Patient just after Aortic Valve Replacement；Report of a Case].

A 67-year-old woman suffered from severe aortic stenosis and atrial fibrillation, and underwent aortic valve replacement with a St. Jude Medical Regent 23-mm valve and pulmonary vein isolation using an AtriCure Isolator Synergy.At 6 days after the operation, she experienced sudden onset of atrial fibrillation, left side paralysis, and dysarthria. Right internal carotid artery embolism was diagnosed via magnetic resonance imaging, and we promptly performed neuroendovascular therapy with a Solitaire FR. Neuroendovascular treatment succeeded, and her neurological function was restored to near-normal. Her post-treatment course was uneventful, and she is currently well without neurological dysfunction.

Arterial location-specific calcification at the carotid artery and aortic arch for chronic kidney disease, diabetes mellitus, hypertension, and dyslipidemia.

Several risk factors for arterial calcification have been reported but controversial. The aim of this study was to clarify the interactions among chronic kidney disease (CKD), diabetes mellitus (DM), hypertension, and dyslipidemia in altering the risk of arterial calcification in the three different arterial locations and the intramural location at the internal carotid artery (ICA) origins. Calcified burdens at the ICA origins, the aortic arch, and its orifices were evaluated in a retrospective fashion by using computed tomography angiography in 397 patients. The multivariate analyses were adjusted for age, gender, CKD, DM, hypertension, dyslipidemia, and current smoking status. Additionally, subgroup analyses in each variable were conducted. Our multivariate logistic regression analyses revealed that CKD was significantly associated with the outside-wall calcification at the ICA origins, whereas DM was only associated with the inside-ICA-wall calcification. Additionally, we found that DM increased the association between CKD and arterial calcification at the aortic arch and its orifices, and the outside-wall at the ICA origins. Hypertension was significantly associated with the calcification at the orifices of the aortic arch branches synergistically with CKD. Dyslipidemia did not have any significant association with calcification in any of the three vascular beds. CKD had the highest prevalence risk of calcification in common with the three different vascular beds. CKD in combination with DM, as well as hypertension in combination with CKD, were key relationships affecting the risk of arterial calcification, especially at the aortic arch and its orifices.

Effect of Twist and Bmi1 on intraductal papillary mucinous neoplasm of the pancreas.

BACKGROUND: Intraductal papillary mucinous neoplasm (IPMN) is a well-established entity among pancreatic neoplasms that ranges from low-grade dysplasia to invasive carcinoma. Epithelial-mesenchymal transition (EMT) contributes to tumor progression in various cancers. Moreover, Notch signaling is one of the important upstream effectors of EMT promotion. Currently, it is unclear whether EMT causes pathological progression of IPMN. AIM: We evaluated the expression of EMT-promoting transcription factors Twist and B cell-specific Moloney murine leukemia virus insertion site 1 (Bmi1) in IPMN. METHODS: Patients who underwent resections at our institute and its affiliated hospital were enrolled in this study (n = 35). Protein expression of EMT markers Twist, Bmi1, Jagged1, and E-cadherin in resected specimens was investigated by immunohistochemistry. Expression of these proteins was compared with the clinicopathological factors and patient survival. RESULTS: Positive expression of Twist and Bmi1 was observed in 40.0% and 42.9% of IPMNs, respectively. Twist and Bmi1 expression was significantly higher in IPMNs with high-grade dysplasia (P < 0.05) and invasive carcinoma (P < 0.05) than that in IPMNs with low-grade dysplasia. High expression of Twist was correlated with Jagged1 expression and inversely correlated with expression of E-cadherin (P = 0.06 and P < 0.05, respectively). In survival analyses, the recurrence rate was significantly higher in the group that showed simultaneous high expression of Twist and Bmi1 (P < 0.05). CONCLUSIONS: Expression of Twist and Bmi1 is associated with aggressiveness and poor prognoses of IPMN through EMT promotion that might be induced by Notch signaling.

Clinicopathological characteristics of patients with non-B non-C hepatocellular carcinoma: a special reference to metabolic syndrome.

BACKGROUND/AIMS: This study was carried out to clarify the clinicopathological features of hepatocellular carcinoma (HCC) arising in patients without viral infection and to confirm the influence of metabolic syndrome (MS) on characteristics in HCC patients. METHODOLOGY: Two hundred and thirty-three hepatectomized HCC patients were enrolled. The status of the hepatitis viral infection was defined; non-B non-C (NBNC) (n = 15), negative for HBs-Ag, HBc-Ab or HCV-Ab; HBV (n = 70); HCV (n = 148). We compared clinicopathological features and surgical outcomes among three groups. Additionally, fifty-six HCC patients who were evaluated on coexistence of MS were divided into two groups and analyzed; MS (n = 16) and non-MS (n = 40) groups. RESULTS: In NBNC-patients, preoperative platelet counts and ICGR15 were significantly better compared to HCV-patients (21.8 x 10(4)/mm3 vs. 11.3 x 10(4)/mm3, 14.0% vs. 19.2%, p <0.05). Body mass index was significantly higher in NBNC-patients (24.9 vs. 22.4, p < 0.05). Overall survival rates were significantly higher in NBNC-patients compared with HBV or HCV-patients (5 y: 87.5% vs. 48.8%, 42.9%, p < 0.05). For NBNC-patients there were significantly more patients in the MS group than in the non-MS group. CONCLUSIONS: HCC with MS included more NBNC-HCC than HBV or HCV related HCC. Aggressive hepatectomy contributed to the favorable outcome in NBNC-patients because of their better liver function.

Role of CD44 expression in non-tumor tissue on intrahepatic recurrence of hepatocellular carcinoma.

BACKGROUND: CD44 is well known to be one of the cancer stem cell markers and is a cell-surface glycoprotein involved in cell-cell interactions, cell adhesion, and cell migration. We investigated the role of CD44 expression in both tumor and non-tumor tissues on recurrence of hepatocellular carcinoma (HCC). METHODS: Forty-eight patients with HCC who underwent hepatic resection at our institution were enrolled in this study. CD44 expressions in both tumor and non-tumor tissues were examined using real time reverse transcription-polymerase chain reaction. The patients were divided into two groups: high and low gene-expression group, based on the CD44 expression level. We compared the clinicopathological factors between the high expression and low expression groups in both tumor and non-tumor tissues. RESULTS: In the tumor tissues, the gene-expression levels of CD44 did not correlate with any clinicopathological parameters. The disease-free survival rate showed no significant difference between the two groups. In non-tumor tissues, although there was no significant relationship between the CD44 expression levels and clinicopathological factors, disease-free survival rate in the CD44 low expression group was significantly better than that in the CD44 high expression group (P < 0.05). In multivariate analysis, the risk factors in tumor recurrence were presence of microscopic portal invasion and high expression level of CD44. CONCLUSION: The CD44 expressions in the non-tumor tissues may predict HCC recurrence.

The beneficial effects of Kampo medicine Dai-ken-chu-to after hepatic resection: a prospective randomized control study.

BACKGROUND/AIMS: After hepatic resection, delayed flatus and impaired bowel movement often cause problematic postoperative ileus. Kampo medicine, Dai-kenchu-to (DKT), is reported to have a various beneficial effects on bowel systems. The aim of this study was to prospectively evaluate effects of DKT after hepatic resection. METHODOLOGY: Thirty-two patients who underwent hepatic resection between July 2007 and August 2008 in Tokushima University Hospital were prospectively divided into DKT group (n=16) and control group (n=16). In DKT group, 2.5 g of DKT was administered orally three times a day from postoperative day (POD) 1. Blood was examined on POD 1, 3, 5 and 7. Postoperative first flatus, bowel movement and full recovery of oral intake, hospital stays and complications were checked. RESULTS: In DKT group, levels of c-reactive protein and beta-(1-3)-D-glucan on POD 3 were significantly decreased (p<0.05). Moreover, postoperative periods for the first flatus, bowel movement and the full recovery of oral intake were significantly shortened in DKT group (p<0.05). CONCLUSIONS: DKT suppressed inflammatory reaction, stimulated bowel movement and improved oral intake after hepatic resection, which may decrease serious morbidity after hepatic resection.

The impact of pegylated-interferon α-2b on partial and massive hepatectomy model in rats.

BACKGROUND/AIMS: The impact of pegylated-interferon (PEG-IFN) α-2b on liver regeneration has not yet been elucidated. METHODOLOGY: Rats were divided into the following four groups: 70% hepatectomy (Hx); 70% Hx+PEG-IFN; 90% Hx and 90% Hx+PEG-IFN group (n=6 each). Rats were pretreated with subcutaneous of PEGIFN α-2b (1.5 µg/kg) administration 24 hours before Hx. Samples were taken 24, 48 and 72 hours after Hx and the following parameters were investigated: blood analysis (AST, WBC, PLT); liver weight to body weight ratio (Lw/Bw ratio); survival and PCNA labeling index (LI). RESULTS: In the 90% Hx model, there was no significant difference between the Hx+PEG-IFN group and the Hx alone group in blood analysis; AST after postoperative 24 hours (2511 vs. 2466 IU/L), WBC (1200 vs. 1290) and PLT (107 vs. 111 x 104/mm³), in Lw/Bw ratio at postoperative 0, 24, 48, 72 hours, respectively (0.38, 0.60, 1.14, 1.69 vs. 0.37, 0.64, 1.12, 1.63), in postoperative survival (40% vs. 45%), and in PCNA LI at postoperative 0, 24, 48, 72 hours, respectively (10.4%, 16.8%, 14.6%, 12.8% vs. 10.0%, 17.1%, 15.6%, 13.7%). In the 70% Hx model, there was no significant difference between the Hx+PEG-IFN group and the Hx alone group for all parameters. CONCLUSIONS: Our data demonstrated that PEG-IFN α-2b did not affect liver regeneration and the early use of PEG-IFN α-2b would cause no problems after liver transplantation using partial grafts including living donor liver transplantation.

Role of thymidylate synthase and dihydropyrimidine dehydrogenase mRNA in intrahepatic cholangiocarcinoma.

PURPOSE: Thymidylate synthase (TS) and dihydropyrimidine dehydrogenase (DPD) are important enzymes in the metabolism of 5-fluorouracil and possible predictive markers. We conducted this study to clarify if TS and DPD gene expressions are a prognostic indicator for intrahepatic cholangiocarcinoma (IHCC). METHODS: The subjects of this study were 21 patients with IHCC who had undergone surgical resection. Intratumoral TS and DPD mRNA expressions were examined using the Danenberg tumor profile method and classified into two groups according to the median value of each. We then compared the clinicopathological variables, including prognosis, between the high and low expression groups. RESULTS: Low DPD expression was correlated with macroscopic type, namely, mass-forming + infiltrative (P = 0.08). Postoperative survival rates in the low DPD expression group were significantly lower than those in the high DPD expression group. Multivariate analysis revealed macroscopic type to be an independent prognostic factor, whereas TS mRNA expression did not correlate with any clinicopathological variables, including prognosis. CONCLUSIONS: Low DPD mRNA expression was related to macroscopic type and associated with poor prognosis. DPD mRNA expression in tumor cells is suggested to be an important regulator of malignant behavior in IHCC.

Clinical impact of lymph node dissection in surgery for peripheral-type intrahepatic cholangiocarcinoma.

PURPOSE: To investigate the prognostic factors of peripheral-type intrahepatic cholangiocarcinoma (PP-IHCC) and evaluate the surgical outcomes according to surgical strategy alterations. METHODS: Twenty-two patients were divided into two groups according to the surgical strategy: an extended surgery group (Ex group: n = 10), composed of those who underwent hepatic lobectomy combined with lymph node (LN) dissection and bile duct resection; and a customized surgery group (Cx group: n = 12), composed of those who underwent hepatectomy and bile duct resection according to tumor spread. LN dissection was not performed in patients without LN metastasis. RESULTS: Multivariate analysis revealed that R2 resection, LN metastasis, and intrahepatic metastasis were independent prognostic factors. LN dissection was significantly infrequent in the Cx group. Survival after curative resection was similar in the two groups (3-year survival: 42.9 vs. 57.1%). Liver metastasis was the most frequent primary recurrence, occurring in more than 80% of patients from both groups. CONCLUSIONS: Curative surgery might improve the prognosis of patients with PP-IHCC, but routine LN dissection is not recommended, particularly for patients without LN metastasis. Surgery alone, including LN dissection, cannot control this type of tumor, and additional treatment should be given.

A modified liver-hanging maneuver focusing on the ligamentum venosum for left hepatic lobectomy.

PURPOSE: The liver-hanging maneuver (LHM) is a useful technique in major hepatectomy. We made modifications to this technique with special reference to the ligamentum venosum for performing a left hepatectomy (LH). The aim of this study was to clarify the usefulness of our new technique. METHODS: Between August 2007 and May 2009, five patients underwent LH using our modified LHM and 12 patients underwent LH using a conventional procedure. The two groups were compared in terms of the patient characteristics, preoperative hepatic functions, surgical records, and outcomes. RESULTS: The characteristics and preoperative hepatic function tests were similar between the modified LHM and non-LHM groups. Intraoperative blood loss was significantly reduced in the modified LHM group compared with the non-LHM group (193 ± 133 vs. 375 ± 167 ml, P < 0.05). The lengths of the operations and time required to perform a parenchymal transection did not differ significantly between the two groups (duration of operations 273 ± 37 vs. 337 ± 70 min; transection times 29 ± 10 vs. 28 ± 13 min). The postoperative complications and hospital stays did not differ significantly between the two groups. CONCLUSION: Our modified LHM can reduce the intraoperative blood loss during LH, and our results have shown the usefulness of this modified technique for LH.

Ultrasound-guided microwave coagulation assists anatomical hepatic resection.

PURPOSE: We describe a new technique of ultrasound (US)-guided microwave coagulation (MC) of the Glissonean pedicle, performed before transection to control the inflow and select the resection area. This report introduces our procedure and evaluates the outcomes of patients treated using this technique. METHODS: The Glissonean pedicles feeding the segment or cone unit were coagulated by US-guided MC, after which transection was performed. We used this US-guided MC technique to perform anatomical resections in 12 patients with hepatocellular carcinoma (MC group). We compared the outcomes of this group with those of a historical group of 10 patients who underwent conventional hepatectomy (control group). The two groups were well matched for age, tumor size, location, and type of hepatectomy. RESULTS: The mean operative times were similar, but the mean blood loss was significantly lower the in MC group than in the control group. Recurrence developed in four patients from the MC group, but local recurrence was not observed. Bile leakage occurred in one patient from the MC group, but the incidences of postoperative complications did not differ between the groups. CONCLUSIONS: Our procedure allows anatomical resection to be performed safely and easily, and helps prevent intrahepatic metastasis via portal flow during the transection.

Skull metastases from extramammary Paget's disease emerging 8 years after initial treatment with no local progression: illustrative case.

BACKGROUND: The foci of distant metastasis from extramammary Paget's disease (EMPD) are the lung, liver, truncal bones, vertebrae, and brain. However, skull metastases have not been reported. OBSERVATIONS: The authors treated a patient with calvarial and skull base metastases from EMPD who had undergone wide local resection of EMPD 8 years before, and they report his clinical course. LESSONS: Because EMPD with distant metastasis is fatal, it should be recognized that EMPD can metastasize to the skull even when it seemed to be in remission for several years.

Hypoxia inducible factor expression in intrahepatic cholangiocarcinoma.

BACKGROUND/AIMS: Intrahepatic cholangiocarcinoma (IHCC) is known to be one of the most malignant tumors. Hypoxia-inducible factor-1 (HIF-1) is a transcription factor, which plays a central role in biologic processes under hypoxic conditions. The aim of this study was to elucidate the role of HIF-1 in IHCC. METHODOLOGY: Thirty-five patients with IHCC who underwent hepatic resection were enrolled in this study. The expression of HIF-1a was determined immunohistochemically and the patients were divided into two groups: HIF-1a positive group (n=22) and HIF-1a negative group (n=13). Clinicopathological variables including prognosis were compared between the two groups. The prognostic factors were investigated by multivariate analysis using Cox's proportional hazard model. RESULTS: HIF-1a expression correlated significantly with higher stage, and tended to correlate with tumor diameter (>4cm), vessels infiltration and intrahepatic metastasis. The prognosis in HIF-1a positive group was poorer than that in HIF-1a negative group (5-year survival: 62.9% vs. 18.3%). Furthermore, HIF-1a positive expression was identified as an independent prognostic factor for both overall and disease free survival. CONCLUSIONS: The findings suggested that the intratumoral HIF-1a regulated malignant behavior and was a new prognostic indicator of IHCC.

Strategy for improving the prognosis of patients with intrahepatic cholangiocarcinoma by surgical treatment†:†Considerations based on experience and a literature review.

The prognosis of patients with intrahepatic cholangiocarcinoma (ICC) is still poor, and the 5-year survival rate in patients undergoing radical surgery (R0) is less than one-third. Since the prognosis depends mainly on tumor factors, so early diagnosis is necessary. To extend the survival time of these patients with a poor prognosis, cases of long-term survival were examined based on the results of our experiences and the literature. It was found that the hepatitis virus was highly involved in the carcinogenesis of ICC, and patients who were infected with hepatitis virus had rather good survival. J. Med. Invest. 68 : 15-21, February, 2021.

[Two elderly patients with advanced breast cancer successfully treated by tri-weekly docetaxel].

Case 1: An 86-year-old woman had an invasive breast cancer with dermal infiltration. Bone metastases were found in the femur and lumbar vertebrae. She was treated with 2 courses of 70 mg docetaxel (DOC) chemotherapy every 3 weeks, after which the tumor dramatically decreased in size. Following this treatment, she underwent a radical mastectomy. Case 2: An 80-year-old woman had a 10 cm tumor in the right breast. Lung and bone metastases were also found. Two 80 mg courses of DOC reduced the lung and bone metastases, and the size of the breast tumor. She underwent a local excision. Hormonal therapy is a standard treatment for hormone-sensitive breast cancer in elderly patients. It is suitable for patients who have a declining quality of life (QOL), although chemotherapy shows a higher response rate and takes less time than hormonal therapy. However, it is difficult to continue chemotherapy until pCR is achieved, even for chemotherapy-effective patients because the side effects of chemotherapy are severe. Therefore, local excision after chemotherapy is necessary for breast cancer patients to improve their QOL, even if there are distant metastatic lesions.

Venous Sinus Stenting for Transverse Sinus Stenosis Associated with Leptomeningeal Carcinomatosis in a Patient with Epidermal Growth Factor Receptor-Mutated Lung Cancer: A Case Report.

BACKGROUND Cerebral venous sinus obstruction associated with leptomeningeal carcinomatosis is an extremely rare complication of advanced non-small-cell lung cancer. There is little information available on the efficacy of therapeutic options because of its rarity and extremely poor prognosis. CASE REPORT A 57-year-old man presented with severe headache, vomiting, and visual loss for 1 month. Head magnetic resonance venography (MRV) showed occlusion of the left transverse sinus. Gd-enhanced MRI showed no abnormal enhancement. Lumbar puncture intracranial pressure was higher than 40 cmH2O. Positive cerebrospinal fluid tumor cytology confirmed the diagnosis of leptomeningeal carcinomatosis (LC). The headache was relieved by repeated lumbar punctures, and ventriculo-peritoneal shunt was performed. Cerebral angiography showed severe stenosis of the left transverse sinus without thrombosis, and significant delay of cerebral circulation. The transverse sinus stenosis was judged to be contributing to raised intracranial pressure, and the patient underwent left transverse sinus stent placement. After the procedure, his visual acuity improved, the visual field was enlarged, and his headache could be controlled by medication. Follow-up Gd-enhanced MRI showed dural enhancement and spinal dissemination. Because molecular biology of the surgical specimen showed epidermal growth factor receptor (EGFR)-activating mutations, he was treated with osimertinib for 2 months. He survived for 8 months following the diagnosis of LC and left transverse sinus stenosis. CONCLUSIONS Venous sinus stenting can offer an effective palliative interventional option for symptom relief of severe headache and visual symptoms, even in the end stage of malignancy.

Effects of chemotherapy on quality of life and night-time sleep of colon cancer patients.

Background : The aim of this study was to investigate quality of life (QOL) and night-time sleep disturbance in colon cancer patients with middle risk chemotherapy for proper antiemetic therapy. Methods : The study enrolled 139 patients with colorectal cancer. All patients received oxaliplatin or irinotecan-based chemotherapy. Patients completed a questionnaire about chemotherapy-induced nausea and vomiting and sleep disturbance. Sleep disturbance was checked, and the relationship between sleep disturbance and nausea was analyzed. Results : The prevalence of nausea was 48.9% (68 / 139). The degree of the nausea was slight / moderate / severe in 51 / 11 / 6 patients, and 12 patients had vomiting. Appetite showed no change / slightly decreased / half / one-fourth / none in 51 / 34 / 33 / 6 / 7 patients. There were significant differences in the mental component summary (MCS) score and the role-social component score (RCS). (MCS : nausea(+) vs nausea(-) 46.4 ±â€…1.1 vs 54.1 ±â€…1.1 p < 0.01 RCS : nausea(+) vs nausea(-) 33.1 ±â€…2.1 vs 41.6 ±â€…2.1 p < 0.01). Using the MCS with a cut-off score of 50, patients were divided into two groups, and nausea was significantly correlated with a low MCS score. Furthermore, patients were divided into two groups using a Pittsburgh Sleep Quality Index cut-off score of 6, and sleep disturbance was correlated with old age and second-line chemotherapy. Conclusions : Nausea affects QOL and night-time sleep of colon cancer patients with middle risk chemotherapy. J. Med. Invest. 67 : 338-342, August, 2020.

Clinical predictors of transient ischemic attack, stroke, or death within 30 days of carotid artery stent placement with distal balloon protection.

PURPOSE: Carotid artery stent placement has been accepted as an effective alternative to carotid endarterectomy (CEA), especially in patients at high risk in the setting of CEA. The purpose of this study was to determine potential clinical risk factors for the development of postprocedural neurologic deficits after carotid artery stent placement. MATERIALS AND METHODS: The clinical characteristics of 58 patients (49 men, nine women; 41 at high risk with CEA, 17 at low risk; median age, 70 years) who underwent carotid artery stent placement with distal balloon protection for 65 hemispheres/arteries (31 asymptomatic lesions and 34 symptomatic lesions) and the combined 30-day complication rates (transient ischemic attack [TIA], minor stroke, major stroke, or death) were analyzed. RESULTS: Six patients (9.0%) experienced a TIA and one patient (1.5%) had a major stroke (1.5%) within 30 days of the procedure. There were no deaths, so the overall 30-day combined stroke and death rate was 1.5%. The chi(2) test revealed that advanced age (>75 years) was a significant clinical predictor of 30-day combined neurologic complications and major adverse effects (P < .01). In addition, a symptomatic lesion was marginally associated with the 30-day incidence of neurologic ischemia on the ipsilateral side (P = .049). CONCLUSIONS: Our data suggest that carotid artery stent placement with distal balloon protection can be performed with similar periprocedural complication rates as CEA. CEA should be the first-line treatment in the management of patients older than 75 years of age.