scholarly journals P423 Treatment escalation and associated cost in German Ulcerative Colitis patients treated with advanced therapies

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S427-S427
Author(s):  
N Picker ◽  
H Patel ◽  
T Wilke ◽  
L Rosin ◽  
B Bokemeyer
Keyword(s):  
Ulcerative Colitis ◽  
Dose Escalation ◽  
Drug Costs ◽  
P Value ◽  
First Year ◽  
Prescription Data ◽  
Kaplan Meier ◽  
Advanced Therapy ◽  
Advanced Therapies

Abstract Background Advanced therapies used in moderate-to-severe Ulcerative Colitis (UC) may show a secondary loss of response (LOR) over time, requiring patients to undergo dose escalation or switching. Our study aimed to investigate the frequency of dose escalation in real-world practice and evaluated the associated cost. Methods Using German claims data (AOK PLUS) including prescription data, we identified UC patients by either at least two confirmed outpatient diagnoses or one primary inpatient diagnosis (ICD-10 K51). Analyzed patients initiated an advanced therapy (anti-TNF, vedolizumab, tofacitinib) between 01/01/2015-30/06/2019. Therapy escalation was defined as dose increase exceeding the recommended maintenance dose according to product labels by more than 150%. Time to first escalation was analyzed using a Kaplan-Meier estimation. The observation ended with the discontinuation of index therapy + 90 days, or loss to follow-up, whatever occurred first. End of therapy was determined in case of a supply gap of >60 days or switch of the advanced therapy. Patients with a follow-up < 6 months were excluded.Direct UC-related resource use and costs accounting for hospitalizations, outpatient treatment, drug costs according to pharmacy sales prices were reported per patient-year (PY). Results Among 574 UC patients who initiated an advanced therapy, 328 patients (median age: 37 years; female: 52.1%; biologic-naïve: 85.4%) with sufficient follow-up time (median: 12.2 months) were identified. Out of these, 59 patients (19%) were dose-escalated within the first year, whereas 73 patients (22%; anti-TNF: 61; vedolizumab: 12) were found to experience a therapy escalation during the whole follow-up time (average daily dose during maintenance therapy: adalimumab: 5.3 mg, infliximab: 14.6 mg, golimumab: 3.7 mg, vedolizumab: 11.1 mg, tofacitinib: n/a). Total observed direct cost related to UC amounted to €39,514/PY (95%-CI: 37,469-41,558), with €37,369/PY (34,852-39,885; Figure 1) caused by UC-related medication (95%). In comparison, UC-related total direct costs and drug costs for patients without any observable escalation were much lower (€30,425/PY [29,672-31,178]; p-value <0.001 and €28,066/PY [27,230-28,902]; p-value <0.001). Frequency of hospitalizations due to UC (0.3 [0.2-0.5] vs. 0.4 [0.3-0.5]; p-value: 0.947) and gastroenterologist visits (2.1 [1.6-2.6] vs. 2.3 [2.1-2.5]; p-value: 0.361) were similar among both groups. Conclusion Nearly one-fifth of observed patients required therapy escalation in the first year, most likely due to secondary LOR. This results in higher UC-related costs. Payers should consider rates and costs of dose escalations when evaluating the cost-effectiveness of advanced therapies.

scholarly journals P464 Steroid dependency in patients with Ulcerative Colitis treated with advanced therapies in a German real-world-setting

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S455-S456
Author(s):  
B Bokemeyer ◽  
N Picker ◽  
T Wilke ◽  
L Rosin ◽  
H Patel
Keyword(s):  
Ulcerative Colitis ◽  
Baseline Period ◽  
Therapy Discontinuation ◽  
Steroid Dependency ◽  
Kaplan Meier ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
Increased Risk ◽  
Claims Data Analysis

Abstract Background An important treatment goal in Ulcerative Colitis (UC) is a long-lasting corticosteroid (CS)-free remission. Avoidance of steroid dependency in these patients is essential as chronic CS use is known to be associated with an increased risk for multiple severe adverse events. This study aimed to identify CS dependency in patients with moderate to severe UC treated with advanced therapies. Methods This German claims data analysis includes adult patients with ≥2 outpatient diagnoses and/or one inpatient diagnosis for UC (ICD-10: K51) in whom an advanced therapy (anti-TNF agent, vedolizumab or tofacitinib) was initiated between 01/01/2015–30/06/2019. CS dependency was indicated by ≥2 prescriptions of systemic CS and/or oral budesonide within a median follow-up of 23.4 months. Prior CS use was evaluated by outpatient prescriptions observed in a 12-months baseline period. Costs were assessed until the end of the study period or loss to follow-up considering all-cause expenses for inpatient and outpatient visits, and approximated indirect cost related to sick-leave days. Exceeding the recommended dose in maintenance therapy by more than 150% was rated as an escalation of therapy. Time to the therapy discontinuation, escalation or first UC-related hospitalization from start of index therapy were estimated using Kaplan-Meier analysis. Results Of 574 included UC patients with a new advanced therapy, 252 (43.9%) received ≥2 prescriptions of CS while on treatment with advanced agents in the observation period up to 24 months. Altogether, 496 patients (86.4%) had prior experience with CS in the 12-months baseline-period. Among patients with ≥2 CS prescriptions, 47.0% had switched their index therapy to another advanced agent after 24 months (31.2% without CS dependency). Median time to therapy discontinuation was 17.3 months in CS-dependent patients; and 19.3 months in those without CS dependency (p = 0.639). There were no differences between naïve or advanced therapy experienced patients, but with clearly more discontinuations in patients with previously more than 1 advanced therapy (p<0.001). CS-dependent patients were more likely to require dose escalation/UC-related hospitalization within the first two years after treatment start (26.7% vs. 16.1%; p = 0.018/ 44.1% vs. 26.6%; p = 0.048; Figure 1). Total cost per patient-year was significantly higher in patients with than without CS dependency (40,884 € vs. 37,449 €; p < 0.001). Conclusion Most UC patients starting new advanced therapies were previously treated with CS, and more than two-fifths continue to be CS dependent even after starting such a therapy. More effective therapies are needed to achieve CS-free remission.

scholarly journals P377 Inadequate response with advanced therapies in real-world patients with Ulcerative Colitis – Results of a German claims database study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S392-S392
Author(s):  
B Bokemeyer ◽  
N Picker ◽  
T Wilke ◽  
L Rosin ◽  
H Patel
Keyword(s):  
Ulcerative Colitis ◽  
Median Time ◽  
Real World ◽  
Index Date ◽  
Sickness Fund ◽  
Inadequate Response ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
Significant Difference

Abstract Background Therapeutic management of Ulcerative Colitis (UC) is challenging, and clinicians are often obliged to attempt a variety of therapies in sequence until an adequate clinical response is achieved. However, real-world data regarding response rates in UC treatment are rare, particularly for later lines of therapy. Thus, this study aimed to investigate the incidence of inadequate response to advanced therapies in patients with UC. Methods This retrospective study was based on claims data from a regional German sickness fund covering the period from 01/2014-06/2019. Patients were included if they had at least two outpatient diagnoses in two different quarters or one inpatient diagnosis of UC (ICD-10: K51) and started a newly introduced advanced therapy (adalimumab, golimumab, infliximab, tofacitinib, vedolizumab) in 01/2015-06/2019. Patients were followed from treatment initiation (index date) until the end of the study period or loss to follow-up (median = 23.4 months). Proxies of inadequate response included: discontinuation (a supply gap of >60 days), switch, escalation (as dose increase exceeding 1.5 times the recommended maintenance dose), augmentation with 5-ASA, corticosteroid (CS) dependency (two CS prescriptions were observed starting more than 14 weeks after the index date), UC-related hospitalization, or UC-related surgery. CS dependency and treatment escalation were only assessed in the maintenance phase. Inadequate response in the analyzed sample was evaluated by means of Kaplan-Meier survival analysis. Results Among 574 UC patients (median age: 39 years; female: 53.5%), in whom an advanced therapy was initiated, 458 (79.8%) received an anti-TNF therapy, 113 (19.7%) vedolizumab and 3 (0.5%) tofacitinib. According to the available baseline period, 72 (12.4%) patients were identified as biologic-experienced. Most patients received CS (86.4%) and/or 5-aminosalicylic acids (81.7%) in the 12-month pre-index period. The median time to inadequate response to the initiated advanced therapy was 4.8 months (IQR: 2.6-11.9; Figure 1) with an inadequate response over 12 months in 75% (Figure 2). There was no significant difference in median time to inadequate response between biologic-naïve and biologic-experienced patients (4.9 vs. 4.7 months; p-value = 0.285). During the observable follow-up period, 172 (61%) patients switched from their index agent to another advanced therapy. Conclusion From the real-world settings in Germany, we found an inadequate response in UC-patients starting an advanced therapy in 75% of patients over 12 months. There is a need for more effective therapies among these patients.

scholarly journals P404 Healthcare utilization and expenditures for patients with Ulcerative Colitis on advanced therapies in Germany

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S411-S412
Author(s):  
N Picker ◽  
B Bokemeyer ◽  
T Wilke ◽  
L Rosin ◽  
H Patel
Keyword(s):  
Ulcerative Colitis ◽  
Sick Leave ◽  
Sickness Fund ◽  
Cost Driver ◽  
Medication Costs ◽  
Outpatient Visits ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
Chronic Inflammatory Condition

Abstract Background Ulcerative Colitis (UC) is a chronic inflammatory condition, which significantly impacts patients’ health-related quality of life and burdens healthcare budgets. Our objective was to provide an overview of the healthcare resource use (HCRU) for the treatment of moderate to severe UC in Germany. Methods A retrospective analysis was conducted using claims data from a German sickness fund (AOK PLUS). Patients were included if they had ≥2 outpatient diagnoses in different quarters and/or one inpatient UC diagnosis (ICD-10: K51), were aged ≥18 years and initiated an advanced therapy (anti-TNFs, vedolizumab, tofacitinib) between 01/01/2015-30/06/2019. HCRU associated with UC treatment was assessed in terms of outpatient visits, work-related sick leave days, and UC caused hospitalizations. Direct UC-related costs (inpatient, outpatient and medication costs based on pharmacy sales price at prescription date) were calculated from the perspective of the German statutory health insurance. All patients were followed from the start of treatment until the end of the study period, or loss to follow-up. In case of treatment discontinuation or change of index therapy, patient follow-up was censored 90 days after the last prescription of index therapy. UC-related HCRU and cost were reported per observable patient-year (PY) and stratified according to prior use of advanced therapies (naïve vs. experienced). Results 574 patients were included (adalimumab: 230, infliximab: 172, golimumab: 56, vedolizumab: 113, tofacitinib: 3). Mean age was 41.9 years; 53.5% were female. On average, 2.5 outpatient visits per PY were billed by general practitioners and 1.4 by gastroenterologists. 27.0% of patients had at least one UC-related hospitalization (mean length of stay: 11.2 days). The mean number of documented UC-related sick leave days amounted to 13.1 per PY. HCRU was similar in therapy-naïve vs. experienced patients (Table 1). Inpatient costs for any cause amounted on average to €4,522/PY, with UC accounting for €3,190/PY (70.5%). Total UC costs amounted to €34.068/PY (Table 2). Expenses for prescribed UC-related drugs amounted to €28,885/PY (95.6% of total drug costs), and outpatient treatment to €511/PY with only €123/PY for Gastroenterologists’ visits (0.4% of total UC-costs/PY). In addition, indirect cost resulting from sick leave due to UC were estimated at €2,979/PY. Conclusion Our study indicates a high economic burden in UC patients who initiated treatment with advanced therapies. UC-related medication was identified as the main cost driver. Furthermore, a substantial proportion of UC patients required hospitalization in the first 12 months after starting new advanced therapy.

Nonfocal Symptoms in Patients with Transient Ischemic Attack and Association with Stroke Risk

2021 ◽  
Vol 19 ◽  
Author(s):  
Shuxiang Yang ◽  
Lu Zhao ◽  
Lulu Pei ◽  
Shuang Cao ◽  
Yuan Gao ◽  
...  
Keyword(s):  
Transient Ischemic Attack ◽  
Stroke Risk ◽  
First Year ◽  
Kaplan Meier ◽  
Predictive Outcome ◽  
One Year ◽  
Ischemic Attack ◽  
Cumulative Risks

Background and Objective: Patients with transient ischemic attack（TIA）occasionally showed nonfocal symptoms, such as decreased consciousness, amnesia and non-rotatory dizziness. This study intended to evaluate the effect of nonfocal symptoms on the prognosis of patients with TIA. Methods: Data from the prospective hospital-based TIA database of the First Affiliated Hospital of Zhengzhou University were analyzed. The predictive outcome was stroke occurrence at 1 year. Cumulative risks of stroke in patients with and without nonfocal symptoms were estimated with Kaplan-Meier models. Results: We studied 1384 patients with TIA (842 men; mean age, 56±13 years), including 450 (32.5%) with nonfocal symptoms. In the first year after TIA, stroke occurred in 168（12.1%） patients. There was no difference in the risk of stroke between patients with both focal and nonfocal symptoms and patients with focal symptoms alone (11.8% vs 12.4%, log-rank; P=0.691). Conclusions: The occurrence of nonfocal symptoms did not increase the risk of stroke at one-year follow-up compared to the occurrence of focal symptoms alone.

MCRS1 EXPRESSION MORE IN TUMOR PART AND SERVES AS A POOR PROGNOSTIC FACTOR IN EXTRAHEPATIC CHOLANGIOCARCINOMA

2021 ◽  
pp. 72-75
Author(s):  
Hung-Chune Maa ◽  
Pham van Tuyen ◽  
Yen-Lin Chen ◽  
Yao-Nan Yuan
Keyword(s):  
Prognostic Factor ◽  
Large Scale ◽  
Surgical Margin ◽  
P Value ◽  
Extrahepatic Cholangiocarcinoma ◽  
Poor Prognostic Factor ◽  
Kaplan Meier ◽  
Survival Plot

INTRODUCTION:Microporous protein 1 (MCRS1) acts as a cancer gene. MCRS1 is associated with poor prognosis in several types of cancer including colorectal cancer, hepatocellular carcinoma, glioma, and non-small cell lung cancer. In the current study, we are trying to shed light on the role of MCRS1 in the extrahepatic cholangiocarcinoma. METHODS: We retrospectively selected 13 patients who diagnosed extrahepatic cholangiocarcinoma. All clinical charts and histopathology reports were reviewed for and recoded for age, gender, tumor size, surgical margin status, lymph node metastasis, distant metastasis and TMN staging. All patients were followed for 1~10 years. The median follow-up period was 3.2 years. RESULTS: The expression level of MCRS1 showed signicantly higher in tumor part than non-tumor part. In the Kaplan-Meier survival plot , the high MCRS1 expression group showed poor survival probability with p value of 0.020. The Hazard ratio of MCRS1 showed 8.393 folds in high MCRS1 expression group when compared with low expression group with the borderline p value of 0.05. CONCLUSION:MCRS1 serves as a poor prognostic factor. Further analysis, no correlation was found in proliferation, apoptosis, angiogenesis and EMT markers. The reason may be the sample size and large-scale study in the future is mandatory

scholarly journals Mid- and long-term efficacy of surgical treatment of Vancouver B2 and B3 periprosthetic femoral fractures

BMC Surgery ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jian-Ning Sun ◽  
Yu Zhang ◽  
Ye Zhang ◽  
Jia-Ming Zhang ◽  
Xiang-Yang Chen ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Survival Rate ◽  
Femoral Fractures ◽  
First Year ◽  
Femoral Prosthesis ◽  
Term Efficacy ◽  
Kaplan Meier ◽  
Sf 36

Abstract Background The incidence of fractures around the femoral prosthesis among patients undergoing hip arthroplasty is increasing and has become the third leading cause of hip revision. While numerous methods for the surgical treatment of periprosthetic femoral fractures (PFFs) have been proposed, only few reports have examined the long-term efficacy of surgical treatment. This study aims to examine the mid-and long-term efficacy of surgical treatment among patients with Vancouver B2 and B3 PFFs. Methods This retrospective study evaluated the surgical outcomes of patients with Vancouver B2 and B3 PFFs between 2007 and 2011. The minimum follow-up time was eight years. Fracture healing, prosthesis stability, complications, patient quality of life SF-36 score, and survival rate were evaluated during the follow-up assessments. Results A total of 83 patients were included and had an average follow-up period of 120.3 months. Among these patients, 69 were classified as Vancouver B2 and were treated with a distal fixation stem, whereas 14 cases were classified as Vancouver B3 and were treated with modular femoral prosthesis by using a proximal femoral allograft technique. A total of 15 patients underwent secondary revision surgery, and prosthesis dislocation was identified as the main cause of secondary revision. 80 (96.4%) cases of fractures were clinically healed. The mortality rate in the first year after surgery was 8.4% (7/83). The overall 5-year Kaplan–Meier survival rate for these patients was 75.9%. Meanwhile, the 5-year Kaplan–Meier survival rate for the implants was 86.9%. The final follow-up SF-36 score of the patients was 48.3 ± 9.8. Conclusions Patients with Vancouver B2 and B3 PFFs show high mortality in the first year after their surgery, and the Kaplan–Meier analysis results showed that such mortality tends to plateau after 5 years. Prosthesis dislocation was identified as the primary cause of secondary revision.

scholarly journals OP26 The first real-life multicentre prospective validation study of the electronic chromoendoscopy score (Paddington International Virtual ChromoendoScopy ScOre) and its outcome in ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S023-S024 ◽  
Author(s):  
M Iacucci ◽  
S C Smith ◽  
A Bazarova ◽  
U N Shivaji ◽  
P Bhandari ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Validation Study ◽  
Real Life ◽  
Mucosal Healing ◽  
Vascular Changes ◽  
Important Goal ◽  
Kaplan Meier ◽  
Virtual Chromoendoscopy

Abstract Background Mucosal healing is an important goal in the treatment of ulcerative colitis (UC). The newly published PICaSSO score characterises subtle mucosal and vascular changes and defines mucosal healing. We aimed to validate in real-life the PICaSSO score and assess its ability to predict relapse. Methods Patients with UC were prospectively recruited from 11 international centres. Participating endoscopists experienced in IBD received training on PICaSSO before starting the study. The rectum and sigmoid were examined using iScan 1,2 and 3 (Pentax, Japan) and inflammatory activity was assessed using UCEIS and PICaSSO. Biopsies were taken for the histological assessment using Robarts Histological Index (RHI) and Nancy. Follow-up was obtained at 12 months. Results A total of 278 patients were recruited (Table 1). The diagnostic performance in predicting histologic healing is shown in Table 2. When using PICaSSO score of ≤3 for mucosal and vascular architecture the AUROC to predict healing by RHI is 0.79 (95% CI 0.74–0.85) and 0.73 (95% CI 0.68–0.80) respectively and when using the Nancy score the AUROC is 0.78 (95% CI 0.72–0.84) and 0.77 (0.71–0.84). A total PICaSSO score of ≤8 and UCEIS score of ≤1 predicts remission at 12 months with an AUROC of 0.73 (0.65–0.80) and 0.71 (0.64–0.79). A Kaplan–Meier curve shows a favourable survival probability without relapse with a PICASSO score of ≤8 (Figure 1). Conclusion This real-life validation study shows the PICaSSO score can predict accurately histological healing and long-term remission and can be a useful tool in the management of UC.

Predictors of Loss To Follow Up and Mortality Among Children ?12 Years Receiving Anti Retroviral Therapy during the First Year at a Referral Hospital in Bali

2016 ◽  
pp. 127 ◽  
Author(s):  
S. Juergens ◽  
A.A.S. Sawitri ◽  
I.W.G. Artawan Eka Putra ◽  
Tuti Parwati Merati
Keyword(s):  
Clinical Characteristics ◽  
Demographic Characteristics ◽  
First Year ◽  
Cox Proportional Hazard Model ◽  
Proportional Hazard ◽  
Proportional Hazard Model ◽  
Loss To Follow Up ◽  
Cox Proportional Hazard ◽  
Kaplan Meier

Background and purpose: Many HIV-infected children in Bali have started antiretroviral therapy (ART), but loss to follow up (LTFU) is a continuing concern, and the issue of childhood adherence is more complex compared to adults.Methods: This was a retrospective study among cohort of 138 HIV+ children on ART in Sanglah General Hospital, Denpasar, Bali from January 2010 to December 2015. Kaplan-Meier analysis was used to describe incidence and median time to LTFU/mortality and Cox Proportional Hazard Model was used to identify predictors. Variables which were analysed were socio-demographic characteristics, birth history, care giver and clinical condition of the children.Results: Mean age when starting ARV therapy was 3.21 years. About 25% experienced LTFU/death by 9.1 month resulting in an incidence rate of 3.28 per 100 child month. The higher the WHO stage, the higher the risk for LTFU/mortality along with low body weight (AHR=0.90; 95%CI: 0.82-0.99).Conclusion: Clinical characteristics were found as predictors for LTFU/mortality among children on ART.

P3649Analysis of clinical and angiographic parameters as predictors of recurrent vasospastic angina

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J.-H Park ◽  
G.-S Yoon ◽  
S.-H Choi ◽  
Y S Beak ◽  
S W Kwan ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Odds Ratio ◽  
Troponin I ◽  
Medication Compliance ◽  
Provocation Test ◽  
Vasospastic Angina ◽  
P Value ◽  
Kaplan Meier ◽  
Male Sex

Abstract Background Patients with vasospastic angina (VA) may have recurrent chest symptoms and life-threatening arrhythmias. Despite regular medications, many VA patients experience recurrent episodes of VA. In this study, we evaluate clinical and angiographic predictors of recurrent VA. Patients and methods From January 2010 to May 2018, a total of 858 patients who underwent ergonovine provocation test were retrospectively reviewed. We excluded the patients who had negative results of provocation test, follow up duration less than 1 month and poor medication compliance. The recurrent-VA group consisted of patients who were re-hospitalized, visited the emergency room, or had repeated coronary angiographies because of chest pain. Results A total of 858 patients who underwent ergonovine provocation tests between January 2010 to May 2018 were retrospectively reviewed. Of them, 162 (mean follow-up duration, 3.0 years) were eligible for our study. The patients were divided into two groups: recurrent-VA (n=33, 20.4%) and stable-VA groups (n=129, 79.6%). Compared with the stable-VA group, the recurrent-VA group consisted mostly of men (93.9% vs. 75.2%, P=0.01), and had low LDL-cholesterol levels (93±27 mg/dl vs. 108±31 mg/dl, P=0.01). In the angiographic findings, a degree of coronary artery disease (CAD) and the site and number of spasm-positive vessels showed no difference between the two groups. Nicorandil was more frequently prescribed at discharge in the stable-VA group (15.2% vs. 35.7%, P=0.02). In the multivariate analysis, the male sex (odds ratio [OR], 5.87; 95% confidence interval [CI], 1.31–26.22; P=0.02) and non-use of nicorandil (OR, 3.51; 95% CI, 1.25–9.84; P=0.01) were the independent predictive factors in the recurrent-VA group. In the Kaplan-Meier analysis, men who did not use nicorandil (n=85, 52.5%) had higher incidences of recurrent angina compared to the other group (n=77, 47.5%). (30.6% vs. 6.6%; p<0.001). Univariate and multivariate analysis Refractory VA (n=33) Stable VA (n=129) Odds ratio [95% CI] P value univariate Odds ratio [95% CI] P value multivariate Age <56 years, n (%) 20 (66) 58 (44) 1.88 [0.86–4.10] 0.11 NA NS Male sex, n (%) 31 (93.9) 97 (75.2) 5.11 [1.15–22.56] 0.03 5.87 [1.31–26.22] 0.02 Smoking, n (%) 17 (51.5) 46 (35.7) 1.91 [0.88–4.14] 0.09 NA NS No AMI presentation, n (%) 11 (33.3) 25 (19.4) 2.08 [0.89–4.84] 0.08 NA NS Troponin-I >0.86 ng/ml, n (%) 2 (7.1) 3 (2.7) 2.74 [0.43–17.27] 0.08 NA NS LDL-C <105 mg/dl, n (%) 21 (63) 58 (49) 1.81 [0.81–4.01] 0.14 NA NS No use of nicorandil, n (%) 5 (15.2) 46 (35.7) 3.10 [1.12–8.58] 0.02 3.51 [1.25–9.84] 0.01 Kaplan-Meier curves Conclusions Male sex and non-use of nicorandil were independent predictors of recurrent VA.

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