• Title/Summary/Keyword: Adverse event

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Efficacy and Safety of Trastuzumab Deruxtecan and Nivolumab as Third- or Later-Line Treatment for HER2-Positive Advanced Gastric Cancer: A Single-Institution Retrospective Study

  • Keitaro Shimozaki;Izuma Nakayama ;Daisuke Takahari;Kengo Nagashima;Koichiro Yoshino ;Koshiro Fukuda;Shota Fukuoka ;Hiroki Osumi ;Mariko Ogura ;Takeru Wakatsuki;Akira Ooki ;Eiji Shinozaki;Keisho Chin ;Kensei Yamaguchi
    • Journal of Gastric Cancer
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    • v.23 no.4
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    • pp.609-621
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    • 2023
  • Purpose: Determination of optimal treatment strategies for HER2-positive advanced gastric cancer (AGC) in randomized trials is necessary despite difficulties in direct comparison between trastuzumab deruxtecan (T-DXd) and nivolumab as third or later-line treatments. Materials and Methods: This single-institution, retrospective study aimed to describe the real-world efficacy and safety of T-DXd and nivolumab as ≥ third line treatments for HER2-positive AGC between March 2016 and May 2022. Overall, 58 patients (median age, 64 years; 69% male) were eligible for the study (T-DXd group, n=20; nivolumab group, n=38). Results: Most patients exhibited a HER2 3+ status (72%) and presented metastatic disease at diagnosis (66%). The response rates of 41 patients with measurable lesions in the T-DXd and nivolumab groups were 50% and 15%, respectively. The T-DXd and nivolumab groups had a median progression-free survival of 4.8 months (95% confidence interval [CI], 3.3, 7.0) and 2.3 months (95% CI, 1.5, 3.5), median overall survival (OS) of 10.8 months (95% CI, 6.9, 23.8) and 11.7 months (95% CI, 7.6, 17.1), and grade 3 or greater adverse event rates of 50% and 2%, respectively. Overall, 64% patients received subsequent treatment. Among 23 patients who received both regimens, the T-DXd-nivolumab and nivolumab-T-DXd groups had a median OS of 14.0 months (95% CI, 5.0, not reached) and 19.3 months (95% CI, 9.5, 25.1), respectively. Conclusions: T-DXd and nivolumab showed distinct efficacy and toxicity profiles as ≥ third line treatments for HER2-positive AGC. Considering the distinct features of each regimen, they may help clinicians personalize optimal treatment approaches for these patients.

A STUDY ON THE EFFECTS OF SEDATION AND RELATED VARIABLES FOR PEDIATRIC DENTAL PATIENTS (소아환자의 진정요법 효과와 그와 연관된 변수에 대한 연구)

  • Kim, Kyoung-Hee;Kim, Seung-Oh;Kim, Jong-Soo
    • Journal of the korean academy of Pediatric Dentistry
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    • v.34 no.2
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    • pp.234-246
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    • 2007
  • The combination of chloral hydrate and hydroxyzine is one of the safest and most commonly used drug regimens for sedating young, uncooperative pediatric dental patients. Midazolam IM or IN and $N_2O/O_2$ inhalation is sometimes administered with chloral hydrate and hydroxyzinecombination when deeper and longer sedation is needed. The purpose of this study was to assess the outcome and safety of chloral hydrate, hydroxyzine and $N_2O/O_2$ in the sedation of a large number of uncooperative pediatric dental patients and to identify variables associated with their effectiveness. In a nine-month retrospective study, 171 records of sedation performed in 94 healthy children(male 46, female 48) with mean age of $30{\pm}8$ months were reviewed. The authors analyzed several variables such as age, sex, weight, methods of drug delivery, waiting time after drug delivery, treatment rendered, treatment time, adverse events, sedation outcome. Eighty five percent of sedation had success behavioral outcome. Sedation sessions rated success used more $N_2O/O_2$ administration and had longer treatment duration than sedation sessions rated failure. A children patient under 36 months of age had enough sleep by only oral administration and the mean waiting time of this case was significantly shorter than that of a children patient over 36 months of age. There was a clear correlation between age and $N_2O/O_2$ using tine, but no correlation between weight and $N_2O/O_2$ using time. There was no statistically significant difference among variables of treatment duration, $N_2O/O_2$ administration and adverse event.

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Detection of Pathogenic Viruses in the Atmosphere during Asian Dust Events in Incheon City (인천지역에서 황사 기간 동안 대기 중의 바이러스 검출에 관한 연구)

  • Park, Jeong Woong;Lim, Young Hee;Kyung, Sun Young;An, Chang Hyeok;Lee, Sang Pyo;Jeong, Seong Hwan
    • Tuberculosis and Respiratory Diseases
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    • v.59 no.3
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    • pp.279-285
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    • 2005
  • Background : Ambient particles during Asian dust events are usually less than $10{\mu}m$ in size, and known to be associated with the adverse effects on the general population. There is little evidence linking Asian dust to adverse effects on the airways. In 2002, the authors found that particulate matter during Asian dust events had an effect on the symptoms and pulmonary function of patients with bronchial asthma. An aggravating factor might be that of a viral infection, but this remains unclear. Conversely, it has been speculated that African dust may carry the virus responsible for foot and mouth disease. Asian dust events are also likely to be responsible for transporting viruses, some of which are pathogenic, and common in many environments. Therefore, in this study, air samples were screened for the presence of viruses. Methods : Air samples were collected 20 times each during Asian dust events and under non-dust conditions, for at least 6 hours per sample, using a high volume air sampler (Sibata Model HV500F), with an airflow rate of 500L/min, between April and August 2003, and between April and August 2004. The samples were then screened for the presence of targeted viruses (Influenza A, B, Hog cholera virus, and Aphthovirus) using a polymerase chain reaction method. Results : One Asian dust event occurred between April and August 2003, and 3 between April and August 2004, with a 24 hour average PM10 level of $148.0{\mu}g/m^3$. The 24 hour average PM10 level was $57{\mu}g/m^3$. There was a significant difference in the PM10 concentration between dusty and clear days. No viruses (Influenza virus, Aphthovirus, and Hog cholera virus) were identified in the air samples obtained during the dusty days. Conclusions : Although no virus was detected in this study, further studies will be needed to identify suspected viruses carried during Asian dust events, employing more appropriate virus detection conditions.

Immunogenicity and Reactogenicity of Inactivated HM175 Strain Hepatitis A Vaccine in Healthy Korean Children (건강한 한국 소아에서 HM175주 A형 간염 불활화 백신의 면역원성 및 이상반응에 관한 연구)

  • Kim, Chang Hwi;Pyun, Bok Yang;Hong, Young Jin;Kang, Jin Han
    • Pediatric Infection and Vaccine
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    • v.7 no.1
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    • pp.120-128
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    • 2000
  • Purpose : Active immunization against hepatitis A with an inactivated vaccine reveals excellent immunogenicity, tolerability and protective efficacy. Inactivated hepatitis A vaccines have been selectively used since 1996 in Korea to prevent hepatitis A. This study was performed to assess the immunogenicity and reactogenicity after two doses of HM175 strain hepatitis A vaccine in healthy Korean children. Methods : 128 healthy children(M/F; 65/63) aged 1 to 15 years, who were seronegative for hepaitatis A, participated in this study. A alum-adsorbed vaccine containing 720 EL.U of antigen form HM175 hepatitis A strain per 0.5 mL dose was injected intramuscularly on the deltoid area. The second dose was given 6 months later, Anti-HAV antibodies were measured by ELISA before and 1 month after each vaccination to assess the immunogenicity. Any local and general adverse events were reported by patients parents with the prepared questionnaire after each vaccination. Results : 120 volunteers(M/F; 60/60) completed the whole series of the study. Seroconversion occurred in all cases after primary and booster vaccination. The mean anti-HAV antibody titer after primary vaccination was 389.2mIU/mL, and 3,609mIU/mL after booster vaccination. And levels of anti-HAV antibodies after booster immunization were significantly higher in female children. The most common local adverse event was soreness on the injection site, but it was mild and resolves within 3 days. Fever was not reported after booster vaccination. Conclusion : Based on these data, we conclude that the inactivated HM175 strain hepatitis A vaccine is highly immunogenic and tolerable in healthy Korean children.

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Palliative Irradiation Using Helical Tomotherapy in Recurrent Pelvic Tumors with Prior Radiotherapy (방사선치료 후 재발한 골반암에서 토모테라피를 이용한 고식적 재치료)

  • Kay, Chul-Seung;Yoo, Eun-Jung;Kim, Ji-Hoon;Ro, Duck-Young;Kim, Ki-Jun
    • Radiation Oncology Journal
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    • v.28 no.3
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    • pp.133-140
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    • 2010
  • Purpose: We retrospectively investigated the effect of irradiation using helical tomotherapy in recurrent pelvic tumors that underwent prior irradiation. Materials and Methods: Fourteen patients with recurrent pelvic tumors consisting of rectal cancer (57.1%), cervical cancer (35.7%) and cancer with an unknown origin (7.1%) were treated with tomotherapy. At the time of irradiation, median tumor size was 3.5 cm and 7 patients complained of pain originating from a recurrent tumor. The median radiation dose delivered to the gross tumor volume, clinical target volume, and planning target volume was 50 Gy, 47.8 Gy and 45 Gy, respectively and delivered at 5 fractions per week over the course of 4 to 5 weeks. Treatment response and duration of local disease control were evaluated using the Response Evaluation Criteria in Solid Tumors (ver. 1.0) and the Kaplan-Meyer method. Treatment-related toxicities were assessed through Common Terminology Criteria for Adverse Events (ver. 3.0). Results: The median follow-up time was 17.3 months, while the response rate was 64.3%. Symptomatic improvement appeared in 6 patients (85.7%). The median duration time of local disease control was 25.8 months. The rates of local failure, distant failure, and synchronous local and distant failure were 57.1%, 21.4%, and 7.1%, respectively. Acute toxicities were limited in grade I or II toxicities, except for one patient. No treatment related death or late toxicity was observed. Conclusion: Helical tomotherapy could be suggested as a feasible palliative option in recurrent pelvic tumors with prior radiotherapy. However, to increase treatment effect and overcome the limitation of this outcome, a large clinical study should be performed.

Early Clinical Experience in Aortic Valve Replacement Using On-X$^{circledR}$Prosthetic Heart Valve (On-X$^{circledR}$ 기계판막을 이용한 대동맥판 치환술의 조기 임상 경험)

  • 안병희;전준경;류상완;최용선;김병표;홍성범;박종춘;김상형
    • Journal of Chest Surgery
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    • v.36 no.9
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    • pp.651-658
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    • 2003
  • Since the first implanted in September 1997, the use of On-X prosthetic heart valve has been increasing around in the world. This study was designed to assess the feasibility, safety, and the postoperative hemodynamics with this new valve in clinical setting. Material and Method: The current study was carried out on 52 patients undergoing aortic valve replacement with this prosthesis between April 1999 to August 2002 at Chonnam National University Hospital to evaluate the surgical results. 52% of the patients were male and the average age at implant was 50$\pm$13 years. The study followed the guidelines of the AATS/STS. Preoperatively, 32(61.5%) patients were in NYHA functional class III or IV and 2 patients had previous aortic valve surgery. Concomitant cardiac surgery was performed in 71.1%. The implanted valve sizes were 19 mm in 13 patients, 21 mm in 26, 23 mm in 10 and 25 mm in 3, respectively. Mean follow-up was 16.6$\pm$10.5 months (1∼39 months). Echocardiographic assessment was performed pre- and immediate postoperatively, as well as 3, 6, 12 months after surgery, evaluating pressure loss and regression of left ventricular hypertrophy. Result: Mean cardiopulmonary bypass time was 191$\pm$94.7 minutes with an aortic cross-clamp time of 142$\pm$51.7 minutes. There was no early and late mortality, Freedom from adverse events at 1 year in the study were as follows: thromboembolism, 95.6$\pm$6%; bleeding events, 90.2$\pm$4%; paravalvular leakage 92.3$\pm$4%; and overall valve-related morbidity at 1 year was 76.6$\pm$3%. There were no cases of valve thrombosis, prosthetic valve endocarditis and structural or non-structural failure. Left ventricular function at 12 months after surgery (EF=62.7$\pm$9.8%) revealed a statistically significant improvement compared to preoperative investigation (EF=55.8$\pm$15.9%, p=0.006). Left ventricular mass index was 247.3$\pm$122.3 g/$m^2$ on preoperative echocardiographic study, but regressed to 155.5$\pm$58.2 g/$m^2$ at postoperative 1 year (p=0.002). Over the follow-up period a further decrease of peak transvalvular gradients was observed in all patients: 62.5$\pm$38.0 mmHg on preoperative assessment, 18.2$\pm$6.8 mmHg at immediate postoperative period (p < 0.0001), 7.6$\pm$5.09 mmHg (p<0.0001) at 6 month, 18.0$\pm$10.8 mmHg (p<0.0001) at 1 year. Conclusion: The On-X prosthetic heart valve performs satisfactorily in the first 1 year period. Clinical outcome by examining NYHA functional classification revealed especially good results. Effective regression of left ventricular hypertrophy and statistically significant decrease of transvalvular gradient were observed over the first year, but longer-term follow-up of this patient group is needed to establish the expected rates for late valve-related events as well as the long-term clinical efficacy of this valve.

Mid-Term Results of Mitral Valve Repair Using a Partial Flexible Band and a Completely Rigid Ring in Patients with Degenerative Mitral Regurgitation (퇴행성 승모판막역류 환자에서 Partial Flexible Band와 Complete Rigid Ring을 이용한 승모판막 성형술의 중기 결과 비교)

  • Kim, Kyung-Hwan;Ahn, Hyuk;Hwang, Ho-Young;Choi, Jin-Ho;Kim, Ki-Bong
    • Journal of Chest Surgery
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    • v.43 no.5
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    • pp.475-481
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    • 2010
  • Background: We evaluated mid-term results of mitral annuloplasty using a flexible band and a completely rigid ring for mitral valve repair in patients with degenerative mitral regurgitation (MR). Material and Method: From January 2004 to September 2008, 71 patients (M:F=36:35, $55{\pm}13$ years) underwent mitral valve repair with mitral annuloplasty for degenerative MR. Ring annuloplasty was done using a Cosgrove-Edwards flexible band (Group I, n=43) or a Carpentier-Edwards classic ring (Group II, n=28). There were no differences in preoperative characteristics of the participants. Average duration of follow-up was 36 months (range: 2~69 mos). Result: There was no in-hospital mortality. Postoperative morbidity, which included atrial fibrillation (n=7) and low cardiac output syndrome (n=5) in groups I and II were similar. There was one late death in group II. The proportion exhibiting freedom from recurrent mitral regurgitation ($\geq$moderate) at 4 years in Groups I and II were, respectively, 94.5 and 91.8%, (p=0.695). Left ventricular ejection fraction decreased in the early postoperative period ($7{\pm}2$ days) and recovered by last follow-up ($25{\pm}16$ mos; p=0.002). The pattern was similar in groups I and II (p=0.905). Re-operation was performed in 3 patients (1 in Group I and 2 in Group II, p=0.316). Four-year event-free survival (free of adverse valve-related events) was 95.2% for Group I and 92.6% for Group II; this difference was not significant, p=0.646). Conclusion: The type of technique used in mitral annuloplasty to repair the mitral valve repair after degenerative MR did not affect mid-term clinical and functional results.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
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    • v.33 no.2
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    • pp.115-126
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    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

Efficacy and Safety of Topical Application of Epidermal Growth Factor (EGF) for Korean Acne Patient (한국인 여드름 환자에서 표피성장인자가 함유된 외용제의 피부 적용에 대한 유효성 및 안전성 평가)

  • Suh, Joon Hyuk;Hyun, Moo Yeol;Jang, Seong Eum;Choi, Sun Young;Kim, Myeung Nam;Kim, Beom Joon
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.42 no.2
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    • pp.111-118
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    • 2016
  • Acne vulgaris is a chronic inflammatory condition characterized by comedo, papule, cyst, nodule and postinflammatory hyperpigmentation. Meanwhile, it is also induced by adverse event of drugs. Among them, acneiform folliculitis is a side effect of epidermal growth factor receptor (EGFR) inhibitor, which is an anticancer agent, and its incidence may occur in upward of 75 ~ 100% of cases. The main method of acne vulgaris treatment is oral antibiotics, retinoids, topical medication and so on. However, it is limitation that teratogenicity caused by retinoids and antibiotic resistance increased by using antibiotics. In this study, we aimed to evaluate the clinical efficacy and safety of topical recombinant human (rh) EGF in treating facial acne vulgaris. Twenty three Koreans (age: 10 ~ 29 years) with mild to moderate acne vulgar participated in the study and applied topical rhEGF cream (trouble control EGF) with 3 products (trouble control clarifying cleansing foam, trouble control all-clear filling toner, redroll calming moisture) on their face twice daily for four weeks. Several assessment methods were applied: Acne lesion counts score by investigator's global assessment, efficacy and satisfaction score by subjects. Skin sebum output level, hydration level and redness level were also measured at each visit. At the final visit, skin sebum level, transepidermal water loss, skin redness statistically decreased and acne lesions (comedone, papule) were statistically reduced. No severe side effects were observed during the study. In conclusion, topical rhEGF seems to be an effective and safe adjuvant treatment option for mild acne vulgaris.

Clinical Results and Optimal Timing of OPCAB in Patients with Acute Myocardial Infarction (급성 심근경색증 환자에서 시행한 OPCAB의 수술시기와 검색의 정도에 따른 임상성적)

  • Youn Young-Nam;Yang Hong-Suk;Shim Yeon-Hee;Yoo Kyung-Jong
    • Journal of Chest Surgery
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    • v.39 no.7 s.264
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    • pp.534-543
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    • 2006
  • Background: There are a lot of debates regarding the optimal timing of operation of acute myocardial infarction (AMI). Off pump coronary artery bypass grafting (OPCAB) has benefits by avoiding the adverse effects of the cardio-pulmonary bypass, but its efficacy in AMI has not been confirmed yet. The purpose of this study is to evaluate retrospectively early and mid-term results of OPCAB in patients with AMI according to transmurality and timing of operation. Material and Method: Data were collected in 126 AMI patients who underwent OPCAB between January 2002 and July 2005, Mean age of patients were 61.2 years. Male was 92 (73.0%) and female was 34 (27.2%). 106 patients (85.7%) had 3 vessel coronary artery disease or left main disease. Urgent or emergent operations were performed in 25 patients (19.8%). 72 patients (57.1%) had non-transmural myocardial infarction (group 1) and 52 patients (42.9%) had transmural myocardial infarction (group 2). The incidence of cardiogenic shock and insertion of intra-aortic balloon pump (IABP) was higher in group 2. The time between occurrence of AMI and operation was divided in 4 subgroups (<1 day, $1{\sim}3\;days,\;4{\sim}7\;days$, >8 days). OPCAB was performed a mean of $5.3{\pm}7.1$ days after AMI in total, which was $4.2{\pm}5.9$ days in group 1, and $6,6{\pm}8.3$ days in group 2. Result: Mean distal an-astomoses were 3.21 and postoperative IABP was inserted in 3 patients. There was 1 perioperative death in group 1 due to low cardiac output syndrome, but no perioperative new MI occurred in this study. There was no difference in postoperative major complication between two groups and according to the timing of operation. Mean follow-up time was 21.3 months ($4{\sim}42$ months). The 42 months actuarial survival rate was $94.9{\pm}2.4%$, which was $91.4{\pm}4.7%$ in group 1 and $98.0{\pm}2.0%$ in group 2 (p=0.26). The 42 months freedom rate from cardiac death was $97.6{\pm}1.4%$ which was $97.0{\pm}2.0%$ in group 1 and $98.0{\pm}2.0%$ in group 2 (p=0.74). The 42 months freedom rate from cardiac event was $95.4{\pm}2.0%$ which was $94.8{\pm}2.9%$ in group 1 and $95.9{\pm}2.9%$ in group 2 (p=0.89). Conclusion: OPCAB in AMI not only reduces morbidity but also favors hospital outcomes irrespective of timing of operation. The transmurality of myocardial infarction did not affect the surgical and midterm outcomes of OPCAB. Therefore, there may be no need to delay the surgical off-pump revascularization of the patients with AMI if surgical revascularization is indicated.