Disclosure Information

Effect of High-dose Angiotensin II Effect of High-dose Angiotensin II Receptor Blocker (ARB) Monotherapy Receptor Blocker (ARB) Monotherapy

versus ARB plus Calcium Channel Blocker versus ARB plus Calcium Channel Blocker Combination on Cardiovascular Events in Combination on Cardiovascular Events in Japanese Elderly High-risk Hypertensive Japanese Elderly High-risk Hypertensive Patients (OSCAR): a Randomized TrialPatients (OSCAR): a Randomized Trial

Hisao OgawaHisao Ogawa11, Shokei Kim-Mitsuyama, Shokei Kim-Mitsuyama22, Tomio , Tomio JinnouchiJinnouchi33, Hideaki Jinnouchi, Hideaki Jinnouchi33, Kunihiko Matsui, Kunihiko Matsui44 and and

Kikuo ArakawaKikuo Arakawa55, for the OSCAR Study Group, for the OSCAR Study Group11 Department of Cardiovascular Medicine, Kumamoto University Graduate School of Department of Cardiovascular Medicine, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan; Medical Sciences, Kumamoto, Japan; 22 Department of Pharmacology and Molecular Department of Pharmacology and Molecular

Therapeutics, Kumamoto University Graduate School of Medical Sciences, Therapeutics, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan; Kumamoto, Japan; 33 Jinnouchi Clinic, Diabetes Care Center, Kumamoto, Japan; Jinnouchi Clinic, Diabetes Care Center, Kumamoto, Japan; 44 Department of General Medicine, Yamaguchi University Hospital, Ube, Japan; Department of General Medicine, Yamaguchi University Hospital, Ube, Japan; 55

Second Department of Internal Medicine, School of Medicine, Fukuoka University, Second Department of Internal Medicine, School of Medicine, Fukuoka University, Fukuoka, JapanFukuoka, Japan

Disclosure InformationDisclosure Information

Hisao Ogawa, MD, PhD

Effect of High-dose Angiotensin II Receptor Blocker Effect of High-dose Angiotensin II Receptor Blocker (ARB) Monotherapy versus ARB plus Calcium Channel (ARB) Monotherapy versus ARB plus Calcium Channel Blocker Combination on Cardiovascular Events in Blocker Combination on Cardiovascular Events in Japanese Elderly High-risk Hypertensive PatientsJapanese Elderly High-risk Hypertensive Patients

Financial Disclosures:Grant support for OSCAR from Japan Heart Foundation Japan Heart Foundation

(Japan)

Grant support from Astellas, AstraZeneca, Bayer, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Eisai, Kowa, Boehringer Ingelheim, Daiichi-Sankyo, Eisai, Kowa, Kyowa Hakko Kirin, MSD, Novartis, Pfizer, Sanofi-Kyowa Hakko Kirin, MSD, Novartis, Pfizer, Sanofi-Aventis, Schering-Plough, and TakedaAventis, Schering-Plough, and Takeda, , for the past 5 years. No other potential conflict of interest relevant to this study was reported.

Study BackgroundStudy Background

ARBs are effective for the treatment of ARBs are effective for the treatment of not only hypertension but also stroke, not only hypertension but also stroke, MI, HF, diabetic nephropathy, etcMI, HF, diabetic nephropathy, etc

High-dose ARB is more effective than High-dose ARB is more effective than low-dose ARB in the prevention of CVD in low-dose ARB in the prevention of CVD in patients with diabetic nephropathy or patients with diabetic nephropathy or HF. HF.

However, it remains to be determined However, it remains to be determined which therapeutic strategy is more which therapeutic strategy is more effective, high-dose ARB or ARB plus effective, high-dose ARB or ARB plus CCB.CCB.

Ogawa H, et al. Hypertens Res. 2009; 32: 575-580

OSCAR StudyOSCAR Study

OSCAR Study compared high-dose ARB OSCAR Study compared high-dose ARB vs. ARB plus CCB in the prevention of vs. ARB plus CCB in the prevention of cardiovascular events in high-risk cardiovascular events in high-risk Japanese elderly hypertensive patientsJapanese elderly hypertensive patients

Multicenter, active-controlled, two-Multicenter, active-controlled, two-arm, parallel group comparison using arm, parallel group comparison using PROBE methodPROBE method

Enrolment from June 2005 to May 2007 Enrolment from June 2005 to May 2007 with 3yrs. follow-upwith 3yrs. follow-up

Conducted at 134 institutions in JapanConducted at 134 institutions in Japan


Other drugs**Other drugs**

Other drugs**Other drugs**

Study DesignStudy Design

Registration/Registration/randomizationrandomization

High-dose ARB groupHigh-dose ARB group

Step 2Step 2

Step 1Step 1

ScreeningScreening

Olmesartan (20 mg)Olmesartan (20 mg)

Run-in treatmentRun-in treatment



Calcium channel blocker*Calcium channel blocker*

ARB plus CCB groupARB plus CCB group

** Azelnidipine or Amlodipine. Azelnidipine or Amlodipine.**Other than ARBs, ACEIs, and **Other than ARBs, ACEIs, and

CCBs.CCBs. Ogawa H, et al. Ogawa H, et al. Hypertens ResHypertens Res. 2009; 32: 575-580. 2009; 32: 575-580

3 years3 years

Inclusion CriteriaInclusion Criteria

Outpatients aged 65-84 yearsOutpatients aged 65-84 years

Olmesartan 20 mg/day monotherapy Olmesartan 20 mg/day monotherapy with SBP ≥140 mmHg and/or DBP ≥90 with SBP ≥140 mmHg and/or DBP ≥90 mmHgmmHg

At least one of the following CV risk At least one of the following CV risk factors: factors: 　　– Cerebrovascular diseaseCerebrovascular disease– Cardiac diseaseCardiac disease– Vascular diseaseVascular disease– Renal dysfuntionRenal dysfuntion– Type 2 DMType 2 DM


Primary EndpointsPrimary Endpoints

Composite of :Composite of :

Fatal and nonfatal CV eventsFatal and nonfatal CV events– Cerebrovascular disease Cerebrovascular disease – Coronary artery disease Coronary artery disease – HFHF– Other arteriosclerotic diseases Other arteriosclerotic diseases – Diabetic microvascular diseases Diabetic microvascular diseases – Renal dysfunctionRenal dysfunction

Non-CV deathNon-CV death


Secondary EndpointsSecondary Endpoints

Incidence of each CV eventIncidence of each CV event

Blood pressure (SBP, DBP) changeBlood pressure (SBP, DBP) change

Serious AEs other than primary Serious AEs other than primary endpointsendpoints


Statistical analysisStatistical analysis

ITT principleITT principle

Primary endpoint: Log-rank test stratified Primary endpoint: Log-rank test stratified by gender, age, and risk factors (baseline by gender, age, and risk factors (baseline CV disease and type2 DM)CV disease and type2 DM)

HR and 95%CI were calculated by stratified HR and 95%CI were calculated by stratified Cox proportional hazards model.Cox proportional hazards model.

Subgroup analysis (predefined)Subgroup analysis (predefined)Interaction-P between CV disease Interaction-P between CV disease (Cerebrovascular disease, Cardiac disease, (Cerebrovascular disease, Cardiac disease, Vascular disease, Renal dysfunction) andVascular disease, Renal dysfunction) andonly type2 DM was estimated.only type2 DM was estimated.


Overview of DispositionOverview of Disposition of Patients of Patients

1,217 1,217 pts. pts. randomizedrandomized1,217 1,217 pts. pts.

randomizedrandomized53 pts. excluded53 pts. excluded

-17 withdrew consent before trial -17 withdrew consent before trial phasephase-36 no data after randomization-36 no data after randomization

53 pts. excluded53 pts. excluded-17 withdrew consent before trial -17 withdrew consent before trial phasephase-36 no data after randomization-36 no data after randomization

578578 assigned assignedhigh-dose ARB grouphigh-dose ARB group(olmesartan 40 mg)(olmesartan 40 mg)

578578 assigned assignedhigh-dose ARB grouphigh-dose ARB group(olmesartan 40 mg)(olmesartan 40 mg)

586586 assigned assignedARB (olmesartan 20 mg)ARB (olmesartan 20 mg)plus CCB (azelnidipine or plus CCB (azelnidipine or

amlodipine) groupamlodipine) group

586586 assigned assignedARB (olmesartan 20 mg)ARB (olmesartan 20 mg)plus CCB (azelnidipine or plus CCB (azelnidipine or

amlodipine) groupamlodipine) group

39 withdrew consent39 withdrew consent31 lost to follow-up31 lost to follow-up11 refused follow-up 11 refused follow-up

from sites from sites

39 withdrew consent39 withdrew consent31 lost to follow-up31 lost to follow-up11 refused follow-up 11 refused follow-up

from sites from sites

578578 available for available forITT analysesITT analyses

578578 available for available forITT analysesITT analyses

31 withdrew 31 withdrew consentconsent

28 lost to follow-up28 lost to follow-up10 refused follow-10 refused follow-

up up from sitesfrom sites

31 withdrew 31 withdrew consentconsent

28 lost to follow-up28 lost to follow-up10 refused follow-10 refused follow-

up up from sitesfrom sites586 586 available foravailable for

ITT analysesITT analyses586 586 available foravailable for

ITT analysesITT analyses

Late-breaking clinical trial ACC 60th Annual ScientificLate-breaking clinical trial ACC 60th Annual Scientific session, April 5, 2011, in New Orleans session, April 5, 2011, in New Orleans

1,164 1,164 pts. evaluablepts. evaluableBPBP≥≥140/90 mmHg by olmesartan 20 mg140/90 mmHg by olmesartan 20 mg

1,164 1,164 pts. evaluablepts. evaluableBPBP≥≥140/90 mmHg by olmesartan 20 mg140/90 mmHg by olmesartan 20 mg

High-dose High-dose ARBARB

(n=578)(n=578)

ARB plus ARB plus CCBCCB

(n=586)(n=586)P value*P value*

Male, n (Male, n ()) 254 (43.9) 254 (43.9) 261 (44.5) 261 (44.5) 0.83820.8382

Age (years)Age (years) 73.673.65.3 5.3 73.673.65.5 5.5 0.86270.8627

BMI (kg/mBMI (kg/m22)) 24.324.33.7 3.7 23.823.83.5 3.5 0.02160.0216

Systolic BP (mmHg)Systolic BP (mmHg) 158.2158.212.6 12.6 157.2157.211.3 11.3 0.15120.1512

Diastolic BP (mmHg)Diastolic BP (mmHg) 85.285.210.1 10.1 84.684.69.8 9.8 0.31820.3182

Heart rate (bpm)Heart rate (bpm) 73.973.99.7 9.7 72.972.99.4 9.4 0.09200.0920

eGFR (mL/min/1.73 meGFR (mL/min/1.73 m22)) 66.566.518.6 18.6 67.967.918.8 18.8 0.23230.2323

Current smoker, n (Current smoker, n ()) 62 (10.8) 62 (10.8) 53 (9.0) 53 (9.0) 0.33130.3313

Current alcohol, n (Current alcohol, n ()) 178 (31.0) 178 (31.0) 193 (33.0) 193 (33.0) 0.44540.4454

History of cardiovascular History of cardiovascular diseasedisease Stroke Stroke Myocardial infarction Myocardial infarction Heart failure Heart failure

405 (70.1)405 (70.1)111 (19.2)111 (19.2)

16 (2.8)16 (2.8)41 (7.1)41 (7.1)

407 (69.5)407 (69.5)96 (16.4)96 (16.4)21 (3.6)21 (3.6)48 (8.2)48 (8.2)

0.81920.81920.20810.20810.42780.42780.48100.4810

Type 2 diabetes Type 2 diabetes 309 (53.5)309 (53.5) 319 (54.4)319 (54.4) 0.73820.7382

Baseline CharacteristicsBaseline Characteristics

Data are mean±SD (Data are mean±SD () ) **tt-tests or -tests or χχ22-tests-testsData are mean±SD (Data are mean±SD () ) **tt-tests or -tests or χχ22-tests-tests


Time-course of SBP and DBPTime-course of SBP and DBP

160160

140140

120120

100100

8080

6060

4040

2020

00 66 1212 1818 2424 3030 3636

180180(mmHg)(mmHg)

00

High-dose ARBHigh-dose ARB

ARB plus CCBARB plus CCB

Systolic BPSystolic BP

Diastolic BPDiastolic BP

(months)(months)


*P<0.05 between groups (adjusted by Holm’s *P<0.05 between groups (adjusted by Holm’s method)method)

*P<0.05 between groups (adjusted by Holm’s *P<0.05 between groups (adjusted by Holm’s method)method)

**

**** ** **

** ** ****

**

**

Primary Composite EndpointPrimary Composite Endpoint

1010

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2020(%)(%)

00

High-dose ARB (58 events)High-dose ARB (58 events)

ARB plus CCB (48 events)ARB plus CCB (48 events)

HR=1.31 (95%CI, 0.89-1.92) HR=1.31 (95%CI, 0.89-1.92) P=0.1717P=0.1717

(months)(months)

ARB plus CCBARB plus CCBHigh-dose ARBHigh-dose ARB

No. at riskNo. at risk578578 559559 526526 505505 477477 460460 450450586586 579579 553553 533533 507507 494494 478478


　　　　　　　　　　 Primary and Secondary Primary and Secondary EndpointsEndpoints

High-dose ARBHigh-dose ARB(n=578)(n=578)

ARB plus CCBARB plus CCB(n=586)(n=586)

No. patients with eventNo. patients with event

HR (95HR (95CI)CI) P valueP value

High-dose ARBHigh-dose ARBbetterbetter

ARB plus CCBARB plus CCBbetterbetter

00 11 22 33 44

Primary composite endpointPrimary composite endpoint

Fatal and nonfatal Fatal and nonfatal cardiovascular eventcardiovascular event

Cerebrovascular diseaseCerebrovascular disease

Coronary artery diseaseCoronary artery disease

Heart failureHeart failure

Other arteriosclerotic diseaseOther arteriosclerotic disease

Diabetic complicationsDiabetic complications

Renal dysfunctionRenal dysfunction

Non-CV deathNon-CV death

5858

4949

2424

66

1212

33

22

22

99

4848

3737

1515

77

88

22

44

11

1111

1.31 (0.89-1.92)1.31 (0.89-1.92)

1.44 (0.94-2.21)1.44 (0.94-2.21)

1.75 (0.92-3.35)1.75 (0.92-3.35)

0.92 (0.31-2.75)0.92 (0.31-2.75)

1.56 (0.64-3.83)1.56 (0.64-3.83)

1.88 (0.31-11.25)1.88 (0.31-11.25)

0.54 (0.10-2.94)0.54 (0.10-2.94)

2.39 (0.21-26.71)2.39 (0.21-26.71)

0.85 (0.35-2.06)0.85 (0.35-2.06)

0.17170.1717

0.09100.0910

0.08480.0848

0.88420.8842

0.32510.3251

0.48420.4842

0.46570.4657

0.46530.4653

0.72030.7203


Secondary endpointSecondary endpoint

Primary Composite Endpoint Primary Composite Endpoint in Patients with Cardiovascular Diseasein Patients with Cardiovascular Disease

ARB plus CCBARB plus CCBHigh-dose ARBHigh-dose ARB

No. at riskNo. at risk405405 391391 364364 346346 329329 315315 306306407407 404404 387387 369369 352352 344344 331331

1010

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2020

00

High-dose ARB (51 events)High-dose ARB (51 events)

ARB plus CCB (34 events)ARB plus CCB (34 events)

HR=1.63 (95%CI, 1.06-2.52) HR=1.63 (95%CI, 1.06-2.52) P=0.0261 P=0.0261 （（ log-rank testlog-rank test ））

(%)(%)

(months)(months)


00 66 1212 1818 2424 3030 3636(months)(months)


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2020

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(%)(%)

1010

HR=1.63 (95%CI, 1.06-2.52) HR=1.63 (95%CI, 1.06-2.52) P=0.0261P=0.0261

High-dose ARB (51 events / 405 pts.)High-dose ARB (51 events / 405 pts.)

ARB plus CCB (34 events / 407 pts.)ARB plus CCB (34 events / 407 pts.)

Cardiovascular Disease(+)Cardiovascular Disease(+)Cardiovascular Disease(+)Cardiovascular Disease(+)

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HR=0.52 (95% CI 0.21-1.28) HR=0.52 (95% CI 0.21-1.28) P=0.1445P=0.1445

High-dose ARBHigh-dose ARB (7 events / 173 pts.)(7 events / 173 pts.)

ARB plus CCB (14 eventsARB plus CCB (14 events / 179 pts.)/ 179 pts.)

2020

00

(%)(%)

Interaction P = 0.0241Interaction P = 0.0241Interaction P = 0.0241Interaction P = 0.0241

Primary Composite Endpoint in SubgroupPrimary Composite Endpoint in Subgroupof Patients with CVD or only Type 2 DMof Patients with CVD or only Type 2 DM

Cardiovascular Disease(-)Cardiovascular Disease(-)(Only Type 2 Diabetes)(Only Type 2 Diabetes)

Cardiovascular Disease(-)Cardiovascular Disease(-)(Only Type 2 Diabetes)(Only Type 2 Diabetes)

Serious AEsSerious AEs

High-dose ARB High-dose ARB （（ N=578N=578 ））


（（ N=586N=586 ）） P valueP value

Serious AEsSerious AEs 47 (8.1%) 47 (8.1%) 51 (8.7%)51 (8.7%) 0.75230.7523

Cancer Cancer incidenceincidence 10 (1.7%)10 (1.7%) 21 (3.6%)21 (3.6%) 0.06720.0672

P values derived from Fisher’s exact test.P values derived from Fisher’s exact test.P values derived from Fisher’s exact test.P values derived from Fisher’s exact test.

Late-breaking clinical trial ACC 60th Annual Scientific session, April 5, 2011, in New Orleans

In the OSCAR study, BP was significantly lower in the In the OSCAR study, BP was significantly lower in the ARB plus CCB group than in the high-dose ARB group.ARB plus CCB group than in the high-dose ARB group.

There were no significant differences in primary There were no significant differences in primary endpoint rate between the high-dose ARB and the ARB endpoint rate between the high-dose ARB and the ARB plus CCB groups. plus CCB groups.

In subgroup of patients with history of CV disease, In subgroup of patients with history of CV disease, primary composite endpoint was significantly higher in primary composite endpoint was significantly higher in the high-dose ARB group than ARB plus CCB group the high-dose ARB group than ARB plus CCB group (P=0.0261). (P=0.0261).

Conversely, in the subgroup of patients with T2DM but Conversely, in the subgroup of patients with T2DM but with no other comorbid conditions, the rate of composite with no other comorbid conditions, the rate of composite primary endpoint was lower in the high-dose ARB group primary endpoint was lower in the high-dose ARB group than in the ARB plus CCB group (P=0.1445than in the ARB plus CCB group (P=0.1445).).

There was a significant treatment-by-subgroup There was a significant treatment-by-subgroup interaction for the primary endpoints for the subgroup interaction for the primary endpoints for the subgroup between cardiovascular disease and only the presence of between cardiovascular disease and only the presence of diabetes (P = 0.0241).diabetes (P = 0.0241).

SummarySummary

The OSCAR study, first large clinical trial to The OSCAR study, first large clinical trial to investigate the efficacy of high-dose ARB vs. investigate the efficacy of high-dose ARB vs. ARB plus CCB in high-risk elderly hypertensive ARB plus CCB in high-risk elderly hypertensive patients, did not show any differences in patients, did not show any differences in reducing CV events/non CV death.reducing CV events/non CV death.

ARB plus CCB was superior in reducing ARB plus CCB was superior in reducing CV CV events/events/non CV deathnon CV death in subgroup of patients with in subgroup of patients with history of CV disease.history of CV disease.

High-dose ARB seemed to prevent High-dose ARB seemed to prevent CV CV events/non CVevents/non CVdeathdeath in patients with diabetes alone in spite of in patients with diabetes alone in spite of the weakness in antihypertensive effect. the weakness in antihypertensive effect. Further study is needed.Further study is needed.

ConclusionConclusion

Back up slides

Achieved Blood PressureAchieved Blood Pressure

High-dose High-dose ARB ARB

(N=578)(N=578)


(N=586)(N=586) P valueP value

AchievedAchieved （％）（％）SBP >140 SBP >140 （（ mmHgmmHg ）） and and DBP >90DBP >90 （（ mmHmmHgg ））

SBP SBP （（ mmHgmmHg ）） **

DBP DBP （（ mmHgmmHg ）） **

62.8 62.8 (359)(359)

136±16.3136±16.3

74.6±10.474.6±10.4

70.770.7(413)(413)

133.4±14.7133.4±14.7

73.1±10.373.1±10.3

0.00410.0041

0.00160.0016

0.01400.0140

Late-breaking clinical trial ACC 60th Annual Scientific session, April 5, 2011, in New Orleans

** at 36 monthsat 36 months** at 36 monthsat 36 months

44

33

22

11

　　　　　　　　 Differences in BP between Differences in BP between GroupsGroups

00 66 1212 1818 2424 3030 3636

55(mmHg)(mmHg)

00

Systolic BPSystolic BP

Diastolic BPDiastolic BP

(months)(months)

Difference in means (High-dose ARB – ARB plus CCB)Difference in means (High-dose ARB – ARB plus CCB)


Membership of CommitteesMembership of Committees

Steering Committee: Steering Committee: Kikuo Arakawa (Chair), Hisao Ogawa, Shokei Kim-Kikuo Arakawa (Chair), Hisao Ogawa, Shokei Kim-Mitsuyama, Tomio JinnouchiMitsuyama, Tomio Jinnouchi

Endpoint Committee: Endpoint Committee: Shuichi Oshima, Yoichiro Hashimoto, Takamichi Shuichi Oshima, Yoichiro Hashimoto, Takamichi NakamuraNakamura

Data and Safety Monitoring Committee: Data and Safety Monitoring Committee: Yasuhiro Ogata, Toshiro YoneharaYasuhiro Ogata, Toshiro Yonehara

Ethics Committee: Ethics Committee: Takao Hashimoto, Ryo Nagao, Satoshi Asai, Wataru Takao Hashimoto, Ryo Nagao, Satoshi Asai, Wataru Shimizu, Hideko AguiShimizu, Hideko Agui

Study Statistician: Kunihiko MatsuiStudy Statistician: Kunihiko Matsui

Study Secretary: Hisao OgawaStudy Secretary: Hisao Ogawa


OSCAR Study GroupOSCAR Study Group

Aichi; Kenji Yamada. Akita; Goro Namekawa, Yasushi Suzuki, Aomori; Kenichi Kimura, Morio Aihara. Aichi; Kenji Yamada. Akita; Goro Namekawa, Yasushi Suzuki, Aomori; Kenichi Kimura, Morio Aihara. Chiba; Akiko Soyama, Michiko Yonemitsu, Tomotane Shishikura, Toshiyuki Imasawa. Ehime; Masahiro Chiba; Akiko Soyama, Michiko Yonemitsu, Tomotane Shishikura, Toshiyuki Imasawa. Ehime; Masahiro Hasui. Fukuoka; Hidenori Urata, Hiroshi Ikezono, Masahiko Seki, Masaki Munekiyo, Takatoshi Otonari, Hasui. Fukuoka; Hidenori Urata, Hiroshi Ikezono, Masahiko Seki, Masaki Munekiyo, Takatoshi Otonari, Tetsuya Ohtsubo, Yasunori Sawayama, Yoichi Hanaoka, Yoshinori Takajo, Yuji Taira. Fukushima; Tetsuya Ohtsubo, Yasunori Sawayama, Yoichi Hanaoka, Yoshinori Takajo, Yuji Taira. Fukushima; Kuniyoshi Shima. Gifu; Hiroyuki Ohbayashi. Hiroshima; Kazuya Shigenobu. Hokkaido; Chieko Kuniyoshi Shima. Gifu; Hiroyuki Ohbayashi. Hiroshima; Kazuya Shigenobu. Hokkaido; Chieko Imamoto, Hiromitsu Yokota, Kazuo Yamagata, Kouichi Kanda, Tateo Ogura, Toshio Tsubokura. Hyogo; Imamoto, Hiromitsu Yokota, Kazuo Yamagata, Kouichi Kanda, Tateo Ogura, Toshio Tsubokura. Hyogo; Akira Kosaka, Akira Tabuchi, Masaharu Shigenobu, Takatoshi Takamiya, Yasuki Makino, Yoshikazu Irie. Akira Kosaka, Akira Tabuchi, Masaharu Shigenobu, Takatoshi Takamiya, Yasuki Makino, Yoshikazu Irie. Kagawa; Hideyasu Kiyomoto, Hirofumi Hitomi. Kagoshima; Yasuhiro Hashiguchi, Yoshihiro Fukuoka, Kagawa; Hideyasu Kiyomoto, Hirofumi Hitomi. Kagoshima; Yasuhiro Hashiguchi, Yoshihiro Fukuoka, Yoshitaka Shintomi. Kanagawa; Fusahiro Nonaka, Hiroshi Takeda, Masato Nishimura, Nariaki Yoshitaka Shintomi. Kanagawa; Fusahiro Nonaka, Hiroshi Takeda, Masato Nishimura, Nariaki Kanemoto, Takayuki Furuki. Kumamoto; Akira Maki, Akira Sato, Eiichiro Tanaka, Etsuro Tsutsumi, Kanemoto, Takayuki Furuki. Kumamoto; Akira Maki, Akira Sato, Eiichiro Tanaka, Etsuro Tsutsumi, Hajime Shono, Haruo Takeda, Hideaki Jinnouchi, Hirofumi Kann, Hiromi Fujii, Hiroyuki Shono, Hisao Hajime Shono, Haruo Takeda, Hideaki Jinnouchi, Hirofumi Kann, Hiromi Fujii, Hiroyuki Shono, Hisao Fujimoto, Hisayasu Terazaki, Junichi Matsubara, Kazuhiko Yamada, Kazuhiro Nishigami, Keiichiro Fujimoto, Hisayasu Terazaki, Junichi Matsubara, Kazuhiko Yamada, Kazuhiro Nishigami, Keiichiro Tsuruta, Kenichi Koyama, Kenji Azuma, Koichiro Kataoka, Koji Sasaki, Kouji Honjio, Kunihiro Ohmori, Tsuruta, Kenichi Koyama, Kenji Azuma, Koichiro Kataoka, Koji Sasaki, Kouji Honjio, Kunihiro Ohmori, Kunio Idegami, Masakazu Matsukawa, Masamitsu Toihata, Mikiko Suematsu, Motoko Tanaka, Osamu Kunio Idegami, Masakazu Matsukawa, Masamitsu Toihata, Mikiko Suematsu, Motoko Tanaka, Osamu Hashiguchi, Ryo Fukami, Seiko Fujimoto, Shinichi Uemura, Shiro Mimori, Shojiro Naomi, Shouji Hashiguchi, Ryo Fukami, Seiko Fujimoto, Shinichi Uemura, Shiro Mimori, Shojiro Naomi, Shouji Maruta, Shuichi Matsuo, Sunao Kojima, Taiji Sekigami, Takashi Fukunaga, Takashi Kudoh, Takashi Maruta, Shuichi Matsuo, Sunao Kojima, Taiji Sekigami, Takashi Fukunaga, Takashi Kudoh, Takashi Ono, Takeshi Koga, Tomio Wakita, Tomohiro Sawada, Toshihiko Sakanashi, Toshihiro Higashi, Yasuhiro Ono, Takeshi Koga, Tomio Wakita, Tomohiro Sawada, Toshihiko Sakanashi, Toshihiro Higashi, Yasuhiro Nagayoshi, Yasuhiro Sakamoto, Yoshihiro Kimura, Yuji Miyao, Yutaka Horio, Kyoto; Ken Takenaka. Nagayoshi, Yasuhiro Sakamoto, Yoshihiro Kimura, Yuji Miyao, Yutaka Horio, Kyoto; Ken Takenaka. Miyazaki; Hiroshi Senokuchi, Hirotsugu Ohta, Juniti Miyata, Naoto Yokota, Takeshi Yamamoto. Miyazaki; Hiroshi Senokuchi, Hirotsugu Ohta, Juniti Miyata, Naoto Yokota, Takeshi Yamamoto. Nagasaki; Hiroyuki Oka, Yoshito Tanioka, Niigata; Toshihide Shu. Okayama; Hirohiko Asonuma, Naoki Nagasaki; Hiroyuki Oka, Yoshito Tanioka, Niigata; Toshihide Shu. Okayama; Hirohiko Asonuma, Naoki Kashihara, Naruya Tomita, Takehiko Tokura, Tamaki Sasaki. Osaka; Hidenori Koyama, katsuo Suyama, Kashihara, Naruya Tomita, Takehiko Tokura, Tamaki Sasaki. Osaka; Hidenori Koyama, katsuo Suyama, Kenei Shimada, Masahito Imanishi, Masanori Emoto, Masayuki Hosoi, Masayuki Nagata, Nobuo Kenei Shimada, Masahito Imanishi, Masanori Emoto, Masayuki Hosoi, Masayuki Nagata, Nobuo Wakaki, Shiro Yanagi, Takao Yoshioka, Takeshi Horio, Tetsuya Hayashi. Saga; Kazuo Moroe, Shiro Wakaki, Shiro Yanagi, Takao Yoshioka, Takeshi Horio, Tetsuya Hayashi. Saga; Kazuo Moroe, Shiro Hata. Saitama; Hideto Muranaka, Masaru Arai, Shouji Mashiba, Souichirou Ishimoto, Tadahiko Hata. Saitama; Hideto Muranaka, Masaru Arai, Shouji Mashiba, Souichirou Ishimoto, Tadahiko Ogasawara, Tomoya Fujino, Tomoyuki Okudaira. Shimane; Yuko Yamane. Shizuoka; Masako Waki. Ogasawara, Tomoya Fujino, Tomoyuki Okudaira. Shimane; Yuko Yamane. Shizuoka; Masako Waki. Tokushima; Akira Ota. Kazuto Okagawa, Kenzo Motoki, Takashi Iwase. Tokyo; Akihiko Hachiya, Hiromi Tokushima; Akira Ota. Kazuto Okagawa, Kenzo Motoki, Takashi Iwase. Tokyo; Akihiko Hachiya, Hiromi Takekawa, Kenzo Matsumura, Masato Yamamoto, Minoru Hojo, Shiho Kaku, Tetsuya Taniguchi, Takekawa, Kenzo Matsumura, Masato Yamamoto, Minoru Hojo, Shiho Kaku, Tetsuya Taniguchi, Yasunaga Hiyoshi, Yutaka Shimizu. Yamaguchi; Hideaki Hanamiya.Yasunaga Hiyoshi, Yutaka Shimizu. Yamaguchi; Hideaki Hanamiya.Late-breaking clinical trial ACC 60th Annual ScientificLate-breaking clinical trial ACC 60th Annual Scientific session, April 5, 2011, in New Orleans session, April 5, 2011, in New Orleans

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