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第五届中第五届中- -日心血管论坛日心血管论坛 Masakazu Yamagishi , MD, FACCMasakazu Yamagishi , MD, FACC Division of Cardiovascular Medicine,Division of Cardiovascular Medicine, Kanazawa University Graduate School of Medicine, Kanazawa University Graduate School of Medicine, Kanazawa, JAPANKanazawa, JAPAN 危险因素的强化干预对冠状动脉疾病危险因素的强化干预对冠状动脉疾病 的进展或消退的作用的进展或消退的作用 申明申明 本研究曾得到Kowa和Shionogi制药公司的赞助. KFCKFC McDMcD Olympics inOlympics in TokyoTokyo Changes in Cholesterol Levels in Japan and USChanges in Cholesterol Levels in Japan and US Increased PCI Even University HospitalIncreased PCI Even University Hospital 200320042005200620072008 左主干病变左主干病变 经皮冠脉介入治疗前 经皮冠脉介入治疗经皮冠脉介入治疗 经皮冠脉介入治疗经皮冠脉介入治疗 经皮冠脉介入治疗经皮冠脉介入治疗 经皮冠脉介入治疗经皮冠脉介入治疗 再狭窄再狭窄 再狭窄再狭窄 再狭窄再狭窄 再再- -再狭窄再狭窄 冠脉搭桥 日本金泽市心脏研究所成员 横浜栄共済病院横浜栄共済病院 富山赤十字病院富山赤十字病院 石川県立中央病院石川県立中央病院 福井県立病院福井県立病院 金沢循環器病院金沢循環器病院 福井循環器病院福井循環器病院 加賀市民病院加賀市民病院 金沢社保病院金沢社保病院 小松市民病院小松市民病院 芳珠記念病院芳珠記念病院 KKRKKR北陸病院北陸病院 舞鶴共済病院舞鶴共済病院 済生会金沢病院済生会金沢病院 高岡市民病院高岡市民病院 金沢大学附属病院金沢大学附属病院 厚生連高岡病院厚生連高岡病院 SubjectsSubjects Number of PCI ACS Male Age Number of risk factors Number of diseased branch Initial success rate 9392 2680 (28.5%) 7128 (75.9%) 68.910.5 2.24 1.64 98.2% 左主干病变左主干病变:随访随访 0200400600 800 1000 1200 P=N.S. 再狭窄発生例(BMS) 累積非再狭窄経過率(BMS) 再狭窄発生例(DES) 累積非再狭窄経過率(DES) Kaplan-Meier法 0 20 40 60 80 100 (%) (天) SYNTAXSYNTAX试验试验 主要不良事件主要发生在 SYNTAX积分高患者行PCI后 COURAGE 研究(血运重建和强化药物的临床评价) 强化药物治疗 PCI 01375624 1.0 0.6 0.9 0.7 0.5 0.8 0 无任何原因死亡或心梗发生的存活率 年 危险比, 1.05; 95%可信区间 (0.87-1.27); p=0.62 (Boden WE. et al.: NEJM 2007:356: 1503) 日本-急性冠脉综合征 普伐他汀 和阿托伐他汀在急性冠脉综合征日本人群的评估 Takeshi Kimura (Kyoto University) Takeshi Morimoto (Kyoto University) Izumi Miki (Kyoto University) Saeko Minematsu (Kyoto University) Takafumi Hiro (Yamaguchi University) Hiroko Kanou(Yamaguchi University) Katsumi Miyauchi (Juntendo University) Natsuko Yamamoto(Juntendo University) Yoshihisa Nakagawa (Tenri Hospital) Yukio Ozaki (Fujita Health University) Masakazu Yamagishi (Kanazawa University) Tetsu Yamaguchi (Toranomon Hospital) Satoshi Saito (Nihon University) Kazuo Kimura (Yokohama City University Medical Center) Hiroyuki Daida (Juntendo University) Masunori Matsuzaki (Yamaguchi University) for the JAPAN-ACS Investigators 终终点 : % 远远离靶病变变5mm以上的位置斑块变块变化体积积百分比 纳纳入标标准 : 诊诊断为为急性冠脉综综合征的患者同时时在IVUS指导导下成功进进行了PCI 研究起止时间时间 : 2005.11.1. 2007.10.31. ( 注册时间时间: - 2006.10.31.) 项项目负责负责人: Masunori Matsuzaki 秘书书: Hiroyuki Daida, Takeshi Kimura 参加人员员 : Katsumi Miyauchi, Yoshihisa Nakagawa, Masakazu Yamagishi, Yukio Ozaki, Takafumi Hiro PCI IVUS 72 小时时后8 - 12 个月 IVUS 普伐他汀普伐他汀 4mg/day4mg/day 阿托伐他汀 20mg /day/day 知情同意书书 随机给给予 Circ J 2006;70:16241628 急性冠脉综综 合征 研究方案 根据性别别、有无糖尿病 和入院时时胆固醇水平进进 行危险险分层层 血脂指标的变化血脂指标的变化 阿托伐他汀 普伐他汀 低密度脂蛋 白胆固醇 甘油三 酯酯 高密度脂 蛋白胆固 醇 非高密度脂蛋白 胆固醇 (%) ( ): 患者数目, meanSD 双样样本 t-检验检验 (两组间组间), 单样单样本 t检验检验 (each group) * : p 0.01, * : p 0.001 高密度脂 蛋白胆固 醇 40mg/dL 基线水平 -40 -30 -20 -10 0 10 20 30 -35.8 22.9 -36.2 19.5 * p=0.9 -30.1 20.8 -30.5 18.9 21.2 75.5 16.2 59.9 9.9 23.5 8.0 21.4 * * * * * * 20.6 24.6 10.8 25.3 * * (39)(46) p=0.08 (124)(125) (124)(124) (124)(125) (122) (123) p=0.6 p=0.5 p=0.9 (Hiro T et al JACC 2009)(Hiro T et al JACC 2009) 术前术后 ID # 008 64岁岁,男性 基线线 (mm3) 斑块容积=84.6 血管容积=168.8 管腔容积=84.2 随访访(mm3) 斑块容积=71.8 血管容积=163.7 管腔容积=91.8 变变化百分比 斑块容积=-15.1 % 血管容积=-3.0% 管腔容积=+9.0% (Hiro T et al JACC 2009)(Hiro T et al JACC 2009) 72nd Annual Scientific Meeting of the Japanese Circulation Society : Late Breaking Clinical Trial Session 斑块容积的变化斑块容积的变化 均值值标标准差 单样单样本 t-检验检验 阿托伐他汀(n=127) 普伐他汀(n=125) -20 -18 -16 -14 -12 -10 -8 -6 -4 -2 0 (%) p=0.5 p=0.5 斑块块容积变积变化的百 分比 斑块块容积积百分比的变变 化 标标准化的斑块块容积变积变化 -12 -10 -8 -6 -4 -2 0 -14 p=0.3 (mm3) 斑块容积变化的均值斑块容积变化的均值 -18.1 14.2 * -16.9 13.9 * -6.26 6.15 * -5.73 6.26 * -9.82 8.58 * -8.75 8.20 * (Hiro T et al JACC 2009)(Hiro T et al JACC 2009) ESTABLISH (ATV 20 mg) JAPAN-ACS (PTV 4 mg) (ATV 20 mg) ESTABLISH () 逆转 (普伐他汀 40 mg)逆转 (阿托伐他汀 80 mg) ASTEROID* (RSV 40mg) A-PLUS () (mg/dL) LDL-C(mean value) -20 -10 0 10 6080100120 Overseas, Chronic Phase JAPAN、Acute Phase(ACS) *标准化的总的斑块容积 ASTEROID: JAMA 2006,295:1556-1565 ESTABLISH: Circulation 2004,110:1061-1068. REVERSAL: JAMA 2004;291:1071-1080JAPAN-ACS: 72th JCS Late Breaking Clinical Trials A-PLUS: Circulation 2004,110;3372-3377 (%) R2=0.7617 R2=0.8807 低密度脂蛋白水平和斑块消退 体積変化率(平均値) The 73rd Annual Scientific Meeting of the Japanese Circulation Society :Late Breaking Clinical Trials II 血管内超声检测罗伐他汀日本冠状动脉粥样硬化人群 中作用的研究 COSMOS Hiroyuki Daida Juntendo University Tadateru Takayama Nihon University Takafumi Hiro Yamaguchi University Masakazu Yamagishi Kanazawa University Atsushi Hirayama Nihon University Satoshi Saito Nihon University Tetsu Yamaguchi Toranomon Hospital Masunori Matsuzaki Yamaguchi University on behalf of COSMOS investigators ClinicalT Identifier: NCT00329160, Sponsors and Collaborators: AstraZeneca Shionogi, Phase: Phase IV The 73rd Annual Scientific Meeting of the Japanese Circulation Society :Late Breaking Clinical Trials II 研究方案研究方案 就诊诊周数: -1 -8 筛选筛选 0 0 7 28 8 32 9 36 10 40 11 44 12 48 13 52 14 56 15 60 16 64 17 68 18 72 19 76 6 24 5 20 4 16 3 12 2 8 1 4 血管内超声/冠脉 造影 血脂水平 超敏C-反应应 蛋白 血管内超声/冠脉造 影 血脂水平 超敏C-反应应蛋白 血脂水平 血脂水平 超敏C反应应蛋白 血脂水平 罗罗伐他汀2.5 - 20 mg Takayama T et al. Circ. J 2007;71 (2) :271-275 从 2.5 mg/day开始,如果低密度脂蛋白胆固醇仍高于80 mg/dL , 剂剂量逐渐渐增加至 20 mg/day 1) 20-75 岁岁 2) 冠心病需行PCI的患者 3) 高胆固醇血症 A) 未干预预的人群: 低密度脂蛋白胆固醇 B) 曾接受过过治疗疗的患者: 140mg/dL 或总总胆固醇220mg/dL 低密度脂蛋白胆固醇 100mg/dL或 总总胆固醇180mg/dL 4) PCI病变变: 75%, 靶病变变: 50%狭窄 The 73rd Annual Scientific Meeting of the Japanese Circulation Society :Late Breaking Clinical Trials II 血脂指标的变化血脂指标的变化 -4.8 +19.8 -38.6 -47.5 -50 0 50 (%)甘油三酯(mg/dL)高密度脂蛋白 胆固醇(mg/dL) 低密度脂蛋白 胆固醇 (mg/dL) LDL-C/ HDL-C 比 p0.0001 p=0.1639 p0.0001 p0.0001 140.2 82.9 47.1 55.2 147.8 130.3 3.12 1.56 基线 随访 p value : 随访 vs. 基线水平 变化百分比的平均值 n=126 The 73rd Annual Scientific Meeting of the Japanese Circulation Society :Late Breaking Clinical Trials II Case: 53岁岁 女性 右冠#2 基线线随访访(76周) 病例报告病例报告 The 73rd Annual Scientific Meeting of the Japanese Circulation Society :Late Breaking Clinical Trials II 冠脉容积指标的变化冠脉容积指标的变化 (%) 斑块容积管径容积血管容积 p0.0001 p=0.4673 p0.0001 -10 -5 0 5 10 +7.25 -5.07 +0.76 变化百分比均值 n=126 Takayama T et al. Circ. J 2009 in press The 73rd Annual Scientific Meeting of the Japanese Circulation Society :Late Breaking Clinical Trials II 低密度脂蛋白胆固醇水平和斑块容积变化百分比的关系低密度脂蛋白胆固醇水平和斑块容积变化百分比的关系 ESTABLISH (ATV 20 mg) ASTEROID: JAMA 2006,295:1556-1565 ESTABLISH: Circulation 2004,110:1061-1068. REVERSAL: JAMA 2004;291:1071-1080JAPAN-ACS: 72th JCS Late Breaking Clinical Trials A-PLUS: Circulation 2004,110;3372-3377 JAPAN-ACS (PTV 4 mg) (ATV 20 mg) ESTABLISH (Placebo) Japanese, ACS R2=0.7617 (mg/dL) Mean LDL-C -20 -10 0 10 6080100120 斑块容积变化百分比 (%) *normalized total plaque volume REVERSAL (PRV 40 mg) REVERSAL (ATV 80 mg) ASTEROID* (RSV 40mg) A-PLUS (Placebo) Western, stable R2=0.8807 COSMOS (RSV 2.5-20 mg) The 73rd Annual Scientific Meeting of the Japanese Circulation Society :Late Breaking Clinical Trials II 糖尿病患者斑块容积负向变化糖尿病患者斑块容积负向变化 -6 -3 0 25 n=69 25 n=57 基线体重指数 6.5 n=32 6.5 n=94 基线糖化血红蛋白 -6.10* -3.82 -6.53* -0.78 p=0.3682 p=0.0454 变化百分比均值 (%) *:p0.02 (follow-up vs. baseline) LDL-CLDL-C Vascular Vascular eventsevents HypertensionHypertension DMDM SmokingSmoking StressStress LDL-C and Other Risk FactorsLDL-C and Other Risk Factors HDL-CHDL-C The 73rd Annual Scientific Meeting of the Japanese Circulation Society :Late Breaking Clinical Trials II Change in Lipid ParametersChange in Lipid Parameters -4.8 +19.8 -38.6 -47.5 -50 0 50 (%)TG (mg/dL) HDL-C (mg/dL) LDL-C (mg/dL) LDL-C/ HDL-C ratio p0.0001 p=0.1639 p0.0001 p0.0001 140.2 82.9 47.1 55.2 147.8 130.3 3.12 1.56 Baseline Follow-up p value : follow-up vs. baseline Mean % Change n=126 (Takayama T et al. Circ. J 2009 in press) liver macrophage CHOL pool LDLR ABCG1 ABCA1 VLDL LDL SR-BI SR-BI ABCA1 apoA-I HDL pre- HDL CETP CD36 Nissen S et al. NEJM 2007(改) Enhanced LDL-C Extraction Through SR-B1 by Enhanced LDL-C Extraction Through SR-B1 by Serum From CETPSerum From CETP DeficiencyDeficiency 0 10 20 30 with anti-SRBI antibody (750:1) 3H-cholesterol efflux (%) without anti-SRBI antibody net efflux CETP欠損症 Homozygotes (n=3) CETP欠損症 Heterozygotes (n=5) Controls (n=10) Miwa K, Kawashiri M, Yamagishi M et al.: Clin Chem Acta 2009 LDL-CLDL-C Vascular Vascular eventsevents HypertensionHypertension DMDM SmokingSmoking StressStress LDL-C and Other Risk FactorsLDL-C and Other Risk Factors HDL-CHDL-C 再会於金沢再会於金沢 金沢城兼六園 主計町茶屋街 Subtitle Text The 5The 5th th China-Japan Cardiovascular Forum China-Japan Cardiovascular Forum Masakazu Yamagishi , MD, FACCMasakazu Yamagishi , MD, FACC Division of Cardiovascular Medicine,Division of Cardiovascular Medicine, Kanazawa University Graduate School of Medicine, Kanazawa University Graduate School of Medicine, Kanazawa, JAPANKanazawa, JAPAN Impact of Aggressive Treatment for Risk Impact of Aggressive Treatment for Risk Factors on Progression or Regression of Factors on Progression or Regression of Coronary Artery DiseaseCoronary Artery Disease Subtitle Text DisclosureDisclosure There is nothing for disclosure except modest supports from Kowa and Shionogi Pharmaceutical Companies. Subtitle Text Left Main LesionLeft Main Lesion Before PCI Subtitle Text PCIPCI Subtitle Text PCIPCI Subtitle Text PCIPCI Subtitle Text PCIPCI Subtitle Text PCIPCI Subtitle Text RestenosisRestenosis Subtitle Text RestenosisRestenosis Subtitle Text RestenosisRestenosis Subtitle Text Re-restenosisRe-restenosis CABG Subtitle Text Members of Kanazawa HeartMembers of Kanazawa Heart 横浜栄共済病院横浜栄共済病院 富山赤十字病院富山赤十字病院 石川県立中央病院石川県立中央病院 福井県立病院福井県立病院 金沢循環器病院金沢循環器病院 福井循環器病院福井循環器病院 加賀市民病院加賀市民病院 金沢社保病院金沢社保病院 小松市民病院小松市民病院 芳珠記念病院芳珠記念病院 KKRKKR北陸病院北陸病院 舞鶴共済病院舞鶴共済病院 済生会金沢病院済生会金沢病院 高岡市民病院高岡市民病院 金沢大学附属病院金沢大学附属病院 厚生連高岡病院厚生連高岡病院 Subtitle Text LMCALMCA:Follow-upFollow-up 0200400600 800 1000 1200 P=N.S. 再狭窄発生例(BMS) 累積非再狭窄経過率(BMS) 再狭窄発生例(DES) 累積非再狭窄経過率(DES) Kaplan-Meier法 0 20 40 60 80 100 (%) (days) Subtitle Text SYNTAX TrialSYNTAX Trial Mace more frequently occurs in patients with high SYNTAX scores after PCI. Subtitle Text COURAGE (Clinical outcomes utilizing revascularization and aggressive drug evaluation) Study Aggressive medical treatment PCI 01375624 1.0 0.6 0.9 0.7 0.5 0.8 0 Survival Free of Death from Any Cause and Myocardial Infarction 年 Hazzard ratio, 1.05; 95% CI (0.87-1.27); p=0.62 (Boden WE. et al.: NEJM 2007:356: 1503) Subtitle Text JAPAN-ACS Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome Takeshi Kimura (Kyoto University) Takeshi Morimoto (Kyoto University) Izumi Miki (Kyoto University) Saeko Minematsu (Kyoto University) Takafumi Hiro (Yamaguchi University) Hiroko Kanou(Yamaguchi University) Katsumi Miyauchi (Juntendo University) Natsuko Yamamoto(Juntendo University) Yoshihisa Nakagawa (Tenri Hospital) Yukio Ozaki (Fujita Health University) Masakazu Yamagishi (Kanazawa University) Tetsu Yamaguchi (Toranomon Hospital) Satoshi Saito (Nihon University) Kazuo Kimura (Yokohama City University Medical Center) Hiroyuki Daida (Juntendo University) Masunori Matsuzaki (Yamaguchi University) for the JAPAN-ACS Investigators Subtitle Text End point : % change in plaque volume at sites 5 mm apart from the culprit lesions Inclusion Criteria : Patients who have been diagnosed as acute coronary syndrome and with successful PCI by IVUS guidance Study period : 2005.11.1. 2007.10.31. ( Enrollment : - 2006.10.31.) Study chair : Masunori Matsuzaki Secretary : Hiroyuki Daida, Takeshi Kimura Working member : Katsumi Miyauchi, Yoshihisa Nakagawa, Masakazu Yamagishi, Yukio Ozaki, Takafumi Hiro PCI IVUS 72 hours8 - 12 months IVUS PitavastatinPitavastatin 4mg/day4mg/day Atorvastatin 20mg /day/day Informed consent Randomized Circ J 2006;70:16241628 Acute Coronary Syndrome Study Protocol stratified by: gender diabetes mellitus TC level on admission Subtitle Text Change in Lipid ParametersChange in Lipid Parameters Atorvastatin Pitavastatin LDL-CTGHDL-CNon-HDL-C (%) ( ): number of patients, meanSD 2 sample t-test (between groups), 1 sample t-test (each group) * : p 0.01, * : p 0.001 HDL-C 40mg/dL at baseline -40 -30 -20 -10 0 10 20 30 -35.8 22.9 -36.2 19.5 * p=0.9 -30.1 20.8 -30.5 18.9 21.2 75.5 16.2 59.9 9.9 23.5 8.0 21.4 * * * * * * 20.6 24.6 10.8 25.3 * * (39)(46) p=0.08 (124)(125) (124)(124) (124)(125) (122) (123) p=0.6 p=0.5 p=0.9 (Hiro T et al JACC 2009)(Hiro T et al JACC 2009) Subtitle Text BeforeAfter ID # 008 64y.o. male Baseline (mm3) Plaque Volume=84.6 Vessel Volume=168.8 Lumen Volume=84.2 Follow Up (mm3) Plaque Volume=71.8 Vessel Volume=163.7 Lumen Volume=91.8 % Change Plaque Volume=-15.1 % Vessel Volume=-3.0% Lumen Volume=+9.0% (Hiro T et al JACC 2009)(Hiro T et al JACC 2009) Subtitle Text Illustration of Change in Plaque VolumeIllustration of Change in Plaque Volume meanSD 1 sample t-test Subtitle Text Atorvastatin (n=127) Pitavastatin (n=125) -20 -18 -16 -14 -12 -10 -8 -6 -4 -2 0 (%) p=0.5 p=0.5 % Change in Plaque Volume Change in % Plaque Volume Change in Normalized Plaque Volume -12 -10 -8 -6 -4 -2 0 -14 p=0.3 (mm3) Mean Change in Plaque VolumeMean Change in Plaque Volume -18.1 14.2 * -16.9 13.9 * -6.26 6.15 * -5.73 6.26 * -9.82 8.58 * -8.75 8.20 * (Hiro T et al JACC 2009)(Hiro T et al JACC 2009) Subtitle Text ESTABLISH (ATV 20 mg) JAPAN-ACS (PTV 4 mg) (ATV 20 mg) ESTABLISH () REVERSAL (PRV 40 mg) REVERSAL (ATV 80 mg) ASTEROID* (RSV 40mg) A-PLUS () (mg/dL) LDL-C(mean value) -20 -10 0 10 6080100120 Overseas, Chronic Phase JAPAN、Acute Phase(ACS) *normalized total plaque volume ASTEROID: JAMA 2006,295:1556-1565 ESTABLISH: Circulation 2004,110:1061-1068. REVERSAL: JAMA 2004;291:1071-1080JAPAN-ACS: 72th JCS Late Breaking Clinical Trials A-PLUS: Circulation 2004,110;3372-3377 (%) R2=0.7617 R2=0.8807 LDL-C Levels and Plaque Regression 体積変化率(平均値) Subtitle Text COronary atherosclerosis Study Measuring effects Of rosuvastatin using intravascular ultrasound in Japanese Subjects COSMOS Hiroyuki Daida Juntendo University Tadateru Takayama Nihon University Takafumi Hiro Yamaguchi University Masakazu Yamagishi Kanazawa University Atsushi Hirayama Nihon University Satoshi Saito Nihon University Tetsu Yamaguchi Toranomon Hospital Masunori Matsuzaki Yamaguchi University on behalf of COSMOS investigators ClinicalT Identifier: NCT00329160, Sponsors and Collaborators: AstraZeneca Shionogi, Phase: Phase IV Subtitle Text Study ProtocolStudy Protocol Visit: Week: -1 -8 Screening 0 0 7 28 8 32 9 36 10 40 11 44 12 48 13 52 14 56 15 60 16 64 17 68 18 72 19 76 6 24 5 20 4 16 3 12 2 8 1 4 IVUS/CAG Lipid Levels hsCRP IVUS/CAG Lipid Levels hsCRP Lipid Levels Lipid Levels hsCRP Lipid Levels Rosuvastatin 2.5 - 20 mg Takayama T et al. Circ. J 2007;71 (2) :271-275 Treatment started with 2.5 mg/day, and if LDL-C80 mg/dL was not achieved, the dosage was titrated to 20 mg/day 1) 20-75 years old 2) Patients with CHD who required PCI 3) Hypercholesterolemia A) Untreated patients: LDL-C B) Prior use patients: LDL-C 140mg/dL or TC220mg/dL 100mg/dL or TC180mg/dL 4) PCI lesion: 75%, target lesion: 50% stenosis Subtitle Text Patient Flow 214 subjects enrolled Completed study n=126 IVUS not analyzable, Lost to follow up, Withdrew consent and others n=87 Rosuvastatin 2.5 - 20 mg/day n=213 Did not receive study drug n=1 Subtitle Text Change in Lipid ParametersChange in Lipid Parameters -4.8 +19.8 -38.6 -47.5 -50 0 50 (%)TG (mg/dL)
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