今日の臨床サポート

虚血性心疾患の外科的治療

著者: 稲葉博隆 順天堂大学 心臓血管外科

著者: 天野篤 順天堂大学 心臓血管外科

監修: 永井良三 自治医科大学

著者校正/監修レビュー済:2017/11/30

概要・推奨   

手術のまとめ:
  1. 虚血性心疾患の外科治療の中心は、虚血心筋に対する血行再建を行う冠動脈バイパス術である。
  1. 手術では、内胸動脈、右胃大網動脈、橈骨動脈、大伏在静脈などのバイパスグラフトを採取し、冠動脈に吻合する。
  1. 冠動脈バイパス術の血行再建の特徴は、病変部の末梢にバイパスグラフトを吻合して、末梢の心筋の血行再建を行うことにより、将来の冠動脈狭窄部の病変の進行とは無関係に、心筋虚血の改善が長期間期待できることである。
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
稲葉博隆 : 特に申告事項無し[2021年]
天野篤 : 特に申告事項無し[2021年]
監修:永井良三 : 未申告[2021年]

まとめ・診察

手術のまとめ  
  1. 虚血性心疾患の外科治療の中心は、虚血心筋に対する血行再建を行う冠動脈バイパス術である。
  1. 手術では、内胸動脈、右胃大網動脈、橈骨動脈、大伏在静脈などのバイパスグラフトを採取し、冠動脈に吻合する。
  1. 冠動脈バイパス術の血行再建の特徴は、冠動脈の狭窄病変、閉塞病変を治療することではなく、病変部の末梢にバイパスグラフトを吻合して、末梢の心筋の血行再建を行う点にある。
  1. この特徴により、将来の冠動脈狭窄部の病変の進行とは無関係に、心筋虚血の改善が長期間期待できることになる。
  1. 最近では、大動脈弁、僧帽弁、さらに大血管の病変を合併し、同時手術が必要になる症例が増加している。
  1. 心筋梗塞の機械的合併症である心室中隔穿孔、乳頭筋断裂による僧帽弁閉鎖不全症、自由壁破裂は予後不良であり、早期診断が不可欠である。
問診・診察のポイント  
  1. 狭心症の症状から、初診時における緊急性の有無を判断する[1]

これより先の閲覧には個人契約のトライアルまたはお申込みが必要です。

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文献 

著者: S Yusuf, D Zucker, P Peduzzi, L D Fisher, T Takaro, J W Kennedy, K Davis, T Killip, E Passamani, R Norris
雑誌名: Lancet. 1994 Aug 27;344(8922):563-70.
Abstract/Text We carried out a systematic overview using individual patient data from the seven randomised trials that have compared a strategy of initial coronary artery bypass graft (CABG) surgery with one of initial medical therapy to assess the effects on mortality in patients with stable coronary heart disease (stable angina not severe enough to necessitate surgery on grounds of symptoms alone, or myocardial infarction). 1324 patients were assigned CABG surgery and 1325 medical management between 1972 and 1984. The proportion of patients in the medical treatment group who had undergone CABG surgery was 25% at 5 years, 33% at 7 years, and 41% at 10 years: 93.7% of patients assigned to the surgery group underwent CABG surgery. The CABG group had significantly lower mortality than the medical treatment group at 5 years (10.2 vs 15.8%; odds ratio 0.61 [95% CI 0.48-0.77], p = 0.0001), 7 years (15.8 vs 21.7%; 0.68 [0.56-0.83], p < 0.001), and 10 years (26.4 vs 30.5%; 0.83 [0.70-0.98]; p = 0.03). The risk reduction was greater in patients with left main artery disease than in those with disease in three vessels or one or two vessels (odds ratios at 5 years 0.32, 0.58, and 0.77, respectively). Although relative risk reductions in subgroups defined by other baseline characteristics were similar, the absolute benefits of CABG surgery were most pronounced in patients in the highest risk categories. This effect was most evident when several prognostically important clinical and angiographic risk factors were integrated to stratify patients by risk levels and the extension of survival at 10 years was examined (change in survival -1.1 [SE 3.1] months in low-risk group, 5.0 [4.2] months in moderate-risk group, and 8.8 [5.4] months in high-risk group; p for trend < 0.003). A strategy of initial CABG surgery is associated with lower mortality than one of medical management with delayed surgery if necessary, especially in high-risk and medium-risk patients with stable coronary heart disease. In low-risk patients, the limited data show a non-significant trend towards greater mortality with CABG.

PMID 7914958  Lancet. 1994 Aug 27;344(8922):563-70.
著者: Whady Hueb, Neuza Lopes, Bernard J Gersh, Paulo R Soares, Expedito E Ribeiro, Alexandre C Pereira, Desiderio Favarato, Antonio Sérgio C Rocha, Alexandre C Hueb, Jose A F Ramires
雑誌名: Circulation. 2010 Sep 7;122(10):949-57. doi: 10.1161/CIRCULATIONAHA.109.911669. Epub 2010 Aug 23.
Abstract/Text BACKGROUND: This study compared the 10-year follow-up of percutaneous coronary intervention (PCI), coronary artery surgery (CABG), and medical treatment (MT) in patients with multivessel coronary artery disease, stable angina, and preserved ventricular function.
METHODS AND RESULTS: The primary end points were overall mortality, Q-wave myocardial infarction, or refractory angina that required revascularization. All data were analyzed according to the intention-to-treat principle. At a single institution, 611 patients were randomly assigned to CABG (n=203), PCI (n=205), or MT (n=203). The 10-year survival rates were 74.9% with CABG, 75.1% with PCI, and 69% with MT (P=0.089). The 10-year rates of myocardial infarction were 10.3% with CABG, 13.3% with PCI, and 20.7% with MT (P<0.010). The 10-year rates of additional revascularizations were 7.4% with CABG, 41.9% with PCI, and 39.4% with MT (P<0.001). Relative to the composite end point, Cox regression analysis showed a higher incidence of primary events in MT than in CABG (hazard ratio 2.35, 95% confidence interval 1.78 to 3.11) and in PCI than in CABG (hazard ratio 1.85, 95% confidence interval 1.39 to 2.47). Furthermore, 10-year rates of freedom from angina were 64% with CABG, 59% with PCI, and 43% with MT (P<0.001).
CONCLUSIONS: Compared with CABG, MT was associated with a significantly higher incidence of subsequent myocardial infarction, a higher rate of additional revascularization, a higher incidence of cardiac death, and consequently a 2.29-fold increased risk of combined events. PCI was associated with an increased need for further revascularization, a higher incidence of myocardial infarction, and a 1.46-fold increased risk of combined events compared with CABG. Additionally, CABG was better than MT at eliminating anginal symptoms. Clinical Trial Registration Information- URL: http://www.controlled-trials.com.
REGISTRATION NUMBER: ISRCTN66068876.

PMID 20733102  Circulation. 2010 Sep 7;122(10):949-57. doi: 10.1161/CI・・・
著者: Peter K Smith, Robert M Califf, Robert H Tuttle, Linda K Shaw, Kerry L Lee, Elizabeth R Delong, R Eric Lilly, Michael H Sketch, Eric D Peterson, Robert H Jones
雑誌名: Ann Thorac Surg. 2006 Oct;82(4):1420-8; discussion 1428-9. doi: 10.1016/j.athoracsur.2006.04.044.
Abstract/Text BACKGROUND: Treatment of coronary artery disease (CAD) is evolving with better medications, improvements in percutaneous coronary intervention (PCI), and enhanced techniques for coronary artery bypass grafting (CABG).
METHODS: In this study, 18,481 patients with significant (>75% stenosis) CAD treated at a single center between 1986 and 2000 were assigned to one of three groups based on initial treatment strategy: medical therapy (MED) (n = 6862), PCI (n = 6292), or CABG (n = 5327). Each group was categorized into 3 groups according to baseline severity of CAD: low-severity (predominantly 1-vessel), intermediate-severity (predominantly 2-vessel), and high-severity (all 3-vessel), and prospectively evaluated in Cox models for all-cause mortality adjusted for cardiac risk, comorbidity, and propensity for selection of a specific treatment. Treatments were compared for the entire period and three eras (1: 1986 to 1990; 2: 1991 to 1995; 3: 1996 to 2000), the last encompassing widespread availability of PCI with stenting.
RESULTS: Survival significantly improved in all groups for all degrees of CAD, despite increasing severity of illness. Revascularization strategies provided significant survival over MED with 8.1, 10.6, and 23.6 additional months per 15 years of follow-up for low-severity, intermediate-severity, and high-severity CAD, respectively. Therapeutic improvements led to increased survival of 5.3 additional months per 7 years of follow-up (95% confidence interval, 0.2 to 10.2; p = 0.039) in era 3 for CABG compared with PCI for high-severity CAD.
CONCLUSIONS: Initial revascularization strategies result in significant survival advantage over MED for all CAD levels. Patients with high-severity CAD have reduced survival with PCI compared with those initially treated with CABG.

PMID 16996946  Ann Thorac Surg. 2006 Oct;82(4):1420-8; discussion 1428・・・
著者: E Varnauskas
雑誌名: N Engl J Med. 1988 Aug 11;319(6):332-7. doi: 10.1056/NEJM198808113190603.
Abstract/Text We studied survival rates among 767 men with good left ventricular function who participated in the European Coronary Surgery Study, 10 to 12 years after they were randomly assigned to either early coronary bypass surgery or medical therapy. At the projected five-year follow-up interval, we observed a significantly higher survival rate (+/- 95 percent confidence interval) in the group that was assigned to surgical treatment than in the group assigned to medical treatment (92.4 +/- 2.7 vs. 83.1 +/- 3.9 percent; P = 0.0001). During the subsequent seven years, the percentage of patients who survived decreased more rapidly in the surgically treated than in the medically treated group (70.6 +/- 5.8 vs. 66.7 +/- 5.3 percent at 12 years). Thus, the improvement in the survival rate among patients with stable angina who were treated surgically appears to have been attenuated after five years. However, the gradually diminishing difference between the two survival curves still favored surgical treatment after 12 years (P = 0.04), despite the fact that 136 patients in the medically treated group had coronary bypass surgery and 23 in the "surgically treated" group did not. The benefit of surgical treatment tended to be greater, but not significantly so, as assessed by interaction analysis in the subgroups of patients who were older or who had signs of ischemia or previous infarction on the resting electrocardiogram, a markedly ischemic response to exercise testing, peripheral arterial disease, an absence of hypertension, and proximal obstruction in the left anterior descending artery. The reasons for the loss of a beneficial effect of surgery after five years are unknown and merit further study.

PMID 3260659  N Engl J Med. 1988 Aug 11;319(6):332-7. doi: 10.1056/NE・・・
著者: Alida E Borger van der Burg, Jeroen J Bax, Eric Boersma, Marianne Bootsma, Lieselot van Erven, Ernst E van der Wall, Martin J Schalij
雑誌名: Am J Cardiol. 2003 Apr 1;91(7):785-9.
Abstract/Text Survivors of cardiac arrest due to ventricular arrhythmias are at risk for recurrent events. The role of revascularization in secondary prevention for survivors of cardiac arrest has been addressed in various studies with conflicting results. A total of 142 survivors of cardiac arrest with coronary artery disease were evaluated according to a standardized protocol, including 2-dimensional echocardiography, myocardial perfusion scintigraphy, coronary angiography, and electrophysiologic testing. Revascularization of scintigraphically documented ischemic myocardial regions was performed in 44 patients (31%). Final therapy was based on the results of electrophysiologic testing. Four-year survival rates were 100% for revascularized noninducible patients, 84% for revascularized inducible patients, 91% for nonrevascularized noninducible patients, and 72% for nonrevascularized inducible patients. Only 1 patient (<1% of study population) died suddenly. Recurrences were much more frequent in patients without revascularization (38% vs 7%, p <0.001) and the recurrence rate was 0% in the revascularized noninducible patients. Thus, revascularization of ischemically jeopardized myocardium in survivors of cardiac arrest resulted in excellent survival; moreover, in absence of inducible ventricular arrhythmias, the recurrence rate was 0%. Systematic evaluation of survivors of cardiac arrest due to ventricular arrhythmias allows risk stratification and guidance of subsequent antiarrhythmic therapy.

PMID 12667561  Am J Cardiol. 2003 Apr 1;91(7):785-9.
著者: Dumbor L Ngaage, Alexander R J Cale, Michael E Cowen, Steven Griffin, Levant Guvendik
雑誌名: Ann Thorac Surg. 2008 Apr;85(4):1278-81. doi: 10.1016/j.athoracsur.2007.12.035.
Abstract/Text BACKGROUND: Ischemic ventricular fibrillation/tachycardia (VF/VT) treated by myocardial revascularization, often with an implanted cardioverter defibrillator, prevents sudden cardiac death. Early series have suggested that recurrent VF/VT threatens survival even after treatment. As late outcome is unknown, we sought to determine if the early survival benefit is sustained.
METHODS: From January 1999 through January 2007, 93 consecutive patients (75 male, 81%) presented with ischemic VF/VT; 21% survived cardiac arrest and underwent coronary artery bypass graft surgery at our institution. We analyzed their early and late survival.
RESULTS: Median age was 66 years (range, 44 to 88). Clinical presentation included class III/IV angina (46%), controlled heart failure (43%), prior myocardial infarction (68%), left ventricular ejection fraction less than 0.30 (23%) and 0.30 to 0.50 (35%), left main stem disease (24%), and triple-vessel disease (67%). Surgical revascularization, mostly nonelective (urgent 73%, emergency 7%), was combined with aortic valve replacement in 5 patients and left ventricular pseudoaneurysm repair in 3. Ischemic territories and mean number of diseased coronaries (2.6) corresponded to the grafted territories and average number of grafts (2.5). Operative mortality was 6.5% (n = 6, median EuroSCORE [European System for Cardiac Operative Risk Evaluation] predicted mortality 9). Recurrent VF/VT occurred early postoperatively in 21 patients (24%). All patients had electrophysiologic studies postoperatively and 40% received an implanted cardioverter defibrillator. Of 12 late deaths (16%) at follow-up extending to 8 years, 4 (33%) were due to cardiac causes. Five-year survival was 88%, equivalent to that (83% to 85%) reported for patients with sinus rhythm preoperatively.
CONCLUSIONS: Complete myocardial revascularization for ischemic VF/VT yields excellent early and late results; 5-year survival is comparable to that of patients with preoperative sinus rhythm.

PMID 18355509  Ann Thorac Surg. 2008 Apr;85(4):1278-81. doi: 10.1016/j・・・
著者: Arie Pieter Kappetein, Ted E Feldman, Michael J Mack, Marie-Claude Morice, David R Holmes, Elisabeth Ståhle, Keith D Dawkins, Friedrich W Mohr, Patrick W Serruys, Antonio Colombo
雑誌名: Eur Heart J. 2011 Sep;32(17):2125-34. doi: 10.1093/eurheartj/ehr213. Epub 2011 Jun 22.
Abstract/Text AIMS: Long-term randomized comparisons of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in left main coronary (LM) disease and/or three-vessel disease (3VD) patients have been limited. This analysis compares 3-year outcomes in LM and/or 3VD patients treated with CABG or PCI with TAXUS Express stents.
METHODS AND RESULTS: SYNTAX is an 85-centre randomized clinical trial (n= 1800). Prospectively screened, consecutive LM and/or 3VD patients were randomized if amenable to equivalent revascularization using either technique; if not, they were entered into a registry. Patients in the randomized cohort will continue to be followed for 5 years. At 3 years, major adverse cardiac and cerebrovascular events [MACCE: death, stroke, myocardial infarction (MI), and repeat revascularization; CABG 20.2% vs. PCI 28.0%, P< 0.001], repeat revascularization (10.7 vs. 19.7%, P< 0.001), and MI (3.6 vs. 7.1%, P= 0.002) were elevated in the PCI arm. Rates of the composite safety endpoint (death/stroke/MI 12.0 vs. 14.1%, P= 0.21) and stroke alone (3.4 vs. 2.0%, P= 0.07) were not significantly different between treatment groups. Major adverse cardiac and cerebrovascular event rates were not significantly different between arms in the LM subgroup (22.3 vs. 26.8%, P= 0.20) but were higher with PCI in the 3VD subgroup (18.8 vs. 28.8%, P< 0.001).
CONCLUSIONS: At 3 years, MACCE was significantly higher in PCI- compared with CABG-treated patients. In patients with less complex disease (low SYNTAX scores for 3VD or low/intermediate terciles for LM patients), PCI is an acceptable revascularization, although longer follow-up is needed to evaluate these two revascularization strategies.

PMID 21697170  Eur Heart J. 2011 Sep;32(17):2125-34. doi: 10.1093/eurh・・・
著者: Friedrich W Mohr, Marie-Claude Morice, A Pieter Kappetein, Ted E Feldman, Elisabeth Ståhle, Antonio Colombo, Michael J Mack, David R Holmes, Marie-angèle Morel, Nic Van Dyck, Vicki M Houle, Keith D Dawkins, Patrick W Serruys
雑誌名: Lancet. 2013 Feb 23;381(9867):629-38. doi: 10.1016/S0140-6736(13)60141-5.
Abstract/Text BACKGROUND: We report the 5-year results of the SYNTAX trial, which compared coronary artery bypass graft surgery (CABG) with percutaneous coronary intervention (PCI) for the treatment of patients with left main coronary disease or three-vessel disease, to confirm findings at 1 and 3 years.
METHODS: The randomised, clinical SYNTAX trial with nested registries took place in 85 centres in the USA and Europe. A cardiac surgeon and interventional cardiologist at each centre assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments. Eligible patients suitable for either treatment were randomly assigned (1:1) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG. Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries. We analysed a composite rate of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT00114972.
FINDINGS: 1800 patients were randomly assigned to CABG (n=897) or PCI (n=903). More patients who were assigned to CABG withdrew consent than did those assigned to PCI (50 vs 11). After 5 years' follow-up, Kaplan-Meier estimates of MACCE were 26·9% in the CABG group and 37·3% in the PCI group (p<0·0001). Estimates of myocardial infarction (3·8% in the CABG group vs 9·7% in the PCI group; p<0·0001) and repeat revascularisation (13·7%vs 25·9%; p<0·0001) were significantly increased with PCI versus CABG. All-cause death (11·4% in the CABG group vs 13·9% in the PCI group; p=0·10) and stroke (3·7%vs 2·4%; p=0·09) were not significantly different between groups. 28·6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32·1% of patients in the PCI group (p=0·43) and 31·0% in the CABG group with left main coronary disease had MACCE versus 36·9% in the PCI group (p=0·12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25·8% of the CABG group vs 36·0% of the PCI group; p=0·008; high score, 26·8%vs 44·0%; p<0·0001).
INTERPRETATION: CABG should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For patients with less complex disease (low SYNTAX scores) or left main coronary disease (low or intermediate SYNTAX scores), PCI is an acceptable alternative. All patients with complex multivessel coronary artery disease should be reviewed and discussed by both a cardiac surgeon and interventional cardiologist to reach consensus on optimum treatment.
FUNDING: Boston Scientific.

Copyright © 2013 Elsevier Ltd. All rights reserved.
PMID 23439102  Lancet. 2013 Feb 23;381(9867):629-38. doi: 10.1016/S014・・・
著者: Mark A Hlatky, Derek B Boothroyd, Laurence Baker, Dhruv S Kazi, Matthew D Solomon, Tara I Chang, David Shilane, Alan S Go
雑誌名: Ann Intern Med. 2013 May 21;158(10):727-34. doi: 10.7326/0003-4819-158-10-201305210-00639. Epub 2013 Apr 23.
Abstract/Text BACKGROUND: Randomized trials of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) suggest that patient characteristics modify the effect of treatment on mortality.
OBJECTIVE: To assess whether clinical characteristics modify the comparative effectiveness of CABG versus PCI in an unselected, general patient population.
DESIGN: Observational treatment comparison using propensity score matching and Cox proportional hazards models.
SETTING: United States, 1992 to 2008.
PATIENTS: Medicare beneficiaries aged 66 years or older.
INTERVENTION: Multivessel CABG or multivessel PCI.
MEASUREMENTS: The CABG-PCI hazard ratio (HR) for all-cause mortality, with prespecified treatment-by-covariate interaction tests, and the absolute difference in life-years of survival in clinical subgroups after CABG or PCI, both over 5 years of follow-up.
RESULTS: Among 105 156 propensity score-matched patients, CABG was associated with lower mortality than PCI (HR, 0.92 [95% CI, 0.90 to 0.95]; P < 0.001). Association of CABG with lower mortality was significantly greater (interaction P ≤ 0.002 for each) among patients with diabetes (HR, 0.88), a history of tobacco use (HR, 0.82), heart failure (HR, 0.84), and peripheral arterial disease (HR, 0.85). The overall predicted difference in survival between CABG and PCI treatment over 5 years was 0.053 life-years (range, -0.017 to 0.579 life-years). Patients with diabetes, heart failure, peripheral arterial disease, or tobacco use had the largest predicted differences in survival after CABG, whereas those with none of these factors had slightly better survival after PCI.
LIMITATION: Treatments were chosen by patients and physicians rather than being randomly assigned.
CONCLUSION: Multivessel CABG is associated with lower long-term mortality than multivessel PCI in the community setting. This association is substantially modified by patient characteristics, with improvement in survival concentrated among patients with diabetes, tobacco use, heart failure, or peripheral arterial disease.
PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

PMID 23609014  Ann Intern Med. 2013 May 21;158(10):727-34. doi: 10.732・・・
著者: BARI 2D Study Group, Robert L Frye, Phyllis August, Maria Mori Brooks, Regina M Hardison, Sheryl F Kelsey, Joan M MacGregor, Trevor J Orchard, Bernard R Chaitman, Saul M Genuth, Suzanne H Goldberg, Mark A Hlatky, Teresa L Z Jones, Mark E Molitch, Richard W Nesto, Edward Y Sako, Burton E Sobel
雑誌名: N Engl J Med. 2009 Jun 11;360(24):2503-15. doi: 10.1056/NEJMoa0805796. Epub 2009 Jun 7.
Abstract/Text BACKGROUND: Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established.
METHODS: We randomly assigned 2368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy. Primary end points were the rate of death and a composite of death, myocardial infarction, or stroke (major cardiovascular events). Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention.
RESULTS: At 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical-therapy group (87.8%, P=0.97) or between the insulin-sensitization group (88.2%) and the insulin-provision group (87.9%, P=0.89). The rates of freedom from major cardiovascular events also did not differ significantly among the groups: 77.2% in the revascularization group and 75.9% in the medical-treatment group (P=0.70) and 77.7% in the insulin-sensitization group and 75.4% in the insulin-provision group (P=0.13). In the PCI stratum, there was no significant difference in primary end points between the revascularization group and the medical-therapy group. In the CABG stratum, the rate of major cardiovascular events was significantly lower in the revascularization group (22.4%) than in the medical-therapy group (30.5%, P=0.01; P=0.002 for interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the groups, although severe hypoglycemia was more frequent in the insulin-provision group (9.2%) than in the insulin-sensitization group (5.9%, P=0.003).
CONCLUSIONS: Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision. (ClinicalTrials.gov number, NCT00006305.)

2009 Massachusetts Medical Society
PMID 19502645  N Engl J Med. 2009 Jun 11;360(24):2503-15. doi: 10.1056・・・
著者: Michael E Farkouh, Michael Domanski, Lynn A Sleeper, Flora S Siami, George Dangas, Michael Mack, May Yang, David J Cohen, Yves Rosenberg, Scott D Solomon, Akshay S Desai, Bernard J Gersh, Elizabeth A Magnuson, Alexandra Lansky, Robin Boineau, Jesse Weinberger, Krishnan Ramanathan, J Eduardo Sousa, Jamie Rankin, Balram Bhargava, John Buse, Whady Hueb, Craig R Smith, Victoria Muratov, Sameer Bansilal, Spencer King, Michel Bertrand, Valentin Fuster, FREEDOM Trial Investigators
雑誌名: N Engl J Med. 2012 Dec 20;367(25):2375-84. doi: 10.1056/NEJMoa1211585. Epub 2012 Nov 4.
Abstract/Text BACKGROUND: In some randomized trials comparing revascularization strategies for patients with diabetes, coronary-artery bypass grafting (CABG) has had a better outcome than percutaneous coronary intervention (PCI). We sought to discover whether aggressive medical therapy and the use of drug-eluting stents could alter the revascularization approach for patients with diabetes and multivessel coronary artery disease.
METHODS: In this randomized trial, we assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG. The patients were followed for a minimum of 2 years (median among survivors, 3.8 years). All patients were prescribed currently recommended medical therapies for the control of low-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin. The primary outcome measure was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke.
RESULTS: From 2005 through 2010, we enrolled 1900 patients at 140 international centers. The patients' mean age was 63.1±9.1 years, 29% were women, and 83% had three-vessel disease. The primary outcome occurred more frequently in the PCI group (P=0.005), with 5-year rates of 26.6% in the PCI group and 18.7% in the CABG group. The benefit of CABG was driven by differences in rates of both myocardial infarction (P<0.001) and death from any cause (P=0.049). Stroke was more frequent in the CABG group, with 5-year rates of 2.4% in the PCI group and 5.2% in the CABG group (P=0.03).
CONCLUSIONS: For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke. (Funded by the National Heart, Lung, and Blood Institute and others; FREEDOM ClinicalTrials.gov number, NCT00086450.).

PMID 23121323  N Engl J Med. 2012 Dec 20;367(25):2375-84. doi: 10.1056・・・
著者: Mouin S Abdallah, Kaijun Wang, Elizabeth A Magnuson, John A Spertus, Michael E Farkouh, Valentin Fuster, David J Cohen, FREEDOM Trial Investigators
雑誌名: JAMA. 2013 Oct 16;310(15):1581-90. doi: 10.1001/jama.2013.279208.
Abstract/Text IMPORTANCE: The FREEDOM trial demonstrated that among patients with diabetes mellitus and multivessel coronary artery disease, coronary artery bypass graft (CABG) surgery resulted in lower rates of death and myocardial infarction but a higher risk of stroke when compared with percutaneous coronary intervention (PCI) using drug-eluting stents. Whether there are treatment differences in health status, as assessed from the patient's perspective, is unknown.
OBJECTIVES: To compare the relative effects of CABG vs PCI using drug-eluting stents on health status among patients with diabetes mellitus and multivessel coronary artery disease.
DESIGN, SETTING, AND PARTICIPANTS: Between 2005 and 2010, 1900 patients from 18 countries with diabetes mellitus and multivessel coronary artery disease were randomized to undergo either CABG surgery (n = 947) or PCI (n = 953) as an initial treatment strategy. Of these, a total of 1880 patients had baseline health status assessed (935 CABG, 945 PCI) and comprised the primary analytic sample.
INTERVENTIONS: Initial revascularization with CABG surgery or PCI.
MAIN OUTCOMES AND MEASURES: Health status was assessed using the angina frequency, physical limitations, and quality-of-life domains of the Seattle Angina Questionnaire at baseline, at 1, 6, and 12 months, and annually thereafter. For each scale, scores range from 0 to 100 with higher scores representing better health. The effect of CABG surgery vs PCI was evaluated using longitudinal mixed-effect models.
RESULTS: At baseline, mean (SD) scores for the angina frequency, physical limitations, and quality-of-life subscales of the Seattle Angina Questionnaire were 70.9 (25.1), 67.3 (24.4), and 47.8 (25.0) for the CABG group and 71.4 (24.7), 69.9 (23.2), and 49.2 (25.7) for the PCI group, respectively. At 2-year follow-up, mean (SD) scores were 96.0 (11.9), 87.8 (18.7), and 82.2 (18.9) after CABG and 94.7 (14.3), 86.0 (19.3), and 80.4 (19.6) after PCI, with significantly greater benefit of CABG on each domain (mean treatment benefit, 1.3 [95% CI, 0.3-2.2], 4.4 [95% CI, 2.7-6.1], and 2.2 [95% CI, 0.7-3.8] points, respectively; P < .01 for each comparison). Beyond 2 years, the 2 revascularization strategies provided generally similar patient-reported outcomes.
CONCLUSIONS AND RELEVANCE: For patients with diabetes and multivessel CAD, CABG surgery provided slightly better intermediate-term health status and quality of life than PCI using drug-eluting stents. The magnitude of benefit was small, without consistent differences beyond 2 years, in part due to the higher rate of repeat revascularization with PCI.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00086450.

PMID 24129463  JAMA. 2013 Oct 16;310(15):1581-90. doi: 10.1001/jama.20・・・

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