Marius Reto Bigler MD, PhD , Andrea Kieninger-Gräfitsch MD , Christine Tschannen RN, Raphael Grossenbacher RN, Christian Seiler MD
{"title":"永久性乳内动脉闭塞对慢性冠状动脉综合征的临床疗效:一项双盲、随机、假对照试验。","authors":"Marius Reto Bigler MD, PhD , Andrea Kieninger-Gräfitsch MD , Christine Tschannen RN, Raphael Grossenbacher RN, Christian Seiler MD","doi":"10.1016/j.amjcard.2024.06.030","DOIUrl":null,"url":null,"abstract":"<div><p>The Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome (CLIMACCS) trial, a randomized, sham-controlled trial, tested the clinical efficacy of permanent internal mammary artery (IMA) device occlusion on symptoms in patients with chronic coronary syndrome (CCS), coronary artery occlusive blood supply, and myocardial ischemia. This was a prospective trial in 101 patients with CCS randomly allocated (1:1) to IMA device occlusion (verum group) or to IMA sham intervention (placebo group). The primary study end point was the change in treadmill exercise time (ET) (ΔET in seconds) at 6 weeks after trial intervention. Secondary study end points were the changes in collateral flow index (CFI) and angina pectoris during a simultaneous 1-minute proximal balloon occlusion of a coronary artery. CFI is the ratio between simultaneous mean coronary occlusive, divided by mean aortic pressure, both subtracted by central venous pressure. In the verum and placebo groups, the ET changed from 398 ± 176 seconds to 421 ± 198s in the verum group (p = 0.1745) and from 426 ± 162 seconds to 430 ± 166 seconds in the placebo group (p = 0.55); ΔET amounted to +23 ± 116s and +4 ± 120 seconds, respectively (p = 0.44). CFI change during follow-up equaled +0.022 ± 0.061 in the verum and −0.039 ± 0.072 in the placebo group (p <0.0001). Angina pectoris at follow-up during the coronary balloon occlusion for CFI measurement had decreased or disappeared in 20 of 48 patients in the verum group and in 9 of 47 patients in the placebo group (p = 0.0242). In conclusion, permanent IMA device occlusion tends to augment treadmill ET in response to increased coronary artery occlusive blood supply, which is reflected by mitigated symptoms and signs of myocardial ischemia.</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":"225 ","pages":"Pages 160-170"},"PeriodicalIF":2.3000,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002914924004673/pdfft?md5=457757363c9410015f78c1cde0aed3b4&pid=1-s2.0-S0002914924004673-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome: A Double-Blind, Randomized, Sham-Controlled Trial\",\"authors\":\"Marius Reto Bigler MD, PhD , Andrea Kieninger-Gräfitsch MD , Christine Tschannen RN, Raphael Grossenbacher RN, Christian Seiler MD\",\"doi\":\"10.1016/j.amjcard.2024.06.030\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>The Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome (CLIMACCS) trial, a randomized, sham-controlled trial, tested the clinical efficacy of permanent internal mammary artery (IMA) device occlusion on symptoms in patients with chronic coronary syndrome (CCS), coronary artery occlusive blood supply, and myocardial ischemia. This was a prospective trial in 101 patients with CCS randomly allocated (1:1) to IMA device occlusion (verum group) or to IMA sham intervention (placebo group). The primary study end point was the change in treadmill exercise time (ET) (ΔET in seconds) at 6 weeks after trial intervention. Secondary study end points were the changes in collateral flow index (CFI) and angina pectoris during a simultaneous 1-minute proximal balloon occlusion of a coronary artery. CFI is the ratio between simultaneous mean coronary occlusive, divided by mean aortic pressure, both subtracted by central venous pressure. In the verum and placebo groups, the ET changed from 398 ± 176 seconds to 421 ± 198s in the verum group (p = 0.1745) and from 426 ± 162 seconds to 430 ± 166 seconds in the placebo group (p = 0.55); ΔET amounted to +23 ± 116s and +4 ± 120 seconds, respectively (p = 0.44). CFI change during follow-up equaled +0.022 ± 0.061 in the verum and −0.039 ± 0.072 in the placebo group (p <0.0001). Angina pectoris at follow-up during the coronary balloon occlusion for CFI measurement had decreased or disappeared in 20 of 48 patients in the verum group and in 9 of 47 patients in the placebo group (p = 0.0242). In conclusion, permanent IMA device occlusion tends to augment treadmill ET in response to increased coronary artery occlusive blood supply, which is reflected by mitigated symptoms and signs of myocardial ischemia.</p></div>\",\"PeriodicalId\":7705,\"journal\":{\"name\":\"American Journal of Cardiology\",\"volume\":\"225 \",\"pages\":\"Pages 160-170\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-07-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0002914924004673/pdfft?md5=457757363c9410015f78c1cde0aed3b4&pid=1-s2.0-S0002914924004673-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0002914924004673\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Cardiology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002914924004673","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome: A Double-Blind, Randomized, Sham-Controlled Trial
The Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome (CLIMACCS) trial, a randomized, sham-controlled trial, tested the clinical efficacy of permanent internal mammary artery (IMA) device occlusion on symptoms in patients with chronic coronary syndrome (CCS), coronary artery occlusive blood supply, and myocardial ischemia. This was a prospective trial in 101 patients with CCS randomly allocated (1:1) to IMA device occlusion (verum group) or to IMA sham intervention (placebo group). The primary study end point was the change in treadmill exercise time (ET) (ΔET in seconds) at 6 weeks after trial intervention. Secondary study end points were the changes in collateral flow index (CFI) and angina pectoris during a simultaneous 1-minute proximal balloon occlusion of a coronary artery. CFI is the ratio between simultaneous mean coronary occlusive, divided by mean aortic pressure, both subtracted by central venous pressure. In the verum and placebo groups, the ET changed from 398 ± 176 seconds to 421 ± 198s in the verum group (p = 0.1745) and from 426 ± 162 seconds to 430 ± 166 seconds in the placebo group (p = 0.55); ΔET amounted to +23 ± 116s and +4 ± 120 seconds, respectively (p = 0.44). CFI change during follow-up equaled +0.022 ± 0.061 in the verum and −0.039 ± 0.072 in the placebo group (p <0.0001). Angina pectoris at follow-up during the coronary balloon occlusion for CFI measurement had decreased or disappeared in 20 of 48 patients in the verum group and in 9 of 47 patients in the placebo group (p = 0.0242). In conclusion, permanent IMA device occlusion tends to augment treadmill ET in response to increased coronary artery occlusive blood supply, which is reflected by mitigated symptoms and signs of myocardial ischemia.
期刊介绍:
Published 24 times a year, The American Journal of Cardiology® is an independent journal designed for cardiovascular disease specialists and internists with a subspecialty in cardiology throughout the world. AJC is an independent, scientific, peer-reviewed journal of original articles that focus on the practical, clinical approach to the diagnosis and treatment of cardiovascular disease. AJC has one of the fastest acceptance to publication times in Cardiology. Features report on systemic hypertension, methodology, drugs, pacing, arrhythmia, preventive cardiology, congestive heart failure, valvular heart disease, congenital heart disease, and cardiomyopathy. Also included are editorials, readers'' comments, and symposia.