Verheye Stefan, Jolicœur E Marc, Behan Miles W, Pettersson Thomas, Sainsbury Paul, Hill Jonathan, Vrolix Mathias, Agostoni Pierfrancesco, Engstrom Thomas, Labinaz Marino, de Silva Ranil, Schwartz Marc, Meyten Nathalie, Uren Neal G, Doucet Serge, Tanguay Jean-François, Lindsay Steven, Henry Timothy D, White Christopher J, Edelman Elazer R, Banai Shmuel
From Antwerp Cardiovascular Center, Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp (S.V., N.M.), and Ziekenhuis Oost-Limburg Hospital, Genk (M.V.) - both in Belgium; Montreal Heart Institute, Montreal (E.M.J., S.D., J.-F.T.), Ottawa Heart Institute, Ottawa (M.L.), and Neovasc, Richmond, BC (M.S.) - all in Canada; Royal Infirmary of Edinburgh, Edinburgh (M.W.B., N.G.U.), Bradford Royal Infirmary, Bradford (P.S., S.L.), and Kings College Hospital (J.H.) and the National Heart and Lung Institute, Imperial College London, and National Institute for Health Research Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust (R.S.), London - all in the United Kingdom; Kristianstad Central Hospital, Kristianstad, Sweden (T.P.); University Medical Center Utrecht, Utrecht, the Netherlands (P.A.); Rigshospitalet, Copenhagen (T.E.); Cedars-Sinai Medical Center, Los Angeles (T.D.H.); John Ochsner Heart and Vascular Institute, University of Queensland-Ochsner Clinical School, New Orleans (C.J.W.); the Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, and the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston - both in Massachusetts (E.R.E.); and Tel Aviv Medical Center, Tel Aviv University Medical School, Tel Aviv, Israel (S.B.).
N Engl J Med. 2015 Feb 5;372(6):519-27. doi: 10.1056/NEJMoa1402556.
Many patients with coronary artery disease who are not candidates for revascularization have refractory angina despite standard medical therapy. The balloon-expandable, stainless steel, hourglass-shaped, coronary-sinus reducing device creates a focal narrowing and increases pressure in the coronary sinus, thus redistributing blood into ischemic myocardium.
We randomly assigned 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina (on a scale from I to IV, with higher classes indicating greater limitations on physical activity owing to angina) and myocardial ischemia, who were not candidates for revascularization, to implantation of the device (treatment group) or to a sham procedure (control group). The primary end point was the proportion of patients with an improvement of at least two CCS angina classes at 6 months.
A total of 35% of the patients in the treatment group (18 of 52 patients), as compared with 15% of those in the control group (8 of 52), had an improvement of at least two CCS angina classes at 6 months (P=0.02). The device was also associated with improvement of at least one CCS angina class in 71% of the patients in the treatment group (37 of 52 patients), as compared with 42% of those in the control group (22 of 52) (P=0.003). Quality of life as assessed with the use of the Seattle Angina Questionnaire was significantly improved in the treatment group, as compared with the control group (improvement on a 100-point scale, 17.6 vs. 7.6 points; P=0.03). There were no significant between-group differences in improvement in exercise time or in the mean change in the wall-motion index as assessed by means of dobutamine echocardiography. At 6 months, 1 patient in the treatment group had had a myocardial infarction; in the control group, 1 patient had died and 3 had had a myocardial infarction.
In this small clinical trial, implantation of the coronary-sinus reducing device was associated with significant improvement in symptoms and quality of life in patients with refractory angina who were not candidates for revascularization. (Funded by Neovasc; COSIRA ClinicalTrials.gov number, NCT01205893.).
许多冠状动脉疾病患者不适合进行血运重建，尽管接受了标准药物治疗，仍有顽固性心绞痛。球囊扩张式不锈钢沙漏形冠状静脉窦缩窄装置可造成局部狭窄并增加冠状静脉窦压力，从而使血液重新分布到缺血心肌。
我们将104例加拿大心血管学会（CCS）III级或IV级心绞痛（范围为I至IV级，级别越高表明因心绞痛导致的体力活动受限越严重）且有心肌缺血、不适合进行血运重建的患者随机分为两组，一组植入该装置（治疗组），另一组接受假手术（对照组）。主要终点是6个月时CCS心绞痛级别至少改善两级的患者比例。
治疗组35%的患者（52例中的18例）在6个月时CCS心绞痛级别至少改善两级，而对照组为15%（52例中的8例）（P = 0.02）。治疗组71%的患者（52例中的37例）至少改善了一级CCS心绞痛级别，而对照组为42%（52例中的22例）（P = 0.003）。与对照组相比，治疗组使用西雅图心绞痛问卷评估的生活质量有显著改善（100分制的改善程度，分别为17.6分和7.6分；P = 0.03）。在运动时间改善或通过多巴酚丁胺超声心动图评估的壁运动指数平均变化方面，两组间无显著差异。6个月时，治疗组有1例患者发生心肌梗死；对照组有1例患者死亡，3例发生心肌梗死。
在这项小型临床试验中，对于不适合进行血运重建的顽固性心绞痛患者，植入冠状静脉窦缩窄装置与症状及生活质量的显著改善相关。（由Neovasc资助；COSIRA ClinicalTrials.gov编号，NCT01205893。）
