CarboMedics和圣犹达医疗双叶机械心脏瓣膜假体的前瞻性随机比较：十年随访

Prospective randomized comparison of CarboMedics and St. Jude Medical bileaflet mechanical heart valve prostheses: ten-year follow-up.

作者信息

Bryan Alan J, Rogers Chris A, Bayliss Kate, Wild Jan, Angelini Gianni D

机构信息

Bristol Heart Institute, Bristol Royal Infirmary, Bristol, United Kingdom.

出版信息

J Thorac Cardiovasc Surg. 2007 Mar;133(3):614-22. doi: 10.1016/j.jtcvs.2006.08.075.

DOI:10.1016/j.jtcvs.2006.08.075

PMID:17320553

Abstract

OBJECTIVE

This is the final report of a randomized controlled trial comparing the performance of CarboMedics (CarboMedics Inc., Austin, Tex) and St. Jude Medical (St. Jude Medical Inc, St Paul, Minn) bileaflet mechanical heart valve prostheses 10 years after surgery.

METHODS

Between 1992 and 1996, 485 patients undergoing mechanical heart valve replacement were randomized to receive CarboMedics (n = 234) or St. Jude Medical (n = 251) prostheses for aortic (n = 288), mitral (n = 160), or double (n = 37) valve replacements. Patients were followed annually to the end of 2004.

RESULTS

Demographic, preoperative, and operative characteristics were similar between the 2 groups. The median follow-up was 10 years in both groups (CarboMedics 99% complete, St. Jude Medical 98% complete; 3879 patient-years of follow-up). Overall, 165 patients died, 25 of valve-related causes. Ten-year survivals were 66.4% (95% confidence interval: 59.6%-72.3%) and 64.7% (95% confidence interval: 58.0%-70.6%) in the CarboMedics and St. Jude Medical groups, respectively (P = .94). Freedom at 10 years from valve-related mortality was 95.0% (95% confidence interval: 90.8%-97.3%) in the CarboMedics group and 93.0% (95% confidence interval: 88.3%-95.9%) in the St. Jude Medical group. During follow-up, 34 patients had a thromboembolic event, 79 patients had at least 1 bleeding event, and 14 patients required reoperation. There were no significant differences between the groups with respect to freedom from complications (P > or = .12); freedom from thromboembolism at 10 years (CarboMedics: 91.5%, 95% confidence interval: 86.5%-94.7%; St. Jude Medical: 92.2%, 95% confidence interval: 87.5%-95.2%); freedom from bleeding events (CarboMedics: 83.0%, 95% confidence interval: 76.6%-87.8%; St. Jude Medical: 77.5%, 95% confidence interval: 71.1%-82.7%); and freedom from death or valve-related complication (CarboMedics: 51.6%, 95% confidence interval: 44.7%-58.0%; St. Jude Medical: 46.2%, 95% confidence interval: 39.7%-52.4%). Linearized rates per patient-year were 1.1% in the CarboMedics group and 0.8% in the St. Jude Medical group for thromboembolism; 2.3% in the CarboMedics group and 3.2% in the St. Jude Medical group for bleeding events; and 0.72% in the CarboMedics group and 0.47% in the St. Jude Medical group for nonstructural valve dysfunction. International normalized ratio values were similar between the 2 groups throughout the study period.

CONCLUSION

At 10 years, the clinical outcome was similar with respect to these 2 mechanical bileaflet prostheses.

摘要

目的

这是一项随机对照试验的最终报告，比较了CarboMedics（CarboMedics公司，得克萨斯州奥斯汀）和圣犹达医疗（圣犹达医疗公司，明尼苏达州圣保罗）双叶机械心脏瓣膜假体术后10年的性能。

方法

1992年至1996年期间，485例行机械心脏瓣膜置换术的患者被随机分为接受CarboMedics（n = 234）或圣犹达医疗（n = 251）假体，用于主动脉瓣（n = 288）、二尖瓣（n = 160）或双瓣膜（n = 37）置换。对患者进行年度随访直至2004年底。

结果

两组患者的人口统计学、术前和手术特征相似。两组的中位随访时间均为10年（CarboMedics组完成率99%，圣犹达医疗组完成率98%；随访患者年数为3879）。总体而言，165例患者死亡，其中25例死于瓣膜相关原因。CarboMedics组和圣犹达医疗组的10年生存率分别为66.4%（95%置信区间：59.6%-72.3%）和64.7%（95%置信区间：58.0%-70.6%）（P = 0.94）。CarboMedics组10年无瓣膜相关死亡率为95.0%（95%置信区间：90.8%-97.3%），圣犹达医疗组为93.0%（95%置信区间：88.3%-95.9%）。随访期间有34例患者发生血栓栓塞事件，79例患者至少发生1次出血事件，14例患者需要再次手术。两组在并发症发生率（P≥0.12）、10年无血栓栓塞率（CarboMedics组：91.5%，95%置信区间：86.5%-94.7%；圣犹达医疗组：92.2%，95%置信区间：87.5%-95.2%）、无出血事件率（CarboMedics组：83.0%，95%置信区间：76.6%-87.8%；圣犹达医疗组：77.5%，95%置信区间：71.1%-82.7%）以及无死亡或瓣膜相关并发症率（CarboMedics组：51.6%，95%置信区间：44.7%-58.0%；圣犹达医疗组：46.2%，95%置信区间：39.7%-52.4%）方面均无显著差异。CarboMedics组和圣犹达医疗组的血栓栓塞年线性化发生率分别为1.1%和0.8%；出血事件年线性化发生率分别为2.3%和3.2%；非结构性瓣膜功能障碍年线性化发生率分别为0.72%和0.47%。在整个研究期间，两组的国际标准化比值相似。