Melberg Tor, Nordrehaug Jan Erik, Nilsen Dennis W T
Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.
Eur J Cardiovasc Prev Rehabil. 2010 Apr;17(2):235-43. doi: 10.1097/HJR.0b013e3283378880.
Prospective randomized trials comparing the coronary artery disease-related health status outcomes (changes in symptom grade, physical functional capacity and health-related quality of life) after percutaneous coronary intervention at hospitals with and without on-site cardiac surgical backup have not been reported earlier.
We randomly assigned 609 consecutive patients fulfilling pre-specified procedural low-risk criteria to undergo percutaneous coronary intervention at either a community hospital without or a regional hospital with on-site surgical backup. Five hundred and seventy-six patients completed the health status evaluation at baseline and at 6 months follow-up.
At baseline, 91.4% had symptoms, and the mean (standard deviation) Canadian Cardiovascular Society's classification was 2.5 (0.9). The procedural success rates and the changes in health status measures were similar at the two hospitals. Overall there was a substantial relief of symptoms with a reduction in Canadian Cardiovascular Society's classification of 1.9 (1.2), increase in exercise time [1.4 (1.9) min] and reduction in use of antianginal drugs [0.6 (0.9) less drugs] at follow-up compared with baseline (all P<0.001). Health-related quality of life was evaluated with the Short-Form 36 health survey. There were significant and similar improvements in nearly all multi-item and summary scores from baseline to follow-up at the two hospitals. The largest improvements were seen in items related to physical functioning [overall change in Physical Component Score from baseline to follow-up 6.9 (9.1) points, P<0.001] and lowest in the mental health domains [change in Mental Component Score 3.3 (10.7) points, P<0.001].
This study shows that a substantial and comparable gain in coronary artery disease-related health status can be achieved at hospitals both with and without surgical backup.
此前尚未有前瞻性随机试验比较在有和没有现场心脏外科支持的医院进行经皮冠状动脉介入治疗后与冠心病相关的健康状况结果（症状分级、身体功能能力和健康相关生活质量的变化）。
我们将609例连续符合预先指定的低风险手术标准的患者随机分配至无现场手术支持的社区医院或有现场手术支持的区域医院进行经皮冠状动脉介入治疗。576例患者在基线和6个月随访时完成了健康状况评估。
基线时，91.4%的患者有症状，加拿大心血管学会分类的平均（标准差）为2.5（0.9）。两家医院的手术成功率和健康状况指标变化相似。总体而言，与基线相比，随访时症状明显缓解，加拿大心血管学会分类降低了1.9（1.2），运动时间增加了[1.4（1.9）分钟]，抗心绞痛药物使用减少了[少用0.6（0.9）种药物]（所有P<0.001）。使用简短健康调查36评估健康相关生活质量。从基线到随访，两家医院几乎所有多项目和汇总评分均有显著且相似的改善。在与身体功能相关的项目中改善最大[从基线到随访身体成分评分的总体变化为6.9（9.1）分，P<0.001]，在心理健康领域改善最小[心理成分评分变化3.3（10.7）分，P<0.001]。
本研究表明，在有和没有手术支持的医院，与冠心病相关的健康状况均可实现显著且相当的改善。
