Nallamothu Brahmajee K, Normand Sharon-Lise T, Wang Yongfei, Hofer Timothy P, Brush John E, Messenger John C, Bradley Elizabeth H, Rumsfeld John S, Krumholz Harlan M
Center for Clinical Management Research, Ann Arbor VA Medical Center, and Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Department of Health Care Policy, Harvard Medical School, Boston, MA, USA.
Lancet. 2015 Mar 21;385(9973):1114-22. doi: 10.1016/S0140-6736(14)61932-2. Epub 2014 Nov 19.
Recent reductions in average door-to-balloon (D2B) times have not been associated with decreases in mortality at the population level. We investigated this seemingly paradoxical finding by assessing components of this association at the individual and population levels simultaneously. We postulated that the changing population of patients undergoing primary percutaneous coronary intervention (pPCI) contributed to secular trends toward an increasing mortality risk, despite consistently decreased mortality in individual patients with shorter D2B times.
This was a retrospective study of ST-elevation myocardial infarction (STEMI) patients who underwent pPCI between Jan 1, 2005, and Dec 31, 2011, in the National Cardiovascular Data Registry (NCDR) CathPCI Registry. We looked for catheterisation laboratory visits associated with STEMI. We excluded patients not undergoing pPCI, transfer patients for pPCI, patients with D2B times less than 15 min or more than 3 h, and patients at hospitals that did not consistently report data across the study period. We assessed in-hospital mortality in the entire cohort and 6-month mortality in elderly patients aged 65 years or older matched to data from the Centers for Medicare and Medicaid Services. We built multilevel models to assess the relation between D2B time and in-hospital and 6-month mortality, including both individual and population-level components of this association after adjusting for patient and procedural factors.
423 hospitals reported data on 150,116 procedures with a 55% increase in the number of patients undergoing pPCI at these facilities over time, as well as many changes in patient and procedural factors. Annual D2B times decreased significantly from a median of 86 min (IQR 65-109) in 2005 to 63 min (IQR 47-80) in 2011 (p<0·0001) with a concurrent rise in risk-adjusted in-hospital mortality (from 4·7% to 5·3%; p=0·06) and risk-adjusted 6-month mortality (from 12·9% to 14·4%; p=0·001). In multilevel models, shorter patient-specific D2B times were consistently associated at the individual level with lower in-hospital mortality (adjusted OR for each 10 min decrease 0·92; 95% CI 0·91-0·93; p<0·0001) and 6-month mortality (adjusted OR for each 10 min decrease, 0·94; 95% CI 0·93-0·95; p<0·0001). By contrast, risk-adjusted in-hospital and 6-month mortality at the population level, independent of patient-specific D2B times, rose in the growing and changing population of patients undergoing pPCI during the study period.
Shorter patient-specific D2B times were consistently associated with lower mortality over time, whereas secular trends suggest increased mortality risk in the growing and changing pPCI population. The absence of association of annual D2B time and changes in mortality at the population level should not be interpreted as an indication of its individual-level relation in patients with STEMI undergoing primary PCI.
National Heart, Lung, and Blood Institute.
近期平均门球时间(D2B)的缩短与总体人群死亡率的降低并无关联。我们通过同时在个体和总体水平评估这种关联的组成部分,对这一看似矛盾的发现进行了调查。我们推测,尽管D2B时间较短的个体患者死亡率持续下降,但接受直接经皮冠状动脉介入治疗(pPCI)的患者群体变化导致了死亡率风险呈长期上升趋势。
这是一项对2005年1月1日至2011年12月31日期间在国家心血管数据注册库(NCDR)导管介入治疗注册库中接受pPCI的ST段抬高型心肌梗死(STEMI)患者的回顾性研究。我们查找与STEMI相关的导管实验室就诊记录。我们排除了未接受pPCI的患者、转至其他医院接受pPCI的患者、D2B时间少于15分钟或超过3小时的患者,以及在研究期间未持续报告数据的医院的患者。我们评估了整个队列的院内死亡率以及与医疗保险和医疗补助服务中心数据匹配的65岁及以上老年患者的6个月死亡率。我们构建了多层次模型,以评估D2B时间与院内及6个月死亡率之间的关系,包括在调整患者和手术因素后该关联的个体和总体水平组成部分。
423家医院报告了150,116例手术的数据,这些机构接受pPCI的患者数量随时间增加了55%,同时患者和手术因素也有许多变化。年度D2B时间从2005年的中位数86分钟(四分位间距65 - 109)显著降至2011年的63分钟(四分位间距47 - 80)(p<0.0001),同时风险调整后的院内死亡率上升(从4.7%升至5.3%;p = 0.06),风险调整后的6个月死亡率上升(从12.9%升至14.4%;p = 0.001)。在多层次模型中,个体患者特定的D2B时间越短,在个体水平上与较低的院内死亡率(每减少10分钟调整后的比值比为0.92;95%置信区间0.91 - 0.93;p<0.0001)和6个月死亡率(每减少10分钟调整后的比值比为0.94;95%置信区间0.93 - 0.95;p<0.0001)始终相关。相比之下,在研究期间,接受pPCI的患者群体不断增加且发生变化,总体水平上风险调整后的院内和6个月死亡率,独立于个体患者特定的D2B时间,呈上升趋势。
随着时间推移,个体患者特定的D2B时间越短,死亡率始终越低,而长期趋势表明,不断增加且变化的pPCI患者群体的死亡率风险在增加。年度D2B时间与总体人群死亡率变化之间缺乏关联,不应被解释为在接受直接PCI的STEMI患者中其个体水平关系的指标。
国家心肺血液研究所。