Department of Cardiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.
Department of Cardiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Skåne University Hospital, Lund, Sweden.
Am J Cardiol. 2018 Oct 15;122(8):1287-1296. doi: 10.1016/j.amjcard.2018.07.008. Epub 2018 Jul 19.
Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.
大多数报告 ST 段抬高型心肌梗死（STEMI）患者出血情况的研究都是临床试验报告，这些报告可能无法代表真实生活中的发生率。在这项研究中，我们调查了一个未选择的 STEMI 人群的 1 年出血和死亡率发生率，并将随机所有患者临床试验（丹麦第三代急性 STEMI 患者最佳治疗研究（DANAMI-3））的参与者与非参与者进行了比较。在一个单一的大型三级心脏中心，对 2990 例接受直接经皮冠状动脉介入治疗的连续 STEMI 患者的住院病历进行了阅读，并根据心肌梗死溶栓治疗（TIMI）和出血学术研究联合会（BARC）标准对出血进行了分类。第 0 至 30 天发生心肌梗死溶栓治疗轻微和/或主要出血（TMMB）的比例为 4.4%，第 31 至 365 天为 2.1%。DANAMI-3 非参与者（n=887）的 30 天出血率明显高于 DANAMI-3 参与者（n=1603）（7.2%比 2.9%，p<0.0001），但此后无差异（p=0.8）。DANAMI-3 非参与与 30 天 TMMB 显著相关（危险比，1.8，95%置信区间，1.2 至 2.8，p=0.007），但调整复苏性心脏骤停、Killip 分级>2 和贫血后，这种相关性不再存在。心脏骤停、Killip 分级>2 和贫血患者占 30 天 TMMB 的 70.0%，其中大多数为 DANAMI-3 非参与者。第 0 至 30 天的 TMMB 与 30 天死亡率增加相关（危险比 3.1，95%置信区间 1.9 至 5.2，p<0.0001），但此后无差异（p=0.9）。总之，我们发现临床试验（DANAMI-3）的非参与者在 30 天内的 TMMB 明显多于参与者。复苏性心脏骤停、贫血和 Killip 分级>2 的患者 TMMB 发生率较高。临床试验中的出血发生率不能转化为未选择的 STEMI 人群。
