急性ST段抬高的心肌梗死患者行经皮冠状动脉介入时对远端微循环的保护:一项随机对照试验

Context: Atheromatous and thrombotic embolization during percutaneous coronary intervention(PCI) in acute myocardial infarction is common and may result in microcirculatory dysfunction, the prevention of which may improve reperfusion success, reduce infarct size, and enhance event-free survival. Objective: To determine whether protection of the distal microcirculation from thromboembolic debris liberated during primary PCI results in improved reperfusion and decreased infarct size. Design, Setting, and Patients: Prospective randomized controlled trial at 38 academic and community-based institutions in 7 countries enrolling 501 patients aged 18 years or older with ST-segment elevation myocardial infarction(STEMI) presenting within 6 hours of symptom onset and undergoing primary PCI or rescue intervention after failed thrombolysis. Interventions: Patients were randomized between May 20, 2002, and November 21, 2003, to receive PCI with a balloon occlusion and aspiration distal microcirculatory protection systemvs angioplasty without distal protection. Main Outcome Measures: Coprimary end points were ST-segment resolution(STR) measured 30 minutes after PCI by continuous Holter monitoring and infarct size measured by technetium Tc 99m sestamibi imaging between days 5 and 14. Secondary end points included major adverse cardiac events. Results: Among 252 patients assigned to distal protection, aspiration was performed in 97%(242/251), all angioplasty balloon inflations were fully protected in 79%(193/245), and visible debris was retrieved from 73%(182/250). Complete STR was achieved in a similar proportion reperfused with vs without distal protection(63.3%[152/240] vs 61.9%[148/239], respectively; absolute difference, 1.4%[95%confidence interval,-7.7%to 10.5%; P=.78]), and left ventricular infarct size was similar in both groups(median, 12.0%[n=229] vs 9.5%[n=208], respectively; P=.15). Major adverse cardiac events at 6 months occurred with similar frequency in the distal protection and control groups(10.0%vs 11.0%, respectively; P=.66). Conclusions: A distal balloon occlusion and aspiration system effectively retrieves embolic debris in most patients with acute STEMI undergoing emergent PCI. Nonetheless, distal embolic protection did not resultin improved microvascularflow, greater reperfusion success, reduced infarct size, or enhanced event-free survival.

急性ST段抬高心肌梗死患者经皮冠状动脉介入治疗时远端微循环保护的随机对照试验

Context: Atheromatous and thrombotic embolization during percutaneous coronary intervention (PCI) in acute myocardial infarction is common and may result in m icrocirculatory dysfunction, the prevention of which may improve reperfusion suc cess, reduce infarct size, and enhance event-free survival. Objective: To deter mine whether protection of the distal microcirculation from thromboembolic debri s liberated during primary PCI results in improved reperfusion and decreased inf arct size.Design, Setting, and Patients: Prospective randomized controlled trial at 38 academic and community-based institutionsin 7 countries enrolling 501 pa tients aged 18 years or older with ST-segment elevation myocardial infarction(S TEMI) presenting within 6 hours of symptom onset and undergoing primary PCI or r escue intervention after failed thrombolysis. Interventions: Patients were rando mized between May 20, 2002, and November 21, 2003, to receive PCI with a balloon occlusion and aspiration distal microcirculatory protection system vs angioplas ty without distal protection. Main Outcome Measures:Coprimary end points were ST -segment resolution(STR) measured 30 minutes after PCI by continuous Holter mon itoring and infarct size measured by technetium Tc 99m sestamibi imaging between days 5 and 14. Secondary end points included major adverse cardiac events. Resu lts: Among 252 patients assigned to distal protection, aspiration was performed in 97%(242/251), all angioplasty balloon inflations were fully protected in 79 %(193/245), and visible debris was retrieved from 73%(182/250). Complete STR w as achieved in a similar proportion reperfused with vs without distal protection (63.3%[152/240] vs 61.9%[148/239], respectively; absolute difference,1.4%[95 %confidence interval, -7.7%to 10.5%;P = .78]), and left ventricular infarct size was similar in both groups (median, 12.0%[n = 229] vs 9.5%[n = 208],respe ctively; P = .15). Major adverse cardiac events at 6 months occurred with simila r frequency in the distal protection and control groups (10.0%vs 11.0%, respec tively;P = .66). Conclusions: A distal balloon occlusion and aspiration system e ffectively retrieves embolic debris in most patients with acute STEMI undergoing emergent PCI.Nonetheless, distal embolic protection did not result in improved microvascularflow, greater reperfusion suc cess,reduced infarct size, or enhanced event-free survival.

治疗延迟对急性心肌梗死直接经皮冠状动脉介入治疗预后的影响:来自CADILLAC试验的分析

Background: The impact of treatment delays on outcomes after primary percutaneous coronary intervention for acute myocardial infarction is controversial. Methods: The CADILLAC trial randomized 2082 patients with acute myocardial infarction to stenting versus percutaneous transluminal coronary angioplasty, each with or without abciximab. Results: Earlier reperfusion(< 3 vs 3-6 vs >6 hours) was associated with lower 1-year mortality(2.6%vs 4.3%vs 4.8%, P=.046 for< 3 vs ≥3 hours), more frequent grade 2 to 3 myocardial blush(55%vs 53%vs 44%, P=.003), more frequent complete ST-segment resolution(64%vs 68%vs 47%, P=.006), and greater improvement in left ventricular function. Early reperfusion(< 3 vs 3-6 vs≥3 hours)was associated with lower mortality in high-risk patients(3.8%vs 6.9%vs 7.0%, P=.051 for< 3 vs ≥3 hours) but not in low-risk patients(1.4%vs 0.6%vs 1.0%, P=.63). Door-to-balloon times were independently correlated with mortality in patients presenting early after the onset of symptoms(≤2 hours, hazard ratio 1.24, P=.013) but not late(>2 hours, heart rate 0.88, P=.33). Conclusions: Early reperfusion results in superior clinical outcomes, enhanced microvascular reperfusion, and better recovery of left ventricular function. Incremental treatment delays impact mortality more in high-risk versus low-risk patients and more in patients presenting early versus late after the onset of symptoms. These data emphasize the importance of minimizing treatment delays and have implications regarding patient triage for primary percutaneous coronary intervention.

ST段抬高型与非ST段抬高型急性心肌梗死患者行直接经皮冠状动脉介入术后早期及晚期预后(来自于CADILLAC试验)

We determined the outcomes of patients with acute ST-segment elevation(STE) myocardial infarction(STEMI) and non-STEMI(NSTEMI) after primary percutaneous coronary intervention(PCI). The prognosis after primary PCI in STEMI has been extensively studied and defined. Outcomes of patients who undergo primary PCI for NSTEMI are less well established. In total, 2,082 patients with ongoing chest pain for >30 minutes consistent with acute MI were randomized to balloon angioplasty versus stenting, each with/without abciximab. Of 1,964 patients, STEMI was present in 1,725(87.8%) and NSTEMI in 239(12.2%). Compared with STEMI, those with NSTEMI were more likely to have delayed time-to-hospital arrival(2.4 vs 1.8 hours, p=0.0002) and increased door-to-balloon time(3.2 vs 1.9 hours, p< 0.0001). Patients with NSTEMI were more likely to have Thrombolysis In Myocardial Infarction grade 3 flow at baseline(37.3%vs 19.4%, p< 0.0001) and higher ejection fraction(58.7%vs 55.8%, p=0.001), but similar rates of postprocedural Thrombolysis In Myocardial Infarction grade 3 flow. At 1 year, patients with NTEMI had similar mortality(3.4%vs 4.4%, p=0.40) but higher rates of major adverse cardiac events(24.0%vs 16.6%, p=0.007) that was driven by more frequent ischemic target vessel revascularization(21.8%vs 11.9%, p< 0.0001). In conclusion, patients with acute MI without STE who are treated with primary PCI have marked delays to treatment, similar late mortality, and increased rates of ischemic target vessel revascularization compared with patients with STEMI, despite more favorable angiographic features at presentation and similar reperfusion success. The adverse prognosis of patients with NSTEMI should be recognized and efforts made to decrease reperfusion times.

老年急性心肌梗死患者首次行冠状动脉介入治疗的预后:降低晚期血管成形术并发症的阿昔单抗和设备的调查试验(CADILLAC)

Background-Biological age is a strong determinant of prognosis in patients with acute myocardial infarction(AMI). We sought to examine the impact of age after primary percutaneous coronary intervention in AMI and to determine whether routine coronary stent implantation and/or platelet glycoprotein IIb/IIIa inhibitors improve clinical outcomes in elderly patients after primary angioplasty. Methods and Results-In the CADILLAC trial, 2082 patients with AMI were randomized to balloon angioplasty,angioplasty plus abciximab,stenting alone, or stenting plus abciximab. No patient was excluded on the basis of advanced age; patients ranging from 21 to 95 years of age were enrolled. One-year mortality increased for each decile of age, exponentially after 65 years of age(1.6%for patients< 55 years, 2.1%for 55 to 65 years, 7.1%for 65 to 75 years, 11.1%for patients >75 years; P< 0.0001). Elderly patients also had increased rates of stroke and major bleeding compared with their younger counterparts. Among elderly patients (≥65 years), 1-year rates of ischemic target revascularization (7.0%versus 17.6%; P< 0.0001) and subacute or late thrombosis (0%versus 2.2%; P=0.005)were reducedwith stenting comparedwith balloon angioplasty. Routine abciximab administration, although safe,was not of definite benefit in elderly patients. Rates of mortality, reinfarction, disabling stroke, and major bleeding in the elderly were independent of reperfusion modality. Conclusions-Despite contemporary mechanical reperfusion strategies,mortality, major bleeding, and stroke rates remain high in elderly patients undergoing primary percutaneous coronary intervention, outcomes that are not affected by stents or glycoprotein Ⅱb/Ⅲa inhibitors. By reducing restenosis, however, stent implantation improves clinical outcomes in elderly patients with AMI.