Clinical, Functional, and Quality of Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.

PURPOSE: To report 90-day results from the first interim analysis of the STRIKE-PE study, which is evaluating safety, effectiveness, and functional and quality of life (QoL) outcomes of Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System for the treatment of acute pulmonary embolism (PE). METHODS: STRIKE-PE is a prospective, international, multicenter study that will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT. Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and QoL assessments. RESULTS: The first 150 consecutive patients were treated with Lightning 12 CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 before thrombectomy to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four patients (2.7%) experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale and QoL measures, and the NYHA class distribution returned to that reported before the index PE. CONCLUSION: These interim results demonstrate a rapid reduction in RV/LV ratio, achieved with a fast thrombectomy time while maintaining safety. This is accompanied by improvements in 90-day functional and QoL outcomes.

The evolving role of rescue therapy for acute myocardial infarction.

Coronary reperfusion for acute ST-elevation myocardial infarction can be accomplished with fibrinolytic therapy or with percutaneous coronary intervention (PCI). Primary PCI provides more effective and sustained early reperfusion than fibrinolytic therapy, but is only available in a minority of hospitals worldwide. There is a lack of a definite method for identification of patients who have inadequate reperfusion after fibrinolysis. Transfer of patients after fibrinolysis for diagnostic angiography and possible rescue therapy is safe and feasible. Rescue PCI with the use of stents and antiplatelet therapy decreases cardiovascular mortality and morbidity compared with conservative therapy. Increasing use of primary PCI and forming networks to transfer patients to centers that offer primary PCI may decrease the need for rescue therapy in the future.

Angiographic adverse events during percutaneous coronary intervention fail to predict creatine kinase-MB elevation.

We attempted to determine if aggressive detection of angiographic adverse events during coronary intervention could predict subsequent creatine kinase (CK)-MB elevations. During coronary intervention, both fluoroscopy and cine angiography were used to detect angiographic adverse events. At least one angiographic adverse event occurred in 133/251 (53%) of procedures. CK-MB elevation occurred in 24% of procedures. Slow flow during the procedure (P=0.002) and chest discomfort at the end of the procedure (P=0.007) were the strongest predictors of CK-MB elevation. Among procedures with no angiographic adverse events, CK-MB elevation occurred in 15/121 (12%), accounting for 25% of CK-MB elevations. We conclude that CK-MB elevation occurs after angiographically uncomplicated coronary interventions even when angiographic adverse events are aggressively detected. Routine monitoring of cardiac enzymes is necessary to detect all patients who will experience myocardial injury after coronary intervention.

Angiographic and long-term outcomes of "rescue" stenting versus PTCA in failed thrombolysis in acute myocardial infarction.

Percutaneous transluminal coronary angioplasty (PTCA), when performed early after clinically failed thrombolysis, improves acute infarct-artery patency in up to 90% of cases. Limited data are available regarding the role of rescue stenting in this setting. From January 1995 to December 1999, the authors studied all consecutive patients treated with rescue PTCA or rescue stenting within 12 hours of onset of chest pain and clinically failed thrombolytic therapy at their institution. Baseline demographic characteristics, infarct-related artery location, lesion class, left ventricular function, and incidence of multivessel disease were similar between groups (23 patients in each group). Preprocedural TIMI flow 0 was more common in PTCA patients (p=0.025). Quantitative coronary analysis revealed similar incidence of calcification, thrombus burden, minimal lumen diameter (MLD), and lesion length between groups. Post-procedural TIMI 3 flow was more common in stent patients; however, this was not statistically significant (p=0.18). Greater final MLD (p<0.001), less residual stenosis (p<0.001), and a trend toward larger reference vessel diameter (p=0.13) were observed in favor of stent patients. At 6-month follow-up, there was no difference in the incidence of death, myocardial infarction, or readmission for unstable angina between groups. More stent patients (60% vs 27%, p=0.06) were angina free as compared to PTCA patients. Despite similar in-hospital clinical outcomes, the study suggests better angiographic results and 6-month orbidity with rescue stenting.

Clinical predictors of 30-day cardiac events in patients with acute coronary syndrome at a community hospital.

OBJECTIVE: We sought to determine predictors of coronary events (cardiac death, acute myocardial infarction, and urgent revascularization) within 30 days after admission. METHODS: We prospectively collected data on 400 patients admitted through our emergency room for unstable angina and acute coronary syndromes. Patients with ST-segment elevation myocardial infarction and those who required thrombolysis were excluded. RESULTS: Of 383 patients who were eligible, 120 patients had coronary events within 30 days. Statistically significant variables associated with coronary events were advanced age, male sex, family history of premature coronary artery disease (CAD), diabetes mellitus, tobacco abuse, prior congestive heart failure, prior myocardial infarction, and history of CAD. Symptoms at presentation associated with cardiac events were typical angina and shortness of breath. Objective measures of ischemia associated with cardiac events were elevated troponin T, elevated creatine kinase MB, and ischemic electrocardiographic changes. Using forward stepwise regression analysis, we generated a model to predict 30-day major adverse cardiac events. The strongest predicting variable was serum troponin T (accounting for 33% of predicting r2, P < 0.001) followed by typical angina (r2 increasing to 37%), ischemic electrocardiographic changes (40%), prior CAD (42%), family history of premature CAD (44%), shortness of breath (46%), and positive creatine kinase MB (48%). The positive predictive power of the complete model was r2 = 48%, P < 0.001. CONCLUSION: Our model incorporating elements from the patient's demographic, medical history, presentation, and ischemic assessment identified 48% of patients presenting with unstable angina and acute coronary syndromes who will suffer a major adverse cardiac event within 30 days of admission. Although the strongest predictor was identified as serum troponin T, other clinical criteria offered improvement in our predictive abilities. Therefore, good initial clinical evaluation in addition to simple tests such as serum cardiac markers and electrocardiography are valuable in risk stratification of patients presenting with acute coronary syndromes and cardiac chest pain. Additional testing may be necessary to improve the positive predictive value of the model. Cardiac enzymes and electrocardiographic changes have the highest negative predictive value for occurrence of major adverse cardiac events. Identification of high-risk patients is essential to direct resources toward these patients and to avoid unnecessary costs and risk to the low-risk population.

Coronary artery "pseudothrombus" due to collateral flow artifact distal to left circumflex coronary stenosis.

Since the complexity, morbidity, and costs of coronary interventions are increased when coronary thrombus is present, identification of the cause of an angiographic filling defect is potentially important. We present a case report and review our experience with a flow artifact that mimicked thrombus ("pseudothrombus") in the setting of a severe proximal stenosis in the left circumflex coronary artery.

Effect of abciximab on angiographic complications during percutaneous coronary stenting in the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT).

In the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT), abciximab reduced ischemic complications of stent implantation at 30 days and 6 months. The responsible mechanisms remain unclear. We sought to determine if abciximab decreases ischemic complications by decreasing the incidence of angiographic complications during coronary stenting. In EPISTENT, patients were randomized to stenting with abciximab (abciximab group), stenting with placebo (placebo group), or balloon angioplasty with abciximab. Angiographic complications (including major or minor dissection, distal embolization, thrombus postprocedure, side branch or other vessel occlusion, residual stenosis >50%, transient coronary occlusion, and Thrombolysis In Myocardial Infarction final flow <3) were recorded prospectively. Creatine kinase (CK)-MB enzyme levels after intervention were measured at 6-hour intervals. We analyzed angiographic complications and CK-MB elevations in the abciximab group (n = 784) and the placebo group (n = 803). Angiographic complications were 29% less frequent in the abciximab group compared with the placebo group (17.0% vs 23.8%; p = 0.001). In patients with angiographic complications, there was a nonsignificant reduction in the incidence of CK-MB elevation >3 times normal with abciximab therapy (19.7% vs 24.5% in placebo group; p = 0.314). Abciximab (compared with placebo) significantly reduced the incidence of CK-MB elevation >3 times normal in those without any angiographic complications (6.5% vs 10.7%; p = 0.007). In summary, abciximab (compared with placebo) significantly reduced angiographic complications during coronary stenting. Abciximab also prevented CK-MB elevations in patients without angiographic complications.

Stent placement for coronary stenosis in Kawasaki disease: case report and literature review.

A 48-year-old male patient diagnosed with Kawasaki disease in childhood presented with recurrent angina after undergoing coronary artery bypass surgery in 1996. Percutaneous transluminal coronary angioplasty and intracoronary stent placement to a lesion in the proximal ramus intermedius were performed successfully. This case illustrates the complementary nature of percutaneous and surgical myocardial revascularization strategies in appropriately selected patients with Kawasaki disease.