Browsing by Author "Cheema, Asim N. (7004832583)"

Background The safety and efficacy of drug eluting stents (DES) in the setting of ST elevation myocardial infarction (STEMI) is not well established. Methods In the TOTAL trial, patients presenting with STEMI were randomized to routine thrombectomy versus PCI alone. In this post-hoc analysis, propensity matching was used to assess relative safety and efficacy according to type of stent used. Results Each propensity-matched cohort included 2313 patients. The composite primary outcome of cardiovascular death, recurrent MI, cardiogenic shock or class IV heart failure within one year was lower in the DES group (HR 0.67; 95% CI 0.54 to 0.84, p = 0.0004). Cardiovascular death (HR 0.61; 95% CI 0.43 to 0.86, p = 0.005), recurrent MI (HR 0.51; 95% CI 0.35 to 0.75, p = 0.0005), target vessel revascularization (HR 0.47; 95% CI 0.36 to 0.62, p < 0.0001) and stent thrombosis (HR 0.60; 95% CI 0.40 to 0.89, p = 0.01) were lower in the DES group. There was no difference in major bleeding between groups. Conclusions In this observational analysis, the use of DES was associated with improvement in cardiovascular outcomes compared to the use of BMS. These results support the use of DES during primary PCI for STEMI. © 2017 Elsevier Ireland Ltd

BACKGROUND: ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) did not find an overall reduction in cardiovascular events with an initial invasive versus conservative management strategy in chronic coronary disease; however, there were conservative strategy participants who underwent invasive coronary angiography early postrandomization (within 6 months). Identifying factors associated with angiography in conservative strategy participants will inform clinical decision-making in patients with chronic coronary disease. METHODS: Factors independently associated with angiography performed within 6 months of randomization were identified using Fine and Gray proportional subdistribution hazard models, including demographics, region of randomization, medical history, risk factor control, symptoms, ischemia severity, coronary anatomy based on protocol-mandated coronary computed tomography angiography, and medication use. RESULTS: Among 2591 conservative strategy participants, angiography within 6 months of randomization occurred in 8.7% (4.7% for a suspected primary end point event, 1.6% for persistent symptoms, and 2.6% due to protocol nonadherence) and was associated with the following baseline characteristics: enrollment in Europe versus Asia (hazard ratio [HR], 1.81 [95% CI, 1.14-2.86]), daily and weekly versus no angina (HR, 5.97 [95% CI, 2.78-12.86] and 2.63 [95% CI, 1.51-4.58], respectively), poor to fair versus good to excellent health status (HR, 2.02 [95% CI, 1.23-3.32]) assessed with Seattle Angina Questionnaire, and new/more frequent angina prerandomization (HR, 1.80 [95% CI, 1.34-2.40]). Baseline low-density lipoprotein cholesterol <70 mg/dL was associated with a lower risk of angiography (HR, 0.65 [95% CI, 0.46-0.91) but not baseline ischemia severity nor the presence of multivessel or proximal left anterior descending artery stenosis >70% on coronary computed tomography angiography. CONCLUSIONS: Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in <10% of patients. It was associated with frequent or increasing baseline angina and poor quality of life but not with objective markers of disease severity. Well-controlled baseline low-density lipoprotein cholesterol was associated with a reduced likelihood of angiography. These findings point to the importance of a comprehensive assessment of symptoms and a review of guideline-directed medical therapy goals when deciding the initial treatment strategy for chronic coronary disease. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522. GRAPHIC ABSTRACT: A graphic abstract is available for this article. © 2024 American Heart Association, Inc.

Background: During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results. Methods: We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days. Results: The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P = 0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P = 0.02). Conclusions: In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. Copyright © 2015 Massachusetts Medical Society.

Background: Routine thrombus aspiration in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) does not improve clinical outcomes. However, there is remaining uncertainty about the potential benefit in those patients with high thrombus burden, where there is a biological rationale for greater benefit. Objectives: The purpose of this study was to evaluate the benefit of thrombus aspiration among STEMI patients with high thrombus burden. Methods: TOTAL (ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI) was a randomized trial of routine manual thrombectomy versus PCI alone in patients with STEMI (n = 10,732). High thrombus burden (Thrombolysis In Myocardial Infarction thrombus grade ≥3) was a pre-specified subgroup. Results: The primary outcome of cardiovascular (CV) death, MI, cardiogenic shock, or heart failure was not different at 1 year with thrombus aspiration in patients with high thrombus burden (8.1% vs. 8.3% thrombus aspiration; hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.13) or low thrombus burden (6.0% vs. 5.0% thrombus aspiration; HR: 1.22; 95% CI: 0.73 to 2.05; interaction p = 0.41). However, among patients with high thrombus burden, stroke at 30 days was more frequent with thrombus aspiration (31 [0.7%] thrombus aspiration vs. 16 [0.4%] PCI alone, HR: 1.90; 95% CI: 1.04 to 3.48). In the high thrombus burden group, thrombus aspiration did not significantly improve CV mortality at 30 days (HR: 0.78; 95% CI: 0.61 to 1.01; p = 0.06) and at 1 year (HR: 0.88; 95% CI: 0.72 to 1.09; p = 0.25). Irrespective of treatment assignment, high thrombus burden was an independent predictor of death (HR: 1.78; 95% CI: 1.05 to 3.01). Conclusions: In patients with high thrombus burden, routine thrombus aspiration did not improve outcomes at 1 year and was associated with an increased rate of stroke. High thrombus burden is still an important predictor of outcome in STEMI. (A Trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI [TOTAL]; NCT01149044) © 2018 American College of Cardiology Foundation

Objectives: To assess the relationship between preprocedural anticoagulation use and clinical and angiographic outcomes. Background: For patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the optimal timing of anticoagulant administration remains uncertain. Methods: Patients enrolled in the TOTAL trial were stratified based on whether or not they had received any parenteral anticoagulant prior to randomization and PCI. Baseline and procedural characteristics were compared. For one-year clinical outcomes, Cox proportional modeling adjusted on a propensity score was used to analyze differences between groups. Angiographic endpoints were analyzed by logistic regression models adjusted for propensity scores. Results: In the trial, 10,064 patients were enrolled and underwent PCI. Preprocedural anticoagulation was used in 6,381 patients (63%).The most common anticoagulant was intravenous unfractionated heparin (5,188, 81%). Patients who received preprocedural anticoagulation had higher rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI. Pretreatment with anticoagulation was associated with lower use of bailout thrombectomy, GP IIb/IIIa inhibitors, and intra-aortic balloon pump. After adjustment, preprocedural anticoagulation was associated with lower rates of CABG and minor bleeding at 1 year but there were no significant differences in death, stroke, recurrent MI, cardiogenic shock, or congestive heart failure. Conclusions: Preprocedural anticoagulation is associated with improved flow and reduced thrombus in the IRA prior to PCI, less bailout thrombectomy during PCI but no difference in death, recurrent infarction, or heart failure at 1 year. © 2019 Wiley Periodicals, Inc.