Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction
Gibson C.M.,Beth Israel Deaconess Medical Center |
Maehara A.,Columbia University |
Lansky A.J.,Columbia University |
Wohrle J.,University of Ulm |
And 10 more authors.
American Heart Journal | Year: 2011
Background: Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies. Design: INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid-left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding. Summary: INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin. © 2011 Mosby, Inc. All rights reserved. Source
Moore P.W.,Harrisburg Hospital |
Donovan J.W.,Harrisburg Hospital |
Donovan J.W.,Pennsylvania State University |
Burkhart K.K.,Harrisburg Hospital |
And 11 more authors.
Journal of Medical Toxicology | Year: 2014
Both alcohol withdrawal syndrome (AWS) and benzodiazepines can cause delirium. Benzodiazepine-associated delirium can complicate AWS and prolong hospitalization. Benzodiazepine delirium can be diagnosed with flumazenil, a GABA-A receptor antagonist. By reversing the effects of benzodiazepines, flumazenil is theorized to exacerbate symptoms of AWS and precludes its use. For patients being treated for alcohol withdrawal, flumazenil can diagnose and treat benzodiazepine delirium without precipitating serious or life-threatening adverse events. Hospital admission records were retrospectively reviewed for patients with the diagnosis of AWS who received both benzodiazepines and flumazenil from December 2006 to June 2012 at a university-affiliated inpatient toxicology center. The day of last alcohol consumption was estimated from available blood alcohol content or subjective history. Corresponding benzodiazepine, flumazenil, and adjunctive sedative pharmacy records were reviewed, as were demographic, clinical course, and outcome data. Eighty-five patients were identified (average age 50.3 years). Alcohol concentrations were detectable for 42 patients with average 261 mg/dL (10-530 mg/dL). Eighty patients were treated with adjunctive agents for alcohol withdrawal including antipsychotics (n = 57), opioids (n = 27), clonidine (n = 35), and phenobarbital (n = 23). Average time of flumazenil administration was 4.7 days (1-11 days) after abstinence, and average dose was 0.5 mg (0.2-1 mg). At the time of flumazenil administration, delirium was described as hypoactive (n = 21), hyperactive (n = 15), mixed (n = 41), or not specified (n = 8). Response was not documented in 11 cases. Sixty-two (72.9 %) patients had significant objective improvement after receiving flumazenil. Fifty-six patients required more than one dose (average 5.6 doses). There were no major adverse events and minor adverse effects included transiently increased anxiety in two patients: 1 patient who received 0.5 mg on abstinence day 2 and another patient who received 0.2 mg flumazenil on abstinence day 11. This is the largest series diagnosing benzodiazepine delirium after AWS in patients receiving flumazenil. During the treatment of AWS, if delirium is present on day 5, a test dose of flumazenil may be considered to establish benzodiazepine delirium. With the limited data set often accompanying patients with AWS, flumazenil diagnosed benzodiazepine delirium during the treatment of AWS and improved impairments in cognition and behavior without serious or life-threatening adverse events in our patients. © 2014 American College of Medical Toxicology. Source
Giugliano G.R.,Baystate Medical Center |
Falcone M.W.,Providence Hospital |
Mego D.,Arkansas Heart Hospital |
Ebersole D.,Lakeland Regional Medial Center |
And 6 more authors.
Cardiovascular Revascularization Medicine | Year: 2012
Purpose: The primary aim of this study was to prospectively evaluate the safety and efficacy of Excimer laser atherectomy as a primary treatment strategy in consecutively eligible patients presenting for percutaneous coronary intervention (PCI) of degenerated saphenous vein graft (SVG) lesions using a multicenter registry. Prior single-center experience suggested that laser atherectomy may decrease acute procedural complications during treatment of degenerated SVGs, including lesions not amenable to distal protection devices (DPDs). Methods and materials: The COronary graft Results following Atherectomy with Laser investigators enrolled 98 patients at 18 centers between June 23, 2003, and October 4, 2004, with greater than 50% stenosis of an SVG who presented for PCI due to angina pectoris or objective evidence of myocardial ischemia in a concordant myocardial distribution. Laser atherectomy was planned. Patients were excluded if the operator planned to utilize a DPD. Inclusion and exclusion criteria were aligned to those in the Saphenous vein graft Angioplasty Free of Emboli Randomized (SAFER) trial. Results: The primary end point [30-day major adverse cardiac events (MACE)] occurred in 18/98 (18.4%) patients driven primarily by non-q-wave myocardial infarction. Major procedural complications included no reflow (. n=5) and major dissection (. n=1). No perforations occurred. Univariate predictors of 30-day MACE included lesion length, vessel angulation, plaque burden, SVG degeneracy score, number of laser pulses used, and larger-sized laser catheters. Conclusions: This study demonstrated that Excimer laser atherectomy of diseased SVGs is feasible with results comparable to the 30-day MACE in the control population from the SAFER trial. Whether the addition of laser to embolic protection devices is of any clinical utility remains to be tested in future studies. © 2012 Elsevier Inc. Source
Reddy V.Y.,Mount Sinai School of Medicine |
Reddy V.Y.,Heart Health |
Sievert H.,CardioVascular Center Frankfurt |
Halperin J.,Mount Sinai School of Medicine |
And 69 more authors.
JAMA - Journal of the American Medical Association | Year: 2014
Importance While effective in preventing stroke in patients with atrial fibrillation (AF), warfarin is limited by a narrow therapeutic profile, a need for lifelong coagulation monitoring, and multiple drug and diet interactions. OBJECTIVE To determine whether a local strategy of mechanical left atrial appendage (LAA) closure was noninferior to warfarin. Design, Setting, and Participants Protect AFwas a multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 59 hospitals of 707 patients with nonvalvular AF and at least 1 additional stroke risk factor (CHADS2score≥1). Enrollment occurred between February 2005 and June 2008 and included 4-year follow-up through October 2012. Noninferiority required a posterior probability greater than 97.5%and superiority a probability of 95%or greater; the noninferiority margin was a rate ratio of 2.0 comparing event rates between treatment groups. Interventions Left atrial appendage closure with the device (n = 463) or warfarin (n = 244; target international normalized ratio, 2-3). Main Outcomes and Measures A composite efficacy end point including stroke, systemic embolism, and cardiovascular/unexplained death, analyzed by intention-to-treat. Results At a mean (SD) follow-up of 3.8 (1.7) years (2621 patient-years), there were 39 events among 463 patients (8.4%) in the device group for a primary event rate of 2.3 events per 100 patient-years, compared with 34 events among 244 patients (13.9%) for a primary event rate of 3.8 events per 100 patient-years with warfarin (rate ratio, 0.60; 95%credible interval, 0.41-1.05), meeting prespecified criteria for both noninferiority (posterior probability, <99.9%) and superiority (posterior probability, 96.0%). Patients in the device group demonstrated lower rates of both cardiovascular mortality (1.0 events per 100 patient-years for the device group [17/463 patients, 3.7%] vs 2.4 events per 100 patient-years with warfarin [22/244 patients, 9.0%]; hazard ratio [HR], 0.40; 95%CI, 0.21-0.75; P =.005) and all-cause mortality (3.2 events per 100 patient-years for the device group [57/466 patients, 12.3%] vs 4.8 events per 100 patient-years with warfarin [44/244 patients, 18.0%]; HR, 0.66; 95%CI, 0.45-0.98; P =.04). Conclusions and Relevance After 3.8 years of follow-up among patients with nonvalvular AF at elevated risk for stroke, percutaneous LAA closure met criteria for both noninferiority and superiority, compared with warfarin, for preventing the combined outcome of stroke, systemic embolism, and cardiovascular death, as well as superiority for cardiovascular and all-cause mortality. © 2014 American Medical Association. All rights reserved. Source
Farooq U.,Harrisburg Hospital |
Joshi M.,Harrisburg Hospital |
Nookala V.,Harrisburg Hospital |
Cheriyath P.,Harrisburg Hospital |
And 4 more authors.
Environmental Health: A Global Access Science Source | Year: 2010
Background. Pesticides are widely used in households to control insects and weeds. Several studies, over the past decades, have examined the possible relationship of serum concentration of organochlorine pesticides and the development of breast cancer. However, little data exists regarding an association between self-reported, residential exposure to pesticides and breast cancer risk. We, therefore, present a case-control study examining self-reported exposure to household pesticides with regard to associated risk of breast cancer. Methods. This study was conducted in the area in and around New York City, NY and included 1205 patients (447 cases and 758 controls). Cases were defined as women with newly diagnosed breast cancer or carcinoma in-situ, while controls included women with benign breast diseases or those undergoing non-breast related surgery. All patients were asked a series of questions to determine their pesticide exposure, including the type of pesticide, location of exposure (inside vs. outside the home), who applied the pesticide (self vs. a professional) and duration of pesticide use. Logistic regression models were used to estimate unadjusted and adjusted odds ratios (OR) and corresponding 95% confidence intervals (CI). Results. The most common pests encountered in participants' homes were ants, carpenter ants, and cockroaches. The calculated adjusted odds ratios for both self and professionally applied pesticides, specifically against the above mentioned insects, with regard to breast cancer risk were 1.25 (95% CI: 0.79-1.98) and 1.06 (95% CI: 0.65-1.73), respectively. Similarly, odds ratios and confidence intervals were calculated for other types of pesticides. Conclusions. Overall, the results of our study did not show an association between self-reported exposure to pesticides and breast cancer risk. Future studies, utilizing a larger sample size and more specific detail on time frame of pesticide exposure, are needed to further explore this question. © 2010 Farooq et al; licensee BioMed Central Ltd. Source