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Biomedical subjects

James J Ferguson

Publications and source records attributed to James J Ferguson.

At least 37 records · Page 2Linked to original sources
PubMed2004

Coordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: design and rationale of the SYNERGY Library.

Clinical trials and accompanying substudies in patients with acute coronary syndromes (ACS) have over the last several years yielded a wealth of knowledge about the pathophysiology and management of this high-risk condition. The Superior Yield of the New strategy of Enoxaparin, Revascularization, and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) trial is a large-scale, randomized, controlled trial evaluating the effect of enoxaparin and unfractionated heparin on death and myocardial infarction in high-risk patients presenting with non-ST-segment elevation ACS. The SYNERGY Library has been designed as a coordinated series of investigations with simultaneous data acquisition on the same cohort of approximately 500 SYNERGY patients at 60 centers in North America. Specifically, electrocardiograms, coronary arteriograms, inflammatory markers, coagulation studies, and genetic samples will be collected and processed at core laboratory facilities, and the results will be stored in a central repository. This novel strategy for substudy investigation is unprecedented in cardiovascular clinical trials. The goal is to gain significant understanding about this patient population, discover new principles of pathophysiology, identify novel pharmacologic targets, and streamline further drug development. It is hoped that the SYNERGY Library will serve as a model for future substudy design to maximize academic insight within the framework of a large-scale, multicenter trial.

Angina, Unstable↗
PubMed2004

Low-molecular-weight heparins in the cardiac catheterization laboratory.

We describe the unique properties of low-molecular-weight heparins and review studies of the use of these agents in the catheterization laboratory for percutaneous coronary intervention. Recent data regarding bedside monitoring of low-molecular-weight heparin activity are also discussed, as are ongoing and future studies that should be of assistance to clinicians as they consider expanding the use of this newer form of anti-thrombotic therapy.

Angioplasty, Balloon, Coronary↗
PubMed2003

Contemporary utilization and outcomes of intra-aortic balloon counterpulsation in acute myocardial infarction: the benchmark registry.

OBJECTIVES: We sought to examine contemporary utilization patterns and clinical outcomes in patients with acute myocardial infarction (AMI) requiring intra-aortic balloon pump (IABP) counterpulsation. BACKGROUND: Despite increasing experience with and broadened indications for intra-aortic counterpulsation, the current indications, associated complications, and clinical outcomes of IABP use in AMI are unknown. METHODS: Between June 1996 and August 2001, data were prospectively collected from 22,663 consecutive patients treated with aortic counterpulsation at 250 medical centers worldwide; 5,495 of these patients had AMI. RESULTS: Placement of an IABP in AMI patients was most frequently indicated for cardiogenic shock (27.3%), hemodynamic support during catheterization and/or angioplasty (27.2%) or prior to high-risk surgery (11.2%), mechanical complications of AMI (11.7%), and refractory post-myocardial infarction unstable angina (10.0%). Balloon insertions were successful in 97.7% of patients. Diagnostic catheterization was performed in 96% of patients, and 83% underwent coronary revascularization before hospital discharge. The in-hospital mortality rate was 20.0% (38.7% in patients with shock) and varied markedly by indication and use of revascularization procedures. Major IABP complications occurred in only 2.7% of patients, despite median use for three days, and early IABP discontinuation was required in only 2.1% of patients. CONCLUSIONS: With contemporary advances in device technology, insertion technique, and operator experience, IABP counterpulsation may be successfully employed for a wide variety of conditions in the AMI setting, providing significant hemodynamic support with rare major complications in a high-risk patient population.

Adult↗
PubMed2003

Intra-aortic balloon counterpulsation in US and non-US centres: results of the Benchmark Registry.

AIMS: To examine differences in patient characteristics and outcomes in 19636 patients enrolled in the USA and 3027 patients enrolled in other countries undergoing intra-aortic balloon pump (IABP) counterpulsation. METHODS AND RESULTS: Indications for IABP use; a larger percentage of US patients were identified as 'early support and stabilization for angiography or angioplasty' (21.1% US vs 11.8% non-US), and 'pre-operative support for high-risk CABG' (15.9% vs 6.6%). A smaller percentage of US patients vs non-US patients were identified as 'weaning from cardiopulmonary bypass' (14.3% vs 28.2%), and 'refractory ventricular failure' (6.2% vs 9.8%). One out of five patients in both groups was listed as 'cardiogenic shock' (18.9% US vs 20.2% non-US). All cause, risk-adjusted, in-hospital mortality (20.1% vs 28.7%; P<0.001), and mortality with IABP in place (10.8% vs 18.0%; P<0.001) were lower at US vs non-US sites. In both US and non-US institutions, IABP associated complication rates, such as IABP-related mortality (0.05% vs 0.07%), major limb ischaemia (0.9% vs 0.8%), and severe bleeding (0.9% vs 0.8%), were low. CONCLUSIONS: IABP counterpulsation is deployed at an earlier clinical stage in US patients. Mortality rates are higher for non-US patients, particularly for patients with non-surgery cardiac interventions, even after adjusting for risk factors. Complication rates were low. Physicians should therefore not be reluctant to use IABP in high-risk patients undergoing cardiac procedures.

Aged↗
PubMed2003

Combining enoxaparin and glycoprotein IIb/IIIa antagonists for the treatment of acute coronary syndromes: final results of the National Investigators Collaborating on Enoxaparin-3 (NICE-3) study.

BACKGROUND: In high-risk patients with acute coronary syndromes (ACS), there have been concerns relating to the safety of using low molecular weight heparins (LMWH) in combination with a glycoprotein (GP) IIb/IIIa antagonist, and the continued use of LMWH in patients brought to the cardiac catheterization laboratory for percutaneous coronary intervention (PCI). METHODS: The National Investigators Collaborating on Enoxaparin-3 (NICE-3) study was an open-label observational study of enoxaparin in combination with any 1 of 3 available GP IIb/IIIa antagonists in patients presenting with non-ST-elevation ACS. The primary end point was the incidence of major bleeding not related to coronary artery bypass graft (CABG) surgery. Data were also recorded on the incidence of death, myocardial infarction (MI), and urgent revascularization for repeat ischemia. RESULTS: A total of 671 patients with validated data were treated with enoxaparin; 628 of these patients also received a GP IIb/IIIa antagonist (tirofiban, n = 229; eptifibatide, n = 272; abciximab, n = 127); 283 of 628 underwent percutaneous coronary intervention (PCI). The 30-day incidence of non-CABG major bleeding was 1.9%, and was not significantly higher than a prespecified historical control rate of 2.0%. Outcome events included death (1.0% at hospital discharge and 1.6% at 30 days), MI (3.5% and 5.1%, respectively), and urgent revascularization (2.7% and 6.8%, respectively). CONCLUSIONS: The safety of enoxaparin plus a GP IIb/IIIa antagonist was comparable to that of unfractionated heparin plus a GP IIb/IIIa antagonist, as reported in other recent major trials. Patients undergoing PCI can be safely managed with enoxaparin and a GP IIb/IIIa antagonist, without supplemental use of unfractionated heparin.

Abciximab↗
PubMed2002

Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial.

BACKGROUND: Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral agent tranilast has been shown to decrease the frequency of angiographic restenosis after PCI. METHODS AND RESULTS: In this double-blind, randomized, placebo-controlled trial of tranilast (300 and 450 mg BID for 1 or 3 months), 11 484 patients were enrolled. Enrollment and drug were initiated within 4 hours after successful PCI of at least 1 vessel. The primary end point was the first occurrence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months and was 15.8% in the placebo group and 15.5% to 16.1% in the tranilast groups (P=0.77 to 0.81). Myocardial infarction was the only component of major adverse cardiovascular events to show some evidence of a reduction with tranilast (450 mg BID for 3 months): 1.1% versus 1.8% with placebo (P=0.061 for intent-to-treat population). The primary reason for not completing treatment was > or =1 hepatic laboratory test abnormality (11.4% versus 0.2% with placebo, P<0.01). In the angiographic substudy composed of 2018 patients, minimal lumen diameter (MLD) was measured by quantitative coronary angiography. At follow-up, MLD was 1.76+/-0.77 mm in the placebo group, which was not different from MLD in the tranilast groups (1.72 to 1.78+/-0.76 to 80 mm, P=0.49 to 0.89). In a subset of these patients (n=1107), intravascular ultrasound was performed at follow-up. Plaque volume was not different between the placebo and tranilast groups (39.3 versus 37.5 to 46.1 mm(3), respectively; P=0.16 to 0.72). CONCLUSIONS: Tranilast does not improve the quantitative measures of restenosis (angiographic and intravascular ultrasound) or its clinical sequelae.

Administration, Oral↗
PubMed2002

Comparison of outcomes after 8 vs. 9.5 French size intra-aortic balloon counterpulsation catheters based on 9,332 patients in the prospective Benchmark registry.

The Benchmark intra-aortic balloon counterpulsation (IABC) registry maintains prospectively gathered clinical information on a large cohort of IABC patients. The purpose of the present report is to compare in-hospital outcomes and complications in patients treated with the newer 8 vs. 9.5 Fr size catheters. Between January 1997 and August 2000, data on 7,078 9.5 Fr and 2,254 8 Fr IABC insertions were submitted to Benchmark. This was not a randomized comparison but rather a posthoc analysis of prospectively gathered data. There was less limb ischemia with the 8 Fr IABC size catheter. There were no significant differences in bleeding or mortality between the two groups. Smaller IABC catheter size is associated with significantly less limb ischemia, especially in higher-risk patients. The large, population-based, ongoing Benchmark registry provides a useful vehicle for outcomes research concerning the evolving practice of IABC.

Aged↗
PubMed2002

Defining the scope of evidence-based practice for low-molecular-weight heparin therapy in high-risk patients with unstable angina and non-ST-elevation myocardial infarction.

Various therapies have been utilized for the treatment of unstable angina and non-ST-elevation myocardial infarction (NSTEMI). Each therapy has both advantages and disadvantages with regard to clinical outcomes and an increased risk of bleeding. One emerging primary therapy is low-molecular-weight heparin (LMWH). Concerns have emerged, however, over the use of LMWH in patients going to the catheterization laboratory or who receive platelet glycoprotein IIb/IIIa inhibitors. Available trial data point to the safety and efficacy of LMWH in these patients. Eventually, LMWH will probably replace unfractionated heparin (UFH) for the majority of patients with acute coronary syndromes (ACS). At present, however, practitioners need to consider individually how comfortable they are with the available data.

Acute Disease↗
PubMed2002

Multi-year follow-up of abciximab therapy in three randomized, placebo-controlled trials of percutaneous coronary revascularization.

There is considerable evidence supporting the use of platelet glycoprotein IIb/IIIa inhibitors to reduce ischemic complications of percutaneous coronary revascularization. However, long-term follow-up has been limited. In three large-scale randomized trials that tested abciximab at a uniform bolus dose and 12-hour infusion against placebo, in a double-blind fashion, a total of 5799 patients had their long-term follow-up vital status determined at a minimum of 7 years (EPIC), 4.5 years (EPILOG), or 3 years (EPISTENT) after randomization (median, 4.8 years). The prespecified primary endpoint was all-cause mortality by intention-to-treat analysis at 3 years in patients randomly assigned to a common intervention. Follow-up for 5603 of the 5799 patients was 96.6% complete at 3 years; 320 deaths had occurred by that time. After 3 years of follow-up, mortality was 6.4% in the placebo groups and 5.0% in the abciximab groups (hazard ratio [HR] = 0.78; 95% confidence interval [CI]: 0.63 to 0.98; P = 0.03). A similar reduction in mortality was observed on an intention-to-treat basis when all follow-up information was utilized after a median of 4.8 years of follow-up (n = 652 deaths): 12.6% in the placebo groups and 10.2% in the abciximab groups (HR = 0.82; 95% CI: 0.70 to 0.96; P = 0.01).Abciximab treatment reduced all-cause mortality by about 20% during long-term follow-up after percutaneous coronary intervention. The findings were similar in magnitude and consistent in direction for each of the three trials, and the absolute survival benefit appeared to increase over time. Brief intervention with this monoclonal antibody during percutaneous coronary revascularization is associated with significant improvement of long-term survival.

Abciximab↗
PubMed2002

Trends in intraaortic balloon counterpulsation complications and outcomes in cardiac surgery.

BACKGROUND: As the proportion of high-risk patients for cardiac surgery increases, use of intraaortic balloon counterpulsation (IABC) has increased, especially in preoperative therapy. Although the efficacy and cost-effectiveness of IABC have been demonstrated, historically higher complication rates have dissuaded some practitioners from using IABC. METHODS: This report describes IABC use in cardiac surgery, examines trends in complications over time, and compares outcomes in preoperative versus postoperative use in a single prospective worldwide registry over the past 3 years. RESULTS: The frequency of IABC use appears to be increasing with time as the complication rates have dramatically fallen. The overall IABC-related complication rate was 6.5% (460/7,101), and the rate of major complications (requiring surgery or transfusion) was 2.1% (148/7,101). Hospital mortality was significantly lower in patients treated preoperatively with IABC compared with patients treated postoperatively (8.8% vs 28.2%, p < 0.0001), although this may be due to a selection bias in the postoperative group. CONCLUSIONS: Preoperative IABC therapy leads to better patient outcomes in high-risk CABG patients. Improved IABC technology and better surveillance have led to increased use with lower complication rates. Although selection bias is inherent in retrospective studies, the Benchmark Counterpulsation Outcomes Registry outcomes are in close concordance to prospective randomized studies previously reported.

Cardiac Surgical Procedures↗
PubMed2002

Low-molecular-weight heparin therapy for non-ST-elevation acute coronary syndromes and during percutaneous coronary intervention: an expert consensus.

BACKGROUND: Therapy with either low-molecular-weight heparin (LMWH) or glycoprotein (GP) IIb/IIIa receptor antagonists is of benefit to patients with acute coronary syndromes (ACSs). However, algorithms that define how LMWH may be used in patients, proceeding from medical management to intervention and in conjunction with GP IIb/IIIa inhibitors, are lacking. The objectives of this task force were to formulate recommendations based on all available data for the use of LMWH, both with and without GP IIb/IIIa receptor antagonists, and to provide seamless integration of care during the transition from medical to interventional management. METHODS AND RESULTS: An international task force of 14 cardiologists with extensive experience in clinical trials was convened in New York in February 2001 to address issues related to the use of LMWH in patients with non-ST-elevation ACS. Evidence from randomized trials, observational studies, and other reports was discussed, and consensus recommendations were formulated. CONCLUSIONS: Substantial evidence exists that patients receiving LMWH for an ACS can safely undergo cardiac catheterization and percutaneous coronary intervention. Concerns regarding the transition of these patients from the medical service to the cardiac catheterization laboratory should therefore not impede the upstream use of LMWH. Furthermore, LMWH and GP IIb/IIIa receptor antagonists can be used safely in combination, with no apparent increase in the risk of major bleeding. Consensus algorithms for therapy are presented.

Acute Disease↗
PubMed2002

Left ventricular electromechanical mapping: preliminary evidence of electromechanical changes after successful coronary intervention.

BACKGROUND: Postinterventional ischemic myocardial dysfunction and its sequelae are still not well understood. METHODS AND RESULTS: To gain further insight into the immediate physiologic consequences of coronary interventions and to better understand the nature of changes that result from such interventions, we analyzed 96 electromechanical maps from 48 patients before and after successful, uncomplicated percutaneous coronary interventions (PCI). A NOGA system was used to construct the map of the endocardial surface. Reproducibility was confirmed by constructing 10 additional maps in 5 patients who did not undergo an intervening procedure. Discordant areas were defined as those with preserved unipolar voltage (> or =7.5 mV) and diminished linear local shortening (< or =12.5%). On the basis of comparison of the variations in the discordance values (%) in the reproducibility group, patients were considered improved (lower values), worsened (higher values), or unchanged. In the reproducibility group, the mean variation in discordance was 2.18% +/- 1.26%, whereas in the PCI group, it was 21.97% +/- 18.47%. In the PCI group (rotational atherectomy subgroup [n = 10] and stent subgroup [n = 38]), left ventricular discordance values improved in 19 patients (39.6%), worsened in 24 (50%), and remained the same in 5 (10.4%). Of all variables analyzed, only abciximab was significantly associated with postintervention improvement in discordance (P =.02; odds ratio 0.165, 95% CI 0.03-0.88), regardless of the type of intervention performed (P =.61), whereas heparin alone was associated with more discordance after intervention (odds ratio 6.07, 95% CI 1.14-32.40). CONCLUSIONS: We assessed the effect of percutaneous revascularization on myocardium by use of electromechanical data. For the first time, changes in linear local shortening in areas of preserved unipolar voltage were quantified, and worsening after successful Thrombolysis In Myocardial Infarction grade III coronary interventions was registered. The only variable associated with improvement on electromechanical data after interventions was the use of abciximab. This raises the question of the possible potential of this new diagnostic tool in assessing and quantifying postinterventional microvasculature pathological changes.

Abciximab↗