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Robert M Califf

Publications and source records attributed to Robert M Califf.

At least 235 records · Page 13Linked to original sources
PubMed2002

Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials.

BACKGROUND: Platelet glycoprotein IIb/IIIa inhibitors have been shown to reduce cardiac complications in patients undergoing percutaneous coronary intervention. The clinical efficacy of these drugs in acute coronary syndromes, however, is still unclear. We did a meta-analysis of all large randomised trials designed to study the clinical efficacy and safety of glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes who were not routinely scheduled to undergo early coronary revascularisation. METHODS: Inclusion criteria were: randomisation of patients with acute coronary syndromes but without persistent ST elevation; comparison of a glycoprotein IIb/IIIa inhibitor with placebo or control therapy; non-recommendation of early coronary revascularisation during study-drug infusion; and enrollment of at least 1000 patients. Data on individual patients were obtained from all participants in these trials. FINDINGS: Six trials, enrolling 31402 patients, fulfilled the inclusion criteria. 30 days after randomisation, 3530 (11.2%) patients died or developed a myocardial infarction. At 30 days, a 9% reduction in the odds of death or myocardial infarction was seen with glycoprotein IIb/IIIa inhibitors compared with placebo or control (10.8% [1980/18297] vs 11.8% [1550/13105] events; odds ratio 0.91 [95% CI 0.84-0.98]; p=0.015). The relative treatment benefit was similar in subgroups of patients according to important clinical baseline characteristics; hence, the absolute treatment benefit was largest in high-risk patients. An unexpected and significant interaction was seen between sex and allocated treatment, with a treatment benefit in men (0.81 [0.75-0.89] but not in women (1.15 [1.01-1.30]). However, once patients were stratified according to troponin concentration, there was no evidence of a sex difference in treatment response, and a risk reduction was seen in men and women with raised troponin concentrations. Major bleeding complications were increased by glycoprotein IIb/IIIa inhibitors (2.4% [445/18297] vs 1.4% [180/13105]; p<0.0001), but intracranial bleeding was not (16 [0.09%] vs 8 [0.06%]; p=0.40). INTERPRETATION: Glycoprotein IIb/IIIa inhibitors reduce the occurrence of death or myocardial infarction in patients with acute coronary syndromes not routinely scheduled for early revascularisation. The event reduction is greatest in patients at high risk of thrombotic complications. Treatment with a glycoprotein IIb/IIIa inhibitor might therefore be considered especially in such patients early after admission, and continued until a decision about early coronary revascularisation has been made.

Aged↗
PubMed2002

The prognostic value of creatine kinase elevations extends across the whole spectrum of acute coronary syndromes.

OBJECTIVES: The study investigated the relationship among creatine kinase (CK) elevations, clinical characteristics and cardiac events across the whole spectrum of acute coronary syndromes (ACS). BACKGROUND: Elevated serum levels of cardiac enzymes have been shown to be a major prognostic determinant in acute myocardial ischemia. Yet prior to this report, the relation between cardiac enzyme levels and other prognostic determinants across the entire spectrum of ACS has not been explored by a large clinical study. METHODS: We evaluated the relation between the maximum CK ratio (CK level/upper limit of normal) in the early hours following admission and cardiac events at six months in 11,725 patients enrolled in a large trial of ACS. RESULTS: Patients with higher risk characteristics, such as older age, female gender, hypertension, diabetes, prior coronary events or heart failure, more frequently presented without ST-segment elevation on the electrocardiogram and tended to develop lesser enzyme elevations. After adjusting for significant baseline predictors of cardiac events, a continuous correlation was observed between the CK ratio and death (chi-square 63.04, p < 0.0001) and (re)infarction or death (chi-square 55.48, p < 0.0001). This correlation was similar for patients with and without ST-segment elevation. The adjusted incidence of cardiac events at follow-up began to rise even for CK levels within the normal range, the steepest part of the curve residing between one and three times the upper limit of normal. In patients with a CK ratio of >1 to 2 compared with those within the normal range, the adjusted odds ratio for death was 1.26 (95% confidence interval [CI] 0.98 to 1.63), and 1.59 (95% CI 1.38 to 1.90) for (re)infarction and death. For all CK levels, the event rate was higher among patients without ST-segment elevation. CONCLUSIONS: Although high-risk patients with ACS often develop lesser CK elevations, this study demonstrated that even minor enzyme elevations appear to have important and independent prognostic implications.

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PubMed2002

Reduction in vascular access site bleeding in sequential abciximab coronary intervention trials.

We analyzed vascular access site bleeding from the EPIC, EPILOG, and EPISTENT trials to quantify the decrease in vascular bleeding complications in these three trials, especially those attributable to abciximab. The incidence of combined major and minor vascular access site bleeding in nonabciximab (heparin plus placebo) patients progressively decreased from EPIC (8.2%) to EPILOG (2.9%) to EPISTENT (1.7%; P < 0.001). Combined major and minor vascular access site bleeding in abciximab (heparin plus abciximab) patients decreased from EPIC (20%) to EPILOG (5.8%) to EPISTENT (2.2%; P < 0.001). There were more major vascular access site bleeds with abciximab compared to placebo in EPIC (odds ration 3.2; P < 0.001) but not in EPILOG or EPISTENT. Modified abciximab and heparin dosing and improved vascular access site management strategies have decreased the risk of vascular access bleeding during coronary intervention and have essentially eliminated the excess access site bleeding associated with abciximab.

Abciximab↗
PubMed2002

Matching resources to treatment decisions for patients with acute coronary syndromes.

Multiple dynamic forces are having an impact on the way cardiovascular disease is treated today and will be in the future. These forces include extended life expectancy, decreased disability, and accelerated improvement in the effectiveness of medical technology. All of these forces will lead to a predictable increase in health care costs. Cardiologists must also be cognizant of the rise in health care consumerism; patients are assuming a larger role in decisions about their medical care and treatment. All of these factors are driving the climate of evidence-based medicine, particularly in the cardiovascular field. Payers and the government are beginning to require the clinical community to define quality. In turn, these third parties are beginning to measure quality as defined by the profession and to hold providers accountable for the quality of what they do. Although the frontier of genetic prediction in therapeutics will serve as an intellectual focus for bringing these issues closer to the forefront in cardiovascular medicine, the fundamental provision of value in health care (high quality at reasonable cost) cannot wait on genomics. Because the amount of evidence in acute coronary syndromes (ACS) exceeds other areas of medicine, therapies for ACS will undergo increasingly intense scrutiny.

Acute Disease↗
PubMed2002

The need for a national infrastructure to improve the rational use of therapeutics.

The current medical care environment has created expectations that exceed its capabilities, one effect of which has been an increasing awareness of lapses in the quality of healthcare, including medical errors. As more new therapies reach clinical application, the expectations on the part of the public are unlikely to lessen, and yet the ability to assure patients that the benefits of these therapies are known, and that they are without serious side-effects or untoward consequences, eludes the healthcare system. Based on initial experience with a new federal program, the Centers for Education and Research on Therapeutics (CERTs), we propose a national approach to therapeutics education and research, through a public-private partnership that involves academic medical centers, the federal government, industry, and the public. Through a concerted approach, we believe that significant gaps in our understanding of key issues in therapeutics and our ability to educate practitioners, policy makers, and consumers can be significantly enhanced in a manner that could not be achieved without a coordinated approach.

Drug Therapy↗
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

Dissociation between hemodynamic changes and symptom improvement in patients with advanced congestive heart failure.

BACKGROUND: Changes in hemodynamic measures often serve as surrogate end points in efficacy trials for advanced heart failure, although there are few objective data to support this practice. AIMS: We compared changes in hemodynamic variables vs. changes in symptoms of decompensated heart failure in patients enrolled in a randomized trial. METHODS: We studied 201 patients with New York Heart Association (NYHA) class IIIb or IV heart failure and ejection fraction < or = 25% for > or = 3 months. Patients underwent continuous monitoring by pulmonary-artery catheter during inpatient drug administration. We assessed the relations of changes in hemodynamic variables (baseline minus final measure) to changes at 2 weeks in congestive heart failure symptoms, NYHA class, Yale Dyspnea-Fatigue Index (YDFI) score, and distance achieved in a 6-min walk. RESULTS: No hemodynamic measure significantly predicted either symptom score or NYHA classification. Mean pulmonary artery pressure and pulmonary capillary wedge pressure did show some relation to change in YDFI score in univariable, but not multivariable, analysis. No hemodynamic measure correlated significantly with changes in distance achieved in the 6-min walk test. CONCLUSION: We noted no significant association between improved hemodynamics and improved symptoms in patients with advanced heart failure. Other measures may need to be evaluated as surrogate end points in future trials.

Aged↗
PubMed2002

An automated strategy for bedside aPTT determination and unfractionated heparin infusion adjustment in acute coronary syndromes: insights from PARAGON A.

BACKGROUND: Intravenous unfractionated heparin remains a cornerstone of anticoagulation therapy for patients with acute coronary syndromes, but regulation to a target aPTT is challenging. We assessed unfractionated heparin infusion regulation by bedside, whole-blood aPTT testing and computerized, algorithmic infusion adjustment, and further evaluated the relationship of achieving the target aPTT with clinical outcomes. METHODS AND RESULTS: We studied 1,275 patients randomized to unfractionated heparin in PARAGON-A, which tested lamifiban with or without unfractionated heparin versus unfractionated heparin. All patients had baseline and 6-hour blinded, bedside aPTTs, then aPTTs per algorithm. A central computer translated encrypted values to algorithmic dose-adjustment commands. We assessed the ability to achieve and maintain aPTTs of 50-70 seconds and associations of 6- and 12-hour aPTTs and time-to-target with 30-day outcomes.Overall, the median 6-hour aPTT was 50-70 seconds and remained so throughout infusion. Individually, only 33.6% of patients achieved 6-hour target-range aPTTs, and only 40% of all aPTTs were in-range. After achieving target, only 42% of subsequent measures were in-range. Thirty-day death or myocardial infarction (death/MI) increased non-significantly as time-to-target increased (p = 0.08). Thirty-day mortality was similar if target aPTT was reached, regardless of timing. Death/MI trended lower if target aPTT was reached by 8 hours (p = 0.10). The best clinical outcomes were associated with in-range aPTTs. CONCLUSIONS: This study represents the most systematic monitoring and regulation of unfractionated heparin anticoagulation to date. Although average anticoagulation achieved target range, wide inter- and intra-patient variability may have important implications for clinical outcomes.

Acetates↗
PubMed2002

The determinants of activated partial thromboplastin time, relation of activated partial thromboplastin time to clinical outcomes, and optimal dosing regimens for heparin treated patients with acute coronary syndromes: a review of GUSTO-IIb.

CONTEXT: Unfractionated heparin remains widely utilized in the treatment of acute coronary syndromes (ACS). However, limited data exist on optimal dosing and range of activated partial thromboplastin time (aPTT) in this setting. A large trial of thrombolysis for acute myocardial infarction has reported an association between longer aPTTs and adverse outcomes. OBJECTIVES: Estimate the optimal heparin-dosing regimen in achieving early therapeutic aPTTs (50 to 75 seconds) and determine the association of aPTT and death, reinfarction, and bleeding in population with ACS. DESIGN: Subgroup analysis within a randomized, controlled trial of 5861 patients given unfractionated heparin who had aPTTs at 6, 12, or 24 hours, with outcome analyses by weight categories. SETTING: In 373 hospitals in 13 countries from May 1994 to October 1995. PATIENTS: A total of 12142 patients admitted for ACS, stratified by the presence (n = 4131) or absence (n = 8011) of ST-segment elevation, and randomized to 72 hours of unfractionated heparin. RESULTS: In a simulated weight-adjusted model, based on retrospective grouping by weight, a simulated dose of 60-U/kg bolus and 12-U/kg/h infusion resulted in the highest proportion of therapeutic aPTTs. After adjustment for baseline variables, longer 12-hour aPTT was associated with the composite of 30-day death or reinfarction in patients not treated with thrombolytic therapy (odds ratio, 1.10; 95% CI, 1.00 to 1.22; P = 0.047). Longer aPTT at 6 hours was associated with increased moderate or severe bleeding for the entire cohort. There was also a significant, nonlinear correlation of the 12-hour aPTT with moderate or severe bleeding in thrombolysis-treated patients. CONCLUSIONS: For ACS patients who are treated with heparin, aPTT is highly associated with body weight. Longer aPTT within the first 12 hours is associated with adverse outcomes in ACS. Heparin dosing for ACS should be weight based.

Acute Disease↗
PubMed2002

Persistence of delays in presentation and treatment for patients with acute myocardial infarction: The GUSTO-I and GUSTO-III experience.

STUDY OBJECTIVE: Early treatment with fibrinolytic therapy substantially decreases mortality in acute myocardial infarction (AMI). We examined delays to hospital arrival and treatment in 2 large, multinational, randomized trials of fibrinolytic therapy: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO-III). METHODS: We evaluated delays to hospital arrival, time from arrival to treatment, and total time to treatment in the 27,849 US patients with AMI enrolled in GUSTO-I or GUSTO-III. Time intervals were defined prospectively for total time to treatment and symptom onset to hospital arrival as 0 to 2 hours (early), 2 to 4 hours, or more than 4 hours (late). Time to fibrinolytic therapy once in hospital was prospectively defined as 0 to 1 hour (early) or more than 1 hour (late). Socioeconomic data were also obtained from patients enrolled in the GUSTO-III trial. RESULTS: In GUSTO-III, as in GUSTO-I, patients who arrived at the hospital later were older (64 years versus 60 years; P =.001) and more often female (35% versus 27%; P =.001), black (6% versus 4%; P =.02), and diabetic (25% versus 16%; P =.001). These groups also received treatment later once in hospital, as did patients with hypertension (48% versus 42%; P =.001), previous angina (46% versus 36%; P =.001), and previous infarction (21% versus 16%; P =.001). Higher levels of education, professional occupations, and private health insurance were associated with significantly earlier arrival and treatment. Although in hospital time to treatment has decreased (66 minutes to 48 minutes; P <.0001), time to arrival has not changed over the past 7 years, averaging 84 minutes. CONCLUSION: Certain groups of patients with AMI, including the elderly, women, diabetic patients, and minorities, exhibit delays to hospital arrival and treatment in the emergency setting. Patients with higher educational levels, professional occupations, and private health insurance arrive at the hospital sooner and receive treatment more quickly. Patients and health care providers must be educated regarding high-risk populations for delay to maximize benefit from fibrinolytic therapy.

Age Distribution↗
PubMed2002

Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial.

BACKGROUND: Myocardial (re)infarction (MI), a common trial end point, can be difficult to identify because of inconclusive signs and symptoms. We examined disagreement between investigator and clinical events committee (CEC) reporting of MIs in an international, randomized trial. METHODS: The primary end point of the PARAGON-B trial was a 30-day composite of death, MI (CEC adjudicated), or ischemia-driven intervention. If CEC and investigator determinations of MI differed, we sent investigators event summaries and rationales for CEC decisions and asked whether they now agreed with the CEC assessment. If they still disagreed, they were to provide a rationale and supporting data. Such cases were reviewed, and a final decision was made. RESULTS: Overall, 1736 of 5225 (33%) patients had suspected MIs; the CEC adjudicated 483 of 1736 (28%) as MIs. In 404 patients (23%), investigator and CEC assessments of MI differed; 270 MIs were identified by the CEC but not investigators, and 134 were identified by investigators but not the CEC. Most disagreements concerned periprocedural MIs, but some reflected clinical ischemia and enzyme elevations. Letters for 382 disagreements were sent and returned by investigators, and investigators came to agree with CEC assessments in 307 cases (80%). For the other 75 cases (20%), after review the investigators' assessments were confirmed in 10 cases, and the original CEC decisions were supported in the other 65 cases. CONCLUSIONS: Investigators misreport MI end points, but most later agree with CEC assessments. These data support standard, independent adjudication of suspected MIs for accurate reporting, which may affect evaluations of therapies, sample-size calculations, and event-rate comparisons across trials.

Clinical Enzyme Tests↗
PubMed2002

Heparin dosing and outcome in acute coronary syndromes: the GUSTO-IIb experience. Global Use of Strategies to Open Occluded Coronary Arteries.

BACKGROUND: This study analyzed relationships among heparin dosage, patient characteristics, and 30-day outcome because optimal unfractionated-heparin dosing in acute coronary syndromes remains uncertain. METHODS: Patients (n = 5335) randomized to heparin therapy in the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb trial were studied. The heparin dose was adjusted to a target activated partial thromboplastin time (aPTT) and normalized for the patient's weight. Mortality and cardiac (re)infarction within 30 days and their association with patient characteristics and heparin dosing were evaluated. RESULTS: The lowest mortality rate appeared with a heparin dose of approximately 14 U/kg/h or an aPTT of approximately 70 seconds. Heparin dosing was a significant predictor of outcome after adjusting for presenting coronary syndrome; a trend remained after adjusting for other baseline differences. This association was lost when adjusted for the aPTT result. Patients who died early appeared to have lower heparin dosing than those with later mortality (P =.012). Heparin "resistance" with relatively high heparin dosages and low aPTT values did not increase the risk for adverse outcome. CONCLUSIONS: There is a defined, dose-associated benefit of unfractionated heparin in acute coronary syndromes similar to that seen previously in thrombolytic-treated infarctions. Heparin therapy is complicated by its complex biologic interactions and relatively crude measures of its effect. Better measures of heparin effectiveness and strategies need to be developed with either better antithrombin agents or adjunctive therapies such as antiplatelet regimens to treat patients who require benefits beyond that supplied by unfractionated heparin.

Aged↗
PubMed2002

Relationship between activated clotting time during percutaneous intervention and subsequent bleeding complications.

BACKGROUND: Approximately 50% of percutaneous coronary interventions in the United States are performed with unfractionated heparin and no IIb/IIIa agent. The operator must weigh the risks and benefits of more intensive anticoagulation during these percutaneous interventions. This study helps clarify the relationship between patient and procedural factors, such as the intensity of heparin anticoagulation as measured by activated clotting time (ACT), and the risk of blood loss and bleeding complications. METHODS: Four hundred twenty-nine patients undergoing elective or urgent percutaneous coronary intervention were followed up prospectively for 72 hours after intervention for clinical bleeding complications. Blood loss, defined as the difference between preprocedural and nadir postprocedural hematocrit adjusted for interval transfusions, was also tracked. In-laboratory ACTs, as well as other potential clinical and procedural predictors of blood loss and bleeding risk, were collected and analyzed. RESULTS: Maximum in-laboratory ACT was significantly related to blood loss as measured by the change in hematocrit (P =.017) and to the risk of major bleeding complications (P =.002). In multivariate analysis, patient age (P =.004), sex (P =.014), procedure length (P <.001), and additional interventions (P <.001) were significant, independent predictors of blood loss. Major bleeding complications were significantly, independently predicted by patient age (P <.001), additional interventions (P =.015), and maximum in-laboratory ACT (P <.001). CONCLUSIONS: Compared with the other clinical and procedural predictors of bleeding complications, maximum in-laboratory ACT was second only to patient age in significance as a multivariate predictor of postprocedural bleeding complications. Maximum in-laboratory ACT was found to be the most significant modifiable univariate and multivariate predictor of clinical bleeding complications after percutaneous coronary intervention. Particularly in patients with nonmodifiable risk factors for blood loss and bleeding complications such as advanced age, female sex, and multiple and prolonged procedures, avoiding high intensity anticoagulation with unfractionated heparin is associated with lower bleeding risk.

Age Factors↗
PubMed2002

Predicting outcome after thrombolysis in acute myocardial infarction according to ST-segment resolution at 90 minutes: a substudy of the GUSTO-III trial. Global Use of Strategies To Open occluded coronary arteries.

BACKGROUND: Resolution of ST-segment elevation after thrombolysis for acute myocardial infarction has been shown to have prognostic significance 3 hours (180 minutes) after the initiation of therapy. Whether prognostically useful information can be achieved as early as 90 minutes after thrombolysis is unknown. METHODS: An electrocardiographic substudy of 2352 patients from the Global Use of Strategies To Open occluded coronary arteries (GUSTO-III) trial was undertaken to compare outcomes according to ST-segment resolution at 90 minutes versus 180 minutes after administration of thrombolytic therapy. RESULTS: Of 2352 patients in the substudy, 2241 had a baseline and 90-minute electrocardiogram, and 2218 had a baseline and 180-minute ECG. Complete ST-segment resolution occurred in 44.2% of patients at 90 minutes and 56.5% of patients at 180 minutes. ST-segment resolution at both 90 and 180 minutes was associated with lower 30-day and 1-year mortality. Multivariate analysis revealed ST-segment resolution at 90 minutes to be an equally strong predictor of 30-day mortality as resolution at 180 minutes. Patients who were at particularly high risk for mortality were those aged >70 years, those who presented with Killip class >1, and those with anterior infarctions. CONCLUSIONS: The presence of ST-segment resolution on standard 12-lead electrocardiographic monitoring 90 minutes after thrombolysis is a useful independent predictor of mortality at 30 days and 1 year. The potential for obtaining prognostic results as early as 90 minutes after thrombolysis sets a new precedent for optimum electrocardiographic monitoring times in these patients.

Aged↗
PubMed2002

Promise of combined low-molecular-weight heparin and platelet glycoprotein IIb/IIIa inhibition: results from Platelet IIb/IIIa Antagonist for the Reduction of Acute coronary syndrome events in a Global Organization Network B (PARAGON B).

BACKGROUND: Low-molecular-weight heparin (LMWH) has a more predictable anticoagulant effect than unfractionated heparin (UFH), is easier to administer, and does not require monitoring. Minimal data are available on LMWH combined with platelet glycoprotein (GP) IIb/IIIa inhibitors. METHODS: In the Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network B (PARAGON B) trial, patients with an acute coronary syndrome were randomized to receive the IIb/IIIa inhibitor lamifiban or a placebo. To rigorously explore the potential benefits of LWMH and GP IIb/IIIa inhibition, we analyzed the rates of ischemic complications and safety outcomes in PARAGON B. RESULTS: Approximately one fifth of the patients received LMWH (805 vs 4395 UFH). For the overall cohort, the incidence of death/myocardial infarction (MI)/severe recurrent ischemia (SRI) was 12.2%, and this composite end point was numerically lowest in the lamifiban with LMWH group (10.2%). Similarly, the incidence of death/MI was 11.0% for the entire cohort and lowest in the lamifiban and LMWH group (9.0%). The lower event rate for patients taking LMWH in the lamifiban group was sustained at 6 months, with a lower revascularization rate (51.5% vs 42.8%) and a lower composite of death/MI (13.8% vs 11.9%). Bleeding was comparable in the 2 heparin groups (1.4% with UFH vs 0.9% with LMWH). The propensity adjusted odds ratio for 30-day revascularization was significantly lower with LMWH (odds ratio 0.67, 95% CI 0.57-0.79, P <.001). There were no significant differences in death/MI/SRI at 30 days (P =.465), death/MI at 30 days (P =.264), and stroke at 30 days with the type of heparin use (P =.201) after propensity risk adjustment. CONCLUSIONS: In the PARAGON B trial, use of LMWH in conjunction with a GP IIb/IIIa inhibitor was safe and associated with a lower revascularization rate. These findings support the rationale and promise for combining GP IIb/IIIa blockers and LMWH for future management of acute coronary syndrome.

Acetates↗