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David J Cohen

Publications and source records attributed to David J Cohen.

At least 73 records · Page 4Linked to original sources
PubMed2004

Effects of stent length and lesion length on coronary restenosis.

The choice of drug-eluting versus bare metal stents is based on costs and expectations of restenosis and thrombosis risk. Approaches to stent placement vary from covering just the zone of maximal obstruction to stenting well beyond the lesion boundaries (normal-to-normal vessel). The independent effects of stented lesion length, nonstented lesion length, and excess stent length, on coronary restenosis have not been evaluated for bare metal or drug-eluting stents. We analyzed the angiographic follow-up cohort (1,181 patients) from 6 recent bare metal stent trials of de novo lesions in native coronary arteries. Stent length exceeded lesion length in 87% of lesions (mean lesion length 12.4 +/- 6.3 mm, mean stent length 20.0 +/- 7.9 mm, mean difference 7.6 +/- 7.9 mm). At 6- to 9-month follow-up, the mean percent diameter stenosis was 39.1 +/- 20.1%. In an adjusted multivariable model of percent diameter stenosis, each 10 mm of stented lesion length was associated with an absolute increase in percent diameter stenosis of 7.7% (p <0.0001), whereas each 10 mm of excess stent length independently increased percent diameter stenosis by 4.0% (p <0.0001) and increased target lesion revascularization at 9 months (odds ratio 1.12, 95% confidence interval 1.02 to 1.24). Significant nonstented lesion length was uncommon (12.5% of cases). In summary, stent length exceeded lesion length in most stented lesions, and the amount of excess stent length increased the risk of restenosis independent of the stented lesion length. This analysis supports a conservative approach of matching stent length to lesion length to reduce the risk of restenosis with bare metal stents.

Clinical Trials as Topic↗
PubMed2004

Importance of mitral regurgitation inpatients undergoing percutaneous coronary intervention for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.

OBJECTIVES: We sought to determine the prognostic importance of mitral regurgitation (MR) in patients undergoing percutaneous coronary intervention for acute myocardial infarction (AMI). BACKGROUND: Mitral regurgitation has been associated with a poor prognosis in patients treated with thrombolytic therapy for AMI. The prognostic significance of MR in patients undergoing mechanical reperfusion therapy for AMI is unknown. METHODS: Left ventriculography was performed during the index procedure in 1,976 (95%) of 2,082 non-shock patients enrolled in a prospective, multicenter, randomized trial of mechanical reperfusion strategies in AMI. The severity of operator-assessed MR was divided into four strata: none (n = 1,726), mild (n = 192), and moderate/severe (n = 58). RESULTS: Patients with progressively more severe MR were older (p < 0.0001), were more often women (p < 0.0001), and had higher Killip class (p = 0.0007). More severe grades of MR correlated with triple-vessel disease (p < 0.0001) and lower left ventricular ejection fraction (LVEF) as measured during the index procedure (p = 0.0004). Increasingly severe MR was strongly associated with a higher mortality at 30 days (1.4% vs. 3.7% vs. 8.6%, respectively; p < 0.0001) and at one year (2.9%, 8.5%, 20.8%, respectively; p < 0.0001). By multivariate analysis, the presence of even mild MR was an independent predictor of long-term mortality (mild MR, relative risk [RR] = 2.40, p = 0.005; moderate/severe MR, RR = 2.82, p = 0.006). CONCLUSIONS: Mitral regurgitation of any degree present on the baseline left ventriculogram during the index procedure is a powerful, independent predictor of mortality in patients undergoing mechanical reperfusion therapy for AMI. The presence of MR identifies high-risk patients in whom close out-patient follow-up is warranted, and who may benefit from aggressive adjunctive medical or surgical therapies.

Abciximab↗
PubMed2004

Stent thrombosis after successful sirolimus-eluting stent implantation.

BACKGROUND: Stent thrombosis (ST) is a rare but devastating complication of coronary stent implantation, occurring in 0.5% to 1.9% of patients with bare metal stents. The incidence of ST with drug-eluting stents is less well studied, particularly among patients outside of clinical trials. METHODS AND RESULTS: The aim of this study was to evaluate the incidence and potential risk factors for ST in patients receiving sirolimus-eluting stents (SES) in the "real world" after commercial release in the United States in April 2003. All 652 patients who underwent SES implantation (776 lesions treated) at our institution between April and October 2003 were followed up prospectively after the procedure (median follow-up 100 days). During that period, 7 patients (1.1%, 95% CI 0.4% to 2.2%) developed ST within a range of 2 to 13 days, and 1 patient had an ST-elevation myocardial infarction on day 39 with evidence of thrombus within the SES at angiography. Patients with an ST had significantly smaller final nominal balloon diameters (2.75 versus 3.00 mm, P=0.04), and in 4 (57%) of the 7 patients with ST versus 1.7% of patients without ST (P<0.001), antiplatelet therapy had been discontinued after the procedure. Among the ST patients, 1 died and 5 had myocardial infarctions. CONCLUSIONS: In this single-center experience, the incidence of ST after SES implantation was approximately 1%, which is within the expected range of bare metal stents. The discontinuation of antiplatelet therapy was strongly associated with the development of ST in this patient population.

Combined Modality Therapy↗
PubMed2004

Can we afford to eliminate restenosis? Can we afford not to?

Over the past decade, coronary stenting has emerged as the dominant form of percutaneous coronary revascularization. However, bare metal stents remain limited by a high incidence of restenosis, leading to frequent repeat revascularization procedures and substantial economic burden. Antiproliferative drug-eluting stents (DES) have recently demonstrated dramatic reductions in rates of restenosis, compared with conventional stenting, but important concerns about their costs have been raised. In this article, we summarize current evidence on the economic impact of restenosis and explore the potential benefits and economic outcomes of DES. In addition to examining the long-term costs of this promising technology, we consider the potential cost-effectiveness of DES from a health care system perspective and the impact of specific patient, lesion, and provider characteristics on these parameters.

Coronary Restenosis↗
PubMed2004

Drug-eluting stent task force: final report and recommendations of the working committees on cost-effectiveness/economics, access to care, and medicolegal issues.

Coronary artery disease remains a major health problem worldwide. Since introduction of percutaneous transluminal coronary angioplasty and stents, much progress has been made. Percutaneous coronary intervention, however, has been limited by restenosis (repeat obstruction of arteries that have been previously treated. Introduction of drug-eluting stents (DESs) in April 2003 was a major breakthrough in preventing restenosis. In March 2003, The Society for Cardiovascular Angiography and Interventions (SCAI) published a position statement on the clinical implications of DESs, recommending an evidence-based adoption strategy. Subsequently, in May 2003, SCAI formed a multidisciplinary Drug Eluting Stent (DES) Task Force to address the significant nonclinical ramifications posed by DESs: medicolegal, financial, and access to care. The Task Force included representatives from physician societies, industry, academia, the reimbursement community, and health policy organizations. The resultant report presents analyses, options, and recommendations regarding those nonclinical issues based on the collective experience and knowledge of the Task Force members. The Task Force trusts that this report will be of value to the diverse constituencies involved with introduction of this important new technology.

Advisory Committees↗
PubMed2004

Willingness to pay for avoiding coronary restenosis and repeat revascularization: results from a contingent valuation study.

BACKGROUND: Despite technological improvements, percutaneous coronary intervention (PCI) remains limited by restenosis requiring further revascularization procedures during the ensuing year. New technologies aiming to reduce restenosis are expensive and may increase net healthcare costs. Economic evaluations of such therapies have been performed, but have been hindered by the need to assess the disutility of short-term health care events and repeat coronary revascularization as well as the lack of benchmark standards for intermediate health outcomes. The contingent valuation approach may offer particular advantages when evaluating treatments that improve short-term health outcomes. OBJECTIVE: To examine patients' willingness to pay (WTP) for treatments that may reduce the risk of restenosis and repeat revascularization after PCI. METHODS: We used a contingent valuation approach to evaluate WTP among participants in two large clinical trials evaluating new PCI devices. The baseline scenario described a 30% probability of repeat revascularization following the initial procedure. Patients were asked to indicate, using a close-ended (referendum) question, their out of pocket WTP for an improved treatment that would reduce this risk. Three different prices (500 dollars, 1000 dollars, and 1500 dollars) and three levels of absolute risk reduction (10, 20, and 30%) were randomly varied creating nine sub-samples of patients. Patients' responses were analyzed using both parametric and non-parametric methods. RESULTS: 1642 patients completed the WTP question. The WTP medians for the 10 and 20% risk reductions were 273 dollars and 366 dollars, respectively; the median WTP for the 30% risk reduction was significantly higher at 1162 dollars (P<0.001). Higher household income (OR=1.57, P<0.001) was independently associated with a higher WTP. CONCLUSIONS: Although short-lived, avoidance of coronary restenosis may have considerable value to patients undergoing percutaneous coronary interventions. These findings may have important implications for emerging technologies such as drug-eluting stents.

Aged↗
PubMed2004

Role of oral bacterial flora in calcific aortic stenosis: an animal model.

BACKGROUND: Calcific aortic stenosis is a major public health problem in the United States. The mechanism of calcification remains unclear. The hypothesis that low grade chronic or recurrent bacterial endocarditis with specific calcifiable bacteria is a cause of calcification of the aortic valves was investigated using an animal model. Such bacteria are typically present as part of the normal human oral flora. METHODS: Forty New Zealand white rabbits were divided into four groups: group 1, control (1 ml of normal saline); group 2, Corynebacterium matruchotti 100,000 colonies; group 3, Streptococcus sanguis II 10 colonies; and group 4, C matruchotti 100,000 colonies plus S sanguis II 10 colonies. Animals were inoculated with bacteria through a flexible catheter placed through the aortic valve through a right carotid cut down. Inoculations were repeated every 3 days the first 2 weeks and then twice a week thereafter. At postmortem examination the aortic valves were harvested, embedded in paraffin, and stained with von Kossa stain. They were also examined by scanning and transmission electron micrography. RESULTS: Group 4 had 93.3% large calcifications (confluent calcium densities that are easily recognized with minimal magnification) and 6.6% small microcalcifications (dustlike microscopic particles requiring a compound microscope to appreciate) of the aortic valves. Group 3 exhibited large calcification in 20% and small in 40% of the aortic valves. Group 1 and group 2 had no evidence of calcification. CONCLUSIONS: These results suggest that recurrent low-grade endocarditis from calcifying oral bacteria, particularly when occurring with synergistic strains, may be one cause of calcific aortic stenosis.

Animals↗
PubMed2004

In-hospital costs of self-expanding nitinol stent implantation versus balloon angioplasty in the femoropopliteal artery (the VascuCoil Trial).

PURPOSE: Although several prospective studies have examined the safety and efficacy of stent placement for femoropopliteal arterial disease, the current cost of these procedures is unknown. To estimate and compare hospital costs associated with conventional balloon angioplasty (percutaneous transluminal angioplasty [PTA]) and stent placement for patients with symptomatic peripheral arterial disease, the authors performed a prospective economic evaluation in conjunction with the Intracoil Femoropopliteal Stent Trial (VascuCoil). MATERIALS AND METHODS: Between May 1997 and December 1999, 266 patients with stenotic or occluded superficial femoral or popliteal arteries were prospectively randomized to treatment with the IntraCoil stent or PTA. Detailed resource use and cost data for each patient's initial revascularization procedure and ensuing hospitalization were collected and analyzed on an intention-to-treat basis. RESULTS: Compared with conventional balloon angioplasty, stent placement did not improve clinical outcomes but increased procedure duration, equipment costs, and physician services. As a result, initial hospital costs were approximately 3,500 dollars higher for patients randomized to the IntraCoil stent, compared with PTA (8,435 dollars vs 4,980 dollars; P < .001). CONCLUSIONS: As performed in the VascuCoil trial, primary stent placement for femoropopliteal disease did not improve clinical outcomes but increased initial treatment costs by more than 3,000 dollars. Because there were no substantial differences in subsequent clinical outcomes between the two treatments, it is unlikely that these increased initial costs would be offset by savings in follow-up costs. These findings suggest that a strategy of routine stent implantation for patients undergoing femoropopliteal PTA is not optimal on economic grounds and that PTA with provisional stent implantation is preferred.

Aged↗
PubMed2004

An evidence-based approach to the use of drug-eluting stents in clinical practice.

Less than a year after their release, drug-eluting stents are being used in more than 70% of patients who undergo percutaneous intervention for obstructive coronary disease in the United States. This unprecedented quick adoption was fueled by results of several randomized trials that demonstrated a profound reduction in restenosis rates compared with bare-metal stents. Subset analysis of the drug-eluting stent trials shows a strong restenosis reduction rate across a wide range of patient characteristics; however, these broad beneficial effects are based on randomized subjects who may not represent the actual population currently being treated with coronary stents. This review presents an analysis of the available data on the approved drug-eluting stents, including patient subsets that may or may not benefit; potential stent-specific complications; and a discussion of costs, risks, and cost-effectiveness.

Coronary Restenosis↗
PubMed2003

Cost-effectiveness of coronary stenting and abciximab for patients with acute myocardial infarction: results from the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) trial.

BACKGROUND: Both stenting and the glycoprotein IIb/IIIa inhibitor abciximab improve outcomes for patients undergoing primary angioplasty for acute myocardial infarction (AMI). However, the cost-effectiveness of these strategies is unknown. METHODS AND RESULTS: We performed a prospective cost-utility analysis among US participants in the CADILLAC trial. Patients with AMI (n=1703) were randomized to stenting versus balloon angioplasty (PTCA) and abciximab versus no abciximab according to a 2-by-2 factorial design. Total 1-year costs and lifetime incremental cost-effectiveness ratios, measured as cost per quality-adjusted year of life (QALY) gained, were calculated. Compared with PTCA, stenting increased procedural costs by 1148 dollars and initial hospital costs by 1384 dollars (both P<0.001). By 1-year, stenting led to fewer repeat revascularization procedures and reduced follow-up medical care costs by 1215 dollars, such that aggregate costs were similar for the PTCA and stent groups (18 690 dollars versus 18 859 dollars, P=0.75). The cost-effectiveness ratio for stenting versus PTCA was favorable at 11 237 dollars/QALY gained and remained <20 000 dollars/QALY in sensitivity analyses. Compared with standard anticoagulation, abciximab increased initial procedural costs by 1122 dollars (P<0.001). By facilitating accelerated hospital discharge, abciximab reduced length of stay by approximately 0.6 days, offsetting most of the drug costs. These cost offsets were not maintained, however; aggregate 1-year costs for the abciximab group were 1244 dollars greater than for standard therapy (19 389 dollars versus 18 145 dollars , P=0.02). Abciximab was reasonably cost-effective (cost-effectiveness ratio 21 305 dollars/QALY) only if nonsignificant differences in 1-year mortality (3.7% versus 4.3%, P=0.62) were incorporated in the analysis. CONCLUSIONS: Primary stenting is a highly cost-effective treatment for AMI. The cost-effectiveness of abciximab in this setting is uncertain and depends primarily on whether long-term survival is enhanced.

Abciximab↗
PubMed2003

Feasibility and implications of an early discharge strategy after percutaneous intervention with abciximab in acute myocardial infarction (the CADILLAC Trial).

Early complications may hamper efforts to hasten discharge after primary percutaneous coronary intervention (PCI) for myocardial infarction (MI). Glycoprotein IIb/IIIa inhibitors, by reducing early recurrent ischemia, may aid in these efforts. We examined whether adjunctive abciximab could accelerate discharge and reduce costs within a trial of primary PCI after acute MI. The CADILLAC trial randomized 2,082 patients with MI to 1 of 4 reperfusion strategies in a 2 x 2 factorial design: angioplasty, angioplasty with abciximab, stent implantation, or stenting with abciximab. Patients randomized to abciximab had postprocedural heparin withheld, and discharge scheduled for days 1.5 to 2 (low-risk patients) or days 2 to 3 (high-risk patients) after MI if they were stable. Other patients were discharged at the physician's discretion. Abciximab treatment was associated with significant reductions in the primary end points of in-hospital death, reinfarction, ischemic target vessel revascularization (TVR), or disabling stroke (5.6% vs 2.7%, p = 0.003)--largely reflecting reduced ischemic TVR (3.8% vs 1.4%, p = 0.002)--and in early subacute thrombosis (1.3% vs 0.2%, p = 0.01). Hospitalization was significantly shorter in abciximab-treated patients (median 3.1 vs 3.5 days, p <0.001), but total in-hospital costs did not differ significantly (13,413 +/- 5,309 US dollars vs 13,000 +/- 6,006 US dollars, p = 0.13). Rates of the composite end point did not differ significantly during the week after discharge (0.8% vs 0.2%, p = 0.10), nor did component event rates. Abciximab during primary PCI is associated with fewer early adverse outcomes, likely contributing to offset its cost. Hospitalizations after primary PCI are so short, however, that efforts to accelerate discharge with abciximab appear unfeasible, and overall costs remain unchanged.

Abciximab↗
PubMed2003

Outcomes of optimal or "stent-like"balloon angioplasty in acutemyocardial infarction: the CADILLAC trial.

OBJECTIVES: We sought to compare outcomes between patients with acute myocardial infarction (AMI) undergoing percutaneous transluminal coronary angioplasty (PTCA) with an optimal or "stent-like" result versus patients who underwent routine stent placement. BACKGROUND: Recent studies in patients with AMI undergoing stent implantation have suggested that PTCA may no longer be a relevant treatment modality for stent eligible lesions. However, whether routine stent placement is superior or necessary when an optimal PTCA or "stent-like" result is achieved is unknown. METHODS: In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial, 2,082 patients with AMI were randomly assigned to undergo PTCA alone, PTCA + abciximab, stenting alone, or stenting + abciximab. Outcomes were compared in patients achieving an optimal acute PTCA result (residual core laboratory diameter stenosis <30% without significant dissection) versus those assigned to routine stenting. RESULTS: Optimal PTCA was achieved in 40.7% of patients randomized to balloon angioplasty, including 38.5% and 42.7% assigned to PTCA alone and PTCA + abciximab, respectively. Ischemic target vessel revascularization (TVR) at 30 days occurred more frequently after optimal PTCA than routine stenting (5.1% vs. 2.3%, p = 0.007). The one-year composite adverse event rate (death, reinfarction, disabling stroke, or TVR) was greater after optimal PTCA than routine stenting (21.9% vs. 13.8%, p < 0.001), driven largely by increased rates of ischemic TVR (19.1% vs. 9.1%, p < 0.001); no significant differences were present in the rates of death, reinfarction, or disabling stroke between the two groups. Angiographic restenosis also was more common with optimal PTCA than routine stenting (36.2% vs. 22.2%, p = 0.003). Even a post-PTCA diameter stenosis of <20% (realized in 12% of patients) did not result in outcomes equivalent to stenting. CONCLUSIONS: Even if an optimal result is achieved after primary PTCA in AMI, early and late outcomes can be further improved with routine stent implantation.

Abciximab↗
PubMed2003

Impact of a practice guideline for patients with atrial fibrillation on medical resource utilization and costs.

Health care resource utilization is high for patients presenting with acute atrial fibrillation (AF). The potential for treatment algorithms to safely reduce resource consumption in this setting has not been prospectively evaluated. We designed and implemented a practice guideline for the management of patients presenting to the emergency department (ED) with the primary diagnosis of AF, with emphasis on appropriate cardioversion, use of oral rate-controlling medications, and expedited referral to an outpatient AF clinic. We prospectively collected clinical and resource utilization data on all such patients for 14 months before and after institution of the guideline. Institution of the guideline was associated with a decreased rate of hospital admission (from 74% to 38%), with no differences in ED return visits or hospital readmission within 30 days. No strokes or deaths were observed. This large decrease in resource utilization during the intervention phase of the study translated to an average decrease in 30-day total direct health care costs of approximately $1,400 US dollars per patient. Our clinical and cost outcomes were minimally affected after statistical adjustment for baseline differences between study groups. We conclude that the implementation of our practice guideline was feasible, safe, and effective. Widespread adoption of such practices may have large financial implications for the health care system.

Aged↗
PubMed2003

Effect of abciximab versus tirofiban on activated clotting time during percutaneous intervention and its relation to clinical outcomes--observations from the TARGET trial.

Previous evidence suggests that the monoclonal antibody abciximab may have a more potent anticoagulant effect than small-molecule glycoprotein (GP) IIb/IIIa inhibitors. We prospectively reviewed collected heparin dose, activated clotting time (ACT), and corresponding clinical outcome data from The Do Tirofiban and ReoPro Give Similar Efficacy Outcome Trial (TARGET), a direct comparison of tirofiban versus abciximab in patients who underwent percutaneous intervention. Of the 4,809 patients enrolled in the trial, 3,739 patients (78%) had an ACT measured after the administration of GP IIb/IIIa and heparin (peak procedural ACT); this formed the population for the present study. Mean total heparin dose was 75 +/- 32 and 76 +/- 31 U/kg in the tirofiban and abciximab groups, respectively. The resultant mean peak ACTs were 296 +/- 91 and 299 +/- 89 seconds (p = 0.09). In a subset of patients with both baseline ACT (before any heparin or GP IIb/IIIa therapy) and peak procedural ACT measurements, the difference in ACT between these time points was 80 +/- 97 vs 82 +/- 101 seconds (p = 0.44) for the tirofiban and abciximab groups, respectively. After adjusting for patients' weight, weight-adjusted heparin dose, and method of ACT measurement in a multiple linear regression analysis, the type of GP IIb/IIIa inhibitor was not predictive of the peak ACT (p = 0.24). When stratified by ACT quartile, no statistically significant difference in bleeding or ischemic end points between the tirofiban and abciximab cohorts was observed. In this large contemporary percutaneous coronary intervention trial, there was no observed difference in the anticoagulant effect of tirofiban and abciximab, as measured by the ACT, or in the incidence of bleeding or ischemic complications in each ACT quartile.

Abciximab↗
PubMed2003

Administration of rabbit antithymocyte globulin (thymoglobulin) in ambulatory renal-transplant patients.

BACKGROUND: Antilymphocyte globulins have been used for the treatment and prevention of acute rejection in renal-allograft recipients. Thymoglobulin, rabbit antithymocyte globulin (RATG), has been shown to be effective for these indications and has been used primarily on an inpatient basis because of the recommendation that it be administered through a central line. METHODS: We retrospectively reviewed the charts of all patients treated with RATG since its first use in 1999. After premedication, the dose of RATG was administered over 4 to 6 hours, with 1,000 units of heparin and 20 mg of hydrocortisone to reduce the incidence of thrombosis and local tissue reaction. All adverse reactions were recorded. RESULTS: Eighteen patients underwent a total of 57 outpatient infusions. Of the 57 infusions, 52 (91%) were without complication. Five infusions (9%) were complicated by infiltrates. No serious reactions were noted. CONCLUSIONS: These data confirm that peripheral, outpatient administration of RATG is safe.

Acute Disease↗
PubMed2003

Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial.

CONTEXT: The direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI). OBJECTIVE: To determine the efficacy of bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications. DESIGN, SETTING, AND PARTICIPANTS: The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. INTERVENTIONS: Patients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. MAIN OUTCOME MEASURES: The primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization. RESULTS: Provisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P =.32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P =.40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001). CONCLUSIONS: Bivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.

Abciximab↗