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Background: The REPLACE-2 trial demonstrated the noninferiority of bivalirudin with provisional glycoprotein IIb/IIIa (GPIIb/IIIa) blockade as compared with heparin plus planned GPIIb/IIIa blockade among patients undergoing percutaneous coronary revascularization. Provisional drug was used in 374 (6%) of the 6010 patients. We sought to analyze the predictors for provisional drug use and to assess the outcomes in this cohort., Methods: Outcome among the 5.2% of patients in the heparin plus GPIIb/IIIa blockade group and the 7.2% of patients in the bivalirudin group who received provisional placebo or GPIIb/IIIa inhibitor, respectively, was compared against patients without provisional drug use and between randomized arms. Multivariate models identified predictors of provisional drug use and outcome at 30 days, 6 months, and 1 year., Results: Myocardial infarction, repeat revascularization, and bleeding events occurred more frequently among patients who required provisional drug than those who did not, but there were no differences in 1-year mortality. Ischemic and hemorrhagic end points occurred at similar rates among patients receiving provisional drug in either the heparin plus GPIIb/IIIa group compared with the bivalirudin group. Independent predictors of provisional drug use were randomization to bivalirudin, recent infarction, multilesion intervention, impaired pretreatment coronary flow, and lesion complexity. Provisional drug use, but not randomization to bivalirudin, independently predicted 30-day and 6-month ischemic events., Conclusions: Provisional administration of a GPIIb/IIIa inhibitor is associated with more frequent ischemic and bleeding events, reflecting the procedural complications that led to the use of provisional drug. The proportion of bivalirudin-treated patients who will require provisional GPIIb/IIIa blockade, however, is not large enough to have a significant deleterious impact on the overall incidence of ischemic end points or to invalidate the strategy of bivalirudin plus provisional GPIIb/IIIa blockade.

Background: Platelet glycoprotein IIb/IIIa antagonists reduce complications following percutaneous coronary intervention (PCI). There are limited data comparing different agents., Objective: The purpose of this study was to compare in-hospital and 30-day outcomes in 2 sequential cohorts of consecutive patients undergoing PCI at our institution who received abciximab or eptifibatide., Methods: The first cohort included patients who received abciximab between September 1, 1998, and January 9, 1999, and the second included patients who were treated with eptifibatide between January 11 and April 27, 1999. Per formulary decision, during the latter period, patients with renal insufficiency continued to be treated with abciximab and were ineligible for therapy with eptifibatide. Major adverse cardiac events (MACEs) were evaluated by one or more of the authors and compared., Results: A total of 319 patients were treated with abciximab and 301 with eptifibatide. There were no differences in baseline characteristics between the 2 groups, with the exception of a significantly higher proportion of patients with chronic renal insufficiency in the abciximab-treated group (4% vs 0% with eptifibatide; P = 0.03) The majority of interventions were performed for an acute coronary syndrome. Procedural success was 97% in both groups. Eptifibatide patients were treated for a mean 20.4 (5.2) hours, with 10.1% receiving the drug before the procedure. There were no differences in overall or individual MACEs in hospital or at 30 days., Conclusion: Our data suggest similar in-hospital and 30-day outcomes for abciximab- and eptifibatide-treated patients undergoing PCI.

Pulmonary hemorrhage following percutaneous coronary intervention is a very rare complication that has been previously reported in association with abciximab and tirofiban, but not with clopidogrel. We report the case of a 56-year-old man who developed diffuse alveolar hemorrhage after receiving clopidogrel for placement of a coronary stent. Since clopidogrel is a commonly used medication, clinicians should be aware of this potentially life-threatening complication.

The direct antithrombin, bivalirudin, did not reduce angiographic restenosis measured either as the dichotomous restenosis rate of 62% for bivalirudin and 58% for heparin (p = 0.70), or as the late loss in lumen diameter of 0.44 +/- 0.47 mm for bivalirudin and 0.39 +/- 0.53 mm for heparin (p = 0.62). Direct thrombin inhibition with bivalirudin neither reduces angiographic restenosis nor alters the impact of several established risk factors for restenosis.

Background: Although the development of thrombus or dissection during percutaneous transluminal coronary angioplasty (PTCA) increases the risk of abrupt vessel closure, the magnitude of the effect is difficult to define., Objective: The aim of the study was to determine prospectively the effect of the development of thrombus or dissection on PTCA procedural outcome., Methods: Data from 591 consecutive angioplasty procedures involving 756 lesions at 9 clinical centers were included in a prospective registry with a core angiographic laboratory., Results: Clinical success (defined as < 50% stenosis of all target lesions assessed in a core angiographic laboratory, with no major complications of death, Q wave or non-Q wave myocardial infarction or emergency CABG) was achieved in 497 patients (84%). Major complications occurred in 45 (7.6%). Abrupt vessel closure, including both established closure (TIMI grade 0 or I flow) and impending closure (> 50% stenosis, TIMI grade 0-2 flow, plus use of additional interventions) occurred in 65 patients (11%). Angiographically visible dissections developed in 40% of lesions; more severe grades of dissection were associated with reduced success rates, and increased incidence of and abrupt vessel closure and major complication. Angiographic evidence of thrombus (filling defects) developed in 12.3% of lesions; the presence of thrombus was associated with significantly lower procedural success (61% vs. 86%) and significantly higher rates of abrupt vessel closure (28% vs 7%) and major complications (24% vs. 6%). With multivariable analysis, thrombus was identified as an independent predictor of procedural success, abrupt vessel closure, and major complications., Conclusions: The development of severe dissections or thrombus following PTCA is associated with significantly lower procedural success rates and higher rates of abrupt vessel closure and major complications. Patients who develop severe dissection or thrombus may be appropriate candidates for more aggressive forms of therapy.

We compared visual estimate and digital caliper measurement of coronary stenoses, utilizing both a 50% and 70% diameter reduction as a definition of significance and both experienced angiographers and cardiology fellows as readers. Ten angiograms were interpreted twice, using the different methods, by four readers, two months apart. The angiograms were divided into 12 vessel segments. Stenoses were judged more severe by visual estimate in 11 segments. Seven of twelve segments had significant differences between readers using the visual estimate, but no significant differences were obtained using caliper measurements. Variability was highest for fellows using the visual method. Interobserver agreement was highest using the digital caliper and the 70% criteria. Intraobserver agreement was most dependent on the amount of time taken in film interpretation. The digital caliper appears to be preferable in interpreting angiograms, particularly for cardiology fellows.