Effect of eptifibatide on angiographic complications during percutaneous coronary intervention in the IMPACT--(Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis) II Trial.

We sought to determine whether eptifibatide reduces elevation of creatine kinase (CK)-MB isoenzyme release during coronary intervention by preventing angiographic complications, by minimizing the sequelae of angiographic complications once they occur, or by other mechanisms. In the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis trial, patients underwent coronary intervention during treatment with placebo versus the glycoprotein IIb/IIIa receptor inhibitor eptifibatide. Eptifibatide decreased ischemic complications at 24 hours and 30 days. CK-MB elevations and in-laboratory angiographic complications (including major dissection, distal embolization, residual thrombus, abrupt closure, residual stenosis >50%, and side branch occlusion) were prospectively recorded. The incidence of any angiographic complication was lower in eptifibatide-treated patients (33%) than in placebo-treated patients (38%, p = 0.019). For patients with angiographic complications, there was a trend toward a reduced incidence of any elevation in CK-MB in the first 24 hours (29%, 135/0.75 eptifibatide dose; 33%, 135/0.5 eptifibatide dose; 37%, placebo). Among patients without angiographic complications, there was a similar trend toward fewer abnormal CK-MB levels in patients receiving eptifibatide (17% and 18% in eptifibatide arms vs 21% placebo). Thus, eptifibatide reduces angiographically evident complications during coronary intervention, but this effect accounts for only 1/3 of the reduced frequency of CK-MB elevations observed with eptifibatide. When angiographic complications occur, eptifibatide reduces rates of subsequent CK-MB elevation, accounting for another 1/3 of the reduction in CK-MB elevations. Finally, eptifibatide reduces the incidence of periprocedural CK-MB elevations in patients without angiographically evident complications, accounting for 1/3 of eptifibatide's overall effect in reducing of CK-MB elevations in patients undergoing percutanous coronary intervention.

Effect of glycoprotein IIb/IIIa receptor inhibition on angiographic complications during percutaneous coronary intervention in the ESPRIT trial.

OBJECTIVES: We sought to determine whether eptifibatide decreases the incidence of in-laboratory angiographic complications and to determine the relationship of angiographically evident complications to elevations of creatine kinase-MB (CK-MB) enzyme levels during percutaneous coronary intervention. BACKGROUND: In the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial, eptifibatide during coronary intervention was associated with decreased ischemic complications at 48 h and 30 days. METHODS: Patients (n = 2,064) were randomized to placebo versus eptifibatide (two 180 microg/kg boluses 10 min apart and as a continuous infusion of 2 microg/kg per min) during percutaneous coronary stenting. Angiographic complications including major dissection, distal embolization, residual thrombus, abrupt closure, residual stenosis >50% and side-branch occlusion were prospectively recorded by the operator. Creatine kinase-MB levels were measured after the procedure and every 6 h thereafter. The incidence of angiographic complications and CK-MB elevation was determined for eptifibatide versus placebo groups. RESULTS: Eptifibatide-treated patients demonstrated nonsignificant trends toward fewer angiographic complications (10 vs. 12% for placebo patients, p = 0.13) and, for patients with angiographic complications, fewer subsequent CK-MB elevations (43 vs. 50% for placebo patients, p = 0.31). In patients without any angiographic complications, the incidence of CK-MB elevation >3 times the normal was 7% with placebo and 4% with eptifibatide (p = 0.003). CONCLUSIONS: Eptifibatide during nonurgent coronary stent intervention only minimally (and insignificantly) reduces the incidence of angiographic complications and subsequent CK-MB elevations in patients developing an angiographic complication. The greater effect is to reduce myocardial infarction in patients undergoing otherwise uneventful coronary stent implantation as well as in the overall study population.

Effectiveness of transluminal extraction atherectomy for debulking saphenous vein graft in-stent restenosis.

Treatment of in-stent restenosis in saphenous vein grafts often requires initial debulking, but transluminal extraction catheter (TEC) atherectomy is seldom used for this purpose, and most discussions omit this option. Our experience with 6 episodes of TEC used successfully for saphenous vein graft in-stent restenosis and review of 7 other reported cases suggests TEC may be safe and effective for debulking saphenous vein graft restenosis lesions.

Importance of delayed imaging for blunt renal trauma.

The advent of noninvasive computed tomography of the abdomen and pelvis for evaluation of blunt renal trauma has led to the practice of expectant management for hemodynamically stable patients. Although expectant management of higher grade injuries (American Association for the Surgery of Trauma Renal Injury Scale) would intuitively result in an increased frequency of urologic complications, this has not been previously examined in a large series of patients utilizing contemporary radiologic imaging techniques. A retrospective review of patients from a single institution within a recent 4-year period revealed 4 grade I, 13 grade II, 21 grade III, 7 grade IV, and 4 grade V injuries. None of grade 1, 15% of grade II, 38% of grade III, 43% of grade IV, and 100% of grade V injuries had one or more (15 major and 11 minor) urologic complications. The incidence of urinary complications correlated significantly with increasing grade (0%, 15%, 38%, 43%, and 100% for grades I to V, respectively; r = 0.94, p = 0.0158). Of the delayed urologic complications, 50% were diagnosed on follow-up imaging studies and 33% of them required intervention. Therefore we advocate repeat imaging 2 to 4 days after trauma resulting in grade III to V blunt renal lacerations to identify delayed complications that may require intervention.

Incidence of intracranial hemorrhage complicating treatment with glycoprotein IIb/IIIa receptor inhibitors: a pooled analysis of major clinical trials.

PURPOSE: The major risk of therapy with platelet glycoprotein IIb/IIIa receptor inhibitors is bleeding. We reviewed trials using these agents to determine if bleeding risks include an increased incidence of intracranial hemorrhage. METHODS: A Medline search identified 14 randomized trials of intravenous platelet glycoprotein IIb/IIIa receptor inhibitors for patients undergoing percutaneous coronary intervention or who had an acute coronary syndrome. We compared the incidence of intracranial hemorrhage among 15,850 patients treated with glycoprotein IIb/IIIa inhibitors with that among 12,039 patients treated with placebo. RESULTS: The incidence of intracranial hemorrhage with heparin plus any IIb/IIIa inhibitor was similar to placebo with heparin (0.12% vs 0.09%, odds ratio = 1.3, 95% confidence interval: 0.6 to 3.1, P = 0.59). The incidence of intracranial hemorrhage with glycoprotein IIb/IIIa drugs alone was similar to that with heparin alone (0.07% vs 0.06%), albeit with a wide confidence interval (odds ratio = 1.2, 95% confidence interval: 0.1 to 16, P = 1.0). CONCLUSIONS: Intravenous glycoprotein IIb/IIIa receptor inhibitors alone or in combination with heparin do not cause a statistically significant excess of intracranial hemorrhage as compared with heparin alone. Because of small numbers, the data do not exclude the possibility of an excess of intracranial hemorrhage in some groups of patients treated with glycoprotein IIb/IIIa receptor inhibitors.

Thrombocytopenia complicating treatment with intravenous glycoprotein IIb/IIIa receptor inhibitors: a pooled analysis.

BACKGROUND: Despite the increasingly prevalent role of platelet glycoprotein (GP) IIb/IIIa receptor inhibitors in acute coronary syndromes and percutaneous coronary interventions, the incidence and clinical relevance of thrombocytopenia occurring with their use remain unclear. METHODS: We identified 8 placebo-controlled, randomized, large trials of GP IIb/IIIa receptor inhibitors reporting the incidence of thrombocytopenia, grouped by severity. The clinical courses of 42 patients with GP IIb/IIIa-related thrombocytopenia in these studies and other case reports were reviewed for bleeding complications. RESULTS: Abciximab increased mild thrombocytopenia compared with placebo (4.2% vs 2.0%; P <.001; odds ratio 2.14) and increased severe thrombocytopenia compared with placebo (1.0% vs 0.4%; P =.01; odds ratio 2.48). Small-molecule IIb/IIIa inhibitors did not significantly increase mild or severe thrombocytopenia compared with placebo. Mild thrombocytopenia occurred more frequently in acute coronary syndrome trials than in coronary intervention trials, even in patients not receiving any IIb/IIIa inhibitors. No major bleeding sequelae were reported in 23 patients with severe thrombocytopenia or in 19 patients with profound thrombocytopenia. CONCLUSIONS: Abciximab, but not eptifibatide or tirofiban, increases the incidence of thrombocytopenia compared with placebo in patients also treated with heparin. Thrombocytopenia associated with GP IIb/IIIa inhibition does not routinely lead to severe bleeding complications.

Timing of and risk factors for myocardial ischemic events after percutaneous coronary intervention (IMPACT-II). Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis.

We studied both the time course and risk factors for adverse clinical events after percutaneous coronary intervention (PCI). Such information is critical to clinical decision-making, but scant quantitative data exist to describe the time course of these adverse outcomes. Patients enrolled in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis-II (IMPACT-II) trial were analyzed. Patients undergoing elective, urgent, or emergency PCI (n = 4,010) were randomized to receive either placebo or 1 of 2 eptifibatide regimens during intervention. We evaluated the time to the primary end point of the trial, the 30-day composite of death, myocardial infarction, repeat nonelective PCI, nonelective bypass surgery, or stenting for abrupt closure. Adverse events occurred in 407 patients (10.1%). Because the risk of events declined substantially between 6 and 9 hours (66% occurred within 6 hours), events were classified as occurring before or after 6 hours. Independent predictors of "early" events included dissection, pre- and postprocedural coronary blood flow, side-branch occlusion, procedural thrombolytic use, previous bypass, presentation with unstable angina, absence of diabetes, and hyperlipidemia. The predictors of "late" events included lower weight, increased baseline heart rate, coronary dissection, and procedural thrombolytic use. The risk of ischemic events were greatest immediately after PCI and rapidly declined, so that by 9 hours the hazard function plot was flat; 66% of events occurred within 6 hours of PCI. Knowledge of the risk factors for early and late events help risk-stratify patients before and after intervention for myocardial ischemic events.

Ad hoc coronary intervention.

Ad hoc coronary intervention is a percutaneous revascularization procedure performed at the same sitting as diagnostic cardiac catheterization. While this appears to be an efficient strategy, the safety and cost of ad hoc coronary intervention compared with delayed coronary intervention have not been clearly documented. Special preparation and precautions are necessary for patients in whom ad hoc coronary intervention is anticipated. Ad hoc coronary intervention is not appropriate if informed consent has not been previously obtained or if it would pose greater risks than delayed intervention. While ad hoc coronary intervention is often efficient and effective, its use should be individualized. Cathet. Cardiovasc. Intervent. 49:130-134, 2000.

Bleeding complications with platelet glycoprotein IIb/IIIa receptor antagonists.

Platelet glycoprotein (GP) IIb/IIIa receptor antagonists are being used with increasing frequency in the settings of percutaneous coronary interventions and acute ischemic syndromes. The development of bleeding complications following GPIIb/IIIa blockade represents a significant limitation to its effectiveness. Baseline characteristics predictive of future bleeding events in patients receiving platelet GPIIb/IIIa receptor antagonist include older age, low body weight, evolving myocardial infarction, and female sex. In patients undergoing percutaneous coronary interventions with adjunctive GPIIb/IIIa inhibition, the risk of bleeding, particularly from the femoral vascular access site, may be reduced through the use of low-dose, weight-adjusted heparin (70 U/kg), avoidance of postprocedural heparin, and early vascular sheath removal. Strategies to reduce the incidence of bleeding complications in patients receiving GPIIb/IIIa inhibitors are proposed in this article.

Bleeding complications of glycoprotein IIb-IIIa receptor inhibitors.

Large clinical studies have demonstrated an unequivocal clinical benefit of antithrombotic therapy with inhibitors of the platelet surface-membrane glycoprotein (GP) IIb-IIIa receptor in a broad range of patients with ischemic heart disease. Potent antiplatelet effects of these agents, however, may increase the risk of bleeding complications, as occurred in the first large evaluation of this therapy, the Evaluation of c7E3 for Prevention of Ischemic Complications (EPIC) trial with abciximab (c7E3 Fab; ReoPro((R)); Centocor, Malvern, Pa). Although the incidence of bleeding events in subsequent studies has been reduced through the use of a low-dose, weight-adjusted heparin regimen and early removal of vascular sheaths in patients who have undergone percutaneous coronary interventions, hemorrhage continues to be the most common complication of GP IIb-IIIa inhibitor therapy. This review summarizes current experience related to bleeding complications with various GP IIb-IIIa inhibitors and suggests strategies for improved management of bleeding in patients receiving these agents.

Telephone reporting of the results of cardiac procedures: feasibility and primary care physician preferences.

PURPOSE: We evaluated the feasibility and time required for routine telephone communication with primary care physicians after cardiac procedures and surveyed primary care physicians as to their preferences for the method and content of reports of cardiac procedures. SUBJECTS AND METHODS: A phone call was made within 1 day of the procedure during normal working hours to the primary care physician for all 414 patients who underwent cardiac catheterizations or interventions during a 1-year period. Subsequently, all 211 primary care physicians were mailed a questionnaire on the effectiveness of phone calls as compared with other communication methods. RESULTS: The primary care physician was reached with one call for 51% of patients and could not be contacted with up to five calls to office, clinic, or hospital for 32% of patients. Mean (+/- SD) phone time per patient was 4.1 (+/- 2.0) minutes. Surveys were returned by 119 (56%) of 211 referring physicians. Telephone communication was rated as "very helpful" by 69%. Most primary care physicians (86%) were "very" or "a little pleased" to receive phone calls. Survey respondents identified the summary of the results and the recommendations for treatment as the most important parts of the report. Respondents preferred personal phone calls or faxed reports to phone messages left with office staff, reports sent by electronic mail, or mailed written reports. CONCLUSIONS: Most primary care physicians find personal phone calls helpful and desirable, but the effectiveness of routine phone calls is limited by the availability of primary care physicians during working hours and the time required for phonereporting.

Comparison of slow oscillating versus fast balloon inflation strategies for coronary angioplasty.

Previous studies suggest that slow and/or oscillating balloon inflation during coronary angioplasty may decrease the incidence of coronary dissection and improve clinical outcomes. To compare the effect of slow oscillating versus conventional fast inflation techniques on the incidence of severe coronary dissection during angioplasty, 622 patients were randomized to slow oscillating inflation versus fast inflation. Angiographic outcomes of the procedures and in-hospital clinical events were recorded. The primary end point of severe (type C, D, E, F) dissection occurred in 7.7% of patients undergoing slow oscillation and 6.6% of patients undergoing fast inflation (p = 0.87). Major complications (death, urgent coronary artery bypass graft surgery, stroke, abrupt closure, or Q-wave myocardial infarction) occurred in 4.7% of patients undergoing slow oscillation and 3.5% of patients undergoing fast inflation (p = 0.45). The 2 inflation strategies did not differ in the pressure at which the balloon achieved full expansion, angiographic success rate, residual stenosis, and incidence of all minor and/or major complications. We conclude that there is no benefit of slow oscillating inflation over routine fast inflation in angioplasty. Slow oscillating inflation did not dilate lesions at lower pressures, decrease the incidence of dissection or severe dissection, or reduce the incidence of adverse clinical outcomes.

Clinical outcomes after detection of elevated cardiac enzymes in patients undergoing percutaneous intervention. IMPACT-II Investigators. Integrilin (eptifibatide) to Minimize Platelet Aggregation and Coronary Thrombosis-II.

OBJECTIVES: We examined the relations of elevated creatine kinase (CK) and its myocardial band isoenzyme (CK-MB) to clinical outcomes after percutaneous coronary intervention (PCI) in patients enrolled in Integrilin (eptifibatide) to Minimize Platelet Aggregation and Coronary Thrombosis-II (trial) (IMPACT-II), a trial of the platelet glycoprotein IIb/IIIa inhibitor eptifibatide. BACKGROUND: Elevation of cardiac enzymes often occurs after PCI, but its clinical implications are uncertain. METHODS: Patients undergoing elective, scheduled PCI for any indication were analyzed. Parallel analyses investigated CK (n=3,535) and CK-MB (n=2,341) levels after PCI (within 4 to 20 h). Clinical outcomes at 30 days and 6 months were stratified by postprocedure CK and CK-MB (multiple of the site's upper normal limit). RESULTS: Overall, 1,779 patients (76%) had no CK-MB elevation; CK-MB levels were elevated to 1 to 3 times the upper normal limit in 323 patients (13.8%), to 3 to 5 times normal in 84 (3.6%), to 5 to 10 times normal in 86 (3.7%), and to >10 times normal in 69 patients (2.9%). Elevated CK-MB was associated with an increased risk of death, reinfarction, or emergency revascularization at 30 days, and of death, reinfarction, or surgical revascularization at 6 months. Elevated total CK to above three times normal was less frequent, but its prognostic significance paralleled that seen for CK-MB. The degree of risk correlated with the rise in CK or CK-MB, even for patients with successful procedures not complicated by abrupt closure. CONCLUSIONS: Elevations in cardiac enzymes, including small increases (between one and three times normal) often not considered an infarction, are associated with an increased risk for short-term adverse clinical outcomes after successful or unsuccessful PCI.

Therapeutic repositioning of a Gianturco-Roubin II coronary stent after initial deployment.

Movement of coronary stents after deployment can produce complications. We report a case of stent migration that led to stent coverage of a distal dissection, obviating the need for placement of a second stent. In this case, stent movement was therapeutic.

Echocardiographic detection of pulmonary valve papillary fibroelastoma.

Papillary fibroelastomas of the heart are rare lesions usually discovered at autopsy or incidentally at surgery. Although these lesions are benign and generally asymptomatic, they can cause valvular dysfunction or embolize to vital structures. In this case report, we describe a pulmonary valve papillary fibroelastoma detected by echocardiography in an adult. Most of the 12 cases of pulmonary valve papillary fibroelastoma reported in the literature were discovered incidentally at autopsy or during surgery. To our knowledge, this is the first reported case of pulmonary valve papillary fibroelastoma detected by echocardiography. Rest imaging before exercise echocardiography for evaluation of atypical chest pain in a 42-year-old white female demonstrated a mass on the pulmonary valve. The mass was further characterized by transesophageal echocardiography and excised during open heart surgery. Pulmonary valve papillary fibroelastoma was diagnosed histopathologically. This case illustrates the additional diagnostic value of comprehensive 2D imaging in the rest phase before doing exercise echocardiography.

Polyarteritis nodosa presenting as acute myocardial infarction with coronary dissection.

Coronary manifestations of polyarteritis nodosa (PAN) are rarely identified pre-mortem. We report a 51-year-old female with PAN causing a coronary dissection and new lesions developing over the next 5 days. PAN should be added to the list of differential diagnoses for spontaneous coronary dissections.

Modifiable risk factors for vascular access site complications in the IMPACT II Trial of angioplasty with versus without eptifibatide. Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis.

OBJECTIVES: This study was designed to identify potential predictors of vascular access site (VAS) complications in the large-scale Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) II trial, which studied angioplasty with versus without a new glycoprotein (GP) IIb/IIIa receptor inhibitor (eptifibatide). BACKGROUND: GP IIb/IIIa receptor inhibition during coronary interventions has been associated with excess VAS complications. If other predictors of VAS complications could be identified, they might be manipulated to reduce complications. METHODS: A total of 4,010 patients undergoing percutaneous transluminal coronary revascularization (PTCR) were randomized into one of three bolus/20- to 24-h infusion arms: placebo bolus/placebo infusion; 135-microg/kg body weight eptifibatide bolus/0.5-microg/kg per min eptifibatide infusion; or 135-microg/kg eptifibatide bolus/0.75-microg/kg per min eptifibatide infusion. Heparin during the procedure was weight adjusted and stopped 4 h before sheaths were removed. Logistic regression modeling was used to identify independent predictors of VAS complications. RESULTS: VAS complications were more common in patients treated with eptifibatide (9.9% vs. 5.9% placebo-treated patients, p < 0.001). Multivariate analysis identified eptifibatide therapy (p < 0.0001), advanced age (p = 0.0001), longer time to sheath removal (p = 0.0002), stent placement (with intense post-stent anticoagulation) (p = 0.0004), female gender (p = 0.0006), PTCR within 24 h of thrombolytic therapy (p = 0.002), larger heparin doses during PTCR (p = 0.009), major coronary dissection (p = 0.03) and placement of a venous sheath (p = 0.04) as independent predictors of VAS complications. CONCLUSIONS: VAS complications may be reduced by early sheath removal, by avoiding placement of venous sheaths and by limiting heparin dosing to avoid excessive activated clotting times. Early sheath removal during inhibition of platelet aggregation by eptifibatide is feasible.