Biomedical subjects

S G Ellis

Publications and source records attributed to S G Ellis.

At least 109 records · Page 6Linked to original sources

PubMed1996

The dilemma of diagnosing coronary calcification: angiography versus intravascular ultrasound.

OBJECTIVES: We sought to determine whether careful examination of angiograms in conjunction with other clinical information could reliably detect, quantitate and localize target lesion calcification before a coronary intervention. BACKGROUND: The presence, extent and location of calcium in coronary artery lesions are important determinants of outcome after coronary intervention. Intravascular ultrasound is proposed as a superior technique for identifying patients with coronary artery calcification. However, the precise role of this costly and invasive method has not yet been established. METHODS: Target lesion calcification was assessed in 183 patients (155 men; mean [+/-SD] age 58 +/- 10 years) by angiography and intravascular ultrasound before a planned percutaneous coronary intervention. RESULTS: Ultrasound detected calcium in 138 patients (>90 degrees in 56, 91 degrees to 180 degrees in 52, 181 degrees to 270 degrees in 22 and > 270 degrees in 8), whereas angiography showed calcification in 63 (1+ in 32, 2+ in 27 and 3+ in 4). The two techniques agreed in 92 patients and disagreed in 91. Sensitivity and specificity of angiography were 40% and 82%, respectively. The arc of calcium by ultrasound was greater in patients with angiographically visible calcification (175 degrees +/- 85 degrees vs. 108 degrees +/- 71 degrees, p=0.0001). The depth of calcification by ultrasound was superficial in 61 patients (44%), deep in 68 (49%) and mixed in 8 (7%). The sensitivity of angiography in identifying superficial calcium was 35%. Of 120 patients without angiographically visible calcium at the target lesion site, 83 showed calcium by ultrasound. The only predictor of ultrasound calcium in these 120 patients was angiographic calcification elsewhere in the coronary tree (p=0.0001). The probability of any calcium and superficial >90 degrees calcium were 60% and 12%, respectively, in the 90 patients without angiographic calcifications anywhere in the coronary tree. CONCLUSIONS: Despite poor sensitivity, angiography may help identify patients requiring intravascular ultrasound. When it is angiographically visible, the arc of calcium is likely to be large and superficial. Angiographic calcification at a remote site is a predictor of angiographically undetected target lesion calcium. Patients without angiographic calcification in the coronary tree may not need routine ultrasound examination, as the likelihood of >90 degrees superficial calcium is low.

Aged↗

PubMed1996

Analysis and comparison of operator-specific outcomes in interventional cardiology. From a multicenter database of 4860 quality-controlled procedures.

BACKGROUND: Medical consumers are increasingly requesting methods to discriminate among the results of different providers. Standards for appropriate modeling, risk adjustment, and evaluation ("scorecarding") in this setting are not well developed, although such evaluation is being performed by the medical insurance industry and by several states in the United States. Our objectives were to develop and examine clinically meaningful methodology for assessing the operator-specific results for percutaneous coronary revascularization. METHODS AND RESULTS: From a multicenter database of patients treated since January 1, 1990, we used training and validation samples (n = 4860) to develop several models for risk adjustment and applied them to 38 providers performing 25 to 523 procedures in the database. Models were developed using multivariable logistic regression techniques for combinations of the end points of death, myocardial infarction, bypass surgery, and procedural success. Models were evaluated for predictive accuracy by using receiver operating characteristic (ROC) analysis, for the capacity to discriminate between superior and inferior provider outcomes, and for subjectivity and concordance. Major complications occurred in 3.6% of patients. The area under the ROC curve (with perfect discriminatory accuracy, area = 1.0; with no apparent accuracy, area = 0.5) in the validation sample, and frequency of identification of operators with outcomes outside the 95% CI for the outcome in question for the models were for death, 0.85 and 7.9%; for death, Q-wave infarction, and bypass surgery, 0.77 and 13.2%; for death, all infarction, and bypass surgery, 0.66 and 10.5%; and for procedural success, 0.76 and 23.7%. For the models as a group, identification of outliers was inversely related to provider volume (P = .05). Models evaluating non-Q-wave infarction or requiring measurement of percent diameter stenosis were identified as being most susceptible to provider manipulation. CONCLUSIONS: For percutaneous coronary revascularization, modeling to discriminate between provider outcomes is limited by the low incidence of major adverse events, subjectivity or susceptibility to manipulation of more frequently occurring adverse events, the generally modest predictive capacity of the models, and the low volume of individual provider treatments. Modeling will be most useful in the identification of providers with extremely poor outcomes and for discrimination between providers with very large procedural volume. Until improved understanding of the biological and mechanical correlates of major complications allows the development of more predictive models, interpretation of the results of scorecarding, particularly for low-volume providers, should be made with caution.

Female↗

PubMed1996

Subacute stent thrombosis: evolving issues and current concepts.

During percutaneous coronary revascularization, intracoronary stents are effective in the treatment of abrupt vessel closure and improvement of suboptimal angioplasty results, and compared to balloon angioplasty, they reduce stenosis recurrence. Opposing these benefits, subacute thrombosis of stents is associated with a substantial increase in periprocedural morbidity and mortality. To review factors associated with stent thrombosis and to study the impact of evolving procedural techniques on the incidence of stent thrombosis, we reviewed all English articles from MEDLINE (1988 to 1995) with key words "stent" and "thrombosis." Stent registry data and recent abstracts from scientific meetings were also reviewed. Factors related to the clinical setting, the lesion, the stent and the procedural technique that affect the risk of stent thrombosis were identified. Sixty clinical studies were reviewed and include 7,914 patients receiving intracoronary stents. Studies were separated into those reporting stents placed emergently or electively without adjunct high-pressure balloon inflations, stents placed in saphenous vein graft conduits, and stents placed with high-pressure balloon inflations but without subsequent oral anticoagulants. Overall, subacute thrombosis was substantially higher in stents placed emergently (10.1%) compared to those placed electively (4.3%). Among contemporary trials employing high-pressure balloon inflations, the rate of stent thrombosis appears markedly lower (1.3%) despite reduced postprocedural anticoagulation. Taken together, these studies suggest factors associated with a heightened risk of stent thrombosis, many of which can be avoided with proper case selection and contemporary techniques.

Coronary Artery Bypass↗

PubMed1996

Cost-efficacy modeling of catheter reuse for percutaneous transluminal coronary angioplasty.

OBJECTIVES: Our goal was to provide the range of cost savings associated with various catheter reuse strategies. BACKGROUND: Percutaneous transluminal coronary angioplasty catheters are commonly reused in several countries outside the United States. However, the cost-effectiveness of such reuse strategies has not been evaluated. METHODS: Three theoretical models of catheter reuse were constructed using the actual costs for treating patients with coronary angioplasty at the Cleveland Clinic. Costs were calculated based on the number of balloon catheters, the amount of contrast agent used and the rates for urgent revascularization that were observed in a prospective Canadian study on catheter reuse. RESULTS: The median cost to treat a lesion by means of coronary angioplasty using new catheters was $8,800 per patient. In reuse models, the potential to reduce cost depended on the number of balloon catheters used and the rates of urgent revascularization. The "best care" scenario offered a potential savings of $480 (5.5% of total in-hospital cost), whereas the "worst case" scenario resulted in an increased cost of $1,075 (12.2% of total in-hospital cost) compared with the single-use strategy. Cost of the "likely case" scenario was similar to that of the single-use strategy. Sensitivity analyses identified the different rates of revascularization and cost of balloon catheters required to offset potential savings in each strategy. CONCLUSIONS: Although reusing coronary angioplasty catheters may reduce total in-hospital costs, even a modest increase in complications requiring urgent revascularization may offset any potential savings. However, if an increase in complications and procedure time can be avoided, the reuse strategy has significant economic potential and, ultimately, may be extended to other percutaneous coronary interventional equipment.

Angioplasty, Balloon, Coronary↗

PubMed1996

Defining the appropriate threshold of creatine kinase elevation after percutaneous coronary interventions.

The threshold of creatine kinase elevation after coronary interventions has been set at levels ranging in different studies from 2 to > 5 times the laboratory's upper limit of normal. This high variability is caused by the absence of any systematic evaluation of the prognostic implications of cardiac-enzyme elevation in this setting. This study was undertaken to evaluate the clinical, morphologic, and procedural correlates, and the long-term follow-up of two commonly used thresholds of creatine kinase (CK) elevation after successful percutaneous coronary interventions, in an attempt to define the level of postprocedural cardiac enzymes that correlates with adverse clinical outcome. We examined 4664 consecutive patients who underwent successful coronary angioplasty or directional atherectomy at the Cleveland Clinic. Group I (4480 patients) had CK > or = 2 times control levels after the procedure (i.e., < or = 360 IU/L). Group II (123 patients) had a peak level between 361 and 900 IU/L, and group III (61 patients) had a peak level >900 IU/L with positive myocardial isoenzymes (CK-MB > 4%). Elevation of cardiac enzymes was associated with distinct clinical, morphologic, and procedural characteristics, including coronary embolism, recent infarction, transient in-laboratory closure, hemodynamic instability, vein graft procedures, and large dissections. Clinical follow-up was available in 4644 (99.6%) patients, with a mean follow-up of 36 +/- 22 months. Kaplan-Meier survival analysis adjusted with Cox proportional hazards regression model showed that cardiac-enzyme elevation was an important correlate of cardiac death (risk ratio, 2.19; p < 0.0001). The groups with elevated cardiac enzymes had a higher incidence of cardiac death compared with group I (p < 0.0001). There was also a trend toward more cardiac hospitalizations in the same groups (p = 0.15). The incidence of cardiac death and cardiac hospitalization on follow-up was not different between groups II and III, This study shows that CK elevations between 2 and 5 times control values after successful coronary interventions are associated with an adverse long-term outcome. The findings suggest that an appropriate CK threshold that has prognostic implications would be twice the upper limit of normal.

Angioplasty, Balloon, Coronary↗

PubMed1996

Training in cardiac catheterization at high-volume and low-volume centers: is there a difference in case mix?

Current guidelines recommend that cardiology trainees participate+ in a minimum of 100 cardiac catheterization procedures during their clinical training (volume minimum level 1 training). To examine the differences in case mix seen by cardiology trainees during their training in cardiac catheterization, we examined the first 100 cases done by two trainees at different hospitals. One hospital was a high-volume center performing > 5500 procedures/year, and the other was a low-volume center performing < 1500 procedures/year. Demographic and clinical characteristics of the patients undergoing cardiac catheterization were similar at the two hospitals. Indications were also similar, with the only exception being a higher rate of urgent/emergent cases among patients seen at the low-volume center (8% vs 1%). Minor differences in procedural techniques were present at the two hospitals, with the trainee at the high-volume center having more experience with arm cases (4% vs 0%) and left ventriculograms (77% vs 48%) and the trainee at the low-volume center having more experience with right-heart catheterizations (36% vs 11%) and temporary pacing wires (5% vs 2%). Neither trainee had significant experience with valvular or adult congenital heart disease (2%, low-volume center; 1%, high-volume center). These results suggest that current volume minimums may ensure relatively uniform case mix among physicians who are training in cardiac catheterization at different centers. However, training may be deficient in several areas such as valvular heart disease, congenital heart disease, and arm cases.

Adult↗

PubMed1996

Rationale for local drug delivery.

Although advances during the last decade have transformed the management of coronary artery disease, deficiencies in our understanding of the basic processes of arterial thrombosis and restenosis after percutaneous intervention continue to present major challenges to their prevention. While coronary stenting has in selected cases provided the first effective approach to the problem of restenosis, new devices such as atherectomy have largely proven ineffective in this field. Similarly, despite evidence that many pharmacological agents reduce neointimal hyperplasia in experimental models, in clinical trials these agents have failed to attenuate the restenotic process. This may reflect patients' inability to tolerate the high systemic drug concentrations required to achieve adequate levels for sufficient time at the target site, necessitating a shift in the focus of therapeutic agents for the prevention of thrombosis and restenosis to local or site-specific delivery. The major advantage that local drug delivery may potentially provide is the ability to achieve high and sustained local concentrations of drug without large systemic doses, thus minimizing systemic toxicity.

Animals↗

PubMed1995

Influence of blockade at specific levels of the coagulation cascade on restenosis in a rabbit atherosclerotic femoral artery injury model.

BACKGROUND: The relation among the coagulation cascade, its individual proteins, and the response to vascular injury is largely undefined. We have evaluated the effect of four probes that block specific levels of coagulation cascade on neointimal hyperplasia in the atherosclerotic rabbit arterial injury model. METHODS AND RESULTS: Focal femoral atherosclerosis was induced by air-desiccation injury and hypercholesterolemic diet in 48 New Zealand White rabbits, followed by balloon angioplasty. Active-site inactivated factor VIIa (DEGR-VIIa), which blocks the binding of factor VIIa to tissue factor, was administered (n = 12 arteries) by intravenous bolus (1 mg/kg) at the time of balloon angioplasty and followed by infusion of 50 micrograms.kg-1.h-1 for 3 days; for the control (n = 13 arteries), 150 U heparin was injected as bolus and followed by infusion of saline at 50 microL.kg-1.min-1. Recombinant tissue factor pathway inhibitor (TFPI), which binds factor Xa and inhibits the tissue factor-factor VIIa complex and factor Xa, was given as a 1 mg/kg bolus followed by 15 micrograms.kg-1.min-1 infusion for 3 days (n = 17 arteries). Recombinant tick anticoagulant peptide (TAP; n = 15 arteries) and hirudin (n = 14 arteries), which block factor Xa and thrombin, respectively, were administered as a 1 mg/kg bolus followed by 5 micrograms.kg-1.min-1 infusion for 3 days. These three groups had their own controls (n = 14 arteries). There were no differences among treatment groups in preangioplasty and postangioplasty minimal luminal diameter (MLD) by angiography. The mean MLD 21 days after balloon angioplasty was significantly different between control and DEGR-VIIa-treated groups (0.74 +/- 0.25 and 1.24 +/- 0.27 mm, respectively; P = .0001) and between the TFPI-treated group and others (0.88 +/- 0.21 mm for control, 0.97 +/- 0.22 mm for hirudin-treated, 0.98 +/- 0.14 mm for TAP-treated, and 1.32 +/- 0.21 mm for TFPI-treated arteries; P = .0001 by ANOVA). By quantitative histological analysis, the ratio of neointimal cross-sectional area compared with the area of internal elastic lamina in the DEGR-VIIa-treated group was significantly less than control (0.48 +/- 0.12 versus 0.67 +/- 0.12, P = .0001), and the ratio of neointimal cross-sectional area to the area demarcated by the internal elastic lamina of the TFPI-treated group was significantly reduced compared with the other groups (0.46 +/- 0.20 for TFPI-treated, 0.67 +/- 0.15 for hirudin-treated, 0.61 +/- 0.15 for TAP-treated, and 0.64 +/- 0.13 for control groups; P = .003). CONCLUSIONS: Treatment with DEGR-VIIa or TFPI for 3 days in this rabbit atherosclerotic injury model reduced angiographic restenosis and decreased neointimal hyperplasia compared with controls. These findings highlight the importance of early initiators of the extrinsic coagulation pathway, especially factor VII and tissue factor, in the response to arterial injury.

Angioplasty, Balloon↗

PubMed1995

Pravastatin limitation of atherosclerosis in the coronary arteries (PLAC I): reduction in atherosclerosis progression and clinical events. PLAC I investigation.

OBJECTIVES: This study was designed to evaluate the effect of pravastatin on progression of coronary atherosclerosis and ischemic events in patients with coronary artery disease and mild to moderate hyperlipidemia. BACKGROUND: Few clinical trial data support the use of lipid-lowering therapy in patients with coronary artery disease and mild to moderate elevations in cholesterol levels. METHODS: Four hundred eight patients (mean age 57 years) with coronary artery disease and low density lipoprotein (LDL) cholesterol > or = 130 mg/dl (3.36 mmol/liter) but < 190 mg/dl ([4.91 mmol/liter]) despite diet were randomized in a 3-year study to receive pravastatin or placebo. Atherosclerosis progression was evaluated by quantitative coronary arteriography. RESULTS: Baseline mean LDL cholesterol was 164 mg/dl (4.24 mmol/liter). Pravastatin decreased total and LDL cholesterol and triglyceride levels by 19%, 28% and 8%, respectively, and increased high density lipoprotein cholesterol by 7% (p < or = 0.001 vs. placebo for all lipid variables). Progression of atherosclerosis was reduced by 40% for minimal vessel diameter (p = 0.04), particularly in lesions < 50% stenosis at baseline. There was a consistent although not statistically significant effect on mean diameter and percent diameter stenosis. There were also fewer new lesions in those assigned pravastatin (p < or = 0.03). Myocardial infarction was reduced during active treatment (8 in the pravastatin group, 17 in the placebo group; log-rank test, p < or = 0.05; 60% risk reduction), with the benefit beginning to emerge after 1 year. CONCLUSIONS: In patients with coronary artery disease and mild to moderate cholesterol elevations, pravastatin reduces progression of coronary atherosclerosis and myocardial infarction. The time course of event reduction increases the potential for a relatively rapid decrease in the clinical manifestations of coronary artery disease with lipid lowering.

Aged↗

PubMed1995

In-hospital cost of percutaneous coronary revascularization. Critical determinants and implications.

BACKGROUND: Hospital charges associated with percutaneous transluminal coronary revascularization (PTCR) in the United States exceeded $6 billion in 1994 and are likely to be constrained in some manner in the near future. Despite this high cost to the public, little is known about the major determinants and sources of variability of PTCR. METHODS AND RESULTS: From a consecutive series of 1258 procedures with attempted PTCR at a single tertiary referral center, we analyzed 65 clinical, angiographic, physician, and outcome variables as potential correlates of total (hospital and physician) cost. Direct and indirect costs, both hospital and physician, were determined on the basis of resource utilization using "top-down" methodology and were available for 1237 procedures (1086 patients) (98.3%). Mean (+/- SD) patient age was 62 +/- 11 years, 76% were male, 3% had acute myocardial infarction, 71% had unstable angina, 58% had multivessel disease, left ventricular ejection fraction was 54 +/- 12%, 26% had use of at least one nonballoon revascularization device, and median length of stay was 4.4 days. Procedural success was obtained in 89%, and major complications (death, bypass surgery, or Q-wave myocardial infarction) occurred in 3.8%. The median cost was $9176, but it was asymmetrically distributed, and the interquartile and total ranges were wide ($7333 to $13,845 and $3422 to $193,474, respectively). Analyses of independent correlates of cost and loge(cost) were performed using multivariate linear regression in training and test populations. Modeling found 15 independent preprocedural correlates of loge(cost) (R2 = .37) and 23 overall correlates (R2 = .65), excluding length of stay per se. Additional of length of stay to the model increased the explanatory power of the model to R2 = .82. Preprocedural variables most predictive of loge(cost) included presentation with acute myocardial infarction, decision delay (> 48 hours between admission and diagnostic angiography and/or > 24 hours between angiography and intervention), weekend delay, use of intra-aortic balloon counterpulsation, intention to stent, creatinine > or = 2.0 mg%, and lesion complexity (modified American College of Cardiology/American Heart Association score) (all P < .001). In the model that included postprocedural variables as well, length of stay, noncardiac death, urgent bypass surgery, use of the Rotablator, Q-wave myocardial infarction, rise in creatinine > or = 1.0%, and blood product transfusion were all strong independent correlates of loge(cost) (P < .001). CONCLUSIONS: The range of total hospital costs associated with percutaneous intervention is extraordinarily wide. Baseline patient characteristics account for nearly half of the explained variance, but procedural complications and system delays account for much of the remainder. Quantification of the determinants of cost may promote more economically efficient care in the future.

Aged↗

PubMed1995

Adjunctive selectin blockade successfully reduces infarct size beyond thrombolysis in the electrolytic canine coronary artery model.

BACKGROUND: An adjunctive pharmacological strategy to thrombolytic therapy that is tailored to limit reperfusion injury after thrombolysis could further maximize the unquestioned benefit of restoring flow to ischemic myocardium. Ischemia-reperfusion injury exhibits features characteristic of an acute inflammatory response, including the rapid activation and infiltration of neutrophils. The initial process of neutrophil migration from the circulation to injured tissue is modulated by a group of adhesion molecules called selectins. The purpose of the present study was to assess the efficacy of a selectin blocker (CY 1503) given as an adjunct to thrombolytic therapy to interfere with the inflammatory response after ischemia-reperfusion and subsequently reduce myocardial infarct size in the electrolytic canine model. METHODS AND RESULTS: A fully occlusive thrombus was formed in the left circumflex coronary artery by electrolytic injury in 20 anesthetized open-chest dogs. After occlusion, an infusion of 1 mg/kg recombinant tissue-type plasminogen activator (rTPA) was administered over 20 minutes with either a bolus of placebo or the selectin blocker CY 1503 (40 mg/kg). At the onset of reperfusion, 20 micrograms/kg per minute rTPA was administered for 1 hour to prevent reocclusion. After 1 hour of reperfusion, infarct size, myocardial myeloperoxidase activity, and reperfusion arrhythmias were measured. In CY 1503-treated dogs, there was a significant 69% reduction in infarct size when expressed as a percentage of the area at risk (6.7 +/- 8.4% versus 21.8 +/- 13.6%; P = .008) and a marked reduction in myeloperoxidase activity (0.014 +/- 0.009 versus 0.0370 +/- 0.025 U/min per gram; P = .02) compared with the placebo group. There was no difference between the groups in the occurrence of reperfusion arrhythmias. CONCLUSIONS: Selectin blockade as an adjunct to rTPA-mediated thrombolysis significantly reduces infarct size and myocardial neutrophil infiltration well beyond thrombolysis alone in the electrolytic canine model. These data suggest that selectin blockade is extremely effective at reducing ischemia-reperfusion injury and myocardial infarct size in this model and that the neutrophil is a potent mediator of ischemia-reperfusion injury.

Animals↗

PubMed1995

Long-term outcome of transient, uncomplicated in-laboratory coronary artery closure.

BACKGROUND: Successful reversal of abrupt vessel closure without resultant major ischemic complications (death, Q-wave myocardial infarction, or coronary artery bypass graft surgery) is achieved in nearly half of all cases of abrupt vessel closure. The long-term outcome of these patients has not been previously addressed, and it is not clear whether they have a different prognosis than that of patients who have a successful procedure not associated with transient vessel closure. METHODS AND RESULTS: We examined 4863 consecutive patients who underwent successful percutaneous transluminal coronary angioplasty (PTCA) or directional coronary atherectomy (DCA). Eighty-eight patients had an uncomplicated, successfully reversed transient in-laboratory vessel closure (group 2) and were compared with 4775 patients who had a successful procedure not associated with transient in-laboratory closure (group 1). Clinical follow-up was available in 4839 patients (99.5%), with a mean duration of 41 +/- 23 months (range, 1 to 104 months). Survival analysis showed that successfully treated, uncomplicated transient vessel closure per se does not have an adverse effect on long-term prognosis (death, myocardial infarction, or coronary interventions). However, when the procedure (PTCA or DCA) was associated with an increase in creatine kinase-MB (CK-MB), there was a significant adverse effect on long-term outcome. By multivariate logistic regression, an increase in postprocedure CK-MB was the most significant correlate for cardiac death (risk ratio, 1.25; P < .0001). An increase in CK-MB was also the most important correlate for major ischemic complications (death, infarction, or coronary interventions) on follow-up (risk ratio, 1.08; P = .0005). CONCLUSIONS: Transient, uncomplicated in-laboratory vessel closure per se does not have an adverse long-term effect. However, a concomitant elevation of postprocedure cardiac enzymes has an important and significant adverse effect on long-term outcome. This study suggests that periprocedural creatine kinase isoenzyme determination in patients experiencing in-laboratory coronary closure has important prognostic implications.

Angioplasty, Balloon, Coronary↗

PubMed1995

Significance of a coronary artery with thrombolysis in myocardial infarction grade 2 flow "patency" (outcome in the thrombolysis and angioplasty in myocardial infarction trials). Thrombolysis and Angioplasty in Myocardial Infarction Study Group.

To determine whether pharmacologic reperfusion to Thrombolysis in Myocardial Infarction (TIMI) grade 2 flow during acute myocardial infarction confers the same clinical benefit as restoration of TIMI 3 flow, in-hospital clinical and angiographic outcomes in 1,229 patients prospectively enrolled in the Thrombolysis and Angioplasty in Myocardial Infarction trials were analyzed. Patients were treated with intravenous tissue plasminogen activator or urokinase, or both. Angiography of the infarct-related artery 90 minutes after initiation of thrombolytic therapy demonstrated TIMI grades 0, 1, 2, or 3 flow in 20%, 7%, 17%, and 55% of vessels, respectively. Rescue or adjunctive coronary angioplasty was performed in 80%, 27%, and 16% of patients with TIMI 0/1, 2, or 3 flow, respectively. Predischarge angiography was performed in 963 patients. A significant gradient of increasing mortality was seen in patients with lower TIMI flow (4.3%, 6.1%, and 10.1% with TIMI 3, 2, and 0/1 flow, respectively, p = 0.002). The incidence of congestive heart failure and recurrent ischemia was significantly higher in patients with TIMI 2 than with TIMI 3 perfusion (26% vs 19% for heart failure, p = 0.03; 23% vs 17% for recurrent ischemia, p = 0.05). Acute left ventricular ejection fraction and infarct zone regional wall motion were also significantly improved in patients with TIMI 3 than with TIMI 2 flow, with trends toward better improvement in global and regional function in the TIMI 3 group. These findings were not affected by the use of acute coronary angioplasty.(ABSTRACT TRUNCATED AT 250 WORDS)

Angioplasty, Balloon, Coronary↗

PubMed1995

Multicenter, randomized, double-blind, placebo-controlled trial of the platelet integrin glycoprotein IIb/IIIa blocker Integrelin in elective coronary intervention. IMPACT Investigators.

BACKGROUND: Platelet aggregation and thrombosis have been implicated in the pathogenesis of coronary angioplasty complications. Integrelin, a synthetic cyclic heptapeptide with high affinity and marked specificity for platelet integrin glycoprotein IIb/IIIa, effectively blocks ADP-induced platelet aggregation. METHODS AND RESULTS: In 150 patients undergoing elective percutaneous coronary intervention, random assignment was made to one of three treatment regimens: placebo; a 90-micrograms/kg bolus of Integrelin before angioplasty followed by a 1.0-micrograms.kg-1.min-1 infusion of Integrelin for 4 hours; or a 90-micrograms/kg bolus followed by a 1.0-microgram.kg-1.min-1 infusion of Integrelin for 12 hours. Patients were followed to 30 days for the composite occurrence of myocardial infarction, stent implantation, repeat urgent or emergency percutaneous intervention or coronary bypass surgery, or death. Pharmacodynamic data were obtained in a subset of 31 patients. Administration of a 90-micrograms/kg bolus of Integrelin achieved an 86% inhibition of platelet aggregation, and this inhibition was maintained by a 1.0-microgram.kg-1.min-1 infusion. There was a trend toward reduction in end-point events from 12.2% (placebo) to 9.6% (4-hour infusion) to 4.1% (12-hour infusion), although these differences were not statistically significant (P = .13 for the 12-hour group compared with placebo). Major bleeding occurred in 8%, 8%, and 2% of patients, while minor bleeding was observed in 14%, 33%, and 47% of patients, respectively. There was no difference in bleeding index among groups (1.5, 1.7, and 1.3, respectively), defined as [(change in hematocrit/3)+red blood cell units transfused]. CONCLUSIONS: This first clinical investigation of Integrelin during routine, elective, low- and high-risk coronary intervention supports the potential efficacy of Integrelin in routine coronary interventions. Pharmacodynamic analyses demonstrate that profound and sustained inhibition of platelet function is achieved, although a higher bolus dose may be required. Definitive assessment of efficacy and safety will need to await a large-scale study powered to achieve statistical significance.

Angioplasty, Balloon, Coronary↗

PubMed1995

Coronary lesions at increased risk.

An acute ischemic complication will develop in approximately 7% of patients undergoing coronary angioplasty. In more than half of these patients, thrombus, dissection, or both can be identified angiographically as the underlying cause of abrupt closure; in the remaining cases, an indeterminate morphology is observed. Predictors of dissection-mediated closure include degenerated vein graft, de novo stenosis, proximal tortuosity, high lesion grade, eccentricity, longer lesion length, and angulation. Thrombus-medicated closure is most apt to occur in degenerated vein grafts, lesions related to a recent myocardial infarction, and lesions that contain thrombus before angioplasty. However, the ability of these parameters to predict risk in an individual patient is rather weak. Angioscopy has revealed that the presence of yellow plaque confers a heightened risk of major complications. Lesions that contain areas of calcium adjacent to areas to soft plaque have been identified by intravascular ultrasound as a powerful predictor a major dissection. These sensitive new imaging techniques may eventually permit the targeting of more specific therapies to the underlying cause of closure.

Angioplasty, Balloon, Coronary↗

PubMed1995

Prospective case-control comparison of percutaneous transluminal coronary revascularization in patients with multivessel disease treated in 1986-1987 versus 1991: improved in-hospital and 12-month results. Multivessel Angioplasty Prognosis Study (MAPS) Group.

OBJECTIVES: This study sought to ascertain whether early and 12-month clinical outcomes after percutaneous coronary revascularization have improved between 1986-1987 and 1991. BACKGROUND: Since the mid-1980s, when the results of percutaneous revascularization were considered to be somewhat static, justifying large-scale clinical trials of percutaneous transluminal coronary angioplasty versus other modes of therapy, balloon technology has improved, and several new percutaneous revascularization techniques have become available. The clinical results of the current integrated approach to revascularization compared with those for coronary angioplasty alone in the late 1980s are not known. METHODS: In this prospective case-control study, 200 consecutively treated patients with multivessel disease in 1991 were studied prospectively and compared with 400 consecutive patients from the same centers during 1986-1987. Patients from 1991 were matched with earlier patients on the basis of four previously described prognostic determinants (left ventricular ejection fraction, presence of unstable angina, diabetes and target lesion morphology score) and the treating institution and were assessed for treatment outcome (completeness of revascularization, procedural success and event-free survival [freedom from death, myocardial infarction and further revascularization]). RESULTS: The 1991 cohort of patients was older (mean [+/- SD] age 62 +/- 11 vs. 58 +/- 11 years, p < 0.001) and tended to have slightly worse left ventricular function (ejection fraction 56 +/- 10% vs. 58 +/- 11%, p = 0.009) than the 1986-1987 cohort. Overall lesion morphology risk scores were similar. New devices (other than coronary angioplasty) were used in 26% of patients. The 1991 patient cohort had more frequent total revascularization (35% vs. 21%, p = 0.003), fewer emergency bypass operations (1.0% vs. 5.5%, p = 0.006) and an improved overall procedural success rate (90% vs. 84%, p = 0.04). In addition, at 12 months the event-free survival rate was superior in the 1991 cohort (73.3% vs. 63.6%, p = 0.02), although there was no difference in infarct-free survival rate (94.6% vs. 93.2%, p = NS). CONCLUSIONS: Improved results with percutaneous revascularization in 1991 have important implications for patient care and interpretation of ongoing randomized trials enrolling patients in the late 1980s and intending to compare standard coronary angioplasty with other forms of therapy.

Angioplasty, Balloon, Coronary↗

PubMed1995

Directional atherectomy versus balloon angioplasty for coronary ostial and nonostial left anterior descending coronary artery lesions: results from a randomized multicenter trial. The CAVEAT-I investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial.

OBJECTIVES: We hypothesized that atherectomy would be superior to balloon angioplasty for ostial and nonostial left anterior descending coronary artery lesions. BACKGROUND: Balloon angioplasty of ostial coronary artery lesions has been associated with a lower procedural success rate and a higher rate of complications and of restenosis than angioplasty of nonostial stenoses. Directional coronary atherectomy has been proposed as an alternative therapy for ostial lesions. METHODS: In the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), 1,012 patients were randomized to undergo either procedure; 563 patients had proximal left anterior descending coronary artery lesions, of which 74 were ostial. We compared balloon angioplasty with directional atherectomy for early and 6-month results for ostial as well as nonostial proximal left anterior descending coronary artery lesions. RESULTS: Directional atherectomy led to an initially higher gain in minimal lumen diameter for ostial lesions (1.13 vs. 0.56 mm, respectively, p < 0.001) but a higher rate of adjudicated non-Q wave myocardial infarction (24% vs. 13%, respectively, p < 0.001) than balloon angioplasty and no improvement in restenosis rates (48% vs. 46%, respectively). In the nonostial proximal left anterior descending coronary artery lesions, angiographic restenosis was reduced (51% vs. 66%, p = 0.012), but this was also associated with a higher rate of periprocedural myocardial infarction (8% vs. 2%, p = 0.008 by site and 24% vs. 8%, p < 0.001 by adjudication) and no difference in the need for subsequent coronary artery bypass surgery (7.3% vs. 8.4%, respectively) or repeat percutaneous coronary intervention (24% vs. 26%, respectively). CONCLUSIONS: For ostial left anterior descending coronary artery stenoses, both procedures yielded similar rates of initial success and restenosis, but atherectomy was associated with more non-Q wave myocardial infarction. In this trial the predominant angiographic benefit (increased early gain and less angiographic restenosis) of atherectomy for the left anterior descending coronary artery was in proximal nonostial lesions. However, the tradeoffs for this angiographic advantage were more in-hospital myocardial infarctions and no decrease in clinical restenosis.

Angioplasty, Balloon↗

PubMed1995

Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: the multicenter U.S. Palmaz-Schatz stent experience. The Palmaz-Schatz Stent Study Group.

OBJECTIVES: This study reports the multicenter registry experience evaluating the safety and efficacy of the Palmaz-Schatz stent in the treatment of saphenous vein graft disease. BACKGROUND: Saphenous vein graft angioplasty is associated with frequent periprocedural complications and a high frequency of restenosis. Stent implantation has been shown to reduce restenosis, with improved long-term outcomes in the treatment of native coronary artery disease. Preliminary experience with stent placement in the treatment of saphenous vein graft lesions has been favorable. METHODS: Twenty U.S. investigator sites enrolled a total of 589 symptomatic patients (624 lesions) for treatment of focal vein graft stenoses between January 1990 and April 1992. Follow-up angiography was performed at 6 months, and the clinical course of all study patients was prospectively collected at regular intervals for up to 12 months. RESULTS: Stent delivery was successful in 98.8% of cases, and the procedural success rate was 97.1%. The lesion diameter stenosis decreased from 82 +/- 12% (mean +/- SD) before to 6.6 +/- 10.2% after treatment. Major in-hospital complications occurred in 17 patients (2.9%); stent thrombosis was found in 8 (1.4%); and major vascular or bleeding complications were noted in 83 (14.3%). Six-month angiographic follow-up revealed an overall restenosis rate (> or = 50% diameter stenosis) of 29.7%. Multivariate logistic regression analysis indicated that 1) restenotic lesions, 2) smaller reference vessel size, 3) history of diabetes mellitus, and 4) higher percent poststent diameter stenosis were independent predictors of restenosis. The 12-month actuarial event-free survival was 76.3%. CONCLUSIONS: Stent implantation in patients with focal saphenous vein graft lesions can be achieved with a high rate of procedural success, acceptable major complications, reduced angiographic restenosis and favorable late clinical outcome compared with historical balloon angioplasty control series. The rigorous anticoagulation regimen after stent placement results in more frequent vascular and other bleeding complications. Future randomized studies comparing standard balloon angioplasty with stent implantation are warranted to properly assess the full impact of stent placement in the treatment of saphenous vein graft lesions.

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