Showing papers by "Eric J. Topol published in 1996"
TL;DR: The usefulness of base-line levels of cardiac troponin T and CK-MB and the electrocardiographic category assigned at admission and the presence of confounding factors that impair the detection of ischemia were assessed to assess the usefulness of outcome.
Abstract: Background The prognosis of patients hospitalized with acute myocardial ischemia is quite variable. We examined the value of serum levels of cardiac troponin T, serum creatine kinase MB (CK-MB) levels, and electrocardiographic abnormalities for risk stratification in patients with acute myocardial ischemia. Methods We studied 855 patients within 12 hours of the onset of symptoms. Cardiac troponin T levels, CK-MB levels, and electrocardiograms were analyzed in a blinded fashion at the core laboratory. We used logistic regression to assess the usefulness of base-line levels of cardiac troponin T and CK-MB and the electrocardiographic category assigned at admission — ST-segment elevation, ST-segment depression, T-wave inversion, or the presence of confounding factors that impair the detection of ischemia (bundle-branch block and paced rhythms) — in predicting outcome. Results On admission, 289 of 801 patients with base-line serum samples had elevated troponin T levels (>0.1 ng per milliliter). Mortality with...
1,064 citations
TL;DR: An array of both biodegradable and nonbiodesgradable polymers has been demonstrated to induce a marked inflammatory reaction within the coronary artery with subsequent neointimal thickening, which was not expected on the basis of in vitro tests.
Abstract: Background With the thrombogenic tendency and permanent implant nature of metallic stents, synthetic polymers have been proposed as candidate materials for stents and local drug delivery designs. We investigated the biocompatibility of several synthetic polymers after experimental placement in the coronary artery. Methods and Results Five different biodegradable polymers (polyglycolic acid/polylactic acid [PGLA], polycaprolactone [PCL], polyhydroxybutyrate valerate [PHBV], polyorthoester [POE], and polyethyleneoxide/polybutylene terephthalate [PEO/PBTP]) and three nonbiodegradable polymers (polyurethane [PUR], silicone [SIL], and polyethylene terephthalate [PETP]) were tested as strips deployed longitudinally across 90° of the circumferential surface of coil wire stents. Appropriately sized polymer-loaded stents were implanted in porcine coronary arteries of 2.5- to 3.0-mm diameter. Four weeks after implantation, stent patency was assessed by angiography followed by microscopic examination of the coronary...
895 citations
TL;DR: A clinical prediction rule based on a set of electrocardiographic criteria, which are based on simple ST-segment changes, may help identify patients with acute myocardial infarction, who can then receive appropriate treatment.
Abstract: Background The presence of left bundle-branch block on the electrocardiogram may conceal the changes of acute myocardial infarction, which can delay both its recognition and treatment. We tested electrocardiographic criteria for the diagnosis of acute infarction in the presence of left bundle-branch block. Methods The base-line electrocardiograms of patients enrolled in the GUSTO-1 (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) trial who had left bundle-branch block and acute myocardial infarction confirmed by enzyme studies were blindly compared with the electrocardiograms of control patients who had chronic coronary artery disease and left bundle-branch block. The electrocardiographic criteria for the diagnosis of infarction were then tested in an independent sample of patients presenting with acute chest pain and left bundle-branch block. Results Of 26,003 North American patients, 131 (0.5 percent) with acute myocardial infarction had left bundle-b...
573 citations
TL;DR: Earlier treatment resulted in better outcomes, regardless of thrombolytic strategy, in the international GUSTO-I trial.
428 citations
TL;DR: It is shown that minor elevations in creatine kinase-myocardial band isoenzyme after successful coronary interventions identify a population with a worse long-term prognosis compared with patients with no enzyme elevations and appear to have an adverse effect on long- term prognosis.
Abstract: Background The clinical significance of minor elevations in creatine kinase–myocardial band isoenzyme (CK-MB) after coronary interventions has not been systematically evaluated. Methods and Results We examined 4484 patients who underwent successful percutaneous transluminal coronary angioplasty or directional coronary atherectomy and whose peak CK levels did not exceed twice the upper limit of laboratory normal. Group 1 (3776 patients) had no CK or MB elevation after the procedure (ie, CK ≤180 IU/L, with MB fraction ≤4%). Group 2 (450 patients) had a peak CK level between 100 and 180 IU/L, with MB fraction >4%, and group 3 (258 patients) had a peak CK level between 181 and 360 IU/L, with MB fraction >4%. The strongest correlate of postprocedure CK-MB elevation was the performance of directional coronary atherectomy (odds ratio, 4.1; P<.0001), followed by the development of ≥1 in-lab minor procedural complication (odds ratio, 2.6; P<.0001). Clinical follow-up was available in 4461 patients (99.5%), with a ...
382 citations
TL;DR: Findings suggest that until proven otherwise, the aPTT range of 50 to 70 seconds as optimal with intravenous heparin after thrombolytic therapy should be considered.
Abstract: Background Although intravenous heparin is commonly used after thrombolytic therapy, few reports have addressed the relationship between the degree of anticoagulation and clinical outcomes. We examined the activated partial thromboplastin time (aPTT) in 29 656 patients in the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO-I) trial and analyzed the relationship between the aPTT and both baseline patient characteristics and clinical outcomes. Methods and Results Intravenous heparin was administered as a 5000-U bolus followed by an initial infusion of 1000 U/h, with dose adjustment to achieve a target aPTT of 60 to 85 seconds. aPTTs were collected 6, 12, and 24 hours after thrombolytic administration. Higher aPTT at 24 hours was strongly related to lower patient weight (P<.00001) as well as older age, female sex, and lack of cigarette smoking (all P<.0001). At 12 hours, the aPTT associated with the lowest 30-day mortality, stroke, and bleeding rater; was 50 to 70 seconds. There was an unexpected direct relationship between the aPTT and the risk of subsequent reinfarction. There was a clustering of rt infarction in the first 10 hours after discontinuation of intravenous heparin. Conclusions Although the relationship between aPTT and clinical outcome was confounded to some degree by the influence of baseline prognostic characteristics, aPTTs higher than 70 seconds were found to be associated with higher likelihood of mortality, stroke, bleeding, and reinfarction. These findings suggest that until proven otherwise, we should oo consider the aPTT range of 50 to 70 seconds as optimal with intravenous heparin after thrombolytic therapy.
282 citations
TL;DR: In this article, the outcomes according to age of patients receiving thrombolysis in an international trial were examined for patients aged 85 years and assessed as continuous functions of age.
Abstract: Background Elderly patients with acute myocardial infarction have much to gain from reperfusion with thrombolytic therapy but are also at increased risk of adverse events. We examined outcomes according to age of patients receiving thrombolysis in an international trial. Methods and Results Patients were randomized to streptokinase plus subcutaneous heparin, streptokinase plus intravenous heparin, accelerated tissue plasminogen activator (TPA) plus intravenous heparin, or streptokinase and TPA plus intravenous heparin. Clinical outcomes at 30 days (death, stroke, and nonfatal, disabling stroke) and 1-year mortality were summarized descriptively for patients aged 85 years (n=412) and assessed as continuous functions of age. Older patients had a higher-risk profile with regard to baseline clinical and angiographic characteristics. Mortality at 30 days increased markedly with age (3.0%, 9.5%, 19.6%, and 30.3% in the four groups, respectively), as d...
279 citations
TL;DR: Early (90-min) infarct-related artery patency as well as regional and global ventricular function do not differ between patients with and without diabetes after thrombolytic therapy, except for reduced compensatory hyperkinesia in the noninfarct zone among patients with diabetes.
278 citations
TL;DR: Women who received thrombolytic therapy for treatment of acute myocardial infarction were at greater risk for both fatal and nonfatal complications than men.
Abstract: Objective. —To compare baseline characteristics, complications, and treatment-specific outcomes of women and men with acute myocardial infarction treated with thrombolytic therapy. Design. —Randomized controlled trial. Patients and Setting. —A total of 10315 women and 30706 men with acute myocardial infarction treated in 1081 hospitals in 15 countries as part of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I). Intervention. —One of four thrombolytic regimens: (1) streptokinase with subcutaneous heparin; (2) streptokinase with intravenous heparin; (3) streptokinase plus alteplase (tissue-type plasminogen activator) with intravenous heparin; or (4) accelerated alteplase with intravenous heparin. Main Outcome Measures. —Mortality, stroke, and nonfatal complications during 30-day follow-up. Results. —Women were on average 7 years older than men and delayed 18 minutes (median) longer after symptom onset before presenting to the hospital. After adjustment for age, women more often had a history of diabetes, hypertension, and smoking than men. Time to treatment was significantly longer in women (1.2 vs 1.0 hours; P P P P P P P P Conclusion. —Women who received thrombolytic therapy for treatment of acute myocardial infarction were at greater risk for both fatal and nonfatal complications than men. ( JAMA . 1996;275:777-782)
246 citations
TL;DR: Public dissemination of outcome data may have been associated with increased referral of high-risk patients from New York to an out-of-state regional medical center.
Abstract: Background Since 1989, New York State has disseminated comparative information on outcomes of coronary bypass surgery to the public. It has been suggested that this program played a significant role in the 41% decrease in the risk-adjusted mortality rate between 1989 and 1992. We hypothesized that some high-risk patients had migrated out of state for surgery.
Methods and Results We reviewed 9442 isolated coronary bypass operations performed from 1989 through 1993 to assess referral patterns of case-mix and outcome. Expected and risk-adjusted mortality rates were computed using logistic regression models derived from the Cleveland Clinic and New York State databases. A mortality comparison was performed using the 1980 to 1988 time period as a historical control. Patients from New York (n=482) had a higher frequency of prior open heart surgery (44.0%) than patients from Ohio (n=6046) (21.5%, P <.001), other states (n=1923) (37.4%, P =.008), and other countries (n=991) (17.3%, P <.001). They were also more likely to be in NYHA functional class III or IV (47.6% versus Ohio 42.7%, P =.037; other states, 41.2%, P =.011; other countries, 34.1%, P =.001). The expected mortality rate was thus higher than among other referral cohorts. The observed 5.2% mortality rate among these patients was significantly greater than the 2.9%, 3.1%, and 1.4% mortality rates observed for patients from Ohio ( P =.004), other states ( P =.028), and other countries ( P <.001). These differences in outcome were not apparent between 1980 and 1988 among referrals from within the United States.
Conclusions Public dissemination of outcome data may have been associated with increased referral of high-risk patients from New York to an out-of-state regional medical center.
244 citations
TL;DR: It is concluded that adjunctive c7E3 therapy during direct and rescue PTCA decreased acute ischemic events and clinical restenosis in the EPIC trial, and initial evidence of benefit for glycoprotein IIb/IIIa receptor blockade during P TCA for acute myocardial infarction is provided.
Abstract: Percutaneous transluminal coronary angioplasty (PTCA) for acute myocardial infarction is an attractive alternative to thrombolysis, but is still limited by recurrent ischemia and restenosis. We determined whether adjunctive platelet glycoprotein IIb/IIIa receptor blockade improved outcomes in patients undergoing direct and rescue PTCA in the Evaluation of c7E3 for Prevention of Ischemic Complications (EPIC) trial. Of the 2,099 patients undergoing percutaneous intervention who randomly received chimeric 7E3 Fab (c7E3) as a bolus, a bolus and 12-hour infusion, or placebo, 42 underwent direct PTCA for acute myocardial infarction and 22 patients had rescue PTCA after failed thrombolysis. The primary composite end point comprised death, reinfarction, repeat intervention, or bypass surgery. Outcomes were assessed at 30 days and 6 months. Baseline characteristics were similar in direct and rescue PTCA patients. Pooling the 2 groups, c7E3 bolus and infusion reduced the primary composite end point by 83% (26.1% placebo vs 4.5% c7E3 bolus and infusion, p = 0.06). No reinfarctions or repeat urgent interventions occurred in c7E3 bolus and infusion patients at 30 days, although there was a trend toward more deaths in c7E3-treated patients. Major bleeding was increased with c7E3 (24% vs 13%, p = 0.28). At 6 months, ischemic events were reduced from 47.8% with placebo to 4.5% with c7E3 bolus and infusion (p = 0.002), particularly reinfarction (p = 0.05) and repeat revascularization (p = 0.002). We conclude that adjunctive c7E3 therapy during direct and rescue PTCA decreased acute ischemic events and clinical restenosis in the EPIC trial. These data provide initial evidence of benefit for glycoprotein IIb/IIIa receptor blockade during PTCA for acute myocardial infarction.
TL;DR: Local administration of nanoparticles with incorporated dexamethasone significantly decreased neointimal formation and appears to have important potential for clinical applications in local drug delivery.
Abstract: Background Several perfusion balloon catheters are under investigation for local drug delivery; however, sustained tissue drug levels are difficult to achieve with these techniques. To overcome this problem, sustained-release, biodegradable nanoparticles represent a potential alternative for prolonged local delivery. Methods and Results A biodegradable polylactic-polyglycolic acid (PLGA) copolymer was used to formulate nanoparticles. Fluorescent-labeled nanoparticles were intraluminally administered in a single, 180-second infusion after balloon injury in the rat carotid model. Localization and retention at different time points and biocompatibility of nanoparticles were evaluated. To evaluate the potential of the system in the prevention of neointimal formation, dexamethasone was incorporated into the particles and delivered locally as above. Nanoparticles were seen in the three layers of the artery at 3 hours and 24 hours. At 3 days, they were mainly present in the adventitial layer, decreasing at 7 day...
TL;DR: Younger age and the availability of the procedures appeared to be the major determinants of the use of coronary angiography, whereas coronary anatomy largely determined the use and type of revascularization.
Abstract: Background Clinical trials and practice guidelines have identified clinical criteria for the use of coronary angiography and revascularization procedures after thrombolysis for acute myocardial infarction. The effect of these criteria on clinical practice has not been extensively evaluated. Methods We used classification-and-regression-tree (CART) and logistic-regression models to study the patients in the first Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial, to identify the variables that best predicted the use of angiography and revascularization procedures after thrombolysis. Results Among the 21,772 U.S. patients in the trial, 71 percent underwent coronary angiography before discharge from the hospital. Of these, 58 percent underwent revascularization (73 percent receiving angioplasty). The CART model for the use of angiography showed that age was the variable most predictive of angiography; only 53 percent of patients at least 73 years of age...
TL;DR: One of the most controversial issues in interventional cardiology today is whether small MIs, diagnosed by enzymatic abnormalities coincident with percutaneous coronary interventional procedures, are clinically relevant.
Abstract: One of the most controversial issues in interventional cardiology today is whether small MIs, diagnosed by enzymatic abnormalities coincident with percutaneous coronary interventional procedures, are clinically relevant.1 2 3 4 5 Among interventional cardiologists, the commonly used term “infarctlet” implies a small and insignificant event. However, the importance of these myocardial infarctlets after coronary revascularization procedures is both understudied and underappreciated, despite the well-established prognostic importance of even small enzymatic infarctions in the setting of unstable angina6 or after acute MI.7 The controversy is related in part to the difficulty associated with the diagnosis of nonfatal MI in trials involving myocardial revascularization. This problem was a major issue in the evaluation of coronary artery bypass surgery and was never satisfactorily resolved.8 In the setting of bypass surgery, elevation of CK and CK-MB is routine, and other noninvasive tests designed to detect myocardial injury are also commonly positive. Because a definition for an abnormal extent of necrosis with bypass surgery could not be established or adapted via consensus, the commonly used definition of postbypass infarction is the presence of new Q waves on the postoperative ECG. Unfortunately, this definition misclassifies patients with non–Q-wave infarction as not experiencing myocardial damage, and patients with new, major conduction disturbances (eg, left bundle branch block) may not be accurately diagnosed. A similar problem is evident in the evaluation of percutaneous procedures, and defining postangioplasty infarction exclusively by the presence of Q waves on ECG does not seem appropriate for these percutaneous procedures, in which the absence of any necrosis is a principal goal. This controversial issue was the topic of a recent expert conference that was convened to discuss this problem and attempt to develop a consensus; recommendations from this conference are forthcoming. The purpose of the current article is to …
TL;DR: In high-risk coronary angioplasty, aggressive platelet inhibition with c7E3 Fab, by significantly reducing ischemic events and repeat revascularization, recoups most of the cost of therapy and has the potential to pay for itself.
Abstract: Background In the EPIC trial, c7E3 Fab, an antiplatelet IIb/IIIa receptor antibody, reduced 30-day ischemic end points after high-risk coronary angioplasty by 35% and 6-month ischemic events by 23% but increased in-hospital bleeding episodes.
Methods and Results Of the 2099 patients randomized in EPIC, data were collected on 2038 (97%) for prospective hospital cost and major resources. Physician fees were estimated from the Medicare Fee Schedule. Regression analysis was used to examine the economic tradeoff between reduced ischemic events and increased major bleeding during the initial hospitalization. A potential cost savings of $622 per patient during the initial hospitalization from reduced acute ischemic events with c7E3 Fab was offset by an equivalent rise ($521) in costs as the result of an increase in bleeding episodes. Baseline medical costs for the bolus and infusion c7E3 Fab arm averaged $13 577 (exclusive of drug cost) compared with $13 434 for placebo ( P =.42). During the 6-month follow-up, c7E3 Fab decreased repeat hospitalization rates by 23% ( P =.004) and repeat revascularization by 22% ( P =.04), producing a mean $1270 savings per patient (exclusive of drug cost) ( P =.018). With a cost of $1407 for the bolus and infusion c7E3 Fab regimen, the cumulative net 6-month cost to switch from standard care to routine c7E3 Fab averaged $293 per patient.
Conclusions In high-risk coronary angioplasty, aggressive platelet inhibition with c7E3 Fab, by significantly reducing ischemic events and repeat revascularization, recoups most of the cost of therapy and has the potential to pay for itself.
TL;DR: Simple clinical characteristics can identify a very low risk post-myocardial infarction population by hospital day 4 and use of these criteria for early discharge planning could substantially reduce length of stay for patients with uncomplicated acute myocardial Infarction.
TL;DR: The recent finding that abciximab, a monoclonal antibody fragment directed against IIb/IIIa, reduced clinical restenosis after coronary angioplasty by 26% in patients raises questions about the mechanism of benefit.
TL;DR: The 1-year results demonstrated a saving of 10 lives per 1000 patients treated with accelerated TPA versus streptokinase and subcutaneous or intravenous heparin and Combination thrombolytic therapy had an intermediate benefit but offered no advantage over accelerated T PA treatment alone.
Abstract: Background In the randomized Global Utilization of t-PA and Streptokinase for Occluded Coronary Arteries (GUSTO-I) trial, 41 021 patients received one of four thrombolytic regimens. Patients treated with accelerated tissue plasminogen activator (TPA) had a lower 30-day mortality rate (6.3%) than those treated with the other regimens (7.3%, combined streptokinase groups). Methods and Results Each patient who was alive at 30 days was sent a return postcard to ascertain vital status at 1 year. If the postcard was not returned, the patient (or an alternate specified at randomization) was contacted by telephone. A locator service was used in the United States for patients who could not be located by these methods. Final follow-up was 96% worldwide. One-year mortality rates remained in favor of accelerated TPA (9.1%) over streptokinase with subcutaneous heparin (10.1%, P =.011) and streptokinase with intravenous heparin (10.1%, P =.009). Combination therapy had an intermediate 1-year mortality (9.9%); this outcome was statistically indistinguishable from that with streptokinase ( P =.47) but was marginally different from that with accelerated TPA ( P =.05). Conclusions The 1-year results demonstrated a saving of 10 lives per 1000 patients treated with accelerated TPA versus streptokinase and subcutaneous or intravenous heparin. Combination thrombolytic therapy had an intermediate benefit but offered no advantage over accelerated TPA treatment alone.
TL;DR: Intravenous Integrelin is well tolerated, is a potent reversible inhibitor of platelet aggregation, and added to full-dose heparin reduces the number and duration of Holter ischemic events in patients with unstable angina compared with aspirin.
Abstract: Background Although aspirin is beneficial in patients with unstable angina, it is a relatively weak inhibitor of platelet aggregation. The effect of Integrelin, which inhibits the platelet fibrinogen receptor glycoprotein (GP) IIb/IIIa, on the frequency and duration of Holter ischemia was evaluated in 227 patients with unstable angina. Methods and Results Patients received intravenous heparin and standard anti-ischemic therapy and were randomized to receive oral aspirin and placebo Integrelin; placebo aspirin and low-dose Integrelin, 45 μg/kg bolus followed by a 0.5-μg·kg−1·min−1 continuous infusion; or placebo aspirin and high-dose Integrelin, 90 μg/kg bolus followed by a 1.0-μg·kg−1·min−1 constant infusion. Study drug was continued for 24 to 72 hours, and Holter monitoring was performed. Patients randomized to high-dose Integrelin experienced 0.24±0.11 ischemic episodes (mean±SEM) on Holter lasting 8.41±5.29 minutes over 24 hours of study drug infusion. Patients randomized to aspirin experienced a great...
TL;DR: Data indicate that carboxypeptidase activity is induced in vivo and may influence thrombolysis in dogs with electrically induced thrombosis of the circumflex coronary artery treated with TPA.
Abstract: Background An inducible carboxypeptidase activity in human plasma delays tissue-type plasminogen activator (TPA)–induced clot lysis in vitro. We investigated whether carboxypeptidase activity is induced in vivo during thrombosis and thrombolytic therapy in a canine model of myocardial infarction. Methods and Results By use of synthetic substrate assays, dog plasma was shown to contain an inducible carboxypeptidase activity that is efficiently inhibited by potato carboxypeptidase inhibitor. This inhibitor accelerates TPA-mediated clot lysis in vitro by an average of 27% (n=5, P=.046). Analysis of the inducible carboxypeptidase activity in plasma samples of dogs with electrically induced thrombosis of the circumflex coronary artery treated with TPA revealed that (1) inducible carboxypeptidase activity is increased during thrombosis (8.7±2.0 U/L, P<.013) and thrombolytic therapy (9.9±1.8 U/L, P<.024) compared with baseline (3.2±2.0 U/L); (2) thrombosis is a prerequisite of carboxypeptidase induction during a...
TL;DR: 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, and suggests that an appropriate CK threshold that has prognostic implications would be twice the upper limit of normal.
Book•
01 Jan 1996
TL;DR: Part 1 Major risk factors and primary prevention: lipid abnormalities hypertension, pathogenesis of atherosclerosis, chronic stable angina and other stable conditions.
Abstract: Part 1 Major risk factors and primary prevention: lipid abnormalities hypertension. Part 2 Pathogenesis of atherosclerosis: general principles the normal artery the lesions of atherosclerosis special pathogenetic factors - inflammation and immunity. Part 3 Acute myocardial infarction: pathophysiology clinical presentation and diagnostic techniques acute management pacing postinfarction survival. Part 4 Unstable angina: management of persistent unstability other unstable conditions. Part 5 Chronic stable angina: other stable conditions. Part 6 Noncoronary atherosclerosis.
TL;DR: 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.
Abstract: 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.
TL;DR: Assessment of the magnitude of precordial ST segment depression is useful for acute risk stratification in patients with an inferior myocardial infarction and added significant independent prognostic information after adjustment for clinical risk factors.
TL;DR: The potential for estrogen replacement therapy to reduce angiographic measures of restenosis in postmenopausal women after coronary intervention is demonstrated, particularly in those undergoing atherectomy.
TL;DR: The data suggest that bFGF mediates myocardial salvage independently of angiogenesis and that reperfusion after infarction may attenuate the stimulus for neovascularization.
Abstract: Background Basic fibroblast growth factor (bFGF) has been shown to reduce infarct size in canine acute myocardial infarction; however, the mechanism of tissue salvage remains uncertain. We evaluated the effect of bFGF on infarct size in a model of acute infarction in which coronary occlusion was followed by prolonged reperfusion and sought to determine whether reperfusion attenuates the stimulus for myocardial neovascularization. Methods and Results Anesthetized dogs undergoing 4-hour balloon occlusion of the left anterior descending coronary artery were treated with intracoronary bFGF (n=8) or vehicle (n=6). Ten-microgram doses of bFGF were administered 10 minutes after occlusion and again immediately before reperfusion. Left ventriculograms were obtained before occlusion, after reperfusion, and preceding euthanasia on day 7. Infarct size, expressed as a percentage of the area at risk, was reduced in bFGF-treated dogs (13.7±2.1% versus 28±3.4%; P=.002). Changes in left ventricular ejection fraction, capi...
TL;DR: It is suggested that adjunctive treatment with a higher tier blockade of the coagulation cascade is superior to direct thrombin inhibition in maintaining coronary artery patency following thrombolysis in the experimental canine electrolytic model.
Abstract: The success of current thrombolytic strategies is undermined by ongoing thrombin activity, but it is uncertain whether prevention of thrombin generation or direct thrombin antagonism is effective in achieving more optimal thrombolysis To address this question, 24 dogs with electrically induced coro
TL;DR: The EPIC trial confirmed the increased risk of non-Q wave myocardial infarction with directional atherectomy use compared with PTCA and eliminated this excess risk through bolus and 12-h infusion of the glycoprotein IIb/IIIa receptor inhibitor c7E3.
TL;DR: In this article, the effects of previous hypertension and blood pressure at study entry on the outcomes of patients who had acute myocardial infarction and received thrombolysis were assessed.
Abstract: Background : Despite concern that hypertension increases the risk for intracranial hemorrhage during thrombolysis for acute myocardial infarction, the exact nature of the risk remains unclear. Objective : To assess the effects of previous hypertension and blood pressure at study entry on the outcomes of patients who had acute myocardial infarction and received thrombolysis. Design : Randomized trial. Setting : 1081 hospitals in 15 countries. Patients : 41 021 patients who had myocardial infarction accompanied by ST-segment elevation and who presented to hospitals within 6 hours of symptom onset. Intervention : One of four thrombolytic regimens. Main Outcome Measures : Mortality, stroke subtypes, and death plus disabling stroke in patients with previous hypertension and as functions of blood pressure at entry. Logistic regression analysis of relations among blood pressure at entry, baseline characteristics, and treatment effects. Results : The incidence of total stroke and intracranial hemorrhage increased as systolic blood pressure at entry increased and was particularly high for systolic pressures of about 175 mm Hg or more (incidence of total stroke, 3.4% compared with 1.17% for pressures between 100 and 124 mm Hg). Patients who had systolic blood pressure of 175 mm Hg or more at entry and who received accelerated alteplase therapy had a lower rate of death within 30 days (4.3% compared with 7.8% ; P = 0.044) and a lower rate of death plus disabling stroke (4.9% compared with 8.9% ; P = 0.031) than patients treated with streptokinase, despite having higher rates of total and hemorrhagic stroke (incidence of hemorrhagic stroke, 2.3% compared with 1.5%). Assumptions based on previous trials and rates of stroke from the GUSTO-I (Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries) trial suggest that in hypertensive patients with low risk for death from cardiac causes (no previous infarction, Killip class I), the risk-to-benefit ratio with thrombolysis is about unity, with about 13 lives saved per 1000 persons treated at the risk of about 13 intracranial hemorrhages. Conclusions : Patients with myocardial infarction and very elevated blood pressure who have thrombolysis and patients with myocardial infarction who do not have elevated blood pressure have a similar risk for death, but the risk for stroke is higher in the former group. Future studies should assess 1) the risk-to-benefit ratio of thrombolysis in these patients, especially those at low risk for death from cardiac causes, and 2) whether decreasing elevated blood pressure before thrombolysis reduces the incidence of stroke without increasing mortality rates.