Showing papers by "Eric J. Topol published in 1999"
TL;DR: The time to treatment with direct PTCA, as with thrombolytic therapy, is a critical determinant of mortality in acute myocardial infarction.
Abstract: for the GUSTO-II Investigators Background—Time to treatment with thrombolytic therapy is a critical determinant of mortality in acute myocardial infarction. Little is known about the relationship between the time to treatment with direct coronary angioplasty and clinical outcome. The objectives of this study were to determine both the time required to perform direct coronary angioplasty in the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO-IIb) trial and its relationship to clinical outcome. Methods and Results—Patients randomized to direct coronary angioplasty (n 5565) were divided into groups based on the time between study enrollment and first balloon inflation. Patients randomized to angioplasty who did not undergo the procedure were also analyzed. The median time from study enrollment to first balloon inflation was 76 minutes; 19% of patients assigned to angioplasty did not undergo an angioplasty procedure. The 30-day mortality rate of patients who underwent balloon inflation #60 minutes after study enrollment was 1.0%; 61 to 75 minutes after enrollment, 3.7%; 76 to 90 minutes after enrollment, 4.0%; and $91 minutes after enrollment, 6.4%. The mortality rate of patients assigned to angioplasty who never underwent the procedure was 14.1% (P50.001). Logistic regression analysis revealed that the time from enrollment to first balloon inflation was a significant predictor of mortality within 30 days; after adjustment for differences in baseline characteristics, the odds of death increased 1.6 times ( P50.008) for a movement from each time interval to the next. Conclusions—The time to treatment with direct PTCA, as with thrombolytic therapy, is a critical determinant of mortality. (Circulation. 1999;100:14-20.)
578 citations
TL;DR: In this article, a coronary heart disease is the leading cause of death in the industrialized world and new treatments focus on death as a primary end point, which is intuitively appealing to attempt to better understand the association.
578 citations
TL;DR: The ECG category and creatine kinase level at admission remained highly predictive of death and myocardial infarction after multivariate adjustment for the significant baseline predictors of events.
Abstract: ContextThe presence of ischemic changes on electrocardiogram
(ECG) correlates with poorer outcomes in patients with acute chest
pain.ObjectiveTo determine the prognostic value of various ECG
presentations of acute myocardial ischemia.DesignRetrospective analysis of the presenting ECGs of
patients enrolled in Global Use of Strategies To Open Occluded
Arteries in Acute Coronary Syndromes (GUSTO-IIb).SettingThree hundred seventy-three hospitals in 13 countries in
North America, Europe, Australia, and New Zealand.PatientsA total of 12,142 patients who reported symptoms
of cardiac ischemia at rest within 12 hours of admission and had signs
of myocardial ischemia confirmed by ECG. On presenting ECG, 22% of
patients had T-wave inversion, 28% had ST-segment elevation, 35% had
ST-segment depression, and 15% had a combination of ST-segment
elevation and depression.Main Outcome MeasureAbility of presenting ECG to predict death or
myocardial reinfarction during the first 30 days of follow-up.ResultsThe 30-day incidence of death or myocardial reinfarction
was 5.5% in patients with T-wave inversion, 9.4% in those with
ST-segment elevation, 10.5% in those with ST-segment depression, and
12.4% in those with ST-segment elevation and depression
(P<.001). After adjusting for factors associated with an
increased risk of 30-day death or reinfarction, compared with those who
had T-wave inversion only, the odds of 30-day death or reinfarction
were 1.68 (95% confidence interval [CI], 1.36-2.08) in those with
ST-segment elevation, 1.62 (95% CI, 1.32-1.98) for those with
ST-segment depression, and 2.27 (95% CI, 1.80-2.86) for those with
combined elevation and depression. An elevated creatine kinase level at
admission correlated with a higher risk of death (odds ratio [OR],
2.36; 95% CI, 1.92-2.91) and death or reinfarction (OR, 1.56; 95% CI,
1.32-1.85). The ECG category and creatine kinase level at admission
remained highly predictive of death and myocardial infarction after
multivariate adjustment for the significant baseline predictors of
events.ConclusionsThe ECG at presentation allows immediate risk
stratification across the spectrum of acute coronary syndromes. An
elevated creatine kinase level at admission is associated with worse
outcomes.
530 citations
TL;DR: The GPIIb-IIIa blockers are taking the clinician and patient out of the era of aspirin monotherapy when platelet inhibition is required, with attention to heparin dose the risk of bleeding is not a major concern with these agents.
486 citations
TL;DR: Among patients with diabetes, the combination of abciximab and stenting was associated with a lower rate of repeated target-vessel revascularization than was stenting and placebo or angioplasty and abcximab.
Abstract: Background Inhibition of the platelet glycoprotein IIb/IIIa receptor with the monoclonal-antibody fragment abciximab reduces the acute ischemic complications associated with percutaneous coronary revascularization, whereas coronary-stent implantation reduces restenosis. We conducted a trial to determine the efficacy of abciximab and stent implantation in improving long-term outcome. Methods A total of 2399 patients were randomly assigned to stent implantation and placebo, stent implantation and abciximab, or balloon angioplasty and abciximab. The patients were followed for six months. Results At six months, the incidence of the composite end point of death or myocardial infarction was 11.4 percent in the group that received a stent and placebo, as compared with 5.6 percent in the group that received a stent and abciximab (hazard ratio, 0.47; 95 percent confidence interval, 0.33 to 0.68; P<0.001) and 7.8 percent in the group assigned to balloon angioplasty and abciximab (hazard ratio, 0.67; 95 percent conf...
378 citations
TL;DR: Coronary stenting with abciximab, compared with stenting alone or balloon angioplasty with ab ciximabs, is associated with improved survival and is an economically attractive therapy by conventional standards.
320 citations
TL;DR: There is conclusive evidence of an early benefit of GP IIb/IIIa inhibitors during medical treatment in patients with acute coronary syndromes without persistent ST-segment elevation and in patients subsequently undergoing PCI, GP II-IIIa inhibition protects against myocardial damage associated with the intervention.
Abstract: Background—Glycoprotein (GP) IIb/IIIa receptor blockers prevent life-threatening cardiac complications in patients with acute coronary syndromes without ST-segment elevation and protect against thrombotic complications associated with percutaneous coronary interventions (PCIs) The question arises as to whether these 2 beneficial effects are independent and additive Methods and Results—We analyzed data from the CAPTURE, PURSUIT, and PRISM-PLUS randomized trials, which studied the effects of the GP IIb/IIIa inhibitors abciximab, eptifibatide, and tirofiban, respectively, in acute coronary syndrome patients without persistent ST-segment elevation, with a period of study drug infusion before a possible PCI During the period of pharmacological treatment, each trial demonstrated a significant reduction in the rate of death or nonfatal myocardial infarction in patients randomized to the GP IIb/IIIa inhibitor compared with placebo The 3 trials combined showed a 25% event rate in this period in the GP IIb/III
298 citations
TL;DR: The combination of stenting and abciximab therapy among diabetics resulted in a significant reduction in 6-month rates of death, myocardial infarction, and target-vessel revascularization (TVR) compared with stent-placebo or balloon-abcixIMab therapy.
Abstract: Background —Stenting likely decreases the need for target-vessel revascularization procedures in diabetic patients compared with balloon angioplasty. However, the efficacy of stenting with platelet glycoprotein IIb/IIIa blockade has not yet been assessed in diabetics.
Methods and Results —We analyzed the outcomes of 491 diabetic patients within the multicenter Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial (EPISTENT). Diabetic patients were a prospectively defined subset: 173 were randomized to stent-placebo, 162 to stent-abciximab, and 156 to balloon angioplasty–abciximab. The main end point for this analysis was combined 6-month death, myocardial infarction (MI), or target-vessel revascularization (TVR). The composite end point occurred in 25.2% of stent-placebo, 23.4% of balloon-abciximab, and 13.0% of stent-abciximab patients ( P =0.005). Abciximab therapy, irrespective of revascularization strategy (stent or balloon angioplasty), resulted in a significant reduction in the 6-month death or MI rate: 12.7% for stent-placebo, 7.8% for balloon angioplasty–abciximab, and 6.2% for the stent-abciximab group ( P =0.029). The 6-month TVR rate was 16.6% for stent-placebo, 18.4% for balloon-abciximab, and 8.1% for stent-abciximab ( P =0.021). Compared with stent-placebo, stent-abciximab therapy was associated with a significant increase in angiographic net gain (0.88 versus 0.55 mm; P =0.011) and a decrease in the late loss index (0.40 versus 0.60 mm; P =0.061). The 1-year mortality rate for diabetics was 4.1% for stent-placebo and 1.2% for stent-abciximab patients ( P =0.11).
Conclusions —The combination of stenting and abciximab therapy among diabetics resulted in a significant reduction in 6-month rates of death, MI, and TVR compared with stent-placebo or balloon-abciximab therapy.
298 citations
TL;DR: The findings of a TTP incidence of 0.02% in a cohort of ticlopidine-treated patients following coronary stenting suggests that TTP occurs much more commonly in this population than the estimated incidence of0.0004% in the general population.
Abstract: ContextThrombotic thrombocytopenic purpura (TTP) is a rare
and often fatal disorder characterized by thrombocytopenia,
microangiopathic hemolytic anemia, mental status changes, and renal
dysfunction. Ticlopidine hydrochloride is 1 of several drugs that have
been associated with this disorder and is currently used routinely in
the approximately 500,000 patients per year in the United States
who undergo a percutaneous coronary intervention involving a stent.ObjectivesTo determine the incidence and describe the clinical
course of TTP due to ticlopidine therapy following stenting.DesignRetrospective analysis of cohort of all patients
undergoing coronary stenting at the Evaluation of Platelet IIb/IIIa
Inhibitor for Stenting (EPISTENT) study sites.SettingSixty-three centers throughout the United States and
Canada.PatientsA total of 43,322 patients who underwent a
percutaneous coronary intervention and received a coronary stent during
a 1-year period from 1996 to 1997.Main Outcome MeasuresCases of TTP following stenting during the
1-year period to determine the incidence of TTP due to ticlopidine
therapy following coronary stenting. Additional cases were collected
from these and other centers across North America to further describe
the clinical presentation and course of TTP due to ticlopidine therapy
following stenting.ResultsNine cases of TTP following stenting were recognized at
the 63 centers during the specified period, giving an incidence of 1
case per 4814 patients treated (0.02%; 95% confidence interval, 1
case per 2533 to 1 case per 10,541 patients treated). Ten
additional cases of TTP related to ticlopidine therapy following
stenting were identified from other centers, were identified from the
primary centers outside the predefined period, or involved a
noncoronary stent. Four patients (21%) received ticlopidine for 2
weeks or fewer, 14 patients (74%) for 2 to 4 weeks, and 1 patient
(5%) for 8 weeks. The mean time of ticlopidine treatment prior to TTP
diagnosis was 22 days (range, 5-60 days). The overall mortality rate
was 21% (4/19), with all 4 deaths occurring in patients not treated
with plasmapheresis, whereas there were no deaths among the 13 patients
who received plasmapheresis.ConclusionThe findings of a TTP incidence of 0.02% in our
cohort of ticlopidine-treated patients following coronary stenting
suggests that TTP occurs much more commonly in this population than the
estimated incidence of 0.0004% in the general population. The
mortality rate for this rare complication exceeds 20%. Limiting
ticlopidine therapy to 2 weeks after stenting does not prevent the
development of TTP. Rapid diagnosis and treatment that includes
plasmapheresis are critical for improved survival.
219 citations
TL;DR: The incidence, patient characteristics, timing, clinical course, and angiographic findings differ between the 2 groups, and Mortality from cardiogenic shock is similarly high among patients with and without ST-segment elevation.
Abstract: Background—Cardiogenic shock is usually considered a sequela of ST-segment elevation myocardial infarction. There are limited prospective data on the incidence and significance of shock in non−ST-segment elevation patients. This study assessed the incidence and outcomes of cardiogenic shock developing after enrollment among patients with and without ST-segment elevation in the Global Use of Strategies To Open Occluded Coronary Arteries (GUSTO)-IIb trial. Methods and Results—Among 12 084 patients in GUSTO-IIb who did not present with cardiogenic shock, 4092 (34%) had and 7991 (66%) did not have ST-segment elevation on the enrollment ECG. Cardiogenic shock developed in 4.2% of ST-segment elevation patients compared with 2.5% of patients without ST-segment elevation (odds ratio, 0.581; 95% CI, 0.472 to 0.715; P<0.001). Shock developed significantly later among patients without ST-segment elevation. There were significant differences in baseline characteristics between shock patients with and without ST-segme...
217 citations
TL;DR: 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.
TL;DR: Evidence supporting plaque stabilization by Matrix metalloproteinase inhibitors as well as macrolide antibiotics and gene therapy approaches show promise in achieving plaque stabilization is discussed in detail in this review.
Abstract: Acute coronary syndromes result from fissure, erosion or rupture of a vulnerable atherosclerotic plaque. The characteristics of a vulnerable plaque include a large lipid pool, an abundance of inflammatory cells and mediators, a reduced smooth muscle cell and collagen content and a thin overlying fibrous cap. Potential therapeutic strategies at achieving plaque stabilization have targeted these features. Lipid lowering agents, β-adrenergic blockers, angiotensin converting enzyme inhibitors and antioxidants have been shown to reduce the incidence of acute coronary syndromes, presumably through plaque stabilization. Matrix metalloproteinase inhibitors as well as macrolide antibiotics and gene therapy approaches show promise in achieving plaque stabilization. The evidence supporting plaque stabilization by these agents and the mechanisms by which these agents stabilize plaques are discussed in detail in this review.
TL;DR: In this paper, Abciximab was shown to reduce the incidence of acute ischemic complications within 30 days among a broad spectrum of patients undergoing percutaneous coronary revascularization.
Abstract: Background —Blockade of the platelet glycoprotein IIb/IIIa receptor with the monoclonal antibody fragment abciximab was shown in a placebo-controlled randomized trial to reduce the incidence of acute ischemic complications within 30 days among a broad spectrum of patients undergoing percutaneous coronary revascularization. The durability of clinical benefit in this setting has not been established. Methods and Results —A total of 2792 patients enrolled in the Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade (EPILOG) trial were followed with maintenance of double-blinding for 1 year. Patients had been assigned at the time of their index coronary interventional procedure to receive placebo with standard-dose, weight-adjusted heparin (100 U/kg initial bolus), abciximab with standard-dose, weight-adjusted heparin, or abciximab with low-dose, weight-adjusted heparin (70 U/kg initial bolus). The primary outcome was the composite of death, myocardial infarction, or urgent repeat revascularization by 30 days; this composite end point and its individual components were also assessed at 6 months and 1 year. Rates of any repeat revascularization (urgent or elective), target vessel revascularization, and a composite of death, myocardial infarction, or any repeat revascularization were also reported. Follow-up at 1 year was 99% complete for survival status and 97% complete for other end points. By 1 year, the incidence of the primary composite end point was 16.1% in the placebo group, 9.6% in the abciximab with low-dose heparin group ( P P Conclusions —Acute reductions in ischemic events after percutaneous coronary intervention by abciximab are sustained over follow-up to at least 1 year. Early periprocedural myocardial infarctions suppressed by this therapy are associated with long-term mortality rates.
TL;DR: In this article, a risk assessment prognostic algorithm of 30-day mortality, including clinical and hemodynamic data prospectively collected among patients with cardiogenic shock in the 41,021-patient Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I) trial, was developed.
TL;DR: Although primary angioplasty improves outcomes over thrombolysis, it does not appear to be more beneficial in older than in younger patient groups and the incremental adverse effect of age does not vary by treatment strategy.
TL;DR: Thrombocytopenia was highly correlated with both bleeding and ischemic events, and the presence of this condition identified a more-at-risk patient population.
Abstract: Background—The significance of thrombocytopenia in patients experiencing an acute coronary syndrome (ACS) has not been examined systematically. We evaluated this condition in a large non–ST-elevation ACS clinical trial, with particular interest paid to its correlation with clinical outcomes. Methods and Results—Patients presenting without persistent ST elevation during an ACS were randomized to receive a double-blind infusion of the platelet glycoprotein (GP) IIb/IIIa inhibitor eptifibatide or placebo in addition to other standard therapies including heparin and aspirin. The primary end point was death/nonfatal myocardial infarction (MI) at 30 days, whereas bleeding and stroke were the main safety outcomes. Thrombocytopenia (nadir platelet count <100×109/L or <50% of baseline) occurred in 7.0% of enrolled patients. The time to onset was a median of 4 days in both treatment arms. Patients with thrombocytopenia were older, weighed less, were more likely nonwhite, and had more cardiac risk factors. These pat...
TL;DR: Troponin T testing could be a valuable addition to the evaluation strategy for patients with acute myocardial infarction by independently risk-stratify patients randomized to receive alteplases or reteplase in the GUSTO-III trial.
Abstract: Troponin T has been used successfully to risk stratify patients with acute coronary syndromes, but the utility of this approach using a rapid bedside assay in patients undergoing thrombolysis for ST-segment elevation acute myocardial infarction has not been assessed in a large population. We assessed whether a point-of-care, qualitative troponin T test at enrollment could independently risk-stratify patients randomized to receive alteplase or reteplase in the GUSTO-III trial. Complete troponin T data were available for 12,666 patients (84%) enrolled at 550 hospitals. The primary end point was mortality at 30 days, and the predictive ability of an elevated baseline troponin T level was analyzed (after adjustment for baseline characteristics) with multiple logistic regression. Patients with an elevated troponin T result at enrollment (8.9%) had significantly higher mortality at 30 days (unadjusted 15.7% vs 6.2% for negative patients; p = 0.001), which persisted even after adjustment for age, heart rate, location of infarction, Killip class, and systolic blood pressure. In a multivariable regression model, a positive troponin T result added independently to the prediction of 30-day mortality (chi-square 46, p = 0.001). A positive result with qualitative troponin T testing on admission is an independent marker of higher 30-day mortality. Troponin T testing could be a valuable addition to the evaluation strategy for patients with acute myocardial infarction.
TL;DR: The authors investigated the association between prior aspirin use and clinical outcomes in 9,461 patients with non-ST-elevation acute coronary syndromes enrolled in the Platelet IIb/IIIa in Unstable angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial, before and after adjustment for baseline factors.
Abstract: Aspirin is beneficial in the prevention and treatment of cardiovascular events, but patients who have events while taking aspirin may have worse outcomes than those not on aspirin We investigated the association between prior aspirin use and clinical outcomes in 9,461 patients with non-ST-elevation acute coronary syndromes enrolled in the Platelet IIb/IIIa in Unstable angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial, before and after adjustment for baseline factors We also examined whether eptifibatide has a differential treatment effect in prior aspirin users Prior aspirin users were less likely to have an enrollment myocardial infarction (MI) (vs unstable angina) (439% vs 488%, p = 0001) but more likely to have death or MI at 30 days (161% vs 130%, p = 0001) and at 6 months (199% vs 159%, p = 0001) After adjustment, prior aspirin users remained less likely to have an enrollment MI (odds ratio 088, 95% confidence interval 079 to 097) and more likely to have death or MI at 30 days (odds ratio 116, 95% confidence interval 100 to 133) but not at 6 months (odds ratio 114, 95% confidence interval 098 to 133) In a multivariable model, eptifibatide did not have a different treatment effect in prior aspirin users compared with nonusers (p = 0534) Prior aspirin users had fewer enrollment MIs but worse long-term outcomes than nonusers We found no evidence for a different treatment effect of eptifibatide in prior aspirin users
TL;DR: A difference was not found between diabetics and nondiabetics, nor was any physiological parameter found to be predictive of the response to abciximab, and Diabetic status does not appear to influence this variability.
Abstract: Background —Although the effectiveness of abciximab (c7E3 Fab; ReoPro) in large populations of patients undergoing a percutaneous coronary intervention has been consistently proved in clinical trials, it is unknown whether all patients achieve and maintain target inhibition during treatment. Diabetic patients in particular are a subgroup of patients with known underlying platelet abnormalities whose long-term response to abciximab has been shown to vary from that of nondiabetic patients. Methods and Results —Forty-nine diabetic and 51 nondiabetic patients who received adjunctive abciximab therapy during percutaneous coronary interventions were evaluated prospectively. The degree of platelet function inhibition was determined immediately after the abciximab bolus, 8 hours after the bolus (during the 12-hour abciximab infusion), and the next morning (13 to 26 hours after the bolus) with the use of a rapid platelet function assay (Accumetrics). After the abciximab bolus, platelet function was inhibited by 95±4% (mean±SD). By 8 hours, the average percent inhibition had decreased to 88±9%, with 13% of patients with Conclusions —Although the majority of patients achieve and maintain ≥80% platelet inhibition during the 12-hour infusion with standard-dose abciximab, there is substantial variability among patients. Diabetic status does not appear to influence this variability.
TL;DR: Moderate elevation of cardiac enzymes (creatine kinase-MB, creatine kinase) after percutaneous coronary intervention is associated with an increased risk of mortality and reinfarction during the 6 month follow-up, and measures to reduce such periprocedural infarcts are warranted.
Abstract: Aims Studies on the glycoprotein IIb-IIIa receptor blocker abciximab in patients undergoing percutaneous coronary intervention consistently show a reduction in procedurerelated myocardial infarction. Some such infarcts are characterized by elevated creatine kinase or creatine kinase-MB, without apparent clinical symptoms. The clinical relevance of such ‘creatine kinase leaks’ has been questioned. Therefore we investigated the relationship between postprocedural creatine kinase-MB elevation and outcome at the 6 month follow-up. Methods and Results Creatine kinase-MB, or total creatine kinase values were analysed in 5025 out of 6156 patients enrolled in the CAPTURE, EPIC and EPILOG studies. A consistent gradual increase in 6 month mortality was observed as creatine kinase-MB or creatine kinase levels increased: 1·1%, 2·1%, 1·8%, 3·6% and 6·7% for creatine-MB or creatine ratios (relative to upper limit of normal) <1, 1‐3, 3‐5, 5‐10 and §10, respectively. Also the incidence of death or (recurrent) myocardial infarction was related to creatine kinase-MB or creatine kinase ratios. Subsequent revascularization was not related to periprocedural myocardial infarction. By multivariable analysis, correcting for clinical and angiographic characteristics, mortality at 6 months was related to the enzyme (creatine kinase, creatine kinase-MB) ratio, a history of heart failure and age. The combined end-point of death and myocardial infarction was also related to these factors, as well as to a history of bypass surgery and unstable angina. Conclusion Modest elevation of cardiac enzymes (creatine kinase-MB, creatine kinase) after percutaneous coronary intervention is associated with an increased risk of mortality and reinfarction during the 6 month follow-up. Measures to reduce such periprocedural infarcts are warranted. (Eur Heart J 1999; 20: 1112‐1119)
TL;DR: Appreciation of contemporary risk factors for complications of coronary intervention may assist in patient selection and in risk adjustment for comparison of outcomes between providers.
Abstract: Background—The currently used American College of Cardiology/American Heart Association lesion classification scheme dates from an era when balloon angioplasty was the only percutaneous treatment available and major complications occurred in ≈7% of patients. Major advances in treatment options would suggest that this scheme may be outmoded, but the schemes that have been suggested to update lesion classification have not been widely accepted. Methods and Results—Four thousand one hundred eighty-one consecutive patients (6676 lesions) formed a training set and 2146 patients (4231 lesions) formed a validation set treated from 1995 to 1997 at a single center used by 3 hospital groups. Twenty-seven pretreatment candidate variables were analyzed with the use of stepwise proportional logistic regression, and 9 (nonchronic total occlusion with TIMI flow 0, degenerated vein graft, vein graft age >10 years, lesion length ≥10 mm, severe calcium, lesion irregularity, large filling defect, angulated ≥45 degrees plus ...
TL;DR: Bivalirudin is at least as effective as heparin, with clearly superior safety, and provides an unprecedented net clinical benefit over hepar in patients with ischemic heart disease.
Abstract: Background—Current treatment strategies for percutaneous coronary revascularization and acute coronary syndromes incorporate thrombin inhibition with either unfractionated or fractionated heparin. The peptide bivalirudin (Hirulog) is a direct thrombin inhibitor whose pharmacological properties differ from those of heparin. We conducted a systematic overview (meta-analysis) to assess the effect of bivalirudin on 4 end points: death, myocardial infarction, major hemorrhage, and the composite of death or infarction. Methods and Results—Six trials (5674 patients) represent the randomized, controlled bivalirudin experience, including 4603 patients undergoing elective percutaneous coronary revascularization and 1071 patients with acute coronary syndromes. ORs for the 4 clinical end points were calculated for each trial. Four trials (4973 patients) that compared bivalirudin with heparin were combined with the use of a random-effects model. In these trials, bivalirudin was associated with a significant reduction ...
TL;DR: Most patients with acute myocardial infarction complicated by cardiogenic shock who are alive at 30 days survived at least 1 year and Shock patients who underwent revascularization within 30 days had improved survival at 1 year compared with shock patients who did not receiveRevascularization, even after adjustment for differences in baseline characteristics between the 2 groups.
Abstract: Background—Although 30-day survival is increased in patients with acute myocardial infarction complicated by cardiogenic shock who undergo coronary revascularization, the longer-term outcome in such patients and the duration of benefit from revascularization are unknown. Methods and Results—We analyzed 30-day survivors of acute myocardial infarction in the Global Utilization of Streptokinase and Tissue-Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I) trial and identified 36 333 who had not had cardiogenic shock (systolic blood pressure <90 mm Hg for ≥1 hour, group 1) and 1321 patients who had shock (group 2). Group 2 patients were older and sicker. At 1 year, 97.4% of group 1 patients were alive versus 88.0% of group 2 (P=0.0001). Among group 2 patients, 578 (44%) had undergone revascularization within 30 days (group 2A) and 728 (56%) had not (group 2B). Revascularization was not required by protocol but was selected by the attending physicians. At 1 year, 91.7% of group 2A patients were ali...
TL;DR: Higher heart rate was the most important baseline clinical predictor of nonhemorrhagic stroke, followed by older age, prior anterior myocardial infarction, prior stroke or transient ischemic attack, and diabetes mellitus, and these factors were used to develop a simple scoring nomogram that can predict the risk ofNonhemor rhagic stroke.
Abstract: Background—The incidence of stroke in patients with acute coronary syndromes has not been clearly defined because few trials in this patient population have been large enough to provide stable estimates of stroke rates. Methods and Results—We studied the 10 948 patients with acute coronary syndromes without persistent ST-segment elevation who were randomly assigned to placebo or the platelet glycoprotein IIb/IIIa receptor inhibitor eptifibatide in the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial to determine stroke rates, stroke types, clinical outcomes in patients with stroke, and independent baseline clinical predictors for nonhemorrhagic stroke. Stroke occurred in 79 (0.7%) patients, with 66 (0.6%) nonhemorrhagic, 6 intracranial hemorrhages, 3 cerebral infarctions with hemorrhagic conversion, and 4 of uncertain cause. There were no differences in stroke rates between patients who received placebo and those assigned high-dose eptifibati...
TL;DR: Reteplase did not improve outcome among patients who presented with shock or developed shock after receiving thrombolytics, and remained of limited eYcacy in the treatment and prevention of shock.
Abstract: Results Shock occurred in 260 (5·3%) of 4921 patients randomized to alteplase and 560 (5·5%) of 10 138 patients randomized to reteplase. Of these patients, 28 (10·8%) and 55 (9·8%) randomized to alteplase and reteplase, respectively, presented with shock. In-hospital, 35% and 37% of shock patients assigned to alteplase or reteplase, respectively, underwent coronary angiography, with similar rates of percutaneous (211‐13%) or surgical (22‐3%) revascularization procedures subsequently performed. Death within 30 days occurred in 169 (65%) and 353 (63%) shock patients randomized to alteplase and reteplase, respectively (P=0·59). Of patients presenting with shock, 64% and 58% of patients randomized to alteplase or reteplase died within 30 days (P=0·59). Conclusion Compared with alteplase, reteplase did not improve outcome among patients who presented with shock or developed shock after receiving thrombolytics. The newer-generation thrombolytic agents remain of limited eYcacy in the treatment and prevention of shock. (Eur Heart J 1999; 20: 128‐135)
TL;DR: The use of abciximab for early angioplasty after clinically failed thrombolysis resulted in trends toward lower 30-day mortality and increased bleeding and the composite of death, stroke, or reinfarction did not differ significantly with abcximab treatment.
Abstract: We evaluated the effects of abciximab treatment during early angioplasty after clinically failed thrombolysis for acute myocardial infarction. In the Global Use of Strategies To Open occluded coronary arteries (GUSTO-III) trial of reteplase versus alteplase for acute infarction (n = 15,059), 392 patients underwent angioplasty a median of 3.5 hours after thrombolysis and had complete procedural data. We compared 30-day mortality and in-hospital outcomes between patients who received abciximab (n = 83) and those who did not (n = 309), and (among patients given abciximab) between those randomized to alteplase versus reteplase. Patients given abciximab had anterior infarction less often, but were more often in Killip classes III or IV. The 30-day mortality rate tended to be lower with abciximab (3.6% vs 9.7%, p = 0.076), more so after adjustment for baseline differences (p = 0.042). The composite of death, stroke, or reinfarction did not differ significantly with abciximab treatment (12% vs 14%, p = 0.7), but it occurred less often among abciximab-treated patients who had been randomized to reteplase (n = 55) versus alteplase (n = 28) (7% vs 21%, p = 0.08). Severe bleeding was increased among abciximab-treated patients (3.6% vs 1.0%, p = 0.08), despite less heparin use. No intracranial hemorrhages occurred with abciximab. The use of abciximab for early angioplasty after clinically failed thrombolysis resulted in trends toward lower 30-day mortality and increased bleeding.
TL;DR: The open-artery hypothesis suggests that a patent infarct-related artery confers a survival benefit greater than that expected from myocardial salvage alone, which extends beyond the time when preservation of left ventricular function is expected.
Abstract: We examined the possible benefits of achieving and maintaining infarct-related artery patency beyond the time when preservation of left ventricular function would be expected. The open-artery hypothesis suggests that a patent infarct-related artery confers a survival benefit greater than that expected from myocardial salvage alone, which extends beyond the time when preservation of left ventricular function is expected. We examined the survival experience of patients undergoing thrombolysis in the Global Utilization of Streptokinase and TPA for Occluded Arteries (GUSTO-I) trial for whom data on the patency of the infarct artery were available. Univariable analysis was used to determine the unadjusted relations of angiographic variables and revascularization procedures to both 30-day and 1-year mortality in 30-day survivors. Multivariable analysis was used to test for interactions between patency and each characteristic and to adjust both for all other variables and for baseline characteristics known to predict mortality.In both univariable and multivariable analysis, patients with an open rather than a closed infarct-related artery had significantly lower 30-day mortality (p
TL;DR: The presence of proteinuria is the key determinant of risk following PCI for diabetics with and without proteinuria, and Diabetics without evidence ofproteinuria have similar survival compared with nondiabetics.
TL;DR: In this paper, the authors determined the frequency and effect of prophylactic lidocaine on clinical outcomes with its use in the thrombolytic era and found that the use may not be associated with increased mortality rates.
TL;DR: Data indicate that neurosurgical evacuation may be associated with improved clinical outcomes in patients receiving thrombolytic therapy for acute myocardial infarction, and Physicians treating such patients should consider early neuros surgical consultation and intervention.