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Biomedical subjects

P B Berger

Publications and source records attributed to P B Berger.

At least 19 recordsLinked to original sources

Outcomes of patients with chronic renal insufficiency in the bypass angioplasty revascularization investigation.

BACKGROUND: Although severe chronic kidney disease (CKD) is an independent predictor of mortality among patients with coronary artery disease, the impact of mild CKD on morbidity and mortality has not been fully defined. METHODS AND RESULTS: Morbidity and mortality for the 3608 patients with multivessel coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation randomized trial and registry were compared on the basis of the presence and absence of CKD, defined as a preprocedure serum creatinine level of >1.5 mg/dL. Seventy-six patients had CKD. Patients with renal insufficiency were older and more likely to have a history of diabetes, hypertension, and other comorbidities. Among patients undergoing PTCA, patients with CKD had a greater frequency of in-hospital death and cardiogenic shock (P<0.05 and 0.01, respectively). There was a trend toward a larger proportion of patients with CKD experiencing angina at 5 years (P=0.079). Patients with CKD had more cardiac admissions (P=0.003 and <0.0001 for patients undergoing PTCA and CABG, respectively) and a shorter time to subsequent CABG after initial revascularization than patients without CKD (P=0.01). CKD was associated with a higher risk of death at 7 years, both of all causes (relative risk 2.2, P<0.001) and of cardiac causes (relative risk 2.8, P<0.001). CONCLUSIONS: CKD is associated with an increased risk of recurrent hospitalization, subsequent CABG, and mortality. This increased risk of death is independent of and additive to the risk associated with diabetes.

Angina Pectoris↗

Influence of coronary thrombus on outcome of percutaneous coronary angioplasty in the current era (the Mayo Clinic experience).

Earlier studies documented an increased risk of percutaneous coronary intervention (PCI) in patients with angiographic evidence of thrombus. With newer antiplatelet agents and stents, it is not known whether thrombus is a risk factor after PCI. This study examines whether outcome of PCI in patients with thrombus has improved, and whether thrombus is associated with adverse outcome after PCI in the current era. This single-institution retrospective analysis of PCI in 7,184 patients was divided into 2 periods: group I, 1990 to 1995 (n = 3,640), and group II, 1996 to 1999 (n = 3,544). The groups were subdivided according to the presence or absence of angiographic thrombus before PCI. We compared the outcome of PCI for patients with and without thrombus in group II. A comparison was made in the 2 groups in patients with angiographic thrombus. Procedural success improved in group II compared with group I patients with thrombus (93% vs 88%, p <0.001). There was significant reduction in abrupt closure in the recent era in patients with thrombus (4% vs 7%, p = 0.01). In group II, procedural success remained lower in patients with (93% vs 96%) than without thrombus (p <0.001). After adjusting for the significant univariate characteristics of group II patients, thrombus remained an independent predictor of Q-wave infarction (odds ratio 3.78; 95% confidence interval [CI], 1.8 to 8.0; p <0.0013) and the composite end point of death, Q-wave infarction, and emergency bypass surgery (odds ratio 2.37; 95% CI 1.4 to 4.1; p = 0.002). There was a trend toward increased in-hospital death among patients with thrombus (odds ratio 2.06; 95% CI 0.9 to 4.8; p = 0.09). The 1-year outcome after successful PCI was similar for those with and without thrombus. Despite improvement in the outcome of patients with thrombus undergoing PCI in recent years, thrombus is still an independent predictor of adverse in-hospital outcomes after PCI.

Aged↗

A randomized, placebo-controlled trial of enoxaparin after high-risk coronary stenting: the ATLAST trial.

OBJECTIVES: We performed a multicenter, double-blind placebo-controlled trial to examine the efficacy and safety of enoxaparin in patients at high risk for stent thrombosis (ST). BACKGROUND: The optimal antithrombotic regimen for such patients is unknown. METHODS: We randomized 1,102 patients with clinical, angiographic or ultrasonographic features associated with an increased risk of ST to receive either twice-daily injections of weight-adjusted enoxaparin or placebo for 14 days after stenting. All patients received aspirin and ticlopidine. The primary end point was a 30-day composite end point of death, myocardial infarction (MI) or urgent revascularization. RESULTS: The target enrollment for the study was 2,000 patients. However, the trial was terminated prematurely at 1,102 patients after interim analysis revealed an unexpectedly low event rate. The primary outcome occurred in 1.8% enoxaparin-treated patients versus 2.7% treated with placebo (odds ratio [OR] 0.66; 95% confidence interval [CI] 0.29 to 1.5, p = 0.30); for death or MI the rates were 0.9% vs. 2.2%, respectively (OR 0.41, 95% CI 0.14 to 1.2, p =0.13); and for MI, 0.4% vs. 1.6%, respectively (OR 0.22, 95% CI 0.05 to 0.99, p = 0.04). The groups had comparable rates of major bleeding (3.3% for enoxaparin, 1.6% for placebo, p =0.08), but minor nuisance bleeding was increased with enoxaparin (25% vs. 5.1%, p < 0.001). CONCLUSIONS: The clinical outcomes of patients at increased risk of ST are more favorable than previously reported, rendering routine oral antiplatelet therapy adequate for most. However, given its relative safety and potential to reduce the risk of subsequent infarction, a 14-day course of enoxaparin may be considered for carefully selected patients.

Aged↗

Survival following coronary angioplasty versus coronary artery bypass surgery in anatomic subsets in which coronary artery bypass surgery improves survival compared with medical therapy. Results from the Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: We sought to compare survival after coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA) in high-risk anatomic subsets. BACKGROUND: Compared with medical therapy, CABG decreases mortality in patients with three-vessel disease and two-vessel disease involving the proximal left anterior descending artery (LAD), particularly if left ventricular (LV) dysfunction is present. How survival after PTCA and CABG compares in these high-risk anatomic subsets is unknown. METHODS: In the Bypass Angioplasty Revascularization Investigation (BARI), 1,829 patients with multivessel disease were randomized to an initial strategy of PTCA or CABG between 1988 and 1991. Stents and IIb/IIIa inhibitors were not utilized. Since patients in BARI with diabetes mellitus had greater survival with CABG, separate analyses of patients without diabetes were performed. RESULTS: Seven-year survival among patients with three-vessel disease undergoing PTCA and CABG (n = 754) was 79% versus 84% (p = 0.06), respectively, and 85% versus 87% (p = 0.36) when only non-diabetics (n = 592) were analyzed. In patients with three-vessel disease and reduced LV function (ejection fraction <50%), seven-year survival was 70% versus 74% (p = 0.6) in all PTCA and CABG patients (n = 176), and 82% versus 73% (p = 0.29) among non-diabetic patients (n = 124). Seven-year survival was 87% versus 84% (p = 0.9) in all PTCA and CABG patients (including diabetics) with two-vessel disease involving the proximal LAD (n = 352), and 78% versus 71% (p = 0.7) in patients with two-vessel disease involving the proximal LAD with reduced LV function (n = 72). CONCLUSION: In high-risk anatomic subsets in which survival is prolonged by CABG versus medical therapy, revascularization by PTCA and CABG yielded equivalent survival over seven years.

Aged↗

Point-of-care measured platelet inhibition correlates with a reduced risk of an adverse cardiac event after percutaneous coronary intervention: results of the GOLD (AU-Assessing Ultegra) multicenter study.

BACKGROUND: The optimal level of platelet inhibition with a glycoprotein (GP) IIb/IIIa antagonist necessary to minimize thrombotic complications in patients undergoing a percutaneous coronary intervention (PCI) is currently unknown. METHODS AND RESULTS: Five hundred patients undergoing a PCI with the planned use of a GP IIb/IIIa inhibitor had platelet inhibition measured at 10 minutes, 1 hour, 8 hours, and 24 hours after the initiation of therapy with the Ultegra Rapid Platelet Function Assay (Accumetrics). Major adverse cardiac events (MACES: composite of death, myocardial infarction, and urgent target vessel revascularization) were prospectively monitored, and the incidence correlated with the measured level of platelet function inhibition at all time points. One quarter of all patients did not achieve >/=95% inhibition 10 minutes after the bolus and experienced a significantly higher incidence of MACEs (14.4% versus 6.4%, P=0.006). Patients whose platelet function was <70% inhibited at 8 hours after the start of therapy had a MACE rate of 25% versus 8.1% for those >/=70% inhibited (P=0.009). By multivariate analysis, platelet function inhibition >/=95% at 10 minutes after the start of therapy was associated with a significant decrease in the incidence of a MACE (odds ratio 0.46, 95% CI 0.22 to 0.96, P=0.04). CONCLUSIONS: Substantial variability in the level of platelet function inhibition is achieved with GP IIb/IIIa antagonist therapy among patients undergoing PCI. The level of platelet function inhibition as measured by a point-of-care assay is an independent predictor for the risk of MACEs after PCI.

Abciximab↗

Evaluation of long-term survival after successful percutaneous coronary intervention among patients with chronic renal failure.

We studied the long-term outcomes after percutaneous coronary intervention in dialysis patients and in patients with chronic renal failure (CRF) (serum creatinine > or = 3.0 mg/dl). All-cause mortality at 1 year was 2.9% for the control group, 16.2% for the group with CRF, and 14.1% for dialysis patients. Cardiac mortality at 1 year was 1.9% for ther control group, 15.2% for the group with CRF, and 10.0% for dialysis patients.

Aged↗

Effectiveness and safety of abciximab after failed thrombolytic therapy.

Among 214 patients treated with abciximab within 24 hours of full-dose thrombolytic therapy, major bleeding occurred in 50 patients (23%; 95% confidence interval [CI] 18% to 30%) and intracranial hemorrhage occurred in 3 patients (1.4%; 95% CI 0.3% to 4%). The independent multivariate predictors of major bleeding were age (odds ratio [OR] 1.53/10 years, 95% CI 1.05 to 2.21, p = 0.03), time from thrombolytic to abciximab (OR 0.91/hour, 95% CI 0.83 to 0.99, p = 0.03), and intra-aortic balloon pump insertion (OR 4.42, 95% CI 2.00 to 9.72, p = 0.0002).

Abciximab↗

Effect of abciximab on the outcome of emergency coronary artery bypass grafting after failed percutaneous coronary intervention.

OBJECTIVE: To evaluate the outcome of coronary artery bypass grafting (CABG) for failed percutaneous coronary intervention (PCI) in patients who had received abciximab. PATIENTS AND METHODS: In this retrospective study, we analyzed the records of patients who had PCI at our institution between January 1994 and December 1998 and identified those who had urgent or emergency CABG within 48 hours after PCI. CABG was performed for failed PCI in patients who had ongoing ischemia, hemodynamic compromise, or both. These patients were categorized into 2 groups depending on whether they had been given abciximab during PCI. We compared blood product transfusion requirements, bleeding complications, and frequency of in-hospital adverse events of the 2 groups. RESULTS: Of 5636 patients who had PCI, 77 (1.4%) had urgent or emergency CABG within 48 hours, including 11 who were given abciximab (abciximab group) during PCI and 66 who were not given abciximab (no abciximab group). The 2 groups had similar baseline characteristics. The mean +/- SD time to surgery was 8.4 +/-8.0 hours (median, 6 hours) for the abciximab group vs 12.1 +/- 12.5 hours (median, 4 hours) for the no abciximab group. Major bleeding (Thrombolysis in Myocardial Infarction criteria) occurred in 9 (90%) of 10 patients in the abciximab group vs 48 (77%) of 62 patients in the no abciximab group. The total volumes of intraoperative autotransfusion and transfusion of red blood cells and fresh frozen plasma tended to be higher for the abciximab group. Also, this group received a mean of 13.9 U of platelets vs 3.2 U for the no abciximab group (P<.001). However, no in-hospital deaths occurred among patients in the abciximab group, and adverse events were infrequent and comparable between the 2 groups. No difference was noted between the 2 groups in the frequency of surgical reexploration for bleeding. CONCLUSION: Transfusion requirements are higher for patients who undergo emergency or urgent CABG after having received abciximab during PCI. However, in-hospital adverse events are infrequent and comparable to those for patients who do not receive abciximab.

Abciximab↗

Acute myocardial infarction complicated by heart block in the elderly: prevalence and outcomes.

BACKGROUND: Although second- and third-degree heart block (HB) are common conduction disorders associated with acute myocardial infarction (MI), patient characteristics and HBs association with outcomes, particularly among the elderly, remain poorly defined. METHODS: We evaluated 106,780 Medicare beneficiaries aged 65 years and older treated for acute MI between January 1994 and February 1996 for development of HB. HB and non-HB patients were compared by univariate analysis, and the influence of HB on outcomes was evaluated by unadjusted and multiple logistic regression. RESULTS: HB was documented in 5048 (4.7%) patients; 1646 presented with HB and 3402 developed HB during hospitalization. HB was more common among patients with inferior infarctions than anterior infarctions (7.3% vs 3.0%, P =.001), particularly the cohort of patients with inferior MI treated with reperfusion therapy (8.3%). HB patients had higher rates of in-hospital mortality (29.6% vs. 17.5% vs. non-HB patients, P =.001). After adjustment for demographic and clinical factors, HB remained an independent predictor of in-hospital mortality (relative risk [RR] 1.41, 95% confidence interval [CI] 1. 34-1.48), but HB had no prognostic significance at 1 year among hospital survivors (RR 0.94, 95% CI 0.88-1.01). Mortality risks varied on the basis of MI location. Both anterior MI (RR 1.46, 95% CI 1.30-1.63) and inferior MI (RR 1.52, 95% CI 1.39-1.66) patients with HB had increased risks of in-hospital mortality. There was a trend toward increased mortality among patients with anterior MI (RR 1.15, 95% CI 0.99-1.32) at 1 year, whereas those with inferior MI were at lower risk (RR 0.83, 95% CI 0.75-0.98). CONCLUSIONS: HB is a common complication of acute MI in elderly patients, particularly among patients with inferior MIs who received reperfusion therapy. HB is independently associated with short-term but not long-term mortality.

Age Factors↗

Infarct artery reocclusion after primary angioplasty, stent placement, and thrombolytic therapy for acute myocardial infarction.

BACKGROUND: The benefits of thrombolytic therapy for acute myocardial infarction (AMI) are limited by reocclusion of the infarct-related artery, which occurs in 25% to 30% of patients after successful reperfusion. The frequency of reocclusion after balloon angioplasty and stenting in this setting is less well documented. The aim of this study was to analyze the frequency and timing of reocclusion after percutaneous transluminal coronary angioplasty (PTCA) and stent placement during AMI from all available studies compared with previously published reocclusion rates after thrombolysis. METHODS AND RESULTS: The previously published thrombolysis data included 4231 patients in 19 studies with > or = 75 patients. Only PTCA studies with > or = 50 patients and stent studies with > or = 30 patients, in which routine angiographic follow-up was obtained in > or = 60% of patients, were included. Ten PTCA studies with a total of 1943 patients were analyzed, with follow-up angiography in 1391 (72%). Reocclusion rates ranged from 5% to 16.7%. The stent studies included 698 patients from 7 studies, with follow-up angiography in 92%. Reocclusion rates ranged from 0% to 6%. With the use of logistic regression analysis with allowance for overdispersion, there was a significantly lower rate of reocclusion after PTCA (odds ratio, 0.38; confidence interval, 0.24 to 0.57; P <.0001) and stent placement (odds ratio, 0.11; confidence interval, 0.05 to 0.22; P <.0001) compared with thrombolysis. Reocclusion after stent placement was lower than after PTCA (odds ratio, 0.28; confidence interval, 0.13 to 0.6; P <.0001). CONCLUSIONS: Reocclusion after PTCA and stent placement during AMI is less frequent than after thrombolysis. This may contribute to the superior outcome of patients treated with PTCA and stent placement in this setting.

Angioplasty, Balloon, Coronary↗

Predictors of improvement in left ventricular function after percutaneous revascularization of occluded coronary arteries: a report from the Total Occlusion Study of Canada (TOSCA).

BACKGROUND: The Total Occlusion Study of Canada (TOSCA) is a multicenter, randomized trial evaluating the effect of stenting with > =1 heparin-coated stent on long-term patency after percutaneous coronary intervention by balloon angioplasty of occluded coronary arteries. The purpose of the current study was to compare the effect of stenting and balloon angioplasty on global left ventricular ejection fraction (LVEF) and regional wall motion and to examine what clinical and angiographic factors may have an effect on left ventricular function in this setting. METHODS AND RESULTS: Analysis at the core angiographic laboratory of paired baseline and follow-up left ventricular angiograms, as well as target vessel patency, was possible in 244 of 410 cases. An improvement in LVEF was observed in the entire group (59.4% +/- 11% to 61.0% +/- 11%, P =.003). The LVEF change was +1.84 +/- 7.54 in the stent group (P =.009) and 1.28 +/- 8.16 in the percutaneous transluminal coronary angioplasty group (P =.085). There was no significant intergroup difference. Patients with duration of occlusion < or =6 weeks had an improvement in LVEF (+2.98 +/- 8.68, P =.0006), whereas those with an occlusion duration of > 6 weeks had no improvement (+0.48 +/- 7.01, P not significant). Multivariate analysis revealed baseline LVEF <60%, duration of occlusion < or =6 weeks, and Canadian Cardiology Society angina class I or II to be independent predictors of improvement in LVEF. CONCLUSIONS: The restoration of coronary patency of nonacute occluded coronary arteries is associated with a small but significant improvement in regional and global left ventricular function, especially in patients with recent occlusions and depressed left ventricular function. In spite of significant effect on long-term patency, stenting of nonacute coronary occlusions does not result in significantly better left ventricular function compared with balloon angioplasty in this setting.

Angioplasty, Balloon, Coronary↗