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David E Kandzari

Publications and source records attributed to David E Kandzari.

At least 19 recordsLinked to original sources
PubMed2004

Aspirin dose and six-month outcome after an acute coronary syndrome.

OBJECTIVES: This study was designed to compare the efficacy of low and intermediate aspirin doses in acute coronary syndromes. BACKGROUND: Little is known of the comparative efficacy of low and intermediate aspirin doses in this setting. METHODS: We compared six-month death, myocardial infarction (MI), and stroke in patients with unstable angina or acute MI discharged while receiving low (<150 mg) or intermediate (> or =150 mg) aspirin therapy in the GUSTO IIb and PURSUIT trials (n = 20,521). We used multivariable analysis and performed a propensity analysis in order to adjust for baseline imbalances between the groups. RESULTS: Aspirin doses <150 mg were prescribed to 29.9% (6,128) of patients. By six months, 6.4% of the patients (1,310 of 20,521) had a primary event, 6.2% of the patients receiving <150 mg and 6.6% of the patients receiving aspirin doses > or =150 mg (hazard ratio [HR] 1.06 [95% confidence interval (CI) 0.94 to 1.19], p = 0.35). After adjusting for baseline imbalances and the propensity score for discharge aspirin dose, there was no effect of aspirin dose on the composite end point at six months (HR 0.92 [95% CI 0.79 to 1.07], p = 0.28). However, the higher aspirin dose was associated with a reduction in six-month MI (HR 0.79 [95% CI 0.64 to 0.98], p = 0.03). The outcome was similar when patients were matched on the basis of the propensity score for aspirin dose (HR for death/MI/stroke 0.94 [95% CI 0.80 to 1.12], p = 0.51), although stroke occurred significantly more frequently among patients receiving the higher aspirin dose (HR 1.74 [95% CI 1.01 to 3.02] p = 0.05) and the effect on MI was no longer apparent. CONCLUSIONS: Although these data are non-randomized, they suggest that the aspirin dose upon discharge may influence the clinical course after unstable angina or acute MI.

Aged↗
PubMed2004

Feasibility of endovascular cooling as an adjunct to primary percutaneous coronary intervention (results of the LOWTEMP pilot study).

In a nonrandomized feasibility study of therapeutic hypothermia in acute myocardial infarction, 18 patients were treated with endovascular cooling (Alsius, Irvine, California) as adjunctive therapy to primary percutaneous coronary intervention to assess measures of infarct size (area under the curve creatinine kinase-MB and technetium-99m single-photon emission computed tomography sestamibi) and the quality of myocardial perfusion (continuous ST-segment monitoring). Periprocedural endovascular cooling successfully decreased core body temperature (median 33.5 degrees C) and was well tolerated, which supports the evaluation of adjunctive hypothermia in pivotal trials to limit infarct size and decrease reperfusion injury.

Angioplasty, Balloon, Coronary↗
PubMed2004

Risk factors for intracranial hemorrhage and nonhemorrhagic stroke after fibrinolytic therapy (from the GUSTO-i trial).

Of 592 patients in the Global Utilization of Streptokinase and tPA for Occluded Arteries-I trial who had a stroke during initial hospitalization, the risk for intracranial hemorrhage was significantly greater in those with recent facial or head trauma (odds ratio 13.0, 95% confidence interval 3.4 to 85.5); dementia was additionally associated with an increased risk for intracranial hemorrhage (odds ratio 3.4, 95% confidence interval 1.2 to 10.2). Because facial or head trauma may greatly influence treatment decisions, this risk factor should be incorporated into models designed to estimate the risks and benefits of fibrinolytic therapy.

Aged↗
PubMed2004

Current concepts in the antithrombotic management of non-ST-elevation acute coronary syndromes.

The recognition that thrombosis is fundamental to acute coronary syndromes (ACS) has inspired the development of novel therapies to inhibit platelet aggregation and thrombus formation. Several recent advances have been made in the management of patients with non-ST-segment elevation ACS (NSTE ACS) to improve early and late clinical outcomes. The research efforts leading to these improvements in care have focused on antiplatelet and anticoagulant therapies coupled with early invasive treatment options. In particular, ongoing clinical trials seek to refine treatment strategies for patients relative to individual risk presentation, the availability of facilities for invasive procedures, and the timing of revascularization. However, even despite the proven efficacy of currently available therapies to reduce the occurrence of death and/or myocardial infarction, still many eligible patients with high-risk NSTE ACS do not receive such treatments. This review provides a pathophysiologic rationale for antithrombotic therapies in ACS, examines the results of recent trials, and presents future directions for clinical investigation.

Angina, Unstable↗
PubMed2004

Improved clinical outcomes with abciximab therapy in acute myocardial infarction: a systematic overview of randomized clinical trials.

BACKGROUND: Investigations of glycoprotein (GP) IIb/IIIa inhibition in primary percutaneous coronary intervention (PCI) have suggested the efficacy of abciximab in improving clinical and angiographic outcomes, but sample-size limitations and variability in trial design preclude the ability to generalize these results to a broader patient population. METHODS: Meta-analytic techniques were used to evaluate clinical outcomes from randomized trials comparing GP IIb/IIIa inhibition with placebo or control therapy in primary PCI for acute myocardial infarction (MI). RESULTS: In 3266 patients, treatment with abciximab significantly reduced the 30-day composite end point of death, reinfarction, or ischemic or urgent target-vessel revascularization (TVR; odds ratio [OR], 0.54; 95% CI, 0.40-0.72), with trends toward reduced 30-day death and death or reinfarction. Abciximab resulted in an increased likelihood of major bleeding (OR, 1.74; 95% CI, 1.11-2.72). By 6 months, abciximab significantly reduced the occurrence of death, reinfarction, or any TVR (OR, 0.80; 95% CI, 0.67-0.97), and there were positive trends favoring a decrease in mortality alone and the composite of death or reinfarction. CONCLUSIONS: Treatment with abciximab significantly reduces early adverse ischemic events, a clinical benefit that is maintained at 6-month follow-up. These findings support the use of adjunctive GP IIb/IIIa inhibition in primary PCI.

Abciximab↗
PubMed2004

The challenges of chronic total coronary occlusions: an old problem in a new perspective.

In spite of the remarkable technological innovation and improved outcomes with percutaneous coronary revascularization, chronic coronary artery total occlusions remain a familiar source of procedural frustration and clinical uncertainty. However, considering the recent development of catheter-based technologies specific for chronic total occlusion (CTO) recanalization and the potential for drug-eluting stents to reduce restenosis and reocclusion, this challenging lesion subset is now recognized as the last formidable barrier to percutaneous revascularization success. Further, consistent observations from more recent clinical trials support successful CTO revascularization to avoid subsequent adverse cardiac events and improve long-term overall survival. This review of total coronary occlusions provides an overview of CTO pathophysiology, describes the procedural and clinical outcomes associated with CTO revascularization, and presents future directions for clinical investigation.

Angiography↗
PubMed2003

Feasibility and implications of an early discharge strategy after percutaneous intervention with abciximab in acute myocardial infarction (the CADILLAC Trial).

Early complications may hamper efforts to hasten discharge after primary percutaneous coronary intervention (PCI) for myocardial infarction (MI). Glycoprotein IIb/IIIa inhibitors, by reducing early recurrent ischemia, may aid in these efforts. We examined whether adjunctive abciximab could accelerate discharge and reduce costs within a trial of primary PCI after acute MI. The CADILLAC trial randomized 2,082 patients with MI to 1 of 4 reperfusion strategies in a 2 x 2 factorial design: angioplasty, angioplasty with abciximab, stent implantation, or stenting with abciximab. Patients randomized to abciximab had postprocedural heparin withheld, and discharge scheduled for days 1.5 to 2 (low-risk patients) or days 2 to 3 (high-risk patients) after MI if they were stable. Other patients were discharged at the physician's discretion. Abciximab treatment was associated with significant reductions in the primary end points of in-hospital death, reinfarction, ischemic target vessel revascularization (TVR), or disabling stroke (5.6% vs 2.7%, p = 0.003)--largely reflecting reduced ischemic TVR (3.8% vs 1.4%, p = 0.002)--and in early subacute thrombosis (1.3% vs 0.2%, p = 0.01). Hospitalization was significantly shorter in abciximab-treated patients (median 3.1 vs 3.5 days, p <0.001), but total in-hospital costs did not differ significantly (13,413 +/- 5,309 US dollars vs 13,000 +/- 6,006 US dollars, p = 0.13). Rates of the composite end point did not differ significantly during the week after discharge (0.8% vs 0.2%, p = 0.10), nor did component event rates. Abciximab during primary PCI is associated with fewer early adverse outcomes, likely contributing to offset its cost. Hospitalizations after primary PCI are so short, however, that efforts to accelerate discharge with abciximab appear unfeasible, and overall costs remain unchanged.

Abciximab↗
PubMed2003

Meta-analysis of survival with platelet glycoprotein IIb/IIIa antagonists for percutaneous coronary interventions.

We performed a cumulative meta-analysis of available studies to evaluate the effect of intravenous platelet glycoprotein (GP) IIb/IIIa antagonists on survival at 30 days and 6 months after percutaneous coronary intervention (PCI). Compounds that block the GP IIb/IIIa receptor substantially reduce myocardial infarctions (MIs) and repeat revascularization. We included 12 trials, which enrolled 20,186 patients in all, in the analysis. Overall, 30-day mortality was significantly reduced with GP IIb/IIIa inhibition (odds ratio 0.73, 95% confidence interval 0.55 to 0.96, p = 0.024). Although 10 of the 12 trials showed a beneficial effect of GP IIb/IIIa inhibitor treatment on mortality, no individual trial detected a statistically significant mortality benefit. The 30-day mortality benefit became significant at the p <0.05 level with addition of the ADMIRAL trial and was further enhanced by the CADILLAC trial. No significant heterogeneity was detected in the collection of trials. At 6 months, the odds ratio was 0.84 (95% confidence interval 0.69 to 1.03, p = 0.087). This survival benefit amounts to preventing approximately 1 of every 3 deaths that occur within 30 days after PCI, saving 2.8 lives/1,000 patients treated (number needed to treat, 357). Thus, patients who undergo PCI can expect significantly lower 30-day mortality, in addition to known reductions in nonfatal MI and repeat procedures, with GP IIb/IIa inhibition. There also is increasing evidence that mortality reductions are preserved at 6 months.

Angioplasty, Balloon, Coronary↗
PubMed2003

Reduction of myocardial ischemic injury following coronary intervention (the MC-1 to Eliminate Necrosis and Damage trial).

Myocardial ischemic injury complicating acute myocardial infarction (AMI) and coronary revascularization procedures remains an unresolved clinical dilemma. In preclinical studies, treatment with pyridoxal-5'-phosphate monohydrate (MC-1), a vitamin B6 metabolite, has demonstrated cardioprotective effects. Sixty patients scheduled for elective percutaneous coronary intervention (PCI) who had clinically high-risk characteristics for ischemic complications were randomized to treatment with MC-1 or placebo in a 2:1 double-blinded fashion. The primary end point was defined as infarct size as measured by area under the curve creatine kinase MB (CK-MB) enzymes. Secondary end points included periprocedural ischemia as assessed by continuous electrocardiographic monitoring, 30-day major adverse cardiac events, and net clinical safety, which included liver function testing. The primary end point, median periprocedural CK-MB area under the curve, was reduced from 32.9 ng/ml in the placebo group to 18.6 ng/ml with MC-1 treatment (p = 0.038), reflecting a shift in the distribution of CK-MB. By categorical classification, the occurrence of 30-day nonfatal AMI did not differ between groups. There were no deaths, and 30-day composite adverse event rates were similar (17.9% MC-1 vs 15.0% placebo, p = 1.0). There were no significant differences in ischemia parameters per continuous electrocardiographic monitoring, and no safety issues were identified. In this phase II pilot study, treatment of high-risk patients who underwent PCI with MC-1 was associated with a decrease in the total amount of CK-MB released after PCI. These results support the evaluation of MC-1 in pivotal trials of patients at risk for developing myocardial ischemia, infarction, or reperfusion injury.

Aged↗
PubMed2003

Benefits and risks of abciximab use in primary angioplasty for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.

BACKGROUND: Trials of platelet glycoprotein IIb/IIIa inhibitors as adjuncts to primary percutaneous coronary intervention for acute myocardial infarction (MI) have shown improved early clinical and angiographic outcomes with treatment. However, variations in trial designs, modest sample sizes, and limited long-term follow-up have precluded these studies from being definitive. METHODS AND RESULTS: As a prespecified secondary analysis of the CADILLAC trial, we compared early and late outcomes by abciximab assignment among 2082 patients randomized in an open-label, 2x2 factorial-design trial of primary stenting versus angioplasty and abciximab treatment (n=1052) versus no abciximab treatment (n=1030). Baseline characteristics were balanced between groups. Abciximab treatment was associated with a significant reduction in the composite end point of death, MI, ischemia-driven target-vessel revascularization (TVR), or disabling stroke at 30 days (4.6% versus 7.0%; relative risk, 0.65; 95% CI, 0.46 to 0.93; P=0.01). Subacute thrombosis also was significantly reduced with abciximab treatment. At 12 months, however, rates of the composite end point did not differ significantly (18.4% for controls versus 16.9% for abciximab-treated patients; relative risk, 0.92; 95% CI, 0.76 to 1.10; P=0.29), reflecting a decrease in the relative difference in TVR rates (ie, no effect of abciximab on reducing restenosis). In an angiographic substudy (n=656), myocardial salvage, restenosis, and infarct-artery reocclusion at 7 months were unaffected by abciximab treatment. There was no significant interaction between stenting and abciximab treatment. CONCLUSIONS: Adjunctive abciximab treatment during primary percutaneous coronary intervention significantly enhanced 30-day event-free survival, predominantly by reducing ischemia-driven TVR. Abciximab treatment did not affect the composite end point at 1 year, reflecting a lack of effect on restenosis.

Abciximab↗
PubMed2003

The VB-1 catheter: a novel catheter for peripheral arterial revascularization.

Despite recent advances in catheter-based technologies for peripheral arterial revascularization, adequate guide catheter positioning and support remains a leading procedural challenge. This report describes the adaptation of the Behar Internal Mammary VB-1 catheter for peripheral revascularization procedures in patients with complex anatomy not amendable to other conventional peripheral guide catheters.

Aged↗
PubMed2003

Clinical and angiographic efficacy of a self-expanding nitinol stent in saphenous vein graft atherosclerotic disease: the Stent Comparative Restenosis (SCORES) Saphenous Vein Graft Registry.

BACKGROUND: The Stent Comparative Restenosis (SCORES) Saphenous Vein Graft (SVG) Registry was a multicenter, prospective registry designed to evaluate the safety and efficacy of a self-expanding, nickel-titanium (nitinol) stent for de novo SVG lesions. METHODS: In all, 159 patients with de novo vein graft lesions > or =2.75 and < or =4.25 mm in diameter and <30 mm in length underwent stenting with the Radius self-expanding stent. The primary end point was target vessel failure (TVF) at 9 months, which was defined as a composite of procedural failure, death, myocardial infarction, or target vessel revascularization. RESULTS: Procedural success was achieved in 96.8% of patients, and the 30-day incidence of major adverse cardiac events was 2.5%. The binary rate of restenosis at 6 months was 28.6%. By 9 months, the rate of TVF was 24.5%, and the rate of major adverse cardiac events was 23.1%. The 9-month Kaplan-Meier survival rates for freedom from TVF and target lesion revascularization were 76.0% and 87.9%, respectively. No clinical or angiographic characteristic was predictive of restenosis. CONCLUSIONS: In de novo atherosclerotic SVG disease, the use of a self-expanding, nitinol stent was associated with high initial procedural success and favorable early and intermediate outcomes. Because few studies have examined the influence of stent composition and design in SVG disease, these findings not only show the safety and efficacy of this self-expanding stent in de novo SVG disease, but also merit further comparison with balloon-expandable stents.

Aged↗
PubMed2003

Aspirin use post-acute coronary syndromes: intolerance, bleeding and discontinuation.

BACKGROUND: While aspirin's secondary prevention benefit is clear, prior reports indicate that 19-83% of eligible patients may not use aspirin chronically. METHODS: We investigated intolerance and bleeding while on aspirin and aspirin discontinuation using 5337 post-acute coronary syndrome patients considered appropriate for chronic antiplatelet therapy who were randomly assigned to aspirin in SYMPHONY and 2nd SYMPHONY and followed for 94 (64,157) days. Multivariable logistic regression models tested associations between baseline characteristics and aspirin discontinuation and bleeding. RESULTS: Nearly 18% of patients discontinued study aspirin; 48% subsequently used open-label aspirin and 5% other antiplatelet or anticoagulant therapy. Black race, recurrent ischemia, hypertension, chronic obstructive pulmonary disease, lighter weight, shorter time to treatment and use of non-steroidal anti-inflammatory agents, diuretics, and digitalis were independently associated with early discontinuation. Early discontinuation was less likely in Eastern Europe, Latin America and Asia. Although major or minor bleeding was common (12.6%), only 1.0% of aspirin-treated patients were reported to discontinue due to bleeding. Gastrointestinal (10.5%) and puncture site (7.6%) were the most common bleeding locations. Bleeding risk was associated with lower estimated creatinine clearance, shorter time to treatment, smoking, Killip class >II, higher systolic blood pressure, and use of aspirin or heparin prior to starting study aspirin. CONCLUSIONS: Despite early initiation and close follow-up, more than 9% of aspirin-treated patients discontinued therapy early and remained off treatment. Addressing the factors associated with both bleeding and discontinuation during chronic therapy is necessary to improve adherence to this inexpensive, life-saving therapy.

Acute Disease↗
PubMed2003

Double negatives.

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Coronary Angiography↗
PubMed2003

Contrast nephropathy : an evidence-based approach to prevention.

Contrast-induced nephropathy occurs in 2-10% of patients exposed to intravascular radiographic contrast agents and results in significant morbidity and mortality. Although the exact mechanism of this disorder has not been fully elucidated, contrast nephropathy is probably due to a combination of decreased renal medullary blood flow, resulting in medullary ischemia, and direct toxicity to renal tubules. Contrast nephropathy is most commonly defined as either a >25% increase or a >0.5 mg/dL rise in serum creatinine level within 48 hours of contrast medium exposure. Baseline characteristics associated with an increased risk for development of contrast nephropathy include the presence of baseline renal dysfunction, diabetes mellitus, congestive heart failure, volume depletion, and concomitant administration of nephrotoxic drugs. Many strategies have been investigated in an effort to prevent the occurrence of renal dysfunction following contrast media exposure. Intravenous hydration has been shown to significantly decrease the incidence of nephropathy in high-risk patients. However, trials of several prophylactic pharmacologic interventions have been mostly disappointing, including the administration of calcium channel antagonists, diuretics, dopamine, endothelin receptor antagonists and fenoldopam. The use of N-acetylcysteine has been shown in some trials to decrease the incidence of contrast nephropathy in patients with a baseline renal dysfunction, and should currently be strongly considered in this high-risk patient subgroup in addition to hydration. Our purpose is to review the contemporary literature regarding contrast-induced renal dysfunction and present an evidence-based approach for prevention of this complication.

Acute Kidney Injury↗
PubMed2003

Catheter-based revascularization of the hepatic artery to treat coronary steal from a gastroepiploic artery bypass graft.

During diagnostic cardiac catheterization for symptoms of progressive angina, a high-grade ostial stenosis of an aberrant hepatic artery was identified. The common hepatic artery, which originated directly from the aorta rather than the celiac artery, supplied an in situ gastroepiploic artery bypass graft to the distal right coronary artery. Reduced flow within the bypass graft was observed consistent with a steal phenomenon from the coronary artery. This report describes successful angioplasty and stenting of the hepatic artery to salvage the gastroepiploic bypass graft and resolve the patient s ischemic symptoms.

Angina, Unstable↗