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Biomedical subjects

Alexandra J Lansky

Publications and source records attributed to Alexandra J Lansky.

At least 91 records · Page 5Linked to original sources
PubMed2003

Prospective, randomized evaluation of thrombectomy prior to percutaneous intervention in diseased saphenous vein grafts and thrombus-containing coronary arteries.

OBJECTIVES: We sought to determine whether routine thrombectomy prior to stent implantation in diseased saphenous vein grafts (SVGs) and thrombus-containing native coronary arteries would reduce peri-procedural myonecrosis and subsequently enhance event-free survival. BACKGROUND: Percutaneous coronary intervention in diseased SVGs and thrombotic native coronary arteries is complicated by a high rate of peri-procedural myocardial infarction (MI). Thrombectomy prior to intervention may enhance the safety of intervention and improve early and late outcomes in these high-risk patients. METHODS: At 60 centers in the U.S. and Canada, 797 patients with 839 diseased SVGs or thrombus-containing native coronary arteries were prospectively randomized to stent implantation with versus without prior thrombectomy with the X-SIZER device (ev3, Plymouth, Minnesota). RESULTS: Peri-procedural MI occurred in 15.8% of patients assigned to the X-SIZER device compared with 16.6% of control patients (p = 0.77), although the rate of large MI (pre-specified as the development of new pathologic Q waves or creatine phosphokinase-MB isoenzyme elevation >8 x upper limits of normal) was reduced with X-SIZER device use from 9.6% to 5.5% (multivariate risk ratio 0.35 [95% confidence interval 0.18 to 0.66], p = 0.002). Major adverse cardiac events (cardiac death, MI, or repeat target vessel revascularization) occurred in 16.8% of X-SIZER patients versus 17.1% of control patients at 30 days (p = 0.92), and in 31.3% of X-SIZER patients versus 28.2% of control patients at 1 year (p = 0.35). CONCLUSIONS: Thrombectomy with the X-SIZER device prior to stent implantation in high-risk diseased SVGs and thrombus-containing native coronary arteries may reduce the extent, but not the occurrence, of myonecrosis. Early and late event-free survival, however, were not improved by routine thrombectomy with this device.

Adult↗
PubMed2003

Acute and long-term outcomes of cutting balloon angioplasty followed by gamma brachytherapy for in-stent restenosis.

In-stent restenosis lesions were divided into 2 groups according to the use of cutting balloon (n = 76) or conventional balloon angioplasty (n = 407) before gamma-brachytherapy. Cutting balloon angioplasty, compared with conventional balloon angioplasty, in patients undergoing gamma-brachytherapy for in-stent restenosis is associated with less requirement for new stents (11% vs 22%, p = 0.02) but similar target vessel revascularization (35.1% vs 29.8%, p = 0.4) at follow-up.

Aged↗
PubMed2003

Impact of renal insufficiency in patients undergoing primary angioplasty for acute myocardial infarction.

BACKGROUND: The prognostic importance of renal insufficiency (RI) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) has not been well characterized. METHODS AND RESULTS: PCI was performed in 2082 AMI patients without shock presenting within 12 hours of symptom onset in a prospective, multicenter randomized trial. RI was defined as a calculated (Cockroft-Gault) creatinine clearance (CrCl) < or =60 mL/min. RI at baseline was present in 18% of patients. Compared with patients without RI, patients with RI were older and were more likely to be female; to have hypertension, peripheral vascular disease, or cerebrovascular disease; and to present in heart failure. Mortality was markedly increased in patients with versus without baseline RI both at 30 days (7.5% versus 0.8%, P<0.0001) and at 1 year (12.7% versus 2.4%, P<0.0001). Mortality rates increased incrementally for every 10-mL/min decrease in baseline CrCl. By multivariate analysis, reduced baseline CrCl was a powerful independent predictor of 30-day mortality (hazard ratio, 5.77; P<0.0001) and remained associated with reduced survival at 1 year (hazard ratio, 1.98; P=0.08). Hemorrhagic complications and transfusion requirements were also increased more than 2-fold in patients with RI, as were severe restenosis (diameter stenosis > or =70%; 20.6% versus 11.8%, P=0.024) and infarct artery reocclusion (14.7% versus 7.3%, P=0.02). CONCLUSIONS: Baseline RI in patients with AMI undergoing primary PCI is associated with a markedly increased risk of mortality, as well as bleeding and restenosis. Novel approaches are needed to improve the otherwise poor prognosis of patients with RI and AMI.

Abciximab↗
PubMed2003

Optimal final lumen area and predictors of target lesion revascularization after stent implantation in small coronary arteries.

Despite similar early clinical events, patients who undergo treatment of small vessels are at an increased risk for target lesion revascularization (TLR) after coronary artery stenting. We sought to determine predictors of TLR after stent implantation in small coronary arteries. We identified 423 consecutive patients who underwent intravascular ultrasound (IVUS)-guided small vessel stenting procedures in 465 coronary lesions with an angiographic reference vessel diameter of <2.75 mm. Patients were divided into 2 groups based on a final IVUS lumen area of < or =6.0 mm2 (n=345 lesions, group I) and >6.0 mm2 (n=115, group II). Baseline patient characteristics and in-hospital outcomes were similar between the 2 groups, except for a higher rate of restenotic lesions in group I and bifurcation lesions in group II. Group I had higher TLR rates at 1 year compared with group II patients (39% vs 26%, p = 0.02). The TLR rate appeared to decrease with greater stent expansion, especially at >90% of the reference vessel area, as assessed by IVUS. By multivariate analysis, an IVUS final stent area of < or =6 mm2, diabetes, absence of prior myocardial infarction, and history of intervention were independent predictors of 1-year TLR in this population. Final stent area of >6.0 mm2 and greater stent expansion were associated with a decrease in TLR. Therefore, there does not appear to be any "downside" to aggressive stent implantation strategies in small vessels. In contrast, IVUS allows maximization of final lumen dimensions to minimize clinical restenosis.

Aged↗
PubMed2003

Usefulness of the angiographic pattern of in-stent restenosis in predicting the success of gamma vascular brachytherapy.

The prognostic role of the angiographic pattern of in-stent restenosis after gamma vascular brachytherapy was assessed from a pooled data set of 4 clinical trials comprising 295 irradiated patients with matched baseline and follow-up angiograms. The binary angiographic restenosis rate increased with worsening in-stent restenosis patterns; however, target lesion revascularization and major adverse cardiac event rates increased for focal, diffuse, and proliferative patterns of in-stent restenosis but not for total occlusions.

Aged↗
PubMed2003

Intravascular ultrasound assessment of ulcerated ruptured plaques: a comparison of culprit and nonculprit lesions of patients with acute coronary syndromes and lesions in patients without acute coronary syndromes.

BACKGROUND: It is not clear why some plaque ruptures lead to acute coronary syndromes (ACS) but others do not. METHODS AND RESULTS: We analyzed 80 plaque ruptures in 74 patients and compared culprit lesions of ACS patients with nonculprit lesions of ACS patients and lesions of non-ACS patients; both culprit and nonculprit plaque ruptures were studied in 6 of 54 ACS patients. Intravascular ultrasound findings suggesting thrombus were observed more frequently in culprit lesions of ACS patients (n=35) compared with nonculprit lesions of ACS patients (n=19) and lesions of non-ACS patients (n=26): 60% versus 32% versus 8% (P<0.001). At the minimal lumen site, smaller lumen areas (3.3+/-1.5 versus 5.4+/-2.6 versus 6.1+/-2.0 mm2, P<0.001) and greater area stenosis (61+/-15% versus 50+/-14% versus 46+/-18%, P=0.002) and plaque burden (80+/-8% versus 71+/-8% versus 69+/-10%, P<0.001) were observed in culprit lesions of ACS patients compared with nonculprit lesions of ACS patients and lesions of non-ACS patients. Lesions were longer (18.7+/-6.4 versus 154.9+/-6.1 versus 12.0+/-4.9 mm, P<0.001) and rupture site remodeling indices were greater (1.26+/-0.21 versus 1.24+/-0.21 versus 1.09+/-0.05, P=0.002). Independent predictors of culprit plaque ruptures in ACS patients were smaller minimum lumen areas (P=0.02) and presence of thrombus (P=0.01). CONCLUSIONS: Ruptured plaques in culprit lesions of ACS patients have smaller lumens; greater plaque burdens, area stenosis, and remodeling indices; and more thrombus. Plaque rupture itself does not lead to symptoms. The association of plaque rupture with a smaller lumen area and/or thrombus formation causes lumen compromise and leads to symptoms.

Acute Disease↗
PubMed2003

Outcomes following bail-out abciximab administration during primary intervention in acute myocardial infarction (The CADILLAC Trial).

The utility of glycoprotein IIb/IIIa receptor inhibitors as a "bail-out" modality after unsuccessful primary percutaneous coronary intervention for acute myocardial infarction is unknown. In the CADILLAC trial, of 1,030 control patients, 62 patients (6.0%) crossed over and received abciximab for procedural complications or suboptimal angioplasty results. Compared with patients who received routine upfront abciximab, those treated with bail-out abciximab had markedly lower rates of Thrombolysis In Myocardial Infarction grade 3 flow and increased rates of hemorrhagic and ischemic complications at 30 days and 1 year.

Abciximab↗
PubMed2003

Outcomes of bail-out stenting for suboptimal balloon angioplasty during primary intervention in acute myocardial infarction (The CADILLAC trial).

The results of bail-out stenting after unsuccessful primary balloon angioplasty compared with routine stenting or successful balloon angioplasty in acute myocardial infarction are unknown. In the CADILLAC trial, 168 of 1,044 patients (16.1%) randomized to balloon angioplasty crossed over to stenting after unsuccessful dilatation. Event-free survival was similar after bail-out and routine stenting, and was greater than after successful balloon angioplasty.

Aged↗
PubMed2003

Comparison of effect of glycoprotein IIb/IIIa inhibitors during percutaneous coronary interventions on risk of hemorrhagic stroke in patients >or=75 years of age versus those <75 years of age.

Of 1,369 consecutive patients who underwent stent-assisted coronary angioplasty and who were treated with glycoprotein IIb/IIIa inhibitors during these procedures, 17.5% were >or=75 years of age. Compared with patients <75 years old, those >or=75 years of age had similar procedural and in-hospital outcomes but significantly higher rates of hemorrhagic stroke (0.08% vs 1.2%, p <0.001).

Age Factors↗
PubMed2003

Outcomes of optimal or "stent-like"balloon angioplasty in acutemyocardial infarction: the CADILLAC trial.

OBJECTIVES: We sought to compare outcomes between patients with acute myocardial infarction (AMI) undergoing percutaneous transluminal coronary angioplasty (PTCA) with an optimal or "stent-like" result versus patients who underwent routine stent placement. BACKGROUND: Recent studies in patients with AMI undergoing stent implantation have suggested that PTCA may no longer be a relevant treatment modality for stent eligible lesions. However, whether routine stent placement is superior or necessary when an optimal PTCA or "stent-like" result is achieved is unknown. METHODS: In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial, 2,082 patients with AMI were randomly assigned to undergo PTCA alone, PTCA + abciximab, stenting alone, or stenting + abciximab. Outcomes were compared in patients achieving an optimal acute PTCA result (residual core laboratory diameter stenosis <30% without significant dissection) versus those assigned to routine stenting. RESULTS: Optimal PTCA was achieved in 40.7% of patients randomized to balloon angioplasty, including 38.5% and 42.7% assigned to PTCA alone and PTCA + abciximab, respectively. Ischemic target vessel revascularization (TVR) at 30 days occurred more frequently after optimal PTCA than routine stenting (5.1% vs. 2.3%, p = 0.007). The one-year composite adverse event rate (death, reinfarction, disabling stroke, or TVR) was greater after optimal PTCA than routine stenting (21.9% vs. 13.8%, p < 0.001), driven largely by increased rates of ischemic TVR (19.1% vs. 9.1%, p < 0.001); no significant differences were present in the rates of death, reinfarction, or disabling stroke between the two groups. Angiographic restenosis also was more common with optimal PTCA than routine stenting (36.2% vs. 22.2%, p = 0.003). Even a post-PTCA diameter stenosis of <20% (realized in 12% of patients) did not result in outcomes equivalent to stenting. CONCLUSIONS: Even if an optimal result is achieved after primary PTCA in AMI, early and late outcomes can be further improved with routine stent implantation.

Abciximab↗
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

Safety of an aspirin-alone regimen after intracoronary stenting with a heparin-coated stent: final results of the HOPE (HEPACOAT and an Antithrombotic Regimen of Aspirin Alone) study.

BACKGROUND: Stent thrombosis is an infrequent complication of intracoronary stenting that often has devastating clinical consequences. This study assesses the additional benefit of heparin coating with the BX VELOCITY Balloon-Expandable Stent with HEPACOAT, Carmeda end-point attached heparin (HEPACOAT) in patients with de novo or restenotic native coronary artery lesions treated with aspirin monotherapy after optimal stenting. METHODS AND RESULTS: This was a multicenter, prospective, nonrandomized, pilot study. Two hundred patients (69% men; mean age, 64.1+/-11.2 years) meeting the eligibility criteria were treated with the HEPACOAT stent and aspirin alone after stenting. Any other antiplatelet or anticoagulation therapy was not permitted. Procedural success was achieved in all patients. There were 3 postprocedural non-Q-wave myocardial infarctions. The primary end point of stent thrombosis at 30 days occurred in 2 of 200 patients (1%): in one after blunt chest trauma and in the other in the setting of essential thrombocytosis. Major adverse cardiac events (death, myocardial infarction, target lesion revascularization, and coronary artery bypass grafting) were observed at 30 days in 5 of 200 (2.5%) patients. CONCLUSIONS: The BX VELOCITY stent with HEPACOAT and aspirin alone after the procedure was safe in select patients with de novo or restenotic lesions in native coronary arteries. Heparin coating provides additional protection against stent thrombosis.

Angioplasty, Balloon, Coronary↗
PubMed2003

Comparison of in-hospital and one-year outcomes after multiple coronary arterial stenting in patients > or =80 years old versus those <80 years old.

The present study evaluated in-hospital and 1-year outcomes after multivessel stenting in patients aged > or =80 (75 patients, 241 lesions) and <80 years (894 patients, 2,678 lesions). Despite a high technical success rate of multivessel stenting, octogenarians had higher in-hospital cardiac and noncardiac complication rates and a higher mortality rate at 1-year clinical follow-up compared with their younger counterparts.

Aged↗
PubMed2003

Usefulness of a cobalt chromium coronary stent alloy.

The cobalt chromium Guidant Multi-Link Vision coronary stent was deployed in 267 patients as part of a multicenter international registry. Major adverse cardiovascular events were infrequent, and late (180 days) quantitative angiography demonstrated binary (>50%) in-stent restenosis in 15.7% of patients. This registry establishes the safety and efficacy of this alloy as a coronary stent platform.

Adult↗
PubMed2003

Long-term follow-up of patients after gamma intracoronary brachytherapy failure (from GAMMA-I, GAMMA-II, and SCRIPPS-III).

We report the long-term outcome of 225 patients who failed gamma-brachytherapy for in-stent restenosis. Total adverse events, target vessel revascularization, and myocardial infarction were higher after repeat percutaneous coronary intervention versus coronary artery bypass grafting. Therefore, coronary artery bypass grafting may be the preferable first-line therapy in these patients until other therapies (i.e., drug-eluting stents) are available. Shorter time from brachytherapy to radiation failure and late thrombosis after brachytherapy were independent predictors of adverse events.

Brachytherapy↗
PubMed2003

Correlation of coronary arterial remodeling determined by intravascular ultrasound with angiographic diameter reduction of 20% to 60%.

Negative remodeling is commonly observed in stenotic coronary lesions. It is unknown whether negative remodeling is an early or late event. This study was designed to elucidate when negative remodeling occurs in the development of coronary stenosis. Remodeling was assessed by preintervention intravascular ultrasound in 104 native coronary lesions with intermediate stenosis (20% to 60% of diameter stenosis measured by quantitative coronary angiography). Positive remodeling was defined as lesion external elastic membrane (EEM) cross-sectional area (CSA) greater than the proximal reference, intermediate remodeling as lesion EEM CSA between those of the proximal and distal references, and negative remodeling as lesion EEM CSA less than the distal reference. Positive, intermediate, and negative remodeling were observed in 18%, 32%, and 50%, respectively, of lesions with intermediate stenosis. Lesions with negative and intermediate remodeling had more hard plaque compared with those with positive remodeling (79% vs 70% vs 42%, p = 0.02). Calcium was more frequent in lesions with negative and intermediate remodeling than in those with positive remodeling (52% vs 55% vs 16%, p = 0.01). Lesions with negative remodeling had smaller EEM CSA (11.5 +/- 5.2 vs. 13.7 +/- 3.4 vs 14.5 +/- 5.6 mm(2), p = 0.03) and less plaque (7.9 +/- 4.6 vs 10.8 +/- 3.4 vs 10.8 +/- 4.9 mm(2), p = 0.004) compared with positive and intermediate remodeling lesions, although lumen CSA (3.7 +/- 1.7 vs 2.8 +/- 0.8 vs 3.6 +/- 1.3 mm(2), p = 0.1) and area stenosis (57 +/- 15% vs 59 +/- 14% vs 56 +/- 10%, p = 0.7) were similar. Negative remodeling is frequently observed in lesions with intermediate stenosis. This suggests that negative remodeling occurs early in lesion formation.

Aged↗