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Alexandra J Lansky

Publications and source records attributed to Alexandra J Lansky.

122 records · Page 7Linked to original sources
PubMed2002

Clinical and angiographic outcomes after use of 90Strontium/90Yttrium beta radiation for the treatment of in-stent restenosis: results from the Stents and Radiation Therapy 40 (START 40) registry.

PURPOSE: To evaluate the safety and efficacy of a 40-mm 90Strontium/90Yttrium source train in the management of in-stent restenosis within native coronary arteries. MATERIALS AND METHODS: This multicenter, prospective registry was designed to compare the results of patients with in-stent restenosis treated with a 40-mm source train to the placebo arm of the previously reported randomized Stents and Radiation Trial (START). All patients entered in the registry were treated with repeat balloon angioplasty followed by intravascular brachytherapy. Radiation dose was prescribed based on vessel size. 18 Gy was delivered at 2 mm for vessel diameters between 2.75 and 3.35 mm, and 23 Gy was used for vessels between 3.36 and 4.0 mm. The efficacy endpoints for the START 40 registry included a reduction in the target lesion revascularization (TLR) rate, target vessel revascularization rates, and target vessel failure (TVF) at 8 months. Secondary angiographic efficacy endpoints were binary restenosis at 8 months, in-stent minimum luminal diameter (MLD), and late loss. The safety endpoints included major adverse cardiac events as well as late aneurysm formation. The registry was designed to allow a statistically valid comparison of these results to the placebo group of the START 30 trial. Quantitative angiographic analysis was performed on the 8-month follow-up examination. Rates of restenosis were evaluated for various segments of the treated vessel. A separate analysis was performed to evaluate the relationship between vessel injury length and the radiated segment. RESULTS: A total of 207 patients were entered into the START 40 registry. The postprocedure angiographic results, including the postprocedure MLD and percent diameter stenosis, were similar between the START 40 patients and the placebo group from the START trial in the stented segment of the treated vessel. Eight-month angiographic follow-up was available on 150 patients from the registry. The TLR rate was significantly reduced when compared to the placebo group (11% vs. 22.4% respectively, p = 0.008). A similar reduction was seen in terms of target vessel revascularization (15.9% vs. 24.1%, p = 0.03). The 8-month MLD was found to be significantly larger in the START 40 patients (1.85 mm vs. 1.47 mm, p < 0.0001). The difference seen in the clinical endpoint of TVF (19.3% vs. 25.9%) did not reach statistical significance (p = 0.1). Analysis of the procedural angiograms revealed mismatch between the length of vessel injured and the location of the 90% isodose in 46% of the treated cases. Angiographic analysis revealed that geographic miss was associated with a higher rate of binary restenosis (32% vs. 18% p = 0.04) in the analysis segment. CONCLUSIONS: This multicenter registry demonstrates the safety and efficacy of a 40-mm 90Strontium/90Yttrium source train in the management of patients with in-stent restenosis. Restenosis rates were lowered with the use of this longer source train when compared to the placebo arm of the START trial for lesions with a maximum vessel injury length of 20 mm. Angiographic analysis identified the importance of the accurate delineation of injury length and correct source positioning. These results support the continued use of beta radiation for the treatment of this disease process.

Brachytherapy↗
PubMed2002

Quantitative coronary angiography in regression trials: a review of methodologic considerations, endpoint selection, and limitations.

Several quantitative angiographic methods (visual assessment, digital hand-held calipers, and automated edge detection) have been successfully used to assess coronary atherosclerosis regression. These methods are applicable for (1) continuous measures of disease progression and regression, including patient-based, segment-based, and lesion-based analyses; and (2) categorical assessment of disease progression and regression (the use of a predefined threshold to categorize the course of disease). Angiographic methods and criteria for assessing disease progression each have distinct advantages and disadvantages, which accounts for the methodologic diversity seen in clinical trials.

Coronary Angiography↗
PubMed2002

Impact of normalized myocardial perfusion after successful angioplasty in acute myocardial infarction.

OBJECTIVES: We sought to evaluate and validate the ability of the angiographic myocardial blush grade to risk stratify patients after successful angioplasty in acute myocardial infarction (AMI). BACKGROUND: Although epicardial Thrombolysis In Myocardial Infarction (TIMI)-3 flow is restored in >90% of patients undergoing primary percutaneous coronary intervention (PCI), normal myocardial perfusion may be present less frequently and may detrimentally impact survival. METHODS: A cohort of 173 consecutive patients undergoing intervention within 24 h of AMI onset were studied. High-risk features of this population included failed thrombolysis in 39%, cardiogenic shock in 17% and saphenous vein graft culprit in 11% of patients. RESULTS: Despite the restoration of TIMI-3 flow in 163 (94.2%) patients, myocardial perfusion, as evidenced by normal contrast opacification of the myocardial bed subtended by the infarct artery (myocardial blush), was normal in only 29.4% of patients with TIMI-3 flow following PCI, and in no patient with TIMI 0 to 2 flow. In patients in whom TIMI-3 flow was restored, survival was strongly dependent on the myocardial perfusion grade; one-year cumulative mortality was 6.8% with normal myocardial blush, 13.2% with reduced myocardial blush and 18.3% in patients with absent myocardial blush (p = 0.004). CONCLUSIONS: Abnormal myocardial perfusion is present in most patients following primary or rescue PCI in AMI, despite restoration of brisk epicardial coronary flow. In high risk patients achieving TIMI-3 flow after intervention, the myocardial blush score may be used to stratify prognosis into excellent, intermediate and poor survival. Further study is warranted to examine whether adjunctive mechanical or pharmacologic strategies can further improve myocardial perfusion and survival of patients with acute myocardial infarction undergoing intervention.

Aged↗
PubMed2002

Use of localised intracoronary beta radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial.

BACKGROUND: In-stent restenosis is a major limitation of intracoronary stenting. Ionising gamma radiation has been shown to reduce recurrence of restenosis after stent placement. We aimed to compare the effects of intracoronary beta radiation treatment with those of placebo for clinical and angiographic outcomes of patients with diffuse in-stent restenosis. METHODS: 332 patients with in-stent restenosis underwent successful coronary intervention, and were then randomly allocated to intracoronary beta radiation with a phosphorus-32 source (n=166) or placebo (166) delivered into a centreing balloon catheter through an automatic afterloader. Longer lesions (>22 mm of dilated length) were treated with tandem positioning of the study wire. The primary safety endpoint was major adverse cardiac events, defined as death, myocardial infarction, and repeat target-lesion revascularisation at 9 months. The primary efficacy endpoint was binary angiographic restenosis rate in the analysis segment during 9-months' follow-up. Analysis was by intention to treat. FINDINGS: Procedural success, and in-hospital and 30-day complications were similar among the two groups. 24 (15%) patients in the radiated group had the primary safety endpoint of death, myocardial infarction, or repeat target-lesion revascularisation over 290 days compared with 51 [corrected] (31%) in the placebo group (difference 16% [95% CI 7-25], p = 0.0006). Binary angiographic restenosis rate was lower in the radiated group than the placebo group for the entire analysed segment (difference 25% [14--37], p < 0.0001). INTERPRETATION: Vascular brachytherapy using pure beta-emitter 32P delivered into a centreing catheter via an automatic afterloader can be used to reduce overall revascularisation in patients undergoing treatment for diffuse in-stent restenosis.

Brachytherapy↗
PubMed2002

Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation.

OBJECTIVES: The study was done to investigate the relationship between clinical restenosis and the relative angiographic location of the recurrent restenotic lesion, after treatment of in-stent restenosis with vascular brachytherapy in the Washington Radiation for In-Stent Restenosis Trial (WRIST). BACKGROUND: Intracoronary radiation therapy reduces recurrence of in-stent restenosis. We investigated the above objective in patients enrolled in WRIST. METHODS: The WRIST study randomized 130 patients to double-blinded therapy with gamma irradiation (iridium-192 [(192)Ir]) versus placebo after interventional treatment of diffuse in-stent restenosis. After the intervention and at follow-up, three vessel segments were individually analyzed with quantitative coronary angiography: 1) the "stent," 2) the "radiation ribbon," and 3) the "ribbon+margin" segment (including 5 mm on either end of the injured or radiation-ribbon segment). Receiver operator curves (ROC) were used to assess the value of the follow-up percent diameter stenosis (DS) for each of the three analyzed segments in predicting target vessel revascularization (TVR). RESULTS: (192)Ir reduced recurrent restenosis (23.7% vs. 60.7%, p < 0.001) and the length of recurrent restenosis (8.99 +/- 4.34 mm vs. 17.54 +/- 10.48 mm, p < 0.001) at follow-up compared to placebo. Isolated stent edge (3.4%) and ribbon edge (1.7%) restenoses were infrequent in both groups. The best angiographic surrogate of TVR was the 50% follow-up DS obtained from the ribbon+margin analysis (ROC area 0.806). CONCLUSIONS: In WRIST, not only was (192)Ir therapy effective in reducing restenosis, but it also reduced the lesion length of treatment failures by 50%, and it was not associated with edge proliferation. The restenosis rate obtained from the vessel segment inclusive of the dose fall-off zones was the best correlate of TVR and should become a standard analysis site in all vascular brachytherapy trials.

Brachytherapy↗
PubMed2002

Clinical outcome following percutaneous coronary interventions in patients with chronic renal failure.

The clinical outcome of patients with chronic renal failure (CRF) who undergo percutaneous coronary intervention (PCI) has not been systematically evaluated in a large cohort of patients. We retrospectively analyzed the in-hospital and 1-year clinical outcomes of 10,076 consecutive patients who underwent PCI between January 1994 and December 1997. A total of 95 patients (0.9%) had end-stage renal disease (ESRD) on dialysis, 786 patients (7.8%) had CRF, and 9,125 patients (90.6%) had normal renal function. Despite an angiographic success rate of 97% in all three groups, in-hospital mortality was significantly higher among patients with renal disease, whether they were on dialysis or not, when compared to patients without renal dysfunction (6.8% vs. 4.2% vs. 0.9%; P < 0.0001). At 1-year follow-up, mortality rate was 48.8% for ESRD, 25.7% for patients with CRF, and 5.5%, for patients without renal dysfunction (P < 0.0001). By multivariate analysis, high left ventricular ejection fraction and creatinine clearance were associated with decreased late mortality (OR = 0.84 and 0.95; P < 0.0001), whereas ESRD (OR = 3.65; P = 0.0002), non-Q-wave myocardial infarction (OR = 2.21; P < 0.0001), diabetes mellitus (OR = 1.99; P < 0.0001), and CRF (OR = 1.74; P = 0.003) were independent correlates of increased late mortality. Therefore, PCI in patients with impaired renal function, whether on dialysis or not, is associated with poor in-hospital and 1-year survival.

Aged↗
PubMed2002

Results of the Jostent coronary stent graft implantation in various clinical settings: procedural and follow-up results.

The Jostent coronary stent graft (CSG) is composed of a PTFE layer sandwiched between two stainless steel stents, initially introduced for the treatment of coronary perforations and aneurysms with excellent results. By providing a mechanical barrier, this stent design also may be beneficial in the treatment of complex ulcerated lesions and in-stent restenosis by preventing debris protrusion and neointimal proliferation through the stent struts. To evaluate the safety and efficacy of this stent graft, we implanted 78 CSGs in 70 patients for a broad range of indications, including coronary perforations, aneurysms, degenerated saphenous vein grafts, complex lesions, and in-stent restenosis. The primary angiographic success rate (95.9%) was high, and using intravascular ultrasound (IVUS) guidance during stent implantation and high inflation pressures (19.3 +/- 3.2 atm), stent expansion with optimal symmetry was achieved in 94.7%. One limitation of the Jostent CSG was the side-branch occlusion rate (18.6%) and the resulting non-Q-wave infarction rate in seven cases (mean CK elevation, 238 U/l), acute Q-wave MI in two cases, and transient ventricular fibrillation in one patient after occlusion of the proximal RCA side branch without further complications. Subacute stent thrombosis occurred in four cases (5.7%) 7 to 70 days after stent implantation, despite using combined antiplatelet therapy with aspirin (ASA), ticlopidine, and/or clopidogrel for 30 days. Angiographic follow-up was available in 56 patients (80.0%) after a mean of 159 +/- 49 days, and follow-up IVUS was available in 38 cases. The overall restenosis rate (> 50% diameter stenosis) was 31.6% manifest primarily as edge restenosis (29.8% stent edge vs. 8.8% stent center; P < 0.001). IVUS examinations showed a minimal late lumen loss of 0.4 +/- 2.2 mm(2) within the center of the stent graft vs. 3.2 +/- 2.3 mm(2) at the stent edges (P < 0.001). The restenosis rate in the prespecified subgroups was 33.3% for saphenous vein grafts (2/6 lesions), 30.0% in complex lesions (6/20 lesions), and 38.5% (10/26 lesions) for the treatment of in-stent restenosis. Implantation of the Jostent CSG is feasible and safe, even in complex lesion subsets, and is associated with high primary success rates provided major side branches are avoided. The use of this stent may require an extended time course of antiplatelet therapy. Frequent focal stent edge renarrowing influences the overall restenosis rate. However, in treatment of complex in-stent restenosis and vein graft lesions, stent grafts may offer benefit over conventional therapies. Covered stents such as the JoMed coronary stent graft may become essential for bailout treatment of coronary perforations.

Adult↗
PubMed2002

Balloon-based radiation therapy for treatment of in-stent restenosis in human coronary arteries: results from the BRITE I study.

Catheter-based intracoronary radiation therapy demonstrated reduction of the recurrence rate of in-stent restenosis by 35%-50% when compared to conventional therapy. The objectives of this study were to determine the safety and feasibility of a new balloon-shaped source design and a higher applied dose to reduce the restenosis rates. Thirty-two patients with in-stent restenosis who met study eligibility criteria were successfully treated with standard PCI techniques. Following a successful intervention, a P-32 beta-balloon source was positioned to cover the angioplasty site and a dose of a 20 Gy at 1 mm from the surface of the source was administered. The primary endpoint was a composite of major adverse cardiac events (any death, MI, emergent CABG, or repeat target vessel revascularization) during 6 months of follow-up. At 6 months, only one patient underwent repeat PTCA to the target vessel (3%). There were no instances of death, emergency surgery, late thrombosis, total occlusions, or MI. Binary restenosis measured by QCA at the stented segment was 0% and for the whole analysis vessel was 7.5%. Beta-radiation delivered with a balloon P-32 source design for patients with in-stent restenosis results in lower than expected rate of angiographic and clinical restenosis and the absence of late complications.

Aged↗
PubMed2002

New-device angioplasty in women: clinical outcome and predictors in a 7,372-patient registry.

BACKGROUND: Female gender has been identified as an independent predictor of early complications and mortality after conventional balloon angioplasty. To gain insight into the outcome of women after new-device angioplasty, we reviewed the early and late clinical outcome of 7,372 patients undergoing new-device angioplasty between 1991 and 1996 at the Washington Hospital Center. METHODS: Patients (2,077 women and 5,295 men) with native coronary artery (82.5%) or saphenous vein graft lesions undergoing new-device angioplasty were included in the study. In-hospital and 1-year major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization (TLR), were recorded and compared on the basis of gender. Multivariable logistic regression analysis was performed to identify predictors of in-hospital and late mortality, follow-up MACE, and TLR. RESULTS: Women had more baseline comorbid risk factors and smaller reference vessel size compared with men. Women had a higher in-hospital cardiac mortality (1.39% vs 0.66%, P = 0.002), TLR (2.78% vs 1.81%, P = 0.008), and congestive heart failure (4.18% vs 2.29%, P < 0.001) compared with men. Overall in-hospital MACE tended to be higher among women (4.2% vs 3.3%, P = 0.074). Women had a higher 1-year mortality rate (4.39% vs 3.26%, P = 0.018), but a lower follow-up TLR (15.0% vs 18.1%, P = 0.001) and a lower overall MACE rate (29.2% vs 32.7%, P = 0.007) compared with men. Female gender was an independent predictor of in-hospital mortality (odds ratio 2.28, P = 0.02), but not late mortality. CONCLUSIONS: Although female gender appears to carry an inherent risk of in-hospital mortality after new-device angioplasty, the procedural success and mortality rates are favorable compared with those associated with balloon angioplasty series. The long-term clinical outcome of women after new-device angioplasty is excellent. The use of new devices is a safe and effective alternative strategy for the treatment of women with ischemic coronary artery disease. Device-specific outcomes, including stents, will require further evaluation.

Angioplasty↗
PubMedDate not supplied

Outcomes of percutaneous and surgical revascularization in women.

There are gender-related differences both in the natural history of coronary artery disease (CAD) and in the response to revascularization strategies of patients with CAD. This paper reviews the specific pathophysiology of CAD in women as it influences outcome and current interventional and surgical treatment modalities and outcomes for stable and unstable coronary artery syndromes.

Angioplasty, Balloon, Coronary↗
PubMedDate not supplied

Five-year clinical and angiographic follow-up after intracoronary iridium-192 radiation therapy.

BACKGROUND: Ionizing gamma radiation has been shown to reduce neointimal formation and the incidence of restenosis after balloon angioplasty and stenting in clinical trials. However, the long-term effects of this therapy are unknown. The first cohort of patients to receive intracoronary gamma radiation after balloon angioplasty for the prevention of restenosis have completed a 5-year angiographic and clinical follow-up. The outcome of these patients is presented and discussed. METHODS: Twenty-one patients with unstable angina (22 arteries) underwent standard balloon angioplasty. Intracoronary radiation therapy was performed immediately after the intervention using an Iridium-192 source wire hand-delivered to the angioplasty site. All patients were followed clinically and Quantitative Coronary Analysis (QCA) was performed at 6, 24, 36 and 60 months. RESULTS: Target lesion revascularization occurred in six lesions, three of which were total occlusions (two early within 30 days and one occurred at 2 years), and one patient had a myocardial infarction attributable to a nontarget vessel. Serial QCA detected a binary restenosis rate of 28.6% (n=6) at 6 months. The late loss (0.29 mm) and loss index (0.25) remained low at 2, 3 and 5 years. Angiographic complications included four aneurysms (two procedure related and two occurring within 3 months). At 2 years, only one aneurysm increased in size (46 vs. 27 mm(2)); and at 3 and 5 years, all aneurysms remained unchanged. No other angiographic complications were observed. CONCLUSION: The early clinical and angiographic effects of intracoronary gamma radiation were maintained at 5 years without further increase in the aneurysm formation or apparent new adverse effects related to the radiation therapy between 2 and 5 years.

Adult↗