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Roxana Mehran

Publications and source records attributed to Roxana Mehran.

At least 109 records · Page 6Linked to original sources

Comparison of safety and efficacy between first and second generation of angio-seal closure devices in interventional patients.

Arterial closure devices are safe and effective in selected patients, with complication rates similar to or lower than manual compression. The purpose of this study was to compare the safety and efficacy of the first- and new-generation Angio-Seal devices in patients undergoing PCI. This study found that the new Angio-Seal STS Platform device can secure hemostasis after PCI in a safe and effective manner similar to the old device. The new platform is easier for the operator and for the patients.

Adult↗

Comparison of the angiographic outcomes after beta versus gamma vascular brachytherapy for treatment of in-stent restenosis.

This study was designed to compare the angiographic outcomes of beta versus gamma vascular brachytherapy (VBT). We reviewed the angiographic results of 636 lesions (212 that underwent beta and 212 that underwent gamma VBT, and 212 that received placebo) with native coronary in-stent restenosis matched for lesion length, vessel size, preprocedure minimum lumen diameter (MLD), and time to angiographic follow-up in the various randomized clinical trials and studies. Baseline lesion complexity was similar in these 3 groups. Final MLD was smaller in the beta VBT group than in the gamma VBT or placebo group. At follow-up, beta and gamma VBT significantly reduced both angiographic restenosis (34.4% for beta VBT, 26.4% for gamma VBT, and 50.9% in the placebo group; p <0.0001) and recurrent lesion length (9.2 mm for beta VBT, 8.4 mm for gamma VBT, and 15.5 mm placebo, p <0.0001) compared with placebo. Gamma VBT was associated with a greater reduction in restenosis outside the stent than beta VBT. By multivariable analysis, independent angiographic predictors of treated segment restenosis included beta or gamma VBT, lesion length, and vessel size. In matched lesions, beta and gamma VBT achieved similar reductions in treated segment restenosis and recurrent lesion length compared with placebo.

Adult↗

Increased CK-MB release is a "trade-off" for optimal stent implantation: an intravascular ultrasound study.

OBJECTIVES: We sought to determine the impact of aggressive stent expansion on creatine kinase-MB isoenzyme (CK-MB) release and clinical restenosis. BACKGROUND: Elevation of CK-MB after percutaneous coronary interventions has been associated with late mortality. METHODS: We identified 989 consecutive patients who underwent intravascular ultrasound-guided stenting of 1,015 coronary lesions. Patients were divided into three groups according to stent expansion, defined as the ratio of final lumen over the reference lumen cross-sectional areas: Group 1 (ratio <70%, n = 117 patients with 126 lesions); Group 2 (ratio 70% to 100%, n = 551 patients with 562 lesions); Group 3 (ratio >100%, n = 321 patients with 327 lesions). RESULTS: The peak CK-MB values increased significantly with increasing stent expansion: CK-MB = 3 to 5x normal occurred 16%, 18%, and 25% in Groups 1, 2, and 3, respectively, p = 0.02; CK-MB >5 times normal occurred 9%, 13%, and 16% respectively, p = 0.02. Conversely, at one year follow-up there was a stepwise decrease in target lesion revascularization (11% vs. 19% and 17%, respectively, p = 0.04) and major adverse cardiac events with increasing stent expansion. In addition, there was a trend toward lower mortality in Group 3 (9% vs. 4.4% vs. 4.0%, p = 0.07). CONCLUSIONS: Intravascular ultrasound-guided stent overexpansion (final lumen greater than reference lumen cross-sectional area) is accompanied by a higher periprocedural CK-MB release but a lower target lesion revascularization and a trend toward lower mortality at one year. Increased periprocedural CK-MB release appears as a trade-off for optimal stent implantation and lower clinical restenosis.

Cineangiography↗

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↗

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↗

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↗

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↗

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↗

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↗

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↗

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↗

From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part II.

Atherosclerotic cardiovascular disease results in >19 million deaths annually, and coronary heart disease accounts for the majority of this toll. Despite major advances in treatment of coronary heart disease patients, a large number of victims of the disease who are apparently healthy die suddenly without prior symptoms. Available screening and diagnostic methods are insufficient to identify the victims before the event occurs. The recognition of the role of the vulnerable plaque has opened new avenues of opportunity in the field of cardiovascular medicine. This consensus document concludes the following. (1) Rupture-prone plaques are not the only vulnerable plaques. All types of atherosclerotic plaques with high likelihood of thrombotic complications and rapid progression should be considered as vulnerable plaques. We propose a classification for clinical as well as pathological evaluation of vulnerable plaques. (2) Vulnerable plaques are not the only culprit factors for the development of acute coronary syndromes, myocardial infarction, and sudden cardiac death. Vulnerable blood (prone to thrombosis) and vulnerable myocardium (prone to fatal arrhythmia) play an important role in the outcome. Therefore, the term "vulnerable patient" may be more appropriate and is proposed now for the identification of subjects with high likelihood of developing cardiac events in the near future. (3) A quantitative method for cumulative risk assessment of vulnerable patients needs to be developed that may include variables based on plaque, blood, and myocardial vulnerability. In Part I of this consensus document, we cover the new definition of vulnerable plaque and its relationship with vulnerable patients. Part II of this consensus document will focus on vulnerable blood and vulnerable myocardium and provide an outline of overall risk assessment of vulnerable patients. Parts I and II are meant to provide a general consensus and overviews the new field of vulnerable patient. Recently developed assays (eg, C-reactive protein), imaging techniques (eg, CT and MRI), noninvasive electrophysiological tests (for vulnerable myocardium), and emerging catheters (to localize and characterize vulnerable plaque) in combination with future genomic and proteomic techniques will guide us in the search for vulnerable patients. It will also lead to the development and deployment of new therapies and ultimately to reduce the incidence of acute coronary syndromes and sudden cardiac death. We encourage healthcare policy makers to promote translational research for screening and treatment of vulnerable patients.

Animals↗

From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part I.

Atherosclerotic cardiovascular disease results in >19 million deaths annually, and coronary heart disease accounts for the majority of this toll. Despite major advances in treatment of coronary heart disease patients, a large number of victims of the disease who are apparently healthy die suddenly without prior symptoms. Available screening and diagnostic methods are insufficient to identify the victims before the event occurs. The recognition of the role of the vulnerable plaque has opened new avenues of opportunity in the field of cardiovascular medicine. This consensus document concludes the following. (1) Rupture-prone plaques are not the only vulnerable plaques. All types of atherosclerotic plaques with high likelihood of thrombotic complications and rapid progression should be considered as vulnerable plaques. We propose a classification for clinical as well as pathological evaluation of vulnerable plaques. (2) Vulnerable plaques are not the only culprit factors for the development of acute coronary syndromes, myocardial infarction, and sudden cardiac death. Vulnerable blood (prone to thrombosis) and vulnerable myocardium (prone to fatal arrhythmia) play an important role in the outcome. Therefore, the term "vulnerable patient" may be more appropriate and is proposed now for the identification of subjects with high likelihood of developing cardiac events in the near future. (3) A quantitative method for cumulative risk assessment of vulnerable patients needs to be developed that may include variables based on plaque, blood, and myocardial vulnerability. In Part I of this consensus document, we cover the new definition of vulnerable plaque and its relationship with vulnerable patients. Part II of this consensus document focuses on vulnerable blood and vulnerable myocardium and provide an outline of overall risk assessment of vulnerable patients. Parts I and II are meant to provide a general consensus and overviews the new field of vulnerable patient. Recently developed assays (eg, C-reactive protein), imaging techniques (eg, CT and MRI), noninvasive electrophysiological tests (for vulnerable myocardium), and emerging catheters (to localize and characterize vulnerable plaque) in combination with future genomic and proteomic techniques will guide us in the search for vulnerable patients. It will also lead to the development and deployment of new therapies and ultimately to reduce the incidence of acute coronary syndromes and sudden cardiac death. We encourage healthcare policy makers to promote translational research for screening and treatment of vulnerable patients.

Acute Disease↗

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↗

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↗

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↗

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↗

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↗