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Background: The objective of this intravascular ultrasound (IVUS) analysis was to evaluate the vascular response of the thin-strut TAXUS Liberté stent compared with the otherwise identical TAXUS Express stent. Methods and Materials: The TAXUS ATLAS and TAXUS ATLAS Long Lesion studies are nonrandomized trials comparing the thin-strut TAXUS Liberté stent to historical TAXUS Express controls from the TAXUS IV and TAXUS V trials. A total of 377 patients enrolled in the two TAXUS ATLAS studies were randomly selected for the IVUS subset and compared to 314 TAXUS Express IVUS controls. Results: Despite increased lesion complexity in the TAXUS Liberté group, neointimal formation at 9 months was similar in both stents (TAXUS Liberté 13.8±11.0%; TAXUS Express 13.1±13.8%, P=.56). However, this neointima covered more of the overall stent in the TAXUS Liberté (67.9±32.5%) compared with the TAXUS Express (54.4±37.2%, P<.001), suggesting more uniform neointimal distribution. TAXUS Liberté also showed less pronounced negative remodeling at both stent edges and had significantly less (4.3% vs. 9.6%, P=.04) late incomplete stent apposition (ISA). Conclusions: Despite identical polymer and drug release characteristic, the thin-strut TAXUS Liberté stent demonstrates improved neointimal coverage, better edge remodeling, and less late ISA vs. TAXUS Express, hereby highlighting the importance of the platform design for drug-eluting stents. [ABSTRACT FROM AUTHOR]

Importance: Long-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms., Objective: To describe the final 5-year outcomes of the REPRISE III trial., Design, Setting, and Participants: This prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021., Intervention: Lotus valve or CoreValve/EvolutR TAVR platforms., Main Outcomes and Measures: Valve Academic Research Consortium-2 end points, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up., Results: A total of 912 patients (mean [SD] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. Clinical follow-up data from the REPRISE III trial were available for 581 patients (95.7%) in the Lotus valve group and 285 patients (93.4%) in the CoreValve/EvolutR group. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group vs 52.8% in the CoreValve/EvolutR group (P = .59). Disabling stroke was less frequent with the Lotus valve vs CoreValve/EvolutR (cumulative event rates, 8.3% vs 12.2%; P = .04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs 15.3%; P = .38). Insertion of a new permanent pacemaker (38.9% vs 27.3%; P < .001) and detection of prosthetic aortic valve thrombosis (5.8% vs 1.8%; P = .007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs 2.6%; P < .001) and required the use of a second valve (1.0% vs 3.8%; P < .001) during the procedure compared with those who received the CoreValve/EvolutR. Compared with the Lotus valve group, the CoreValve/EvolutR group had a significantly lower mean (SD) aortic gradient (7.8 [4.2] mm Hg vs 12.6 [6.7] mm Hg; P < .001) and larger valve areas (1.57 [0.56] cm2 vs 1.42 [0.42] cm2; P = .10). After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs 0%; P = .31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs 7.8%; P = .006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups., Conclusions and Relevance: The REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective., Trial Registration: ClinicalTrials.gov Identifier: NCT02202434.

Aim: To compare the efficacy and safety of P2Y 12 inhibitor or aspirin monotherapy for secondary prevention in patients with atherosclerotic cardiovascular disease (ASCVD)., Methods and Results: Medline, Embase, and Cochrane Central databases were searched to identify randomized trials comparing monotherapy with a P2Y 12 inhibitor versus aspirin for secondary prevention in patients with ASCVD (cardiovascular, cerebrovascular, or peripheral artery disease). The primary outcome was major adverse cardiac events (MACE). Secondary outcomes were myocardial infarction (MI), stroke, all-cause mortality, and major bleeding. A random-effects model was used to calculate risk ratios (RR) and the corresponding 95% confidence interval (CI) and heterogeneity among studies was assessed using the Higgins I 2 value. A total of 9 eligible trials (5 with clopidogrel and 4 with ticagrelor) with 61 623 patients were included in our analyses. Monotherapy with P2Y 12 inhibitors significantly reduced the risk of MACE by 11% (0.89, 95% CI 0.84-0.95, I 2 = 0%) and MI by 19% (0.81, 95% CI 0.71-0.92, I2 = 0%) compared with aspirin monotherapy. There was no significant difference in the risk of stroke (0.85, 95% CI 0.73-1.01), or all-cause mortality (1.01, 95% CI 0.92-1.11). There was also no significant difference in the risk of major bleeding with P2Y 12 inhibitor monotherapy compared with aspirin (0.94, 95% CI 0.72-1.22, I 2 = 42.6%). Results were consistent irrespective of the P2Y 12 inhibitor used., Conclusion: P2Y 12 inhibitor monotherapy for secondary prevention is associated with a significant reduction in atherothrombotic events compared with aspirin alone without an increased risk of major bleeding., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.)

Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long-term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre-specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier NCT02202434.

Importance: To our knowledge, REPRISE III is the first large randomized comparison of 2 different transcatheter aortic valve replacement platforms: the mechanically expanded Lotus valve (Boston Scientific) and self-expanding CoreValve (Medtronic)., Objective: To evaluate outcomes of Lotus vs CoreValve after 2 years., Design, Setting, and Participants: A total of 912 patients with high/extreme risk and severe, symptomatic aortic stenosis enrolled between September 22, 2014, and December 24, 2015, were randomized 2:1 to receive Lotus (607 [66.6%]) or CoreValve (305 [33.4%] at 55 centers in North America, Europe, and Australia. The first 2-year visit occurred on October 17, 2016, and the last was conducted on April 12, 2018. Clinical and echocardiographic assessments are complete through 2 years and will continue annually through 5 years., Main Outcomes and Measures: All-cause mortality and all-cause mortality or disabling stroke at 2 years. Other clinical factors included overall stroke, disabling stroke, repeated procedures, rehospitalization, valve thrombosis, and pacemaker implantation. Echocardiographic analyses included effective orifice area, mean gradient, and paravalvular leaks (PVLs)., Results: Of 912 participants, the mean (SD) age was 82.8 (7.3) years, 465 (51%) were women, and the mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 6.8% (4.0%). At 2 years, all-cause death was 21.3% with Lotus vs 22.5% with CoreValve (hazard ratio [HR], 0.94; 95% CI, 0.69-1.26; P = .67) and all-cause mortality or disabling stroke was 22.8% with Lotus and 27.0% with CoreValve (HR, 0.81; 95% CI, 0.61-1.07; P = .14). Overall stroke was 8.4% vs 11.4% (HR, 0.75; 95% CI, 0.48-1.17; P = .21); disabling stroke was more frequent with CoreValve vs Lotus (4.7% Lotus vs 8.6% CoreValve; HR, 0.53; 95% CI, 0.31-0.93; P = .02). More Lotus patients received a new permanent pacemaker (41.7% vs 26.1%; HR, 1.87; 95% CI, 1.41-2.49; P < .01) or had a valve thrombosis (3.0% vs 0.0%; P < .01) compared with CoreValve. More patients who received CoreValve experienced a repeated procedure (0.6% Lotus vs 2.9% CoreValve; HR, 0.19; 95% CI, 0.05-0.70; P < .01), valve migration (0.0% vs 0.7%; P = .05), or embolization (0.0% vs 2.0%; P < .01) than Lotus. Valve areas remained significantly larger and the mean gradient was lower with CoreValve than Lotus (valve area, mean [SD]: Lotus, 1.53 [0.49] cm2 vs CoreValve, 1.76 [0.51] cm2; P < .01; valve gradient, mean [SD]: Lotus, 13.0 [6.7] mm Hg vs 8.1 [3.7] mm Hg; P < .01). Moderate or greater PVL was more frequent with CoreValve (0.3% Lotus vs 3.8% CoreValve; P < .01) at 2 years. Larger improvements in New York Heart Association (NYHA) functional class were observed with Lotus compared with CoreValve (improved by ≥1 NYHA class: Lotus, 338 of 402 [84.1%] vs CoreValve, 143 of 189 [75.7%]; P = .01; improved by ≥2 NYHA classes: 122 of 402 [37.3%] vs 65 of 305 [21.3%])., Conclusions and Relevance: After 2 years, all-cause mortality rates, mortality or disabling stroke were similar between Lotus and CoreValve. Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm., Trial Registration: clinicaltrials.gov Identifier: NCT02202434.

Importance: Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur., Objective: To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR., Design, Setting, and Participants: The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017., Interventions: Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305)., Main Outcomes and Measures: The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set., Results: Among 912 randomized patients (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, -∞ to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, -10.1%; Farrington-Manning 97.5% CI, -∞ to -4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, -6.1%; 95% CI, -9.6% to -2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, -10.2%; 95% CI, -16.3% to -4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%)., Conclusions and Relevance: Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients., Trial Registration: ClinicalTrials.gov Identifier: NCT02202434.

Spontaneous coronary artery dissection (SCAD) is a rare cause of acute coronary syndrome. In the literature, more than 1,200 cases of SCAD have been reported, with a low rate of recurrent spontaneous coronary artery dissection (r-SCAD) described in only 63 cases. Among these patients with r-SCAD, just three cases had three separate episodes of dissection and all were in women. We report the first case of r-SCAD in men, with three episodes of dissection in different coronary arteries and review the published literature on predisposing factors for r-SCAD and its management., (© 2015 Wiley Periodicals, Inc.)

Splenic artery aneurysms are rare, but still the third most common abdominal aneurysm. Rupture is associated with significant morbidity and mortality. Traditionally, cardiologists have rarely been involved in the management of this entity. We present a series of four patients managed percutaneously by interventional cardiology using a combined telescoping guide and cage/coil technique., (© 2014 Wiley Periodicals, Inc.)

Objective: This study evaluated 1-year safety and effectiveness outcomes of the United States regulatory trial for the Ovation Abdominal Stent Graft System (TriVascular Inc, Santa Rosa, Calif) for endovascular repair of abdominal aortic aneurysms (AAAs)., Methods: This prospective, multicenter, single-arm trial was conducted at 36 sites in the United States, Germany, and Chile to evaluate the safety and effectiveness of the Ovation stent graft. From November 2009 to May 2011, 161 patients (88% males; mean age, 73 ± 8 years) with AAAs (mean diameter, 54 ± 9 mm) were treated with the Ovation stent graft. The main body is a modular two-docking limb device with a 14F outer diameter delivery system, active suprarenal fixation, and polymer-filled proximal rings that accommodate the aortic neck for seal. Main inclusion criteria included proximal aortic neck length ≥ 7 mm, inner neck diameter between 16 and 30 mm, distal iliac landing zones length ≥ 10 mm, and diameter between 8 and 20 mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30 days, 6 months, and annually through 5 years. A Clinical Events Committee adjudicated adverse events, an independent imaging core laboratory analyzed imaging, and a Data Safety and Monitoring Board provided study oversight. Complete 1-year follow-up data were available for this report., Results: The Ovation stent graft was implanted successfully in 161 patients (100%), including 69 (42.9%) by percutaneous access. General anesthesia was used in 106 patients (65.8%). Technical success was 100%, and mean procedure time was 110 minutes. Median procedural blood loss was 150 mL, and median hospital stay was 1 day. The 30-day major adverse event rate was 2.5%. At 1 year, AAA-related and all-cause mortality were 0.6% and 2.5%, respectively. Major adverse event and serious adverse event rates through 1 year were 6.2% and 38.5%, respectively. The 1-year treatment success rate was 99.3%. The imaging core laboratory reported no stent graft migration or type I, III, or IV endoleaks. At 1 year, type II endoleaks were identified in 34% of patients, and AAA enlargement was identified in one patient (0.7%). No AAA rupture or conversion to open surgery was reported. AAA-related secondary procedures were performed in 10 patients (6.2%) for 12 findings, including endoleak (six), aortic main body stenosis (three), and iliac limb stenosis or occlusion (three)., Conclusions: The 1-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in treatment of patients with AAAs, particularly in patients with challenging anatomic characteristics, including short aortic necks and narrow iliac arteries. Longer-term follow-up is needed., (Copyright © 2014. Published by Mosby, Inc.)

Aims: Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberté paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels., Methods and Results: The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length≤20 mm and vessel diameter≥2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38±0.51 versus 0.80±0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment., Conclusions: PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.

Background: Comorbid and anatomic characteristics that portend higher procedural risk are well defined for carotid endarterectomy but less so for carotid artery stenting., Methods and Results: We pooled carotid stent data from 4 Cordis-sponsored trials (n=2104) with similar patient cohorts and end point determination to identify predictors of neurological death or stroke within 30 days of the procedure. Median age was 74 years (24% >80 years), 36% were women, and 24.2% were symptomatic in the previous 6 months. There were 88 (4.2%) neurological deaths or strokes at 30 days. Among symptomatic patients, the risk of adverse neurological outcome declined with increasing time between the incident neurological event and carotid stent procedure. In a logistic regression model that included preprocedural and procedural variables, significant multivariable predictors of 30-day neurological death or stroke were older age (continuous), black race, angiographically visible thrombus in symptomatic patients, procedural use of glycoprotein IIb/IIIa inhibitors, procedural transient ischemic attack, final residual stenosis >30%, and periprocedural use of protamine or vasopressors., Conclusions: In this pooled analysis, a number of preprocedural and procedural factors predicted higher risk of stroke and neurological death within 30 days of a carotid stent procedure. Identification of such predictors may help to guide patient selection and further refine procedural technique.

Objectives: This study was designed to compare long-term clinical outcomes of drug-eluting stents (DES) versus bare metal stents (BMS) in patients with saphenous vein graft (SVG) disease in the "real world.", Background: The safety and efficacy of DES versus BMS in SVG remains uncertain due to contradictory reports of either lower revascularization rates with DES; or clinical equivalence to BMS; or even an excess of clinical events associated with DES use., Methods: We identified consecutive patients who underwent stent placement within a de novo SVG lesion between May 1, 2003 and July 31, 2007. Follow-up was obtained at regular intervals. The Kaplan-Meier method was used to produce actuarial survival estimates. Cox regression analysis was used to predict the risk associated with stent type, and propensity scores were generated to risk-adjust the results., Results: The study group included 379 stent recipients (284 DES; 95 BMS) with 410 stented lesions. BMS were placed more frequently in current smokers, acute myocardial infarctions, larger vessels, and longer lesions. In-hospital mortality was higher in BMS recipients than in their DES counterparts (3.2% vs. 0, respectively; P = 0.015). At 3 years, there was no significant difference in clinical adverse event rates between DES and BMS recipients, even after risk adjustment., Conclusions: Three-year adverse event rates are similar among patients treated with DES or BMS in SVG lesions. Therefore, while DES are safe, they do not appear to offer an advantage in terms of long-term graft patency., (Copyright 2009 Wiley-Liss, Inc.)

Objectives: The TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) multicenter studies compared the performance of the thin-strut (0.0038 inch) TAXUS Liberté 2.25-mm stent (Boston Scientific; Natick, Massachusetts) and the TAXUS Liberté 38-mm long stent (Boston Scientific; Natick, Massachusetts) with the earlier paclitaxel-eluting TAXUS Express (Boston Scientific) stent that has identical polymer, drug dosage, and release kinetics but different stent geometry and thicker struts (0.0052 inch)., Background: The TAXUS Liberté stent was designed with thinner and more even strut spacing to provide more uniform drug distribution, as well as increased flexibility and conformability. Clinical benefits of the new stent design have not been evaluated., Methods: The TAXUS ATLAS SV and LL studies are nonrandomized studies comparing outcomes of the TAXUS Liberté 2.25 mm (N = 261) and TAXUS Liberté 38 mm (N = 150) stents to TAXUS Express historical control groups derived from the TAXUS IV and V trials. Inclusion/exclusion criteria for TAXUS Express and Liberté groups were similar in both studies., Results: Each study met its primary end point of noninferiority of 9-month in-segment diameter stenosis. Furthermore, TAXUS Liberté 2.25 mm, when compared with TAXUS Express, significantly reduced the rate of both 9-month angiographic restenosis (18.5% vs. 32.7%, p = 0.0219) and 12-month target lesion revascularization (6.1% vs. 16.9%, p = 0.0039). In addition, TAXUS Liberté 38 mm significantly reduced the risk of 12-month myocardial infarction compared with TAXUS Express (1.4% vs. 6.5%, p = 0.0246)., Conclusions: The thinner-strut TAXUS Liberté stent improved outcomes compared with the earlier TAXUS Express stent in both SVs and LLs (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748; A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475).

Background: Late and very late thrombosis of coronary drug-eluting stents (DES) has received much attention but essentially remains unpredictable. We sought to identify correlates of stent thrombosis (ST) developing >30 days after DES implantation., Methods: We analyzed data from our single-center registry on 5,342 consecutive patients, who underwent a first DES implant between May 2003 and December 2006. The Academic Research Consortium definitions were applied to classify definite, probable, and possible ST. Cox regression analysis was performed to identify predictors of ST., Results: Follow-up information was obtained at 6 months and at 1, 2, and 3 years after DES implantation in 97.2%, 95.2%, 92.4%, and 89.8% of patients, respectively. We identified 34 patients who developed definite and 5 with probable ST >30 days after the index stent procedure. The 3-year cumulative incidence of definite and definite + probable ST >30 days was 1.33% and 1.50%, respectively. By Cox multiple variable regression, predictors of definite + probable ST were age (hazard ratio [HR] 0.95, 95% CI 0.92-0.98, P < .001), current smoking (HR 2.55, 95% CI 1.29-5.07, P = .007), prior percutaneous coronary intervention (HR 2.68, 95% CI 1.42-5.05, P = .002), "off-label" DES indication (HR 3.10, 95% CI 1.10-8.75, P = .032), bifurcation stenting (HR 2.37, 95% CI 1.40-3.99, P = .001), and stenting an occluded vessel (HR 3.02, 95% CI 1.59-5.74, P < .001)., Conclusions: We identified several baseline characteristics, which, when combined, may identify patients at risk for late-occurring ST, particularly after off-label DES placement.

Background: Randomized trials of drug-eluting stents (DES) excluded patients with severe renal insufficiency. We sought to evaluate the impact of baseline renal function on clinical outcomes in recipients of coronary DES., Methods: We retrospectively reviewed our hospital databases to identify consecutive patients who underwent DES implantations between May 2003 and December 2004, subgrouped among 4 ranges of glomerular filtration rate (GFR) between > or = 90 ml per minute and < 30 ml per minute, in 30 ml per minute decrements, and 1 group treated with long-term dialysis. Clinical follow up was obtained at 6 months, 1 year and annually thereafter., Results: Our study group included 2,758 patients with long-term outcomes recorded over a mean follow up of 706 +/- 273 days. The rates of in-hospital adverse events increased significantly as GFR decreased, though no major adverse event occurred among the dialyzed patients. Actuarial survival analyses up to 2 years revealed significant between-groups differences in rates of major adverse cardiac events (MACE) and death (both p < 0.001), while the differences in target vessel revascularization (TVR) rates did not reach statistical significance (p = 0.069). By Cox regression analysis, a GFR < 60 ml per minute remained a significant predictor of 2-year mortality (p < 0.001) and MACE (p < 0.001), but not TVR (p = 0.839)., Conclusions: In conclusion, low rates of TVR were observed over 2 years in DES recipients with a wide range of renal function. Low rates of TVR were countered by high rates of death and MACE among renally insufficient patients over the long term.

Background: The use of bivalirudin in percutaneous coronary interventions has been shown to be clinically safe and effective, and may be associated with shorter hospital stays and lower costs than heparin + glycoprotein (GP) IIb/IIIa inhibition. This study compared the utilization, clinical outcomes and costs associated with the planned use of bivalirudin versus heparin + GP IIb/IIIa inhibition in drug-eluting stent (DES) patients without acute myocardial infarction (MI)., Methods: We retrospectively studied 1,842 patients who underwent DES placement between May 2003 and December 2004. Planned treatment with heparin + GP IIb/IIIa inhibition was administered to 1,305 and planned bivalirudin alone was administered to 537 patients. Clinical follow ups (mean = 782 +/- 204 days) were obtained via telephone or mailed surveys in 1,813 patients (98.4%). Propensity analysis was utilized to adjust for between-groups baseline differences., Results: The unadjusted data revealed similar in-hospital outcomes in both groups. After propensity adjustment, the rate of vascular complications was significantly lower in the bivalirudin-treated group (0.2% vs. 1.2%; p = 0.04). At 1 year, clinical outcomes were similar in both groups. The overall unadjusted and adjusted cost analysis revealed similar mean hospital costs (11,384 U.S. dollars vs. 11,018 U.S. dollars; p = ns) and length of stay (2.9 days vs. 2.8 days; p = ns) in both groups. The unadjusted and adjusted mean hospital costs were significantly lower in patients treated with bivalirudin versus patients who received heparin + abciximab., Conclusions: These observations suggest that bivalirudin is a safe, cost-effective alternative to heparin + GP IIb/IIIa inhibition in patients undergoing DES in the absence of acute MI.

Objectives: The purpose of this study was to examine the outcomes of patients who developed coronary in-stent restenosis (ISR) or stent thrombosis (STH) inside drug-eluting stents (DES)., Background: Drug-eluting stents have markedly reduced the incidence of restenosis. However, when restenosis occurs within a DES, its optimal management remains unclear., Methods: We retrospectively analyzed clinical and angiographic data from 92 patients who underwent revascularization for ISR (n = 84) or STH (n = 8) within a DES at our institution. Regular follow-ups were available up to 2 years. We recorded the occurrence of major adverse cardiac events (MACE), defined as deaths from all causes, myocardial infarction (MI), or target lesion revascularization (TLR), among patients treated by the "DES sandwich" technique or by other treatment methods., Results: In-hospital MACE included 1 periprocedural MI and 2 deaths. Over a mean follow-up of 15 +/- 6 months, the overall rates of death, MI, and TLR were 8.7%, 2.2%, and 30.6%, respectively. By actuarial analysis, the 12-month TLR and MACE rates were 28.2% and 42.9%, respectively., Conclusions: Current treatments of ISR or STH in DES are associated with a high long-term rate of MACE.

The effect of obesity on repeat coronary revascularization and restenosis in patients who undergo stent implantation has not been reported. We therefore examined the database from the multicenter randomized TAXUS-IV trial to determine the effect of body mass index (BMI) on outcomes after bare-metal and drug-eluting stent implantation. In TAXUS-IV, patients were randomized to receive a slow-release, polymer-based, paclitaxel-eluting stent or a bare-metal stent. Outcomes were stratified by baseline BMI. Of the 1,307 randomized patients who had documented BMI, 233 (17.8%) had normal weight (BMI <25 kg/m2), 531 (40.6%) were overweight (BMI < or =25 to 30 kg/m2), and 543 (41.5%) were obese (BMI > or =30 kg/m2). Patients who had been assigned to receive bare-metal stents and were overweight and obese compared with those who had normal weight had higher rates of 9-month binary restenosis (29.2% and 30.5% vs 9.3%, respectively; p = 0.01) and 1-year major adverse cardiac events (20.8% and 23.2% vs 11.1%, respectively; p = 0.02), whereas rates of these events did not differ significantly among those who received a paclitaxel-eluting stent (7.6% and 9.3% vs 4.9%, respectively for binary restenosis; p = 0.65; 11.3% and 10.4% vs 10.1%, respectively; p = 0.82 for major adverse cardiac events). By multivariate analysis, BMI > or =30.0 kg/m2 independently predicted binary restenosis (hazard ratio 4.26, p = 0.005), 1-year target vessel revascularization (hazard ratio 1.95, p = 0.04), and major adverse cardiac events (hazard ratio 1.95, p = 0.004) in patients who received bare-metal stents but not paclitaxel-eluting stents. In conclusion, obesity is an important risk factor for clinical and angiographic restenosis and for composite major adverse cardiac events in patients who receive bare-metal stents. Paclitaxel-eluting stents attenuate the increased risk associated with obesity, such that the intermediate-term prognosis after percutaneous coronary intervention is independent of weight.

Objective: To assess costs and outcomes of coronary stenting and balloon angioplasty with and without adjunctive treatment with abciximab for 3758 consecutive elective percutaneous coronary interventions at a single community center over the 2.5-year period between 1 January 1995 and 30 June 1997., Results: Abciximab was more common among patients who had recently suffered myocardial infarction, patients with unstable angina, and patients with more complex coronary lesions. Use of abciximab in conjunction with balloon angioplasty or stenting and stenting alone was associated with significant reductions in incidence of major adverse cardiovascular events in hospital. Multivariate analysis indicated that use of abciximab and stenting were associated with significant independent effects on risk of an event. Hospital costs were increased for patients administered abciximab, treated with stenting, or both. Total costs and costs inclusive of those incurred in catheterization laboratory and pharmacy increased significantly with increasing complexity of lesions. Multivariate regression analysis (baseline cost US$5621) identified death (US$16098), emergency revascularization (US$13678), usage of multiple stents (US$1423 for each stent), and use of abciximab (US$1269) as independent predictors of a greater cost. One-year follow-up revealed significant differences among treatment strategies in terms of risk of need for subsequent revascularization procedures. Lack of stenting but not use of abciximab was identified as a significant predictor of need for repeat revascularization procedures., Conclusions: Our findings are in general agreement with cost analyses of use of abciximab for populations in clinical trials and suggest that improvements of early clinical outcome with abciximab treatment and stenting justify the incremental cost of treatment in a community hospital setting.

Ad hoc coronary intervention is a percutaneous revascularization procedure performed at the same sitting as diagnostic cardiac catheterization. While this appears to be an efficient strategy, the safety and cost of ad hoc coronary intervention compared with delayed coronary intervention have not been clearly documented. Special preparation and precautions are necessary for patients in whom ad hoc coronary intervention is anticipated. Ad hoc coronary intervention is not appropriate if informed consent has not been previously obtained or if it would pose greater risks than delayed intervention. While ad hoc coronary intervention is often efficient and effective, its use should be individualized. Cathet. Cardiovasc. Intervent. 49:130-134, 2000., (Copyright 2000 Wiley-Liss, Inc.)

Objectives: We examined the procedural and 30-day clinical outcomes among patients receiving aspirin and either ticlopidine or clopidogrel during coronary stenting., Background: Ticlopidine-plus-aspirin has become standard antiplatelet therapy for the prevention of thrombotic complications after coronary stenting. Clopidogrel has a similar mechanism of action as ticlopidine, but both its efficacy and its safety as a pharmacologic adjunct to coronary stenting have not been well described., Methods: This single-center, prospective analysis examined the in-hospital procedural and 30-day clinical outcomes among 875 consecutive patients undergoing coronary stenting who received adjunctive aspirin and either clopidogrel (n = 514; 58.7%) or ticlopidine (n = 361; 41.3%) therapy., Results: Procedural success rates were similar among the clopidogrel- (99.6%) and ticlopidine-treated patients (99.4%). Subacute stent thrombosis (i.e., >24 h < or =30 days) occurred in one clopidogrel-treated (0.2%) and in one ticlopidine-treated (0.3%) patient (p = 0.99). By 30 days following the index procedure, the combined rates of death, nonfatal myocardial infarction and need for target vessel revascularization were similar among patients who received either clopidogrel (2.1%) or ticlopidine (1.4%; p = 0.57) therapy., Conclusions: In this analysis the antiplatelet combination therapy of aspirin-plus-clopidogrel was an effective regimen for preventing thrombotic complications and major adverse cardiovascular events among a broad spectrum of patients undergoing coronary artery stenting.

To assess the implications of coronary stenting with several IIb/IIIa receptor antagonists, total hospital cost and adverse events were reviewed for 674 elective stent procedures from June 1998 through December 1998. The use of IIb/IIIa receptor antagonism and the agent selected were at the discretion of the interventional cardiologist. In-hospital, 30-day and 6-month adverse cardiac events were similar among the treatment strategies. Target vessel revascularization at six months was similar among the treatment strategies. Patients who received a IIb/IIIa receptor blocker with their stent procedure were less likely to be rehospitalized within 30 days. Multivariate regression analysis identified specific factors responsible for prolongation of hospital stay including adverse cardiac events, physician practice pattern and age greater than 70 years (all p < 0.002). Overall hospital cost for patients receiving tirofiban as an adjunct to coronary stenting was approximately $1,000 less than patients receiving abciximab. Total cath lab expenditures were similar for these groups and the savings in hospital cost was directly attributable to a lower pharmacy cost in the tirofiban group. Multivariate regression analysis identified adverse cardiac events, left ventricular systolic dysfunction, multiple stent placement, physician practice and abciximab as significant contributors to increased hospital cost (all p < 0.002). Tirofiban as an adjunct to coronary stenting was not identified by multivariate analysis as a significant contributor to hospital cost. Bleeding rates were similar among the treatment strategies. Thus, coronary stenting in our community hospital is associated with acceptable outcomes regardless of treatment strategy and hospital cost is significantly influenced by the use of IIb/IIIa blockade with stenting and the type of agent selected.

Despite a high procedural success rate, long-term blood pressure control after successful renal artery stenting of hypertensive patients has been inconsistent. This most likely reflects the absence of clinical guidelines for the selection of patients likely to benefit from renal revascularization. A cohort of 150 consecutive hypertensive patients (mean age, 66.7 years; 86 women) with 180 renal artery lesions (> or =75%) underwent primary Palmaz stent deployment. Mean arterial blood pressure (MAP), serum creatinine, and antihypertensive medication requirements were monitored prospectively. Specific definitions of blood pressure cure, improvement, or treatment failure were followed. Renal artery duplex Doppler or angiography was performed to assess stent patency at a mean 13 months (range, 7-15 months). Multivariate logistic regression analysis was used to select clinical variables that best related to a beneficial blood pressure control at follow-up. The procedural success rate was 97.3% (146 patients) and major in-laboratory complications were infrequent (1.3%). Late MAP values in 127 patients (91%) fell from 110 +/- 13.7 to 97.6 +/- 10.6 mm Hg (P < 0.001); antihypertensive medication requirements decreased from 2.9 +/- 1.2 to 1.9 +/- 1.1 (P < 0.01). The 13-month stent restenosis rate defined by duplex Doppler or angiography was 12%. Multivariate logistic regression analysis identified a preprocedure MAP of >110 mm Hg (odds ratio, 2.9; P = 0.003) and bilateral renal stenoses (odds ratio, 4.6; P = 0.009) as predictors of a beneficial blood pressure response at follow-up. This study provides general preprocedure guidelines for the selection of hypertensive patients with atherosclerotic renal lesions likely to benefit from primary Palmaz stenting and confirms a high procedural success and low stent restenosis rate.

Purpose: To determine if depression of creatinine clearance after administration of contrast medium may be prevented with theophylline., Materials and Methods: A nonionic, low-osmolality contrast medium (iopamidol) or an ionic, high-osmolality contrast medium (sodium diatrizoate) was administered to 93 patients. Before the examination, these patients were given theophylline or a placebo orally. There were also 30 patients who received an adenosine-uptake inhibitor (dipyridamole). Creatinine clearance and urinary adenosine levels were measured before and after angiography., Results: Creatinine clearance decreased 18% +/- 4 in the placebo-iopamidol group but did not decrease in the theophylline group; urinary adenosine increased 67% +/- 7. Creatinine clearance decreased 42% +/- 5 in the placebo-sodium diatrizoate group and decreased 24% +/- 3 in the theophylline group; urinary adenosine increased 119% +/- 8. In the dipyridamole group in which iopamidol was given, urinary adenosine increased 96% +/- 7 and creatinine clearance decreased 37% +/- 5., Conclusion: Intrarenal adenosine can be implicated in the pathogenesis of hypertonic contrast medium nephrotoxicity.

Internal mammary arteries are increasingly common conduits for coronary revascularization. Although infrequent, cardiologists are faced with a number of technical failures. We describe a case of combined PTCA to a LIMA insertion stenosis, along with coil embolization of a large unligated intercostal side branch. A complication of embolization is described along with angiographic follow-up.

Combined heart-lung transplantation has been used for end-stage primary pulmonary hypertension. Experience with single-lung transplantation for other conditions suggested that associated severe right ventricular dysfunction resulting from increased afterload would recover after placement of a satisfactory lung allograft. Early experience with the application of single-lung transplantation for pulmonary hypertension supports this contention. We devised a reversible canine model of chronic progressive pressure-overloaded right heart failure by pulmonary artery banding to study the echocardiographic, hemodynamic, and pathological reversibility of the failing right heart. Clinical right heart failure was defined as the development of ascites and pleural effusions. Right heart failure developed in 23 dogs 67 to 348 days after banding, and they were divided into two groups to determine its early and long-term effects. Group 1 dogs (n = 11) were either sacrificed immediately after the onset of right heart failure (n = 5) or unbanded (n = 6); group 2 dogs (n = 12) were maintained in right heart failure for 3 months and then either sacrificed (n = 6) or unbanded. Unbanded dogs in both groups were observed for 4 additional months before sacrifice. A control group of 6 normal dogs was sacrificed for pathological comparisons. After unbanding, the right ventricular systolic pressure fell from 97 +/- 17 mm Hg (group 1) and 88 +/- 31 mm Hg (group 2) to 44 +/- 11 mm Hg and 47 +/- 13 mm Hg, respectively. Despite this persistent gradient across the pulmonary artery, echocardiographic and hemodynamic measures of right ventricular function returned to normal, albeit more slowly in the group 2 dogs.(ABSTRACT TRUNCATED AT 250 WORDS)

The conus artery has long been recognized as an important source of collateral blood supply to a significantly diseased left anterior descending artery. This artery which arises 50% of the time from a separate orifice in the right sinus of Valsalva may also provide collateral circulation to a diseased right coronary artery. To date, there have been no reported instances of the conus artery supplying collateral flow to a totally occluded circumflex artery. In this report we describe such a case in a patient with severe three vessel disease. The implications of such a finding in patient management are also discussed.

We performed a double-blind randomized trial comparing high doses of subcutaneous heparin (12,500 units every 12 hours) with low doses (5000 units every 12 hours) for 10 days in the prevention of left ventricular mural thrombosis in 221 patients with acute anterior myocardial infarction. Left ventricular mural thrombosis was observed by two-dimensional echocardiography on the 10th day after infarction in 10 of 95 patients (11 percent) in the high-dose group and in 28 of 88 patients (32 percent) in the low-dose group (P = 0.0004). One patient in the high-dose group and four in the low-dose group had nonhemorrhagic strokes (P = 0.17). One patient in the low-dose group had a fatal pulmonary embolism. There was no difference in the frequency of hemorrhagic complications, which occurred in six patients in the high-dose group and four in the low-dose group. The mean (+/- SEM) plasma heparin concentration was 0.18 +/- 0.017 U per milliliter in the high-dose group and 0.01 +/- 0.005 U per milliliter in the low-dose group (P less than 0.0001). In the high-dose group, the mean plasma heparin concentration was 0.10 +/- 0.029 U per milliliter among patients with abnormal two-dimensional echocardiograms, as compared with 0.19 +/- 0.019 U per milliliter among patients with normal echocardiograms (P = 0.01). We conclude that heparin administered subcutaneously in a dosage of 12,500 units every 12 hours to patients with acute anterior transmural myocardial infarction is more effective than a lower dosage (5000 units every 12 hours) in preventing left ventricular mural thrombosis.

Percutaneous transluminal coronary angioplasty (PTCA) is widely used to achieve myocardial revascularization because of its high success rate and low rate of complications. A 30% rate of restenosis remains the most serious hurdle to overcome. This phenomenon results from endothelial injury caused by balloon inflation. However, not widely appreciated is that other components of PTCA equipment can cause endothelial injury and lead to new stenoses proximal to the dilated lesion. This phenomenon has serious implications when it involves the left main artery. Described here is a case of restenosis involving the left anterior descending artery as well as accelerated left main disease.