Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR: A Secondary Analysis of the REPRISE III Randomized Clinical Trial.

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.

P2Y12 inhibitor versus aspirin monotherapy for secondary prevention of cardiovascular events: meta-analysis of randomized trials.

Aim: To compare the efficacy and safety of P2Y12 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 P2Y12 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 I2 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 P2Y12 inhibitors significantly reduced the risk of MACE by 11% (0.89, 95% CI 0.84-0.95, I2 = 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 P2Y12 inhibitor monotherapy compared with aspirin (0.94, 95% CI 0.72-1.22, I2 = 42.6%). Results were consistent irrespective of the P2Y12 inhibitor used. Conclusion: P2Y12 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.

Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial.

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.

Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial.

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.

Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial.

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.

Recurrent spontaneous coronary artery dissection: First case report in men with three episodes of spontaneous coronary dissection in separate vascular territories.

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.

One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair.

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.

Endovascular management of splenic artery aneurysms: case series using telescoping guide and cage/coil technique.

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.

Final 5-year results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS ATLAS Long Lesion clinical trials of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions.

OBJECTIVE: To report the final, cumulative, 5-year outcomes from the TAXUS ATLAS program, which studied the use of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions. METHODS: TAXUS ATLAS Workhorse, Small Vessel, and Long Lesion are nonrandomized studies comparing TAXUS Liberté (N=871), TAXUS Liberté 2.25 mm (N=261), and TAXUS Liberté 38 mm (N=150) stents, respectively, with case-matched TAXUS Express historical controls. RESULTS: In the unadjusted analysis, TAXUS Liberté showed comparable 5-year rates of major adverse cardiac events (27.1% TAXUS Express vs. 26.2% TAXUS Liberté, P=0.70) in workhorse lesions and greater 5-year cumulative freedom from target lesion revascularization (78.4 vs. 87.3%, P=0.03) in small vessels. In addition, a lower periprocedural myocardial infarction rate (MI, 4.1 vs. 0.0%; P=0.01) was observed in long lesions versus TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on the 5-year rates of TLR in small vessels (17.9 vs. 13.3%, P=0.36) or MI in long lesions (9.1 vs. 7.0%, P=0.53) was found, although the rates remained numerically lower with TAXUS Liberté. CONCLUSION: Cumulative 5-year results of the TAXUS ATLAS studies suggest that the TAXUS Liberté stent provides similar safety and effectiveness in workhorse lesions, and may provide lower revascularization rates in small vessels and lower periprocedural MI rates in long lesions compared with the TAXUS Express stent, although no statistically significant differences were found following propensity adjustment.

Propensity-matched patient-level comparison of the TAXUS Liberté and TAXUS element (ION) paclitaxel-eluting stents.

Stent design, metal alloy composition, and strut thickness may influence late lumen loss and clinical outcomes after bare metal stent deployment; however, their impact on outcomes after drug-eluting stent deployment is unknown. Although the TAXUS Liberté and ION paclitaxel-eluting stents use similar polymer and drug, the ION stent incorporates a novel thin-strut platinum chromium metal alloy and cell design. We therefore compared patient-level data from 2,298 subjects enrolled into the TAXUS ATLAS (TAXUS Liberté) and PERSEUS (ION) clinical trials. Propensity-score (1:1) matching was performed to adjust for covariate imbalance between stent types. Twelve-month major adverse cardiac events were less frequent after use of the ION compared to the TAXUS Liberté (12.7% vs 8.3%, p <0.001, unadjusted; 12.0% vs 7.5%, p = 0.007, propensity matched) largely because of decreased non-Q-wave myocardial infarction (MI; 2.9% vs 1.4%, p = 0.01, unadjusted; 3.2% vs 0.9%, p = 0.004, propensity matched). The MI difference was predominantly periprocedural and in patients treated with a single stent. In conclusion, this exploratory post hoc analysis demonstrated that the ION was associated with fewer adverse clinical events than the TAXUS Liberté because of decreased non-Q-wave MI. Stent platform-related variables may influence clinical outcomes after drug-eluting stent use despite similar polymer and drug elution. Differences in adjunctive pharmacotherapy and/or stenting technique may also be contributory.

A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial.

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.

Improved strut coverage and less late incomplete apposition with thin-strut TAXUS Liberté vs. TAXUS Express: the importance of stent platform design for drug-eluting stents.

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.

Predictors of neurological events associated with carotid artery stenting in high-surgical-risk patients: insights from the Cordis Carotid Stent Collaborative.

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.

Long-term outcomes of drug-eluting stents versus bare-metal stents in saphenous vein graft disease: results from the Prairie "Real World" Stent Registry.

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.

Correlates of late and very late thrombosis of drug eluting stents.

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.

Long-term results of carotid stenting versus endarterectomy in high-risk patients.

BACKGROUND: We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results. METHODS: The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years). RESULTS: At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral. CONCLUSIONS: In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270 [ClinicalTrials.gov].).

Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut TAXUS Liberté stent: 1-year results from the TAXUS ATLAS program.

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).

Short- and long-term clinical outcomes of coronary drug-eluting stent recipients presenting with chronic renal disease.

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.

Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial.

OBJECTIVES: The goal of this research was to assess non-inferiority of the next-generation TAXUS Liberté stent (Boston Scientific Corp., Natick, Massachusetts) versus the TAXUS Express stent (Boston Scientific Corp.). BACKGROUND: The introduction of drug-eluting stents (DES) has shifted clinical practice towards more complex lesion subsets, prompting the need for more deliverable DES. TAXUS Liberté was designed to combine the established polymer-based, paclitaxel-elution TAXUS technology with the more advanced Liberté stent platform. METHODS: The TAXUS ATLAS study is a global, prospective, single-arm trial evaluating outcomes in de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is an entry-criteria-matched population of TAXUS Express patients from the TAXUS IV and V trials. The primary end point is non-inferiority of TAXUS Liberté versus TAXUS Express for 9-month target vessel revascularization. RESULTS: Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex for TAXUS Liberté than TAXUS Express. The primary non-inferiority end point was met with the 1-sided 95% confidence bound of 2.98% less than the pre-specified non-inferiority margin of 3% (p = 0.0487). CONCLUSIONS: Despite the treatment of more complex lesions with TAXUS Liberté, the primary end point was met, demonstrating that TAXUS Liberté is non-inferior to TAXUS Express. The successful transfer of the proven TAXUS technology to the more advanced TAXUS Liberté platform was demonstrated. (TAXUS ATLAS: TAXUS Liberté-SR Stent for the Treatment of De Novo Coronary Artery Lesions; http://www.clinicaltrials.gov/ct/show/NCT00371709?order=1; NCT00371709).

Bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitors in drug-eluting stent implantations in the absence of acute myocardial infarction: clinical and economic results.

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.