Showing papers by "Stephen G. Ellis published in 2016"

2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions.

Abstract: To ensure that guidelines reflect current knowledge, available treatment options, and optimum medical care, existing clinical practice guideline recommendations are modified and new recommendations are added in response to new data, medications or devices. To keep pace with evolving evidence, the American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Clinical Practice Guidelines (“Task Force”) has issued this focused update to revise guideline recommendations on the basis of recently published data. This update is not based on a complete literature review from the date of previous guideline publications, but it has been subject to rigorous, multilevel review and approval, similar to the full guidelines. For specific focused update criteria and additional methodological details, please see the ACC/AHA guideline methodology manual.1 ### Modernization In response to published reports from the Institute of Medicine2,3 and ACC/AHA mandates,4–7 processes have changed leading to adoption of a “knowledge byte” format. This entails delineation of recommendations addressing specific clinical questions, followed by concise text, with hyperlinks to supportive evidence. This approach better accommodates time constraints on busy clinicians, facilitates easier access to recommendations via electronic search engines and other evolving technology (eg, smart phone apps), and supports the evolution of guidelines as “living documents” that can be …

Paclitaxel-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents

Abstract: mic target lesion revascularization were 27 (13.9%) vs 12 (6.3%) (relative risk [RR], 0.45; 95% confidence interval [CI], 0.24-0.86; P=.01); for ischemic target vessel revascularization, 34 (17.5%) vs 20 (10.5%) (RR, 0.60; 95% CI, 0.36-1.00;P=.046); and for overall major adverse cardiac events, 39 (20.1%) vs 22 (11.5%) (RR, 0.57; 95% CI, 0.350.93; P=.02), with similar rates of cardiac death or myocardial infarction (10 [5.2%] vs 7 [3.7%]; RR, 0.71; 95% CI, 0.28-1.83; P=.48) and target vessel thrombosis (5 [2.6%] vs 3 [1.6%]; RR, 0.61; 95% CI, 0.15-2.50; P=.72). Angiographic restenosis at 9 months was 31.2% (53 of 170 patients) with VBT and 14.5% (25 of 172 patients) with paclitaxeleluting stents (RR, 0.47; 95% CI, 0.30-0.71; P.001).

Insights Into Timing, Risk Factors, and Outcomes of Stroke and Transient Ischemic Attack After Transcatheter Aortic Valve Replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves)

Abstract: Background— Prior studies of stroke and transient ischemic attack (TIA) after transcatheter aortic valve replacement (TAVR) are limited by reporting and follow-up variability. This is a comprehensive analysis of time-related incidence, risk factors, and outcomes of these events. Methods and Results— From April 2007 to February 2012, 2621 patients, aged 84±7.2 years, underwent transfemoral (TF; 1521) or transapical (TA; 1100) TAVR in the PARTNER trial (Placement of Aortic Transcatheter Valves; as-treated), including the continued access registry. Stroke and TIA were identified by protocol and adjudicated by a Clinical Events Committee. Within 30 days of TAVR, 87 (3.3%) patients experienced a stroke (TF 58 [3.8%]; TA 29 [2.7%]; P =0.09), 85% within 1 week. Instantaneous stroke risk peaked on day 2, then fell to a low prolonged risk of 0.8% by 1 to 2 weeks. Within 30 days, 13 (0.50%) patients experienced a TIA (TF 10 [0.67%]; TA 3 [0.27%]; P >0.17). Stroke and TIA were associated with lower 1-year survival than expected (TF 47% after stroke versus 82%, and 64% after TIA versus 83%; TA 53% after stroke versus 80%, and 64% after TIA versus 83%). Risk factors for early stroke after TA-TAVR included more postdilatations, pure aortic stenosis without regurgitation, and possibly more pacing runs, earlier date of procedure, and no dual antiplatelet therapy; high pre-TAVR aortic peak gradient was a risk factor for stroke early after TF-TAVR. Conclusions— Risk of stroke or TIA is highest early after TAVR and is associated with increased 1-year mortality. Modifications of TAVR, emboli-prevention devices, and better intraprocedural pharmacological protection may mitigate this risk. Clinical Trial Registration— URL: . Unique identifier: [NCT00530894][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00530894&atom=%2Fcirccvint%2F9%2F9%2Fe002981.atom

Design and Rationale of the RE-DUAL PCI Trial : A Prospective, Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting

Abstract: Antithrombotic management of patients with atrial fibrillation (AF) undergoing coronary stenting is complicated by the need for anticoagulant therapy for stroke prevention and dual antiplatelet therapy for prevention of stent thrombosis and coronary events. Triple antithrombotic therapy, typically comprising warfarin, aspirin, and clopidogrel, is associated with a high risk of bleeding. A modest-sized trial of oral anticoagulation with warfarin and clopidogrel without aspirin showed improvements in both bleeding and thrombotic events compared with triple therapy, but large trials are lacking. The RE-DUAL PCI trial (NCT 02164864) is a phase 3b, a strategy of prospective, randomized, open-label, blinded-endpoint trial. The main objective is to evaluate dual antithrombotic therapy with dabigatran etexilate (110 or 150 mg twice daily) and a P2Y12 inhibtor (either clopidogrel or ticagrelor) compared with triple antithrombotic therapy with warfarin, a P2Y12 inhibtor (either clopidogrel or ticagrelor, and low-dose aspirin (for 1 or 3 months, depending on stent type) in nonvalvular AF patients who have undergone percutaneous coronary intervention with stenting. The primary endpoint is time to first International Society of Thrombosis and Hemostasis major bleeding event or clinically relevant nonmajor bleeding event. Secondary endpoints are the composite of all cause death or thrombotic events (myocardial infarction, or stroke/systemic embolism) and unplanned revascularization; death or thrombotic events; individual outcome events; death, myocardial infarction, or stroke; and unplanned revascularization. A hierarchical procedure for multiple testing will be used. The plan is to randomize ∼ 2500 patients at approximately 550 centers worldwide to try to identify new treatment strategies for this patient population.

Long-Term Mortality in Patients With Radiation-Associated Coronary Artery Disease Treated With Percutaneous Coronary Intervention

Abstract: Background— The incidence and predictors of long-term mortality after percutaneous coronary intervention (PCI) for radiation-associated coronary artery disease are unknown. Methods and Results— In this observational study of 314 patients (age, 65.2±11.4 years; 233 [74%] women) treated with PCI, 157 patients with previous external beam radiation therapy (XRT) were matched 1:1 with 157 comparison patients with atherosclerotic coronary artery disease without previous XRT, based on age, sex, lesion artery, and PCI type. The primary end point was all-cause mortality, and the secondary end point was cardiovascular mortality. After follow-up of 6.6±5.5 years, there were 101 deaths; 59 in the XRT group and 42 in the comparison group ( P =0.04). On Cox proportional hazards multivariable survival analysis, previous XRT remained an independent predictor of all-cause mortality (hazard ratio [HR] 1.85; 95% confidence interval [CI], 1.21–2.85; P =0.004) and cardiovascular mortality (HR, 1.70; 95% CI, 1.06–2.89; P =0.03). Additional independent predictors of increased all-cause mortality included balloon angioplasty or bare-metal stent placement compared with drug-eluting stent placement (HR, 2.50; 95% CI, 1.61–3.97; P <0.0001), SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score of ≥11 (the sample median; HR, 1.99; 95% CI, 1.32–3.04; P <0.001), New York Heart Association functional class ≥3 (HR, 1.83; 95% CI, 1.15–2.91; P =0.012), history of smoking (HR, 1.88; 95% CI, 1.10–3.09; P =0.022), and age ≥65 years (HR, 1.70; 95% CI, 1.07–2.07; P =0.024). Conclusions— Compared with patients with typical atherosclerotic coronary artery disease, patients with radiation-associated coronary artery disease are at higher risk for mortality after PCI. Previous XRT exposure is independently associated with increased all-cause and cardiovascular mortality in patients treated with PCI.

Management of drug eluting stent in-stent restenosis: A systematic review and meta-analysis

Abstract: Background The optimal management for coronary drug eluting stent in-stent restenosis (DES ISR) is unclear. We performed a meta-analysis of observational and randomized studies to compare the outcomes of management of DES ISR using DES, drug eluting balloon (DEB), or balloon angioplasty (BA). Methods Eligible studies (25 single arm and 13 comparative, including 4 randomized studies with a total of 7,474 patients with DES ISR) were identified using MEDLINE search and proceedings of international meetings. Outcomes studied include major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), stent thrombosis (ST), and mortality. Follow-up ranged from 0.5 to 3.5 years (mean 1.4 years). Results The rate of TLR was significantly lower in the DES (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.36–0.69) and DEB (OR 0.31, 95% CI 0.18–0.55) groups compared to BA. Similarly, TVR rate was significantly lower in the DES (OR 0.55, 95% CI 0.39–0.77) and DEB (OR 0.32, 95% CI 0.18–0.58) groups compared to BA. All other outcomes were similar between the DES/BA and DEB/BA comparisons. TLR was significantly lower in the DES group compared to BA for vessels 2.75 mm. Conclusion Treatment of coronary DES ISR with DES or DEB is associated with a reduction in the risk of TLR and TVR compared to BA alone. The relative risk reduction for TLR with DES is similar to DEB. DEBs have a potential role in the treatment of DES ISR by avoiding placement of another layer of stent. © 2015 Wiley Periodicals, Inc.

Utility of Glycated Hemoglobin for Assessment of Glucose Metabolism in Patients With ST-Segment Elevation Myocardial Infarction.

Abstract: Glycated hemoglobin (HbA1c) is an approved and widely used laboratory investigation for diagnosis of diabetes that is not affected by acute changes in blood glucose. Our aim was to analyze the extent to which routine HbA1c measurements diagnose unknown diabetes mellitus (DM) in patients presenting with ST-segment elevation myocardial infarction (STEMI). We also compared outcomes in patients with newly diagnosed DM, previously established DM and those without DM. Consecutive patients undergoing PCI for STEMI from January 2005 to December 2012 were included and routinely performed admission HbA1c was used to identify patients with previously undiagnosed DM (HbA1c ≥6.5 and no history of DM or DM therapy) and pre-DM (HbA1c 5.7% to 6.4%). Overall 1,686 consecutive patients underwent primary percutaneous coronary intervention for STEMI during the study period and follow-up data were available for 1,566 patients (90%). A quarter of the patients (24%, n = 405) had history of DM, 7% (n = 118) had previously undiagnosed DM, and 38.7% (n = 652) had pre-DM. Mortality was comparable in patients with known DM and newly diagnosed DM both in-hospital (11.1% vs 11.9%, p = 0.87) and at 3-year follow-up (27.3% and 24%). Patients with DM, including those who were newly diagnosed, had higher mortality at 3 years (26.5%) compared to those with pre-DM (12.1%) or no dysglycemia (11.2%, p

Novel 3-Dimensional Vessel and Scaffold Reconstruction Methodology for the Assessment of Strut-Level Wall Shear Stress After Deployment of Bioresorbable Vascular Scaffolds From the ABSORB III Imaging Substudy

Abstract: A 72-year-old female patient underwent successful deployment of a single 3.0 × 18 mm Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) to the mid right coronary artery ([Figures 1A and 1B][1]). The scaffolded segment was imaged simultaneously with coronary

Outcomes of ischaemic mitral regurgitation in anterior versus inferior ST elevation myocardial infarction

Abstract: Background Ischaemic mitral regurgitation (IMR) is a detrimental complication of ST elevation myocardial infarction (STEMI). Objective We sought to determine patient characteristics and outcomes of patients with IMR with focus on anterior or inferior location of STEMI. Methods All patients presenting with STEMI complicated by IMR to our centre who underwent primary percutaneous coronary intervention within the first 12 hours of presentation from 1995 to 2014 were included. IMR was graded from 1+ to 4+ within 3 days of index myocardial infarction by echocardiography, divided into 2 groups based on infarct location and outcomes were compared. Results Overall, 805 patients were included. There were 302 (17.8%) patients with mitral regurgitation (MR) out of the 1700 patients with anterior STEMI while 503 (21.8%) had MR out of the 2305 patients with inferior STEMI. There was no significant difference between both groups in comorbidities, clinical presentation or door-to-balloon time (DBT; median 104 vs 106 min, p=0.5). 30-day and 1-year mortality were higher in anterior STEMI compared with inferior STEMI (14.9% vs 6.8% and 26.4% vs 14.3%, respectively, p<0.001 both), as well as 5-year mortality (39.7% vs 24.8%, p<0.01). When analysis was performed for each grade of IMR, anterior was associated with worse outcomes in every grade. On multivariate cox survival analysis, after adjustment for age, gender, comorbidities, grade of IMR, ejection fraction and DBT, anterior STEMI was still associated with worse outcomes (HR 1.62 (95% CI 1.23 to 2.12), p<0.001). Conclusions Although IMR occurs more frequently with inferior infarction, outcomes are worse following anterior infarction.

One-year clinical outcomes after sirolimus-eluting coronary stent implantation in diabetics enrolled in the worldwide e-SELECT registry

Abstract: Background Diabetes mellitus has worse outcome after percutaneous coronary intervention. Aim We assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year after implantation of sirolimus-eluting stents (SES) in patients with diabetes mellitus in a large multicenter registry. Methods From May 2006 to April 2008, 15,147 unselected consecutive patients were enrolled at 320 centers in 56 countries in a prospective, observational registry after implantation of ≥ 1 SES. Source data were verified in 20% randomly chosen patients at > 100 sites. Adverse events were adjudicated by an independent Clinical Event Committee. Results Complete follow-up at 1 year was obtained in 13,693 (92%) patients, 4,577 (30%) of whom were diabetics. Within diabetics, 1,238 (9%) were insulin-treated diabetics (ITD). Diabetics were older (64 vs. 62 years, P < 0.001), with higher incidence of major coronary risk factors, co-morbidities, and triple-vessel coronary artery disease. Coronary lesions had smaller reference vessel diameter (2.88 ± 0.46 vs. 2.93 ± 0.45 mm, P < 0.001) and were more often heavily calcified (26.1% vs. 22.6%, P < 0.001). At 1 year, diabetics had higher MACE rate (6.8% vs. 3.9%, P < 0.001) driven by ITD (10.6% vs. 5.5%, P < 0.001). Finally, diabetics had significant increase in ST (1.7% vs. 0.7%, P < 0.001), principally owing to ITD (3.4% vs. 1.1%, P < 0.001). There was an overall low risk of major bleeding during follow-up, without significant difference among subgroups. Conclusions In the e-SELECT registry, diabetics represented 30% of patients undergoing SES implantation and had significantly more co-morbidities and complex coronary lesions. Although 1-year follow-up documented good overall outcome in diabetics, higher ST and MACE rates were observed, mainly driven by ITD. © 2015 Wiley Periodicals, Inc.

Bioresorbable stents: The future of interventional cardiology?

Abstract: The introduction of stents has drastically reduced target-lesion restenosis rates associated with percutaneous coronary angioplasty. Bare-metal stents were the first introduced, followed by drug-eluting stents, both of which had significant impacts on the complication rates. Stents, however, have resulted in the emergence of stent thrombosis and stent restenosis, which can cause life-threatening cardiac complications. Three new technological approaches are being investigated to overcome these complications: stents coated with bioresorbable polymers, stents without polymers, and completely bioresorbable stents. Initial results are encouraging, but more data are needed to ascertain their implications for clinical practice.

Assessment of safety of performing percutaneous coronary intervention after a recent episode of gastrointestinal bleeding

Abstract: Background: Little literature exists on the risk of performing coronary intervention (PCI) on patients who have had recent gastrointestinal bleeding (GIB), although bleeding after PCI has been identified as a risk factor for long-term mortality Methods: Patients within the Cleveland Clinic PCI database who had acute GIB within 30 days preceding PCI during the same hospitalization (n = 79) were retrospectively compared to those who had PCI without recent GIB (n = 10 979) for mortality and need for revascularization Baseline characteristics, laboratory values, procedures, morbidities, and mortality were compared using chi-square test for categorical variables and using Wilcoxon rank sum test for continuous variables Mortality data was obtained using Social Security Death Index and demonstrated using Kaplan–Meier method Results: The GIB group had more prevalent history of peptic ulcer disease, GIB, gastrointestinal or liver disease (P < 00001), transient ischemic accident (P = 0017), peripheral vascula