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Coronary Artery Disease: HELP
Articles by Laura Mauri
Based on 66 articles published since 2009
(Why 66 articles?)
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Between 2009 and 2019, Laura Mauri wrote the following 66 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. 2018

Valgimigli, Marco / Bueno, Héctor / Byrne, Robert A / Collet, Jean-Philippe / Costa, Francesco / Jeppsson, Anders / Jüni, Peter / Kastrati, Adnan / Kolh, Philippe / Mauri, Laura / Montalescot, Gilles / Neumann, Franz-Josef / Petricevic, Mate / Roffi, Marco / Steg, Philippe Gabriel / Windecker, Stephan / Zamorano, Jose Luis / Levine, Glenn N / Anonymous3740973. · ·Eur J Cardiothorac Surg · Pubmed #29045581.

ABSTRACT: -- No abstract --

2 Guideline [2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS.] 2017

Valgimigli, Marco / Bueno, Héctor / Byrne, Robert A / Collet, Jean-Philippe / Costa, Francesco / Jeppsson, Anders / Jüni, Peter / Kastrati, Adnan / Kolh, Philippe / Mauri, Laura / Montalescot, Gilles / Neumann, Franz-Josef / Peticevic, Mate / Roffi, Marco / Steg, Philippe Gabriel / Windecker, Stephan / Zamorano, Jose Luis. ·Cardiology, Inselspital, Bern. marco.valgimigli@insel.ch. ·Kardiol Pol · Pubmed #29251754.

ABSTRACT: -- No abstract --

3 Guideline Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A North American Perspective-2016 Update. 2016

Angiolillo, Dominick J / Goodman, Shaun G / Bhatt, Deepak L / Eikelboom, John W / Price, Matthew J / Moliterno, David J / Cannon, Christopher P / Tanguay, Jean-Francois / Granger, Christopher B / Mauri, Laura / Holmes, David R / Gibson, C Michael / Faxon, David P. ·From the Division of Cardiology, University of Florida College of Medicine-Jacksonville (D.J.A.) · St Michael's Hospital, University of Toronto, and the Canadian Heart Research Centre · Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.) · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B., D.P.F.) · Department of Medicine, Population Health Research Institute, Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E.) · Division of Cardiovascular Diseases, Scripps Clinic, La Jolla CA (M.J.P.) · Division of Cardiovascular Medicine and Gill Heart Institute, University of Kentucky, Lexington (D.J.M.) · Brigham and Women's Hospital, Harvard Clinical Research Institute, Harvard Medical School, Boston, MA (C.P.C., L.M.) · Department of Medicine, Montreal Heart Institute, Université de Montréal, QC, Canada (J.-F.T.) · Duke Clinical Research Institute, Duke University, Durham, NC (C.B.G.) · Mayo Clinic, Rochester, MN (D.R.H.) · and Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (C.M.G.). ·Circ Cardiovasc Interv · Pubmed #27803042.

ABSTRACT: The optimal antithrombotic treatment regimen for patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation is an emerging clinical problem. Currently, there is limited evidenced-based data on the optimal antithrombotic treatment regimen, including antiplatelet and anticoagulant therapies, for these high-risk patients with practice guidelines, thus, providing limited recommendations. Over the past years, expert consensus documents have provided guidance to clinicians on how to manage patients with atrial fibrillation undergoing percutaneous coronary intervention. Given the recent advancements in the field, the current document provides an updated opinion of selected North American experts from the United States and Canada on the treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention. In particular, this document provides the current views on (1) embolic/stroke risk, (2) ischemic/thrombotic cardiac risk, and (3) bleeding risk, which are pivotal for discerning the choice of antithrombotic therapy. In addition, we describe the recent advances in pharmacology, stent designs, and clinical trials relevant to the field. Ultimately, we provide expert consensus-derived recommendations, using a pragmatic approach, on the management of patients with atrial fibrillation undergoing percutaneous coronary intervention.

4 Guideline 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. 2016

Levine, Glenn N / Bates, Eric R / Bittl, John A / Brindis, Ralph G / Fihn, Stephan D / Fleisher, Lee A / Granger, Christopher B / Lange, Richard A / Mack, Michael J / Mauri, Laura / Mehran, Roxana / Mukherjee, Debabrata / Newby, L Kristin / O'Gara, Patrick T / Sabatine, Marc S / Smith, Peter K / Smith, Sidney C / Halperin, Jonathan L / Levine, Glenn N / Al-Khatib, Sana M / Birtcher, Kim K / Bozkurt, Biykem / Brindis, Ralph G / Cigarroa, Joaquin E / Curtis, Lesley H / Fleisher, Lee A / Gentile, Federico / Gidding, Samuel / Hlatky, Mark A / Ikonomidis, John S / Joglar, José A / Pressler, Susan J / Wijeysundera, Duminda N. · ·J Thorac Cardiovasc Surg · Pubmed #27751237.

ABSTRACT: -- No abstract --

5 Guideline 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. 2016

Levine, Glenn N / Bates, Eric R / Bittl, John A / Brindis, Ralph G / Fihn, Stephan D / Fleisher, Lee A / Granger, Christopher B / Lange, Richard A / Mack, Michael J / Mauri, Laura / Mehran, Roxana / Mukherjee, Debabrata / Newby, L Kristin / O'Gara, Patrick T / Sabatine, Marc S / Smith, Peter K / Smith, Sidney C. · ·J Am Coll Cardiol · Pubmed #27036918.

ABSTRACT: -- No abstract --

6 Guideline 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. 2013

Levine, Glenn N / Bates, Eric R / Blankenship, James C / Bailey, Steven R / Bittl, John A / Cercek, Bojan / Chambers, Charles E / Ellis, Stephen G / Guyton, Robert A / Hollenberg, Steven M / Khot, Umesh N / Lange, Richard A / Mauri, Laura / Mehran, Roxana / Moussa, Issam D / Mukherjee, Debabrata / Nallamothu, Brahmajee K / Ting, Henry H / Anonymous5470709 / Anonymous5480709 / Anonymous5490709. · ·Catheter Cardiovasc Interv · Pubmed #22065485.

ABSTRACT: -- No abstract --

7 Guideline 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. 2012

Levine, Glenn N / Bates, Eric R / Blankenship, James C / Bailey, Steven R / Bittl, John A / Cercek, Bojan / Chambers, Charles E / Ellis, Stephen G / Guyton, Robert A / Hollenberg, Steven M / Khot, Umesh N / Lange, Richard A / Mauri, Laura / Mehran, Roxana / Moussa, Issam D / Mukherjee, Debabrata / Nallamothu, Brahmajee K / Ting, Henry H / Anonymous640718 / Anonymous650718 / Anonymous660718. · ·Catheter Cardiovasc Interv · Pubmed #22328235.

ABSTRACT: -- No abstract --

8 Editorial Close encounters with errors of the second kind: evaluating risks and benefits of long-term dual antiplatelet therapy. 2015

Yeh, Robert W / Cohen, David J / Mauri, Laura. ·Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. · St. Luke's Mid America Heart Institute, Kansas City, MO, USA. · Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA lmauri1@partners.org. ·Eur Heart J · Pubmed #25796054.

ABSTRACT: -- No abstract --

9 Editorial Dual Antiplatelet Therapy Duration Following Coronary Stenting. [Corrected]. 2015

Yeh, Robert W / Mauri, Laura / Kereiakes, Dean J. ·Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. · Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. · The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, Ohio. Electronic address: lindner@thechristhospital.com. ·J Am Coll Cardiol · Pubmed #25720621.

ABSTRACT: -- No abstract --

10 Editorial Late stent thrombosis: can it be prevented? 2014

Mauri, Laura / Galper, Benjamin Z. ·Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School Boston, Boston, Massachusetts; Harvard Clinical Research Institute, Harvard Medical School Boston, Boston, Massachusetts. Electronic address: lmauri1@partners.org. · Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School Boston, Boston, Massachusetts. ·JACC Cardiovasc Interv · Pubmed #25341706.

ABSTRACT: -- No abstract --

11 Editorial Optimal timing of noncardiac surgery after stents. 2012

Matteau, Alexis / Mauri, Laura. · ·Circulation · Pubmed #22965778.

ABSTRACT: -- No abstract --

12 Review 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. 2016

Levine, Glenn N / Bates, Eric R / Bittl, John A / Brindis, Ralph G / Fihn, Stephan D / Fleisher, Lee A / Granger, Christopher B / Lange, Richard A / Mack, Michael J / Mauri, Laura / Mehran, Roxana / Mukherjee, Debabrata / Newby, L Kristin / O'Gara, Patrick T / Sabatine, Marc S / Smith, Peter K / Smith, Sidney C. ·Focused Update writing group members are required to recuse themselves from voting on sections to which their specific relationships with industry may apply; see Appendix 1 for detailed information. ACC/AHA Task Force on Clinical Practice Guidelines Liaison. ACC/AHA Representative. Evidence Review Committee Chair. American Society of Anesthesiologists/Society of Cardiovascular Anesthesiologists Representative. American Association for Thoracic Surgery/Society of Thoracic Surgeons Representative. Society for Cardiovascular Angiography and Interventions Representative. ·Circulation · Pubmed #27026020.

ABSTRACT: -- No abstract --

13 Review Association of body mass index with mortality and cardiovascular events for patients with coronary artery disease: a systematic review and meta-analysis. 2015

Wang, Zhi Jian / Zhou, Yu Jie / Galper, Benjamin Z / Gao, Fei / Yeh, Robert W / Mauri, Laura. ·Beijing Institute of Heart Lung and Blood Vessel Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China Brigham and Women's Hospital, Boston, Massachusetts, USA Harvard Medical School, Boston, Massachusetts, USA. · Beijing Institute of Heart Lung and Blood Vessel Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. · Brigham and Women's Hospital, Boston, Massachusetts, USA Harvard Medical School, Boston, Massachusetts, USA. · Harvard Medical School, Boston, Massachusetts, USA Massachusetts General Hospital, Boston, Massachusetts, USA Harvard Clinical Research Institute, Boston, Massachusetts, USA. · Brigham and Women's Hospital, Boston, Massachusetts, USA Harvard Medical School, Boston, Massachusetts, USA Harvard Clinical Research Institute, Boston, Massachusetts, USA. ·Heart · Pubmed #26025084.

ABSTRACT: OBJECTIVES: The association between obesity and prognosis in patients with coronary artery disease (CAD) remains uncertain. We undertook a meta-analysis for the effects of body mass index (BMI) on mortality and cardiovascular events in these patients. METHODS: We identified studies that provided risk estimates for mortality or cardiovascular events on the basis of BMI in patients with CAD. Summary estimates of relative risks were obtained for five BMI groups: underweight, normal-weight, overweight, obese and grade II/III obese. Mortality was analysed separately as short-term (<6 months) and long-term (≥6 months). RESULTS: Data from 89 studies with 1 300 794 patients were included. Mean follow-up of long-term estimates was 3.2 years. Using normal-weight as the reference, underweight was associated with higher risk of short-term mortality (2.24 (1.85 to 2.72)) and long-term mortality (1.70 (1.56 to 1.86)), overweight and obesity were both associated with lower risk of short-term mortality (0.69 (0.64 to 0.75); 0.68 (0.61 to 0.75)) and long-term mortality (0.78 (0.74 to 0.82); 0.79 (0.73 to 0.85)), but the long-term benefit of obesity disappeared after 5 years of follow-up (0.99 (0.91 to 1.08)). Grade II/III obesity was associated with lower risk of mortality in the short term (0.76 (0.62 to 0.91)) but higher risk after 5 years of follow-up (1.25 (1.14 to 1.38)). The similar J-shaped pattern was also seen for cardiovascular mortality and across different treatment strategies. Meta-regression found an attenuation of the inverse association between BMI and risk of mortality over longer follow-up. CONCLUSIONS: Our data support a J-shaped relationship between mortality and BMI in patients with CAD. The limitation of current literature warrants better design of future studies.

14 Review Adherence to dual antiplatelet therapy after coronary stenting: a systematic review. 2014

Czarny, Matthew J / Nathan, Ashwin S / Yeh, Robert W / Mauri, Laura. ·Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland. ·Clin Cardiol · Pubmed #24797884.

ABSTRACT: BACKGROUND: Adherence to dual antiplatelet therapy (DAPT) is critical after coronary stenting. Although adherence rates are frequently assessed in clinical trials, adherence rates in the unselected population recommended for treatment but beyond clinical trials are largely unknown. Therefore, we performed a systematic review of published observational studies to describe rates of DAPT adherence, trends in DAPT use over time, and patient-level factors associated with nonadherence. HYPOTHESIS: DAPT adherence declines with increasing time after drug-eluting stent implantation. METHODS: PubMed, Cumulative Index to Nursing and Allied Health Literature, Embase, and Web of Knowledge were searched through November 20, 2012 for studies including patients receiving 1 or more drug-eluting stents and reporting the use of aspirin and/or thienopyridines, or assessing factors associated with nonadherence to DAPT after bare metal or drug-eluting stent placement. RESULTS: We included 34 studies in the description of DAPT adherence and 11 studies in the description of factors associated with nonadherence. Adherence to DAPT and thienopyridines was high at 1 month but declined by 12 months. Aspirin adherence was at least 90% throughout. Factors associated with nonadherence included bleeding, lower education level, immigrant status, and lack of education regarding DAPT. CONCLUSIONS: DAPT adherence is suboptimal at 12 months, and interventions to increase adherence should focus on reducing bleeding risk and improving communication between patients and physicians.

15 Review Saphenous vein graft intervention. 2011

Lee, Michael S / Park, Seung-Jung / Kandzari, David E / Kirtane, Ajay J / Fearon, William F / Brilakis, Emmanouil S / Vermeersch, Paul / Kim, Young-Hak / Waksman, Ron / Mehilli, Julinda / Mauri, Laura / Stone, Gregg W. ·University of California-Los Angeles Medical Center, Los Angeles, California, USA. mslee@mednet.ucla.edu ·JACC Cardiovasc Interv · Pubmed #21851895.

ABSTRACT: Saphenous vein grafts are commonly used conduits for surgical revascularization of coronary arteries but are associated with poor long-term patency rates. Percutaneous revascularization of saphenous vein grafts is associated with worse clinical outcomes including higher rates of in-stent restenosis, target vessel revascularization, myocardial infarction, and death compared with percutaneous coronary intervention of native coronary arteries. Use of embolic protection devices is a Class I indication according to the American College of Cardiology/American Heart Association guidelines to decrease the risk of distal embolization, no-reflow, and periprocedural myocardial infarction. Nonetheless, these devices are underused in clinical practice. Various pharmacological agents are available that may also reduce the risk of or mitigate the consequences of no-reflow. Covered stents do not decrease the rates of periprocedural myocardial infarction and restenosis. Most available evidence supports treatment with drug-eluting stents in this high-risk lesion subset to reduce angiographic and clinical restenosis, although large, randomized trials comparing drug-eluting stents and bare-metal stents are needed.

16 Review Late loss in a disappearing frame of reference: is it still applicable to fully absorbable scaffolds? 2009

Bangalore, Sripal / Mauri, Laura. ·Department of Medicine, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Clinical Research Institution, Boston, MA 02115, USA. ·EuroIntervention · Pubmed #22100675.

ABSTRACT: Bioabsorbable stents are an important advancement in stent technology providing a temporary scaffold and may be augmented with drugs to suppress neointimal hyperplasia.Though changes are being made to the design of the stents, to ensure similar rates of acute recoil, residual stenosis postintervention remains higher when compared to contemporary durable stents. In order to achieve similar clinical restenosis outcomes, bioabsorbable stents must first show similar MLD or percent diameter stenosis at follow-up to drug-eluting stents.While variable different acute gain and post-procedure MLD for bioabsorbable stents make late lumen loss a poor marker for restenosis probability by itself, late loss can be an informative metric for neointimal hyperplasia over time in these stents.Metrics which are independent of acute gain such as minimal luminal diameter and percentage diameter stenosis may make better surrogates for restenosis (Table 1). Moreover, remodelling over time requires measurement of the vessel and lumen diameters in later follow-up. Since the natural history of the vascular response to bioabsorbable stents is in its infancy of investigation, follow-up of these stents at least beyond the duration of polymer is prudent. Finally, given a disappearing frame of reference, both careful angiographic and intravascular ultrasound assessments are helpful to delineate the varying contributions of recoil, remodelling, and neointima formation.

17 Clinical Trial Performance of the resolute zotarolimus-eluting stent in small vessels. 2014

Caputo, Ronald / Leon, Martin / Serruys, Patrick / Neumann, Franz-Josef / Yeung, Alan / Windecker, Stephan / Belardi, Jorge A / Silber, Sigmund / Meredith, Ian / Widimský, Petr / Saito, Shigeru / Mauri, Laura. ·St. Joseph's Hospital Cardiology, Liverpool, New York, New York. ·Catheter Cardiovasc Interv · Pubmed #24659581.

ABSTRACT: BACKGROUND: Drug eluting stents for the treatment of small vessel coronary artery disease have traditionally yielded inferior clinical outcomes compared to the use of DES in large vessels. The benefit of the second-generation Resolute zotarolimus-eluting stent (R-ZES) in small vessels was examined. METHODS: Two-year clinical outcomes from five combined R-ZES studies were compared between patients with small (reference vessel diameter [RVD] ≤2.5 mm; n = 1,956) and large (RVD >2.5 mm; n = 3174) vessels. RESULTS: Despite a higher incidence of comorbidities in the small vessel group, there was no significant difference in target lesion failure (TLF) (10.1% vs. 8.7%; P = 0.54) at 2 years. When the subgroup of patients with diabetes was examined (n = 1,553) there was no significant difference in 2-year TLF in small compared to large vessels (11.2% vs. 11.1%; P = 0.17). Similarly, within the small vessel cohort, no significant difference was seen regarding TLF at 2 years between people with and without diabetes (11.2% vs 9.6%; P = 0.28). CONCLUSION: When used for the treatment of small vessels, the R-ZES appears to provide acceptable clinical results at 2 years when compared to its performance in large vessels.

18 Clinical Trial Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). 2014

Nørgaard, Bjarne L / Leipsic, Jonathon / Gaur, Sara / Seneviratne, Sujith / Ko, Brian S / Ito, Hiroshi / Jensen, Jesper M / Mauri, Laura / De Bruyne, Bernard / Bezerra, Hiram / Osawa, Kazuhiro / Marwan, Mohamed / Naber, Christoph / Erglis, Andrejs / Park, Seung-Jung / Christiansen, Evald H / Kaltoft, Anne / Lassen, Jens F / Bøtker, Hans Erik / Achenbach, Stephan / Anonymous4700783. ·Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. Electronic address: bnorgaard@dadlnet.dk. · Department of Radiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. · Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. · MonashHeart, Monash Medical Center and Monash University, Victoria, Australia. · Department of Cardiology, Okayama University Hospital, Okayama, Japan. · Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. · Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium. · Department of Cardiology, Harrington Heart and Vascular Institute, University Hospitals, Cleveland, Ohio. · Department of Cardiology, Erlangen University Hospital, Erlangen, Germany. · Department of Cardiology and Angiology, Elisabeth-Krankenhaus Essen, Essen, Germany. · Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia. · Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. ·J Am Coll Cardiol · Pubmed #24486266.

ABSTRACT: OBJECTIVES: The goal of this study was to determine the diagnostic performance of noninvasive fractional flow reserve (FFR) derived from standard acquired coronary computed tomography angiography (CTA) datasets (FFR(CT)) for the diagnosis of myocardial ischemia in patients with suspected stable coronary artery disease (CAD). BACKGROUND: FFR measured during invasive coronary angiography (ICA) is the gold standard for lesion-specific coronary revascularization decisions in patients with stable CAD. The potential for FFR(CT) to noninvasively identify ischemia in patients with suspected CAD has not been sufficiently investigated. METHODS: This prospective multicenter trial included 254 patients scheduled to undergo clinically indicated ICA for suspected CAD. Coronary CTA was performed before ICA. Evaluation of stenosis (>50% lumen reduction) in coronary CTA was performed by local investigators and in ICA by an independent core laboratory. FFR(CT) was calculated and interpreted in a blinded fashion by an independent core laboratory. Results were compared with invasively measured FFR, with ischemia defined as FFR(CT) or FFR ≤0.80. RESULTS: The area under the receiver-operating characteristic curve for FFR(CT) was 0.90 (95% confidence interval [CI]: 0.87 to 0.94) versus 0.81 (95% CI: 0.76 to 0.87) for coronary CTA (p = 0.0008). Per-patient sensitivity and specificity (95% CI) to identify myocardial ischemia were 86% (95% CI: 77% to 92%) and 79% (95% CI: 72% to 84%) for FFR(CT) versus 94% (86 to 97) and 34% (95% CI: 27% to 41%) for coronary CTA, and 64% (95% CI: 53% to 74%) and 83% (95% CI: 77% to 88%) for ICA, respectively. In patients (n = 235) with intermediate stenosis (95% CI: 30% to 70%), the diagnostic accuracy of FFR(CT) remained high. CONCLUSIONS: FFR(CT) provides high diagnostic accuracy and discrimination for the diagnosis of hemodynamically significant CAD with invasive FFR as the reference standard. When compared with anatomic testing by using coronary CTA, FFR(CT) led to a marked increase in specificity. (HeartFlowNXT-HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography [HFNXT]; NCT01757678).

19 Clinical Trial Rationale and design of the clinical evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the treatment of de novo lesions in native coronary arteries (the RESOLUTE US clinical trial). 2011

Mauri, Laura / Leon, Martin B / Yeung, Alan C / Negoita, Manuela / Keyes, Michelle J / Massaro, Joseph M. ·Brigham and Women's Hospital, Boston, MA 02115, USA. lmauri1@partners.org ·Am Heart J · Pubmed #21570508.

ABSTRACT: BACKGROUND: Drug-eluting stents (DES) are commonly used to treat obstructive coronary disease and avoid restenosis. Newer DES have been developed to improve effectiveness and safety. We describe a clinical trial to evaluate a DES with a novel polymer that may improve the antirestenosis effectiveness while maintaining the safety standards of currently Food and Drug Administration-approved DES. METHODS: The RESOLUTE US Trial is a multicenter, nonrandomized trial prospectively designed to compare the Resolute zotarolimus-eluting stent (R-ZES) to the Food and Drug Administration-approved Endeavor ZES using patient-level historical control data, adjusting for baseline covariates through propensity score. The stents differ primarily in the polymer, which, in the R-ZES, is designed to elute zotarolimus over a longer period. The study will enroll up to 1,574 patients with ischemic heart disease due to de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. The primary end point is target lesion failure at 12 months postprocedure, defined as the composite of cardiac death, target-vessel myocardial infarction (MI), and clinically driven target lesion revascularization by percutaneous or surgical methods. Secondary end points include device, lesion and procedural success, death, MI, cardiac death and MI, composites of these clinical events, and stent thrombosis at each follow-up assessment up to 5 years postprocedure. CONCLUSIONS: The RESOLUTE US Trial (ClinicalTrials.gov #NCT00726453) is a prospective, multicenter, observational study with a patient-level historical control designed to assess the safety and efficacy of the R-ZES for the treatment of de novo lesions in native coronary arteries.

20 Clinical Trial Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial. 2011

Yeung, Alan C / Leon, Martin B / Jain, Ash / Tolleson, Thaddeus R / Spriggs, Douglas J / Mc Laurin, Brent T / Popma, Jeffrey J / Fitzgerald, Peter J / Cutlip, Donald E / Massaro, Joseph M / Mauri, Laura / Anonymous2980691. ·Stanford University School of Medicine, Palo Alto, California, USA. ·J Am Coll Cardiol · Pubmed #21470813.

ABSTRACT: OBJECTIVES: The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population. BACKGROUND: The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety. METHODS: The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores. RESULTS: Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = -2.8%, upper 1-sided 95% confidence interval: -1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%. CONCLUSIONS: The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453).

21 Article Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. 2018

Berry, Natalia C / Kereiakes, Dean J / Yeh, Robert W / Steg, P Gabriel / Cutlip, Donald E / Jacobs, Alice K / Abbott, J Dawn / Hsieh, Wen-Hua / Massaro, Joseph M / Mauri, Laura / Anonymous3891417. ·Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (N.C.B., L.M.). · Harvard Medical School, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y.). · Baim Institute for Clinical Research, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y., W.-H.H., J.M.M.). · The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K). · The Smith Center for Outcomes Research in Cardiology (R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA. · Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, Département Hospitalo-Universitaire Fibrosis Inflammation Remodeling, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.). · National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, United Kingdom (P.G.S.). · Division of Cardiology, Department of Medicine (D.E.C.). · Boston University School of Medicine, Boston, MA (A.K.J.). · Rhode Island Hospital, Brown University School of Medicine (J.D.A.). · Boston University School of Public Health, MA (J.M.M.). ·Circ Cardiovasc Interv · Pubmed #30354781.

ABSTRACT: BACKGROUND: Women may derive differential benefit from prolonged DAPT (dual antiplatelet therapy) after coronary stenting than men. We assessed whether the risks/benefits of prolonged DAPT differ between women and men. METHODS AND RESULTS: The DAPT study was a randomized double-blind, placebo-controlled trial comparing continued thienopyridine versus placebo beyond 12 months after coronary stenting. We compared rates of myocardial infarction, stent thrombosis, major adverse cardiovascular and cerebrovascular events, and bleeding by sex and randomized treatment. Of 11 648 patients, women (N=2925) were older, with higher prevalence of diabetes mellitus and lower rates of acute coronary syndrome than men. At 12 to 30 months, women had similar adjusted ischemic and bleeding events as men. The effects of continued thienopyridine therapy did not differ significantly by sex for stent thrombosis (women: hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.22-1.36; men: HR, 0.26; 95% CI, 0.15-0.44; interaction P=0.17), myocardial infarction (women: HR, 0.75; 95% CI, 0.50-1.14; men: HR, 0.46; 95% CI, 0.36-0.60; interaction P=0.052), major adverse cardiovascular and cerebrovascular events (women: HR, 0.87; 95% CI, 0.62-1.22; men: HR, 0.70; 95% CI, 0.58-0.85; interaction P=0.26), and bleeding (women: HR, 1.45; 95% CI, 0.88-2.40; men: HR, 1.78; 95% CI, 1.28-2.49; interaction P=0.50). CONCLUSIONS: Women had similar late risks of ischemia and bleeding as men after coronary stent procedures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00977938.

22 Article Rationale and design of the EVOLVE Short DAPT Study to assess 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention. 2018

Mauri, Laura / Kirtane, Ajay J / Windecker, Stephan / Yeh, Robert W / Dauerman, Harold L / Price, Matthew J / Christen, Thomas / Allocco, Dominic J / Meredith, Ian T / Kereiakes, Dean J. ·Division of Cardiovascular Medicine/Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: laura.mauri@gmail.com. · Division of Cardiology, Columbia University/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA. · Bern University Hospital, Bern, Switzerland. · Beth Israel Deaconess Medical Center, Boston, MA, USA. · University of Vermont Larner College of Medicine, Burlington, VT, USA. · Scripps Clinic, La Jolla, CA, USA. · Boston Scientific Corporation, Marlborough, MA, USA. · The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH, USA. Electronic address: lindner@thechristhospital.com. ·Am Heart J · Pubmed #30218844.

ABSTRACT: BACKGROUND: While extended dual antiplatelet therapy (DAPT) with aspirin and a platelet (P2Y TRIAL DESIGN: EVOLVE Short DAPT is a prospective, single-arm, international study that enrolled 2009 high risk bleeding subjects (defined as age ≥75 years, chronic anticoagulation, major bleeding within 12 months, history of stroke, renal insufficiency/failure, or thrombocytopenia) who underwent PCI with the SYNERGY stent. Subjects presenting with acute MI or complex lesions were excluded. After 3 months treatment with DAPT (except those on anticoagulant in whom aspirin is optional), subjects free from stroke, MI, revascularization or ST will be eligible to discontinue P2Y CONCLUSION: The EVOLVE Short DAPT study will prospectively define the safety of DAPT discontinuation at 3 months in high bleeding risk patients treated with the SYNERGY stent.

23 Article Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. 2017

Yeh, Robert W / Kereiakes, Dean J / Steg, P Gabriel / Cutlip, Donald E / Croce, Kevin J / Massaro, Joseph M / Mauri, Laura / Anonymous811322. ·Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: ryeh@bidmc.harvard.edu. · Christ Hospital Heart and Vascular Center and the Lindner Center for Research and Education, Cincinnati, Ohio. · Université Paris-Diderot, INSERM U-1148, Paris, France; Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom. · Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts. · Brigham and Women's Hospital, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts. ·J Am Coll Cardiol · Pubmed #29073947.

ABSTRACT: BACKGROUND: Subjects undergoing coronary stenting with complex lesion anatomy may experience different risks and benefits with prolonged dual antiplatelet therapy. OBJECTIVES: The authors assessed the effect of 30 months versus 12 months of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) based on the presence or absence of anatomically-complex target lesions. METHODS: In the DAPT Study, combined myocardial infarction (MI) or stent thrombosis and moderate/severe bleeding were assessed in enrolled (n = 25,416) and randomized (n = 11,554) subjects. Complex lesions had any of the following characteristics: unprotected left main, >2 lesions/vessel, length ≥30 mm, bifurcation with side branch ≥2.5 mm, vein bypass graft, or thrombus-containing lesion. Events were evaluated according to increasing number of complexity characteristics and compared according to DAPT score. RESULTS: Enrolled subjects with more complex target lesions had higher rates of MI or stent thrombosis in the first 12 months after PCI (3.9% vs. 2.4%; p < 0.001). Among those who were event-free at 12 months, rates of MI or stent thrombosis between 12 and 30 months were similar between those with versus without complex anatomy (3.5% vs. 2.9%; p = 0.07). Reduction of MI or stent thrombosis with continued thienopyridine beyond 12 months versus placebo was similar for subjects with (2.5% vs. 4.5%; hazard ratio: 0.55; 95% confidence interval: 0.38 to 0.79; p = 0.001) and without (2.0% vs. 3.8%; hazard ratio: 0.52; 95% confidence interval: 0.39 to 0.69; p < 0.001) anatomic complexity (p CONCLUSIONS: Complex target-lesion anatomy is associated with increased ischemic events, particularly within the first year after PCI. Among those without events in the first 12 months, the benefits of extending DAPT were similar in subjects with and without complex lesions. A high DAPT score identified those experiencing the most benefit from extended treatment among patients with and without complex anatomy. (The Dual Antiplatelet Therapy Study [DAPT Study]; NCT00977938).

24 Article Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. 2017

Kandzari, David E / Mauri, Laura / Koolen, Jacques J / Massaro, Joseph M / Doros, Gheorghe / Garcia-Garcia, Hector M / Bennett, Johan / Roguin, Ariel / Gharib, Elie G / Cutlip, Donald E / Waksman, Ron / Anonymous5720917. ·Piedmont Heart Institute, Atlanta, GA, USA. Electronic address: david.kandzari@piedmont.org. · Divison of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA. · Catharina Hospital, Eindhoven, Netherlands. · Department of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, MA, USA. · Department of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, MA, USA; Baim Institute for Clinical Research, Boston, MA, USA. · Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA. · Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium. · Department of Cardiology, Rambam Medical Center, Haifa, Israel. · Charleston Area Medical Center, Charleston, WV, USA. · Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, MA, USA. ·Lancet · Pubmed #28851504.

ABSTRACT: BACKGROUND: The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. METHODS: BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. FINDINGS: Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208). INTERPRETATION: The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. FUNDING: BIOTRONIK.

25 Article Usefulness of Intracoronary Brachytherapy for Patients With Resistant Drug-Eluting Stent Restenosis. 2017

Mangione, Fernanda M / Jatene, Tannas / Badr Eslam, Roza / Bergmark, Brian A / Gallagher, Jacob R / Shah, Pinak B / Mauri, Laura / Leopold, Jane A / Sobieszczyk, Piotr S / Faxon, David P / Croce, Kevin J / Bhatt, Deepak L / Devlin, Phillip M. ·Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts; Beneficência Portuguesa de São Paulo Hospital, São Paulo, Brazil. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. · Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. Electronic address: dlbhattmd@post.harvard.edu. ·Am J Cardiol · Pubmed #28583681.

ABSTRACT: In-stent restenosis (ISR) remains a concern even in the drug-eluting stent (DES) era and carries a high risk of recurrence. Brachytherapy is being used as an alternative treatment for resistant ISR, yet the safety and efficacy of this approach has not been well studied. We analyzed the outcomes of 101 patients who underwent coronary brachytherapy for resistant DES ISR. Baseline demographic, clinical, procedural, and outcome data were collected by phone and from electronic records. Comorbidities and overt cardiovascular disease were highly prevalent. Median previous stent layers were 2 with a maximum of 5 layers. Procedural angiographic success rate was 97% and median time to discharge was 1 day after brachytherapy. The primary outcome of target vessel revascularization was 24% at 1 year, 32% at 2 years, and 42% at 3 years. The rate of nonfatal myocardial infarction was 0% at 1 year, 3.5% at 2 years, and 6% at 3 years. The rate of all-cause mortality was 8.5% at 1 year, 12% at 2 years, and 16% at 3 years. We observed only 1 case of late stent thrombosis. After multivariable adjustment, female gender (hazard ratio 2.37, 95% confidence interval 1.02 to 5.52, p = 0.04) and diffuse ISR pattern (hazard ratio 2.95, 95% confidence interval 1.21 to 7.17, p = 0.01) were independently associated with the primary outcome. In conclusion, brachytherapy is feasible for the treatment of resistant DES ISR and is associated with high immediate procedural success and reasonable efficacy in a complex patient population. This approach might be used as an alternative for these patients.

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