Author
Trial Investigators
Bio: Trial Investigators is an academic researcher. The author has contributed to research in topics: Hazard ratio & Aortic valve replacement. The author has an hindex of 2, co-authored 2 publications receiving 3767 citations.
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TL;DR: In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best Available medical therapy alone, decreased the need for urgent revascularization.
Abstract: A b s t r ac t Background The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone. Methods In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. Results Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary endpoint event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event. Conclusions In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.)
2,195 citations
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Columbia University1, Cleveland Clinic2, University of British Columbia3, Cedars-Sinai Medical Center4, Lenox Hill Hospital5, Boston Children's Hospital6, Emory University7, MedStar Washington Hospital Center8, Stanford University9, University of Pennsylvania10, University of Virginia11, Mayo Clinic12, Scripps Health13, Duke University14, Primary Children's Hospital15, University of London16, Edwards Lifesciences Corporation17
TL;DR: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients, but paravalvular regurgitation was more frequent after T AVR and was associated with increased late mortality.
Abstract: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P = 0.41) and at 2 years (Kaplan–Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P = 0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P = 0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P = 0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). Conclusions A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)
2,012 citations
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TL;DR: Mozaffarian, Dariush, Benjamin, Emelia J; Go, Alan S; Arnett, Donna K; Blaha, Michael J; Cushman, Mary; de Ferranti, Sarah; Despres, Jean-Pierre; Fullerton, Heather J; Howard, Virginia J; Huffman, Mark D; Judd, Suzanne E; Kissela, Brett M; Lackland, Daniel T; Lichtman, Judith H; Lisabeth, Lynda D; Liu, Simin; Mackey, Rachel H; Matchar, David B
Abstract: Author(s): Mozaffarian, Dariush; Benjamin, Emelia J; Go, Alan S; Arnett, Donna K; Blaha, Michael J; Cushman, Mary; de Ferranti, Sarah; Despres, Jean-Pierre; Fullerton, Heather J; Howard, Virginia J; Huffman, Mark D; Judd, Suzanne E; Kissela, Brett M; Lackland, Daniel T; Lichtman, Judith H; Lisabeth, Lynda D; Liu, Simin; Mackey, Rachel H; Matchar, David B; McGuire, Darren K; Mohler, Emile R; Moy, Claudia S; Muntner, Paul; Mussolino, Michael E; Nasir, Khurram; Neumar, Robert W; Nichol, Graham; Palaniappan, Latha; Pandey, Dilip K; Reeves, Mathew J; Rodriguez, Carlos J; Sorlie, Paul D; Stein, Joel; Towfighi, Amytis; Turan, Tanya N; Virani, Salim S; Willey, Joshua Z; Woo, Daniel; Yeh, Robert W; Turner, Melanie B; American Heart Association Statistics Committee and Stroke Statistics Subcommittee
5,076 citations
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TL;DR: Author(s): Go, Alan S; Mozaffarian, Dariush; Roger, Veronique L; Benjamin, Emelia J; Berry, Jarett D; Blaha, Michael J; Dai, Shifan; Ford, Earl S; Fox, Caroline S; Franco, Sheila; Fullerton, Heather J; Gillespie, Cathleen; Hailpern, Susan M; Heit, John A; Howard, Virginia J; Huffman, Mark D; Judd
Abstract: Author(s): Go, Alan S; Mozaffarian, Dariush; Roger, Veronique L; Benjamin, Emelia J; Berry, Jarett D; Blaha, Michael J; Dai, Shifan; Ford, Earl S; Fox, Caroline S; Franco, Sheila; Fullerton, Heather J; Gillespie, Cathleen; Hailpern, Susan M; Heit, John A; Howard, Virginia J; Huffman, Mark D; Judd, Suzanne E; Kissela, Brett M; Kittner, Steven J; Lackland, Daniel T; Lichtman, Judith H; Lisabeth, Lynda D; Mackey, Rachel H; Magid, David J; Marcus, Gregory M; Marelli, Ariane; Matchar, David B; McGuire, Darren K; Mohler, Emile R; Moy, Claudia S; Mussolino, Michael E; Neumar, Robert W; Nichol, Graham; Pandey, Dilip K; Paynter, Nina P; Reeves, Matthew J; Sorlie, Paul D; Stein, Joel; Towfighi, Amytis; Turan, Tanya N; Virani, Salim S; Wong, Nathan D; Woo, Daniel; Turner, Melanie B; American Heart Association Statistics Committee and Stroke Statistics Subcommittee
4,969 citations
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TL;DR: Authors/Task Force Members: Franz-Josef Neumann* (ESC Chairperson) (Germany), Miguel Sousa-Uva* (EACTS Chair person) (Portugal), Anders Ahlsson (Sweden), Fernando Alfonso (Spain), Adrian P. Banning (UK), Umberto Benedetto (UK).
4,342 citations
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TL;DR: The medical profession should play a central role in evaluating evidence related to drugs, devices, and procedures for detection, management, and prevention of disease.
4,050 citations
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TL;DR: The If Inhibitor Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Dysfunction is evaluated as well as patients with Diabetes mellitus for Optimal management of Multivessel disease.
Abstract: 99mTc
: technetium-99m
201TI
: thallium 201
ABCB1
: ATP-binding cassette sub-family B member 1
ABI
: ankle-brachial index
ACC
: American College of Cardiology
ACCF
: American College of Cardiology Foundation
ACCOMPLISH
: Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension
ACE
: angiotensin converting enzyme
ACIP
: Asymptomatic Cardiac Ischaemia Pilot
ACS
: acute coronary syndrome
ADA
: American Diabetes Association
ADP
: adenosine diphosphate
AHA
: American Heart Association
ARB
: angiotensin II receptor antagonist
ART
: Arterial Revascularization Trial
ASCOT
: Anglo-Scandinavian Cardiac Outcomes Trial
ASSERT
: Asymptomatic atrial fibrillation and Stroke Evaluation in pacemaker patients and the atrial fibrillation Reduction atrial pacing Trial
AV
: atrioventricular
BARI 2D
: Bypass Angioplasty Revascularization Investigation 2 Diabetes
BEAUTIFUL
: Morbidity-Mortality Evaluation of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Dysfunction
BIMA
: bilateral internal mammary artery
BMI
: body mass index
BMS
: bare metal stent
BNP
: B-type natriuretic peptide
BP
: blood pressure
b.p.m.
: beats per minute
CABG
: coronary artery bypass graft
CAD
: coronary artery disease
CAPRIE
: Clopidogrel vs. Aspirin in Patients at Risk of Ischaemic Events
CASS
: Coronary Artery Surgery Study
CCB
: calcium channel blocker
CCS
: Canadian Cardiovascular Society
CFR
: coronary flow reserve
CHARISMA
: Clopidogrel for High Atherothrombotic Risk and Ischaemic Stabilization, Management and Avoidance
CI
: confidence interval
CKD
: chronic kidney disease
CKD-EPI
: Chronic Kidney Disease Epidemiology Collaboration
CMR
: cardiac magnetic resonance
CORONARY
: The CABG Off or On Pump Revascularization Study
COURAGE
: Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
COX-1
: cyclooxygenase-1
COX-2
: cyclooxygenase-2
CPG
: Committee for Practice Guidelines
CT
: computed tomography
CTA
: computed tomography angiography
CV
: cardiovascular
CVD
: cardiovascular disease
CXR
: chest X-ray
CYP2C19*2
: cytochrome P450 2C19
CYP3A
: cytochrome P3A
CYP3A4
: cytochrome P450 3A4
CYP450
: cytochrome P450
DANAMI
: Danish trial in Acute Myocardial Infarction
DAPT
: dual antiplatelet therapy
DBP
: diastolic blood pressure
DECOPI
: Desobstruction Coronaire en Post-Infarctus
DES
: drug-eluting stents
DHP
: dihydropyridine
DSE
: dobutamine stress echocardiography
EACTS
: European Association for Cardiothoracic Surgery
EECP
: enhanced external counterpulsation
EMA
: European Medicines Agency
EASD
: European Association for the Study of Diabetes
ECG
: electrocardiogram
Echo
: echocardiogram
ED
: erectile dysfunction
EF
: ejection fraction
ESC
: European Society of Cardiology
EXCEL
: Evaluation of XIENCE PRIME or XIENCE V vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization
FAME
: Fractional Flow Reserve vs. Angiography for Multivessel Evaluation
FDA
: Food & Drug Administration (USA)
FFR
: fractional flow reserve
FREEDOM
: Design of the Future Revascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease
GFR
: glomerular filtration rate
HbA1c
: glycated haemoglobin
HDL
: high density lipoprotein
HDL-C
: high density lipoprotein cholesterol
HR
: hazard ratio
HRT
: hormone replacement therapy
hs-CRP
: high-sensitivity C-reactive protein
HU
: Hounsfield units
ICA
: invasive coronary angiography
IMA
: internal mammary artery
IONA
: Impact Of Nicorandil in Angina
ISCHEMIA
: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches
IVUS
: intravascular ultrasound
JSAP
: Japanese Stable Angina Pectoris
KATP
: ATP-sensitive potassium channels
LAD
: left anterior descending
LBBB
: left bundle branch block
LIMA
: Left internal mammary artery
LDL
: low density lipoprotein
LDL-C
: low density lipoprotein cholesterol
LM
: left main
LMS
: left main stem
LV
: left ventricular
LVEF
: left ventricular ejection fraction
LVH
: left ventricular hypertrophy
MACE
: major adverse cardiac events
MASS
: Medical, Angioplasty, or Surgery Study
MDRD
: Modification of Diet in Renal Disease
MERLIN
: Metabolic Efficiency with Ranolazine for Less Ischaemia in Non-ST-Elevation Acute Coronary Syndromes
MERLIN-TIMI 36
: Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes: Thrombolysis In Myocardial Infarction
MET
: metabolic equivalents
MI
: myocardial infarction
MICRO-HOPE
: Microalbuminuria, cardiovascular and renal sub-study of the Heart Outcomes Prevention Evaluation study
MPI
: myocardial perfusion imaging
MRI
: magnetic resonance imaging
NO
: nitric oxide
NSAIDs
: non-steroidal anti-inflammatory drugs
NSTE-ACS
: non-ST-elevation acute coronary syndrome
NYHA
: New York Heart Association
OAT
: Occluded Artery Trial
OCT
: optical coherence tomography
OMT
: optimal medical therapy
PAR-1
: protease activated receptor type 1
PCI
: percutaneous coronary intervention
PDE5
: phosphodiesterase type 5
PES
: paclitaxel-eluting stents
PET
: positron emission tomography
PRECOMBAT
: Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease
PTP
: pre-test probability
PUFA
: polyunsaturated fatty acid
PVD
: peripheral vascular disease
QoL
: quality of life
RBBB
: right bundle branch block
REACH
: Reduction of Atherothrombosis for Continued Health
RITA-2
: Second Randomized Intervention Treatment of Angina
ROOBY
: Veterans Affairs Randomized On/Off Bypass
SAPT
: single antiplatelet therapy
SBP
: systolic blood pressure
SCAD
: stable coronary artery disease
SCORE
: Systematic Coronary Risk Evaluation
SCS
: spinal cord stimulation
SES
: sirolimus-eluting stents
SIMA
: single internal mammary artery
SPECT
: single photon emission computed tomography
STICH
: Surgical Treatment for Ischaemic Heart Failure
SWISSI II
: Swiss Interventional Study on Silent Ischaemia Type II
SYNTAX
: SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery
TC
: total cholesterol
TENS
: transcutaneous electrical neural stimulation
TERISA
: Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina
TIME
: Trial of Invasive vs. Medical therapy
TIMI
: Thrombolysis In Myocardial Infarction
TMR
: transmyocardial laser revascularization
TOAT
: The Open Artery Trial
WOEST
: What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing
Guidelines summarize and evaluate all evidence available, at the time of the writing process, on a particular issue with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition, taking into account the impact on outcome, as well …
3,879 citations