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Article ; Online: National Heart, Lung, and Blood Institute cardiovascular clinical trial perspective.

Pearson, Gail D / Mensah, George A / Rosenberg, Yves / Stoney, Catherine M / Kavounis, Katherine / Goff, David C

2020 Volume 224, Page(s) 25–34

Abstract: The National Heart, Lung, and Blood Institute (NHLBI) has played an important role in funding the clinical science that supports many contemporary cardiology practice guidelines and in shaping the conduct of cardiovascular clinical trials. This ... ...

Abstract	The National Heart, Lung, and Blood Institute (NHLBI) has played an important role in funding the clinical science that supports many contemporary cardiology practice guidelines and in shaping the conduct of cardiovascular clinical trials. This Perspective outlines contemporary funding options as well as select important NHLBI policies, philosophy, and priorities.
MeSH term(s)	Cardiovascular Diseases/therapy ; Clinical Trials as Topic ; Humans ; National Heart, Lung, and Blood Institute (U.S.) ; United States
Language	English
Publishing date	2020-02-26
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2020.02.014
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Article ; Online: Biomarkers and cardiovascular events in patients with stable coronary disease in the ISCHEMIA Trials.

Newman, Jonathan D / Anthopolos, Rebecca / Ruggles, Kelly V / Cornwell, Macintosh / Reynolds, Harmony R / Bangalore, Sripal / Mavromatis, Kreton / Held, Claes / Wallentin, Lars / Kullo, Iftikar J / McManus, Bruce / Newby, L Kristin K / Rosenberg, Yves / Hochman, Judith S / Maron, David J / Berger, Jeffrey S

American heart journal

2023 Volume 266, Page(s) 61–73

Abstract: Importance: Biomarkers may improve prediction of cardiovascular events for patients with stable coronary artery disease (CAD), but their importance in addition to clinical tests of inducible ischemia and CAD severity is unknown.: Objectives: To ... ...

Abstract	Importance: Biomarkers may improve prediction of cardiovascular events for patients with stable coronary artery disease (CAD), but their importance in addition to clinical tests of inducible ischemia and CAD severity is unknown. Objectives: To evaluate the prognostic value of multiple biomarkers in stable outpatients with obstructive CAD and moderate or severe inducible ischemia. Design and setting: The ISCHEMIA and ISCHEMIA CKD trials randomized 5,956 participants with CAD to invasive or conservative management from July 2012 to January 2018; 1,064 participated in the biorepository. Main outcome measures: Primary outcome was cardiovascular death, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. Secondary outcome was cardiovascular death or MI. Improvements in prediction were assessed by cause-specific hazard ratios (HR) and area under the receiver operating characteristics curve (AUC) for an interquartile increase in each biomarker, controlling for other biomarkers, in a base clinical model of risk factors, left ventricular ejection fraction (LVEF) and ischemia severity. Secondary analyses were performed among patients in whom core-lab confirmed severity of CAD was ascertained by computed cardiac tomographic angiography (CCTA). Exposures: Baseline levels of interleukin-6 (IL-6), high sensitivity troponin T (hsTnT), growth differentiation factor 15 (GDF-15), N-terminal pro-B-type natriuretic peptide (NT-proBNP), lipoprotein a (Lp[a]), high sensitivity C-reactive protein (hsCRP), Cystatin C, soluble CD 40 ligand (sCD40L), myeloperoxidase (MPO), and matrix metalloproteinase 3 (MMP3). Results: Among 757 biorepository participants, median (IQR) follow-up was 3 (2-5) years, age was 67 (61-72) years, and 144 (19%) were female; 508 had severity of CAD by CCTA available. In an adjusted multimarker model with hsTnT, GDF-15, NT-proBNP and sCD40L, the adjusted HR for the primary outcome per interquartile increase in each biomarker was 1.58 (95% CI 1.22, 2.205), 1.60 (95% CI 1.16, 2.20), 1.61 (95% 1.22, 2.14), and 1.46 (95% 1.12, 1.90), respectively. The adjusted multimarker model also improved prediction compared with the clinical model, increasing the AUC from 0.710 to 0.792 (P < .01) and 0.714 to 0.783 (P < .01) for the primary and secondary outcomes, respectively. Similar findings were observed after adjusting for core-lab confirmed atherosclerosis severity. Conclusions and relevance: Among ISCHEMIA biorepository participants, biomarkers of myocyte injury/distension, inflammation, and platelet activity improved cardiovascular event prediction in addition to risk factors, LVEF, and assessments of ischemia and atherosclerosis severity. These biomarkers may improve risk stratification for patients with stable CAD.
MeSH term(s)	Humans ; Female ; Aged ; Male ; Coronary Artery Disease/diagnosis ; Growth Differentiation Factor 15 ; Stroke Volume ; Ventricular Function, Left ; Biomarkers ; Myocardial Infarction ; Prognosis ; Atherosclerosis ; Natriuretic Peptide, Brain ; Peptide Fragments
Chemical Substances	Growth Differentiation Factor 15 ; Biomarkers ; Natriuretic Peptide, Brain (114471-18-0) ; Peptide Fragments
Language	English
Publishing date	2023-08-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2023.08.007
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Article ; Online: Digital Tool-Assisted Hospitalization Detection in the Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention Study Compared to Traditional Site-Coordinator Ascertainment: Intervention Study.

Avram, Robert / Byrne, Julia / So, Derek / Iturriaga, Erin / Lennon, Ryan / Murthy, Vishakantha / Geller, Nancy / Goodman, Shaun / Rihal, Charanjit / Rosenberg, Yves / Bailey, Kent / Farkouh, Michael / Bell, Malcolm / Cagin, Charles / Chavez, Ivan / El-Hajjar, Mohammad / Ginete, Wilson / Lerman, Amir / Levisay, Justin /

Marzo, Kevin / Nazif, Tamim / Tanguay, Jean-Francois / Pletcher, Mark / Marcus, Gregory M / Pereira, Naveen L / Olgin, Jeffrey

Journal of medical Internet research

2023 Volume 25, Page(s) e47475

Abstract: Background: Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary ... ...

Abstract	Background: Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study extended the main TAILOR-PCI trial's follow-up to 2 years, using a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile phone surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. Objective: The objectives were to evaluate geofencing-triggered notifications and routine monthly mobile phone surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. Methods: US and Canadian participants from the TAILOR-PCI Digital Follow-Up Study were invited to download the Eureka Research Platform mobile app, opting in for location tracking using geofencing, triggering a smartphone-based survey if near a hospital for ≥4 hours. Participants were sent monthly notifications for CV hospitalization surveys. Results: From 85 participants who consented to the Digital Study, downloaded the mobile app, and had not previously completed their final follow-up visit, 73 (85.8%) initially opted in and consented to geofencing. There were 9 CV hospitalizations ascertained by study coordinators among 5 patients, whereas 8 out of 9 (88.9%) were detected by routine monthly hospitalization surveys. One CV hospitalization went undetected by the survey as it occurred within two weeks of the previous event, and the survey only allowed reporting of a single hospitalization. Among these, 3 were also detected by the geofencing algorithm, but 6 out of 9 (66.7%) were missed by geofencing: 1 occurred in a participant who never consented to geofencing, while 5 hospitalizations occurred among participants who had subsequently turned off geofencing prior to their hospitalization. Geofencing-detected hospitalizations were ascertained within a median of 2 (IQR 1-3) days, monthly surveys within 11 (IQR 6.5-25) days, and site coordinator methods within 38 (IQR 9-105) days. The geofencing algorithm triggered 245 notifications among 39 participants, with 128 (52.2%) from true hospital presence and 117 (47.8%) from nonhospital health care facility visits. Additional geofencing iterative improvements to reduce hospital misidentification were made to the algorithm at months 7 and 12, elevating the rate of true alerts from 35.4% (55 true alerts/155 total alerts before month 7) to 78.7% (59 true alerts/75 total alerts in months 7-12) and ultimately to 93.3% (14 true alerts/5 total alerts in months 13-21), respectively. Conclusions: The monthly digital survey detected most CV hospitalizations, while the geofencing survey enabled earlier detection but did not offer incremental value beyond traditional tools. Digital tools could potentially reduce the burden on study coordinators in ascertaining CV hospitalizations. The advantages of timely reporting via geofencing should be weighed against the issue of false notifications, which can be mitigated through algorithmic refinements.
MeSH term(s)	Humans ; Clopidogrel/therapeutic use ; Percutaneous Coronary Intervention ; Follow-Up Studies ; Pilot Projects ; Canada ; Hospitalization
Chemical Substances	Clopidogrel (A74586SNO7)
Language	English
Publishing date	2023-11-10
Publishing country	Canada
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2028830-X
ISSN	1438-8871 ; 1438-8871
ISSN (online)	1438-8871
ISSN	1438-8871
DOI	10.2196/47475
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Article ; Online: Chasing the storm: Recruiting non-hospitalized patients for a multi-site randomized controlled trial in the United States during the COVID-19 pandemic.

Hu, Kelly / Tardif, Jean-Claude / Huber, Melanie / Daly, Maria / Langford, Aisha T / Kirby, Ruth / Rosenberg, Yves / Hochman, Judith / Joshi, Avni / Bassevitch, Zohar / Pillinger, Michael H / Shah, Binita

Clinical and translational science

2021 Volume 15, Issue 4, Page(s) 831–837

Abstract: Randomized controlled trials (RCTs) remain the gold standard to evaluate clinical interventions, producing the highest level of evidence while minimizing potential bias. Inadequate recruitment is a commonly encountered problem that undermines the ... ...

Abstract	Randomized controlled trials (RCTs) remain the gold standard to evaluate clinical interventions, producing the highest level of evidence while minimizing potential bias. Inadequate recruitment is a commonly encountered problem that undermines the completion and generalizability of RCTs-and is even more challenging when enrolling amidst a pandemic. Here, we reflect on our experiences with virtual recruitment of non-hospitalized patients in the United States for ColCorona, an international, multicenter, randomized, placebo-controlled coronavirus disease 2019 (COVID-19) drug trial. Recruitment challenges during a pandemic include constraints created by shelter-in-place policies and targeting enrollment according to national and local fluctuations in infection rate. Presenting a study to potential participants who are sick with COVID-19 and may be frightened, overwhelmed, or mistrusting of clinical research remains a challenge. Strategies previously reported to improve recruitment include transparency, patient and site education, financial incentives, and person-to-person outreach. Active measures taken during ColCorona to optimize United States recruitment involved rapid expansion of sites, adjustment of recruitment scripts, assessing telephone calls versus text messages for initial contact with participants, institutional review board-approved financial compensation, creating an infrastructure to systematically identify potentially eligible patients, partnering with testing sites, appealing to both self-interest and altruism, and large-scale media efforts with varying degrees of success.
MeSH term(s)	COVID-19/epidemiology ; Humans ; Multicenter Studies as Topic ; Pandemics ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Text Messaging ; United States/epidemiology
Language	English
Publishing date	2021-12-24
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13211
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Article ; Online: Sex Differences in Revascularization, Treatment Goals, and Outcomes of Patients With Chronic Coronary Disease: Insights From the ISCHEMIA Trial.

Reynolds, Harmony R / Cyr, Derek D / Merz, C Noel Bairey / Shaw, Leslee J / Chaitman, Bernard R / Boden, William E / Alexander, Karen P / Rosenberg, Yves D / Bangalore, Sripal / Stone, Gregg W / Held, Claes / Spertus, John / Goetschalckx, Kaatje / Bockeria, Olga / Newman, Jonathan D / Berger, Jeffrey S / Elghamaz, Ahmed / Lopes, Renato D / Min, James K /

Berman, Daniel S / Picard, Michael H / Kwong, Raymond Y / Harrington, Robert A / Thomas, Boban / O'Brien, Sean M / Maron, David J / Hochman, Judith S

Journal of the American Heart Association

2024 Volume 13, Issue 5, Page(s) e029850

Abstract: Background: Women with chronic coronary disease are generally older than men and have more comorbidities but less atherosclerosis. We explored sex differences in revascularization, guideline-directed medical therapy, and outcomes among patients with ... ...

Abstract	Background: Women with chronic coronary disease are generally older than men and have more comorbidities but less atherosclerosis. We explored sex differences in revascularization, guideline-directed medical therapy, and outcomes among patients with chronic coronary disease with ischemia on stress testing, with and without invasive management. Methods and results: The ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial randomized patients with moderate or severe ischemia to invasive management with angiography, revascularization, and guideline-directed medical therapy, or initial conservative management with guideline-directed medical therapy alone. We evaluated the primary outcome (cardiovascular death, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest) and other end points, by sex, in 1168 (22.6%) women and 4011 (77.4%) men. Invasive group catheterization rates were similar, with less revascularization among women (73.4% of invasive-assigned women revascularized versus 81.2% of invasive-assigned men; Conclusions: Women had less extensive coronary artery disease and, therefore, lower revascularization rates in the invasive group. Despite lower risk factor goal attainment, women with chronic coronary disease experienced similar risk-adjusted outcomes to men in the ISCHEMIA trial. Registration: URL: http://wwwclinicaltrials.gov. Unique identifier: NCT01471522.
MeSH term(s)	Female ; Humans ; Male ; Chronic Disease ; Coronary Artery Disease/therapy ; Coronary Artery Disease/complications ; Goals ; Myocardial Infarction/therapy ; Myocardial Ischemia/therapy ; Myocardial Ischemia/complications ; Sex Characteristics ; Treatment Outcome
Language	English
Publishing date	2024-02-27
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2653953-6
ISSN	2047-9980 ; 2047-9980
ISSN (online)	2047-9980
ISSN	2047-9980
DOI	10.1161/JAHA.122.029850
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Article ; Online: Genetic-Guided Oral P2Y

JACC. Cardiovascular interventions

2023 Volume 16, Issue 7, Page(s) 816–825

Abstract: Background: Genetic-guided P2Y: Objectives: Here, the authors detail a prespecified analysis of cumulative endpoints. The primary endpoint was cumulative incidence rate of ischemic events at 12 months. Cumulative incidence of major and minor bleeding ...

Abstract	Background: Genetic-guided P2Y Objectives: Here, the authors detail a prespecified analysis of cumulative endpoints. The primary endpoint was cumulative incidence rate of ischemic events at 12 months. Cumulative incidence of major and minor bleeding was a secondary endpoint. Cox proportional hazards models as adapted by Wei, Lin, and Weissfeld were used to estimate the effect of this strategy on all observed events. Methods: The TAILOR-PCI trial was a prospective trial including 5,302 post-PCI patients with acute and stable coronary artery disease (CAD) who were randomized to genetic-guided P2Y Results: Among 5,276 patients (median age 62 years; 25% women; 82% acute CAD; 18% stable CAD), 1,849 were LOF carriers (903 genetic-guided; 946 conventional therapy). The cumulative primary endpoint was significantly reduced in the genetic-guided group compared with the conventional therapy (HR: 0.61; 95% CI: 0.41-0.89; P = 0.011) with no significant difference in cumulative incidence of major or minor bleeding (HR: 1.36; 95% CI: 0.67-2.76; P = 0.39). Conclusions: Among CYP2C19 LOF carriers undergoing PCI, a genetic-guided strategy resulted in a statistically significant reduction in cumulative ischemic events without a significant difference in bleeding. (Tailored Antiplatelet Therapy Following PCI [TAILOR-PCI]; NCT01742117).
MeSH term(s)	Humans ; Female ; Middle Aged ; Male ; Clopidogrel/adverse effects ; Platelet Aggregation Inhibitors/adverse effects ; Cytochrome P-450 CYP2C19/genetics ; Percutaneous Coronary Intervention/adverse effects ; Prospective Studies ; Treatment Outcome ; Hemorrhage/etiology ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/therapy ; Coronary Artery Disease/complications ; Acute Coronary Syndrome/therapy ; Purinergic P2Y Receptor Antagonists/adverse effects
Chemical Substances	Clopidogrel (A74586SNO7) ; Platelet Aggregation Inhibitors ; Cytochrome P-450 CYP2C19 (EC 1.14.14.1) ; Purinergic P2Y Receptor Antagonists
Language	English
Publishing date	2023-04-10
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2023.01.356
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Article ; Online: Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the CABANA Trial.

Poole, Jeanne E / Bahnson, Tristram D / Monahan, Kristi H / Johnson, George / Rostami, Hoss / Silverstein, Adam P / Al-Khalidi, Hussein R / Rosenberg, Yves / Mark, Daniel B / Lee, Kerry L / Packer, Douglas L

Journal of the American College of Cardiology

2020 Volume 75, Issue 25, Page(s) 3105–3118

Abstract: Background: The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a ... ...

Abstract	Background: The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant 14% relative reduction in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest. Objectives: The purpose of this study was to assess recurrence of AF in the CABANA trial. Methods: The authors prospectively studied CABANA patients using a proprietary electrocardiogram recording monitor for symptom-activated and 24-h AF auto detection. The AF recurrence endpoint was any post-90-day blanking atrial tachyarrhythmias lasting 30 s or longer. Biannual 96-h Holter monitoring was used to assess AF burden. Patients who used the CABANA monitors and provided 90-day post-blanking recordings qualified for this analysis (n = 1,240; 56% of CABANA population). Treatment comparisons were performed using a modified intention-to-treat approach. Results: Median age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0%. Over 60 months of follow-up, first recurrence of any symptomatic or asymptomatic AF (hazard ratio: 0.52; 95% confidence interval: 0.45 to 0.60; p < 0.001) or first symptomatic-only AF (hazard ratio: 0.49; 95% confidence interval: 0.39 to 0.61; p < 0.001) were both significantly reduced in the catheter ablation group. Baseline Holter AF burden in both treatment groups was 48%. At 12 months, AF burden in ablation patients averaged 6.3%, and in drug-therapy patients, 14.4%. AF burden was significantly less in catheter ablation compared with drug-therapy patients across the 5-year follow-up (p < 0.001). These findings were not sensitive to the baseline pattern of AF. Conclusions: Catheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up. Furthermore, AF burden was also significantly reduced in catheter ablation patients, regardless of their baseline AF type. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508).
MeSH term(s)	Aged ; Anti-Arrhythmia Agents/administration & dosage ; Anti-Arrhythmia Agents/adverse effects ; Atrial Fibrillation/diagnosis ; Atrial Fibrillation/drug therapy ; Atrial Fibrillation/physiopathology ; Atrial Fibrillation/surgery ; Catheter Ablation/adverse effects ; Catheter Ablation/methods ; Catheter Ablation/statistics & numerical data ; Electrocardiography, Ambulatory/methods ; Electrocardiography, Ambulatory/statistics & numerical data ; Female ; Humans ; Intention to Treat Analysis/statistics & numerical data ; Male ; Outcome and Process Assessment, Health Care ; Recurrence ; Stroke/etiology ; Stroke/prevention & control ; Time
Chemical Substances	Anti-Arrhythmia Agents
Language	English
Publishing date	2020-07-02
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	605507-2
ISSN	1558-3597 ; 0735-1097
ISSN (online)	1558-3597
ISSN	0735-1097
DOI	10.1016/j.jacc.2020.04.065
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Article ; Online: Improving the Design of Future PCI Trials for Stable Coronary Artery Disease: JACC State-of-the-Art Review.

Marquis-Gravel, Guillaume / Moliterno, David J / Francis, Darrel P / Jüni, Peter / Rosenberg, Yves D / Claessen, Bimmer E / Mentz, Robert J / Mehran, Roxana / Cutlip, Donald E / Chauhan, Cynthia / Quella, Susan / Zannad, Faiez / Goodman, Shaun G

Journal of the American College of Cardiology

2020 Volume 76, Issue 4, Page(s) 435–450

Abstract: The role of percutaneous coronary interventions in addition to medical therapy for patients with stable coronary artery disease continues to be debated in routine clinical practice, despite more than 2 decades of randomized controlled trials. The ... ...

Abstract	The role of percutaneous coronary interventions in addition to medical therapy for patients with stable coronary artery disease continues to be debated in routine clinical practice, despite more than 2 decades of randomized controlled trials. The residual uncertainty arises from particular challenges facing revascularization trials. Which endpoint do doctors care about, and which do patients care about? Which participants should be enrolled? What background medical therapy should we use? When is placebo control relevant? In this paper, we discuss how these questions can be approached and examine the merits and disadvantages of possible options. Engaging multiple stakeholders, including patients, researchers, regulators, and funders, to ensure the design elements are methodologically valid and clinically meaningful should be an aspirational goal in the development of future trials.
MeSH term(s)	Coronary Artery Disease/surgery ; Humans ; Percutaneous Coronary Intervention/methods ; Quality Improvement ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/standards ; Research Design
Language	English
Publishing date	2020-04-28
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	605507-2
ISSN	1558-3597 ; 0735-1097
ISSN (online)	1558-3597
ISSN	0735-1097
DOI	10.1016/j.jacc.2020.05.060
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Article ; Online: Effect of CYP2C19 Genotype on Ischemic Outcomes During Oral P2Y

Pereira, Naveen L / Rihal, Charanjit / Lennon, Ryan / Marcus, Gil / Shrivastava, Sanskriti / Bell, Malcolm R / So, Derek / Geller, Nancy / Goodman, Shaun G / Hasan, Ahmed / Lerman, Amir / Rosenberg, Yves / Bailey, Kent / Murad, M Hassan / Farkouh, Michael E

JACC. Cardiovascular interventions

2021 Volume 14, Issue 7, Page(s) 739–750

Abstract: Objectives: The aim of this study was to examine the effect of CYP2C19 genotype on clinical outcomes in patients with coronary artery disease (CAD) who predominantly underwent percutaneous coronary intervention (PCI), comparing those treated with ... ...

Abstract	Objectives: The aim of this study was to examine the effect of CYP2C19 genotype on clinical outcomes in patients with coronary artery disease (CAD) who predominantly underwent percutaneous coronary intervention (PCI), comparing those treated with ticagrelor or prasugrel versus clopidogrel. Background: The effect of CYP2C19 genotype on treatment outcomes with ticagrelor or prasugrel compared with clopidogrel is unclear. Methods: Databases through February 19, 2020, were searched for studies reporting the effect of CYP2C19 genotype on ischemic outcomes during ticagrelor or prasugrel versus clopidogrel treatment. Study eligibility required outcomes reported for CYP2C19 genotype status and clopidogrel and alternative P2Y Results: Of 1,335 studies identified, 7 RCTs were included (15,949 patients, mean age 62 years; 77% had PCI, 98% had acute coronary syndromes). Statistical heterogeneity was minimal, and risk for bias was low. Ticagrelor and prasugrel compared with clopidogrel resulted in a significant reduction in ischemic events (relative risk: 0.70; 95% confidence interval: 0.59 to 0.83) in CYP2C19 loss-of-function carriers but not in noncarriers (relative risk: 1.0; 95% confidence interval: 0.80 to 1.25). The test of interaction on the basis of CYP2C19 genotype status was statistically significant (p = 0.013), suggesting that CYP2C19 genotype modified the effect. An additional 4 observational studies were found, and adding them to the analysis provided the same conclusions (p value of the test of interaction <0.001). Conclusions: The effect of ticagrelor or prasugrel compared with clopidogrel in reducing ischemic events in patients with CAD who predominantly undergo PCI is based primarily on the presence of CYP2C19 loss-of-function carrier status. These results support genetic testing prior to prescribing P2Y
MeSH term(s)	Cytochrome P-450 CYP2C19/genetics ; Genotype ; Humans ; Middle Aged ; Myocardial Infarction ; Platelet Aggregation Inhibitors/adverse effects ; Ticlopidine ; Treatment Outcome
Chemical Substances	Platelet Aggregation Inhibitors ; CYP2C19 protein, human (EC 1.14.14.1) ; Cytochrome P-450 CYP2C19 (EC 1.14.14.1) ; Ticlopidine (OM90ZUW7M1)
Language	English
Publishing date	2021-03-17
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Research Support, N.I.H., Extramural
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2021.01.024
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Article ; Online: Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA.

Mark, Daniel B / Spertus, John A / Bigelow, Robert / Anderson, Sophia / Daniels, Melanie R / Anstrom, Kevin J / Baloch, Khaula N / Cohen, David J / Held, Claes / Goodman, Shaun G / Bangalore, Sripal / Cyr, Derek / Reynolds, Harmony R / Alexander, Karen P / Rosenberg, Yves / Stone, Gregg W / Maron, David J / Hochman, Judith S

Circulation

2022 Volume 145, Issue 17, Page(s) 1294–1307

Abstract: Background: ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary ... ...

Abstract	Background: ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy. Methods: In 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index). Results: Median age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2-2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (95% CI, 1.6-5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI, 0.2-6.1), Angina Frequency 3.2 points (95% CI, 1.2-5.1), Quality of Life/Health Perceptions 5.3 points (95% CI, 2.8-7.8). For the Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index scores were higher for INV (3.2 points [95% CI, 0.6-5.7]), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5%-12.8%) and was unaffected by treatment assignment. Conclusions: In the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences. Registration: URL: https://www. Clinicaltrials: gov; Unique identifier: NCT01471522.
MeSH term(s)	Aged ; Angina Pectoris/therapy ; Chronic Disease ; Conservative Treatment ; Coronary Disease ; Female ; Humans ; Ischemia ; Male ; Quality of Life
Language	English
Publishing date	2022-03-09
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	80099-5
ISSN	1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
ISSN (online)	1524-4539
ISSN	0009-7322 ; 0069-4193 ; 0065-8499
DOI	10.1161/CIRCULATIONAHA.121.057363
Database	MEDical Literature Analysis and Retrieval System OnLINE

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