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Coronary Artery Disease: HELP
Articles by Gheorghe Doros
Based on 9 articles published since 2010
(Why 9 articles?)
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Between 2010 and 2020, Gheorghe Doros wrote the following 9 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
1 Clinical Trial Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy. 2016

Vaduganathan, Muthiah / Bhatt, Deepak L / Cryer, Byron L / Liu, Yuyin / Hsieh, Wen-Hua / Doros, Gheorghe / Cohen, Marc / Lanas, Angel / Schnitzer, Thomas J / Shook, Thomas L / Lapuerta, Pablo / Goldsmith, Mark A / Laine, Loren / Cannon, Christopher P / Anonymous4950862. ·Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. Electronic address: dlbhattmd@post.harvard.edu. · University of Texas Southwestern and Veterans Affairs North Texas Health Care System, Dallas, Texas. · Harvard Clinical Research Institute, Boston, Massachusetts; Department of Biostatistics, Boston University, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts. · Newark Beth Israel Medical Center, Newark, New Jersey. · University of Zaragoza, Instituto de Investigación Sanitaria Aragón, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Zaragoza, Spain. · Departments of Physical Medicine and Rehabilitation and Internal Medicine-Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. · Parexel International, Waltham, Massachusetts. · Lexicon Pharmaceuticals, Basking Ridge, New Jersey. · Constellation Pharmaceuticals, Cambridge, Massachusetts. · Yale School of Medicine, New Haven, Connecticut; VA Connecticut Healthcare System, West Haven, Connecticut. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts. ·J Am Coll Cardiol · Pubmed #27012778.

ABSTRACT: BACKGROUND: The COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial) showed that proton-pump inhibitors (PPIs) safely reduced rates of gastrointestinal (GI) events in patients requiring dual antiplatelet therapy (DAPT). However, utilization of appropriate prophylactic PPI therapy remains suboptimal, especially with low-dose aspirin. OBJECTIVES: The authors investigated the safety and efficacy of PPI therapy in patients receiving DAPT in low- and high-dose aspirin subsets. METHODS: Randomized patients with available aspirin dosing information in COGENT (N = 3,752) were divided into "low-dose" (≤ 100 mg) and "high-dose" (>100 mg) aspirin groups. The primary GI and cardiovascular endpoints were composite upper GI events and major adverse cardiac events, respectively. All events were adjudicated by independent, blinded gastroenterologists and cardiologists. RESULTS: Median duration of follow-up was 110 days. Low-dose aspirin users (n = 2,480; 66.1%) were more likely to be older, female, and have higher rates of peripheral artery disease, prior stroke, and hypertension, whereas high-dose aspirin users (n = 1,272; 33.9%) had higher rates of hyperlipidemia, smoking, a history of percutaneous coronary intervention, and were more than twice as likely to be enrolled from sites within the United States (80.4% vs. 39.8%). High-dose aspirin was associated with similar 180-day Kaplan-Meier estimates of adjudicated composite GI events (1.7% vs. 2.1%; adjusted hazard ratio: 0.88; 95% confidence interval: 0.46 to 1.66) and major adverse cardiac events (4.8% vs. 5.5%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.48 to 1.11) compared with low-dose aspirin. Randomization to PPI therapy reduced 180-day Kaplan-Meier estimates of the primary GI endpoint in low-dose (1.2% vs. 3.1%) and high-dose aspirin subsets (0.9% vs. 2.6%; p for interaction = 0.80), and did not adversely affect the primary cardiovascular endpoint in either group. CONCLUSIONS: Gastroprotection with PPI therapy should be utilized in appropriately selected patients with coronary artery disease requiring DAPT, even if the patients are on low-dose aspirin. (Clopidogrel and the Optimization of Gastrointestinal Events Trial [COGENT]; NCT00557921).

2 Article Association of Outpatient Practice-Level Socioeconomic Disadvantage With Quality of Care and Outcomes Among Older Adults With Coronary Artery Disease: Implications for Value-Based Payment. 2020

Wadhera, Rishi K / Bhatt, Deepak L / Kind, Amy J H / Song, Yang / Williams, Kim A / Maddox, Thomas M / Yeh, Robert W / Dong, Liyan / Doros, Gheorghe / Turchin, Alexander / Joynt Maddox, Karen E. ·Heart and Vascular Center, Brigham and Women's Hospital (R.K.W., D.L.B.), Harvard Medical School, Boston, MA. · Richard and Susan Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center (R.K.W., R.W.Y.), Harvard Medical School, Boston, MA. · Geriatrics Division, Department of Medicine, School of Medicine and Public Health, University of Wisconsin, Madison (A.J.H.K.). · Baim Institute for Clinical Research, Boston, MA (Y.S., L.D., A.T.). · Division of Cardiology, Department of Medicine, Rush University Medical Center, Chicago, IL (K.A.W.). · Cardiovascular Division, Department of Medicine, Washington University School of Medicine, Saint Louis, MO (T.M.M., K.E.J.M.). · Department of Biostatistics, Boston University, MA (G.D.). · Department of Medicine, Brigham and Women's Hospital (A.T.), Harvard Medical School, Boston, MA. · Center for Health Economics and Policy, Institute for Public Health at Washington University, Saint Louis, MO (K.E.J.M.). ·Circ Cardiovasc Qual Outcomes · Pubmed #32228065.

ABSTRACT: BACKGROUND: Medicare patients with coronary artery disease (CAD) have been a significant focus of value-based payment programs for outpatient practices. Physicians and policymakers, however, have voiced concern that value-based payment programs may penalize practices that serve vulnerable populations. This study evaluated whether outpatient practices that serve socioeconomically disadvantaged populations have worse CAD outcomes, and if this reflects the delivery of lower-quality care or rather, patient and community factors beyond the care provided by physician practices. METHODS AND RESULTS: Retrospective cohort study of Medicare fee-for-service patients ≥65 years with CAD at outpatient practices participating in the the Practice Innovation and Clinical Excellence registry from January 1, 2010 to January 1, 2015. Outpatient practices were stratified into quintiles by the proportion of most disadvantaged patients-defined by an area deprivation score in the highest 20% nationally-served at each practice site. Prescription of guideline recommended therapies for CAD as well as clinical outcomes (emergency department presentation for chest pain, hospital admission for unstable angina or acute myocardial infarction [AMI], 30-day readmission after AMI, and 30-day mortality after AMI) were evaluated by practice-level socioeconomic disadvantage with hierarchical logistic regression models, using practices serving the fewest socioeconomically disadvantaged patients as a reference. The study included 453 783 Medicare fee-for-service patients ≥65 years of age with CAD (mean [SD] age, 75.3 [7.7] years; 39.7% female) cared for at 271 outpatient practices. At practices serving the highest proportion of socioeconomically disadvantaged patients (group 5), compared with practices serving the lowest proportion (group 1), there was no significant difference in the likelihood of prescription of antiplatelet therapy (odds ratio [OR], 0.94 [95% CI, 0.69-1.27]), β-blocker therapy if prior myocardial infarction or left ventricular ejection fraction <40% (OR, 0.97 [95% CI, 0.69-1.35]), ACE (angiotensin-converting enzyme) inhibitor or angiotensin receptor blocker if left ventricular ejection fraction <40% and/or diabetes mellitus (OR, 0.93 [95% CI, 0.74-1.19]), statin therapy (OR, 0.88 [95% CI, 0.68-1.14]), or cardiac rehabilitation (OR, 0.45 [95% CI, 0.20-1.00]). Patients cared for at the most disadvantaged-serving practices (group 5) were more likely to be admitted for unstable angina (adjusted OR, 1.46 [95% CI, 1.04-2.05]). There was no significant difference in the likelihood of emergency department presentation for chest pain or hospital admission for AMI between practices. Thirty day mortality rates after AMI were higher among patients at the most disadvantaged-serving practices (aOR, 1.31 [95% CI, 1.02-1.68]), but 30-day readmission rates did not differ. All associations were attenuated after additional adjustment for patient-level area deprivation index. CONCLUSIONS: Physician outpatient practices that serve the most socioeconomically disadvantaged patients with CAD perform worse on some clinical outcomes, despite providing similar guideline-recommended care as other practices, and consequently could fare poorly under value-based payment programs. Social factors beyond care provided by outpatient practices may partly explain worse outcomes. Policymakers should consider accounting for socioeconomic disadvantage in value-based payment programs initiatives that target outpatient practices.

3 Article The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale. 2019

Mauri, Laura / Doros, Gheorghe / Rao, Sunil V / Cohen, David J / Yakubov, Steven / Lasala, John / Wong, S Chiu / Zidar, James / Kereiakes, Dean J. ·Harvard Medical School. · Baim Institute for Clinical Research; Department of Biostatistics, Boston University. · The Duke Clinical Research Institute. · Saint Luke's Mid America Heart Institute, Kansas City, MO. · OhioHealth Riverside Methodist Hospital. · Washington University School of Medicine in St. Louis. · Weil Cornell Medicine. · University of North Carolina. · The Christ Hospital and Lindner Research Center. Electronic address: Lindner@thechristhospital.com. ·Am Heart J · Pubmed #31415994.

ABSTRACT: Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

4 Article Differences in Management of Coronary Artery Disease in Patients With Medicare Advantage vs Traditional Fee-for-Service Medicare Among Cardiology Practices. 2019

Figueroa, Jose F / Blumenthal, Daniel M / Feyman, Yevgeniy / Frakt, Austin B / Turchin, Alexander / Doros, Gheorghe / Gao, Qi / Song, Yang / Joynt Maddox, Karen E. ·Department of Medicine, Harvard Medical School, Boston, Massachusetts. · Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts. · Division of General Internal Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. · Division of Cardiology, Massachusetts General Hospital, Boston. · VA Boston Healthcare System, Boston, Massachusetts. · Boston University School of Public Health, Boston, Massachusetts. · Division of Endocrinology, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. · Baim Clinical Research Institute, Boston, Massachusetts. · Department of Biostatistics, Boston University, Boston, Massachusetts. · Cardiovascular Division, Department of Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri. ·JAMA Cardiol · Pubmed #30785590.

ABSTRACT: Importance: One-third of Medicare beneficiaries are enrolled in Medicare Advantage (MA), Medicare's private plan option. Medicare Advantage incentivizes performance on evidence-based care, but limited information exists using reliable clinical data to determine whether this translates into better quality for patients with coronary artery disease (CAD) enrolled in MA compared with those enrolled in traditional fee-for-service (FFS) Medicare. Objective: To determine differences in evidence-based secondary prevention treatments and intermediate outcomes among patients with CAD enrolled in MA vs FFS Medicare. Design, Setting, and Participants: In this observational, retrospective, cohort study, deidentified data from patients 18 years or older diagnosed as having CAD between January 1, 2013, and May 1, 2014, at cardiology practices participating in the Practice Innovation and Clinical Excellence (PINNACLE) registry were studied, including 35 563 patients enrolled in MA and 172 732 enrolled in FFS Medicare. Data were analyzed from March to July 2018. Exposures: Medicare Advantage enrollment. Main Outcomes and Measures: Medication prescription patterns among eligible patients and intermediate outcomes, including blood pressure and low-density lipoprotein cholesterol. Results: Of the 35 563 patients with CAD enrolled in MA, 20 193 (56.8%) were male, and the mean (SD) age was 76.7 (7.6) years; of the 172 732 patients with CAD enrolled in FFS Medicare, 100 025 (57.9%) were male, and the mean (SD) age was 77.5 (8.0) years. Patients enrolled in MA were younger, less likely to be white, and more likely to be female and to have heart failure, diabetes, and chronic kidney disease compared with those enrolled in FFS Medicare. Compared with FFS Medicare beneficiaries, MA beneficiaries were more likely to receive secondary prevention treatments, including β-blockers (80.6% vs 78.8%; P < .001), angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (70.7% vs 65.1%; P < .001), and statins (68.4% vs 64.5%; P < .001). Patients enrolled in MA were also more likely to receive all 3 medications when eligible (48.9% vs 40.4%; P < .001). After adjustment, MA beneficiaries had higher odds of receiving guideline-recommended therapy compared with FFS Medicare beneficiaries for β-blockers (odds ratio, 1.10; 95% CI, 1.04-1.17; P = .002), angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (odds ratio, 1.13; 95% CI, 1.08-1.19; P < .001), and all 3 medications (odds ratio, 1.23; 95% CI, 1.001-1.50; P = .047). There were no significant differences in intermediate outcomes between those enrolled in MA and FFS Medicare, including systolic and diastolic blood pressure and low-density lipoprotein cholesterol levels. Conclusions and Relevance: Among patients with CAD in the PINNACLE registry, MA beneficiaries had more comorbidities than FFS Medicare beneficiaries and were more likely to receive secondary prevention treatments. However, this did not translate into differences in intermediate outcomes. These findings suggest that MA plans may drive improvements in process-based quality measures for Medicare beneficiaries, although this may have a limited effect on improving patient outcomes over FFS Medicare.

5 Article Subgroup Analysis Comparing Ultrathin, Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin, Durable Polymer Everolimus-Eluting Stents in Acute Coronary Syndrome Patients. 2018

Roguin, Ariel / Kandzari, David E / Marcusohn, Erez / Koolen, Jacques J / Doros, Gheorghe / Massaro, Joseph M / Garcia-Garcia, Hector M / Bennett, Johan / Gharib, Elie G / Cutlip, Donald E / Waksman, Ron. ·Rambam Medical Center, Haifa, Israel (A.R., E.M.). · Piedmont Heart Institute, Atlanta, GA (D.E.K.). · Catharina Hospital, Eindhoven, the Netherlands (J.J.K.). · Baim Institute for Clinical Research, Boston, MA (G.D.). · Department of Biostatistics and Epidemiology, Boston University School of Public Health, MA (J.M.M.). · Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, DC (H.M.G.-G., R.W.). · Department of Cardiovascular Medicine, University Hospitals Leuven, Belgium (J.B.). · Charleston Area Medical Center, WV (E.G.G.). · Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, MA (D.E.C.). ·Circ Cardiovasc Interv · Pubmed #30354631.

ABSTRACT: BACKGROUND: Presentation with acute coronary syndromes (ACS) constitutes a high-risk subset of patients with worse outcome after percutaneous coronary intervention. We report clinical outcomes in subjects with ACS from the BIOFLOW V trial (BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions) comparing an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP-SES) with a thin strut (81 μm) durable polymer everolimus-eluting stent (DP-EES). METHODS AND RESULTS: Among 1334 patients randomized to 2:1 treatment with either BP-SES or DP-EES, 677 (50.7%) ACS patients without ST-segment-elevation myocardial infarction (MI; 454 BP-SES and 223 DP-EES) were identified in the retrospective post hoc analysis. The primary end point of 12-month target lesion failure, individual component end points, and stent thrombosis were evaluated. Recurrent MI was defined as a ≥50% increase of creatine kinase-myocardial band or in the absence of creatine kinase-myocardial band, troponin >50% increase over previous level and >3× the upper limit of normal). All events were adjudicated by a blinded independent clinical events committee. Overall, baseline clinical, angiographic, and procedural characteristics of the ACS population were similar between the 2 treatment groups. At 12 months, target lesion failure occurred in 5.6% (24/426) of BP-SES patients versus 11.0% (23/209) in DP-EES patients ( P=0.02); target lesion failure composite components were cardiac death, 0% versus 1.0% ( P=0.11); target vessel-related MI, 3.5% versus 9.7% ( P=0.003); and clinically driven target lesion revascularization, 2.8% versus 3.4% ( P=0.80). Spontaneous target vessel MI was 0.5% (2/425) for BP-SES versus 2.4% (5/206) for DP-EES ( P=0.041). Stent thrombosis rates at 1 year were similar (0.5% versus 1.0%; P=0.601). CONCLUSIONS: In the ACS subgroup population of the BIOFLOW V study, treatment with BP-SES compared with DP-EES was associated with a significantly lower rate of 12-month target lesion failure, a difference driven by significantly lower periprocedural MI and spontaneous MI. These findings support treatment with an ultrathin strut BP-SES in ACS patients undergoing percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02389946.

6 Article Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin Durable Polymer Everolimus-Eluting Stents. 2018

Kandzari, David E / Koolen, Jacques J / Doros, Gheorghe / Massaro, Joseph J / Garcia-Garcia, Hector M / Bennett, Johan / Roguin, Ariel / Gharib, Elie G / Cutlip, Donald E / Waksman, Ron / Anonymous1540963. ·Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org. · Catharina Hospital, Eindhoven, the Netherlands. · Department of Biostatistics and Epidemiology, Boston University School of Public Health, Baim Institute for Clinical Research, Boston, Massachusetts. · Department of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, Massachusetts. · Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC. · Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium. · Department of Cardiology, Rambam Medical Center, Haifa, Israel. · Charleston Area Medical Center, Charleston, West Virginia. · Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, Massachusetts. ·J Am Coll Cardiol · Pubmed #30257191.

ABSTRACT: BACKGROUND: Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture, and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies. OBJECTIVES: The authors sought to compare late-term clinical outcomes among patients treated with an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial. METHODS: BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed. RESULTS: Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 2-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference; 95% confidence interval: -8.16% to -0.91%; p = 0.015), driven by differences in target vessel myocardial infarction (MI) (5.3% vs. 9.5%; p = 0.01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%; p = 0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (p = 0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% vs. 1.0%; p = 0.045). CONCLUSIONS: In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years, favoring treatment with BP SES over DP EES. Significantly lower cumulative target lesion revascularization and late/very late stent thrombosis were also observed with BP SES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946).

7 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 / Anonymous4350917. ·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.

8 Article Efficacy and Safety of Proton-Pump Inhibitors in High-Risk Cardiovascular Subsets of the COGENT Trial. 2016

Vaduganathan, Muthiah / Cannon, Christopher P / Cryer, Byron L / Liu, Yuyin / Hsieh, Wen-Hua / Doros, Gheorghe / Cohen, Marc / Lanas, Angel / Schnitzer, Thomas J / Shook, Thomas L / Lapuerta, Pablo / Goldsmith, Mark A / Laine, Loren / Bhatt, Deepak L / Anonymous5780866. ·Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Mass. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Mass; Harvard Clinical Research Institute, Boston, Mass. · University of Texas Southwestern and Veterans Affairs North Texas Health Care System, Dallas. · Harvard Clinical Research Institute, Boston, Mass; Department of Biostatistics, Boston University, Mass. · Harvard Clinical Research Institute, Boston, Mass. · Newark Beth Israel Medical Center, NJ. · University of Zaragoza, Instituto de Investigación Sanitaria Aragón, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Zaragoza, Spain. · Departments of Physical Medicine and Rehabilitation and Internal Medicine-Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, Ill. · PAREXEL International, Waltham, Mass. · Lexicon Pharmaceuticals, Basking Ridge, NJ. · Constellation Pharmaceuticals, Cambridge, Mass. · Yale School of Medicine, New Haven, Conn; VA Connecticut Healthcare System, West Haven, Conn. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Mass. Electronic address: dlbhattmd@post.harvard.edu. ·Am J Med · Pubmed #27143321.

ABSTRACT: BACKGROUND: Proton-pump inhibitors (PPIs) have been demonstrated to reduce rates of gastrointestinal events in patients requiring dual antiplatelet therapy (DAPT). Data are limited regarding the efficacy and safety of PPIs in high-risk cardiovascular subsets after acute coronary syndrome or percutaneous coronary intervention. METHODS: All patients enrolled in COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial) were initiated on DAPT (with aspirin and clopidogrel) for various indications within the prior 21 days. These post hoc analyses of the COGENT trial evaluated the efficacy and safety of omeprazole compared with placebo in subsets of patients requiring DAPT for the 2 most frequent indications: 1) patients undergoing percutaneous coronary intervention (for any indication) within 14 days of randomization (n = 2676; 71.2%); and 2) patients presenting with acute coronary syndrome managed with or without percutaneous coronary intervention (n = 1573; 41.8%). Unadjusted Cox proportional hazards models were used to estimate effect sizes through final follow-up. RESULTS: Median follow-up duration was 110 days (interquartile range 55-167). In percutaneous coronary intervention-treated patients, omeprazole significantly reduced rates of composite gastrointestinal events at 180 days (1.2% vs 2.7%; hazard ratio [HR] 0.43; 95% confidence interval [CI], 0.22-0.85; P = .02) without increasing composite cardiovascular events (5.4% vs 6.3%; HR 1.00; 95% CI, 0.67-1.50; P = 1.00). Similarly, omeprazole lowered risk of the primary gastrointestinal endpoint at 180 days in patients presenting with acute coronary syndrome (1.1% vs 2.7%; HR 0.37; 95% CI, 0.13-1.01; P = .05) without a significant excess in cardiovascular events (5.6% vs 4.5%; HR 1.40; 95% CI, 0.77-2.53; P = .27). CONCLUSIONS: PPI therapy attenuates gastrointestinal bleeding risk without significant excess in major cardiovascular events in high-risk cardiovascular subsets, regardless of indication for DAPT. Future studies will be needed to clarify optimal gastroprotective strategies for higher-intensity and longer durations of DAPT.

9 Minor Mortality risk with dual antiplatelet therapy? 2015

Yeh, Robert W / Elmariah, Sammy / Doros, Gheorghe / Kereiakes, Dean J / Mauri, Laura. ·Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Harvard Clinical Research Institute, Boston, MA, USA. Electronic address: ryeh@partners.org. · Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Harvard Clinical Research Institute, Boston, MA, USA. · Harvard Clinical Research Institute, Boston, MA, USA; Department of Biostatistics, Boston University, Boston MA, USA. · The Lindner Research Center, The Christ Hospital Heart and Vascular Center, Cincinnati, OH, USA. · Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Harvard Clinical Research Institute, Boston, MA, USA. ·Lancet · Pubmed #26530618.

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