MedicalResearch.com Interview with:
David H. Howard, PhD
Professor, Health Policy and Management
Rollins School of Public Health
Emory University, Atlanta, Georgia
MedicalResearch.com: What is the background for this study? Response: Application of the False Claims Act (FCA) to medically unnecessary care is controversial, both in the courts and in the Department of Justice. Although there haven’t been many FCA suits against hospitals and physicians for performing unnecessary percutaneous coronary interventions (PCIs), the suits that have occurred have been against some of the highest-volume hospitals and physicians. Some cardiologists have been sentenced to prison.
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MedicalResearch.com Interview with:
[caption id="attachment_40933" align="alignleft" width="200"] Example of Open Cardiac Stent[/caption]
Chun Shing Kwok, MBBS, MSc, BSc, MRCP(UK)
Clinical Lecturer in Cardiology...
MedicalResearch.com Interview with:
Elad Asher, M.D, M.H.A
Interventional Cardiologist,
Director Intensive Cardiac Care Unit
Deputy Director Heart Institute
Assuta Ashdod Medical Center
MedicalResearch.com: What is the background for this study?
Response: Dual antiplatelet therapy represents the standard care for treating ST elevation myocardial infarction (STEMI) patients. Given the higher risk of peri-procedural thrombotic events in patients undergoing primary percutaneous coronary intervention (PPCI), there is a need to achieve inhibition of platelet aggregation (IPA) more promptly. Although chewing ticagrelor has been shown to be more efficient for IPA in stable coronary disease and in patients with acute coronary syndrome (ACS)/non-ST elevation myocardial infarction (NSETMI), there are no studies that have specifically assessed the efficacy and safety of chewing ticagrelor in STEMI patients. Therefore, the aim of our study was to investigate whether chewing ticagrelor (180mg) loading dose is associated with more favorable platelet inhibitory effects compared with the conventional way of swallowing whole tablets loading dose in STEMI patients undergoing PPCI.
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MedicalResearch.com Interview with:Professor Christopher P. Cannon MD
Executive Director, Cardiometabolic Trials, Baim Institute
Cardiologist Brigham and Women's Hospital
Baim Institute for Clinical Research
Columbia University College of Physicians and Surgeons
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The trial explored whether a dual therapy approach of anticoagulation and P2Y12 antagonist - without aspirin - in non-valvular atrial fibrillation (AF) patients following percutaneous coronary intervention (PCI) and stent placement would be as safe, and still efficacious, as the current standard treatment – triple therapy. For more detailed background on the study, readers may want to review the first paragraph of the article in the New England Journal of Medicine.
Results showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with dabigatran, when compared to triple therapy with warfarin.
In the study, the risk for the primary safety endpoint (time to major or clinically relevant non-major bleeding event) was 48 percent lower for dabigatran 110 mg dual therapy and 28 percent lower for dabigatran 150 mg dual therapy (relative difference), with similar rates of overall thromboembolic events.
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MedicalResearch.com Interview with:
Dr. Ion S. Jovin, MD, ScD
Associate Professor of Medicine at Virginia Commonwealth University Pauley Heart Center
Director of the Cardiac Catheterization Laboratories and
Site Director of the VCU Interventional Cardiology Fellowship Program at
McGuire V.A. Medical Center
Visiting Assistant Professor in the Department of Surgery/Cardiothoracic Surgery
Yale University, New Haven, CT
MedicalResearch.com: What is the background for this study? What are the main findings?Response: There is still uncertainty regarding the best anticoagulant for patients with acute ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI) and especially PCI done via radial (as opposed to femoral) access. Our study compared outcomes of patients with STEMI treated with PCI done via radial access in the NCDR database who received one of the two main anticoagulants: bivalirudin and heparin. There is a large degree of variation in the use of the two anticoagulants in PCI and in primary PCI both within the United States but also in the world.
We did not find a statistically significant difference between the outcomes of the two groups of patients, but we also found that a significant number of patients in both the heparin and in the bivalirudin group were also treated with additional medicines that inhibit platelet activation (glycoprotein IIb/IIIa inhibitors).
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MedicalResearch.com Interview with:
Nayan Agarwal MD
Intervention Cardiology Fellow,
University of Florida,
Gainesville, FL
MedicalResearch.com: What is the background for this study? Response: Long term anticoagulation is indicated in patients with mechanical heart valves, prior thromboembolic events, atrial fibrillation etc, to prevent recurrent thrombo-embolic episodes. About 20-30% of these patients also have concomitant ischemic heart disease requiring percutaneous coronary intervention (PCI).
Post PCI, patients require treatment with dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor) to prevent stent thrombosis. Thus, these patients may end up needing triple antithrombotic therapy with oral anticoagulant (OAC) and DAPT, which increases the bleeding risk.
Both American College of Cardiology(ACC) and European Society of Cardiology (ESC), currently recommend triple therapy in these patients. Recently new evidence has emerged that such patients can be managed with dual therapy of a single antiplatelet (SAPT) and OAC. Hence, we decided to do a systematic review of these studies to evaluate safety and efficacy of dual therapy of SAPT and OAC against triple therapy of DAPT and OAC.
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MedicalResearch.com Interview with:
Mohamed Khayata, MD
Internal Medicine Resident PGY-3
Cleveland Clinic Akron General
Akron, Ohio
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Previous studies showed that patients with ST-elevation myocardial infarction (STEMI) who had elevated creatinine and/or impaired creatinine clearance on presentation had higher short- and long-term mortality independent of other cardiovascular risk factors.
We used the National Cardiovascular Database Registry to investigate the impact of creatinine levels at the time of presentation on the cardiovascular outcomes in patients who presented with STEMI.
Our study showed that elevated creatinine levels correlated with higher incidence of atrial fibrillation, bleeding, heart failure, and cardiogenic shock during hospital stay after the percutaneous intervention.
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MedicalResearch.com Interview with:Emmanouil S. Brilakis, MD, PhD
Director, Center for Advanced Coronary Interventions
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
Adjunct Professor of Medicine
University of Texas Southwestern Medical School at Dallas
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Calcification in the coronary arteries might hinder lesion crossing, equipment delivery and stent expansion and contribute to higher rates of in-stent restenosis, as well as stent thrombosis. In this project we sought to examine the impact of calcific deposits on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a contemporary, multicenter registry.
We analyzed the outcomes of 1,476 consecutive CTO PCIs performed in 1,453 patients between 2012 and 2016 at 11 US centers. Data collection was performed in a dedicated online database (PROGRESS CTO: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention, Clinicaltrials.gov Identifier: NCT02061436).
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MedicalResearch.com Interview with:
Thomas Engstrøm MD, PhD
The Heart Center | Rigshospitalet | University of Copenhagen | Denmark
Professor in cardiology | University of Lund | Sweden
Adjunct professor in cardiology | University of Aalborg | DenmarkMedicalResearch.com: What is the background for this study? What are the main findings?
Response: Timely reperfusion by primary angioplasty (primary PCI) in patients with ST-elevation myocardial infarction is mandatory. However reperfusion it self can harm the myocardium - so called reperfusion injury. During a number of years ischemic postconditioning (iPOST) by repetitive interruptions of blood flow after reperfusion has been a promising technique to address reperfusion damage.
The trial investigated the effect of iPOST in 1200 patients treated with primary PCI and in addition either iPOST or conventional angioplasty.
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MedicalResearch.com Interview with:Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC
Executive Director of Interventional Cardiovascular Programs,
Brigham and Women’s Hospital Heart & Vascular Center
Professor of Medicine, Harvard Medical School
Boston, MA 02115
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Cangrelor is a potent, fast on, fast off, intravenous ADP receptor antagonist that is now available for use during PCI. Glycoprotein IIb/IIIa inhibitors are intravenous antiplatelet agents that work by a different mechanism. Doctors have asked whether there is any advantage to combining them or whether one class is preferable to the other during PCI.
We analyzed close to 25,000 patients from the CHAMPION trials. Cangrelor’s efficacy in reducing peri-procedural ischemic complications in patients undergoing PCI was present
irrespective of glycoprotein IIb/IIIa inhibitor administration. However, glycoprotein IIb/IIIa inhibitor use resulted in substantially higher bleeding rates, regardless of whether the patient was randomized to cangrelor or to clopidogrel.
Thus, in general, cangrelor and glycoprotein IIb/IIIa inhibitors should not routinely be combined. If an operator wishes to use a potent intravenous antiplatelet during PCI, cangrelor is similarly efficacious as glycoprotein IIb/IIIa inhibitors, but with less bleeding risk.
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MedicalResearch.com Interview with:
Eric A. Secemsky, MD MSc
Interventional Cardiology Fellow
Massachusetts General Hospital
Harvard Medical School
Fellow, Smith Center for Outcomes Research in Cardiology
Beth Israel Deaconess Medical Center
MedicalResearch.com: What is the background for this study?
Response: Use of oral anticoagulant (OAC) therapy prior to coronary stenting is a significant predictor of post-procedural bleeding events. Previous studies have estimated that the frequency of chronic OAC use among patients undergoing percutaneous coronary intervention (PCI) is between 3% to 7%. Yet many of these analyses examined select patient populations, such as those admitted with acute myocardial infarction or atrial fibrillation, and preceded the market approval of non-vitamin K antagonist oral anticoagulants (NOACs). As such, the contemporary prevalence of OAC use among all-comers undergoing PCI, as well as associated risks of adverse events, are currently unknown.
Therefore, we used PCI data from a large, integrated healthcare system to determine current use of oral anticoagulant use among all-comers undergoing coronary stenting and the related short- and long-term risks of therapy.
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MedicalResearch.com Interview with: Nish Patel, MD and Nileshkumar J. Patel, MD
University of Miami Miller School of Medicine
MedicalResearch.com: What is the background for this study?Response: Out of hospital cardiac arrest (OHCA) is estimated to affect approximately 300,000 people in the United States annually. Pulseless ventricular tachycardia (VT) or ventricular fibrillation (VF) contributes 23-54% of OHCA patients, with the median values at the lower end of this range. Coronary artery disease is thought to be responsible for up to 70% of these OHCA cases.
It has been suggested that urgent coronary intervention in unconscious patients after cardiac arrest may improve survival. In the 2015 American Heart Association (AHA) guidelines, coronary angiography is recommended in patients with OHCA patients with a suspected cardiac etiology and ST elevations (STE) on ECG (Class of recommendation I, Level of evidence B), and it should be considered in patients after cardiac arrest presenting without STE but with suspected cardiac etiology of cardiac arrest (Class of recommendation II a, Level of evidence B). However, there is paucity of information about the use of coronary angiography and percutaneous coronary intervention (PCI) and its potential benefit for the VT/VF OHCA patient population.
Therefore, we reviewed the Nationwide Inpatient Sample (NIS), to examine temporal trends of coronary angiography and PCI in VT/VF OHCA in the United States, for patients with and without STE. We also studied the temporal trends of survival to discharge in these patient populations.
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MedicalResearch.com Interview with:Christian A. McNeely, M.D.
Resident Physician - Internal Medicine
Barnes-Jewish Hospital
Washington University Medical Center
MedicalResearch.com: What is the background for this study?Response: Prior research has demonstrated that readmission in the first 30 days after percutaneous coronary intervention (PCI) is common, reported around one in six or seven Medicare beneficiaries, and that many are potentially preventable. Since 2000, there have been significant changes in the management of coronary artery disease and the use of PCI. Additionally, in the last decade, readmission rates have become a major focus of research, quality improvement and a public health issue, with multiple resulting national initiatives/programs which may be affecting care. Therefore, in this study, we sought to examine contemporary trends in readmission characteristics and associated outcomes of patients who underwent PCI using the Medicare database from 2000-2012.
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MedicalResearch.com Interview with:
Henning Kelbæk, MD
Department of Cardiology
Roskilde Hospital Roskilde, Denmark
Medical Research: What is the background for this study? What are the main findings?
Dr. Kelbæk: The background to conduct the DANAMI 3-Primulti trial is the uncertainty of which strategy is most favourable to the patient with ST-segment elevation myocardial infarction: to treat the culprit (resposible for the acute infarction) lesion only or to treat all visible lesions (complete revascularisation)
The main findings of the PRIMULTI trial are that patients with ST-segment elevation myocardial infarction and multivessel disease, benefit from supplementary complete revascularisation of lesions in non-infarct related arteries when the second procedure is done during the index admission guided by measurement of the fractional flow reserve. This strategy results in a significant reduction in the combination of all-cause mortality, nonfatal reinfarction, and ischaemia-driven revascularisation.
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MedicalResearch.com Interview with:
Dr Scot GargFRCP PhD (Hons) FESC
Cardiology Department, Royal Blackburn Hospital
United Kingdom
Medical Research: What is the background for this study?
Dr. Garg: In contrast to other countries, in particular the United States, the UK has seen a vast expansion in the number of PCI centres operating without on-site surgical support. Part of the reason for this is that outcome data from these centres are from modest populations at short-term follow-up; consequently the ACC/AHA have failed to give delivery of PCI in centres without surgical back-up a strong endorsement. The study was ultimately driven therefore to show whether any differences existed in mortality between patients having PCI in centres with- and without surgical support at long-term follow-up in large unselected population cohort.
Medical Research: What are the main findings?
Dr. Garg: The study included the largest population of patients treated in centres without off-site surgical support (n=119,036) and main findings were that following multi-variate adjustment there were no differences in mortality for patients treated at centres with- or without surgical support at 30-days, 1-year or 5-year follow-up irrespective of whether patients were treated for stable angina, NSTEMI or STEMI. Furthermore, similar results were seen in a sensitivity analysis of a propensity matched cohort of 74,001 patients. (more…)
MedicalResearch.com Interview with:
Herbert D. Aronow, MD, MPH, FACC, FSCAI, FSVMGovernor, American College of Cardiology (ACC) – Michigan Chapter
Chair, ACC Peripheral Vascular Disease Section
Trustee, Society for Vascular MedicineMedical Research: What is the background for this study? What are the main findings?
Dr. Aronow: Psychomotor and cognitive performance may be impaired by sleep deprivation. Interventional cardiologists perform emergent, middle-of-the-night procedures, and may be sleep-deprived as a consequence. Whether performance of middle-of-the-night percutaneous coronary intervention (PCI) procedures impacts outcomes associated with PCI procedures performed the following day is not known. (more…)
MedicalResearch.com Interview with:Dr. P. Michael Ho, MD PhD
Denver Veteran Affairs Medical Center,
University of Colorado, Denver, Section of Cardiology
Denver, Colorado 80220.
Medical Research: What is the background for this study? What are the main findings?Dr. Ho: There is increasing interest in measuring health care value, particularly as the healthcare system moves towards accountable care. Value in health care focuses on measuring outcomes achieved relative to costs for a cycle of care. Attaining high value care - good clinical outcomes at low costs - is of interest to patients, providers, health systems, and payers. To date, value assessments have not been operationalized and applied to specific patient populations. We focused on percutaneous coronary intervention (PCI) because it is an important aspect of care for patients with ischemic heart disease, is commonly performed and is a costly procedure. In this study, we evaluated 1-year risk-adjusted mortality and 1-year risk-standardized costs of care for all patients who underwent PCI in the VA healthcare system from 2008 to 2010.
We found that median one-year unadjusted hospital mortality rate was 6.13% (interquartile range 4.51% to 7.34% across hospitals). Four hospitals were significantly above the one-year risk standardized median mortality rate, with median mortality ratios ranging from 1.23 to 1.28; no hospitals were significantly below median mortality. Median 1-year total unadjusted hospital costs were $46,302 (IQR of $37,291 to $57,886) per patient. There were 16 hospitals above and 19 hospitals below the risk standardized average cost, with risk standardized ratios ranging from 0.45 to 2.09 reflecting much larger magnitude of variability in costs compared to mortality. These findings suggest that there are opportunities to improve PCI healthcare by reducing costs without compromising outcomes. This approach of evaluating outcomes and costs together may be a model for other health systems and accountable care organizations interested in operationalizing value measurement. (more…)
MedicalResearch.com Interview with:
Yan Liang, MD, PHD on behalf of co-authors
Emergency and Intensive Care Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, ChinaMedical Research: What is the background for this study? What are the main findings?
Response: The background of this study is mainly derived from the results of CURRENT-OASIS7 which has shown a 7-day 150 mg maintenance dose (MD) clopidogrel could reduce cardiovascular events among subgroup patients undergoing percutaneous coronary intervention (PCI) compared with the 75 mg/day regimen. We conducted a meta-analysis based on 17 randomized controlled trials to determine whether prolonging the high MD clopidogrel (≥150 mg) treatment period to at least 4 weeks could reduce major adverse cardiac events (MACEs) in the PCI patients with and without high on-clopidogrel platelet reactivity (HPR).
Our study concluded that the high maintenance dose clopidogrel was associated with a significant reduction in the risk of MACEs in PCI patients without increasing the rate of “Major/Minor bleeding” or “Any bleeding” in comparison with standard 75mg MD clopidogrel, and the “HPR Patients” subgroup were also benefited from such high MD treatment.
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MedicalResearch.com Interview with:
Dr. Bilal Iqbal MD
Royal Brompton and Harefield NHS Foundation Trust
Harefield Hospital
Middlesex United Kingdom.Medical Research: What is the background for this study? What are the main findings?
Dr. Iqbal: The optimal strategy for revascularization of bystander coronary disease at the time of PPCI is unknown. Certainly, this has been the focus of recent debate and randomized controlled trials. We evaluated a strategy of culprit vessel versus multivessel intervention at the time PPCI in the real world setting. We conducted an observational analysis of 3984 consecutive patients with STEMI undergoing Primary percutaneous coronary intervention (PPCI) who had multivessel disease. We excluded patients with cardiogenic shock and patients with bystander LMS disease, which may potentially dictate staged surgical intervention. When analysing all-cause mortality at 1 year, we found that a strategy of culprit vessel intervention only at the time of PPCI was associated with increased survival at 1 year.
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MedicalResearch.com Interview with:Katharina Mayer MD
Deutsches Herzzentrum München,
Technische Universität München,
Munich, Germany
Medical Research: What are the main findings of the study?
Dr. Mayer:Patients whose platelets do not respond well to aspirin carry a higher risk of death or stent thrombosis. Platelet response to aspirin is an independent predictor of ischemic events in patients undergoing percutaneous coronary interventions (PCI).
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MedicalResearch.com Interview with: Thomas M. Maddox, MD MSc FACC FAHA
Cardiology, VA Eastern Colorado Health Care System
Associate Director, VA CART Program
Associate Professor, Department of Medicine, University of Colorado School of Medicine
Medical Research: What are the main findings of the study?Dr. Maddox: We were curious to know if the VA, as a provider of PCI at centers without on-site CT surgery, was providing better access to its veterans without compromising their safety. We were pleased to find that there was evidence of better access, with patients reducing their drive time to PCI facilities by, on average, 90 minutes. In addition, there was no compromised safety. Rates of both peri-procedural and 1-year adverse outcomes were low and no different between centers with and without on-site CT surgery.
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MedicalResearch.com Interview with Steven M. Bradley, MD, MPH
Veterans Affairs, Eastern Colorado Health CareSystem
Denver, Colorado
Medical Research: What are the main findings of the study?Dr. Bradley: In 539 hospitals participating in the CathPCI Registry that performed elective coronary angiography on more than 500,000 patients, 22% of patients were asymptomatic at the time of coronary angiography. We observed marked variation in the hospital rate of angiography performed in asymptomatic patients, ranging from 0.2% to 66.5%, suggesting broad variation in the quality of patient selection for coronary angiography across hospitals. Additionally, hospitals with higher rates of asymptomatic patients at diagnostic angiography also had higher rates of inappropriate PCI, due to greater use of PCI in asymptomatic patients. These findings suggest that patient selection for diagnostic angiography is associated with the quality of patient selection for PCI as determined by Appropriate Use Criteria. By addressing patient selection upstream of the catheterization laboratory, we may improve on the optimal use of both angiography and PCI.
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MedicalResearch.com Interview with: Cheol Whan Lee andSeung-Jung Park
Division of Cardiology, Asan Medical Center,
University of Ulsan
Seoul, Korea
Medical Research: What are the main findings of the study?Answer: The time window of DES (drug-eluting stent) failure is widely variable from soon after DES implantation to several years after DES implantation. We observed patients with late DES failure are commonly presented with acute coronary syndrome. We hypothesized that temporal patterns of DES failure may be different, and analyzed all patients with first DES failure at our institution. We found that late drug-eluting stent failure is more likely to progress to acute myocardial infarction, aggressive angiographic patterns, and worse outcomes following retreatment.
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MedicalResearch.com Interview with: Laurie Lambert, PhD
Unité d'évaluation en cardiologie
Institut national d'excellence en santé
et en services sociaux (INESSS)
Montréal, Québec
MedicalResearch: What are the main findings of the study?Dr. Lambert: Patients with ST-elevation myocardial infarction (STEMI) are frequently transferred for percutaneous coronary reperfusion from a hospital without this capability. Favourable outcomes depend on minimizing delays to treatment. A major component of delay is the time from the patient’s arrival at the first hospital’s emergency department to departure to the hospital where percutaneous reperfusion will be performed, the ‘door-in-door-out’ time or DIDO. We characterized this component of delay in a systematic field evaluation of STEMI treatment over a large and populous geographic area.
The major contributors to DIDO time were the delays
(1) from the initial in-hospital ECG acquisition to transfer activation by the emergency physician and
(2) from arrival of the transfer ambulance at the first hospital to departure of the ambulance for the primary percutaneous coronary intervention center. When the DIDO interval was timely (30 minutes or less as recommended by guidelines), reperfusion treatment was far more frequently within guideline-recommended delays (90 minutes or less). In fact, this benchmark of DIDO time was met in only 14% of cases. We identified a number of factors associated with untimely DIDO, an important one being an ambiguous presenting ECG. DIDO times were faster when patients arrived at the first hospital by ambulance particularly when retransfer to the second hospital was with the same ambulance that had remained on standby.
MedicalResearch.com Interview with: Judith Kooiman
Department of Thrombosis and Hemostasis
Leiden University Medical Center
Leiden, The Netherlands
MedicalResearch.com: What are the main findings of the study?Dr. Kooiman: The main finding of our study is that trans radial PCI (TRI) is associated with a significantly lower risk of AKI compared with trans femoral PCI (TFI), after adjustment for confounding factors.
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MedicalResearch.com Interview with:Dhruv S. Kazi, MD, MSc, MS
Assistant Adjunct Professor
Division of Cardiology San Francisco General Hospital
Department of Medicine, and
Department of Epidemiology and Biostatistics
University of California San Francisco
MedicalResearch.com: What is the background of your study?
Dr. Kazi: When we first asked the research question -what is the role of genotyping among patients receiving a stent for ACS, we quickly realized that there were no RCTs that had directly compared ticagrelor with prasugrel. But in our opinion, that was precisely the reason to build a model and systematically synthesize the available literature. There are nearly half a million PCIs for ACS in the US each year, and each time, the physician and patients have to examine the trade-offs between the various alternatives. What our model does is that it explicates the trade-offs - makes them transparent, and quantifies them. So patients and physicians can make an informed decision on what is the optimal therapy for them.
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