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AUGUSTUS: Less Bleeding, Fewer Events With Apixaban and No Aspirin in Patients With AFib and ACS


Patients with both atrial fibrillation (AFib) and acute coronary syndrome (ACS) had a significantly reduced risk of bleeding when treated with apixaban vs. a vitamin K antagonist (VKA) and when taking placebo vs. aspirin, according to results of the AUGUSTUS trial presented at ACC.19 in New Orleans.

A total of 4,614 patients (median age, 70.7 years; 29 percent women) were enrolled and randomized within 14 days (mean, 6.6 days) of an ACS episode or stent insertion to apixaban (5 mg twice daily) or VKA and to either a daily baby aspirin or matching placebo. All patients were required to be taking clopidogrel (90 percent did) or another P2Y12 inhibitor during the trial. The primary endpoint was major or clinically relevant nonmajor bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) definition. Secondary endpoints included a composite of death or hospitalization and a composite of death or stroke, heart attack, stent thrombosis or urgent revascularization.

After six months, the bleeding risk was reduced by 31 percent among patients taking apixaban vs. warfarin (p<0.001) and by 47 percent among patients taking placebo vs. aspirin. The highest bleeding rates were reported among patients treated with VKA and aspirin (18.7 percent) and the lowest rates occurred among those taking clopidogrel, apixaban and placebo (7.3 percent).

A primary endpoint event occurred in 10.5 percent of patients taking apixaban vs. 14.7 percent taking a VKA (p<0.001 for noninferiority and superiority). This event rate was 16.1 percent with aspirin and 9 percent with placebo (hazard ratio, 1.89; p<0.001). The number needed to treat to avoid one primary event was 24 with apixaban vs. VKA.

Deaths and hospitalizations were highest in patients taking VKA and aspirin (27.5 percent) and lowest for those taking apixaban and placebo (22.0 percent). Patients in the apixaban group had a 50 percent lower risk of stroke compared with those taking VKA.

“We have shown that when it comes to treating this high-risk patient population, less may be more,” said lead author Renato D. Lopes, MD, PhD, FACC. “Our findings show that the combination of apixaban and a drug such as clopidogrel – without aspirin – is the safest treatment regimen for this difficult-to-treat group of patients, without significantly increasing ischemic events such as heart attacks, strokes and blood clots.”



Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction - DAPA-HF

Among patients with symptomatic HFrEF, dapagliflozin was beneficial. Dapagliflozin vs. placebo was associated with a reduction in cardiovascular deaths and heart failure events. Dapagliflozin was also associated with improvement in symptoms. Benefit was consistent across the age spectrum, in diabetics/nondiabetics, and across the range of baseline health status. There was no sign of adverse safety events. The baseline use of sacubitril-valsartan was low. Dapagliflozin may signal a new approach in the treatment of patients with HFrEF.


Dapagliflozin Effect on Cardiovascular EventsThrombolysis in Myocardial Infarction 58 - DECLARETIMI 58

The results of this trial indicate that dapagliflozin is superior to placebo in improving glycemic control and noninferior but not superior for reducing MACE in patients with DM2 and high CV risk. There was a reduction in HF hospitalizations, and also a salutary effect on renal outcomes. Among patients with HFrEF, dapagliflozin reduced HF hospitalizations, and CV and all-cause mortality; however, this cohort comprised only about 4% of the total population. Unlike canagliflozin, there was no clear safety signal regarding increased amputations. These are important findings, and more or less consistent with findings noted with other selective inhibitor of sodiumglucose cotransporter 2 (SGLT-2) inhibitors. These drugs reduce hyperglycemia in patients with DM2 by reducing renal glucose reabsorption and thus increasing urinary glucose excretion.

Following the much-publicized CV safety concerns with rosiglitazone, the FDA mandated that all new diabetes drugs conduct studies demonstrating CV safety. The upper limit of the 95% CI for the HR had to be <1.8 for premarketing studies and <1.3 for postmarketing studies. This trial thus establishes the CV safety profile of dapagliflozin for use in patients with DM2. The reduction in HF hospitalization was noted even among patients with prior HF, and has been noted for the other SGLT-2 inhibitors. Dipeptidyl peptidase-4 (DPP-4) inhibitors on the other hand, particularly saxagliptin, may increase the risk of HF.



Intracoronary Stenting and Antithrombotic Regimen 5 - ISAR-REACT 5

In patients across the acute coronary syndrome spectrum undergoing planned coronary angiography, prasugrel was superior to ticagrelor at preventing major adverse ischemic events. Findings were similar among the tested subgroups. Benefit from prasugrel was accomplished without an increase in major bleeding. In addition to comparing two drugs, this trial was also comparing two strategies among the NSTEMI patients; pretreatment with ticagrelor (i.e., before coronary angiography) and delayed treatment with prasugrel (i.e., after coronary angiography defined). The hypothesis of this trial was that pretreatment with ticagrelor would translate into a reduction in major adverse ischemic events; however, the opposite finding was observed. The reason for this finding is unknown, but irreversible platelet inhibition from prasugrel warrants consideration. The degree of benefit observed exceeds that seen with clopidogrel versus placebo, which is difficult to explain.

Current treatment guidelines give preference to a potent P2Y12 inhibitor over clopidogrel, but data have been lacking to recommend one particular potent P2Y12 inhibitor over another. It is important to note that patients with history of stroke, transient ischemic attack, or intracranial hemorrhage were excluded from study participation. It is also important to emphasize that prasugrel was administered to NSTEMI patients after coronary angiography/before PCI and there was a dose reduction for patients 75 years or weight <60 kg.



Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 - STOPDAPT-2

Among patients undergoing PCI for stable and unstable cardiovascular disease, 1-month DAPT followed by clopidogrel monotherapy was superior to 12-month DAPT followed by aspirin monotherapy at preventing net adverse clinical events. One-month DAPT was noninferior to 12-month DAPT at preventing major adverse ischemic events and superior to 12-months DAPT at preventing TIMI major/minor bleeding. BARC 3 or 5 bleeding was low, but 1-month DAPT was also associated with a reduction in this outcome compared with 12-month DAPT. The design of this trial is like the GLOBAL LEADERS trial.


International Study of Comparative Health Effectiveness With Medical and Invasive Approaches - ISCHEMIA

Among patients with stable ischemic heart disease and moderate to severe ischemia on noninvasive stress testing, routine invasive therapy failed to reduce major adverse cardiac events compared with optimal medical therapy. There was also no benefit from invasive therapy regarding all-cause mortality or cardiovascular mortality/myocardial infarction. One-third of subjects reported no angina symptoms at baseline. Routine invasive therapy was associated with harm at 6 months (increase in periprocedural myocardial infarctions) and associated with benefit at 4 years (reduction in spontaneous myocardial infarction). These results do not apply to patients with current/recent acute coronary syndrome, highly symptomatic patients, left main stenosis, or left ventricular ejection fraction <35%.

Although the overall interpretation of this trial was negative, there were mixed findings with evidence for both harm and benefit. This signals that: 1) invasive therapy for stable ischemic heart disease patients needs to be carefully considered in the context of angina burden and background medical therapy, and 2) likelihood that optimal coronary revascularization can be achieved with low procedural complications.



Apple Heart Study Identifies AFib in Small Group of Apple Watch Wearers


Offering a glimpse at how wearable technology may help flag potential health problems, the Apple Watch was able to detect atrial fibrillation (AFib) in a small group of people who had received an alert of an irregular heartbeat, said researchers presenting results from the Apple Heart Study at ACC.19 in New Orleans.

The Apple Watch and corresponding Heart Study app uses photoplethysmography to intermittently measure blood flow activity and detect subtle changes that might indicate an irregular heartbeat. A tachogram is then created and is analyzed by an algorithm. The aim of the study, presented by Mintu Turakhia, MD, MS, was to identify patients with an irregular pulse watch notification who have AFib on a subsequent electrocardiogram (ECG) patch.

A total of 419,297 people self-enrolled in the study. Participants could not have AFib or be taking anticoagulants and were required to have an Apple Watch and compatible iPhone. They were given information about the study when they downloaded the Heart Study app. Detection of five of six repeat tachograms of an irregular pulse within a 48-hour period triggered a notification to be sent via the app. Participants receiving a notification were prompted to contact the study doctor through the app for a video consultation to determine if the participant should wear an ECG patch. The patch was worn for up to seven days.

The primary endpoints were AFib >30 seconds on ECG patch and simultaneous AFib on ECG patch and tachogram.

A pulse notification was received by 2,161 participants (0.52 percent). Notification rates were most frequent in participants over age 65 (slightly >3.0 percent) and lowest among those under 40 (0.16 percent). Patches were sent to 658 participants and 450 were returned and included in the analysis. AFib was identified in 34 percent of those who received a notification and wore the ECG patch.

"AFib can come and go, particularly early on in the course of the disease. It's not surprising for it to go undetected in subsequent ECG patch monitoring. So while only 34 percent of people who were still having AFib on the ambulatory ECG, that doesn't mean that 66 percent didn't have AFib. It just means that AFib may not have been there at the time," Turakhia said. "These parameters help us understand how we, as clinicians, should think about these notifications."

The positive predictive value (PPV) for the tachogram was 71 percent and the PPV for notification was 84 percent. About half of participants receiving an irregular pulse notification contacted a study doctor. Subsequent surveys showed that 57 percent of participants who received an alert sought medical care outside of the study regardless of whether they had been seen virtually by a study doctor. "This is encouraging because it tracks with our understanding of AFib as being more common as you get older," Turakhia said, adding that the overall study population represented a striking cross section of cardiovascular risk.

The study had several limitations, including reliance on self-reported data from participants and the potential for a high number of false positive heart rhythms that could then lead to further unnecessary tests and undue anxiety for patients.  Additionally, the target enrollment of 500,000 participants, with 75,000 aged 65 or older, was not reached.

ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC, also noted that while the watch and corresponding app "offers promise," its accuracy is still far short of more traditional and currently used monitoring techniques. "This is just a glimpse of the future, but we have a ways to go," he said.

Turakhia said the trial does represent "a paradigm shift" for how clinical studies can be conducted. "We don't have to bring people into a brick and mortar clinic and give the study intervention," he said.



The new ACC and American Heart Association (AHA) primary prevention guideline provides a comprehensive roadmap of strategies that can be used and tailored to help prevent or slow the development of atherosclerotic cardiovascular disease (ASCVD). The guideline, released today during ACC.19 in New Orleans, LA, also emphasizes the need to identify and address personal or social barriers (e.g., income and education levels, cost concerns, lack of health insurance, access to healthy foods or safe places to exercise, life stressors) as part of overall prevention, and sets a new tone for aspirin use, saying it should rarely be used.

“The most important way to prevent cardiovascular disease … is by adopting heart healthy habits and to do so over one’s lifetime,” said Roger S. Blumenthal, MD, FACC, co-chair of the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. “More than 80 percent of all cardiovascular events are preventable through lifestyle changes, yet we often fall short in terms of implementing these strategies and controlling other risk factors.”

The guideline consolidates existing recommendations and new research, expert consensus documents, and clinical practice guidelines into a single source of guidance on the primary prevention of ASCVD. It underscores healthy lifestyle changes and risk assessment as the cornerstone of preventing cardiovascular disease and goes a step further by providing practical advice based on the latest research and proven interventions for improving diet and exercise, tobacco cessation and optimally controlling other risk factors like obesity, diabetes, high cholesterol and high blood pressure.

Some of the key lifestyle recommendations include engaging in regular exercise (at least 150 minutes of moderate-intensity activity each week); aiming for and maintaining a healthy weight; avoiding tobacco (including vaping or second-hand smoke); and eating healthier by choosing more vegetables, fruits, legumes, nuts, whole grains, and fish, while limiting trans fats, added sugars, red meats, sodium and saturated fats.

Recommendations related to team-based care, shared decision-making, and assessment of social determinants of health are also included. “Social determinants of ASCVD risk – and their impact on the patient’s ability to prevent or treat risk factors – must be taken into account,” the authors said. “Clinicians need to consider patients’ health literacy and education levels and assess patients’ motivation to improve their lifestyle habits.”

Other guideline highlights include a recommendation that aspirin rarely be used to help prevent heart attacks and stroke in people without known cardiovascular disease. The authors cite recent research suggesting the bleeding risks associated with aspirin may outweigh the benefits. “Clinicians should be very selective in prescribing aspirin for people without known cardiovascular disease,” Blumenthal said. “It’s much more important to optimize lifestyle habits and control blood pressure and cholesterol as opposed to recommending aspirin. Aspirin should be limited to people at the highest risk of cardiovascular disease and a very low risk of bleeding.”

Additionally, based on a simplified synopsis of the latest ACC/AHA Cholesterol Guideline, the new guideline suggests statins be recommended with lifestyle changes to prevent cardiovascular disease among people with elevated low density lipoprotein cholesterol levels (≥ 190 mg/dl), type 2 diabetes, and anyone who is deemed to have a high likelihood of having a stroke or heart attack upon reviewing their medical history and risk factors and having a detailed discussion with their clinician.

However, the authors note: “Even if a blood pressure–reducing medication, lipid-lowering medication, or diabetes medication is ultimately prescribed, lifestyle goals should be emphasized on a regular basis. Only when a person’s risk is sufficiently high should medications to reduce ASCVD risk be considered as part of a shared decision-making process for optimal treatment.”

The 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease was simultaneously published in the Journal of the American College of Cardiology and Circulation.

Visit the Primary Prevention of Cardiovascular Disease Guideline Hub on ACC.org for clinician and patient resources. The JACC Prevention Guideline Hub also has tools including the central illustration.





The results of this trial indicate that the use of icosapent ethyl 2 g twice daily was superior to placebo in reducing high triglycerides (TGs), CV events, and CV death among patients with high TGs and either known CV disease or those at high risk for developing it, and who were already on statin therapy with relatively well-controlled LDL levels. Rates of revascularization and MI were lower, while atrial fibrillation/flutter and bleeding were higher with icosapent ethyl. Results were maintained in the USA cohort.

These are very interesting findings, and come on the heels of several negative trials with n3 fatty acid supplementation. One aspect of this medication is that it has a higher dose of purified eicosapentaenoic acid (EPA) (4 g/day) than what was tested in other clinical trials. Other trials with moderate to high doses of EPA are ongoing. This is one of the first non-LDL targeted trials to show a CV benefit, and will likely be featured in future guidelines.



All told, the set includes 22 new measures: six performance measures; six process quality measures; and 10 structural quality measures. Of note, performance measures are generally developed based on the highest quality of evidence; whereas quality measures may be useful for local quality improvement but are not yet appropriate for public reporting or pay-for-performance programs.

According to the authors, the new category of 10 structural quality measures were created to "evaluate the capability and capacity of various levels of the U.S. health care system to implement the 2017 Hypertension Clinical Practice Guidelines recommended strategies, such as standardized BP measurement, protocols, electronic health record surveillance, telehealth, team-based care, a single plan of care and performance measures."  In addition, the document stresses the importance of measuring atherosclerotic cardiovascular disease similar to the hypertension guidelines, noting that end users of the new performance measure set should "incorporate this risk assessment process in order to achieve successful implementation as a key component of quality improvement for patients with high BP."

"There are three major goals of this document," adds Donald E. Casey, Jr., MD, MPH, MBA, chair of the writing committee. "First, to develop new performance measures designed to evaluate the control of patients with Stage 1 high BP (130-139) in a manner identical to the current measure commonly used by the National Committee for Quality Assurance and the Centers for Medicare and Medicaid Services for Stage 2 high BP (≥ 140), separately for Stage 1 and combined with Stage 2 into a single composite measure. Second, to provide new measures intended to evaluate treatment and monitoring of patients with high BP, including the assessment of lifestyle modification (any stage), medication adherence (Stage 2 and Stage 1 with atherosclerotic cardiovascular disease risk ≥ 10 percent) and home BP monitoring (Stage 1 and Stage 2, separately and combined). Third, to provide a standardized measurement framework for comprehensive assessment of a 'care delivery unit' (rather than at the clinician or health plan levels) as a guide to designing and implementing an evidence-based system of care for patients with high BP based on the 2017 ACC/AHA High Blood Pressure Guidelines."

Moving forward, "the effective implementation of this measure set by clinicians, care teams, and health systems will lead to significant improvements in effective detection and treatment of high BP for millions of people across the U.S.," said the authors.



Non-vitamin K oral anticoagulants (NOACs), are now recommended as the preferred alternative to warfarin for reducing the risk of stroke associated with atrial fibrillation (AFib), according to the 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation released Jan. 28 by the ACC, American Heart Association and Heart Rhythm Society and simultaneously published in the Journal of the American College of Cardiology.

The new guidanceis based on new data from clinical trials and/or new U.S. Food and Drug Administration indications for thromboembolism protection devices. The focused update includes revisions to the sections on anticoagulation, catheter ablation of AFib, management of AFib complicating acute coronary syndrome, and new sections on device detection of AFib and weight loss.

Of note, the authors explain that NOACs – including dabigatran, rivaroxaban, apixaban and edoxaban – are now the preferred recommended drug class over warfarin to reduce stroke risk in appropriate AFib patients, unless patients have moderate-to-severe mitral stenosis or a mechanical heart valve.

"New scientific studies show that NOACs may be safer for patients because there is less risk of bleeding, and they may also be more effective at preventing blood clots than warfarin," said Craig T. January, MD, PhD, FACC, co-chair of the focused update.

Further, the decision to use an anticoagulant should not be influenced by whether the AFib is paroxysmal, persistent or permanent. Renal and hepatic function should also be tested before initiation of an NOAC and at least annually thereafter.

In addition, reversal agents may be helpful when there are signs of severe bleeding caused by a NOAC or when a patient on a NOAC needs an emergency surgical procedure; idarucizumab is recommended for the reversal of dabigatran and andexanet alfa "can be useful" for the reversal of rivaroxaban and apixaban.

January explains that NOACs may be used in people at lower risk of stroke than previously thought, but the evidence for this recommendation is not yet definitive. He adds that emerging research is beginning to suggest that the benefit of NOACs for reducing stroke risk outweighs the risk of taking them.



PARTNER 3 and EVOLUT Confirm Benefits of TAVR Over Surgery in Low-Risk Patients


Outcomes after transcatheter aortic valve replacement (TAVR) were superior or at least as good as those following surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis at low surgical risk, according to results of the PARTNER 3 and EVOLUT trials presented at ACC.19 in New Orleans. Both studies were published simultaneously in the New England Journal of Medicine.

Both studies compared the outcomes of TAVR with those of SAVR in patients with severe aortic stenosis and a low risk of death with surgery. In PARTNER 3, Martin B. Leon, MD, FACC, et al., randomized 1,000 patients to either TAVR with a third-generation balloon-expandable valve or standard SAVR with a bioprosthetic valve. The primary endpoint was the composite of death from any cause, stroke or re-hospitalization at one year after the procedure.

The assigned procedure was performed in 950 patients. Two patients in the TAVR group and four in the surgery group died during the index hospitalization. At one year, the primary endpoint occurred in 8.5 percent of the TAVR group compared with 15.1 percent of the surgery group, meeting the requirements for both noninferiority (p<0.001) and superiority of TAVR vs. surgery (p<0.001).

The Kaplan-Meir analysis of the primary endpoint components with TAVR vs. surgery found mortality rates of 1.0 percent vs. 2.5 percent, stroke rates of 1.2 percent vs. 3.1 percent, and rehospitalization rates of 7.3 percent vs. 11.0 percent, respectively. The length of hospital stay was reduced from seven to three days with TAVR.

“This is a landmark study because it involves 80 percent of the people who are currently being treated ith surgery for aortic stenosis. Our hope was that TAVR would be noninferior or comparable to surgery, and we were surprised to find an almost 50 percent reduction in the primary endpoint, from 15.1 percent in the surgical group to 8.5 percent with TAVR,” said Leon.

In EVOLUT, Michael J. Reardon, MD, FACC, et al. randomized 1,468 patients to TAVR with a self-expanding bioprosthesis compared with surgical replacement. The primary endpoint was the composite of death from any cause or disabling stroke at 24 months.

The as-treated cohort included 1,403 patients. At 24 months, death or disabling stroke occurred in 5.3 percent of the TAVR group compared with 6.7 percent of the surgery group, meeting the prespecified criteria for noninferiority. The mortality rate from any cause was 4.5 percent in both groups. The rate of disabling stroke was 1.1 percent with TAVR vs. 3.5 percent with SAVR.

At 30 days, TAVR was statistically superior to surgery for the secondary combined endpoint of all-cause mortality or disabling stroke (0.8 vs. 2.6 percent). Patients receiving TAVR had significantly better quality of life and hemodynamics at 30 days.

“We’ve now looked at a broad risk spectrum of patients – those at high, intermediate and low surgical risk – and these series of trials have shown that TAVR is better than or as good as surgery in terms of disabling strokes and deaths from all causes,” Reardon said. “Given this data, it now seems reasonable to consider moving TAVR in low risk patients to a class I guideline indication on par with surgery for patients with severe aortic stenosis.” Reardon noted that PARTNER 3 and EVOLUT are probably the final trials of TAVR vs. surgery, given the positive outcomes of both studies.



New Training Statement Formally Defines Level III Echocardiography Training


A new advanced training statement from the ACC, American Heart Association and American Society of Echocardiography defines the training requirements for performing Level III echocardiographic procedures. The 2019 ACC/AHA/ASE Advanced Training Statement on Echocardiography was published Feb. 19 in the Journal of the American College of Cardiology, and is the first time that Level III training for echocardiography has been formally defined.

The advanced training statement complements the ACC 2015 Core Cardiovascular Training Statement (COCATS 4), which defines the training requirements for all clinical cardiologists. The new document outlines the length of training, the types of disorders that should be reviewed, the number of various procedures typically required for competence and the knowledge base and skill required to be an advanced echocardiographer. It acknowledges that the number of procedures needed to achieve competency may vary from one individual to another, and the education and training of advanced echocardiographers should occur in a structured clinical learning environment, usually within a formal cardiology fellowship program. The training statement also outlines the resources that are typically required in these training programs and includes requirements for echocardiographic lab accreditation and teaching faculty guidelines.

"All cardiologists should have a basic understanding of echocardiographic techniques – their strengths, limitations and appropriate use," said Susan E. Wiegers, MD, FACC, chair of the writing committee. "Although it is expected that most, if not all, fellows will achieve Level II competency in echocardiography during their three years of general cardiology training, this document describes the more focused, in-depth experience required for Level III competency."

The writing committee recognizes that the indications, technology and capabilities of cardiac ultrasound are continually advancing. The competencies defined in this document equip the advanced echocardiographer with the knowledge needed to acquire new skills as they emerge.

"The use of cardiovascular ultrasound is a key component in the care of many patients in the hospital and outpatient office as well as guiding interventional cardiac procedures in the catheterization lab and the operating room," Wiegers said. "It is important to define what is required to become a Level III echocardiographer."

The document was developed in collaboration with the American Thoracic Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Anesthesiologists and Society of Critical Care Medicine.



The U.S. Food and Drug Administration (FDA) has approved an expanded indication for several transcatheter heart valves (Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO) to include patients with severe aortic valve stenosis at low surgical risk.

The FDA is the first medical products regulatory body in the world to expand the indication for transcatheter aortic valve replacement (TAVR) to this patient population. As part of the approval process, manufacturers are required to continue to follow patients enrolled in their randomized studies for 10 years to further monitor safety and effectiveness, including long-term valve durability. Additionally, manufacturers will also participate in the STS/ACC TVT Registry in order to provide the FDA with additional surveillance over a 10-year period.

According to the FDA, the transcatheter heart valves "should not be used in patients who cannot tolerate blood thinning medications or have an active infection in the heart or elsewhere. Additionally, the CoreValve Evolut R and CoreValve Evolut PRO devices should not be used in patients who have sensitivity to titanium or nickel."

"The treatment paradigm for aortic stenosis has evolved from a discussion about risk of surgery to one where anatomy really will dictate the choice between TAVR and SAVR," says ACC Surgeons' Council member Joseph Cleveland, MD, FACC. "For most patients, the preferred treatment will be TAVR unless specific conditions like concomitant multivessel coronary artery disease, the presence of an aortic aneurysm, or aortic root anatomy which is not suitable for a TAVR exist. The FDA's approval of TAVR now allows access for all patients with aortic stenosis to have greater treatment options with a lower risk of major complications. Clearly optimal treatment for patients will continue to include a heart team approach to assist patients in choosing the most appropriate therapy for treatment of their aortic stenosis."

Earlier this year, results of the landmark PARTNER 3 and EVOLUT trials presented at ACC.19 in New Orleans and simultaneously published in the New England Journal of Medicine showed outcomes after TAVR were superior or at least as good as those following surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis at low surgical risk.

In June, CMS finalized revisions to the national coverage determination that governs coverage of TAVR. That coverage was written to evolve with future indications changes, so TAVR is covered when an FDA-approved complete aortic valve and implantation system is used for that system's FDA-approved indication.


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