New Hypertension Guidelines to Debut at AHA Scientific Sessions

November 08, 2017

ANAHEIM, CA -The two major US general cardiology societies are set to unveil their latest hypertension clinical practice guidelines, expected to be the first in which SPRINT makes a major appearance, at next week's American Heart Association (AHA) 2017 Scientific Sessions.

2017 Hypertension Clinical Practice Guidelines

The field has anticipating the new guidelines for at least 2 years. It was at the AHA 2015 sessions when the first detailed SPRINT findings were presented, with its provocative support for a systolic blood pressure target threshold of 120 mm Hg for antihypertensive therapy.

That raised questions about, among other things, the safety and practicality of blood-pressure–lowering treatment to a systolic blood-pressure target threshold of 120 mm Hg. It also seemed to befuddle clinicians who had already embraced the more relaxed targets from the Eighth Joint National Committee (JNC8), released only a couple of years earlier.

Fast forward to AHA 2017, when a day of presentations detailing the new guidelines will frame them in a way that's relevant to cardiologists as well as the primary-care physicians on the front lines of blood-pressure control, said Dr Eric Peterson (Duke University Medical Center, Durham, NC), who chairs the sessions' program committee.

"The writers of the guidelines have made them very approachable," he told | Medscape Cardiology. At the meeting, "we've embedded them in a way that gives some of the background data but also really gets into what it might mean for the average practitioner."

The 2017 Hypertension Clinical Practice Guidelines of the AHA and American College of Cardiology will be presented on Monday of the meeting (November 13, 2:00-3:15 PM, Hall D). It will be followed by a special session that will discuss different aspects of the guidelines and lay out many of the practice implications (Clinical Practice Guidelines for Blood Pressure Management: Next Steps; Monday, November 13, 5:15–7:15 PM in Ballroom A).

Creatures of habit among those following their own late-breaking science (LBS) track, beware: those sessions are split between Ballroom CD and Hall D.

LBS 1, CABG and EP Periprocedural Dilemmas

Sunday, November 12, 3:45–5:00 PM, Hall D

Leading the session is a presentation on the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, which randomized about 5000 patients undergoing cardiac surgery to receive red-cell transfusions intra- or postoperatively according to a "restrictive" or "liberal" strategy.

The restrictive strategy allows red-cell transfusion if the patients' hemoglobin goes below 75 g/L during surgery or the postop phase. The liberal approach allows the transfusions if hemoglobin is <95 g/L "intraoperatively, postoperatively in the intensive care unit, and/or <85 g/L on the ward."

Current practice tends to vary from center to center, according to Peterson. "The guidelines have moved a little bit to more conservative practice, but I think if you look at routine clinical practice, you see a pretty wide range."

Next are the 12-month primary results from the Dual Acetylsalicylic Acid Plus Ticagrelor or Ticagrelor Alone Antiplatelet Strategy After Coronary Artery Bypass Surgery (DACAB) trial, which randomized about 500 patients undergoing elective CABG to three different antiplatelet regimens on an open-label basis.

After stopping oral antiplatelets before surgery, the patients will resume it within 24 hours of the procedure, one-third of patients to each of aspirin 100 mg/day, ticagrelor 90 mg twice daily plus the same dosage of aspirin, and solely ticagrelor 90 mg twice daily. The primary end point is graft patency by CT angiography.

The Prevention of Serious Adverse Events Following Angiography (PRESERVE) trial follows. It's a randomized, placebo-controlled comparison of four infusion regimens for prevention of contrast-induced nephropathy in >5100 high-risk patients undergoing procedures using iodinated contrast. The patients, all with compromised renal function, received either isotonic saline, saline plus oral N-acetylcysteine, isotonic bicarbonate, or N-acetylcysteine plus isotonic bicarbonate.

The trial of Continued versus Interrupted Novel Oral Anti-Coagulant at the Time of Device Surger (BRUISE CONTROL-2) randomized about 660 adults with atrial fibrillation (AF) and increased stroke-risk scores receiving one of several new oral anticoagulants (NOACs) before scheduled surgery to implant, change out, or revise a pacemaker or implantable defibrillator system.

The patients either continued on their long-term NOAC regimen throughout the surgery or discontinued it temporarily for the procedure and were followed for the end point of hematoma within 2 weeks calling for another operation.

LBS 2, Late-Breaking Science in Prevention

Monday, November 13, 9:00–10:15 AM, Ballroom CD

First in the session, the Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD), is an exploration in Japan of, among other things, whether the kind of intensive statin regimen used in patients with high-risk CAD is appropriate also for those with milder chronic disease.

It randomized >13,000 patients with either a remote history of revascularization or acute coronary syndromes, or simply with dyslipidemia, to receive pitavastatin (Livalo, Livazo, Kowa Pharmaceuticals) at either 1 mg/day or 4 mg/day and then be followed for 3 to 6 years.

Statin therapy is well characterized in Asian populations, Peterson observed, but REAL-CAD compares statins for intensive vs moderate LDL-cholesterol lowering, looking to see whether the intensive-therapy approach should be extended to more patients.

Scheduled next are two subgroup analysis from the FOURIER trial, which had tested evolocumab (Repatha, Amgen) on top of standard statins in >27,000 patients with atherosclerotic cardiovascular disease. The two presentations are billed as focusing on patients with peripheral artery disease and a history of MI, respectively.

Afterward on the slate is a follow-up analysis of the CANTOS trial, which caused a stir recently after showing a significant drop in risk of recurrent cardiovascular events on treatment with canakinumab (Ilaris, Novartis), an engineered anti-inflammatory antibody.

The new analysis of the trial, which had randomized >10,000 patients with a history of MI and chronically elevated levels of the inflammatory biomarker high-sensitivity C-reactive protein (hs-CRP), is said to focus on residual inflammatory and cholesterol risk.

LBS 3, Latest Insights into Hypertension Management

Monday, November 13, 10:45–12:00 PM, Hall D

The first presentation in the session, labeled Blood Pressure Measurement in SPRINT, will aim to clarify a controversy revolving around the study. Many point out that blood pressure in SPRINT was measured unsupervised, with automated devices, and after the patients sat for 5 minutes undisturbed, and contend the readings don't relate well to common clinical practice.

Next, the Gastric Bypass To Treat Obese Patients With Steady Hypertension (GATEWAY) study is looking at the effect of laparoscopic Roux-en-Y gastric bypass surgery in adults with obesity who are on at least two blood-pressure–lowering drugs for hypertension. The end point is change in number of antihypertensive agents over 1 year. Diabetes type 1 or type 2 is an exclusion criterion.

LBS 4, Sweet Spot in Cardiometabolic Care

Monday, November 13, 3:45–5:00 PM, Ballroom CD

As with most drug innovations, Peterson said, the adoption of therapy with drugs that were developed for diabetes but found to reduce cardiovascular risk for the specific indication of heart disease has been slow.

Top questions about the two drug classes, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide-1 (GLP-1) agonists, include whether there are some populations with heart disease who will benefit more than others.

Eventually, Peterson said, "I suspect they'll work themselves into more and more of the prediabetes population and those who have obesity and metabolic syndrome."

Yet their mechanism of cardiovascular benefit remains elusive. "It's pretty clear that it's not through lowering of glucose," he said.

Although those questions aren't necessarily addressed by studies at the AHA sessions, LBS 4 contains several secondary trial analyses that explore the two diabetes drug classes in cardiovascular disease.

The presentations include a CANVAS (CANVAS)  trial analysis called Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events in Type 2 Diabetes, one from EXSCEL titled Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease; and one from the EMPA-REG OUTCOME trial announcing that Empagliflozin Reduces Mortality and Hospitalization for Heart Failure in Patients With Type 2 Diabetes and Peripheral Artery Disease.

LBS 05, New Insights Into the Risks, Benefits, and Costs of Antithrombotic Therapy

Tuesday, November 14, 2017, 10:45–12:00 PM, Hall D

The session features a cost-effectiveness analysis from COMPASS. That trial saw significant reductions in ischemic atherosclerotic events in patients taking a combination of low-dose (2.5 mg twice daily) rivaroxaban (Xarelto, Bayer/Janssen) and aspirin 100 mg daily vs aspirin alone, in patients with peripheral artery disease or with stable CAD.

Following COMPASS, the presentations include a substudy of POISE-2 looking at its patients with a history of PCI. The trial had previously found little apparent clinical benefit from giving aspirin or clonidine at cardiac surgery.

Also on the schedule: 1-year results for a trial whose primary end point was set at 7 days. As previously reported, PRAGUE-18 had randomized 1230 patients with ST-segment elevation MI (STEMI) to receive prasugrel (Effient, Lilly/Daiichi-Sankyo) or ticagrelor (Brilinta, Brilique, Possia, AstraZeneca) after primary PCI. After both a week and at 30 days, neither agent showed an advantage for composite clinical end points in the underpowered trial.

LBS 6, Evaluating Quality Improvement and Patient-Centered Care Interventions

Tuesday, November 14, 3:45–5:15 PM, Ballroom CD

The session leads with a trial with an imploring acronym, the Study of a Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT), which sought to determine whether a special protocol for a clinical pharmacist consultation with patients can improve adherence to medications for dyslipidemia, hypertension, or diabetes.

The trial involving about 250 primary-care physicians in 14 practices who randomized >4000 patients not adhering well to their meds and with poor or worsening control of their disease to receive either standard care or the consultations followed by "intensive support" that included tailored follow-up text and video motivational messages.

Next on the schedule is the Improving Care Processes for Patients With Possible Acute Coronary Syndrome (ICare-ACS) trial from New Zealand, exploring "accelerated" diagnostic pathways for patients with chest pain in the emergency department. "Does this improve rates of safe discharge within 6 hours?" the study asks.

The Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device (DECIDE-LVAD) trial is testing an intervention for adult patients undergoing evaluation for a destination-therapy left ventricular assist device (LVAD), aimed at promoting shared decision-making and improved education and acceptance of the treatment.

LBS 7, Innovative Therapies and Novel Applications

Wednesday, November 15, 9:00–10:15 AM, Ballroom CD

At last year's AHA sessions, a single-arm observational study suggested that implantation of the IASD System II (Corvia Medical) interatrial shunt could improve hemodynamics and some functional measures in patients with heart failure and preserved ejection fraction (HFpEF). That led to a randomized trial of the novel approach that will appear at this year's sessions.

The REDUCE LAP-HF I trial assigned patients similar to those in the pilot study to either receive the device or intracardiac echocardiography only. They were followed for change in exercise pulmonary capillary wedge pressures and for major adverse cardiac, cerebrovascular, or renal events at 1 month.

Similarly following up on a promising pilot study from 2015, the Temporary Neurotoxin Treatment to Prevent Postoperative Atrial Fibrillation (TNT-POAF) trial randomized an estimated 130 patients undergoing standard on-pump CABG, valve surgery, or both to also receive epicardial fat-pad injections of botulinum toxin in an effort to prevent postoperative atrial fibrillation.

The fat pads contain ganglia that support vagal innervation and have an endocrine function, which are thought to promote postoperative AF. The apparent success of the injections in the pilot study both impressed and fascinated observers.

Next on the schedule: the Progenitor Cell Release Plus Exercise to Improve Functional Performance in PAD (PROPEL) trial, which assessed the functional effects of supervised treadmill exercise for 26 weeks with or without injections of granulocyte macrophage colony stimulating factor (GM-CSF), six doses over 2 weeks, in 210 patients with peripheral artery disease. The latter treatment is known to increase levels of CD34+ hematopoietic progenitor cells.

Last on the LBS schedule is the Halt Cardiomyopathy Progression in Duchenne (HOPE-Duchenne) trial, a small safety and tolerability study of a cell therapy in male patients at least 12 years old with cardiomyopathy related to confirmed Duchenne muscular dystrophy. Secondary end points include cardiac structure, functional,  quality-of-life, and biomarker measures.

The cell therapy consists of intracoronary infusion of cardiosphere-derived cells (CAP-1002, Capricor), an investigational preparation of allogeneic cardiac stem cells that in preliminary studies seemed to promote myocardial regeneration.

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