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Top News From ACC 2017: Slideshow

Steve Stiles; Darbe Rotach; Olivier Douliery; Patrice Wendling; Larry Hand; Sue Hughes; Deborah Brauser; Marlene Busko; Megan Brooks  |  March 29, 2017

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Slide 1

The latest advances in prevention and treatment of cardiovascular disease greeted attendees at the American College of Cardiology (ACC) 2017 Scientific Sessions, held March 17 to 19, in Washington, DC.

Slide 2

Among the key studies presented this year:

  • FOURIER: Evolocumab added to statins has clear benefit
  • ABSORB-3 at 2 years: More CV events with bioresorbable vascular scaffold
  • GEMINI-ACS-1: No increase in post-ACS bleeds with rivaroxaban vs aspirin
  • EINSTEIN CHOICE: Rivaroxaban beats aspirin for VTE recurrence
  • SURTAVI: TAVR non-inferior to SAVR in intermediate-risk patients
  • ORION-1: LDL-C dives on novel anti-PCSK9 agent inclisiran
  • Higher leaflet-thrombosis risk with TAVR, DAPT not protective
Slide 3

Evolocumab Added to Statins Cuts CV Events in FOURIER Trial

In addition to significantly lowering LDL-C levels, the PCSK9 inhibitor evolocumab (Repatha, Amgen) decreased the risk of major CV events in the long-anticipated FOURIER outcomes trial. The study, which included more than 27,000 participants with atherosclerotic CVD already receiving statins, showed that patients who received injections of evolocumab at doses of 140 mg every other week or 420 mg monthly had a 15% reduced risk for the composite of MI, stroke, CV death, coronary revascularization, and unstable angina hospitalization at 22 months compared with those receiving placebo (P<0.001). For a key secondary end point (MI, stroke, or CV death), the study showed a 20% risk reduction with evolocumab (P<0.001). The results were showcased during the first late-breaking clinical-trials session by Dr Marc S Sabatine (Brigham and Women's Hospital and Harvard Medical School, Boston, MA), with simultaneous publication in the New England Journal of Medicine.

Slide 4

ABSORB-3 at 2 Years: More CV Events With Absorb BVS vs Xience

Patients who received the Absorb (Abbott Vascular) bioresorbable vascular scaffold (BVS) in the ABSORB-3 trial showed a primary outcome—counting only events occurring between the 1-year and 2-year marks—that was noninferior to that of patients receiving Abbott's Xience everolimus-eluting metal stent. But cumulative events in the study out to 25 months told a different story, reported Dr Stephen G Ellis (Cleveland Clinic, OH), one in which major adverse cardiac events were more prevalent with the Absorb BVS stent compared with the popular Xience. By then, the rate of the target-lesion-failure primary end point (a composite of cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization) came to 10.9% for patients in the Absorb group and 7.8% for those in the Xience (hazard ratio 1.42, 95% CI 1.04–1.94; P=0.03). At this point, said Ellis, "I think the physician should have a careful and somewhat nuanced discussion with the patient before they decide what type of stent or scaffold to put in."

Image from Steven Gregory

Slide 5

Rivaroxaban Doesn’t Increase Post-ACS Bleeding vs Aspirin: Study

In the GEMINI-ACS-1 phase 2 study, the risk for increased bleeding was similar whether patients with ACS were treated with a P2Y12 inhibitor plus either the factor Xa inhibitor rivaroxaban (Xarelto, Bayer/Janssen) or aspirin. The study showed that 5% of those receiving standard dual antiplatelet therapy (DAPT) of aspirin and a P2Y12 inhibitor for >1 year had TIMI clinically significant bleeding not related to CABG (the primary end point)—as did those receiving low-dose rivaroxaban in place of aspirin. The results continued to be similar even when types of P2Y12 inhibitor (clopidogrel or ticagrelor) were compared. "This showed that aspirin could, at least potentially, be substituted if the outcomes are good. That said, this wasn't an outcomes trial; that still needs to be done," noted lead author Dr E Magnus Ohman (Duke University School of Medicine, Durham, NC). "With this being a phase 2 trial, it should not inform practice," Ohman said. "This is just a stepping-stone to try to better define how we can go forward with combinations of therapy in the future."

Slide 6

EINSTEIN CHOICE: Rivaroxaban Beats Aspirin for VTE Recurrence

In patients with VTE who had completed 6 to 12 months of anticoagulation therapy but for whom it was uncertain as to whether longer-term treatment was needed, extended therapy with rivaroxaban (Xarelto, Bayer/Janssen) at either 20 mg or 10 mg was more effective than aspirin at preventing recurrent VTE without an increased risk of bleeding in the EINSTEIN CHOICE trial. Clinicians could safely prescribe rivaroxaban for prevention of recurrent VTE without concern for increased risk of bleeding, Dr Philip S Wells (University of Ottawa, ON) said in his presentation, which coincided with publication in the New England Journal of Medicine. The EINSTEIN CHOICE study was the first to directly compare the safety and effectiveness of rivaroxaban and aspirin in patients at risk for a recurrent VTE, Wells noted.

Slide 7

SURTAVI: TAVR, SAVR Stand Toe-to-Toe in Intermediate-Risk Patients

The SURTAVI trial hit its noninferiority end point, making it the second prospective randomized trial to show transcatheter aortic-valve replacement (TAVR) is comparable to surgery in severe aortic-stenosis patients deemed intermediate risk. Using mostly first-generation Medtronic CoreValve and some newer Evolut R bioprothesis valves, the primary end point of all-cause death or disabling stroke at 24 months was estimated at 12.6% for TAVR and 14% for surgery. "The guidelines were just updated and for intermediate-risk, TAVR is now a 2a, but with these data it will need updating and should even get a class 1 indication. These are outstanding data," lead author Dr Michael J Reardon (Methodist DeBakey Heart and Vascular Center, Houston, TX) said to an overflow crowd that began assembling hours in advance of the late-breaking clinical-trial session here.

Slide 8

LDL-C Plunges on Novel Anti-PCSK9 Agent Inclisiran: ORION-1

Treatment with inclisiran (Alnylam/the Medicines Company), which suppresses PCSK9 synthesis in the liver, can dramatically lower LDL cholesterol and may be suitable for injection every 6 months, suggest results of the phase 2 randomized ORION-1 trial. Such a dosing schedule would distinguish the potential dyslipidemia agent from the more familiar antibody-based PCSK9 inhibitors alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen), which are injected every few weeks. The ORION-1 trial was presented here by Dr Kausik K Ray (Imperial College London, UK), with simultaneous publication in the New England Journal of Medicine. The results support an interim analysis from the trial presented last year, which also showed that inclisiran injections were associated with long-lasting reductions in both PCSK9 and LDL-C.

Slide 9

Higher Leaflet-Thrombosis Risk With TAVR, DAPT Not Protective

Registry data suggest that the frequency and severity of subclinical leaflet thrombosis is greater with transcatheter (TAVR) than surgical (SAVR) aortic valves and that oral anticoagulation but not dual antiplatelet therapy (DAPT) is protective. Among 890 patients with interpretable 4D computed tomography scans, subclinical leaflet thrombosis was present in 3.6% of 138 patients treated with SAVR and 13.4% of 752 patients treated with TAVR. It was observed in 14.9% of patients on DAPT compared with 3.6% on oral anticoagulation (P<0.0001). Rates of transient ischemic attack (5.7% vs 0.9%; P=0.0005) and composite stroke or TIA (10.4% vs 3.4%; P=0.001) were higher in patients with leaflet thrombosis. Senior author Dr Raj Makkar (Cedars-Sinai Medical Center, Los Angeles, CA) stressed that the findings do not prove causality, only an association, and that further evaluation is needed in randomized, controlled trials.

Slide 10

PCSK9 Inhibitor Access Snarled in Red Tape, Rejections

In the first year after gaining US approval, more than half of prescriptions for the PCSK9 inhibitors alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen) were rejected and one in three were never picked up from the pharmacy, according to data on 45,029 patients in the Symphony Health Solutions database, which covers 90% of retail, 70% of specialty, and 60% of mail-order pharmacies in the US. Physicians are struggling with how to balance getting their patients on the therapies they need with how many resources they have in house, noted study presenter Dr Ann Marie Navar (Duke Clinical Research Institute, Durham, NC). A recent study estimated provider practices are spending 20 hours a week on prior authorizations. "As a cardiologist, it took me hours and hours and hours to try to get my first patient a PCSK9 inhibitor, and I still haven't succeeded for that particular patient, and it's really frustrating," said Navar.

Slide 11

Fewer Re-PCIs After Primary PCI Plus FFR-Guided Intervention

In the COMPARE-ACUTE trial of patients undergoing PCI for acute ST-elevation MI (STEMI), a strategy of further PCI beyond the infarct-related artery (IRA) guided by fractional flow reserve (FFR) assessments was associated with significant reductions in a composite clinical end point compared with IRA–only primary PCI. The benefit, seen for the composite of all-cause mortality, nonfatal MI, any revascularization, or cerebrovascular events at 12 months, appeared to be driven mainly by fewer repeat revascularizations in the FFR-guidance group, reported Dr Pieter C Smits (Maasstad Hospital, Rotterdam, the Netherlands). The study showed that "deferring treatment of angiographically significant coronary lesions in non–infarct-related arteries with an FFR >0.8 is safe and efficient," he said, but the study "was not powered to detect low-frequency events such as death, reinfarction, and stroke." The study was simultaneously published in the New England Journal of Medicine.

Slide 12

Meds Sans PCI Judged OK for CTO in Trial, Methods Questioned

In patients with chronic total occlusion (CTO) of a coronary artery, medical therapy was not inferior to PCI for the primary outcome of a composite of death, MI, stroke, or any revascularization at 3 years, in the prospective, randomized DECISION-CTO trial. Moreover, patients who had optimal medical therapy alone did not report worse angina or quality of life at 3 years than patients who underwent PCI of the completely occluded vessel. Optimal medical therapy could be a "reasonable" initial treatment strategy for coronary CTO compared with PCI, said study presenter Dr Seung-Jung Park (University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea). Findings from this first randomized trial comparing the two strategies for CTO in some ways conflict with those from observational studies that have favored CTO revascularization. The DECISION-CTO trial also had several methodologic limitations and weaknesses, some experts cautioned, and they called for more randomized controlled trials.

Slide 13

No Cognitive Impairment on Evolocumab in EBBINGHAUS Study

Taking the PCSK9 inhibitor evolocumab (Repatha, Amgen) on top of statins did not affect memory or cause other cognitive problems for up to 2 years in the EBBINGHAUS study, a substudy of the FOURIER outcomes trial. Including nearly 2000 FOURIER participants, the substudy showed no significant differences up to 19 months between those receiving subcutaneous injections of evolocumab 140 mg every other week or 420 mg monthly plus continued statin use and those on placebo, according to four cognitive functioning measures, a patient questionnaire, and physician reports. In exploratory analyses, cognitive function was also not affected by LDL-C status, even for those who had an end-of-study level of <25 mg/dL. "The findings should remove some concerns that patients have voiced, based on their looking up of 'Dr Google,'" said Dr Robert P Giugliano (Brigham and Women's Hospital), who presented the data.

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