2018: Cardiology News at A Glance Most important trials published in 2018

COAPT trial

This prospective, multicenter, open-label, randomized trial aimed to assess the use of transcatheter mitral valve repair in heart failure (HF) patients with mitral regurgitation due to left ventricular dysfunction. A total of 614 patients were randomized to either receiving guideline-directed medical therapy (GDMT) alone or GDMT in addition to transcatheter mitral-valve repair. The primary efficacy endpoint was all hospitalizations due to heart failure at 24 months of follow-up, while the primary safety endpoint was freedom from device-related complications at 12 months of follow-up. The study showed that the device group had a lower risk of hospitalization for HF (HR 0.53, 95% CI 0.4-0.7) and all-cause mortality (HR 0.62, 95% CI 0.46-0.82) at 24 months. Moreover, the rate of freedom from device complications at 12 months was 96.6% which exceeded the prespecified safety threshold. Continue reading

Mechanistic Study Delves Into Heart Failure Benefits Noted With Empagliflozin EMPA-HEART Cardiolink-6 - EMPA-HEART

The EMPA-HEART trial showed that empagliflozin resulted in beneficial effects on left ventricular remodeling at 6 months among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD) but normal ejection fraction and without a clear heart failure history. The findings were presented by Dr. Subodh Verma at the American Heart Association Annual Scientific Sessions (AHA 2018) in Chicago, Illinois. Continue reading

Dapaglifozin ‘DECLARED’ Effective in the Reduction of Heart Failure Hospitalizations in Diabetic Population DECLARE-TIMI 58: Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes

The DECLARE–TIMI 58 trial, published in the New England Journal of Medicine and presented at AHA 2018 showed that in patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin was non-inferior for reduction of MACE as compared to placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure. Continue reading

Fish Oil or Vitamin D Supplementation as Protection Against Cardiovascular Events or Cancer Suffers Deteriorating ‘VITAL’ Signs  AHA 2018: Vitamin D and Omega-3 Trial (VITAL)

The VITAL trial conducted by Manson et al. showed that supplementation with either n–3 fatty acids at a dose of 1 g/day or vitamin D3 at a dose of 2000 IU/day was not effective for primary prevention of cardiovascular or cancer events among healthy middle-aged men and women over 5 years of follow-up. The results were reported on Saturday at the American Heart Association Scientific Sessions meeting in Chicago and online in the New England Journal of Medicine. Continue reading

The Latest Incarnation of the Blood Cholesterol Management Guideline 2018: Numbers Matter, Lower LDL-C is better A Special Report From the American Heart Association and American College of Cardiology

The AHA/ACC 2018 guideline on the management of blood cholesterol, endorsed by at least 10 other medical societies, was published online in the Journal of the American College of Cardiology and in Circulation to coincide with its grand unveiling at the American Heart Association (AHA) Scientific Sessions 2018 in Chicago, Illinois.  Continue reading

Type 2 Diabetes: SGLT2 Inhibitors Demonstrate Robust Benefits on Cardiovascular and Renal Outcomes SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials

The results of a study presented at AHA 2018 have shown that SGLT2 inhibitors (SGLT2i ) have robust benefits on the reduction of hospitalization for heart failure (HF) and progression of renal disease regardless of existing atherosclerotic cardiovascular disease (ASCVD) or a history of HF. The findings were published online in The Lancet. Continue reading

Periprocedural loading dose of Atorvastatin reduces MACE in patients with ACS undergoing PCI: Is this a Pleiotropic effect? Timing of Loading Dose of Atorvastatin in Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes: Insights From the SECURE-PCI Randomized Clinical Trial

A study by Lopes and his colleagues published in JAMA Cardiology has shown that in patients with ACS undergoing PCI, periprocedural loading doses of atorvastatin appeared to reduce the rate of Major Adverse Cardiovascular Events (MACE) at 30 days, primarily in patients with ST-segment elevation myocardial infarction. Insights from the Statins Evaluation in Coronary Procedures and Revascularization (SECURE-PCI) randomized clinical trial showcased this beneficial effect to be preserved and consistent, regardless of the timing of atorvastatin administration, including within 2 hours before PCI. Continue reading

Vascular Video Series Part 9: AHA’s Goal for Reducing Cardiovascular Death by 20% in 2020 Dr. Libby, Dr. Bonaca, and Dr. Gibson Discuss

This video is supported by an unrestricted educational grant.

Portico TAVR study demonstrates low rates of stroke, death at 1 year One-Year Outcomes with a Self-Expanding, Repositionable Transcatheter Heart Valve in Severe Aortic Stenosis Patients: PORTICO-I

Results from the Portico 1 study were presented during a late-breaking session at the Transcatheter Cardiovascular Therapeutics conference in San Diego showing that transcatheter aortic valve replacement (TAVR) with the new transcatheter heart valve (THV) in patients at increased surgical risk is associated with low 1-year mortality and stroke rates. In the study, favorable hemodynamic results at 1 year were observed with low transvalvular pressure gradient and incidence of significant Paravalvular leakage (PVL).   The results were also published online in the Journal of American College of Cardiology. Continue reading

Pulmonary Artery Denervation Improves Pulmonary HTN in Heart Failure Pulmonary Artery Denervation Significantly Increases 6-minute Walk Distance for Patients with Combined Pre- and Post-capillary Pulmonary Hypertension Associated with the Left Heart Failure: PADN-5 Study

The findings of the Pulmonary artery denervation (PADN) trial, presented at the TCT conference on Sept 23rd have shown that PADN is associated with significant improvements in hemodynamic and clinical outcomes including 6-minute walk distance (6MWD) and pulmonary vascular resistance (PVR) in patients with combined pre- and post-capillary pulmonary hypertension CpcPH. The results of this study were simultaneously published in JACC: Interventions. Continue reading

Tiered Approach for Management of Angina Patients With No Obstructive CAD Shows Benefit TCT 2018: Stratified Medical Therapy Using Invasive Coronary Function Testing In Angina, CorMicA Trial

For angina patients without obstructive coronary artery disease (CAD), adjunctive testing of coronary vascular function during coronary angiography followed by medical therapy targeted to the findings improved angina outcomes, according to the CorMicA trial. In the study published in the Journal of the American College of Cardiology, a tiered approach for assessment for microvascular and/or vasospastic angina among patients with stable angina and no evidence of significant epicardial disease was deemed superior to usual care. Continue reading

‘Rota Regret’ Makes Training in High-Speed Rotablation A Necessity, for Interventionalists Dealing with Heavily Calcified Coronary Lesions High-Speed Rotational Atherectomy Versus Modified Balloons Before Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions: The Randomized PREPARE-CALC Trial. 

The results of PREPARE-CALC trial, presented at TCT 2018, have shown that among patients with severely calcified coronary lesions, the routine use of upfront high-speed rotational atherectomy (RA) increases stent deliverability compared with the use of balloon modification techniques such as scoring or cutting balloons (MB), with similar rates of angiographic late lumen loss and other clinical outcomes at 9 months. In his presentation in San Diego, the author, Dr. Gert Richardt emphasized that a strategy of provisional MB remained feasible, safe, and effective as long as bailout RA was readily available and offered the advantages of compatibility with smaller sized catheters and less irradiation. Continue reading

Encouraging Outcomes in ABSORB IV Pave the Way for Polymeric Coronary Bioresorbable Vascular Scaffolds Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial

In the long saga of ABSORB trials, the ABSORB IV trial presented at the TCT conference 2018 showed that polymeric coronary bioresorbable vascular scaffolds (BVS) were non-inferior to cobalt-chromium-based Xience DES for cardiovascular outcomes of target lesion failure and angina in fairly simple lesion types, with lower acute procedural success in a 1 year period. The results for this trial were published today in The Lancet. Continue reading

Optimal IVUS Guidance for Stent Placement: A Clear Winner? Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers: The ULTIMATE trial

The results of the ULTIMATE trial, presented at the TCT conference 2018, have shown that IVUS-guided PCI is superior to angiography-guided PCI in the prevention of target vessel failure in an all-comers population. The study findings have been simultaneously published in the Journal of the American College of Cardiology. Continue reading

How Accurate is the Fractional Flow Reserve Derived From Routine Coronary Angiography? Results from TCT 2018, FAST-FFR study: Accuracy of Fractional Flow Reserve Derived From Coronary Angiography

The FAST-FFR study conducted by Fearon and his colleagues, and presented at the annual TCT conference 2018, has shown that Fractional Flow Reserve (FFRangio) measured from the coronary angiogram alone has a high sensitivity, specificity and accuracy compared with pressure-wire derived Fractional Flow Reserve (FFR). The results of this study were published ahead of print in Circulation. Continue reading

Tricuspid Edge-to-Edge Valve Repair Safe in Patients with Torrential Tricuspid Regurgitation TCT 2018: Results from the TriValve Registry

Results from a subgroup analysis of the TriValve Registry presented at TCT 2018 showed that interventional tricuspid edge-to-edge valve repair was safe with improvement in outcomes in patients, with high procedural success rates. Continue reading

Corevalve Evolut R (Medtronic) and Edwards Sapien 3 (Edward Lifesciences) Valves Reveal Equivalence in Transcatheter Aortic Valve Implantation (TAVI) in a Head-to-Head Comparison Results From The SOLVE-TAVI Trial Presented at the 30th Annual 2018 TCT Conference

Results from an open-label, multi-center, 2×2 factorial design randomized trial powered for equivalence, comparing the self-expanding Corevalve Evolut R valve to balloon expandable Edwards Sapien 3 valve, have shown that the two valves were equivalent to each other in terms of decreasing all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation (p=0.02). Trial results presented at the 2018 TCTMD conference held at San Diego, California, also showed equivalence in a comparison between general anesthesia vs local anesthesia (with conscious sedation) in terms of decreasing all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury (p=0.02). Continue reading

Landmark COAPT trial Demonstrates the Benefit of Transcatheter Mitral-Valve Repair Using MitraClip in Patients with Heart Failure TCT 2018: Findings of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial

The spectacular results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial, presented at TCT 2018, show that transcatheter mitral valve approximation using the MitraClip, on a background of maximally tolerated guideline-directed medical therapy (GDMT) was superior to GDMT alone in the reduction of Heart Failure (HF) hospitalization and mortality in symptomatic HF patients with grade 3-4+ Mitral regurgitation (MR). These landmark findings were simultaneously published today in the New England Journal of Medicine. Continue reading

Polymer-Free Amphilimus-Eluting stents: A Novel Elution Technology Results of the ReCre8 study, TCT 2018

Polymer-free amphilimus-eluting stents (PF-AES) are non-inferior to permanent-polymer zotarolimus-eluting stents (PP-ZES) in terms of target-lesion failure at 12 months, according to the results of the ReCre8 study, presented by Pieter R. Stella, MD, Ph.D. (University Medical Center, Utrecht, the Netherlands) at TCT 2018. The results for the first RCT comparing PF-AES versus latest generation PP ZES in an all-comers PCI population were simultaneously published in Circulation. Continue reading

Polymer coated sustained-release Eluvia DES outshines non-polymer coated Zilver DES for femoropopliteal artery stenosis Clinical outcomes at 1 year presented at TCTMD 2018

A randomized global, prospective, multi-center, single-blind trial comparing the Eluvia paclitaxel-eluting stent (Boston Scientific) to  Zilver PTX paclitaxel-eluting stent (Cook Medical) has shown that the Eluvia stent outperformed Zilver in terms of efficacy, which was defined as primary patency at 12 months. These findings, published in The Lancet, were presented by Dr. William Gray at the annual TCT 2018 conference held in San Diego today. Continue reading