Rank in order (top to bottom) the following trials reported in 2018 that have or will have the greatest impact on your practice.
NOTION (Nordic Aortic Valve Intervention). In patients with severe degenerative aortic stenosis with a low STS PROM score, CoreValve transcatheter aortic valve replacement (TAVR) has similar 1-year clinical outcomes compared with surgical aortic valve replacement. However, TAVR was associated with more aortic regurgitation, a lower symptomatic benefit, and a higher need for a permanent pacemaker.
ANNEXA-4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding). Andexanet was associated with serious bleeding control in patients taking Xa inhibitors.
RADIANCE-HTN SOLO (A Study of the ReCor Medical Paradise System in Clinical Hypertension) and SPYRAL HTN-ON MED (Investigation of Catheter-Based Renal Denervation in Patients With Uncontrolled Hypertension in the Presence of Antihypertensive Medications). These trials confirm the short-term hypertension treatment efficacy for renal denervation and support the potential re-emergence of ablation as a treatment technique.
PRESERVE (Prevention of Serious Adverse Events Following Angiography) Subgroup Analysis: Strategies to Reduce Acute Kidney Injury and Improve Clinical Outcomes After Percutaneous Coronary Intervention. Sodium bicarbonate and n-acetylcysteine failed to show benefit in preventing contrast-related kidney damage in percutaneous coronary intervention (PCI) in patients with pre-existing renal risk.
CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) 1-Year Results. Culprit-only PCI in acute myocardial infarction (MI) and shock persisted as showing less mortality and need for renal replacement therapy but with a greater late risk of revascularization and hospitalization for heart failure (HF).
COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). Transcatheter mitral valve repair with MitraClip (Abbott; Abbott Park, IL) on a background of maximally tolerated guideline-directed medical therapy was superior to guideline-directed medical therapy alone in reducing HF hospitalization and mortality in symptomatic HF patients with 3-4+ mitral regurgitation.
VERDICT (Very Early vs Deferred Invasive Evaluation Using Computerized Tomography). This trial demonstrated that early invasive therapy was associated with outcomes similar to delayed invasive therapy except in higher-risk patients (GRACE Score >140).
SCOT-HEART (Scottish Computed Tomography of the HEART). Coronary computed tomography angiography leads to a reduction in 5-year coronary heart disease death or non-fatal MI. There was greater invasive coronary angiography and coronary revascularization early, but lower rates were evident at 1 year.
DTU (Mechanically Unloading the LV and Delaying Reperfusion in Patients With Anterior STEMI). This exploratory trial for unloading with a 30-minute delay prior to reperfusion with acute MI to improve myocardial salvage demonstrated safety and feasibility as background for a definitive trial.
FREEDOM Follow-On Study (Long-term Survival following Multivessel Revascularization in Patients with Diabetes). This study showing 5-year outcomes of the FREEDOM trial showed continued better outcomes for coronary artery bypass graft surgery in the patients with diabetes mellitus.