TAVR UNLOAD—Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis

Studies have shown an association between moderate aortic stenosis (AS) and increased mortality, particularly in patients with heart failure with reduced ejection fraction (HFrEF). The TAVR UNLOAD trial compared transcatheter aortic valve replacement (TAVR) to guideline-directed medical therapy (GDMT) in patients with HFrEF and moderate AS.

DCB-BIF Trial—Comparison of Noncompliant Balloon With Drug-Coated Balloon Angioplasty for Side Branch Stenosis After Provisional Stenting for Patients With True Coronary Bifurcation Lesions

One of the main challenges of bifurcation stenting using a provisional approach is the management of the side branch lesion. This DCB-BIF trial evaluated the efficacy of drug-coated balloon angioplasty vs. noncompliant balloon (NCB) angioplasty for management of the stenotic side branch after provisional stenting in patients with simple true coronary bifurcations. 

HELP PCI Trial—Early Administration of Heparin at First Medical Contact Versus in the Cathlab for STEMI Patients Undergoing Primary Percutaneous Coronary Intervention

Achieving early restoration of blood flow in the infarct-related artery (IRA) is critical to attenuating myocardial injury and improving the prognosis in ST-segment elevation myocardial infarction (STEMI) patients. The HELP PCI trial evaluated the effect of the administration of unfractionated heparin (UFH) at first medical contact versus in the cath lab in STEMI patients. 

EARLY TAVR Trial—Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

Untreated severe aortic stenosis is associated with increased mortality and reduced quality of life. Limited data involving several small trials have demonstrated improved outcomes in surgical aortic valve replacement (SAVR) in asymptomatic patients with severe aortic stenosis. Currently, no such data exist for transcatheter aortic valve replacement (TAVR) in asymptomatic, severe aortic stenosis. EARLY TAVR is the first prospective, multicenter, randomized, controlled trial to challenge current approaches to guideline management of asymptomatic, severe aortic stenosis with use of early TAVR. 

PEERLESS Trial—Large-Bore Mechanical Thrombectomy vs. Catheter-Directed Thrombolysis for Treatment of Intermediate-Risk Pulmonary Embolism

The management of pulmonary embolism has changed with new and multiple catheter-based options. It is unknown if large-bore mechanical thrombectomy (LBMT) vs. catheter-directed thrombolysis (CDT) in the treatment of intermediate-high risk pulmonary embolism (PE) is effective and safe. The PEERLESS trial compared the efficacy and safety of LBMT with CDT in treating intermediate-high-risk PE. 

ECLIPSE Trial—A Large-Scale, Randomized Trial of Orbital Atherectomy vs. Conventional Balloon Angioplasty in Severely Calcified Coronary Arteries Prior to DES Implantation

Patients with severely calcified lesions require proper lesion preparation to improve procedural success. It is unknown whether routine atherectomy before percutaneous coronary intervention (PCI) will improve patient outcomes. The ECLIPSE trial evaluated orbital atherectomy before drug-eluting stent (DES) implantation compared with conventional PCI without atherectomy among patients with calcified coronary lesions.