The last results of the SORT OUT V submitted in PCR 2012 showed that biolimus eluting stent with biodegradable polymer was not able to reach the non-inferiority versus sirolimus eluting stent with permanent polymer. Results to 3 years are now available, and the new device reached the non-inferiority with a MACE rate of 11.2% for...
APPOSITION IV: self-expanding DES in acute coronary syndrome
This study was designed to compare the apposition and neointimal coverage of struts by optical coherence tomography (OCT) of the new self-expanding sirolimus eluting stent (STENTYS SES) at 4 and 9 months in patients with STE-ACS. 152 patients randomized to STENTYS SES (n = 90) versus zotarolimus-eluting balloon-expandable stent (n = 62) were included. The...
HEAT PPCI: Bivalirudin raises major cardiac events and does not reduce bleeding. The most controversial and criticized study at the ACC 14.
This randomized trial of a single center with consent obtained after randomization compared the use of bivalirudin versus heparin with the use of glycoprotein inhibitors arescue only in patients having ST segment elevation myocardial infarction.The primary efficacy endpoint was a composite of death, stroke, and myocardial revascularization of the target lesion and the primary safety...
American Registry for percutaneous aortic valve replacement,one-year evolution of nearly 6000 patients
TVT STS / ACC registrywas developed to obtain data from all patients undergoing percutaneous aortic valve replacement (TAVR) in the United States. The clinical outcome at 30 days was recently published (Macket al, JAMA 2013) but there are few data on the longer-term treatment that is already incorporated in clinical practice in the United States.The...
ALECARDIO Trial: Aleglitazar associated with severe adverse events in diabetic patients with acute coronary syndrome
This randomized, double-blind, placebo-controlled, multicenter work evaluated the potential cardiovascular reduction risk and the long-term safety profile of Aleglitazar, compared with placebo in patients with type 2 diabetes experiencing an acute coronary syndrome. A total of 7226 patients were randomized at 12 weeks post-acute coronary event to receive Aleglitazar 150 ug or placebo. The study...
CoreValve superior to surgical aortic valve replacement in high-risk patients
The aim of this study was to compare percutaneous aortic valve replacement (TAVR) with the self-expanding Valve Core with conventional surgery in patients at high surgical risk. Patients with a valve area < 0.8 cm2 , valvular index ≤ 0.5 cm2 , a mean gradient of > 40 mmHg or peak speeds above 4m /s...
STABILITY Trial: Daraplabid no benefits in chronic coronary artery disease
Daraplabid is a selective oral inhibitor of lipoprotein-associated phospholipase (Lp -PLA2)which is a potential agent for reducing cardiovascular events in patients with chronic ischemic heart disease.Lp-PLA2 is an enzyme found in the blood andatherosclerotic plaques and high levels are associated with an increased risk of cardiovascular events.Direct inhibition of this enzyme with proinflammatory Daraplabid may...
TOPCAT: Spironolactone in heart failure with preserved ejection fraction
The aldosterone blockade has shown benefit in the treatment of heart failure with systolic dysfunction after stroke. The aim of this study was to evaluate the effect of spironolactone in patients with preserved ejection fraction. This was a multicenter, randomized study that included 1722 patients in the spironolactone group and 1723 in the placebo group....
VISTA 16: anti-inflammatory agent in acute coronary syndromes
There is evidence that inflammation would have an impact on the prognosis of patients experiencing acute coronary syndromes. The phospholipase A2 inhibitor Varespladib has positive effects on lipid and inflammatory markers. This double-blind, multicenter planned to randomize 5145 patients with acute coronary syndrome to Varespladib or placebo. The primary endpoint was a combination of cardiovascular...
CORAL: Angioplasty versus medical treatment of renal artery stenosis
Atherosclerotic stenosis of the renal artery is common in the elderly population. Previous clinical trials showed no benefit with angioplasty in relation to renal function but their use for preventing cardiovascular events was still uncertain. A total of 947 patients with atherosclerotic renal artery and systolic hypertension (need two or more drugs) or renal dysfunction...