NOAC in "real world" patients with atrial fibrillation in Italy: results from the ISPAF-2 (Indagine Sicoa Paziente Con Fibrillazione Atriale) survey study.

In the past few years, new oral anticoagulants (NOACs) targeting directly a single activated clotting factor, have been developed for the treatment of non-valvular atrial fibrillation (AF), which are currently recommended as first-line therapy in AF. The aim of this study is to provide an overall picture on the extent to which oral anticoagulation (OAC) with NOACs correspond to actually prescribed OAC therapy in an unselected, real world, population of consecutive patients with AF in Italy. Compliance with the therapy and quality of life were also assessed.

RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation.

Aims: We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI).

Methods And Results: Forty-eight consecutive patients with chronic kidney disease (CKD) scheduled for TAVI were assigned to: 1) hydration with sodium bicarbonate solution (Control group), or 2) hydration with RenalGuard Therapy (RenalGuard group). Hypotension was defined as periprocedural mean blood pressure <55 mmHg.

Novel approaches for preventing or limiting events (Naples) III trial: randomized comparison of bivalirudin versus unfractionated heparin in patients at increased risk of bleeding undergoing transfemoral elective coronary stenting.

Objectives: This study sought to assess the safety and the efficacy of bivalirudin compared with unfractionated heparin (UFH) alone in the subset of patients at increased risk of bleeding undergoing transfemoral elective percutaneous coronary intervention (PCI).

Background: Bivalirudin, a synthetic direct thrombin inhibitor, determines a significant decrease of in-hospital bleeding following PCI.

Methods: This is a single-center, investigator-initiated, randomized, double-blind, controlled trial.

Impact of a high loading dose of atorvastatin on contrast-induced acute kidney injury.

Background: The role of statins in the prevention of contrast-induced acute kidney injury (CIAKI) is controversial.

Methods And Results: First, we investigated the in vivo effects of atorvastatin on CIAKI. Patients with chronic kidney disease enrolled in the Novel Approaches for Preventing or Limiting Events (NAPLES) II trial were randomly assigned to (1) the atorvastatin group (80 mg within 24 hours before contrast media [CM] exposure; n=202) or (2) the control group (n=208).

Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II): RenalGuard System in high-risk patients for contrast-induced acute kidney injury.

Background: The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury.

Methods And Results: The Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) trial is a randomized, multicenter, investigator-driven trial addressing the prevention of contrast-induced acute kidney injury in high-risk patients. Patients with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.

Renal insufficiency following contrast media administration trial II (REMEDIAL II): RenalGuard system in high-risk patients for contrast-induced acute kidney injury: rationale and design.

Aims: The combined prophylactic strategy of sodium bicarbonate plus N-acetylsyteine (NAC) seems to be effective in preventing contrast induced acute kidney injury (CI-AKI) in patients at low-to-medium risk. However, in patients at high and very high risk the rate of CI-AKI is still high. In this subset of patients the anticipated advantages of the RenalGuard(tm) System should be investigated.

Novel approaches for preventing or limiting events in diabetic patients (Naples-diabetes) trial: a randomized comparison of 3 drug-eluting stents in diabetic patients.

Background: To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients.

Methods And Results: Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed.

Cystatin C and contrast-induced acute kidney injury.

Background: Cystatin C (CyC) is more sensitive than serum creatinine (sCr) to rapidly detect acute changes in renal function.

Methods And Results: We measured CyC together with sCr in 410 consecutive patients with chronic kidney disease undergoing either coronary and/or peripheral angiography and/or angioplasty. sCr was assessed at baseline and 24 and 48 hours after contrast media exposure.

Novel approaches for preventing or limiting events (Naples) II trial: impact of a single high loading dose of atorvastatin on periprocedural myocardial infarction.

Objectives: Atorvastatin administered at least 7 days before the percutaneous coronary intervention (PCI) reduces the rate of periprocedural myocardial infarction (MI). It is unknown whether a single, high (80 mg) loading dose of atorvastatin may reduce the rate of periprocedural MI.

Background: Periprocedural MI is a prognostically important complication of PCI.

Comparison of coronary drug-eluting stents versus coronary artery bypass grafting in patients with diabetes mellitus.

We compared 1-year outcome after drug-eluting stent (DES) implantation with off-pump bypass grafing (OPCABG) in patients with type 2 diabetes mellitus and multivessel coronary artery disease involving the proximal segment of the left anterior descending coronary artery. All consecutive diabetic patients treated by DES (DES group) or OPCABG (CABG group) in our institution from April 2002 to December 2004 because of de novo coronary lesions were included. Patients in the CABG group (n = 149) were older and had a higher rate of 3-vessel disease than those in the DES group (n = 69).

Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies.

Background: Volume supplementation by saline infusion combined with N-acetylcysteine (NAC) represents an effective strategy to prevent contrast agent-induced nephrotoxicity (CIN). Preliminary data support the concept that sodium bicarbonate and ascorbic acid also may be effective in preventing CIN.

Methods And Results: Three hundred twenty-six consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, were randomly assigned to prophylactic administration of 0.

Gadolinium-based contrast agents and nephrotoxicity in patients undergoing coronary artery procedures.

Objective: We tested whether gadolinium-based contrast agent is less nephrotoxic than iodinated-contrast media.

Background: Iodinated contrast agents are nephrotoxic. Some data suggest that gadolinium-based contrast agent may be less nephrotoxic than iodinated-contrast media.

Nephrotoxicity of low-osmolality versus iso-osmolality contrast agents: impact of N-acetylcysteine.

Background: Recent data support that iodixanol, an iso-osmolality contrast agent, is less nephrotoxic than low-osmolality contrast agents when hydration is the only prophylactic strategy used. We evaluated the nephrotoxicity of iso- and low-osmolality contrast agents with prophylactic administration of N-acetylcysteine (NAC) along with hydration.

Methods: Two hundred and twenty-five patients with chronic renal insufficiency (serum creatinine >1.

Sirolimus-eluting stent implantation in diabetic patients with multivessel coronary artery disease.

Background: Restenosis rate is lower after sirolimus-eluting stent (SES) implantation than after bare metal stent (BS) implantation. We evaluated the impact of SES implantation on immediate and 12-month outcome in diabetic patients with multivessel coronary artery disease (MVD).

Methods: From April 2002 to September 2003, 100 consecutive diabetic patients with MVD without previous myocardial revascularization underwent successful elective percutaneous coronary intervention (PCI) with SES on native coronary arteries at our institutions.

Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction.

Aims: Peri-procedural non-Q-wave myocardial infarction is a frequent and prognostically important complication of percutaneous coronary intervention (PCI). It has been postulated that statins may reduce the rate of myocardial injury after PCI.

Methods And Results: Four hundred and fifty-one patients scheduled for elective PCI and not on statins were randomly assigned to either no treatment or to statin treatment.

N-Acetylcysteine versus fenoldopam mesylate to prevent contrast agent-associated nephrotoxicity.

Objectives: We performed a study to assess the efficacy of fenoldopam mesylate (a specific agonist of the dopamine-1 receptor) as compared with N-acetylcysteine (NAC) in preventing contrast agent-associated nephrotoxicity (CAN).

Background: Prophylactic administration of NAC, along with hydration, prevents CAN in patients with chronic renal insufficiency who are undergoing contrast media administration. Preliminary data support the hypothesis that fenoldopam might be as effective as NAC.

Standard vs double dose of N-acetylcysteine to prevent contrast agent associated nephrotoxicity.

Aims: Prophylactic administration of N-acetylcysteine (NAC) (600mg orally twice daily), along with hydration, prevents contrast agent-associated nephrotoxicity (CAN) induced by a low dose of non-ionic, low-osmolality contrast dye. We tested whether a double dose of NAC is more effective to prevent CAN.

Methods And Results: Two-hundred-twenty-four consecutive patients with chronic renal insufficiency (creatinine level > or =1.

Acetylcysteine and contrast agent-associated nephrotoxicity.

Objectives: Prophylactic acetylcysteine along with hydration seems to be better than hydration alone in preventing the reduction in renal function induced by a contrast dye.

Background: Contrast media can lead to acute renal failure that may occasionally require hemodialysis.

Methods: One hundred eighty-three consecutive patients with impairment of renal function, undergoing coronary and/or peripheral angiography and/or angioplasty, were randomly assigned to receive 0.