Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty - the Remedy Trial.

BACKGROUND: Periprocedural myocardial infarction (MI) is a frequent complication of percutaneous coronary intervention (PCI). Statins might reduce its incidence. The aims of the present study are to assess whether such benefit is a class-effect or whether differences exist between various lipid-lowering strategies and whether cardioprotection is exerted by increasing circulating endothelial progenitor cells (EPCs). METHODS: The REMEDY study will enroll a total of 1080 patients submitted to elective PCI. Eligible patients will be randomized into 4 groups: 1) placebo; 2) atorvastatin (80 mg + 40 mg before PCI); 3) rosuvastatin (40 mg twice before PCI); and 4) rosuvastatin (5 mg) and ezetimibe (10 mg) twice before PCI. Peri-procedural MI is defined as an elevation of markers of cardiac injury (either CK-MB or troponin I or T) values >5x the upper reference limit estimated at the 99th percentile of the normal distribution, or a rise >20 % in case of baseline values already elevated. EPCs will be assessed before, at 24 h and - in a subset of diabetic patients - at 3 months after PCI (EPC-substudies). The primary endpoint of the main REMEDY study is the rate of peri-procedural MI in each of the 4 treatment arms. Secondary endpoints are the combined occurrence of 1-month major adverse events (MACE, including death, MI, or the need for unplanned revascularization); and any post-procedural increase in serum creatinine. Endpoints of the EPC-substudies are the impact of tested regimens on 1) early (24-h) and 3-month EPC levels and functional activity; 2) stent strut re-endothelialization and neointimal hyperplasia; 3) 1-year MACE. REMEDY will add important information on the cardioprotective effects of statins after PCI.

Mini-Bentall: An Interesting Approach for Selected Patients.

OBJECTIVE: Minimally invasive surgery through an upper hemisternotomy for aortic valve replacement has become the routine approach with excellent results. Actually, the same minimally invasive access is used for complex ascending aorta procedures only in few centers. We report our experience with minimally invasive approach for aortic valve and ascending aorta replacement using Bentall technique. METHODS: From January 2010 to November 2015, a total of 238 patients received ascending aorta and aortic valve replacement using Bentall De Bono procedure at our institution. Low- and intermediate-risk patients underwent elective surgery with a minimally invasive approach. The "J"-shaped partial upper sternotomy was performed through a 6-cm skin incision from the notch to the third right intercostal space. Patients who had previous cardiac surgery or affected by active endocarditis were excluded. The study included 53 patients, 44 male (83 %) with a median age of 63 years [interquartile range (IQR), 51-73 years]. A bicuspid aortic valve was diagnosed in 27 patients (51%). RESULTS: A biological Bentall using a pericardial Mitroflow or Crown bioprosthesis implanted in a Valsalva graft was performed in 49 patents. The remaining four patients were treated with a traditional mechanical conduit. Median cardiopulmonary bypass time and median cross-clamp time were respectively 84 (IQR, 75-103) minutes and 73 (IQR, 64-89) minutes. Hospital mortality was zero as well as 30-day mortality. Median intensive care unit and hospital stay were 1.9 and 8 days, respectively. The study population compared with patients treated with standard full sternotomy and similar preoperative characteristics showed similar results in terms of postoperative outcomes with a slightly superiority of minimally invasive group mainly regarding operative times, incidence of atrial fibrillation, and postoperative ventilation times. CONCLUSIONS: A partial upper sternotomy is considered a safe option for aortic valve replacement. Our experience confirms that a minimally invasive approach using a partial upper J-shaped sternotomy can be a safe alternative approach to the standard in selected patients presenting with complex aortic root pathology.