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Background/purpose: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms., Methods/materials: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤28 mm long; diameter ≥2.25 mm to ≤4.50mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure., Results: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p<0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months., Conclusions: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: The primary aim of this study was to prospectively evaluate the safety and efficacy of Excimer laser atherectomy as a primary treatment strategy in consecutively eligible patients presenting for percutaneous coronary intervention (PCI) of degenerated saphenous vein graft (SVG) lesions using a multicenter registry. Prior single-center experience suggested that laser atherectomy may decrease acute procedural complications during treatment of degenerated SVGs, including lesions not amenable to distal protection devices (DPDs)., Methods and Materials: The COronary graft Results following Atherectomy with Laser investigators enrolled 98 patients at 18 centers between June 23, 2003, and October 4, 2004, with greater than 50% stenosis of an SVG who presented for PCI due to angina pectoris or objective evidence of myocardial ischemia in a concordant myocardial distribution. Laser atherectomy was planned. Patients were excluded if the operator planned to utilize a DPD. Inclusion and exclusion criteria were aligned to those in the Saphenous vein graft Angioplasty Free of Emboli Randomized (SAFER) trial., Results: The primary end point [30-day major adverse cardiac events (MACE)] occurred in 18/98 (18.4%) patients driven primarily by non-q-wave myocardial infarction. Major procedural complications included no reflow (n=5) and major dissection (n=1). No perforations occurred. Univariate predictors of 30-day MACE included lesion length, vessel angulation, plaque burden, SVG degeneracy score, number of laser pulses used, and larger-sized laser catheters., Conclusions: This study demonstrated that Excimer laser atherectomy of diseased SVGs is feasible with results comparable to the 30-day MACE in the control population from the SAFER trial. Whether the addition of laser to embolic protection devices is of any clinical utility remains to be tested in future studies., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Arterial puncture closure devices have improved time to hemostasis and ambulation after percutaneous coronary intervention (PCI) relative to traditional manual compression, though complication rates for both methods leave room for improvement. In a pilot registry, the authors evaluated a topical hemostatic dressing containing poly-N-acetyl glucosamine (p-GlcNAc) post PCI in fully anticoagulated patients., Methods and Results: In 100 patients undergoing PCI via the common femoral artery in the short-stay unit, the p-GlcNAc hemostatic dressing was applied with 15 minutes of manual compression at arterial access sites after arterial sheath removal. Procedural antiplatelet and anticoagulation therapies were aspirin, clopidogrel and bivalirudin. Patients were observed during 2 hours of bed rest and attempted to ambulate 2 hours post hemostasis. Effectiveness was assessed based on times to hemostasis and ambulation. Data were stratified by time elapsed since bivalirudin bolus or discontinuation of infusion (30 minutes, > 30-60 minutes, > 60 minutes). Mean time to hemostasis was 15.5 minutes. Mean time from hemostasis to ambulation was 2.08 hours; 87% of patients ambulated at 2 hours. Sheaths were removed at a mean 40.38 minutes after discontinuing bivalirudin. Anticoagulation status (as assessed by time since discontinuation of bivalirudin) did not influence time to hemostasis or ambulation. There was a single major complication (pseudoaneurysm), two minor rebleeds requiring additional manual compression, and 1 hematoma > 5 cm., Conclusions: This p-GlcNAc topical hemostatic dressing safely achieved hemostasis at arterial access sites and early ambulation, even with nearly immediate sheath removal after PCI with systemic anticoagulation using bivalirudin.