Ablation for Atrial Fibrillation Combined With Left Atrial Appendage Closure.

OBJECTIVES: The study sought to determine long-term clinical effects of combining catheter ablation (CA) and left atrial appendage (LAA) occlusion (LAAO) in a single procedure. BACKGROUND: CA relieves symptoms in atrial fibrillation (AF), but freedom from AF is not assured. Thus, oral anticoagulation (OAC) remains necessary in high stroke risk patients. LAAO has proved a viable alternative for preventing thromboembolic complications. METHODS: Symptomatic patients with drug-refractory AF (CHADS2 ≥1) and indications for LAAO were included. Transesophageal echocardiography was performed to assess LAA size/anatomy/thrombus. After CA, LAAO was performed using the Watchman device (Atritech, Inc., Plymouth, Minnesota, Minnesota). At 3 months, OAC was switched to aspirin/clopidogrel if LAAO criteria were met. RESULTS: From September 2009 to October 2013, 62 patients (22 female, 64 ± 8 years of age, CHADS2 2.5) underwent combined procedures. Indications for LAAO included history of stroke despite OAC (29.0%), contraindications for OAC (24.2%), high stroke risk (24.2%), and miscellaneous reasons (22.6%). LAAO resulted in complete acute closure in all, with a median number of 1 device. After a median follow-up of 38 (range: 25 to 45) months, 95% of the patients met the criteria for successful sealing and 78% could discontinue OAC, while recurrence of AF was documented in 42%. During long-term follow-up, 3 ischemic strokes were observed with an annual stroke risk of 1.7%, which is lower than the expected annual risk of 6.5%. CONCLUSIONS: LAAO combined with CA for AF can be performed successfully and safely in a single procedure, with a lower than expected stroke rate. Further studies are necessary to determine which patients benefit most from the combined therapy.

A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study.

BACKGROUND: Percutaneous recanalization of total coronary occlusion (TCO) was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST) with drug-eluting stents (DES) for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO. METHODS/DESIGN: The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany) compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA) in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence tomography is performed in the first 60 randomized patients at 9 months to assess neointima thickness, percentage of neointima coverage, and stent strut malapposition and coverage. Personnel blinded to the allocated treatment will review all angiographic and optical coherence assessments. Secondary clinical endpoints include major adverse cardiac events, clinically driven target vessel revascularization, target vessel failure and stent thrombosis to 5-year clinical follow-up. An independent clinical event committee blinded to the allocated treatment will review all clinical events. TRIAL REGISTRATION: Clinical Trials.gov: NCT01516723. Patient recruitment started in February 2012.

Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions.

BACKGROUND: Sirolimus-eluting stents markedly reduce the risk of restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions. METHODS AND RESULTS: In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n = 100) were randomly assigned to receive bare metal BxVelocity stents and half (n = 100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment restenosis rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent restenosis rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary restenosis rate of 7% compared with 36% in the bare metal stent group (P < 0.001). The in-segment binary restenosis rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P < 0.0001), resulting in a target lesion revascularization rate of 4% in the sirolimus group versus 19% in the bare metal group (P < 0.001). Patients who received the drug-eluting stent also had significantly lower rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events. CONCLUSIONS: In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary restenosis, resulting in significantly less need for target lesion and target vessel revascularization.