Prior Stroke in PFO Patients Is Associated With Both PFO-Related and -Unrelated Factors.

Background and Purpose: To identify factors associated with prior stroke at presentation in patients with cryptogenic stroke (CS) and patent foramen ovale (PFO). Methods: We studied cross-sectional data from the International PFO Consortium Study (NCT00859885). Patients with first-ever stroke and those with prior stroke at baseline were analyzed for an association with PFO-related (right-to-left shunt at rest, atrial septal aneurysm, deep venous thrombosis, pulmonary embolism, and Valsalva maneuver) and PFO-unrelated factors (age, gender, BMI, hypertension, diabetes mellitus, hypercholesterolemia, smoking, migraine, coronary artery disease, aortic plaque). A multivariable analysis was used to adjust effect estimation for confounding, e.g., owing to the age-dependent definition of study groups in this cross-sectional study design. Results: We identified 635 patients with first-ever and 53 patients with prior stroke. Age, BMI, hypertension, diabetes mellitus, hypercholesterolemia, coronary artery disease, and right-to-left shunt (RLS) at rest were significantly associated with prior stroke. Using a pre-specified multivariable logistic regression model, age (Odds Ratio 1.06), BMI (OR 1.06), hypercholesterolemia (OR 1.90) and RLS at rest (OR 1.88) were strongly associated with prior stroke.Based on these factors, we developed a nomogram to illustrate the strength of the relation of individual factors to prior stroke. Conclusion: In patients with CS and PFO, the likelihood of prior stroke is associated with both, PFO-related and PFO-unrelated factors.

Incidence, predictors, and relevance of acute kidney injury in patients undergoing left atrial appendage closure with Amplatzer occluders: a multicentre observational study.

AIMS: Acute kidney injury (AKI) remains a frequent complication after cardiac interventions, such as left atrial appendage closure (LAAC), yet limited data are available on the incidence and clinical implication of AKI in this setting. We sought to assess incidence, predictors and relevance of AKI after LAAC. METHODS AND RESULTS: We retrospectively analyzed 95 LAAC patients in three European centers. AKI was defined according to the Acute Kidney Injury Network (AKIN) classification. The incidence of AKI was 13.7% with mild AKI in 92.3% and AKI stage > II in 7.7%. Total contrast volume was not linked to the occurrence of AKI (AKI: 127 ± 83 vs. no AKI: 109 ± 92 ml, p = 0.41), however increasing contrast volume (CV) to glomerular filtration rate (GFR) ratio (CV/GFR ratio) was associated with an increased risk of AKI (OR, per unit increase: 1.24, 95% CI 0.97-1.58, p = 0.08). ROC-analysis revealed a moderate predictive value of CV/GFR ratio for the prediction of AKI (AUC: 0.67, 95% CI 0.50-0.84, p = 0.05). Furthermore, AKI was associated with significantly increased mortality 6 months and 1 year after LAAC. No significant difference in the incidence of AKI was observed between patients with mere fluoroscopic and additional echocardiographic guidance (16.3% vs. 11.5%, p = 0.56). CONCLUSION: Whereas mild AKI is common in patients after LAAC, severe AKI is rare. AKI after LAAC is associated with poor baseline renal function, increased doses of contrast (CV/GFR ratio) and impaired outcome. Future studies will be needed to elaborate the benefit of reducing or avoiding contrast volume regarding this endpoint.

Left atrial appendage closure for "primary primary" prevention during percutaneous closure of septal defects in patients with large atria but no atrial fibrillation.

BACKGROUND: Percutaneous atrial septal defect (ASD) closure is a routine procedure to prevent right ventricular failure, pulmonary hypertension, or paradoxical embolism. The latter is the typical reason for percutaneous patent foramen ovale (PFO) closure. Atrial enlargement represents a risk for develop-ing atrial fibrillation (AF). Percutaneous left atrial appendage (LAA) closure is emerging as a preven-tive therapy for patients in AF who suffered from a previous stroke or bleeding (secondary prevention) or patients without previous stroke or bleeding (primary prevention). Percutaneous septal closure, particularly that of large ASDs, may inhibit future percutaneous left atrial access when required for LAA closure. Reported herein is the feasibility and safety of concomitant percutaneous closure of the LAA and a septal shunt, mostly large ASDs, in patients without AF, in the sense of "primary primary" preventive LAA closure. The first "primary" relates to "in anticipation of AF" and potentially also for "for prevention of AF". The second "primary" relates to "prevention of stroke or bleeding". METHODS: Thirteen consecutive patients, older than 40 years without any clinical or electrocardio-graphic evidence of AF, underwent percutaneous closure of large ASDs or PFOs in the presence of enlarged atria at the university hospitals of Bern and Zurich between April 2013 and June 2015. They concomitantly received "primary primary" preventive LAA closure after informed consent. RESULTS: Mean patient age was 58 ± 9 years (46% male). Procedural success was achieved in all pa-tients and no major adverse events occurred acutely or during the following 2.0 ± 0.8 years. No patient developed AF. CONCLUSIONS: Concomitant closure of ASD or PFO in the presence of enlarged atria and LAA for "primary primary" prevention appears feasible and safe but has yet to prove its justification.

No significant gender difference in hospitalizations for acute coronary syndrome in Switzerland over the time period of 2001 to 2010.

BACKGROUND: Morbidity and mortality from cardiovascular diseases have decreased since the 1970s in most Western societies. However, it is unclear if this positive trend can also be found in younger women suffering from acute coronary syndrome (ACS). METHODS: This is a prospective single center registry study including 11.015 women and men hospitalized for a first ACS between the years 2001 and 2010. We analyzed ACS rates according to sex and age group using Poisson regression in order to assess temporal trends. RESULTS: Overall ACS hospitalization rates per 100.000 inhabitants increased by 31% between 2001 and 2010 (Rate Ratio (RR) of 1.31, 95% CI 1.20-1.43; p<0.001) with a similar increase in men (RR 1.29, p<0.00001) and women (RR 1.35, p<0.0001). Analyses of age-specific ACS rates showed a significant increase in ACS hospitalization rates only for the age groups 70-79years (p=0.003) and 80+ years (p<0.00001). None of the age matched subgroups showed a sex related significant difference in trend for ACS hospitalization rates. Temporal trends for recorded risk factors showed a significant increase in smoking (p=0.03), and a trend to increased obesity prevalence (p=0.06) in females in the age group 60-69years. CONCLUSIONS: In contrast to other studies, we found no evidence for a particular increase in the number of younger women referred for a first ACS during the years 2001 and 2010. Potential negative effects of smoking and obesity on ACS incidence may be delayed to women older than 70years.

Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug.

OBJECTIVES: Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. METHODS: Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. RESULTS: Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients' mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). CONCLUSIONS: Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.

Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices.

OBJECTIVES: The aim of this study was to assess predictors of adverse 1-week outcomes and determine the effect of left atrial appendage (LAA) morphology following LAA closure (LAAC) with Amplatzer devices. BACKGROUND: Percutaneous LAAC is a valuable treatment option for stroke prevention in patients with atrial fibrillation. Determinants of procedural safety events with Amplatzer occluders are not well established, and the possibly interrelating effect of LAA anatomy is unknown. METHODS: Between 2009 and 2014, 500 consecutive patients with atrial fibrillation ineligible or at high risk for oral anticoagulation underwent LAAC using Amplatzer devices. Procedure- and device-related major adverse events (MAEs) were defined as the composite of death, stroke, major or life-threatening bleeding, serious pericardial effusion, device embolization, major access-site vascular complication, or need for cardiovascular surgery within 7 days following the intervention. RESULTS: Patients (mean age 73.9 ± 10.1 years) were treated with Amplatzer Cardiac Plug (n = 408 [82%]) or Amulet (n = 92 [18%]) devices. Early procedural success was 97.8%, and MAEs occurred in 29 patients (5.8%). Independent predictors of MAEs included device repositioning (odds ratio: 9.13; 95% confidence interval: 2.85 to 33.54; p < 0.001) and left ventricular ejection fraction <30% (odds ratio: 4.08; 95% confidence interval: 1.49 to 11.20; p = 0.006), with no effect of device type or size. Angiographic LAA morphology, characterized as cauliflower (33%), cactus (32%), windsock (20%), or chicken wing (15%), was not associated with procedural success (p = 0.51) or the occurrence of MAEs (p = 0.78). CONCLUSIONS: In this nonrandomized study, procedural success of LAAC using Amplatzer devices was high. MAEs within 7 days were predicted by patient- and procedure-related factors. Although LAA morphology displayed substantial heterogeneity, outcomes were comparable across the spectrum of LAA anatomies.

Catheter-based treatment of paravalvular leaks.

The incidence of paravalvular leaks after surgical valve replacement is estimated to be 2-17%. Paravalvular leaks (PVL) can be asymptomatic and not require treatment or can cause haemolysis or heart failure. If symptomatic or if the severity of the leak is moderate or severe, redo surgery is a therapeutic option, but this is accompanied by a high perioperative risk and a high recurrence rate. A lower risk alternative is percutaneous PVL closure, with a 1-2% risk of periprocedural death or need for reoperation. These procedures are often intricate, which is reflected by a rather modest rate of procedural success (reported to be around 80%). This requires that better technical solutions become available in the future. Today, only two dedicated devices for PVL closure exist, the AMPLATZER Vascular Plug III and the paravalvular leak device. Besides, many non-dedicated devices are used, such as atrial septal occluders, ventricular septal occluders and a variety of vascular plugs. While aortic PVL are approached with a retrograde transarterial approach, mitral PVL can be approached using either an antegrade transvenous approach (transseptal), a retrograde transapical approach or, rarely, a retrograde transaortic approach.

Safety and efficacy of ticagrelor and clopidogrel in primary percutaneous coronary intervention.

OBJECTIVE: The effects of ticagrelor in the subpopulation of patients with ST-elevation myocardial infarction (STEMI) were consistent with those observed in the overall Platelet Inhibition and Patient Outcomes (PLATO) study. However, this subgroup included patients initially or ultimately treated conservatively. The aim of this study is to compare treatment using ticagrelor with treatment using clopidogrel in patients with STEMI undergoing primary percutaneous coronary intervention (PCI). METHODS: This post-hoc subgroup analysis compared ticagrelor with clopidogrel in 4949 PLATO patients with STEMI that were treated with primary PCI within 12 h of admission. The primary endpoint was cardiovascular death, myocardial infarction or stroke. The safety endpoint consisted of any major bleeding. Secondary endpoints included stent thrombosis. The analysis was not adequately powered to establish significance of any treatment effects. RESULTS: During a median of 286 days, the primary endpoint occurred in 7.9% of ticagrelor-treated patients versus 8.6% of clopidogrel-treated patients (HR 0.91, 95% CI 0.75 to 1.12, p=0.38). Major bleeding occurred in 6.7% in ticagrelor-treated patients versus 6.8% of clopidogrel-treated patients (HR 0.97, 95% CI 0.77 to 1.22, p=0.79). No interactions were observed for the treatment effect of ticagrelor versus clopidogrel on the primary efficacy (p=0.40) and primary safety endpoints (p=0.15) as compared with the full PLATO population. Treatment with ticagrelor versus clopidogrel reduced the occurrence of definite stent thrombosis (HR 0.58, 95% CI 0.37 to 0.89, p=0.013). CONCLUSIONS: In the subset of patients with STEMI treated with primary PCI, ticagrelor compared with clopidogrel was safe, and efficacy outcomes were consistent with the overall PLATO trial. TRIAL REGISTRATION NUMBER: NCT00391872; Results.

Safety of Prasugrel Loading Doses in Patients Pre-Loaded With Clopidogrel in the Setting of Primary Percutaneous Coronary Intervention: Results of a Nonrandomized Observational Study.

OBJECTIVES: The aim of this study was to assess the safety of the concurrent administration of a clopidogrel and prasugrel loading dose in patients undergoing primary percutaneous coronary intervention. BACKGROUND: Prasugrel is one of the preferred P2Y12 platelet receptor antagonists for ST-segment elevation myocardial infarction patients. The use of prasugrel was evaluated clinically in clopidogrel-naive patients. METHODS: Between September 2009 and October 2012, a total of 2,023 STEMI patients were enrolled in the COMFORTABLE (Comparison of Biomatrix Versus Gazelle in ST-Elevation Myocardial Infarction [STEMI]) and the SPUM-ACS (Inflammation and Acute Coronary Syndromes) studies. Patients receiving a prasugrel loading dose were divided into 2 groups: 1) clopidogrel and a subsequent prasugrel loading dose; and 2) a prasugrel loading dose. The primary safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding in hospital at 30 days. RESULTS: Of 2,023 patients undergoing primary percutaneous coronary intervention, 427 (21.1%) received clopidogrel and a subsequent prasugrel loading dose, 447 (22.1%) received a prasugrel loading dose alone, and the remaining received clopidogrel only. At 30 days, the primary safety endpoint was observed in 1.9% of those receiving clopidogrel and a subsequent prasugrel loading dose and 3.4% of those receiving a prasugrel loading dose alone (adjusted hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.25 to 1.30, p = 0.18). The HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) bleeding score tended to be higher in prasugrel-treated patients (p = 0.076). The primary safety endpoint results, however, remained unchanged after adjustment for these differences (clopidogrel and a subsequent prasugrel loading dose vs. prasugrel only; HR: 0.54 [95% CI: 0.23 to 1.27], p = 0.16). No differences in the composite of cardiac death, myocardial infarction, or stroke were observed at 30 days (adjusted HR: 0.66, 95% CI: 0.27 to 1.62, p = 0.36). CONCLUSIONS: This observational, nonrandomized study of ST-segment elevation myocardial infarction patients suggests that the administration of a loading dose of prasugrel in patients pre-treated with a loading dose of clopidogrel is not associated with an excess of major bleeding events. (Comparison of Biomatrix Versus Gazelle in ST-Elevation Myocardial Infarction [STEMI] [COMFORTABLE]; NCT00962416; and Inflammation and Acute Coronary Syndromes [SPUM-ACS]; NCT01000701).

Percutaneous closure of the patent foramen ovale, easy does it.

Closure of the patent foramen ovale does not benefit from echocardiographic guidance in the majority of cases. Guiding these procedures with fluoroscopy only reduces procedure time, radiation exposure, and amount of contrast medium. There is a clear trend to abandon echocardiographic guidance for this procedure over time and with growing experience.

Clinical impact of gastrointestinal bleeding in patients undergoing percutaneous coronary interventions.

BACKGROUND: The risk factors and clinical sequelae of gastrointestinal bleeding (GIB) in the current era of drug-eluting stents, prolonged dual antiplatelet therapy, and potent P2Y12 inhibitors are not well established. We determined the frequency, predictors, and clinical impact of GIB after percutaneous coronary interventions (PCIs) in a contemporary cohort of consecutive patients treated with unrestricted use of drug-eluting stents. METHODS AND RESULTS: Between 2009 and 2012, all consecutive patients undergoing PCI were prospectively included in the Bern PCI Registry. Bleeding Academic Research Consortium (BARC) GIB and cardiovascular outcomes were recorded within 1 year of follow-up. Among 6212 patients, 84.1% received new-generation drug-eluting stents and 19.5% received prasugrel. At 1 year, GIB had occurred in 65 patients (1.04%); 70.8% of all events and 84.4% of BARC ≥ 3B events were recorded > 30 days after PCI. The majority of events (64.4%) were related to upper GIB with a more delayed time course compared with lower GIB. Increasing age, previous GIB, history of malignancy, smoking, and triple antithrombotic therapy (ie, oral anticoagulation plus dual antiplatelet therapy) were independent predictors of GIB in multivariable analysis. GIB was associated with increased all-cause mortality (adjusted hazard ratio, 3.40; 95% confidence interval, 1.67-6.92; P = 0.001) and the composite of death, myocardial infarction, or stroke (adjusted hazard ratio, 3.75; 95% confidence interval, 1.99-7.07; P < 0.001) and was an independent predictor of all-cause mortality during 1 year. CONCLUSIONS: Among unselected patients undergoing PCI, GIB has a profound effect on prognosis. Triple antithrombotic therapy emerged as the single drug-related predictor of GIB in addition to patient-related risk factors within 1 year of PCI. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02241291.

Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland.

OBJECTIVE: To assess safety up to 1 year of follow-up associated with prasugrel and clopidogrel use in a prospective cohort of patients with acute coronary syndromes (ACS). METHODS: Between 2009 and 2012, 2286 patients invasively managed for ACS were enrolled in the multicentre Swiss ACS Bleeding Cohort, among whom 2148 patients received either prasugrel or clopidogrel according to current guidelines. Patients with ST-elevation myocardial infarction (STEMI) preferentially received prasugrel, while those with non-STEMI, a history of stroke or transient ischaemic attack, age ≥75 years, or weight <60 kg received clopidogrel or reduced dose of prasugrel to comply with the prasugrel label. RESULTS: After adjustment using propensity scores, the primary end point of clinically relevant bleeding events (defined as the composite of Bleeding Academic Research Consortium, BARC, type 3, 4 or 5 bleeding) at 1 year, occurred at a similar rate in both patient groups (prasugrel/clopidogrel: 3.8%/5.5%). Stratified analyses in subgroups including patients with STEMI yielded a similar safety profile. After adjusting for baseline variables, no relevant differences in major adverse cardiovascular and cerebrovascular events were observed at 1 year (prasugrel/clopidogrel: cardiac death 2.6%/4.2%, myocardial infarction 2.7%/3.8%, revascularisation 5.9%/6.7%, stroke 1.0%/1.6%). Of note, this study was not designed to compare efficacy between prasugrel and clopidogrel. CONCLUSIONS: In this large prospective ACS cohort, patients treated with prasugrel according to current guidelines (ie, in patients without cerebrovascular disease, old age or underweight) had a similar safety profile compared with patients treated with clopidogrel. CLINICAL TRIAL REGISTRATION NUMBER: SPUM-ACS: NCT01000701; COMFORTABLE AMI: NCT00962416.

Safety, feasibility, and long-term results of percutaneous closure of atrial septal defects using the Amplatzer septal occluder without periprocedural echocardiography.

OBJECTIVES: We sought to assess the safety and efficacy of percutaneous closure of atrial septal defects (ASDs) under fluoroscopic guidance only, without periprocedural echocardiographic guidance. BACKGROUND: Percutaneous closure of ASDs is usually performed using simultaneous fluoroscopic and transthoracic, transesophageal (TEE), or intracardiac echocardiographic (ICE) guidance. However, TEE requires deep sedation or general anesthesia, which considerably lengthens the procedure. TEE and ICE increase costs. METHODS: Between 1997 and 2008, a total of 217 consecutive patients (age, 38 ± 22 years; 155 females and 62 males), of whom 44 were children ≤16 years, underwent percutaneous ASD closure with an Amplatzer ASD occluder (AASDO). TEE guidance and general anesthesia were restricted to the children, while devices were implanted under fluoroscopic guidance only in the adults. For comparison of technical safety and feasibility of the procedure without echocardiographic guidance, the children served as a control group. RESULTS: The implantation procedure was successful in all but 3 patients (1 child and 2 adults; 1.4%). Mean device size was 23 ± 8 mm (range, 4-40 mm). There was 1 postprocedural complication (0.5%; transient perimyocarditis in an adult patient). At last echocardiographic follow-up, 13 ± 23 months after the procedure, 90% of patients had no residual shunt, whereas a minimal, moderate, or large shunt persisted in 7%, 1%, and 2%, respectively. Four adult patients (2%) underwent implantation of a second device for a residual shunt. During a mean follow-up period of 3 ± 2 years, 2 deaths and 1 ischemic stroke occurred. CONCLUSION: According to these results, percutaneous ASD closure using the AASDO without periprocedural echocardiographic guidance seems safe and feasible.

Transcarotid aortic valve-in-valve implantation for degenerated stentless aortic root conduits with severe regurgitation: a case series.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is routinely performed via the transfemoral and the transapical route. Subclavian and direct aortic access are described alternatives for TAVI. Recently, the transcarotid approach has been shown to be feasible among patients with limited vascular access and severe native aortic valve stenosis. We aim to investigate the feasibility of transcatheter aortic valve-in-valve implantation via the transcarotid access in patients with severe aortic regurgitation due to degenerated stentless Shelhigh conduits using the 29 mm Medtronic CoreValve bioprosthesis. METHODS: Three patients with complex vascular anatomy undergoing transcatheter valve-in-valve implantation via the transcarotid route were enrolled in the study. The procedure was performed under general anaesthesia using surgical cut-down to facilitate vascular access. Immediate procedural results as well as echocardiographic and clinical outcomes after 30 days and 6 months of the follow-up were recorded and analysed. RESULTS: All three patients underwent unproblematic TAVI and experienced dramatic improvement of symptoms. Mean transvalvular gradient was 3, 6 and 11 mmHg, respectively. Effective orifice area ranged between 1.7 and 2.2 cm(2). Only mild paravalvular regurgitation was detected by echocardiography after 30 days of the follow-up. CONCLUSIONS: The transcarotid approach can be safely performed for valve-in-valve procedures using the Medtronic CoreValve in patients with limited vascular access. It enables accurate positioning and implantation of the prosthesis.

Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation.

BACKGROUND: Transcatheter left atrial appendage (LAA) occlusion has been proven to be an effective treatment for stroke prophylaxis in patients with atrial fibrillation. For this purpose, the Amplatzer cardiac plug (ACP) was introduced. Its second generation, the Amulet, was developed for easier delivery, better coverage, and reduction of complications. AIM: To investigate the safety and efficacy of first generation versus second generation Amplatzer occluders for LAA occlusion. METHODS: Retrospective analysis of prospectively collected data from the LAA occlusion registries of the Bern and Zurich university hospitals. Comparison of the last consecutive 50 ACP cases versus the first consecutive 50 Amulet cases in patients with non-valvular atrial fibrillation. For safety, a periprocedural combined endpoint, which is composed of death, stroke, cardiac tamponade, and bailout by surgery was predefined. For efficacy, the endpoint was procedural success. RESULTS: There were no differences between the two groups in baseline characteristics. The percentage of associated interventions during LAA occlusion was high in (78% with ACP vs. 70% with Amulet p = ns). Procedural success was similar in both groups (98 vs. 94%, p = 0.61). The combined safety endpoint for severe adverse events was reached by a similar rate of patients in both groups (6 vs. 8%, p = 0.7). Overall complication rate was insignificantly higher in the ACP group, which was mainly driven by clinically irrelevant pericardial effusions (24 vs. 14%, p = 0.31). Death, stroke, or tamponade were similar between the groups (0 vs. 2%, 0 vs. 0%, or 6 vs. 6%, p = ns). CONCLUSION: Transcatheter LAA occlusion for stroke prophylaxis in patients with atrial fibrillation can be performed with similarly high success rates with first and second generations of Amplatzer occluders. According to this early experience, the Amulet has failed to improve results of LAA occlusion. The risk for major procedural adverse events is acceptable but has to be taken into account when selecting patients for LAA occlusion, a preventive procedure.

Five-year results of a randomised comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularisation.

AIMS: Stents with a passive coating of titanium-nitride-oxide (TiNO) have been compared with Endeavor® zotarolimus-eluting stents (E-ZES) with regard to the primary endpoint of in-stent late lumen loss at six to eight months. The objective of the present analysis was to compare the long-term outcomes of TiNO stents with E-ZES up to five years of clinical follow-up. METHODS AND RESULTS: A total of 302 patients had been randomly allocated to treatment with TiNO or E-ZES. Up to five years of follow-up, major adverse cardiac events (MACE), the composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularisation (TLR), were observed in 27.6% of patients treated with TiNO stents and 25.3% of patients treated with E-ZES (RR 1.13, 95% CI: 0.72-1.75, p=0.60), with the majority of events related to clinically indicated TVR (TiNO 21.7% versus E-ZES 20.7%, RR 1.10, 95% CI: 0.67-1.81). There were no differences with respect to individual events including cardiac death, myocardial infarction or stent thrombosis between the two treatment arms up to five years of follow-up. A majority of patients remained free from angina throughout the entire study duration (TiNO 77.3% versus E-ZES 76.1%, p=0.92). CONCLUSIONS: Final five-year outcomes of the TIDE trial comparing TiNO stents with E-ZES revealed increased rates of MACE driven primarily by clinically indicated TVR. The TIDE trial is registered at ClinicalTrials.gov: NCT00492908.

Long-term outcomes of biodegradable versus durable polymer drug-eluting stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of individual patient data from three randomised trials.

AIMS: Arterial plaque rupture and thrombus characterise ST-elevation myocardial infarction (STEMI) and may aggravate delayed arterial healing following durable polymer drug-eluting stent (DP-DES) implantation. Biodegradable polymer (BP) may improve biocompatibility. We compared long-term outcomes in STEMI patients receiving BP-DES vs. durable polymer sirolimus-eluting stents (DP-SES). METHODS AND RESULTS: We pooled individual patient-level data from three randomised clinical trials (ISAR-TEST-3, ISAR-TEST-4 and LEADERS) comparing outcomes from BP-DES with DP-SES at four years. The primary endpoint (MACE) comprised cardiac death, MI, or target lesion revascularisation (TLR). Secondary endpoints were TLR, cardiac death or MI, and definite or probable stent thrombosis. Of 497 patients with STEMI, 291 received BP-DES and 206 DP-SES. At four years, MACE was significantly reduced following treatment with BP-DES (hazard ratio [HR] 0.59, 95% CI: 0.39-0.90; p=0.01) driven by reduced TLR (HR 0.54, 95% CI: 0.30-0.98; p=0.04). Trends towards reduction were seen for cardiac death or MI (HR 0.63, 95% CI: 0.37-1.05; p=0.07) and definite or probable stent thrombosis (3.6% vs. 7.1%; HR 0.49, 95% CI: 0.22-1.11; p=0.09). CONCLUSIONS: In STEMI, BP-DES demonstrated superior clinical outcomes to DP-SES at four years. Trends towards reduced cardiac death or myocardial infarction and reduced stent thrombosis require corroboration in specifically powered trials.