The aim of this study was to observe the percentage of thromboembolic and haemorrhagic events over a 2-year follow-up in patients with non-valvular atrial fibrillation (NVAF) undergoing closure of ...the left atrial appendage (LAA) with an occlusion device. Observed events and CHADS2 (congestive heart failure, hypertension, age, diabetes, stroke history), CHA2DS2-VASc (also adding: vascular disease and sex) and HAS-BLED (hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use)-predicted events were compared.
LAA closure with an occlusion device was performed in 167 NVAF patients contraindicated for oral anticoagulants and recruited from 12 hospitals between 2009 and 2013. At least two transoesophageal echocardiograms were performed in the first 6 months postimplantation. Antithrombotics included clopidogrel and aspirin. Patients were monitored for death, stroke, major and relevant bleeding and hospitalisation for concomitant conditions. Mean age was 74.68±8.58, median follow-up was 24 months, 5.38% had intraoperative complications and implantation was successful in 94.6% of subjects. Mortality during follow-up was 10.8%, mostly (9.5%) non-cardiac related. Bleeding occurred in 10.1% of subjects, 5.7% major and 4.4% minor though relevant, and 4.4% suffered stroke. Major bleeding and stroke/transient ischaemic attack events within 2 years (annual event rates, 290 patients/year) were less frequent than expected from CHADS2 (2.4% vs 9.6%), CHA2DS2-VASc (2.4% vs 8.3%) and HAS-BLED (3.1% vs 6.6%) risk scores (p<0.001, p=0.003, p=0.047, respectively).
LAA closure with an occlusion device in patients contraindicated for oral anticoagulants is a therapeutic option associated with fewer thromboembolic and haemorrhagic events than expected from risk scores, particularly in the second year postimplantation.
Background
Thrombocytopenia after transcatheter aortic valve implantation (TAVI) is common and has been related to higher mortality and major complications. No comparison between balloon‐expandable ...(BEV) and self‐expanding valves (SEV) regarding drop platelet count (DPC) has been reported to date. The objectives of this study were to analyze the differences in DPC between BEVs or SEVs and their prognostic implications in clinical outcomes.
Methods
We retrospectively analyzed patients undergoing TAVI. Platelet counts after TAVI were collected. Two groups were created: DPC ≤ 30% and DPC > 30%. VARC‐2 criteria were used to define outcomes.
Results
Study population was composed of 195 patients (age 77.5 ± 6.7, 57.4% males). All of them but one experienced DPC (mean DPC 31.9 ± 15.3%). DPC was significantly higher among the patients treated with BEV compared to those treated with SEV (36.3 ± 15.1% vs 27.7 ± 14.4, P < 0.001). After multivariate analysis, the use of BEV was independently associated with a higher rate of DPC > 30% (67.4% vs 36.0%; OR 3.4; 95% CI, 1.42‐8.16). At 30 days, the DPC > 30% was associated with a higher rate of life‐threatening/major bleeding, major vascular complications, in‐hospital sepsis and mortality. At one year, there were no statistically significant differences in the mortality rate between groups (6.35% vs 10.0%, HR 1.54; 95% CI, 0.56–4.25).
Conclusions
In this study, the use of BEV was associated with a higher risk of DPC after TAVI. A DPC rate > 30% was associated with an increased risk of major complications at 30 days.
Predictors of antiplatelet therapy discontinuation (ATD) during the first year after drug-eluting stent implantation are poorly known.
This was a prospective study with 3-, 6-, 9-, and 12-month ...follow-up of patients receiving at least 1 drug-eluting stent between January and April 2008 in 29 hospitals. Individual- and hospital-level predictors of ATD were assessed by hierarchical-multinomial regression analysis. ATD could be assessed in 1622 candidates for follow-up (82.5%). A total of 234 patients (14.4%) interrupted at least 1 antiplatelet therapy drug, predominantly clopidogrel (n=182, 11.8%). Bleeding events or invasive procedures led to ATD in 109 patients. This was predicted by renal impairment (odds ratio OR 2.81, 95% confidence interval CI 1.48 to 5.34), prior major hemorrhage (OR 3.77, 95% CI 1.41 to 10.03), and peripheral arterial disease (OR 1.78, 95% CI 1.01 to 3.15). Medical decisions led to ATD in 70 patients; this was predicted by long-term use of anticoagulant therapy (OR 3.88, 95% CI 1.26 to 11.98), undergoing the procedure in a private hospital (OR 13.3, 95% CI 1.69 to 105), and not receiving instructions about medication (OR 2.8, 95% CI 1.23 to 6.36). Thirty-nine patients interrupted ATD on their own initiative, mainly immigrants (OR 3.78, 95% CI 1.2 to 11.98) and consumers of psychotropic drugs (OR 2.58, 95% CI 1.3 to 5.12).
ATD during the first year after drug-eluting stent implantation is based mainly on patient decision or a medical decision not associated with major bleeding events or major surgical procedures. Individual- and hospital-level variables are important to predict ATD.
Background
Chronic total occlusions (CTOs) are present in more than one third of older patients with myocardial ischemia, but controversy remains about the best therapeutic approach.
Aims
To compare ...long‐term survival after CTO revascularization (percutaneous coronary intervention PCI or coronary artery bypass graft CABG) versus medical treatment (MT) alone in patients aged 75 and older.
Methods and results
A total of 1,252 consecutive patients with at least one CTO were identified from 2010 to 2014 in our center. Patients were stratified by age (<75 years vs. ≥75 years) in the present analysis. All‐cause and cardiac mortality were assessed at a median follow‐up of 3.5 years.
In the older subgroup (26%), patients were more likely to be treated with MT alone (71% vs. 43% of younger patients; p < 0.001). Patients undergoing revascularization were younger and had higher left ventricular ejection fraction (LVEF) and lower age, creatinine, ejection fraction (ACEF) score (age/LVEF +1 if creatinine >2.0 mg/dL), compared to the MT group (p < 0.05). As compared to MT, revascularization predicted lower rates of cardiac mortality and all‐cause mortality in older patients, both in the subgroups treated with CABG (hazard ratio HR 0.35, 95% confidence interval CI 0.17–0.71; HR 0.39, 95%CI 0.18–0.81) and PCI (HR 0.57, 95%CI 0.33–0.98; HR 0.59, 95%CI 0.28–1.2). No differences in mortality were observed according to type of revascularization procedure.
Conclusions
Among patients aged at least 75 years with a CTO, revascularization (PCI or CABG) rather than MT alone may portend a better outcome in terms of all‐cause and cardiac mortality.
Background
Chronic total occlusion (CTO) is common in patients with diabetes mellitus. Data on the long‐term outcomes after treatment of CTOs in this high‐risk population are scarce.
Aim
To compare ...the long‐term clinical outcomes of CTO revascularization either by coronary artery bypass graft (CABG) or successful percutaneous coronary intervention (PCI) versus optimal medical treatment (MT) alone in patients with diabetes.
Methods and Results
A total of 538 consecutive patients with diabetes and at least one CTO were identified from 2010 to 2014 in our center. In the present analysis, patients were stratified according to the CTO treatment strategy that was selected. MT was selected in 61% of patients whereas revascularization in the remaining 39%. Patients undergoing revascularization were younger, had higher left ventricular ejection fraction (LVEF), lower ACEF score, and more positive myocardial ischemia detection results compared to the MT group (p < .001).Patients referred for CABG had higher rates of left main disease compared to the PCI and MT groups (32% vs. 3% and 11%, respectively; p < .001). Complete revascularization was more often achieved in the CABG group, compared to the PCI group (62% vs. 32% p < .001). Multivariable analysis showed that revascularization with CABG was associated with lower rates of all‐cause and cardiac mortality rates compared to MT, hazard ratio (HR) 0.41, 95% confidence interval (CI) 0.25–0.70, p < .001 and HR 0.40, 95% CI 0.20–81, p = .011, respectively. Successful CTO‐PCI showed a trend towards benefit in all‐cause mortality (HR 0.58, 95% CI 0.33–1.04, p = .06).
Conclusion
In our registry, CTO revascularization in diabetic patients, especially with CABG, was associated with lower long‐term mortality rates as compared to MT alone.
Percutaneous coronary intervention (PCI) for chronic total coronary occlusions (CTO) improves clinical symptoms and quality of life. The longer-term safety of PCI compared to optimal medical therapy ...(OMT) remains uncertain.
We sought to evaluate the long-term safety of PCI for CTO in a randomised trial as compared to OMT.
A total of 396 patients with a symptomatic CTO were enrolled into a randomised, multicentre clinical trial comparing PCI and OMT. Half of the patients had a single CTO; the others had multivessel disease. Non-CTO lesions were treated prior to randomisation (2:1 ratio). During follow-up, crossover from OMT to PCI occurred in 7.3% (1 year) and 17.5% (3 years) of patients.
At 3 years, the incidence of cardiovascular death or nonfatal myocardial infarction was not significantly different between the groups (OMT 3.7% vs PCI 6.2%; p=0.29). By per-protocol analysis, the difference remained non-significant (OMT 5.7% vs PCI 4.7%; p=0.67). Overall, major adverse cardiovascular events (MACE) were more frequent with OMT (OMT 21.2% vs PCI 11.2%), largely because of ischaemia-driven revascularisation. The rates of stroke or hospitalisation for bleeding were not different between the groups.
At 3 years there was no difference in the rate of cardiovascular death or myocardial infarction between PCI or OMT among patients with a remaining single coronary CTO. The MACE rate was higher in the OMT group due largely to ischaemia-driven revascularisation. CTO PCI appears to be a safe option for patients with a single remaining significant coronary CTO. CinicalTrials.gov: NCT01760083.
The aims of this registry were to determine the incidence, predictors, and prognostic value of periprocedural acute kidney injury (AKI) after left atrial appendage closure (LAAC).
No data exist on ...the occurrence of AKI after LAAC.
A total of 355 patients undergoing LAAC were included in the study. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, after the procedure or the need for hemodialysis during index hospitalization.
The incidence of AKI was 9%, and patients with worse baseline renal function were at higher risk for developing AKI (odds ratio: 1.32; 95% confidence interval CI: 1.09 to 1.61; p = 0.004 for each 10 ml/min decrease in glomerular filtration rate). In-hospital bleeding events occurred more frequently in the AKI group (5.3% vs. 15.6%; p = 0.037). After a median follow-up period of 18 months, patients in the AKI group had higher mortality (hazard ratio HR: 2.59; 95% CI: 1.36 to 4.92; p = 0.004), more embolic events (HR: 6.14; 95% CI: 2.23 to 16.92; p = 0.001) and major bleeding events (HR: 2.36; 95% CI: 0.89 to 6.24; p = 0.083). The occurrence of AKI was an independent predictor of midterm mortality (HR: 2.00; 95% CI: 1.02 to 3.91; p = 0.044).
The occurrence of AKI was relatively frequent following LAAC, and patients with lower renal glomerular filtration rates were at high risk for developing this complication. AKI identified a group of patients with worse midterm outcomes, highlighting the importance of further preventive strategies in this population.
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Limited data exist on the treatment and outcomes of patients with chronic total occlusions due to in-stent restenosis (CTO-ISR). We sought to evaluate results and clinical outcomes in percutaneous ...interventions over CTO-ISR.
We conducted a registry in 16 centres involving consecutive patients undergoing attempted percutaneous intervention over CTO-ISR. A total of 233 patients were included, 192 (82.4%) with a successful acute result. The success rate was significantly lower in patients with: lesion in the circumflex artery, ostial lesions, J score >3 and no femoral access. The presence of tandem lesions (OR 0.19, 95% CI: 0.06-0.68; p=0.01) was identified as an independent predictor for outcome. After a median follow-up of 20 months, cardiac death in the successful vs. failed groups was 3% and 8.3%, respectively (p=0.09). Independent predictors for mortality were previous CABG (HR 8, 95% CI: 1.3-50; p=0.02) and multivessel disease (HR 2.3, 95% CI: 1.2-4.3; p=0.01). In the successful group, TLR was 15%, re-occlusion 6% and definite/probable stent thrombosis 1.8%.
Percutaneous treatment of CTO due to ISR in contemporary practice shows a high success rate, resulting in good long-term results. The angiographic and procedural predictors identified may contribute to improving procedural outcome through better patient selection.
Drug-coated balloons (DCBs) have theoretical advantages over drug-eluting stents (DESs) to facilitate stent healing. We studied whether, in patients undergoing primary coronary interventions (pPCIs), ...a strategy of DCB after bare-metal stent improves early healing as determined by optical coherence tomography (OCT) compared with new-generation DES.
pPCI patients were randomized (1:1) to treatment with new-generation sirolimus-eluting stents (DES group) or DCB-strategy. Vessel healing was assessed by OCT at 90 days.
Fifty-three patients were randomized (26 DES vs. 27 DCB). At 90 days, both strategies showed a low rate of uncovered struts (3.2 vs. 3.2%, P = 0.64) and a very high and similar rate of covered and apposed struts (96.6 vs. 96.1%, respectively; P = 0.58). However, DCB group had a significantly lower rate of major coronary evaginations (68 vs. 37%, P = 0.026), and more frequently developed a thin homogeneous neointimal layer (20 vs. 70.4%, P = 0.001) suggesting distinct superior healing at 3 months compared to DES.
In pPCI both, sirolimus-DES and DCB-strategy, provide excellent strut coverage at 3 months. However, DCB ensures more advanced and optimal stent healing compared to sirolimus-DES. Further research is needed to determine whether, in patients undergoing pPCI, DCB offers superior long-term clinical and angiographic outcomes than new-generation DES (NCT03610347).
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