Abstract Introduction and objectives: Evidence of the long-term prognostic benefit of new generation drug-eluting stents (DES) is limited, especially in the context of primary percutaneous coronary ...interventions. The goal of this study was to compare the long-term prognostic impact of the implantation of DESs versus bare-metal stents (BMSs) in real-world patients undergoing primary percutaneous coronary interventions. Methods: A cohort study was conducted with 1499 consecutive patients diagnosed with ST-segment elevation myocardial infarction who underwent percutaneous coronary interventions between January 2008 and December 2015. A total of 24.9% of the patients received a DES. A matched propensity score analysis yielded 2 groups of 262 matched patients depending on whether they were treated with a DES or a BMS. Results: During follow-up (median 1015 days), the patients who received DES had a lower all-cause mortality rate (6.5% vs 12.2%; P = .049) a lower composite endpoint of major adverse cardiac events (16.4% vs 25.2%; P = .049) and a lower patient-oriented composite endpoint of death from any cause, myocardial infarction and revascularization at follow-up (12.6% vs 22.5%; P = .017). No differences were seen in the definite stent thrombosis rate. Conclusions: In our registry, in a real-world population of consecutive patients undergoing primary percutaneous coronary interventions, the use of DES versus BMS associated more survival and less clinically significant major adverse cardiac events and patient-oriented composite endpoints in a long-term follow-up, without any differences in stent thrombosis.
We evaluated the incidence, clinical predictors, and outcomes of contrast-induced nephropathy (CIN) after coronary angiography in patients with myocardial infarction and normal kidney function. We ...studied 202 consecutive patients with glomerular filtration rate >60 mL/min/1.73 m2. The CIN was defined according to 3 definitions: increases in serum creatinine (sCr) ≥25%, ≥0.3 mg/dL, and ≥0.5 mg/dL. The CIN occurred in 56 (27.7%), 42 (20.8%), and 13 (6.4%) patients, respectively. In multivariate analysis, the presence of a high Global Registry of Acute Coronary Events (GRACE) risk score (>140) was an independent predictor of CIN in its milder forms (≥25% and ≥0.3 mg/dL of rise in sCr). Increase in sCr ≥0.3 mg/dL was an independent predictor of bleeding. Increase in sCr ≥0.5 mg/dL was an independent predictor of in-hospital cardiac events (mortality, myocardial infraction MI, and heart failure). As conclusion, the GRACE score is a useful tool to predict CIN in patients with MI and normal renal function.
Beneficial properties of bioresorbable vascular scaffolds (BVS) regarding to vasomotility restoration and no caging of the vessel make them attractive devices in chronic total occlusions (CTO) ...revascularization. However, more evidence is needed attending to their use in this specific setting. We aim to determine feasibility and safety of BVS use in CTO revascularization attending to struts coverage and apposition, as well as re-stenosis and stent thrombosis (ST) rates. 29 BVS were deployed in 9 CTO lesions revascularization (mean J-CTO score ≥3) with an acute procedural success rate of 100%. Clinical and angiographic follow-up was performed 6 months later, including intracoronary analyses from optical coherence tomography (OCT) images. 44,723 struts were analyzed within the total 636 mm of scaffolded vessel. Mean length scaffolded per lesion was 70.66 ± 31.01 mm with a mean number of 3.22 BVS. 2051 struts (4.59%) were identified as uncovered, being most of them (98.4%) neither malapposed nor disrupted. Mean thickness of struts’ coverage was 0.13 ± 0.05 mm. Incomplete strut apposition (ISA) percentage was 0% as no malapposed struts were detected and 134 struts were identified as disrupted, which represents a 0.29% from the total. Mean vessel, scaffold, and lumen diameters were 3.87 ± 0.51, 2.97 ± 0.49, and 2.68 ± 0.50 mm, respectively. Neither in-stent re-stenosis nor ST was detected. During follow-up, none of our patients died, suffered from stroke or needed target lesion revascularization. Clinical and angiographic 6-month follow-up (including OCT analyses) of BVS in CTO revascularization suggests their effectiveness and safety, even in very complex chronic occluded lesions. Nevertheless, more evidence is needed
Transcatheter mitral valve repair (TMVR) is an effective therapy for high-risk patients with severe mitral regurgitation (MR) but heart failure (HF) readmissions and death remain substantial on ...mid-term follow-up. Recently, right ventricular (RV) to pulmonary arterial (PA) coupling has emerged as a relevant prognostic predictor in HF. In this study, we aimed to assess the prognostic value of tricuspid annular plane systolic excursion (TAPSE) to PA systolic pressure (PASP) ratio as a non-invasive measure of RV-to-PA coupling in patients undergoing TMVR with MitraClip (Abbott, CA, USA).
Multicentre registry including 228 consecutive patients that underwent successful TMVR with MitraClip. The sample was divided in two groups according to TAPSE/PASP median value: 0.35. The primary combined endpoint encompassed HF readmissions and all-cause mortality.
Mean age was 72.5 ± 11.5 years and 154 (67.5%) patients were male. HF readmissions and all-cause mortality were more frequent in patients with TAPSE/PASP ≤ 0.35: Log-Rank 8.844,
= 0.003. On Cox regression, TAPSE/PASP emerged as a prognostic predictor of the primary combined endpoint, together with STS-Score. TAPSE/PASP was a better prognostic predictor than either TAPSE or PASP separately.
TAPSE/PASP ratio appears as a novel prognostic predictor in patients undergoing MitraClip implantation that might improve risk stratification and candidate selection.
Renal dysfunction in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) indicates a poor long-term prognosis. However, the ...prognostic value of the improvement or stabilisation of renal function during follow-up has not yet been assessed. This study aimed to investigate the long-term predictive impact of the improvement or stabilisation of renal function after one year of follow-up in patients with STEMI undergoing pPCI with renal dysfunction at discharge.
This prospective, single-centre cohort study included 2170 consecutive patients with STEMI who underwent pPCI. The glomerular filtration rate (GFR) was determined at hospital discharge and one-year follow-up. The median clinical follow-up was 72 months.
Among the 2004 patients, 393 (19.6%) had a GFR <60 ml/min, and 1611 (80.4%) had a GFR ≥ 60 ml/min at discharge. Among patients with GFR <60 ml/min, data at one-year follow-up were available for 342. Of these patients, 127 (32%) showed improvement in renal function (defined as improvement in the Kidney Disease Improving Global Outcomes (KDIGO) chronic kidney disease (CKD) classification), 47 (12%) showed worsening of renal function (defined as worsening of the KDIGO CKD classification), and 168 (43%) showed no category changes. Improvement or stabilisation of GFR at one year of follow-up was associated with a reduction of major adverse cardiovascular events (MACE) HR 0.51, 95% CI: 0.35–0.75, p = 0.001 and all-cause mortality HR 0.54, 95% CI: 0.34–0.84, p = 0.007 during follow-up.
The improvement or stabilisation of renal function at one-year follow-up in patients with STEMI and renal dysfunction is associated with a better long-term prognosis.
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BACKGROUND:There are few randomized trials comparing bioprostheses for transcatheter aortic valve replacement (TAVR), and no trials compared TAVR bioprostheses with supra-annular design. The SCOPE 2 ...trial was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut valves.
METHODS:SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years with an indication for transfemoral TAVR as agreed by the Heart Team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary endpoint, powered for non-inferiority of the ACURATE neo valve, was all-cause death or stroke at 1 year. The key secondary endpoint, powered for superiority of the ACURATE neo valve, was new permanent pacemaker implantation at 30 days.
RESULTS:Among 796 randomized patients (mean age 83.2±4.3 years; mean STS-PROM score 4.6± 2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary endpoint occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference 1.8%, upper one-sided 95% confidence limit 6.1%, p=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference -7.5%, 95% confidence interval -12.4 to -2.60, p=0.0027). No significant differences were observed in the components of the primary endpoint. Cardiac death at 30 days (2.8% vs. 0.8%, p=0.03) and 1 year (8.4% vs. 3.9%, p=0.01), and moderate or severe aortic regurgitation at 30 days (10% vs. 3%, p=0.002) were significantly increased in the ACURATE neo group.
CONCLUSIONS:Transfemoral TAVR with the self-expanding ACURATE neo did not meet non- inferiority compared to the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year.
CLINICAL TRIAL REGISTRATION:URLhttps://clinicaltrials.gov/ Unique IdentifierNCT03192813.
ABSTRACT Introduction and objectives: Coronary lesions with stent overlapping are associated with higher neointimal proliferation that leads to more restenosis. Furthermore, the tapering of coronary ...arteries is a major challenge when treating long coronary lesions. This study attempted to assess the safety and clinical level of performance of long nontapered sirolimus-eluting coronary stent systems (> 36 mm) to treat long and diffused de novo coronary lesions in real-world scenarios. Methods: This was a prospective, non-randomized, multicentre study that included 696 consecutive patients treated with the long nontapered BioMime sirolimus-eluting coronary stent system in long and diffused de novo coronary lesions. The safety endpoint was major adverse cardiovascular events defined as a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, and major bleeding at the 12-month follow-up. Results: Of a total of 696 patients, 38.79% were diabetic. The mean age of all the patients was 64.6 ± 14 years, and 80% were males. The indication for revascularization was acute coronary syndrome in 63.1%. A total of 899 lesions were identified out of which 742 were successfully treated with long BioMime stents (37 mm, 40 mm, 44 mm, and 48 mm). The cumulative incidence of major adverse cardiovascular events was 8.1% at the 12-month follow-up including cardiac death (2.09%), myocardial infarction (1.34%), and total stent thrombosis (0.5%). Conclusions: This study confirms the safety and good performance of long nontapered BioMime coronary stents to treat de novo coronary stenosis. Therefore, it can be considered a safe and effective treatment for long and diffused de novo coronary lesions in the routine clinical practice.
ABSTRACT Introduction and objectives: This study primary endpoint was to present the in-hospital all-cause mortality of the Spanish TAVI registry from its inception until 2018. Secondary endpoints ...included other in-hospital clinical events, 30-day all-cause mortality, and an assessment of the time trend of this registry. Methods: All consecutive patients included in the Spanish TAVI registry were analyzed. In this time-based analysis, the population was been divided into patients treated before 2014 (cohort A: 2009-2013) and patients treated between 2014 and 2018 (cohort B). Results: From August 2007 to June 2018, 7180 patients were included. The mean age was 81.2 ± 6.5 years and 53% were women. The logistic EuroSCORE was 12% (8-20). Transfemoral access was used in 89%. In-hospital and 30-day all-cause mortality was 4.7% and 5.7%, respectively. On the time-based analyses during the hospital stay, the rate of myocardial infarction, stroke, need for pacemakers, tamponade, coronary obstruction, and vascular complications was similar between both groups. However, cohort B showed less need for conversion to surgery and malapposition of the valve. Also, the implant success rate increased from 93% to 96% (P< .001). In-hospital and 30-day all-cause mortality was significantly lower in cohort B, (OR, 0.65; IC95%, 0.48-0.86; P= .003 and OR, 0.71; IC95%, 0.54-0.92; P= .002, respectively). Conclusions: The time trend analysis of the Spanish TAVI registry showed a change in the patients’ clinical profile and an improvement in the in-hospital clinical outcomes and 30-day all-cause mortality in patients treated more recently.
Transcatheter mitral valve repair (TMVR) could improve survival in functional mitral regurgitation (FMR), but it is necessary to consider the influence of left ventricular ejection fraction (LVEF). ...Therefore, we compare the outcomes after TMVR with Mitraclip
between two groups according to LVEF.
In an observational registry study, we compared the outcomes in patients with FMR who underwent TMVR with and without LVEF <30%. The primary endpoint was the combined one-year all-cause mortality and unplanned hospital readmissions due to HF. The secondary end-points were New York Heart Association (NYHA) functional class and mitral regurgitation (MR) severity. Propensity-score matching was used to create two groups with the same baseline characteristics, except for baseline LVEF.
Among 535 FMR eligible patients, 144 patients with LVEF <30% (group 1) and 144 with LVEF >30% (group 2) had similar propensity scores and were included in the analyses. The primary study endpoint was significantlly higher in group 1 (33.3% vs. 9.4%,
= 0.002). There was a maintained improvement in secondary endpoints without significant differences among groups.
FMR patients with LVEF <30% treated with MitraClip
had higher mortality and readmissions than patients with LVEF ≥30% treated with the same device. However, both groups improved the NYHA functional class and MR severity.
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