Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial.

BACKGROUND: Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. METHODS: In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. FINDINGS: 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047). INTERPRETATION: Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction. FUNDING: Spanish Heart Foundation.

Recurrent syncope after left atrial appendage occlusion.

We present the case of a 72-year-old woman with permanent atrial fibrillation and contraindication to long-term oral anticoagulant therapy who underwent left atrial appendage (LAA) occlusion. A 24-mm Amplatzer Cardiac Plug (St Jude Medical) device was deployed. The inferior part of the external disc of the device appeared to be over the posterior leaflet of the mitral valve but no significant mitral stenosis or mitral regurgitation was detected before deployment. After the procedure the patient suffered several syncopes when she tried to stand up. A transesophageal echocardiography (TEE) was performed and no significant differences on the device position were detected, it was not possible to perform the TEE in a stand-up position due to the patient symptoms (hypotension, tachycardia, dizziness, and loss of consciousness). After discussion with the surgical team, surgical removal of the device and surgical exclusion of LAA was performed. The symptoms disappeared and the patient was discharged. In the best of our knowledge, this is the first time that recurrent syncope has been described as a complication of LAA occlusion.

Right atrial thrombosis associated with hemodialysis catheter: first description of recurrence in a poorly understood problem.

Catheter-related right atrial thrombosis (CRAT) is an underreported and potentially life-threatening complication of central venous catheter in hemodialysis patients. The accurate incidence is unknown, with reported rates ranging from 2 to 12.8% [1] in series, up to 29% [2] in a postmortem prospective study, and high mortality rates (18%) [1]. The optimal treatment for CRAT is controversial and nonsystematized, including anticoagulation, thrombolysis, and surgical thrombectomy. We report two cases of CRAT in dialysis patients, who underwent surgical thrombectomy. One case required reintervention because of recurrence, a first reported case in hemodialysis population.

Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial.

BACKGROUND: Everolimus-eluting stent (EES) reduces the risk of restenosis in elective percutaneous coronary intervention. However, the use of drug-eluting stent in patients with ST-segment elevation myocardial infarction (STEMI) is still controversial. Data regarding the performance of second-generation EES in this setting are scarce. We report the 1-year result of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) trial, comparing EES with bare-metal stents (BMS) in patients with STEMI. METHODS: This multicentre, prospective, randomised, all-comer controlled trial was done in 12 medical centres in three countries. Between Dec 31, 2008, and May 15, 2010, we recruited patients with STEMI up to 48 h after the onset of symptoms requiring emergent percutaneous coronary intervention. Patients were randomly assigned (ratio 1:1) to receive EES or BMS. Randomisation was in blocks of four or six patients, stratified by centre and centralised by telephone. Patients were masked to treatment. The primary endpoint was the patient-oriented combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularisation at 1 year and was analysed by intention to treat. The secondary endpoints of the study included the device-oriented combined endpoint of cardiac death, target vessel myocardial infarction or target lesion revascularisation, and rates of all cause or cardiac death, recurrent myocardial infarction, target lesion or target vessel revascularisation, stent thrombosis, device and procedure success, and major and minor bleeding. This trial is registered with ClinicalTrials.gov, number NCT00828087. FINDINGS: Of the 1504 patients randomised, 1498 patients were randomly assigned to receive EES (n=751) or BMS (n=747). The primary endpoint was similar in both groups (89 [11·9%] of 751 patients in the EES group vs 106 [14·2%] of 747 patients in the BMS group; difference -2·34 [95% CI -5·75 to 1·07]; p=0·19). Device-oriented endpoint (44 [5·9%] in the EES group vs 63 [8·4%] in the BMS group; difference -2·57 [95% CI -5·18 to 0·03]; p=0·05) did not differ between groups, although rates of target lesion and vessel revascularisation were significantly lower in the EES group (16 [2·1%] vs 37 [5·0%], p=0·003, and 28 [3·7%] vs 51 [6·8%], p=0·0077, respectively). Rates of all cause (26 [3·5%] for EES vs 26 [3·5%] for BMS, p=1·00) or cardiac death (24 [3·2%] for EES vs 21 [2·8%] for BMS, p=0·76) or myocardial infarction (10 [1·3%] vs 15 [2·0%], p=0·32) did not differ between groups. Stent thrombosis rates were significantly lower in the EES group (4 [0·5%] patients with definite stent thrombosis in the EES group vs 14 [1·9%] in the BMS group and seven [0·9%] patients with definite or probable stent thrombosis in the EES group vs 19 [2·5%] in the BMS group, both p=0·019). Although device success rate was similar between groups, procedure success rate was significantly higher in the EES group (731 [97·5%] vs 705 [94·6%]; p=0·0050). Finally, Bleeding rates at 1 year were comparable between groups (29 [3·9%] patients in the EES group vs 39 [5·2%] in the BMS group; p=0·19). INTERPRETATION: The use of EES compared with BMS in the setting of STEMI did not lower the patient-oriented endpoint. However, at the stent level both rates of target lesion revascularisation and stent thrombosis were reduced in recipients of EES. FUNDING: Spanish Heart Foundation.

Everolimus-eluting stent versus bare metal stent in proximal left anterior descending ST-elevation myocardial infarction: insights from the EXAMINATION trial.

BACKGROUND: ST-elevation myocardial infarctions (STEMI) caused by proximal left-anterior descending (LAD) lesions have more myocardium at risk and worse outcomes than those located in other segments. The aim is to compare outcomes of patients with STEMI and proximal-LAD lesions treated with bare-metal stents (BMS) versus everolimus-eluting stents (EES). METHODS: The EXAMINATION trial randomized 1498 STEMI patients to BMS versus EES. The primary end point was the patient-oriented combined of all-cause death, any-recurrent myocardial infarction (MI) and any-revascularization. The secondary end point included the device-oriented combined of cardiac death, target-vessel MI and target-lesion revascularization (TLR). RESULTS: STEMI with a proximal-LAD occlusion was observed in 290 patients (BMS = 132 and EES = 158). Both groups were similar except for diabetes (12.9% vs 24.1%; P = .016). At 1 year, the primary end point was observed in 18.9% and 9.5% of patients treated with BMS and EES, respectively (P = .023). The secondary end point was observed in 11.4% and 5.1%, respectively (P = .053). There were no differences in cardiac death (4.5% vs 3.8%; P = .750) and MI (1.5% vs 0%; P = .121). BMS had higher rate of TLR compared to EES (6.8% vs 1.3%; P = .014). Patients with proximal-LAD STEMI had higher mortality than patients with non proximal-LAD STEMI (5.5% vs 2.9%; P = .027). Proximal-LAD lesions treated with BMS tended to increase the risk of the primary end point compared with other segments (18.9% vs 13.0%; P = .079). However, EES implanted in proximal-LAD had similar outcomes compared with other locations (9.5% vs 12.0%; P = .430). Adjusting for confounders, the interaction between BMS and proximal-LAD location was associated with the primary end point. CONCLUSION: Patients with STEMI and proximal-LAD lesions treated with EES have better outcomes compared with BMS at 1 year. Although further investigations are required, it seems reasonable to consider EES for proximal-LAD STEMI-lesions.

Titanium-nitride-oxIde-coated stents multicenter registry in diaBEtic patienTs: the TIBET registry.

We sought to explore the immediate clinical and angiographic results of the Titan(®) stent implantation in diabetic patients, as well as the major adverse cardiac events (MACE) at 6-month follow-up. We enrolled 156 consecutive diabetic patients admitted to undergo percutaneous intervention for at least one significant (50%) coronary lesion. All lesions were treated with the Titan(®) stent implantation according to the contemporary interventional techniques. Patients were prospectively followed-up for at least 6 months. The primary endpoint was MACE at 6-month follow-up [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR)]. Secondary endpoints included angiographic and clinical procedural success, in-hospital MACE, TLR at 6-month follow-up, and stent thrombosis. The mean age was 66.7 ± 9.6 years, (68.4% males). A total of 197 Titan(®) stents were implanted in 163 lesions. Direct stenting was performed in 45.2% of the cases. The mean stent diameter was 3.1 ± 0.61 mm, and the mean length was 18.0 ± 8.9 mm. Average stent deployment pressure was 13.9 ± 4.2 bars. Angiographic procedural success was achieved in 154 (98.7%) cases, and clinical procedural success was achieved in 153 (98.1%) cases. One patient developed in-hospital non-Q-wave MI following the procedure. Clinical follow-up was completed in 155 (99.4%) patients. Three patients (1.9%) died of a cardiac or unknown cause, and two (1.3%) developed MI. TLR was performed in 11 patients (7.1%). Cumulative MACE at 6-month follow-up occurred in 16 (10.3%) patients. No patient suffered stent thrombosis. Titan(®) stent implantation in diabetic patients achieves an excellent immediate clinical and angiographic outcome, with a low incidence of MACE at mid-term follow-up.

Electrocardiographic changes of ST-elevation myocardial infarction in patients with complete occlusion of the left main trunk without collateral circulation: differential diagnosis and clinical considerations.

Acute coronary syndromes due to involvement of the left main trunk usually present with subtotal occlusion and electrocardiographic pattern with predominant ST depression (non-ST-elevation myocardial infarction). The cases with complete occlusion frequently present an ST-elevation myocardial infarction pattern, but these patients usually die before reaching the hospital. We present a series of 7 patients with total left main trunk occlusion without collateral circulation showing ST-elevation myocardial infarction pattern. The electrocardiographic pattern is similar to left anterior descending coronary artery proximal occlusion to first septal and first diagonal but without ST elevation in V(1) and aVR because of left circumflex coronary artery compromise. In 4 (60%) of 7 of cases, there is also advanced right bundle-branch block plus superoanterior hemiblock. Despite severe clinical state at entrance (5/7 presented cardiac arrest/cardiogenic shock), 3 patients (43%) survived after percutaneous coronary intervention.

Ruptured sinus of Valsalva aneurysm: A reversible cause of suprasystemic pulmonary hypertension.

Management of patients with congenital heart defects and associated pulmonary arterial hypertension remains a major concern. With evolving targeted drug therapies and new iterations of transcatheter devices, treatment of appropriately selected patients with severe pulmonary hypertension, classically considered inoperable, has become feasible. We report the case of a patient with concomitant ruptured right sinus of Valsalva aneurysm and ventricular septal defect, with early reversal of suprasystemic pulmonary pressures following successful percutaneous closure of ruptured sinus of Valsalva.

Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience.

BACKGROUND: In most patients with atrial fibrillation (AF) and stroke, there is thrombotic embolization from the left atrial appendage (LAA). Percutaneous closure of the LAA is a novel alternative for the treatment of patients with AF at a high risk of stroke, in whom long-term anticoagulation therapy is not possible or not desired. This study details the initial experience with the Amplatzer Cardiac Plug (ACP) in humans. METHODS: Investigator-initiated retrospective preregistry data collection to evaluate procedural feasibility and safety up to 24 hr after implantation of the ACP, a nitinol device designed for percutaneous trans-septal implantation in LAA of patients with paroxysmal, permanent, or persistent AF. RESULTS: In 137 of 143 patients, LAA occlusion was attempted, and successfully performed in 132 (96%). There were serious complications in 10 (7.0%) patients (three patients with ischemic stroke; two patients experienced device embolization, both percutaneously recaptured; and five patients with clinically significant pericardial effusions). Minor complications were insignificant pericardial effusions in four, transient myocardial ischemia in two, and loss of the implant in the venous system in one patient. CONCLUSION: The implantation of the ACP device is a feasible method for percutaneous occlusion of the LAA.

Updating national diagnostic reference levels for interventional cardiology and methodological aspects.

The aim of this study is to propose national diagnostic reference levels (DRL) for updating in the field of interventional cardiology and to include technical details to help plan optimization. Medical physics experts and interventional cardiologists from 14 hospitals provided patient dose indicators from coronary angiography and percutaneous coronary interventions. Information about X-ray system dose settings and image quality was also provided. The dose values from 30,024 procedures and 26 interventional laboratories were recorded. The national DRLs proposed for coronary angiography and percutaneous coronary interventions were respectively 39 and 78 Gy·cm2 for air kerma area product (PKA), 530 and 1300 mGy for air kerma at reference point (Ka,r), 6.7 and 15 min of fluoroscopy time and 760 and 1300 cine images. 36% of the KAP meters required correction factors from 10 to 35%. The dose management systems should allow these corrections to be included automatically. The dose per image in cine in reference conditions differed in a factor of 5.5. Including X-ray system dose settings in the methodology provides an insight into the differences between hospitals. The DRLs proposed for Spain in this work were similar to those proposed in the last European survey. The poor correlation between X-ray systems dose settings and patient dose indicators highlights that other factors such as operation protocols and complexity may have more impact in patient dose indicators, which allows a wide margin for optimization. Dose reduction technology together with appropriate training programs will be determinant in the future reduction of patient dose indicators.

The Tryton® dedicated bifurcation stent: Five-year clinical outcomes.

AIMS: We report the first 5 year clinical follow-up data for the Tryton® bifurcation stent. METHODS AND RESULTS: Clinical outcomes at five years were collected from 8 centres. Non-hierarchical Major Adverse Cardiovascular Events (MACE) and Major Adverse Cerebrovascular and Cardiovascular Events (MACCE) were collected. Diabetic and non-diabetic populations were compared, along with small (≤2.5 mm) vs large (>2.5 mm) side branch size. 173 patients with a follow up rate of 98% at 5 years were analysed. Non-hierarchical MACE was low at 9.8%, consisting of cardiac death of 1.2% (n = 2) and MI of 1.7% (n = 3). Target lesion revascularization (TLR) rate was 6.9% (n = 12). Non-hierarchical MACCE was also low, with major bleeding in 2.3% (n = 4) and strokes in 1.7% (n = 3) of patients. There was only 1 case (0.6%) of stent thrombosis that was definite and occurred very late (782 days). All-cause mortality was low, with 8.7% combined cardiac and non-cardiac death (n = 15). Diabetic patients had significantly higher event rates, but there was no difference in events with lesion stratification by side branch size. CONCLUSIONS: The Tryton® Side-Branch Stent has a non-hierarchical MACE of 9.8% and MACCE of 13.9% at 5 years. The TLR was 6.9% with only 1 case of stent thrombosis recorded.

Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention?

BACKGROUND: Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions. METHODS: We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents (<3.50 mm), among 1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention, randomly allocated to everolimus-eluting DES or to an equivalent BMS platform in the EXAMINATION trial (Clinical Evaluation of the Xience-V Stent in Acute Myocardial Infarction Trial). Clinical events up to 5 years of follow-up were evaluated. RESULTS: Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (Pint=0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27-1.02; P=0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34-1.03; P=0.066). CONCLUSIONS: Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00828087.

Left Atrial Appendage Occlusion as Adjunctive Therapy to Anticoagulation for Stroke Recurrence.

BACKGROUND: Stroke recurrence despite optimal oral anticoagulation (OAC) might represent a novel indication for left atrial appendage occlusion (LAAO). The heterogeneity of these patients is generally high, as the presence of valvular atrial fibrillation (VAF) is common. The aim of this study was to explore the role of LAAO as an adjunctive therapy to OAC in patients with recurrent stroke despite optimal OAC. METHODS: The study screened consecutive patients who underwent percutaneous LAAO at nine centers between 2009 and 2017. Patients with recurrent stroke despite optimal OAC were selected and those with an absolute or relative contraindication to OAC were not included in the study. RESULTS: Among 837 patients who underwent LAAO between the study period, a total of 22 (2.6%) met the inclusion criteria. There was a high percentage of VAF (38%) and 59% presented more than one cardioembolic event before LAAO. All patients underwent successful implantation of the device and no procedural major adverse events were reported. In all but 3 patients, anticoagulation was continued after LAAO. With a median clinical follow-up of 1.8 years (range, 0.7-2.8 years), only 1 stroke and 1 transient ischemic attack were reported, translating into a significant reduction of cerebrovascular events before and after LAAO (2.0 ± 1.0 events vs 0.1 ± 0.3 events; P<.01). Imaging follow-up revealed only 1 case of device thrombosis. CONCLUSIONS: LAAO as an adjunctive therapy to OAC seems to be feasible and safe in patients with previous cardioembolic events despite optimal OAC. In our series, this strategy was associated with a low rate of cerebrovascular events after LAAO.

Sirolimus-eluting stents versus bare-metal stents in patients with in-stent restenosis: results of a pooled analysis of two randomized studies.

BACKGROUND: Treatment of patients with in-stent restenosis (ISR) remains a challenge. We sought to compare results of sirolimus-eluting stents (SES) with those of bare-metal stents (BMS) in patients with ISR. METHODS: The results obtained in the stent arm of two randomized studies were analyzed. The RIBS I study (450 patients with ISR) allocated 224 patients to BMS; the RIBS II study (150 patients with ISR) allocated 76 patients to SES. Complete 1-year follow-up was obtained in all 300 patients treated with stents. RESULTS: Although inclusion/exclusion criteria were identical in the two studies, when compared with patients in the BMS group, patients in the SES arm had more adverse baseline characteristics, more diffuse lesions, and smaller vessels. However, late angiographic findings including in-segment recurrent restenosis rate (11 vs. 38%, P < 0.001), minimal lumen diameter (2.52 vs. 1.63 mm, P < 0.001), and late loss (0.13 vs. 1.04 mm, P < 0.001) were significantly better after SES. The 1-year event-free survival was also significantly improved in the SES group (88 vs. 78%, P < 0.05), as the result of a lower requirement for repeated revascularizations (10.5 vs. 19.6%, P < 0.05). Prespecified subgroup analyses were consistent with the main outcome measures. After adjusting for (a) imbalances in baseline characteristics (restenosis OR 0.11 [95% confidence interval (CI) 0.03-0.36]; adverse events hazard ratios (HR) 0.33 [95% CI 0.13-0.84]) and (b) the propensity score (restenosis OR 0.08 [95% CI 0.03-0.28]; adverse events HR 0.24 [95% CI 0.09-0.66]), results of the SES group were superior to those obtained in the BMS group. CONCLUSIONS: When compared with BMS, SES improved the long-term clinical and angiographic outcome of patients with ISR.

Long-term outcomes following percutaneous left atrial appendage closure in patients with atrial fibrillation and contraindications to anticoagulation.

PURPOSE: We aimed to evaluate the late clinical outcomes of percutaneous LAA closure in patients with atrial fibrillation (AF) and contraindication to oral anticoagulation. METHODS: Consecutive AF patients with contraindications to oral anticoagulation who underwent successful LAA closure between December 2008 and March 2013 at four centers were included. RESULTS: A total of 101 patients (median age 76 [IQR 69-80] years, 48% women, mean CHA2DS2-VASc 5 ± 2; HAS-BLED 4 ± 1) were included. Eighty-six (85.1%) patients received an Amplatzer Cardiac Plug/Amulet device and 15 (14.9%) patients a Watchman device. The mean follow-up period was 4 ± 1 years. During 358.6 patient-years of follow-up, 7 (6.9%) patients suffered a major stroke (2 cases per 100 person-years; expected rate: 6.2 cases per 100 person-years), and 20 (19.8%) patients experienced at least one episode of major bleeding (6.4 cases per 100 person-years; expected rate: 9.0 cases per 100 person-years). There were no cases of late adverse events related to the device. A total of 34 (33.7%) patients died during follow-up (9.5 cases per 100 person-years). Older age, male sex, low ejection fraction, and chronic kidney disease were identified as predictive factors of late mortality. CONCLUSIONS: Percutaneous LAA closure is safe and effective in the long term in patients with AF with contraindications to anticoagulation. However, a high long-term mortality rate was observed in this high-risk population. Comprehensive patient assessment prior to undergoing LAA closure should identify patients in whose comorbidities limit their overall prognosis.

Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial.

BACKGROUND: Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. METHODS: Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. RESULTS: The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. CONCLUSIONS: Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values.

Incidence, Predictors, and Prognostic Value of Acute Kidney Injury Among Patients Undergoing Left Atrial Appendage Closure.

OBJECTIVES: 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). BACKGROUND: No data exist on the occurrence of AKI after LAAC. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Role of ST-Segment Resolution in Patients With ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention (from the 5-Year Outcomes of the EXAMINATION [Evaluation of the Xience-V Stent in Acute Myocardial Infarction] Trial).

In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR < 50% and STR < 70% at the 30-minute post-pPCI electrocardiogram. Primary end point was the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization at 5-year follow-up. Both baseline and post-PCI 30-minute electrocardiograms were available for STR assessment in 1,351 patients. Of these patients, 228 (16.9%) and 500 (37.0%) exhibited STR < 50% and STR < 70%, respectively. At 5-year follow-up, the POCE was observed more frequently in patients with STR < 50% (hazard ratio [HR] 1.556; 95% confidence interval [CI] 1.194 to 2.027; p <0.001) and in patients with STR < 70% (HR 1.460, 95% CI 1.169 to 1.824, p <0.001) compared with patients with STR > 50% and STR ≥ 70%, respectively. In both cases, this difference was mainly driven by a significant increase in the rate of all-cause death and any revascularization. After multivariable adjustment, STR < 70%, but not STR < 50%, resulted as a 5-year independent predictor of POCE (adjusted HR 1.338, 95% CI 1.008 to 1.778, p = 0.044). In conclusion, in patients with STEMI, the evaluation of 70% STR after pPCI provides independent prognostic information at 5-year follow-up and it can be used to identify patients at high risk of very long-term cardiovascular events.

Correlates of non-target vessel-related adverse events in patients with ST-segment elevation myocardial infarction: insights from five-year follow-up of the EXAMINATION trial.

AIMS: The aim of this substudy was to determine the five-year correlates of non-TV-related adverse events (AE) in STEMI patients included in the EXAMINATION trial. METHODS AND RESULTS: The EXAMINATION trial randomised 1,498 STEMI patients to bare metal or everolimus-eluting stent implantation. In this substudy, patients were analysed according to non-TV-related AE, defined as the composite of either non-TV revascularisation (non-TVR) or non-TV-related myocardial infarction (MI). At five-year follow-up, 125 patients (8.3%) exhibited 136 non-TV-related AE (124 [8.3%] non-TVR, 12 [0.8%] non-TV-related MI), accounting for 47.1% of 289 non-fatal cardiac events overall. These patients had a higher incidence of diabetes mellitus (p<0.001), arterial hypertension (p=0.032), previous MI (p=0.073), multivessel disease (p<0.001), and incomplete revascularisation (p=0.049), and a lower rate of ST-segment resolution >70% (p=0.042) as compared to the rest. At Cox analysis, previous MI (HR 1.872, 95% CI: 1.004-3.489; p=0.048), incomplete revascularisation (HR 1.746, 95% CI: 1.029-2.963; p=0.039) and diabetes (HR 1.942, 95% CI: 1.292-2.919; p=0.001) were independent correlates of non-TV-related AE. CONCLUSIONS: In STEMI patients undergoing primary percutaneous coronary intervention, previous MI, incomplete revascularisation and diabetes resulted in being independent correlates of five-year non-TV-related AE.