Effects of Triple Therapy in Patients With Non-Valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention Regarding Thromboembolic Risk Stratification.

BACKGROUND: The effects of dual antiplatelet therapy (DAPT) and triple therapy (TT: DAPT plus oral anticoagulation) in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) regarding to CHA2DS2-VASc score remain undefined.We compare the effect of TT vs. DAPT in this setting regarding the CHA2DS2-VASc score. METHODS AND RESULTS: In a prospective multicenter registry, 585 patients (75.2% male, 73.2 ± 8.2 years) with AF undergoing PCI were followed up during 1 year. Of them, 157 (26.8%) had a CHA2DS2-VASc=1, and 428 (73.2%) had a CHA2DS2-VASc ≥2. TT was prescribed in 51.6% with CHA2DS2-VASc=1 and in 55.5% with CHA2DS2-VASc ≥ 2. Patients with CHA2DS2-VASc=1 receiving TT had a similar thromboembolism rate to those on DAPT (1.2% vs. 1.3%, P=0.73), but more total (19.5% vs. 6.9%, P=0.01) and a tendency to more major (4.9% vs. 0%, P=0.06) bleeding. However, patients with CHA2DS2-VASc ≥ 2 receiving TT had a lower thromboembolism rate (1.7% vs. 5.3%, P=0.03) and a trend towards more bleeds (21.8% vs. 15.6%, P=0.06), with an excess of major bleeding (8.4% vs. 3.1%, P=0.01). Rates of major adverse cardiac events (MACE) in both CHA2DS2-VASc subgroups were similar, irrespective of treatment. In a Cox multivariate analysis, TT was associated to major bleeding, but not with MACE. CONCLUSIONS: In patients with AF and CHA2DS2-VASc=1 undergoing PCI, the use of TT involves a high risk of bleeding without a significant benefit in preventing thromboembolism.

Worse 12-month prognosis in women with non-valvular atrial fibrillation undergoing percutaneous coronary intervention.

BACKGROUND: Limited data exists on the impact of sex on outcomes in non-valvular atrial fibrillation (NVAF) patients undergoing percutaneous coronary intervention (PCI). We explored the impact of sex on ischemic and bleeding events in these patients within 1-year. METHODS: A prospective register included 1021 patients with NVAF undergoing PCI and 253 (24.8%) were women. The primary end point was a composite of cardiovascular death, stroke or systemic embolism (SSE). The secondary end-point was major bleeding events defined as a Bleeding Academic Research Consortium (BARC ≥ 3a). RESULTS: Women were older (76.8 ±â€¯7.7 vs 71.8 ±â€¯9.1 years, p < 0.0001), and presented more often CHA2DS2-VASc ≥ 2 (adjusted HR 1.15; 95%CI 1.13-1.18, p < 0.0001) and HAS-BLED ≥ 3 (adjusted HR 1.12; 95%CI 1.10-1.14, p < 0.0001) than men. The use of oral anticoagulant at discharge was similar in both sexes (55.9% vs 56.5%, p = 0.45). The time in therapeutic range (TTR ≥ 65%) was lower in women than in men (35.6 ±â€¯24.6% vs 48.9 ±â€¯27.2%, p = 0.002). The incidence of adverse events was higher in women (39.9% vs 28.9%, p = 0.01). After adjusting for confounder variables, cardiovascular death or SSE rate (16.6% vs 10.4%; adjusted HR 1.58; 95%CI 1.07-2.31; p = 0.01) and major bleeding (11.5% vs 5.0%; adjusted HR 2.17; 95%CI 1.31-3.59; p = 0.003) were higher in women, as was cardiovascular death (adjusted HR 1.71; 95%CI, 1.18-2.46, p = 0.004). TTR was negatively correlated with any bleeding event in women (r = -0.41; p = 0.03). CONCLUSIONS: Female with NVAF undergoing PCI showed a lower TTR than men and TTR was associated with bleeding events. Female sex was an independent risk factor for cardiovascular death and major bleeding.

Safety of drug-eluting stents compared to bare metal stents in patients with an indication for long-term oral anticoagulation: A propensity score matched analysis.

BACKGROUND: Drug-eluting stents (DES) reduce stent restenosis compared with bare-metal stents (BMS). However, their use in patients requiring long-term oral anticoagulation (OAC) is controversial owing to increased risk of bleeding associated with OAC plus antiplatelet treatment over time. OBJECTIVE: To assess the safety of DES vs BMS in patients requiring long-term OAC for any reason. METHODS: Prospective observational multicenter study conducted at 6 teaching centers of patients undergoing percutaneous coronary intervention who required OAC for any reason. Adverse outcomes were analyzed at 1 year of follow-up. RESULTS: We identified 1002 patients requiring OAC (mean age: 72 years, male 72%). Six- hundred and thirteen patients (61.2%) received BMS and 389 (38.8%) DES. Diabetes, previous PCI, myocardial infarction and acute coronary syndrome at admission (P < 0.0001) were more common in patients with DES. Antithrombotic prescribing was similar at discharge between groups (TT: 51.5% vs 50.9%, clopidogrel plus OAC: 7.0% vs 5.0% and DAPT: 41.4% vs 42.7%, p = 0.52). DES and BMS patients showed similar rates of total bleeding (15.2% vs 13.4%, adjusted HR 0.82 [0.58-1.17, p = 0.82 and major bleeding (6.2% vs 6.0%; adjusted HR 1.22 [0.71-2.09], p = 0.46) and MACE (15.2% vs 18.6%, adjusted HR: 0.82 [0.57-1.17], p = 0.28, while restenosis was lower in patients with DES (5.3% vs 8.5%, adjusted HR. (0.52 [0.29-0.92], p = 0.02. Cox analysis after propensity score selection of 368 matched pairs demonstrated that DES use was not associated with a higher incidence of total bleeding or major bleeding. CONCLUSION: DES use is safe in patients with an indication for long-term OAC.

Prognostic Value of Initial Left Ventricular Remodeling in Patients With Reperfused STEMI.

OBJECTIVES: This study sought to establish the best definition of left ventricular adverse remodeling (LVAR) to predict outcomes and determine whether its assessment adds prognostic information to that obtained by early cardiac magnetic resonance (CMR). BACKGROUND: LVAR, usually defined as an increase in left ventricular end-diastolic volume (LVEDV) is the main cause of heart failure after an ST-segment elevated myocardial infarction; however, the role of assessment of LVAR in predicting cardiovascular events remains controversial. METHODS: Patients with ST-segment elevated myocardial infarction who received percutaneous coronary intervention within 6 h of symptom onset were included (n = 498). CMR was performed during hospitalization (6.2 ± 2.6 days) and after 6 months (6.1 ± 1.8 months). The optimal threshold values of the LVEDV increase and the LV ejection fraction decrease associated with the primary endpoint were ascertained. Primary outcome was a composite of cardiovascular mortality, hospitalization for heart failure, or ventricular arrhythmia. RESULTS: The study was completed by 374 patients. Forty-nine patients presented the primary endpoint during follow-up (72.9 ± 42.8 months). Values that maximized the ability to identify patients with and without outcomes were a relative rise in LVEDV of 15% (hazard ratio [HR]: 2.1; p = 0.007) and a relative fall in LV ejection fraction of 3% (HR: 2.5; p = 0.001). However, the predictive model (using C-statistic analysis) failed to demonstrate that direct observation of LVAR at 6 months adds information to data from early CMR in predicting outcomes (C-statistic: 0.723 vs. 0.795). CONCLUSIONS: The definition of LVAR that best predicts adverse cardiovascular events should consider both the increase in LVEDV and the reduction in LV ejection fraction. However, assessment of LVAR does not improve information provided by the early CMR.

Prognostic Value of Strain by Tissue Tracking Cardiac Magnetic Resonance After ST-Segment Elevation Myocardial Infarction.

OBJECTIVES: The aim of this study was to evaluate the prognostic value of strain as assessed by tissue tracking (TT) cardiac magnetic resonance (CMR) soon after ST-segment elevation myocardial infarction (STEMI). BACKGROUND: The prognostic value of myocardial strain as assessed post-STEMI by TT-CMR is unknown. METHODS: The authors studied the prognostic value of TT-CMR in 323 patients who underwent CMR 1 week post-STEMI. Global (average of peak segmental values [%]) and segmental (number of altered segments) longitudinal (LS), circumferential, and radial strain were assessed using TT-CMR. Global and segmental strain cutoff values were derived from 32 control patients. CMR-derived left ventricular ejection fraction, microvascular obstruction, and infarct size were determined. Results were validated in an external cohort of 190 STEMI patients. RESULTS: During a median follow-up of 1,085 days, 54 first major adverse cardiac events (MACE), which included 10 cardiac deaths, 25 readmissions for heart failure, and 19 readmissions for reinfarction were documented. MACE was associated with more severe abnormalities in all strain indexes (p < 0.001), although only global LS was an independent predictor (p < 0.001). The MACE rate was higher in patients with a global LS of ≥-11% (22% vs. 9%; p = 0.001). After adjustment for baseline and CMR variables, global LS (hazard ratio [HR]: 1.21; 95% confidence interval [CI]: 1.11 to 1.32; p < 0.001) was associated with MACE. In the external validation cohort, a global LS ≥-11% was seen in a higher proportion of patients with MACE (34% vs. 9%; p < 0.001). Global LS predicted MACE after adjustment for baseline and CMR variables (HR: 1.18; 95% CI: 1.04 to 1.33; p = 0.008). The addition of global LS to the multivariate models, including baseline and CMR variables, did not significantly improve the categorical net reclassification improvement index in either the study group (-0.015; p = 0.7) or in the external validation cohort (-0.019; p = 0.9). CONCLUSIONS: TT-CMR provided prognostic information soon after STEMI. However, it did not substantially improve risk reclassification beyond traditional CMR indexes.

Impact of Triple Therapy in Elderly Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

BACKGROUND AND PURPOSE: Selecting an ideal antithrombotic therapy for elderly patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) can be challenging since they have a higher thromboembolic and bleeding risk than younger patients. The current study aimed to assess the efficacy and safety of triple therapy (TT: oral anticoagulation plus dual antiplatelet therapy: aspirin plus clopidogrel) in patients ≥75 years of age with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). METHODS: A prospective multicenter study was conducted from 2003 to 2012 at 6 Spanish teaching hospitals. A cohort study of consecutive patients with AF undergoing PCI and treated with TT or dual antiplatelet therapy (DAPT) was analyzed. All outcomes were evaluated at 1-year of follow-up. RESULTS: Five hundred and eighty-five patients, 289 (49%) of whom were ≥75 years of age (79.6±3.4 years; 33% women) were identified. TT was prescribed in 55.9% of patients at discharge who had a higher thromboembolic risk (CHA2DS2VASc score: 4.23±1.51 vs 3.76±1.40, p = 0.007 and a higher bleeding risk (HAS-BLED ≥3: 88.6% vs 79.2%, p = 0.02) than those on DAPT. Therefore, patients on TT had a lower rate of thromboembolism than those on DAPT (0.6% vs 6.9%, p = 0.004; HR 0.08, 95% CI: 0.01-0.70, p = 0.004). Major bleeding events occurred more frequently in patients on TT than in those on DAPT (11.7% vs 2.4%, p = 0.002; HR 5.2, 95% CI: 1.53-17.57, p = 0.008). The overall mortality rate was similar in both treatment groups (11.9% vs 13.9%, p = 0.38); however, after adjustment for confounding variables, TT was associated with a reduced mortality rate (HR 0.33, 95% CI: 0.12-0.86, p = 0.02). CONCLUSIONS: In elderly patients with AF undergoing PCI, the use of TT compared to DAPT was associated with reduced thromboembolism and mortality rates, although a higher rate of major bleeding.

Outcome prediction in terms of functional disability and mortality at 1 year among ICU-admitted severe stroke patients: a prospective epidemiological study in the south of the European Union (Evascan Project, Andalusia, Spain).

OBJECTIVES: To analyse 1-year mortality and functional disability outcomes and resource use in critical stroke patients admitted to ICU. DESIGN AND SETTING: Multi-centre, prospective, observational study in 28 Spanish hospitals. PATIENTS. Patients admitted for acute stroke from March-August 1999. INTERVENTION: Collection of data on: severity by Apache III and Glasgow Coma Score; neurological lesion, hospital and 1-year mortality; functional disability at 1 year by Barthel Index and Glasgow Outcome Scale; ICU length of stay, life support techniques, and neurosurgical interventions. MEASUREMENT AND RESULTS: We studied 132 patients: 21% with subarachnoid haemorrhage (SAH), 58% intracerebral haemorrhage (ICH), 20% ischaemic stroke (ISC); Apache III 63+/-29 ICU stay 13+/-12 days; 74% required mechanical ventilation. Hospital and 1-year mortality was 33% (22%:ISC, 32%:SAH, 37%:ICH) and 53.8% (66%:ISC, 39%:SAH, 54%:ICH), respectively. Age, APACHE III, and diagnosis defined hospital mortality. Age, APACHE III, and Glasgow Coma Score defined 1-year mortality. Barthel Index score improved ( P<0.001) between discharge and 1 year; 73% of patients presented severe disability at discharge vs. 26% at 1 year; 8% minimal/no disability at discharge vs. 43.3% at 1 year. Only 17% of subarachnoid haemorrhage patients presented severe disability at 1 year. Admission Apache III and hospital-discharge Barthel Index scores were related to functional outcome at 1 year. CONCLUSIONS: Critical stroke patients are characterized by high severity of illness, elevated resource consumption, and poor outcomes that are mainly influenced by severity and age. Glasgow Coma Score-measured neurological severity is the main determinant of future functional capacity, which is greater at 1 year.