Search

Background: Anemia is common in patients with acute myocardial infarction (AMI), and is an independent predictor of mortality. The optimal transfusion strategy in these patients is unclear. Hypothesis: We hypothesized that a "restrictive" transfusion strategy (triggered by hemoglobin ≤8 g/dL) is clinically noninferior to a "liberal" transfusion strategy (triggered by hemoglobin ≤10 g/dL), but is less costly. Methods: REALITY is an international, randomized, multicenter, open-label trial comparing a restrictive vs a liberal transfusion strategy in patients with AMI and anemia. The primary outcome is the incremental cost-effectiveness ratio (ICER) at 30 days, using the primary composite clinical outcome of major adverse cardiovascular events (MACE; comprising all-cause death, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia) as the effectiveness criterion. Secondary outcomes include the ICER at 1 year, and MACE (and its components) at 30 days and at 1 year. Results: The trial aimed to enroll 630 patients. Based on estimated event rates of 11% in the restrictive group and 15% in the liberal group, this number will provide 80% power to demonstrate clinical noninferiority of the restrictive group, with a noninferiority margin corresponding to a relative risk equal to 1.25. The sample size will also provide 80% power to show the cost-effectiveness of the restrictive strategy at a threshold of €50 000 per quality-adjusted life year. Conclusions: REALITY will provide important guidance on the management of patients with AMI and anemia. Sin financiación 3.287 JCR (2021) Q3, 74/143 Cardiac & Cardiovascular Systems 0.983 SJR (2021) Q1, 82/356 Cardiology and Cardiovascular Medicine No data IDR 2021 UEM

Aims Major bleeding events in heart failure (HF) patients are poorly described. We sought to investigate the importance of major bleeding and its impact on outcomes in HF patients. Methods and results We analysed incident bleeding and ischaemic events during a 3 year follow‐up in 2910 HF outpatients included in a prospective multicentre registry. Major bleeding was defined as a Type ≥3 bleed using the Bleeding Academic Research Consortium definition. Ischaemic event was a composite of ischaemic stroke and myocardial infarction. Events were adjudicated by a blinded committee. At inclusion, most patients (89%) received at least one antithrombotic: anticoagulation (53.9%) and/or antiplatelet therapy (46.2%). Bleeding occurred in 111 patients {3 year cumulative incidence: 3.6% [95% confidence interval (CI) 3.0–4.3]} and ischaemic events in 102 patients [3 year cumulative incidence: 3.3% (95% CI 2.7–4.0)]. Most bleedings were Bleeding Academic Research Consortium 3a (32.5%) or 3b (31.5%). Most frequent sites of bleeding were gastrointestinal (40.6%) and intracranial (27.9%). Variables associated with bleeding were atrial fibrillation [hazard ratio (HR) = 2.63 (95% CI 1.66–4.19), P

Background It remains uncertain whether patients with atrial fibrillation (AF) requiring long-term oral anticoagulation (OAC) and with stable coronary artery disease (CAD) should receive antiplatelet therapy (APT) in addition to OAC. Hypothesis APT in addition to OAC would be more effective than OAC alone in preventing ischaemic events in such patients. Methods In the international REduction of Atherothrombosis for Continued Health (REACH) Registry including 68 236 outpatients with or at risk for atherothrombosis, we identified 2347 patients with stable CAD and AF receiving vitamin K antagonists (VKA). Using propensity score matching, patients treated with VKA (n = 1481) were compared with those receiving VKA + APT at inclusion (n = 866). The primary outcome was major adverse cardiovascular events (MACE) at 4 years (cardiovascular death, myocardial infarction, or stroke). Secondary outcomes were all-cause death and bleeding leading to hospitalization and transfusion. Results Patients receiving VKA only were older (74 vs 72 years, P < 0.01), had less diabetes (37% vs 42%, P = 0.02), and less frequent history of percutaneous coronary intervention (28.7% vs 43.9%, P < 0.01). The mean CHA2DS2-VaSc score was 4.9 in the VKA group vs 4.7 in the VKA + APT group (P < 0.01). After propensity score matching, the rate of MACE was similar between groups: hazard ratio = 1.01 (0.77-1.33) (P = 0.94), whereas bleeding tended to be more frequent in the VKA + APT group: odds ratio = 1.87 (0.99-3.50) (P = 0.051). Conclusions In this observational analysis, the use of APT in addition to OAC in patients with stable CAD and AF was not associated with lower risk of ischemic events but possibly with higher bleeding rates. Randomized trials are necessary to determine the optimal long-term antithrombotic strategy.

Objectives: This study aimed to analyze the impact of replacing heparin with bivalirudin in octogenarians undergoing percutaneous coronary intervention (PCI) on postprocedure hemorrhage and 6-month mortality. Background: Randomized trials comparing the antithrombin agent bivalirudin with heparin as the intraprocedural anticoagulant identify a reduction in periprocedural bleeding after PCI. Further, the occurrence of such bleeding seems to predict an increased risk of death or myocardial infarction both in-hospital and at long-term follow-up. Importantly, elderly people who are at the greatest risk of post-PCI bleeding complications are underrepresented in these randomized trials. Methods: From 2000 to 2007, 2,766 consecutive patients from our center who were ≥80 years of age underwent PCI with stent implantation and were included in this analysis. Bivalirudin was used in 1,207 (43.6%) patients and heparin in 1,559 (56.4%). We compared the rates of post-PCI bleeding complications and 6-month mortality. Results: The overall in-hospital bleeding and 6-month mortality rates were 4.6% and 11.8%, respectively. By multivariate logistic regression and after adjustment by propensity score analysis, bivalirudin was associated with a significant decrease in in-hospital bleedings (HR = 0.41, 95% CI = 0.23–0.73, P = 0.003). By multivariate Cox analysis, bivalirudin was also associated with a significant decrease (HR = 0.6, 95% CI = 0.4–0.9, P = 0.01) and in-hospital bleedings with a significant increase in the 6-month mortality (HR = 2.5, 95% CI = 1.6–3.9, P < 0.001). Conclusion: This study suggests an important subset for use of bivalirudin in lieu of heparin that will benefit the very elderly. © 2009 Wiley-Liss, Inc.

Since the first clinical angioplasty by Gruntzig in 1977, restenosis has been the primary drawback of percutaneous coronary intervention (PCI). In the balloon era. restenosis was correlated with elastic recoil and negative remodeling of the arterial wall. Later, introduction of stents proved to be a significant advance in reducing the elastic recoil and negative remodeling at the treatment site but stimulated proliferation, migration of smooth muscle cells, and neointimal hyperplasia, thereby generating a new type of restenosis, in-stent restenosis. Brachytherapy and drug-eluting stents (DES) may be considered the two breakthroughs against neointimal hyperplasia. However, concerns about stent thrombosis and incomplete elimination of in-stent restenosis with DES in complex lesions and patients justify the pursuit of research in this field. Non-stent based local drug delivery and particularly the use of paclitaxel-eluting balloons could be one of these strategies. We aimed to review the concept, preclinical-, and clinical data available with non-stent based local drug delivery and, in particular, with paclitaxel-eluting balloons. © 2009 Wiley-Liss, Inc.

Background: The rate of drug-eluting stent (DES) in-stent restenosis (ISR) exceeds 10% in complex subsets of patients and lesions. The optimal management of DES ISR remains undetermined. Vascular brachytherapy (VBT) is proven to be effective for the treatment of bare metal stent ISR but its outcome for DES ISR has not been established. Methods: Ninety-nine consecutive patients who presented with ISR following DES implantation in 122 lesions were subjected to conventional percutaneous coronary intervention with adjunct VBT using either beta radiation (Beta Rail in 74 patients [82.2%] and the Galileo system in 13 patients [14.4%]) or gamma radiation (Checkmate system in 3 patients [3.3%]). Patients were followed clinically for major adverse cardiac events (MACE) during 1-year follow-up. Results: A high proportion of patients in this cohort presented with complex ISR; 31.1% had recurrences of ISR to the same site, 55% had diffuse or proliferate pattern of restenosis, and 23 lesions (18.9%) were located in a saphenous vein graft. Procedural success and uneventful in-hospital course were documented in all patients post VBT. At 12 months' follow-up, the target lesion revascularization (TLR) rate was 11% and the overall MACE rate was 26%. Patients with multiple episodes of ISR to the same site had a TLR of 16% and MACE rate of 35.5%. Conclusions: VBT for the treatment of DES ISR was found to be effective and safe and should be considered for the treatment of DES ISR, in particular in complex patients with multiple recurrences.