Current Use of Oral Anticoagulation Therapy in Elderly Patients with Atrial Fibrillation: Results from an Italian Multicenter Prospective Study-The ISNEP Study.

Background: Atrial fibrillation (AF) is the most common heart arrhythmia, and its prevalence increases with age. Oral Anticoagulant Therapy (OAT) with non-vitamin K antagonist oral anticoagulants (NOACs) or vitamin K antagonists (VKAs) is essential to avoid thromboembolic events in AF. However, this treatment is associated with a high risk of bleeding and low adherence in elderly patients. Aim: The aim was to evaluate the real-world use of OAT in a population of patients aged ≥80 years in twenty-three Italian centers and to investigate the tolerance of and patient satisfaction with this therapy. Methods: The ISNEP Study is a multicenter cross-sectional study enrolling patients with AF and aged ≥80 years and treated with either NOACs or VKAs. A written questionnaire was administered to each patient to evaluate the adherence to and patient satisfaction with this therapy. Results: The study included 641 patients with a mean age of 85 (82−87) years. The use of NOACs was reported in 93.0% of cases, with the remaining 7.0% treated with VKAs. A history of stroke events was reported in five (11.1%) and one (0.2%) patients in the VKA and NOAC groups, respectively. The rate of referred ecchymosis/epistaxis was significantly higher in the VKA group compared to the NOAC group (p < 0.001). Patients receiving NOACs reported a substantial improvement in their quality of life compared to the VKA group. Conclusions: A small, but not negligible, proportion of elderly AF patients is still treated with VKAs. Patients treated with NOAC have a higher level of satisfaction with the therapy and complete adherence.

Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial.

OBJECTIVES: This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). BACKGROUND: Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS. METHODS: A total of 313 patients ≥ 75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year. RESULTS: During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03). CONCLUSIONS: The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185).

Routine versus selective coronary artery bypass for left main coronary artery revascularization: the Appraise a Customized Strategy for Left Main Revascularization (CUSTOMIZE) study.

BACKGROUND: Current guidelines recommend coronary artery bypass grafting (CABG) as the first choice of revascularization in patients with unprotected left main coronary artery (ULMCA) disease. We tested the hypothesis that a non guideline-driven approach to ULMCA revascularization which uses percutaneous coronary intervention (PCI) by default and CABG in selected patients may be as safe as the traditional guideline-driven approach. METHODS: Between March 2002 and December 2008, PCI has been used as a default strategy for ULMCA revascularization in Center 1 (non guideline-driven [NGD] group), whereas CABG has been used as a default strategy in Center 2 (guideline-driven [GD] group). RESULTS: A total of 838 patients with ULMCA disease were included. Of these 67.1% and 32.9% were treated in the NGD and GD groups, respectively. A significant higher risk of major adverse cardiac events (MACE) (hazard ratio [HR] 1.60, 95% confidence interval [CI] 1.10-2.33, p=0.014) and target vessel revascularization (HR 2.44, 95% CI 1.26-4.72, p=0.008) occurred at 24 months in the NGD group as compared with GD Group. Adjustment by means of propensity score did not result in substantial changes with regard to the subcomponent safety and efficacy endpoints. Conversely, the composite of MACE was no longer significant according to all types of statistical adjustment. CONCLUSIONS: In a large registry of patients with ULMCA disease undergoing revascularization in current clinical practice, an approach based on PCI and the selective use of CABG gives results which are not inferior to those of a traditional approach guided by the current guidelines.

Usefulness of SYNTAX score to select patients with left main coronary artery disease to be treated with coronary artery bypass graft.

OBJECTIVES: The purpose of our study was to investigate the utility of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score in aiding patient selection for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in a large contemporary registry of patients undergoing revascularization of left main coronary artery. BACKGROUND: The SYNTAX score has been developed as a combination of several validated angiographic classifications aiming to grade the coronary lesions with respect to their functional impact, location, and complexity. METHODS: Between March 2002 and December 2008, 819 patients with left main coronary artery disease underwent revascularization in 2 Italian centers. We compared clinical outcomes of PCI versus CABG in patients with SYNTAX score < or =34 and patients with SYNTAX score >34. RESULTS: The rates of 2-year mortality were similar between CABG and PCI in the group of patients with SYNTAX score < or =34 (6.2% vs. 8.1%, p = 0.461). Among patients with SYNTAX score >34, those treated with CABG had lower rates of mortality (8.5% vs. 32.7%, p < 0.001) than those treated with PCI. After statistical adjustment, revascularization by PCI resulted in a similar risk of death compared with CABG in patients with SYNTAX score < or =34 (hazard ratio: 0.81, 95% confidence interval: 0.33 to 1.99, p = 0.64) and in a significantly higher risk in patients with SYNTAX score >34 (hazard ratio: 2.54, 95% confidence interval: 1.09 to 5.92, p = 0.031). CONCLUSIONS: A SYNTAX score threshold of 34 may usefully identify a cohort of patients with left main disease who benefit most from surgical revascularization in terms of mortality.

Detection of coronary artery anomalies and coronary aneurysms by multislice computed tomography coronary angiography.

We report some variants, anomalies and aneurysms of the coronary artery tree observed in patients referred to our radiology department for suspected or known coronary artery diseases. 265 patients, with heart rate < 70 beats per minute and stable clinical conditions, underwent 64-MSCT. They were intravenously given contrast medium followed by saline as a chaser. Images and data were reconstructed and evaluated by two radiologists. Seven out of these patients (5 males and two females) were found to have abnormalities (variants or anomalies) of coronary arteries or coronary aneurysms, with an incidence respectively of 1.88% and 0.75%. Two patients had an anomalous origin of the left coronary artery from the pulmonary artery, as previously described (Castorina S et al., 2008). As regards the other patients, one had separate origins of the anterior descendant and circumflex arteries from the left lateral sinus with two ostia, one had quadrifurcation of the left coronary trunk, one had agenesis of the left coronary ostium and trifurcation of the right coronary artery and two had coronary aneurysms. Images acquired by 64-MSCT, because of their spatial dislocation, permit anatomical study from different perspectives. Our data confirm the ability of MSCT to evaluate, in a few seconds, anomalies of coronary arteries offering additional information for a more complete diagnosis.

Sicilian DES Registry: prospective in-hospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients.

OBJECTIVE: This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world. METHODS: From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure. RESULTS: Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%). CONCLUSIONS: Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.

Drug therapy during percutaneous coronary interventions in stable and unstable coronary artery disease: the Italian Drug Evaluation in Angioplasty (IDEA) study.

BACKGROUND: Although periprocedural drug therapy has been shown to improve the outcome of percutaneous coronary intervention (PCI), information regarding its use in daily clinical practice is limited. METHODS: We conducted a national survey on periprocedural drug therapy across the spectrum of PCI practice in Italy. Seventy-nine centers (41% of the Italian interventional cath labs) with a fair distribution across the country volunteered to enroll consecutive patients undergoing PCI for any indication from September 15 to 29, 2003. RESULTS: Of the 1517 patients enrolled, 745 (49 %) had stable coronary disease and 772 (51%) acute coronary syndromes (ACS): 457 without and 315 with ST-segment elevation. Stenting was used in 89% of cases. N-acetylcysteine was used in 23% of the patients with preexisting renal dysfunction. Thienopyridine (63% clopidogrel) pretreatment was given in 49 % of the cases and, at logistic regression analysis, was independently associated with prior myocardial infarction (p < 0.001), prior PCI (p = 0.007), stable coronary disease (p = 0.005), and treatment in northern Italy (p < 0.05). Platelet glycoprotein (GP) IIb/IIIa receptor blockers (50% abciximab 50% tirofiban) were used in 22% of the stable patients and 40 % of those with ACS, a proportion increasing to 62 % when PCI was undertaken as an emergency procedure. Off-label use of these drugs was frequent (direct cath lab use of tirofiban in 55% of the cases; bailout use: 16% with abciximab and 26% with tirofiban). At logistic regression analysis, independent predictors of GP IIb/IIIa receptor blocker use were emergency procedure (odds ratio 3.6, 95 % confidence interval 2.6 to 5.0, p < 0.0001) and treatment for an ACS (odds ratio 1.6, 95% confidence interval 1.3 to 2.1, p = 0.0002). An emergency procedure was the only independent predictor for the use of abciximab instead of tirofiban (odds ratio 4.1, 95% confidence interval 2.6 to 6.5, p < 0.0001). Triple periprocedural antiplatelet therapy, including aspirin, a thienopyridine and a GP IIb/IIIa receptor blocker was administered in only 21% of cases. At discharge, all stented patients received aspirin and a thienopyridine. Despite complete procedural success in > 90% of cases, 50% of the patients were discharged on symptomatic anti-ischemic therapy. CONCLUSIONS: A wide gap exists between guideline recommendations and periprocedural drug therapy in PCI, the only exception being full prescription of aspirin and a thienopyridine at discharge after stenting. In patients with ACS, thienopyridine pretreatment is often used as a surrogate for GP IIb/IIIa blockade, whose use rather is associated with emergency procedures. Off-label use of drugs is not uncommon.

[Potential impact of drug-eluting stents in Sicily: results from a multicenter survey and cost-benefit analysis of drug-eluting stents versus bare metal stents]. / Impatto potenziale dello stent medicato nella pratica clinica siciliana: risultati di una "survey" multicentrica e di un'analisi costo-beneficio rispetto allo stent metallico.

BACKGROUND: The recent introduction of drug-eluting stents (DES) has shown, in randomized controlled trials, to reduce the incidence of restenosis as compared to bare metal stents (BMS). Since their cost is considerably higher than that of BMS, the study assessed the economic impact of the adoption of this new therapy in the Sicilian clinical practice. METHODS: An economic evaluation was carried out by means of a linear decision model developed in Excel that simulated and compared costs and clinical pathway, within 1 year of the intervention, of hypothetical groups of patients with de novo lesions undergoing angioplasty with DES or BMS. Clinical data were obtained from the available literature and adapted to the Sicilian reality, using data from an original survey conducted in 7 local cath labs. The survey collected information on the anatomical case-mix of the population treated, the average number of stents used in the various procedures and the methods of treatment for in-stent restenosis. RESULTS: Compared to BMS, DES allows to avoid, on average, 11.8 revascularizations out of 100 patients over a period of 1 year, but requires to bear an incremental net cost of Euro 931 for the annual treatment of each patient. The cost-benefit ratio is more favorable for those categories of patients/lesions in which the risk of in-stent restenosis is higher and, at the same time, the number of stents implanted per procedure is lower (single-vessel diabetics and small vessels). CONCLUSIONS: The results of the study show how, within the scope of a policy that has tended more and more to rationalize the use of available health resources, the use of the expensive DES is not justified from an economic point of view in groups of patients and types of lesions in which a BMS is also associated with a lower likelihood of revascularization. Therefore, the study provides a starting point for consideration by hospital centers, suggesting the use of a mixture of DES for the treatment of lesions/patients at the highest risk of restenosis and BMS for the treatment of lesions/patients at lower risk of re-intervention.