Outcomes 1 year after thrombus aspiration for myocardial infarction.

BACKGROUND: Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) has not been proved to reduce short-term mortality. We evaluated clinical outcomes at 1 year after thrombus aspiration. METHODS: We randomly assigned 7244 patients with STEMI to undergo manual thrombus aspiration followed by PCI or to undergo PCI alone, in a registry-based, randomized clinical trial. The primary end point of all-cause mortality at 30 days has been reported previously. Death from any cause at 1 year was a prespecified secondary end point of the trial. RESULTS: No patients were lost to follow-up. Death from any cause occurred in 5.3% of the patients (191 of 3621 patients) in the thrombus-aspiration group, as compared with 5.6% (202 of 3623) in the PCI-only group (hazard ratio, 0.94; 95% confidence interval [CI], 0.78 to 1.15; P=0.57). Rehospitalization for myocardial infarction at 1 year occurred in 2.7% and 2.7% of the patients, respectively (hazard ratio, 0.97; 95% CI, 0.73 to 1.28; P=0.81), and stent thrombosis in 0.7% and 0.9%, respectively (hazard ratio, 0.84; 95% CI, 0.50 to 1.40; P=0.51). The composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis occurred in 8.0% and 8.5% of the patients, respectively (hazard ratio, 0.94; 95% CI, 0.80 to 1.11; P=0.48). The results were consistent across all the major subgroups, including grade of thrombus burden and coronary flow before PCI. CONCLUSIONS: Routine thrombus aspiration before PCI in patients with STEMI did not reduce the rate of death from any cause or the composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis at 1 year. (Funded by the Swedish Research Council and others; TASTE ClinicalTrials.gov number, NCT01093404.).

Rationale and design of the Randomized Intervention with CPAP in Coronary Artery Disease and Sleep Apnoea--RICCADSA trial.

RATIONALE: Obstructive sleep apnoea (OSA) is common in coronary artery disease (CAD) and a possible cause of increased mortality. To date, there is a lack of randomized controlled trials to draw the conclusion that all CAD patients should be investigated for OSA and subsequently be treated with continuous positive airway pressure (CPAP). OBJECTIVE: The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over a 3-year period in CAD patients with OSA. Secondary outcomes include cardiovascular biomarkers, cardiac function and maximal exercise capacity at 3-month- and 1-year follow-ups. PATIENTS AND METHODS: A sample of 400 CAD patients (100 non-sleepy OSA patients randomized to CPAP, 100 to non-CPAP; 100 sleepy OSA patients on CPAP, and 100 CAD patients without OSA) will be included. So far, 240 patients have been enrolled in the trial since December 31, 2005. CONCLUSION: The RICCADSA trial will contribute to defining the impact of CPAP on prognosis of CAD patients with OSA.

Patients expectations and fulfilment of expectations before and after treatment for suspected coronary artery disease assessed with a newly developed questionnaire in combination with established health-related quality of life questionnaires.

BACKGROUND: Clinical decision-making is often based on evidence of outcome after a specific treatment. Healthcare providers and patients may, however, have different perceptions and expectations of what to achieve from a certain healthcare measure. AIMS: To evaluate patients' expectations, perceptions and health related quality of life (HRQoL) before a care process including coronary angiography for suspected coronary artery disease and to evaluate the fulfilment of these expectations in relation to established patient reported outcome measures (PROMs) 6 months later. Furthermore, an aim was to try to define meaningful patient reported experience measures (PREMs) in this population. METHODS: 544 patients planned for coronary angiography completed a newly developed questionnaire to assess expectations and perceptions of treatment, the expectation questionnaire (ExpQ) and two established HRQoL questionnaires together with the established generic Short-Form 36 (SF36) and the disease specific Seattle Angina Questionnaire (SAQ). RESULTS: Patients had before the intervention, in general, high expectations of improvement after investigation and treatment and there was a positive attitude towards life style changes, medication and participation in decision-making regarding their own treatment. Only, 56.4% of the patients, however, reported fulfilment of treatment expectations. Fulfilment of treatment expectations correlated strongly with improvement in HRQoL after the care process. CONCLUSIONS: To measure patients ´ expectations and fulfilments of these may offer simple and meaningful outcomes to evaluate a healthcare process from a patient ´s perspective. To approach patients' expectations may also strengthen patient involvement in the care process with the possibilities of both higher patient satisfaction and medical results of the treatment.