Safety and feasibility of selective intracoronary hypothermia in acute myocardial infarction.

AIMS: Hypothermia reduces reperfusion injury and infarct size in animal models of acute myocardial infarction if started before reperfusion. Human studies have not confirmed benefit, probably due to insufficient myocardial cooling and adverse systemic effects. This study sought to assess the safety and feasibility of a novel method for selective, sensor-monitored intracoronary hypothermia. METHODS AND RESULTS: Ten patients undergoing primary percutaneous coronary intervention (PPCI) were included. Saline at room temperature was administered distal to the culprit lesion through an inflated overthe- wire balloon (OTWB) in order to cool the endangered myocardium for 10 minutes (occlusion phase). Next, the OTWB was deflated and cooling continued with saline at 4°C for another 10 minutes (reperfusion phase). A sensor-tipped temperature wire in the distal coronary artery allowed titration of the infusion rate to achieve the desired coronary temperature (6°C below body temperature). Target coronary temperature was achieved within 27 seconds (median; IQR 21-46). Except for two patients with inferior wall infarction experiencing transient conduction disturbances, no side effects occurred. Systemic temperature remained unchanged. Finally, PPCI was performed as per routine. CONCLUSIONS: Selective hypothermia of the infarct area by intracoronary infusion of saline provides a novel method to reduce coronary temperature quickly and guarantee local myocardial hypothermia. In anterior wall myocardial infarctions, the protocol appeared safe, without serious haemodynamic or systemic side effects. In inferior wall myocardial infarctions, transient conduction abnormalities of short duration occurred. Potentially, selective intracoronary delivery of hypothermia could attenuate reperfusion injury caused by traditional PPCI.

Effects of a nurse-coordinated prevention programme on health-related quality of life and depression in patients with an acute coronary syndrome: results from the RESPONSE randomised controlled trial.

BACKGROUND: Improvement of health-related quality of life (HRQOL) is an important goal in preventive cardiology. HRQOL is also related to depressive symptoms, which represent a common co-morbidity and risk factor in patients with an acute coronary syndrome (ACS). Comprehensive nurse-coordinated prevention programmes (NCPP) in secondary care have been shown to reduce cardiovascular risk, however their effects on HRQOL and depressive symptoms have not been evaluated. We therefore investigated HRQOL and depressive symptoms in a secondary analysis in the RESPONSE trial, evaluating the effect of a NCPP on cardiovascular risk. METHODS: RESPONSE was a multicentre (n = 11) randomised controlled trial in ACS-patients in secondary and tertiary healthcare settings evaluating a NCPP. The intervention consisted of four outpatient nurse clinic visits in the first 6 months after the index event, focusing on healthy lifestyles, biometric risk factors and medication adherence, in addition to usual care. The control group received usual care only. The outcome was change in HRQOL as measured by the MacNew questionnaire and change in depressive symptoms as measured by Beck's Depression Inventory (BDI) questionnaire at 12-months follow-up relative to baseline. RESULTS: Of 754 patients randomised, 615 were analysed for HRQOL; 120 for depressive symptoms. At baseline, HRQOL was 5.17 (SD 1.09) and 5.20 (SD1.04) (scale range 1.0 to 7.0) in the intervention and control group, respectively. At 12 months follow-up, HRQOL increased by 0.57 (SD 0.89) in the intervention group as compared with 0.42 (SD 0.90) in the control group (p = 0.03). This increase was observed across all relevant subscales. The BDI decreased by 1.9 in the intervention group as compared with 0.03 in the control group (p = 0.03) (scale range 1.0 to 63). CONCLUSION: Participation in a NCPP is associated with a modest but statistically significant increase in HRQOL, and a decrease of depressive symptoms, both of which are highly relevant to patients. A reduction in depressive symptoms may in addition contribute to a reduction in the overall risk of recurrent events. TRIAL REGISTRATION: Dutch trials register: NTR1290 . Registered 24 April 2008.

Comparison of drug-eluting and bare-metal stents for primary percutaneous coronary intervention with or without abciximab in ST-segment elevation myocardial infarction: DEBATER: the Eindhoven reperfusion study.

OBJECTIVES: The goal of this study was to demonstrate superiority of sirolimus-eluting stents (SES) over bare-metal stents (BMS) and of abciximab over no abciximab in primary percutaneous coronary intervention (PCI). BACKGROUND: Drug-eluting stents (DES) are increasingly used in primary PCI, but the recommendations for use in primary PCI are based on a few randomized controlled trials with selected patients. The usefulness of abciximab in primary PCI is not established. METHODS: Nine hundred seven patients referred to the Catharina Hospital were randomized to SES or BMS, and to abciximab or no abciximab in a prospective, randomized, open 2 × 2 factorial trial with blinded evaluation. Primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction (MI), stroke, repeat revascularization, and bleeding at 1 year (stent arm) and the composite of death, target vessel MI, target vessel revascularization (TVR), and bleeding at 30 days (abciximab arm). RESULTS: At 1 year, the rate of MACCE was lower in the SES arm (16.5% vs. 25.8%, p = 0.001), mainly driven by less repeat revascularization (9.8% vs. 16.8%; p = 0.003) and without influencing the cumulative incidence of death and MI (5.2% vs. 5.8%; p = 0.68). At 30 days, the rate of the composite of death, target vessel MI, TVR, and bleeding was lower in the abciximab arm (8.2% vs. 12.4%, p = 0.04), mainly driven by less TVR due to less stent thrombosis (1.2% vs.7.4%, p < 0.001). However, bleeding complications occurred more frequently in the abciximab group (5.7% vs. 2.8%, p = 0.03). CONCLUSIONS: Primary PCI with SES reduces adverse events at 1 year, mainly by reduction of repeat revascularization, whereas abciximab reduces early stent thrombosis, at the expense of more bleeding complications. (Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction [DEBATER]; NCT00986050).