Prospective, multicenter, randomized, controlled pilot trial of peritoneal hypothermia in patients with ST-segment- elevation myocardial infarction.

BACKGROUND: Systemic hypothermia may reduce infarct size if established before reperfusion. The large surface area of the bowel may facilitate rapid hypothermia. We therefore examined the feasibility, safety, and efficacy of hypothermia induced by an automated peritoneal lavage system in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. METHODS AND RESULTS: Patients with ST-segment-elevation myocardial infarction within 6 hours of symptom onset were randomized to peritoneal hypothermia before and for 3 hours after percutaneous coronary intervention versus control. The primary safety end point was the 30-day composite rate of death, reinfarction, ischemia-driven target vessel revascularization, major bleeding, sepsis, pneumonia, peritonitis, severe arrhythmia, or renal failure. The primary efficacy end point was infarct size assessed by cardiac MRI on day 3 to 5. Fifty-four patients were randomized at 7 centers to hypothermia (n=28) versus control (n=26). Hypothermia was successfully initiated in 96.3% of patients, and median [interquartile range] temperature at first balloon inflation was 34.7 [34.0-34.9]°C. Median door-to-balloon times in the hypothermia and control groups were 62 [51-81] and 47 [37-55] minutes, respectively (P=0.007). The primary safety end point occurred in 6 (21.4%) and 0 (0%) patients in the hypothermia and control groups, respectively (P=0.01), including 3 versus 0 stent thrombosis events. Infarct size was 17.2% [15.1-20.6] and 16.1% [10.0-22.2] in the hypothermia and control groups, respectively (P=0.54). CONCLUSIONS: Peritoneal hypothermia is feasible and achieves rapid cooling with only a modest increase in treatment times in the setting of ST-segment-elevation myocardial infarction. However, in the present randomized trial, peritoneal hypothermia was associated with an increased rate of adverse events without reducing infarct size. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01655433.

Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial.

BACKGROUND: Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure. We undertook a single-blind trial to assess this approach. METHODS: Patients with New York Heart Association (NYHA) class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. They were randomly assigned by use of a centralised electronic system to management with a wireless implantable haemodynamic monitoring (W-IHM) system (treatment group) or to a control group for at least 6 months. Only patients were masked to their assignment group. In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group. The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months. The safety endpoints assessed at 6 months were freedom from device-related or system-related complications (DSRC) and freedom from pressure-sensor failures. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661. FINDINGS: In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (n=270) compared with 120 in the control group (n=280; rate 0·31 vs 0·44, hazard ratio [HR] 0·70, 95% CI 0·60-0·84, p<0·0001). During the entire follow-up (mean 15 months [SD 7]), the treatment group had a 39% reduction in heart-failure-related hospitalisation compared with the control group (153 vs 253, HR 0·64, 95% CI 0·55-0·75; p<0·0001). Eight patients had DSRC and overall freedom from DSRC was 98·6% (97·3-99·4) compared with a prespecified performance criterion of 80% (p<0·0001); and overall freedom from pressure-sensor failures was 100% (99·3-100·0). INTERPRETATION: Our results are consistent with, and extend, previous findings by definitively showing a significant and large reduction in hospitalisation for patients with NYHA class III heart failure who were managed with a wireless implantable haemodynamic monitoring system. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management. FUNDING: CardioMEMS.

Gender-based outcomes after paclitaxel-eluting stent implantation in patients with coronary artery disease.

OBJECTIVES: We sought to determine whether gender influences the results of paclitaxel-eluting stent implantation. BACKGROUND: The TAXUS-IV trial demonstrated the safety and effectiveness of the slow-release, polymer-based, paclitaxel-eluting TAXUS stent compared to bare-metal stents in patients undergoing elective coronary intervention. Whether these results are generalizable to women is not known. METHODS: A total of 1,314 patients with coronary lesions 10- to 28-mm long in 2.5- to 3.75-mm vessels were randomized to TAXUS stent versus bare-metal EXPRESS stents (Boston Scientific Corp., Natick, Massachusetts). Outcomes examined were stratified by gender. RESULTS: A total of 662 patients (including 187 women) were assigned to the TAXUS stent, and 652 (180 women) received the control stent. Women were older than men, and had more hypertension, diabetes, renal insufficiency, unstable angina, and heart failure, but less smoking. Among patients receiving the TAXUS stent, women compared with men had higher unadjusted one-year rates of target lesion revascularization (TLR) (7.6% vs. 3.2%, p = 0.03), though female gender was not an independent predictor of TLR (odds ratio [OR] = 1.72 [95% confidence interval (CI) 0.68 to 4.37], p = 0.25). Moreover, restenosis rates were similar in men and women treated with the TAXUS stent (8.6% vs. 7.6%, respectively, p = 0.80), as was late loss (0.22 vs. 0.23 mm, p = 0.90). Compared to control stents, treatment with the TAXUS stent in women resulted in a significant reduction in nine-month restenosis (8.6% vs. 29.2%, p = 0.0001) and one-year TLR (7.6% vs. 14.9%, p = 0.02). The only independent predictor of freedom from restenosis in women was randomization to the TAXUS stent (OR = 0.28 [95% CI 0.11 to 0.74], p = 0.01). CONCLUSIONS: The benefits of the paclitaxel-eluting stent in reducing clinical and angiographic restenosis are generalizable to women.

Polymer-based paclitaxel-eluting stents reduce in-stent neointimal tissue proliferation: a serial volumetric intravascular ultrasound analysis from the TAXUS-IV trial.

OBJECTIVES: The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effects of polymer-based, paclitaxel-eluting stents on in-stent neointima formation and late incomplete stent apposition. BACKGROUND: The TAXUS-IV trial demonstrated that the slow-release, polymer-based, paclitaxel-eluting stent reduces angiographic restenosis and the need for repeat revascularization procedures. Serial IVUS studies reveal details of the pattern of vascular responses provoked by stent implantation that provide insight into device safety and efficacy. METHODS: In the TAXUS-IV trial, patients were randomized to the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). As part of a formal substudy, complete volumetric IVUS data were available in 170 patients, including 88 TAXUS patients and 82 controls, at implantation and at nine-month follow-up. RESULTS: No baseline differences were present in the clinical characteristics or IVUS parameters between the control and TAXUS groups. At nine-month follow-up, IVUS lumen volumes were larger in the TAXUS group (123 +/- 43 mm(3) vs. 104 +/- 44 mm(3), p = 0.005), due to a reduction in neointimal volume (18 +/- 18 mm(3) vs. 41 +/- 23 mm(3), p < 0.001). Millimeter-by-millimeter analysis within the stent demonstrated uniform suppression of neointimal growth along the entire stent length. Late lumen loss was similar at the proximal edge of the stent between the two groups, and reduced with the TAXUS stent at the distal edge (p = 0.004). Incomplete stent apposition at nine months was observed in only 3.0% of control and 4.0% of TAXUS stents (p = 0.12). CONCLUSIONS: Polymer-based, paclitaxel-eluting TAXUS stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete stent apposition.