Mesh-covered embolic protection stent implantation in ST-segment-elevation myocardial infarction: final 1-year clinical and angiographic results from the MGUARD for acute ST elevation reperfusion trial

The MGuard, a bare metal stent covered with a polymer mesh, was designed to reduce distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction. In the MGUARD for Acute ST Elevation Reperfusion trial, the primary end point of complete ST-segment resolution was significantly improved with the MGuard compared with control. We evaluated 1-year clinical and angiographic results.METHODS AND RESULTS:Patients with ST-segment-elevation myocardial infarction ≤12 hours undergoing primary percutaneous coronary intervention of a single de novo native lesion were randomized to the MGuard versus any commercially available metallic stent (39.8% drug-eluting). Clinical follow-up was performed through 1 year, and angiography at 13 months was planned in 50 MGuard patients. There was no difference in major adverse cardiac events (1.8% versus 2.3%; P=0.75) at 30 days between the groups. Major adverse cardiac events at 1 year were higher with the MGuard, driven by greater ischemia-driven target lesion revascularization (8.6% versus 0.9%; P=0.0003). Conversely, mortality tended to be lower with the MGuard at 30 days (0% versus 1.9%; P=0.04) and at 1 year (1.0% versus 3.3%; P=0.09). Late lumen loss at 13 months in the MGuard was 0.99±0.80 mm, and binary restenosis was 31.6%.CONCLUSIONS:In patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, a trend toward reduced 1-year mortality was present in patients treated with the MGuard stent. Target lesion revascularization and major adverse cardiac events rates during follow-up were higher in the MGuard group than in the control stent group, and angiographic late loss of the MGuard was consistent with that expected from bare metal stents.

Early glycoprotein IIb-IIIa inhibitors in primary angioplasty-abciximab long-term results (EGYPT-ALT) cooperation: individual patient's data meta-analysis.

BACKGROUND: Even although time to treatment has been shown to be a determinant of mortality in primary angioplasty, the potential benefits are still unclear from early pharmacological reperfusion by glycoprotein (Gp) IIb-IIIa inhibitors. Therefore, the aim of this meta-analysis was to combine individual data from all randomized trials conducted on upstream as compared with late peri-procedural abciximab administration in primary angioplasty. METHODS: The literature was scanned using formal searches of electronic databases (MEDLINE and EMBASE) from January 1990 to December 2010. All randomized trials on upstream abciximab administration in primary angioplasty were examined. No language restrictions were enforced. RESULTS: We included a total of seven randomized trials enrolling 722 patients, who were randomized to early (n = 357, 49.4%) or late (n = 365, 50.6%) peri-procedural abciximab administration. No difference in baseline characteristics was observed between the two groups. Follow-up data were collected at a median (25th-75th percentiles) of 1095 days (720-1967). Early abciximab was associated with a significant reduction in mortality (primary endpoint) [20% vs. 24.6%; hazard ratio (HR) 95% confidence interval (CI) = 0.65 (0.42-0.98) P = 0.02, P(het) = 0.6]. Furthermore, early abciximab administration was associated with a significant improvement in pre-procedural thrombolysis in myocardial infarction (TIMI) 3 flow (21.6% vs. 10.1%, P < 0.0001), post-procedural TIMI 3 flow (90% vs. 84.8%, P = 0.04), an improvement in myocardial perfusion as evaluated by post-procedural myocardial blush grade (MBG) 3 (52.0% vs. 43.2%, P = 0.03) and ST-segment resolution (58.4% vs. 43.5%, P < 0.0001) and significantly less distal embolization (10.1% vs. 16.2%, P = 0.02). No difference was observed in terms of major bleeding complications between early and late abciximab administration (3.3% vs. 2.3%, P = 0.4). CONCLUSIONS: This meta-analysis shows that early upstream administration of abciximab in patients undergoing primary angioplasty for ST-segment elevation myocardial infarction (STEMI) is associated with significant benefits in terms of pre-procedural epicardial re-canalization and ST-segment resolution, which translates in to significant mortality benefits at long-term follow-up.

Early glycoprotein IIb-IIIa inhibitors in primary angioplasty (EGYPT) cooperation: an individual patient data meta-analysis.

BACKGROUND: Even though time-to-treatment has been shown to be a determinant of mortality in primary angioplasty, the potential benefits from early pharmacological reperfusion by glycoprotein (Gp) IIb-IIIa inhibitors are still unclear. The aim of this meta-analysis was to combine individual data from all randomised trials conducted on facilitated primary angioplasty by the use of early Gp IIb-IIIa inhibitors. METHODS AND RESULTS: The literature was scanned by formal searches of electronic databases (MEDLINE, EMBASE) from January 1990 to October 2007. All randomised trials on facilitation by the early administration of Gp IIb-IIIa inhibitors in ST-segment elevation myocardial infarction (STEMI) were examined. No language restrictions were enforced. Individual patient data were obtained from 11 out of 13 trials, including 1662 patients (840 patients (50.5%) randomly assigned to early and 822 patients (49.5%) to late Gp IIb-IIIa inhibitor administration). Preprocedural Thrombolysis in Myocardial Infarction Study (TIMI) grade 3 flow was more frequent with early Gp IIb-IIIa inhibitors. Postprocedural TIMI 3 flow and myocardial blush grade 3 were higher with early Gp IIb-IIIa inhibitors but did not reach statistical significance except for abciximab, whereas the rate of complete ST-segment resolution was significantly higher with early Gp IIb-IIIa inhibitors. Mortality was not significantly different between groups, although early abciximab demonstrated improved survival compared with late administration, even after adjustment for clinical and angiographic confounding factors. CONCLUSIONS: This meta-analysis shows that pharmacological facilitation with the early administration of Gp IIb-IIIa inhibitors in patients undergoing primary angioplasty for STEMI is associated with significant benefits in terms of preprocedural epicardial recanalisation and ST-segment resolution, which translated into non-significant mortality benefits except for abciximab.

Circulating N-terminal brain natriuretic peptide precursor and endothelin levels in patients with syndrome X and left bundle branch block with preserved systolic function.

BACKGROUND: Deterioration of left ventricular function during follow-up was reported in some patients with syndrome X and concomitant left bundle branch block. The patients with syndrome X and left bundle branch block has been frequently presented with elevated Endothelin-1 (ET-1) level while brain natriuretic peptide (BNP) (a sensitive marker of left ventricular dysfunction) has not been measured in patients with syndrome X. METHODS: The purpose of the present study was to assess left ventricular diastolic function, levels of N-terminal Brain Natriuretic Peptide (NT-proBNP) precursor and biochemical parameters of endothelial function in patients with syndrome X complicated by left bundle branch block but preserved left ventricular systolic function (group A, n=8). The echocardiographic and neurohormonal measures in these patients were compared to those in patients with syndrome X without left bundle branch block (group B, n=13), and controls (group C, n=15). RESULTS: At rest and after exercise the serum concentration of NT-proBNP was significantly higher in group A than in the controls (at rest: 232+/-96 vs. 133+/-23 fmol/ml, P=0.03; after exercise: 313+/-96 vs. 180+/-33 fmol/ml, P=0.02). The highest concentration of endothelin-1 was also found in group A, being significantly higher than in the controls (6.81 vs. 4.52 pg/ml, P<0.05). Mitral flow abnormalities were detected in left bundle branch block patients. Accordingly, the lowest E/A ratio was in group A and it differed significantly from that in group C (0.85 vs. 1.1, P<0.05). E/A ratio inversely correlated with plasma NT-proBNP concentration in patients with left bundle branch block (r=-0.48, P=0.02). CONCLUSIONS: Elevated NT-proBNP and endothelin-1 plasma concentrations were demonstrated in patients with syndrome X complicated by left bundle branch block even when left ventricular systolic function was still preserved. In this subgroup the magnitude of left ventricular diastolic dysfunction correlated with the increase of BNP level which reflects neurohormonal activation.

End-stage renal disease and its management in older adults.

The older patient with renal disease presents the nephrologist with a formidable problem list: treatment of end-stage renal disease (ESRD) in these patients can be viewed as a continuum in the management of several diseases at one time. The older ESRD patient with complex medical problems is a challenge to the health care team, clearly requiring the cooperation of physician, nurse, dialysis technician, social worker, dietician, physical medicine specialist, and a host of other subspecialists. The outcomes, however, are gratifying, in that a satisfactory and enjoyable autumn of life is attainable for many.

Does low-calcium dialysate accelerate secondary hyperparathyroidism in continuous ambulatory peritoneal dialysis patients?

A lower-calcium dialysate has been advocated for continuous ambulatory peritoneal dialysis (CAPD) patients for the purpose of increasing oral calcium intake as a phosphate binder and decreasing the need for aluminum-containing phosphate binders and, hence, decreasing the risk of aluminum intoxication. Twelve CAPD patients were evaluated retrospectively after switching from a dialysate containing 3.5 mEq/L of calcium to a new dialysate containing 2.5 mEq/L of calcium. Patients were on the new dialysate for at least 1 year. Serum calcium, phosphate, alkaline phosphatase, aluminum, and intact or N-terminal parathyroid hormone (I-PTH, N-PTH) were measured. Calcium, phosphate, and aluminum did not change significantly. Alkaline phosphatase doubled, but was not statistically significant. I-PTH and N-PTH rose from 2.9 +/- 2.24 to 7.4 +/- 7.4 times normal (p < 0.012). Three of 7 patients who had x-ray evaluations before, during, and 1 year after change of dialysate had radiographic progression of bone disease. Three patients required a parathyroidectomy due to the development of severe secondary hyperparathyroidism. In conclusion, the indiscriminate use of dialysate containing 2.5 mEq/L of calcium, in CAPD patients, may place the patients at higher risk for progression of hyperparathyroidism.

Low-dose subcutaneous erythropoietin in continuous ambulatory peritoneal dialysis.

We evaluated changes in hematocrit in patients on continuous ambulatory peritoneal dialysis (CAPD) before and after the administration of erythropoietin (EPO). Thirty-five patients were evaluated at the beginning of treatment with CAPD and after an average of 3.5 years on CAPD; mean hematocrit (Hct) rose from 25.4 +/- 5.4% to 28.1 +/- 6.7% (P less than 0.001). In the period before EPO administration 11 patients required a total of 44 transfusions (one patient needed 23 transfusions). Fifteen patients were started on subcutaneous erythropoietin 3,000 units 3 times a week and were followed for a mean period of 6.3 months. Hct rose from 23.8 +/- 1.8% to 25.2 +/- 2.4% (P less than 0.01) within the first 2 weeks and up to 27.5 +/- 3.7% (P less than 0.01) in the fourth week. By the eighth week the target Hct (30 to 35%) was reached. During the next 5 months the EPO doses were adjusted to each patient's needs ranging between 2,000 U per week to 4,000 U 3 times per week. Mild hypertension was the only side effect seen in some of the patients. In conclusion low dose subcutaneous EPO is effective in managing the anemia of patients on CAPD with only minor side effects.

Ten years' experience with continuous ambulatory peritoneal dialysis.

Up to January 1989, 171 patients were trained at our center on continuous ambulatory peritoneal dialysis (CAPD), and 17 on continuous cyclic peritoneal dialysis (CCPD). Over 10 years, we have gained 5,068 patient-months experience. Patient survival was 60% and 31% at 5 and 10 years, respectively. In contrast, diabetics had a survival of 32% at 5 years. Major complications included 499 new episodes of peritonitis, 304 exit-site infections, 22 hernias, five bowel perforations, one hydrothorax, and three episodes of sclerosing encapsulating peritonitis. Our technique survival has been 62% and 40% at 5 and 10 years, respectively. We believe that CAPD is a viable dialysis technique for long-term treatment of chronic renal failure and it should be offered as an option to intermittent hemodialysis.

Chronic dialysis in a patient with cystic fibrosis.

To our knowledge this is the first case reported in the literature of a patient with cystic fibrosis and end-stage renal disease, who was on dialysis for 2 years. We discuss here the possible mechanisms responsible for what has been called 'the cystic fibrosis nephropathy' and its consequences.

Immune stimulation. A new approach in the treatment of glomerulonephritis.

We discuss here a new approach to the treatment of idiopathic membranous glomerulonephritis (IMGN). Steroids and cytotoxic drugs have been used during the last years for the treatment of this disease, but the results are controversial. We develop here the hypothesis that the pathogenesis of IMGN is a relative incompetence of the immune system in clearing foreign antigens. Therefore, most patients should benefit from immune stimulation in the direction of a greater and more avid immune response.