REMEDIAL II: Contrast-induced acute kidney injury lowered with RenalGuard System
American College of Cardiology 60th Annual Scientific Sessions
NEW ORLEANS — Compared with conventional hydration treatment, use of the RenalGuard System in patients with chronic kidney disease improved the safety of image-guided cardiology procedures, which led to fewer cases of contrast-induced acute kidney injury, according to findings presented here.
“This trial demonstrates that the RenalGuard System [PLC Medical Systems] is very good device to prevent contrast-induced acute kidney injury in high-risk patients,” said Carlo Briguori, MD, PhD, lead study author and director, Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples, in a press conference.
The Italy-based study was conducted at four interventional cardiology centers and included 292 patients with chronic kidney disease. Patients were scheduled for coronary and/or peripheral angiography and/or angioplasty between January 2009 and December 2010. They were randomized to receive either conventional hydration that included a combination of N-acetylcysteine (NAC) and sodium bicarbonate solution or hydration with normal saline plus NAC and low-dose furosemide controlled by the RenalGuard System. Biomarkers such as serum creatinine (sCr) and cystatin C were assessed the day before and up to 1 week following the procedure.
The researchers reported that the primary endpoint of the development of contrast-induced acute kidney injury CI-AKI (sCr increase ≥0.3 mg/dL at 48 hours) was nearly two times higher in the conventional treatment group (20.5% vs. 11%; P=.025). Non-statistically significant more patients experienced stage 2 or 3 damage in the conventional arm (23% vs. 6%; P=.14) as well.
Additional analysis revealed that a lower rate of in-hospital renal failure requiring dialysis occurred in the RenalGuard System group (0.7% vs. 4.1%; P=0.056), although rates of in-hospital stay and major adverse events were similar between groups.
For Briguori, the rate of dialysis was the most important clinical finding, because it shows the possibility to prevent this very improbable complication. – by Brian Ellis
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Platinum chromium stent performance comparable to cobalt chromium stent at 1 year
American College of Cardiology 60th Annual Scientific Sessions
NEW ORLEANS — Results from the PLATINUM trial indicated that the safety and efficacy of the platinum chromium everolimus-eluting stent were noninferior to those of a cobalt chromium everolimus-eluting stent at 1 year.
Researchers for the trial enrolled 1,530 patients undergoing angioplasty between January and September 2009 and randomly assigned them to receive either a platinum chromium stent (n=768) or a cobalt chromium stent as a control (n=762). The composite primary endpoint consisted of target vessel-related cardiac death, target vessel-related MI or ischemia-driven target lesion revascularization (TLR).
According to the results, the platinum chromium stent was noninferior to the cobalt chromium stent (3.4% vs. 2.9%; P=.001 for noninferiority). There were also no differences between the groups for other safety and efficacy measures, including stent thrombosis (0.4% vs. 0.4%) and TLR (1.9% vs. 1.9%). There were no differences in all-cause mortality between the two groups (3.0% in cobalt chromium group vs. 2.4% in platinum chromium; P=.049).
“A novel platinum chromium everolimus-eluting stent has been developed which has been shown to be noninferior to the predicate cobalt chromium everolimus-eluting stent for target lesion failure, with nonsignificant differences in measures of safety and efficacy demonstrated through 12-month follow-up after PCI,”Gregg W. Stone, MD, professor of medicine and director of CV research at New York Presbyterian Hospital/Columbia University Medical Center, said in a presentation.
Stone pointed out that the study’s limitations included the exclusion of patients with acute MI, chronic total occlusion, bifurcation, left main coronary artery lesions, saphenous vein graft lesions, ostial lesions or lesions with thrombus or excessive tortuosity or calcification. The trial was also not designed to assess differences in deliverability, acute performance or ease of use. – by Eric Raible
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EXCELLENT: Guidelines may have overestimated length of DAPT after DES
American College of Cardiology 60th Annual Scientific Sessions
NEW ORLEANS — Instead of the 12 months currently recommended by guidelines for dual antiplatelet therapy following drug-eluting stent insertion, new data from the EXCELLENT trial have suggested that 6 months of therapy may be all that is necessary to produce equivalent results.
In order to generate these findings, researchers conducted a 19-center trial in which 1,443 patients were randomly assigned to 6 or 12 months of dual-antiplatelet therapy (DAPT) in addition to aspirin following insertion of a drug-eluting stent. Inclusion criteria of the prospective, open-label trial included >50% stenosis by visual estimation, evidence of myocardial ischemia and location of target lesion in a native coronary artery. The patients were then followed for at least 2 additional years.
Among the 1,428 patients in which 12-month data was available for, target vessel failure – cardiac death, MI and target vessel revascularization – occurred in 4.7% of patients in the 6-month group and 4.4% in the 12-month group. This primary endpoint, according to analysis, showed non-inferiority between 6-month and 12-month groups with a pre-specified non-inferiority margin of 40 percent (P=0.0031).
Additionally, the safety endpoint, which was a composite of death, MI, cerebrovascular accident, stent thrombosis and thrombolysis in MI bleeding, was 3.4% in the 6-month group vs. 3.1% in the 12-month group (P=.678).
“At least in low-risk patients, [those] non-diabetic and treated with second generation DES, we may safely discontinue clopidogrel [Plavix, Sanofi-Aventis] at about 6 months, especially in patients that are at high-risk of bleeding,” concluded Hyeon-Cheol Gwon, MD, PhD, with the department of cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and study researcher, in a press conference. - by Brian Ellis
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MAGELLAN: Rivaroxaban efficacy comparable to enoxaparin in acutely ill
American College of Cardiology 60th Annual Scientific Sessions
NEW ORLEANS — Results of the MAGELLAN trial demonstrate that, when used as thromboprophylaxis in acutely ill hospital patients, rivaroxaban was not inferior to enoxaparin when used short-term and was slightly superior to enoxaparin followed by placebo when used long-term. However, compared with enoxaparin, rivaroxaban was associated with an increased rate of bleeding.
“Not only did we show that rivaroxaban was effective in this setting, but we also showed that at 35 days patients are still at risk for venous thrombosis,” Alexander T. Cohen, MD, of the department of surgery at King's College Hospital, London, said during a press conference. “We had a 5.7% frequency in the control arm, which was higher than the benchmark data of about 4%.”
The phase 3 trial compared oral rivaroxaban with subcutaneous enoxaparin (Lovenox, Sanofi-Aventis) in patients admitted to the hospital for acute HF, acute infectious disease and acute respiratory insufficiency or other acute medical conditions. Patients from 52 countries (n=8,101) were randomly assigned to rivaroxaban for 35 days (n=4,050) or enoxaparin for 10 days (n=4,051); both groups received placebo. The primary endpoint was a composite of asymptomatic proximal deep vein thrombosis, symptomatic deep vein thrombosis, symptomatic non-fatal pulmonary embolism and venous thromboembolism-related death. The primary safety outcome was a composite of treatment-related major bleeding and clinically relevant non-major bleeding.
At 10-days follow-up, the primary endpoint was similar between both groups: 2.7% of patients in both arms experienced the primary endpoint (relative risk ratio=0.968; P=.0025 for non-inferiority, one-sided).
At 35-days follow-up, researchers documented superiority in the rivaroxaban arm compared with enoxaparin followed by placebo: 4.4% of patients in the rivaroxaban group experienced the primary endpoint vs. 5.7% in the enoxaparin group (relative RR=0.771; P=.0211 for superiority, two-sided).
Conversely, enoxaparin was superior to rivaroxaban in reducing the rate of bleeding at both 10 and 35 days: at 10-days 1.2% of patients in the enoxaparin arm experienced clinically relevant bleeding vs. 2.8% of patients in the rivaroxaban group (relative RR=2.3; P<.0001). Similarly at 35 days, 1.7% of patients in the enoxaparin group had clinically relevant bleeding vs. 4.1% of patients in the rivaroxaban group (relative RR=2.5; P<.0001). According to Cohen, rates of liver and CV events were similar in both groups.
“We’ve shown that we have an effective drug; we have an ongoing problem and we have to look carefully at the bleeding and see if we can work out why this occurred and whether there are any groups that can benefit,” Cohen said. – by Stacey L. Fisher