Comparing Obtura Vascular Closure Device to Manual Compression for Achieving Hemostasis After Percutaneous Transfemoral Procedures: A Randomized Study.

PURPOSE: This trial was designed and aimed to compare safety and efficacy of Obtura™ vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization. MATERIAL AND METHODS: This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA). RESULTS: The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26±3.39 vs 23.95±8.24 minutes; p<0.0001) and TTA (155.44±125.32 vs 723.84±197.98 minutes; p<0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events. CONCLUSIONS: The study demonstrated favorable safety and efficacy of Obtura™ VCD with a significantly short TTH and TTA compared to MC. CLINICAL IMPACT: In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients' access sites to feel uncomfortable while it is being deployed.

Clinical expert consensus document on the use of percutaneous left ventricular assist devices during complex high-risk PCI in India using a standardised algorithm.

Over the past decade, percutaneous left ventricular assist devices (pLVAD), such as the Impella microaxial flow pump (Abiomed), have been increasingly used to provide haemodynamic support during complex and high-risk revascularisation procedures to reduce the risk of intraprocedural haemodynamic compromise and to facilitate complete and optimal revascularisation. A global consensus on patient selection for the use of pLVADs, however, is currently lacking. Access to these devices is different across the world, thus, individual health care environments need to create and refine patient selection paradigms to optimise the use of these devices. The Impella pLVAD has recently been introduced in India and is being used in several centres in the management of high-risk percutaneous coronary intervention (PCI) and cardiogenic shock. With this increasing utilisation, there is a need for a standardised evaluation protocol to guide Impella use that factors in the unique economic and infrastructural characteristics of India's health care system to ensure that the needs of patients are optimally managed. In this consensus document, we present an algorithm to guide Impella use in Indian patients: to establish a standardised patient selection and usage paradigm that will allow both optimal patient outcomes and ongoing data collection.

Efficacy of rosuvastatin in achieving target HDL, LDL, triglycerides and total cholesterol levels in type 2 diabetes mellitus (T2DM) with newly diagnosed dyslipidaemia: an open label, nonrandomised, non-interventional and observational study in India.

UNLABELLED: Asian Indians with dyslipidaemia should be treated as aggressively as if they had a CHD risk equivalent-similar to the treatment of patients with diabetes or heart disease. OBJECTIVE: To evaluate efficacy of Rosuvastatin in achieving target HDL, LDL, triglycerides and total cholesterol levels in type 2 diabetes mellitus (T2DM) patients with newly diagnosed dyslipidaemia, but without known coronary artery disease. METHODS: The study was an open label, nonrandomised, non-interventional, observational study in India involving T2DM patients who require statin therapy to control dyslipidaemia. Data were collected at baseline, interim (8 weeks) and subsequently at 16 weeks of Rosuvastatin (10 and 20 mg) therapy. Efficacy of the treatment was assessed by evaluating whether subjects reached target LDL and total cholesterol levels according to NCEP ATP III guidelines. RESULTS: Four thousand three hundred and sixty-nine patients completed the study. Out of 4369, 1115 (25.52%) have achieved a target LDL level of < 100 mg/dL and 2930 (67.06%) falls under HDL level of 40-60 mg/dL.The mean change in HDL levels was 5.56 mg/dL in females and 4.59 mg/dL in males. Overall 63.95% of patients had achieved the total cholesterol target and 50.06% achieved triglyceride target. The adverse events reported were generally mild. CONCLUSION: On the basis of the above results, it can be concluded that Rosuvastatin safely and beneficially alters the entire spectrum of lipoproteins in Indian patients.

Intravenous platelet blockade with cangrelor during PCI.

BACKGROUND: Intravenous cangrelor, a rapid-acting, reversible adenosine diphosphate (ADP) receptor antagonist, might reduce ischemic events during percutaneous coronary intervention (PCI). METHODS: In this double-blind, placebo-controlled study, we randomly assigned 5362 patients who had not been treated with clopidogrel to receive either cangrelor or placebo at the time of PCI, followed by 600 mg of clopidogrel. The primary end point was a composite of death, myocardial infarction, or ischemia-driven revascularization at 48 hours. Enrollment was stopped when an interim analysis concluded that the trial would be unlikely to show superiority for the primary end point. RESULTS: The primary end point occurred in 185 of 2654 patients receiving cangrelor (7.0%) and in 210 of 2641 patients receiving placebo (8.0%) (odds ratio in the cangrelor group, 0.87; 95% confidence interval [CI], 0.71 to 1.07; P=0.17) (modified intention-to-treat population adjusted for missing data). In the cangrelor group, as compared with the placebo group, two prespecified secondary end points were significantly reduced at 48 hours: the rate of stent thrombosis, from 0.6% to 0.2% (odds ratio, 0.31; 95% CI, 0.11 to 0.85; P=0.02), and the rate of death from any cause, from 0.7% to 0.2% (odds ratio, 0.33; 95% CI, 0.13 to 0.83; P=0.02). There was no significant difference in the rate of blood transfusion (1.0% in the cangrelor group and 0.6% in the placebo group, P=0.13), though major bleeding on one scale was increased in the cangrelor group, from 3.5% to 5.5% (P<0.001), because of more groin hematomas. CONCLUSIONS: The use of periprocedural cangrelor during PCI was not superior to placebo in reducing the primary end point. The prespecified secondary end points of stent thrombosis and death were lower in the cangrelor group, with no significant increase in the rate of transfusion. Further study of intravenous ADP blockade with cangrelor may be warranted. (ClinicalTrials.gov number, NCT00385138.)