Cobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I).

BACKGROUND: The CoStar stent is a novel cobalt chromium stent designed specifically for drug delivery. The COSTAR I trial represents the first-in-man study of the CoStar Paclitaxel-Eluting Coronary Stent System evaluating three dose release formulations of paclitaxel in a bioresorbable polymer matrix in the treatment of de novo coronary lesions. METHODS: The COSTAR I Trial was a prospective, multi-center registry enrolling 87 patients in four Indian centers for treatment of up to two de novo lesions = 25 mm in length in a reference vessel 2.5-3.5 mm in diameter. Three dose release formulations were studied: 30 microg eluted over 10 days bidirectionally (Group 1, n =10), 10 microg eluted over 30 days abluminally (Group 2, n=40) and 3 microg eluted over 30 days abluminally (Group 3, n = 37). RESULTS: Demographics and lesion characteristics were similar between the groups and treatment in all three groups included small caliber vessels (RVD 2.45 +/- 0.30 - 2.57 +/- 0.36 mm). The primary endpoint of in-stent late loss at four months was lowest in Group 2 (0.43 +/- 0.43 mm) compared to Group 1 and Group 3 (0.51 +/- 7 mn; 0.74 mm and 1.07 +/- 0.65 mm respectively). In-segment late loss followed similar trends, being lowest in Group 2 (0.24 +/- 0.39 mm) compared to Groups 1 and 3 (0.52 +/- 0.66 mm and 0.76 +/- 0.57 mm respectively). Group 2 demonstrated better angiographic out-comes at 12 months with in-stent late loss of 0.55 +/- 0.38 mm when compared to Groups 1 and 3 (0.90 +/- 0.76 mm and 0.74 +/- 0.55 mm respectively). Cumulative binary restenosis rates at twelve months were 1.9%, 35.7% and 39.1% in Groups 2, 1 and 3 respectively. Clinical outcomes trended similarly with cumulative MACE rates at twelve months being lowest at 7.5% in Group 2 as compared to 20% in Group 1 and 21.6% in Group 3 respectively. CONCLUSIONS: In this first-in-man feasibility trial, angiographic and clinical results seen with the extended release formulation at a higher dose (10 microg/30 days) demonstrate the feasibility of the CoStar stent platform in the treatment of native coronary lesions. It also demonstrates the importance of drug dose and release kinetics.

Protein C deficiency leading to pulmonary thromboembolism in a patient with hereditary spherocytosis.

Hereditary protein C deficiency results in a hypercoagulable state that can manifest itself as venous thrombosis and pulmonary embolism. The prevalence of this condition, even among patients with familial thrombosis, is quite low. We report a case of protein C deficiency presenting as massive pulmonary thromboembolism in a patient with hereditary spherocytosis, an uncommon hemolytic disorder not usually associated with increased thrombotic risk. A review of the literature revealed only a few cases of thrombosis associated with hereditary spherocytosis, and none of them had protein C deficiency. This makes the present case the first of its kind to be reported.

EMPIRE (Escorts Multiple ProNova Implantation Registry) Study: Evaluating the ProNova SES in De Novo Coronary Artery Lesions.

BACKGROUND: The main limitation of percutaneous coronary intervention (PCI) with bare metal stents was the increased incidence of instant restenosis. The introduction of drug-eluting stents has decreased the rate of restenosis. Various DESs, using different drugs and stent designs, are now being used in interventional cardiology worldwide. The EMPIRE study was conducted to evaluate the safety and efficacy of the slow-release sirolimus-eluting ProNova stent in de novo coronary artery lesions in patients with single- or multi-vessel disease. METHODS AND RESULTS- A total of 300 patients, enrolled in a single-centre registry, were successfully implanted with ProNova, a sirolimus-eluting stent (SES). They were followed up clinically, first at 30 days and then six months after the procedure for parameters like death, target vessel failure, documented myocardial infarction (MI) and restenosis. Assessment of binary restenosis was done angiographically at six months. The primary success rate of stent implantation was 100%, the percentage of acute major adverse cardiac events (MACE) being 0% and 2% at 30 days and six months, respectively. Angiographic restenosis was documented in 12.6% of the patients enrolled in the study. CONCLUSION: The ProNova stent was found to be safe and effective in this trial.

Covered stents deployed for coarctation of aorta with aneurysm.

Three patients presented to us with upper extremity hypertension and aortic coarctation. Aortic angiograms and spiral computerized tomography delineated the anatomy at the site of coarctation and the associated small aneurysmal dilation. They were taken up for percutaneous stenting of the coarctation segment with cheathum-platinum covered stents. Post-deployment, there was a significant fall in pullback gradients and exclusion of the aneurysms.