ABSTRACT
OBJECTIVES: To report long-term results of a novel sirolimus-eluting stent with biodegradable polymer BACKGROUND: Newer generation drug-eluting stents are characterized by thin struts, improved platform design and highly biocompatible polymer carrying the antiproliferative drug. The RapstromTM stent, sharing these features, showed promising outcomes in preclinical models and in a first-in-man trial. METHODS: The present study is a multicenter, non-randomized post-market registry, including patients with de novo coronary artery disease treated with implantation of one or more Rapstrom stents. Primary endpoint of the study was the rate of major adverse cardiac events (MACE) at three-year follow-up. RESULTS: 1073 patients were enrolled, with a high prevalence of diabetes (35%) and acute coronary syndrome at presentation (82%); at three-year follow up, MACE rate was 14.8%, with a low incidence of definite or probable stent thrombosis (0.75%). CONCLUSIONS: These data confirm the good clinical performance of the Rapstrom stent, supporting the concept that the combination of thin struts and biodegradable polymer is associated with positive clinical outcomes.
Subject(s)
Absorbable Implants , Acute Coronary Syndrome/surgery , Cardiovascular Agents/administration & dosage , Coronary Stenosis/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Sirolimus/administration & dosage , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/epidemiology , Cardiovascular Agents/adverse effects , Comorbidity , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/epidemiology , Coronary Thrombosis/epidemiology , Humans , Incidence , Percutaneous Coronary Intervention/adverse effects , Prevalence , Product Surveillance, Postmarketing , Prosthesis Design , Registries , Risk Factors , Sirolimus/adverse effects , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: We report the use of positron emission tomography (PET) using 18F-FDG for the diagnosis of carditis in children with rheumatic heart disease (RHD). MATERIAL AND METHODS: Thirty-six children aged 6-17 years (seventeen males and nineteen females) with isolated rheumatic significant mitral regurgitation (MR) underwent FDG-PET scanning of the heart after fasting for 6 h within a period of 2 years. They were divided into two groups based on Jones criteria - acute rheumatic carditis and chronic RHD. Age- and gender-matched twelve children who underwent whole body ¹8F-FDG-PET scan for routine PET scan for oncological evaluation was taken as controls. Nineteen patients had active carditis and 17 were chronic RHD cases. RESULTS: All 12 controls and all 17 cases with chronic RHD with MR showed diffuse uptake pattern. Of the 19 active cases, 14 showed ¹8F-FDG uptake in the myocardium, 5 did not show any uptake. Thus the finding of no uptake pattern on ¹8F-FDG-PET scan had a sensitivity of 26% but positive predictive value of 100% for acute carditis cases. This study describes the ¹8F-FDG-PET uptake pattern in children with RHD and in 12 age-matched control subjects in the fasting state. Those with chronic RHD with MR showed diffuse myocardial uptake pattern similar to that of the control group. Patients with active carditis showed mixed results; the majority showed diffuse uptake pattern. CONCLUSION: In view of its poor sensitivity, ¹8F-FDG-PET is not recommended as a routine imaging modality for the diagnosis of rheumatic carditis.
