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: Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first real-life human experience with the rapamycin-eluting biodegradable polymer-coated Rapstrom stent. METHODS: All consecutive patients with single de novo native coronary stenosis (<30 mm and between 2.5 and 4.0 mm) were enrolled. Major adverse cardiac events (MACE) at 1 year (cardiac death, myocardial infarction [Q and non-Q], or ischemia-driven target lesion revascularization) were the primary end-point. RESULTS: A total of 123 patients were enrolled. The stent was implanted without complications in all patients, and no MACE were recorded at 30 days. At 12-month follow-up 9 patients (7.3%) experienced a MACE and 4 (3.2%) required a target lesion revascularization, while 1 (1%) stent thrombosis was recorded. A planned angiographic follow-up (FU) was performed in 73 patients (59%) at 9.4 ± 2.6 months following the index procedure. In-stent late loss was 0.16 ± 0.09 mm, and in-segment late loss was 0.18 ± 0.8 mm. CONCLUSION: The Rapstrom biodegradable polymer rapamycin-eluting stent appeared safe and efficacious in this first real-life human experience, due to a low late lumen loss. Larger randomized studies are required to confirm these preliminary results.
Subject(s)
Absorbable Implants , Coronary Stenosis/therapy , Drug-Eluting Stents , Sirolimus/administration & dosage , Coronary Angiography , Delayed-Action Preparations , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Revascularization/statistics & numerical data , Prospective Studies , Thrombosis/etiologyABSTRACT
We present a case of cardiac tamponade following umbilical venous catheterization in a neonate, an uncommon, yet potentially fatal complication. Timely diagnosis by echocardiography and urgent pericardiocentesis proved lifesaving.
Subject(s)
Cardiac Tamponade/etiology , Catheterization/adverse effects , Umbilical Veins/surgery , Cardiac Tamponade/diagnosis , Cardiac Tamponade/surgery , Echocardiography , Humans , Infant, Newborn , Pericardial Effusion/diagnosis , Pericardial Effusion/etiology , PericardiocentesisABSTRACT
We report a case of transient complete heart block following occlusion of the first septal perforator branch after stent deployment in the left anterior descending coronary artery. The patient was treated with temporary transvenous pacing and reverted spontaneously to normal atrioventricular conduction after 3 days.