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3 results on '"Chiarandà G"'

1. A randomized comparison of amiodarone and class IC antiarrhythmic drugs to treat atrial fibrillation in patients paced for sinus node disease: the Prevention Investigation and Treatment: A Group for Observation and Research on Atrial arrhythmias (PITAGORA) trial.

Author

Gulizia M, Mangiameli S, Orazi S, Chiarandà G, Piccione G, Di Giovanni N, Colletti A, Pensabene O, Lisi F, Vasquez L, Grammatico A, and Boriani G

Subjects
Aged, Aged, 80 and over, Arrhythmia, Sinus diagnosis, Arrhythmia, Sinus mortality, Atrial Fibrillation mortality, Cardiac Pacing, Artificial, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Electrocardiography, Female, Flecainide administration & dosage, Follow-Up Studies, Humans, Male, Probability, Propafenone administration & dosage, Prospective Studies, Reference Values, Risk Assessment, Single-Blind Method, Sotalol administration & dosage, Statistics, Nonparametric, Survival Rate, Treatment Outcome, Amiodarone administration & dosage, Anti-Arrhythmia Agents administration & dosage, Arrhythmia, Sinus therapy, Atrial Fibrillation drug therapy, Atrial Fibrillation prevention & control
Abstract

Background: Rhythm control is an important goal in the treatment of recurrent atrial tachyarrhythmias (AT). The PITAGORA study was a randomized trial in patients paced for sinus node disease (SND), designed to test the noninferiority of class IC antiarrhythmic drugs (AADs) to amiodarone in terms of a primary end point composed of death, permanent AT, cardiovascular hospitalization, atrial cardioversion, or AAD change., Methods: Randomization was stratified to assign 2 patients to amiodarone and 2 patients to class IC AADs: propafenone or flecainide. One hundred seventy-six patients (46% men, 72 +/- 8 years) were enrolled. Device diagnostics continuously monitored AT recurrences and duration., Results: In a mean follow-up of 20 +/- 9 months, the primary end point occurred in 23 (30.7%) of 75 class IC patients and in 28 (40.0%) of 70 amiodarone patients. The absolute difference in the end point incidence (-9.3%; 95% CI between 3.7% and -22.3%) confirmed the noninferiority of class IC to amiodarone (P = .007). Kaplan-Meier 1-year freedom from AT episodes >10 minutes, 1 day, and 7 days was 40%, 73%, and 91% for amiodarone and 28%, 78%, and 86% for class IC AADs (P = nonsignificant)., Conclusions: In patients paced for SND and suffering from AT, class IC AADs proved not to be inferior to amiodarone in terms of the primary composite end point described or end points which were differently composed of mortality, efficacy, or AAD side effects. The AADs studied also showed similar results in terms of symptoms, quality of life, and freedom from AT recurrences.

Published
2008
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2. Design and rationale of a randomized study to compare amiodarone and Class IC anti-arrhythmic drugs in terms of atrial fibrillation treatment efficacy in patients paced for sinus node disease: the PITAGORA trial.

Author

Gulizia M, Mangiameli S, Chiarandà G, Spadola V, Di Giovanni N, Colletti A, Bulla V, Circo A, Pensabene O, Vasquez L, Vaccaro I, and Grammatico A

Subjects
Female, Humans, Italy, Male, Prospective Studies, Research Design, Surveys and Questionnaires, Treatment Outcome, Amiodarone therapeutic use, Anti-Arrhythmia Agents therapeutic use, Arrhythmia, Sinus therapy, Atrial Fibrillation drug therapy, Cardiac Pacing, Artificial
Abstract

Aims: Many sinus node disease (SND) patients suffer from atrial fibrillation (AF). Anti-arrhythmic drugs (AADs) are the therapeutic mainstay for AF prophylaxis. The PITAGORA trial has a multicentre, prospective, randomized, single blind design to compare amiodarone with Class IC AADs in patients who have an AF history and are paced for SND., Methods and Results: Starting from January 2001, 176 patients received a Medtronic AT500 pacemaker. AADs were randomly assigned with a 3 : 2 ratio between Class III and Class IC. Randomization was stratified in order to assign two patients to amiodarone and one patient to sotalol every three Class III AAD patients. After a 5-month observational period, Ramp or Burst+ ATP therapies were enabled in a randomized way, maintained for 4 months, and then crossed over. Total follow-up period is 21 months. The primary long-term objective is to show the non-inferiority of IC AADs compared with amiodarone in terms of time to first occurrence of a composite endpoint (death, atrial cardioversion, hospitalizations due to AF or heart failure, or change of AADs). Data will be analysed on an intention-to-treat basis. The primary short-term objective is to compare Ramp vs. Burst+ efficacy in terminating atrial tachyarrhythmias treated by the device. Secondary endpoints are major clinical events, medication toxicity, symptoms, AF burden, and quality-of-life., Conclusion: Given the high morbidity and healthcare costs associated with AF, new therapeutic strategies are needed. The results of the PITAGORA trial may help in guiding AADs therapy and ATP programming in SND patients suffering from AF.

Published
2006
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3. A randomized comparison of amiodarone and class IC antiarrhythmic drugs to treat atrial fibrillation in patients paced for sinus node disease: the Prevention Investigation and Treatment: A Group for Observation and Research on Atrial arrhythmias (PITAGORA) trial

Author

Francesco Lisi, Giuseppe Boriani, Andrea Grammatico, S. Mangiameli, Nicolò Di Giovanni, Ludovico Vasquez, Michele Massimo Gulizia, Serafino Orazi, Giacomo Chiarandà, Guglielmo Piccione, Orazio Pensabene, Andrea Colletti, Gulizia M, Mangiameli S, Orazi S, Chiarandà G, Piccione G, Di Giovanni N, Colletti A, Pensabene O, Lisi F, Vasquez L, Grammatico A, and Boriani G

Subjects
Male, medicine.medical_treatment, Amiodarone, Propafenone, law.invention, Electrocardiography, Randomized controlled trial, law, Reference Values, Atrial Fibrillation, 80 and over, Single-Blind Method, Prospective Studies, Sinus, Aged, 80 and over, Flecainide, medicine.diagnostic_test, Sotalol, Statistics, Cardiac Pacing, Artificial, Aged, Anti-Arrhythmia Agents, Arrhythmia, Sinus, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Probability, Risk Assessment, Statistics, Nonparametric, Survival Rate, Treatment Outcome, Atrial fibrillation, Anesthesia, Artificial, Combination, Cardiology, Drug, Cardiology and Cardiovascular Medicine, Arrhythmia, medicine.drug, medicine.medical_specialty, Randomization, Antiarrhythmic agent, Dose-Response Relationship, Drug Therapy, Internal medicine, medicine, Nonparametric, business.industry, medicine.disease, Cardiac Pacing, business
Abstract

BACKGROUND: Rhythm control is an important goal in the treatment of recurrent atrial tachyarrhythmias (AT). The PITAGORA study was a randomized trial in patients paced for sinus node disease (SND), designed to test the noninferiority of class IC antiarrhythmic drugs (AADs) to amiodarone in terms of a primary end point composed of death, permanent AT, cardiovascular hospitalization, atrial cardioversion, or AAD change. METHODS: Randomization was stratified to assign 2 patients to amiodarone and 2 patients to class IC AADs: propafenone or flecainide. One hundred seventy-six patients (46% men, 72 +/- 8 years) were enrolled. Device diagnostics continuously monitored AT recurrences and duration. RESULTS: In a mean follow-up of 20 +/- 9 months, the primary end point occurred in 23 (30.7%) of 75 class IC patients and in 28 (40.0%) of 70 amiodarone patients. The absolute difference in the end point incidence (-9.3%; 95% CI between 3.7% and -22.3%) confirmed the noninferiority of class IC to amiodarone (P = .007). Kaplan-Meier 1-year freedom from AT episodes >10 minutes, 1 day, and 7 days was 40%, 73%, and 91% for amiodarone and 28%, 78%, and 86% for class IC AADs (P = nonsignificant). CONCLUSIONS: In patients paced for SND and suffering from AT, class IC AADs proved not to be inferior to amiodarone in terms of the primary composite end point described or end points which were differently composed of mortality, efficacy, or AAD side effects. The AADs studied also showed similar results in terms of symptoms, quality of life, and freedom from AT recurrences.

Published
2008

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