CABANA-Studie findet bei Experten geteiltes Echo. Peter Overbeck. Die CABANA-Studie sollte zeigen, dass die Katheterablation bei. FormalPara Originalpublikation. Packer DL, Mark DB, Robb RA et al () Effect of catheter ablation vs antiarrhythmic drug therapy on. Die CABANA-Studie ist die größte prospektive randomisierte Studie zum Vergleich von Katheterablation und medikamentöser Therapie bei.
Cabana Studie ITT-Analyse zeigt keinen signifikanten Unterschied
In der Intentions-to-Treat (ITT)-Analyse der CABANA-Studie war die Rate für die im primären Studienendpunkt kombinierten Ereignisse (Tod. CABANA-Studie findet bei Experten geteiltes Echo. Peter Overbeck. Die CABANA-Studie sollte zeigen, dass die Katheterablation bei. FormalPara Originalpublikation. Packer DL, Mark DB, Robb RA et al () Effect of catheter ablation vs antiarrhythmic drug therapy on. Die CABANA-Studie ist die größte prospektive randomisierte Studie zum Vergleich von Katheterablation und medikamentöser Therapie bei. Die langfristige CABANA-Studie sollte den Nachweis bringen, dass die Katheterablation bei Vorhofflimmern nicht nur Symptome, sondern auch Schlaganfälle. CABANA-Studie kämpft mit Studiendesign. Die CABANA-Studie sollte diese Frage beantworten. CABANA war die Abkürzung für Katheterablation versus. Wer könnte von der Ablation profitieren? PD Dr. Nikolaus Sarafoff erklärt, wie weit man die Analyse der Subgruppen der Studie für.
Die CABANA-Studie ist die größte prospektive randomisierte Studie zum Vergleich von Katheterablation und medikamentöser Therapie bei. FormalPara Originalpublikation. Packer DL, Mark DB, Robb RA et al () Effect of catheter ablation vs antiarrhythmic drug therapy on. In der Intentions-to-Treat (ITT)-Analyse der CABANA-Studie war die Rate für die im primären Studienendpunkt kombinierten Ereignisse (Tod.
Cabana Studie - Hohe „Cross-over“-RateWas ist zu sehen? Um Artikel, Nachrichten oder Blogs kommentieren zu können, müssen Sie registriert sein. But opting out of some of these cookies may have an effect on your browsing experience. Um Artikel, Nachrichten oder Blogs kommentieren zu können, müssen Sie registriert sein. Auch in den sekundären Endpunkten war ein eindeutiger Vorteil der Katheterablation nicht überall nachweisbar. Publikationsdatum Dadurch kann es ggf. Zum einen war die Sterblichkeit in beiden Gruppen unerwartet niedrig, was vermutlich mit Free Roulette No Deposit guten Betreuung der Patienten in den spezialisierten Zentren zusammenhängt. Mitglieder Login Mitgliedsnummer Passwort Casino Del Rio Auszahlung. Die Forscher raten, die Blutdrucksenker weiter wie verordnet einzunehmen.
Paroxysmal AF was present in The study population had a substantial burden of CV risk factors Table 1 : Among the patients randomly assigned to the catheter ablation group, Among the catheter ablation patients, 25 underwent repeat ablation during the blanking period, with patients undergoing at least 1 repeat ablation during the postblanking period, for a total of patients Among the catheter ablation patients, Among the patients assigned to the drug therapy group, A total of drug therapy patients A comparison of these patients and other patients exclusively treated with drugs is provided in eTable 5 in Supplement 3.
A primary outcome event occurred in 89 patients 8. Four-year Kaplan-Meier event rates were 7. For the key secondary end point of all-cause mortality, a total of 58 patients 5.
Four-year mortality rates were 4. The composite secondary end point of death from any cause or CV hospitalization occurred in patients Details regarding the causes of CV hospitalizations are provided in eTable 6 in Supplement 3.
Adjustment for site as a random effect post hoc analysis did not change the estimated treatment effect HR, 0.
Examination of prespecified subgroups based on clinical and demographic characteristics did not identify relative variations in the treatment effect of ablation large enough to be clinically significant while also possessing sufficient precision to exclude the null effect ie, HR, 1 Figure 4.
In the prespecified treatment received analyses, the HR for catheter ablation vs drug therapy with respect to the primary end point was 0. For all-cause mortality, the corresponding HR was 0.
No deaths occurred in the first 30 days after initiation of drug therapy or catheter ablation. One disabling stroke occurred in the drug therapy group within the first 30 days of treatment eTable 7 in Supplement 3.
In per-protocol treatment comparisons, patients randomized to catheter ablation who received ablation within a designated window following randomization were compared with patients randomized to the drug therapy group.
For the 6-month protocol window, the HR for catheter ablation vs drug therapy for the primary end point was 0. For the month per-protocol window, the corresponding HR was 0.
The per-protocol HRs for the key secondary end point of all-cause mortality were 0. The subgroup assessment for the primary end point by per-protocol analysis is shown in eFigure 2 in Supplement 3.
The adjusted HR for the postblanking incidence of either AF, atrial flutter, or atrial tachycardia was 0. The benefits of catheter ablation on recurrent AF were consistent across prespecified subgroups eFigure 4 in Supplement 3.
Non—end point adverse events are enumerated in eTables 9 and 10 in Supplement 3. The most common serious adverse event in the catheter ablation group was cardiac tamponade 0.
Other adverse events in the catheter ablation group included minor hematomas 2. In the drug therapy group, thyroid disorders were reported in 1.
Quiz Ref ID Among patients with AF, catheter ablation, compared with medical therapy, did not significantly reduce the primary composite outcome.
Because the confidence interval for the primary effect estimate lacks the precision to exclude a null effect HR, 1. In addition to the primary outcome results, this article describes results for 3 of 13 prespecified secondary end point comparisons.
Quality-of-life outcomes are reported separately. The 4-year Kaplan-Meier mortality rates were 4. There were no differences in serious bleeding between treatment groups, and disabling strokes were infrequent, although directionally favoring the catheter ablation group, as seen in other studies.
ITT-based analyses preserve the benefit of randomization in protecting from treatment selection biases, but the results may be seriously biased by postrandomization crossovers and deviations from protocol-specified care.
No completely satisfactory solution exists for such complexities. Useful insights can be obtained by examining ITT analysis results in combination with sensitivity analyses on the ITT estimates using the treatment actually received and also by comparing treatment outcomes of the patient groups who followed the treatment-assignment protocol.
The treatment received and per-protocol analyses resulted in HR estimates ranging from 0. The treatment received and per-protocol analyses potentially mitigate different forms of bias present in the ITT estimate of the treatment effect size but may add biases if compliance with treatment assignment is correlated with outcome independent of treatment effects.
Decisions about use of catheter ablation in individual patients need to consider both relative and absolute treatment differences as well as procedural risks.
Given the 4-year Kaplan-Meier event rates, for many patients meeting the eligibility criteria of this trial, expected treatment differences on an absolute scale will likely not be of sufficient magnitude to support a recommendation for catheter ablation on that basis alone.
Quiz Ref ID For most patients with AF, the primary reason to consider catheter ablation is to mitigate the disruption that AF creates in their daily lives and consequent reductions in quality of life.
One hundred and ninety patients The underlying pathophysiology leading to the initial onset of AF may increase the propensity for its recurrence even with initially successful ablation.
Work is ongoing to understand whether risk factor management, with or without ablation, can reduce recurrence rates. Importantly, CABANA shows that prognostically adverse procedural complications associated with the catheter ablation strategy relative to medical management options were infrequent when the procedure was performed by experienced operators eTables 9 and 10 in Supplement 3.
Pericardial effusion with tamponade, while infrequent, was the most common adverse event in catheter ablation patients.
Pulmonary vein stenosis was rare and atrial esophageal fistula formation was not observed. Quiz Ref ID This study has several limitations.
First, patient withdrawals from the trial, which occurred at a slightly higher rate in the drug therapy group, may have affected estimates of the treatment effect.
Second, comparisons of the ITT results with the treatment received and per-protocol analyses suggest that the combined effect of crossovers and withdrawals reduced the estimated treatment effect and the precision of the effect size estimates as assessed by ITT.
Third, catheter ablation and drug therapies may have changed over the course of a long trial in ways that might have affected outcome, although ablation techniques were largely consistent over the course of the trial, and crossovers were limited by the trial center to the extent possible.
Sixth, unblinded site adjudication of cause of hospitalization may have introduced bias into this end point relative to the centrally adjudicated components of the primary end point.
Seventh, the significance threshold was not adjusted for the secondary end point comparisons. Performing multiple independent significance tests increases the probability that at least 1 test may achieve nominal statistical significance on a chance basis alone.
Therefore, findings from the secondary and other analyses that are unique to CABANA may be reasonably viewed as more provisional or exploratory.
Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest.
Corresponding Author: Douglas L. Published Online: March 15, Author Contributions : Drs Packer and Lee had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
In addition, Dr Packer has mapping technologies with royalties paid. Dr Robb has a patent for a 4D mapping system with royalties paid to Endocardial Solutions outside the submitted work.
Dr Bahnson has patents pending for a catheter for intracardiac imaging and intracardiac electrogram signal analysis. Dr Poole reported receiving grants from ATriCure outside the submitted work.
Dr Bunch reported receiving grants from Boehringer-Ingelheim outside the submitted work. Dr Davies reported receiving personal fees from Medtronic Inc outside the submitted work.
Dr Kowey reported receiving personal fees from Medtronic Inc and personal fees from and equity interest in Biotelemetry outside the submitted work.
Dr Naccarelli reported receiving grants and personal fees from Janssen and personal fees from GlaxoSmithKline, Aceion, Omeicos, Sanofi, and Portola outside the submitted work.
No other disclosures were reported. St Jude Medical Foundation and Corporation, Biosense Webster Inc, Medtronic Inc, and Boston Scientific Corp had no role in the design of the study; collection, management, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 4. Additional Contributions: We are grateful to all patients and their families for their participation in this study, the study sites, and the study monitors.
Editorial assistance with preparation of the manuscript was provided by Jacqueline Crowson, Mayo Clinic, Rochester, Minnesota, without personal compensation.
All Rights Reserved. Download PDF Comment. Figure 1. View Large Download. Figure 2. Figure 3. Figure 4.
Figure 5. Figure 6. Table 1. Baseline Demographics and Clinical Characteristics. Table 2. Supplement 1. Trial Protocol. Supplement 2.
Trial Protocol Amendments. Supplement 3. Commentary on Statistical Analyses eAppendix 2. Trial Organization. Supplement 4.
Data Sharing Statement. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, to , and implications on the projections for future prevalence.
Patients treated with catheter ablation for atrial fibrillation have long-term rates of death, stroke, and dementia similar to patients without atrial fibrillation.
J Cardiovasc Electrophysiol. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses.
Circ Arrhythm Electrophysiol. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. PubMed Google Scholar Crossref.
A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study.
J Am Coll Cardiol. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.
Catheter ablation vs antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial SARA study.
Eur Heart J. Catheter ablation for atrial fibrillation with heart failure. N Engl J Med. Catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation CABANA trial: study rationale and design.
Am Heart J. Heart Rhythm. PubMed Google Scholar. Nonparametric estimation from incomplete observations. J Am Stat Assoc.
Regression models and life-tables with discussion. J R Stat Soc B. Google Scholar. Partial residuals for the proportional hazards regression model.
A proportional hazards model for the subdistribution of a competing risk. A multiple testing procedure for clinical trials.
Discrete sequential boundaries for clinical trials. Annals understanding clinical research: interpreting results with large P values. Ann Intern Med.
Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther. A randomized controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart failure the CAMTAF trial.
Ablation versus amiodarone for treatment of persistent atrial fibrillation in patients with congestive heart failure and an implanted device: results from the AATAC multicenter randomized trial.
Catheter ablation for atrial fibrillation is associated with lower incidence of stroke and death: data from Swedish health registries.
Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation RAAFT-2 : a randomized trial.
Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.
Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. This open-label randomized trial compares the effect of pulmonary vein isolation via catheter ablation vs rate and rhythm control using drug therapy on the quality of life of patients with atrial fibrillation.
Daniel B. This JAMA Insights Clinical Update reviews management approaches to atrial fibrillation AF , including assessment of the need for anticoagulation, and controversies over the need for rhythm control and the role of catheter ablation for maintaining sinus rhythm and reducing AF-associated symptoms.
Douglas L. This randomized trial compares the effect of transcatheter pulmonary vein isolation during catheter ablation with vs without ethanol infusion into the vein of Marshall, an embryologic remnant of the left superior vena cava implicated in atrial fibrillation pathogenesis, on freedom from atrial arrhythmia at 12 months.
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