Guest guest Posted June 25, 2002 Report Share Posted June 25, 2002 Personally, I have afib coupled with cardiomyopathy and although rate control through pacing has helped significantly, I still feel much better and am much less susceptible to fatigue when I'm in rhythm (which I haven't been in for several months). > Hi all, > > I am wondering what the group thinks about the subject studies. They > were massive studies, and were done by national health institutes, > rather than by drug companies. > > My read is that rate control is at least as effective as rythym > contol....measured by the survival rates over about five years. The > studies were just released in March, but should seriously impact the > method of treatment for afib. Just put the above initials in your > search engine to read about the studies. > > In my case of Feb. 2002 discovered continuous afib, both doctors were > at first saying that we should do cardioversion, but since the > studies were published are saying that they don't think cardioversion > is appropriate.....just control the heart rate with digoxin and > diltiazem, and of course get the INR to 2.0 with coumadin. > > H Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 HI I am in the UK and the way AF is treated here is a little bit different to the rest of the world. the arfirm studies were completed many years ago and the then with the technology and drugs they had then' the result was. As long as you feel well and can tolerate AF then you will be left alone and go on with your life. The reason being the cost outweighed the treatments Just a few years a ago even only 12 months ago it was relieve easy to get you back into NSR but keeping you there was almost impossible in some cases. Then along came the PVA and Dofetilide and I believe this has all changed now. The whole treatment is polarised. We have seen this as in the UK ablation for AFlutter is being hailed as a good treatment for Afib. Now on the other hand Prof. Haissigurre in Bordeaux France the master of the PVA has stated to me that if AF is caught fairly quickly then there is a good chance of a cure . It its left then there is a chance of MULTI FOCAL AF in the Atria appearing where its almost impossible to burn away, with out damaging the Atria. This is the theory that AF behest AF (Camm Waktarie) and the focals cause foculs. Prof H is working on a linear ablation to try and combat this. I believe that one of our members may have had this as well as a PVA. Thats my 2p/c worth and this is only my opinion and I am not a DR. C AFFIRM and RACE Hi all, I am wondering what the group thinks about the subject studies. They were massive studies, and were done by national health institutes, rather than by drug companies. My read is that rate control is at least as effective as rythym contol....measured by the survival rates over about five years. The studies were just released in March, but should seriously impact the method of treatment for afib. Just put the above initials in your search engine to read about the studies. In my case of Feb. 2002 discovered continuous afib, both doctors were at first saying that we should do cardioversion, but since the studies were published are saying that they don't think cardioversion is appropriate.....just control the heart rate with digoxin and diltiazem, and of course get the INR to 2.0 with coumadin. H Web Page - http://groups.yahoo.com/group/AFIBsupport FAQ - http://groups.yahoo.com/group/AFIBsupport/files/Administrative/faq.htm For more information: http://www.dialsolutions.com/af Unsubscribe: AFIBsupport-unsubscribe List owner: AFIBsupport-owner For help on how to use the group, including how to drive it via email, send a blank email to AFIBsupport-help Nothing in this message should be considered as medical advice, or should be acted upon without consultation with one's physician. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 I see that you had an ablation about a year ago with Prof H in France. How did that turn out?? Dave L > HI > > I am in the UK and the way AF is treated here is a little bit different to the rest of the world. the arfirm studies were completed many years ago and the then with the technology and drugs they had then' the result was. > > Now on the other hand Prof. Haissigurre in Bordeaux France the master of the PVA has stated to me that if AF is caught fairly quickly then there is a good chance of a cure . It its left then there is a chance of MULTI FOCAL AF in the Atria appearing where its almost impossible to burn away, with > out damaging the Atria. This is the theory that AF behest AF (Camm Waktarie) and the focals cause foculs. > Prof H is working on a linear ablation to try and combat this. > I believe that one of our members may have had this as well as a PVA. > > Thats my 2p/c worth and this is only my opinion and I am not a DR. > > > C > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 Ok No Meds since September 2001. I lost my thyroid to Amiodarone and this is causing me problems. john Re: AFFIRM and RACE I see that you had an ablation about a year ago with Prof H in France. How did that turn out?? Dave L > HI > > I am in the UK and the way AF is treated here is a little bit different to the rest of the world. the arfirm studies were completed many years ago and the then with the technology and drugs they had then' the result was. > > Now on the other hand Prof. Haissigurre in Bordeaux France the master of the PVA has stated to me that if AF is caught fairly quickly then there is a good chance of a cure . It its left then there is a chance of MULTI FOCAL AF in the Atria appearing where its almost impossible to burn away, with > out damaging the Atria. This is the theory that AF behest AF (Camm Waktarie) and the focals cause foculs. > Prof H is working on a linear ablation to try and combat this. > I believe that one of our members may have had this as well as a PVA. > > Thats my 2p/c worth and this is only my opinion and I am not a DR. > > > C > > Web Page - http://groups.yahoo.com/group/AFIBsupport FAQ - http://groups.yahoo.com/group/AFIBsupport/files/Administrative/faq.htm For more information: http://www.dialsolutions.com/af Unsubscribe: AFIBsupport-unsubscribe List owner: AFIBsupport-owner For help on how to use the group, including how to drive it via email, send a blank email to AFIBsupport-help Nothing in this message should be considered as medical advice, or should be acted upon without consultation with one's physician. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 <<Hi all, I am wondering what the group thinks about the subject studies. They were massive studies, and were done by national health institutes, rather than by drug companies. [snip]>> I'd be quite concerned if my Doctor thought the results were applicable to me. In the AFFIRM study participants were mostly 65 years or older and had minor or no symptoms from AF. I was 29 when I first got AF four years ago and am almost bed ridden when I'm in AF. The only thing I have managed is rate control but I can say without a shadow of doubt I would be much happier if I could maintain sinus rhythm. I don't know if either study measured happiness but it's a serious consideration for me (certainly comes before longevity). Yes, my rate control keeps me out of hospital and may well keep me alive for a long time but my quality of life is seriously impaired both when I'm in AF and trying to manage things around it. Even if maintaining NSR posed a greater health risk because of the medication I would seriously consider it for the quality of life improvements (if only I could find something that kept me out of AF!). On the other hand, if your AF does not bother you and you are able to be as active as you want then it looks like controlling your rate may be a good option. I've pinched this quote from the bottom of http://www.naspe.org/library/naspe_on_clinical_trials/affirm/ " This trial presents how important new information that will aid physicians in the treatment of patients with atrial fibrillation. It is very important to remember the type of patient enrolled, since the results pertain to that patient and cannot be readily extrapolated to all others. Most important is the criterion that the treating physicians concluded that their patients could be adequately managed by either strategy-thus, patients who have intolerable symptoms of AF even with good rate control, which is a sizeable group, especially in younger patients, were excluded from this trial. The data from AFFIRM does NOT pertain to such individuals. Further, AFFIRM studied older patients, and whether these results would be the same in younger individuals is not known. " ( N. Prystowsky, M.D.) I think it's vital to figure out how applicable the study is to you before considering the conclusions. -- D (33, Leeds, UK) vagal AF for 24 hours every 16 days Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 Thanks for the rseponse Did you have a a single procedure or did you need a follow up. Was it a PVA, PVI or atrial focus ablation or a combination. Were there any problems with stenosis. What does Prof H say about the likelyhood of further focii developing in the veins or atria after focus ablation. Presumably a PVI would protect against further focii developing in the PVs. Dave L > > HI > > > > I am in the UK and the way AF is treated here is a little bit > different to the rest of the world. the arfirm studies were completed > many years ago and the then with the technology and drugs they had > then' the result was. > > > > Now on the other hand Prof. Haissigurre in Bordeaux France the > master of the PVA has stated to me that if AF is caught fairly > quickly then there is a good chance of a cure . It its left then > there is a chance of MULTI FOCAL AF in the Atria appearing where its > almost impossible to burn away, with > > out damaging the Atria. This is the theory that AF behest AF (Camm > Waktarie) and the focals cause foculs. > > Prof H is working on a linear ablation to try and combat this. > > I believe that one of our members may have had this as well as a > PVA. > > > > Thats my 2p/c worth and this is only my opinion and I am not a DR. > > > > > > C > > > > > > > > > Web Page - http://groups.yahoo.com/group/AFIBsupport > FAQ - http://groups.yahoo.com/group/AFIBsupport/files/Administrative/faq.htm > For more information: http://www.dialsolutions.com/af > Unsubscribe: AFIBsupport-unsubscribe@y... > List owner: AFIBsupport-owner@y... > For help on how to use the group, including how to drive it via email, > send a blank email to AFIBsupport-help@y... > > Nothing in this message should be considered as medical advice, or should be acted upon without consultation with one's physician. > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 -Hi , I agree with you but I have encountered Dr who still think that its being in AF even if you feel rough is ok and they quote study to back up their finding. I think this is a case of over work and only reading part of the text. you would not think the Uk is the 4th Richest nation in the world when you look at our health cre. john C Ps glad to see your still looking in. <<Hi all, I am wondering what the group thinks about the subject studies. They were massive studies, and were done by national health institutes, rather than by drug companies. [snip]>> I'd be quite concerned if my Doctor thought the results were applicable to me. In the AFFIRM study participants were mostly 65 years or older and had minor or no symptoms from AF. I was 29 when I first got AF four years ago and am almost bed ridden when I'm in AF. The only thing I have managed is rate control but I can say without a shadow of doubt I would be much happier if I could maintain sinus rhythm. I don't know if either study measured happiness but it's a serious consideration for me (certainly comes before longevity). Yes, my rate control keeps me out of hospital and may well keep me alive for a long time but my quality of life is seriously impaired both when I'm in AF and trying to manage things around it. Even if maintaining NSR posed a greater health risk because of the medication I would seriously consider it for the quality of life improvements (if only I could find something that kept me out of AF!). On the other hand, if your AF does not bother you and you are able to be as active as you want then it looks like controlling your rate may be a good option. I've pinched this quote from the bottom of http://www.naspe.org/library/naspe_on_clinical_trials/affirm/ " This trial presents how important new information that will aid physicians in the treatment of patients with atrial fibrillation. It is very important to remember the type of patient enrolled, since the results pertain to that patient and cannot be readily extrapolated to all others. Most important is the criterion that the treating physicians concluded that their patients could be adequately managed by either strategy-thus, patients who have intolerable symptoms of AF even with good rate control, which is a sizeable group, especially in younger patients, were excluded from this trial. The data from AFFIRM does NOT pertain to such individuals. Further, AFFIRM studied older patients, and whether these results would be the same in younger individuals is not known. " ( N. Prystowsky, M.D.) I think it's vital to figure out how applicable the study is to you before considering the conclusions. -- D (33, Leeds, UK) vagal AF for 24 hours every 16 days Web Page - http://groups.yahoo.com/group/AFIBsupport FAQ - http://groups.yahoo.com/group/AFIBsupport/files/Administrative/faq.htm For more information: http://www.dialsolutions.com/af Unsubscribe: AFIBsupport-unsubscribe List owner: AFIBsupport-owner For help on how to use the group, including how to drive it via email, send a blank email to AFIBsupport-help Nothing in this message should be considered as medical advice, or should be acted upon without consultation with one's physician. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 I had all my veins PVA and two extra foci in the atria. I had a one ablation session on the Monday and another on the Wednesday. back in May 2001. I dont think about it if it come again then I will go back to France but this has been firmly placed in the back of my mind and I am trying to enjoy life. For instance I am 50 now I got this at 44. This year we have had to holiday and another planned for September. I making up lost time but not going mad just taking it easy . Also I have just finished a CIsco course and passed it, something I could not dream of doing before as I could not breath or keep awake . C Re: AFFIRM and RACE Thanks for the rseponse Did you have a a single procedure or did you need a follow up. Was it a PVA, PVI or atrial focus ablation or a combination. Were there any problems with stenosis. What does Prof H say about the likelyhood of further focii developing in the veins or atria after focus ablation. Presumably a PVI would protect against further focii developing in the PVs. Dave L > > HI > > > > I am in the UK and the way AF is treated here is a little bit > different to the rest of the world. the arfirm studies were completed > many years ago and the then with the technology and drugs they had > then' the result was. > > > > Now on the other hand Prof. Haissigurre in Bordeaux France the > master of the PVA has stated to me that if AF is caught fairly > quickly then there is a good chance of a cure . It its left then > there is a chance of MULTI FOCAL AF in the Atria appearing where its > almost impossible to burn away, with > > out damaging the Atria. This is the theory that AF behest AF (Camm > Waktarie) and the focals cause foculs. > > Prof H is working on a linear ablation to try and combat this. > > I believe that one of our members may have had this as well as a > PVA. > > > > Thats my 2p/c worth and this is only my opinion and I am not a DR. > > > > > > C > > > > > > > > > Web Page - http://groups.yahoo.com/group/AFIBsupport > FAQ - http://groups.yahoo.com/group/AFIBsupport/files/Administrative/faq.htm > For more information: http://www.dialsolutions.com/af > Unsubscribe: AFIBsupport-unsubscribe@y... > List owner: AFIBsupport-owner@y... > For help on how to use the group, including how to drive it via email, > send a blank email to AFIBsupport-help@y... > > Nothing in this message should be considered as medical advice, or should be acted upon without consultation with one's physician. > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 , You may have the new studies, released in March 2002, confused with something else. Of course, the study may not apply to each individual case. It seems like good background science though. H AFFIRM and RACE Hi all, I am wondering what the group thinks about the subject studies. They were massive studies, and were done by national health institutes, rather than by drug companies. My read is that rate control is at least as effective as rythym contol....measured by the survival rates over about five years. The studies were just released in March, but should seriously impact the method of treatment for afib. Just put the above initials in your search engine to read about the studies. In my case of Feb. 2002 discovered continuous afib, both doctors were at first saying that we should do cardioversion, but since the studies were published are saying that they don't think cardioversion is appropriate.....just control the heart rate with digoxin and diltiazem, and of course get the INR to 2.0 with coumadin. H Web Page - http://groups.yahoo.com/group/AFIBsupport FAQ - http://groups.yahoo.com/group/AFIBsupport/files/Administrative/faq.htm For more information: http://www.dialsolutions.com/af Unsubscribe: AFIBsupport-unsubscribe List owner: AFIBsupport-owner For help on how to use the group, including how to drive it via email, send a blank email to AFIBsupport-help Nothing in this message should be considered as medical advice, or should be acted upon without consultation with one's physician. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 > <<Hi all, > I am wondering what the group thinks about the subject studies. They > were massive studies, and were done by national health institutes, > rather than by drug companies. > [snip]>> > > I'd be quite concerned if my Doctor thought the results were applicable to > me. In the AFFIRM study participants were mostly 65 years or older and had > minor or no symptoms from AF. <snip> The quality of life issue is of the utmost importance to everyone, but particularly to those who are still reasonably active. There is a danger here, that physicians (the majority??), who may be struggling to treat AF by maintaining NSR, will seize on that part of the study which they perceive will make their own lives easier, and apply those particular findings as a " one size fits all solution " while ignoring the conditions attached to the findings. There may also be cost advantages in not trying to maintain rythmn. Patients, in most instances, will not have read the published information, and may not be in a strong and informed position. This approach may be understandable, but it is unlikely to be in the best interests of the patient. A decision to treat by rate control only, while eliminating possible adverse effects of drug treatment, must surely in the long term result in a deterioration of atrial muscle and increase the likely hood of clot formation. What are the relative risks at any given age? Dave L Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 No I have not seen this can you advise and give a brief overview. By the way Age does seem to be taken into account here in the UK if you in your late 60s Amiodarone seem to be the first resort If you want please post your particulars either on or off the board and I will go through them with you. C Re: AFFIRM and RACE , You may have the new studies, released in March 2002, confused with something else. Of course, the study may not apply to each individual case. It seems like good background science though. H AFFIRM and RACE Hi all, I am wondering what the group thinks about the subject studies. They were massive studies, and were done by national health institutes, rather than by drug companies. My read is that rate control is at least as effective as rythym contol....measured by the survival rates over about five years. The studies were just released in March, but should seriously impact the method of treatment for afib. Just put the above initials in your search engine to read about the studies. In my case of Feb. 2002 discovered continuous afib, both doctors were at first saying that we should do cardioversion, but since the studies were published are saying that they don't think cardioversion is appropriate.....just control the heart rate with digoxin and diltiazem, and of course get the INR to 2.0 with coumadin. H Web Page - http://groups.yahoo.com/group/AFIBsupport FAQ - http://groups.yahoo.com/group/AFIBsupport/files/Administrative/faq.htm For more information: http://www.dialsolutions.com/af Unsubscribe: AFIBsupport-unsubscribe List owner: AFIBsupport-owner For help on how to use the group, including how to drive it via email, send a blank email to AFIBsupport-help Nothing in this message should be considered as medical advice, or should be acted upon without consultation with one's physician. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2002 Report Share Posted June 26, 2002 , I will paste below the AFFIRM story, then the RACE study. They were taken from: http://www.naspe.org/library/naspe_on_clinical_trials/ As others have already stated, these trials do not apply to people with intolerable afib conditions. That happens to be my situation. H AFFIRM Clinical Trial Presented at ACC Annual Scientific Session 2002 on March 18, 2002 D. Wyse, MD, PhD, FACC Professor of Medicine, Division of Cardiology University of Calgary Calgary, AB, Canada Dr. Wyse is Chair, AFFIRM Study Planning and Steering Committee The major consequences of atrial fibrillation include stroke and an association with increased mortality. A minority of patients also will develop tachycardia-induced cardiomyopathy if they remain in atrial fibrillation with rapid ventricular rates for prolonged periods. The conventional treatments for patients with recurrent atrial fibrillation are anticoagulation with rhythm control or ventricular rate control. Most physicians in North America prefer strategies that restore and maintain sinus rhythm. However, there is little data documenting the relative benefits of rate vs. rhythm control with respect to endpoints such as stroke, mortality, and patient reported symptoms. AFFIRM: A Large, Multicenter Trial Studying Rate Versus Rhythm Control AFFIRM is the largest A Fib trial to date and the first investigation using an intent-to-treat analysis of total mortality as the primary endpoint in an investigation of rhythm versus rate control. The trial includes 4,060 patients enrolled at more than 200 sites in Canada and the United States between 1995 and 1999. As of March 2002, at least two years of follow-up had been achieved for every patient (mean 3.5 years). A total of 74 patients withdrew consent and were excluded from the data analysis and another 29 patients were lost to follow up. Patient Population: Patients were 65 years of age or older, or under 65 with at least one stroke risk factor, including high blood pressure, diabetes, previous stroke, and poor ventricular function. All patients had ECG-documented atrial fibrillation lasting at least six hours and were able to take anticoagulation. The enrolling physician deemed long-term treatment (up to 5 years) appropriate, and that either rate or rhythm control reasonably could be applied. Methods: Patients were randomized to rhythm or rate control groups, and treating physicians chose from an approved menu of pharmacologic and nonpharmacologic therapies. Investigators were encouraged to continue anticoagulation with warfarin. In the rate control arm, discontinuation of warfarin was a protocol violation unless a contraindication developed. AFFIRM Results Patient Demographics: The mean age of the patients was 70. Approximately 60% were male and 8% were minorities. Approximately 70% had hypertension, 39% had coronary artery disease, 23% had a previous history of heart failure and 13% had a previous stroke. Diabetes was present in 20%, pulmonary disease in 20% and valvular heart disease in 13%. One-third had reduced ventricular function by echocardiography. The primary diagnosis at time of enrollment was hypertension in 51% of patients and coronary artery disease in 26%. More than 90% of patients in the rate control arm remained on warfarin. Those who discontinued developed a contraindication to the agent during the trial, or the physician did not use warfarin if the patient was in sinus rhythm. In the rhythm control group, 70% of the patients were on warfarin throughout the study. Mortality: Results showed no pronounced difference between rate and rhythm control, although a fairly strong tendency toward increased mortality in the rhythm control arm (353 vs. 302 deaths, p ~ 0.06) was demonstrated. Stroke: The majority of strokes occurred in patients who stopped warfarin or had an INR below 2.0 (70% of strokes in the rate control arm and 80% in the rhythm control arm). The slight increase in the number of strokes in the rhythm control was not statistically significant. Other Outcomes: There were more hospitalizations in the rhythm control arm. A small number (15) experienced Torsade de pointes, significantly more in the rhythm control arm (13 vs. 2). There also was a small number (17) of bradycardic cardiac arrests that were more frequent in the rhythm control arm (14 vs. 3). No significant difference in the number of cardiac arrests due to ventricular tachycardia or fibrillation, nor in the composite endpoint of death plus disabling stroke, anoxic encephalopathy, resuscitated cardiac arrest and fatal hemorrhage was observed between the two groups. Data on quality of life and functional capacity will be presented at an upcoming meeting. However, analysis as of March 2002 shows no differences. Discussion: The primary implication of the AFFIRM results presented at ACC is that rate control is as efficacious as rhythm control in these patients. Results show no significant difference in mortality, but a trend toward an increase in deaths in the rhythm control arm (353 vs. 302 deaths). Strokes were more common in patients who stopped anticoagulation or received a subtherapeutic dose in both study groups. The difference in mortality and hospitalizations, which have an impact on cost, suggest that rate control may be preferred. This novel finding is contrary to the initial treatment strategy of the majority of North American physicians who use rate control only when rhythm control does not manage the arrhythmia. Conclusion: Based on the findings of AFFIRM, rate control should be considered as a primary therapy in patients such as those enrolled in AFFIRM, or as secondary therapy if rhythm control does not work in a short time. Anticoagulation should be continued even when the patient is in sinus rhythm. Commentary This trial presents how important new information that will aid physicians in the treatment of patients with atrial fibrillation. It is very important to remember the type of patient enrolled, since the results pertain to that patient and cannot be readily extrapolated to all others. Most important is the criterion that the treating physicians concluded that their patients could be adequately managed by either strategy-thus, patients who have intolerable symptoms of AF even with good rate control, which is a sizeable group, especially in younger patients, were excluded from this trial. The data from AFFIRM does NOT pertain to such individuals. Further, AFFIRM studied older patients, and whether these results would be the same in younger individuals is not known. N. Prystowsky, M.D. RACE Clinical Trial Report submitted by Wang, MD Late-Breaking Clinical Trials I Presented at American College of Cardiology, 2002 Prof.dr. Harry J.G.M. Crijns Hypothesis: The hypothesis was that rate control of persistent atrial fibrillation is not inferior to rhythm control. Study Design: The trial was conducted in 35 centers in the Netherlands. Patients were randomized to a rate control and a rhythm control arm. In the Rhythm Control Arm, electrical cardioversion was performed. Sotalol was the first drug initiated. If early recurrence (<6 months) of atrial fibrillation occurred, electrical cardioversion was performed and flecainide or propafenone was initiated. If again early recurrence occurred, amiodarone was initiated and electrical cardioversion was performed. If early recurrence occurred, atrial fibrillation was accepted or AV ablation was performed. If late recurrence (> 6 months) occurred, cardioversion was performed with no change in drugs. In the Rate Control Arm, for lone atrial fibrillation, aspirin was given. In other groups, oral anticoagulation was performed to achieve an INR 2-3.5. Anticoagulation was given for one month before and 1 month after electrical cardioversion. If chronic sinus rhythm occurred, oral anticoagulation was stopped. Otherwise, oral anticoagulation or aspirin were continued. Inclusion criteria: Persistent atrial fibrillation/atrial flutter >24 hours duration, < 1 year duration of atrial fibrillation 1-2 electrical cardioversions in the past 2 years On oral anticoagulation Exclusion criteria: Transient atrial fibrillation Class IV heart failure sick sinus syndrome Permanent pacemaker amiodarone severe systemic disease Endpoints: The primary endpoint was a composite of cardiovascular death, heart failure hospitalization, thromboembolic complications, severe bleeding, pacemaker implantation, and severe adverse effects. Severe bleeding included bleeding causing a decrease in hemoglobin level of > 2g/l, retroperitoneal or intracranial hemorrhage, bleeding requiring transfusion or hospitalization, or fatal bleeding. Rate control drugs included beta-blockers, calcium channel blockers, and digoxin. These drugs decreased the heart rate to less than 100 beats per minute. If there were no symptoms or tolerable symptoms, atrial fibrillation was accepted. If the symptoms were intolerable, electrical cardioversion or AV junction ablation was performed. Principal Findings: Rate Control Rhythm Control N=256 N=266 Age 68±9 68±9 Male 63% 64% Hypertension 43% 55% Coronary artery disease 29% 26% Valve disease 18% 16% Cardiomyopathy 11% 7% Lone AF 21% 21% At three year followup, 40% of patients in Rhythm Control Arm were in sinus rhythm and 10% of patients in Rate Control Arm were in sinus rhythm. Primary endpoint in the Rate Control Arm was seen in 17.2% of patients compared to 22.6% of patients in the Rhythm Control Arm with a 90% confidence interval (-11%, 0.4%) . Therefore, the inferiority hypothesis was rejected. The death rate was 7.0% in the rate group and 6.7% in the rhythm control. The nonfatal events were greater in the Rhythm Control group (approx. 15%) compared to 10% in the rate Control Arm. Rate Control Rhythm Control Primary endpoint 17.2% 22.6% Cardiovascular mortality 7.0% 6.7% Heart failure 3.5% 4.5% Thromboembolic Events 5.5% 7.5% Bleeding 4.7% 3.4% Adverse events 0.8% 4.5% Pacemaker implantation 1.2% 3.0% The presence of hypertension was associated with decreased benefit in rhythm control arm. However, this observation has limitations since it results from post hoc analysis. No Hypertension Primary Endpoint Hypertension Primary Endpoint Rate Control 17.1% Rhythm Control 12.5% Rate Control 17.3% Rhythm Control 30.8% Conclusions: There is no difference in the composite endpoint (composite of cardiovascular death, heart failure hospitalization, thromboembolic complications, severe bleeding, pacemaker implantation, and severe adverse effects) between the two strategies. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 27, 2002 Report Share Posted June 27, 2002 > , > > I will paste below the AFFIRM story, then the RACE study. They were taken from: > > http://www.naspe.org/library/naspe_on_clinical_trials/ That's very interesting, because there seems to be a modest increase in mortality in the rhythm control groups in each study vs. the rate control groups, and the second study seems to indicate that the problem is when the folks in the rhythm control group also have hypertension. Of course, all we need now is docs saying rate control is just as good as rhythm control for those of us who have to hole up on the sofa when in afib. As someone previously noted, I hope they read the whole report and don't jump to conclusions. Quote Link to comment Share on other sites More sharing options...
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