Here the link to our study examining the effect of first-line ablation vs AAD on AF progression.
Thanks to @AHAScience for welcoming me back to present the results, and to @NEJM for the simultaneous publication.
@CCI_CIC @UBCDoM @CHRS_SCR@SCC_CCS
https://t.co/dO410eGr5B
It’s been a crazy weekend bouncing between the Global EP summit in Cleveland and the HRx meeting in Atlanta. Two very different forums with two different programs and goals, but definitely fantastic in their own right.
Where the Global EP meeting offers novel insights regarding the clinical care we are delivering right now, HRx offers a peek into the future about what we might be doing in a few years.
Despite the different focuses, these meeting offered a wonderful opportunity to catch up with friends.
Thank you to Oussama Wazni, Jonathan Piccini, MD, MHS and Prashanthan Sanders for inviting me to participate in these meetings.
@DilawriCVI
This is an amazing and joyful story to read.
The whole thing is an incredibly important and universal message, and one that I don’t want to spoil.
But whether it’s parenting, or a doctor-patient relationship, or mentorship, it’s important to be generous and humble; to recognise our actions echo; that small experiences for us can be incredibly momentous for others; and that people may not always remember what you did, but they’ll always remember how you made them feel.
When Thunder GM Sam Presti was 17, he played one-on-one against a random guy at a health club outside Boston.
The moment was so memorable and formative, he decided to track the guy down 30 years later.
And that was just the beginning of the story.
https://t.co/2AvcyrJBSP
Just sitting on the runway waiting to head east on the redeye towards HRX. I’m excited to catch up with another year of innovation and see where our friend is heading. I’m sure Jon and Prash have put together an excellent program.
@PrashSanders@peterkistler3@javadm20@drlouisesegan@drjohnm That was my point in a different discussion. Both got active treatment. One invasively and one non-invasively. Short follow-up so benefit of cardioversion probably still retained in a proportion.
Agree. Binary freedom from 30 seconds of recurrent AF is a terrible endpoint. Particularly when patients have more advanced disease.
Imagine if the coronary stent trials had a Kaplan Meier curve for first episode of chest discomfort post stent.
Or if the hypertension trials evaluated time to first systolic BP > 140 mmHg
I’d read it in the context of the rest of the trials done over the past 2 years and recognise that all point to benefit with mean differences of 5, 18, and 30 points.
If they were serious about placebo effect they wouldn’t have cardioverted the control group.
In my mind active treatment in both randomised groups is contrary to the idea of a “sham”
“Sham” was active treatment (cardioversion) so there should be an improvement in quality of life in that group
But more to the point - a clinically meaningful improvement in afeqt is 5 points.
The difference between groups was 5.4 points in this study (95%CI 1-9.8)
So patients being ablated were significant Better than those cardioverted.
Which is the same result as the other two sham controlled trials.
@drjohnm Yes the difference between groups in the mixed-model was significant and met the clinically relevant threshold of 5·4 points (95% CI 1·0 to 9·8), thus aligning with the two previous trials.
@djc795@cpgale3 There have been two others. This is the third.
https://t.co/Ys7EHfbCAr
https://t.co/lhMCMJb5mN
The other two showed significant differences in AF burden and quality of life.
So this new trial is the outlier.
I think that’s the problem of adjunctive ablation trials - anything we add is going to have a marginal effect over and above PVI.
Plus, there will be no benefit in a subset, which will dilute the overall difference. For example, in pifpaf they stratified randomisation by scar. Perhaps PWA is best for that group?
This was a great hotline session - multiple interesting trials presented including PIFPAF, which is a positive trial in my mind.
Though the chosen primary was consistent with the consensus document, in persistent AF it’s not necessarily a meaningful endpoint.
For comparison, if they had used the avant guard endpoint it would have been considered significant.
So it really highlights that the choice you make in study design has big implications of the perception of the result.
In the case of this study - looking across all endpoints - you see that PWA resulted in a significantly lower af burden. To me this matters as it’s telling us that there is a physiologic benefit to a laying the posterior wall.
Then if you look across the other presented studies - HALT AF and PEAK AF - reinforced the value of homogenizing the posterior wall. Effectively reinforcing the result.
The problem of all modern stroke prevention trials is a decreasing event rate, due to several factors including better background therapy.
If I were designing a trial several years ago I would have used Olesen data to estimate event rate (left). This is likely where the 2% per year comes from.
But modern event rates are lower (0.5%) which is in line with this trial.
Despite that the stroke reduction was a significant 90%, which is in line with NOAC trials (slightly generous as I put it closer to 80-85%).
I would never have expected 0.45, a gross underestimate of effect.
Can’t comment on the antiplatelet as I’m not sure how it favours DOAC. More use would decrease difference in both bleeding and stroke
This is an incredibly important study.
The just presented SINGLE-AF trial randomised patients with a single risk factor (other than sex), demonstrating a significant reduction in stroke, systemic embolism, major bleeding, or death from cardiovascular causes at 24 months.
Although the @SCC_CCS AF guidelines (https://t.co/hHMD4TWMf9) have advocated for OAC for this group of patients for many years, sometimes at contrast with other national societies, its nice to see that this approach has been validated in a large RCT.
https://t.co/8bIC4Q1KYn
@crowanmd That’s incorrect. The reduction in ischemic stroke was significant [0.10 (0.01 to 0.77)] as was the reduction in stroke and systemic embolism [0.10 (0.01 to 0.77)]
I don’t entirely agree with @kaulcsmc
There’s a large group of “low risk” AF that sits in a grey zone.
In the past few years we’ve got multiple trials addressing this group
1. NOAH and ARTESIA looked at OAC in DDAF
2. OCEAN, ODIN, ALONE looked at OAC in postablation AF.
3. SINGLE looked at OAC for low chadsva AF
All are examining AF in the range of ~1% annual stroke risk (though previous estimates, eg Olesen, would have thought this would be in the 1.5-2% annual stroke risk range)
For this trial - it’s a superiority trial that showed superiority. It’s incredibly important data and it does inform practice.
I don’t necessarily conflate that statement with it will lead to people to prescribe more OAC (that’s an interpretation of absolute benefit).
But I now can hold up a trial that demonstrates randomised data in a previously unstudied population.