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The Take Home: AHA
The annual American Heart Association Scientific Sessions took place this past November in Orlando, Florida. The 5-day meeting featured late-breaking reports, posters, debates and more on topics spanning the field of cardiology.
During and after the meeting, Cardiology Today’s Intervention spoke with experts for their takes on the most important presentations for interventional cardiology. Interviewees included Sripal Bangalore, MD, MHA, with NYU Langone Medical Center; Editorial Board member Peter C. Block, MD, with Emory University; Robert O. Bonow, MD, with Northwestern University Feinberg School of Medicine; James A. de Lemos, MD, with University of Texas Southwestern Medical Center; Farouc A. Jaffer, MD, PhD, with Massachusetts General Hospital; and Frank W. Sellke, MD, with Brown Medical School and Lifespan Hospitals.
IVUS-XPL
Bangalore: IVUS-XPL was a trial looking at IVUS-guided everolimus-eluting stent (EES) placement in long coronary lesions. We know from the first-generation drug-eluting stent data that IVUS-guided PCI might improve outcomes. That translated to everyone wanting to post-dilate these lesions if they could not do IVUS. But what has changed is that with great results from the second-generation stents, a proportion of operators were not doing the routine post-dilatation anymore as they had done with the first-generation stents. For long lesions, stent optimization is critical.
In this trial, investigators found a significant reduction in MACE (HR = 0.48; 95% CI, 0.28-0.83), mainly driven by target lesion revascularization (HR = 0.51; 95% CI, 0.28-0.91) associated with IVUS-guided PCI. This points to the fact that you can further optimize stent placement, even in the era of second-generation stents, by using IVUS-guided PCI. It may be time for people who were not post-dilating or using IVUS guidance to rethink their procedure. The event rates were low, and interestingly, there were no significant differences in stent thrombosis (HR = 1; 95% CI, 0.14-7.1), which might just point to the fact that the fluoropolymer on the EES is thrombo-resistant.
Bonow: This study shows that IVUS has potential in patients with long lesions. It could lead to greater utilization of IVUS and better outcomes. In the United States, there may already be a tendency for greater balloon dilatation after implantation of the stent, so we may already be doing this, as opposed to needing IVUS to guide stent deployment. Likely, the effect will be individualized to centers that have expertise with IVUS and are comfortable with using it routinely.
RIVER-PCI
Photo credit: Provided by the American Heart Association; printed with permission.
Bangalore: The RIVER-PCI study, the main results of which were presented at TCT 2015, was a disappointment, mainly because incomplete revascularization is pretty common and ranolazine (Ranexa, Gilead Sciences) is a pretty potent agent to relieve angina. So it was surprising that in this group of patients there was no difference compared with placebo. A subanalysis presented at AHA 2015 looked at quality of life and angina frequency. It further emphasized that this trial was indeed negative and there wasn’t a substantial benefit to using ranolazine in patients with incomplete PCI. There was no difference in Seattle Angina Questionnaire angina frequency score between ranolazine and placebo at 1 month (P = .62), 6 months (P = .23) or 12 months (P = .94).
Now that we know this most potent agent didn’t work, it takes us back to the drawing board. We need to look for other therapies, including that if medications are not really helping, maybe being aggressive and trying to open up the completely occluded arteries might be the way to go to relieve the symptoms.
Sellke: Patients who get PCI often have an incomplete revascularization, and sometimes they have a recurrence of their angina. It was hoped that ranolazine would remedy that situation, but the trial has found that it really provided no benefit. Patients who have incomplete revascularization don’t always have angina, so there’s really no good reason to treat these patients. There is no good survival benefit and there’s no pain relief, so there’s really no good reason to treat them with ranolazine.
DAPT SCORE CALCULATOR
de Lemos: Also presented at the meeting, based on the cohort from the DAPT study, a score has been created that may help clinicians determine who should and should not receive dual antiplatelet therapy for more than 1 year after stenting. A very straightforward clinical message emerges from this analysis: For those 50% of individuals with a DAPT Score 2, there is clear net benefit with extending the duration of dual antiplatelet therapy. For the subgroup with a score < 2, there is also a clear message: There is harm in extending the duration. This is an important study and a major step forward.
A couple of caveats: The score is generalizable only to a DAPT study-like population of stable patients who have tolerated 1 year of dual antiplatelet therapy, and the study did not include patients receiving oral anticoagulants. Replication is definitely necessary. The models in this study were fit to the specific dataset, and there were a couple of surprising features, including the fact that only one bleeding variable emerges, and that there is a monotonic association across scores of bleeding. There are likely not a large number of datasets that would be suitable for evaluating this, but PEGASUS-TIMI 54 may be one of them.
As presenter Robert W. Yeh, MD, MSc, MBA, suggested, the model discrimination was only moderate, but in point of fact is comparable to other clinical scores used widely in CV practice, including the CHA2DS2-VASc score.
This offers a data-derived personalized medicine tool. There has been so much attention on precision medicine using complex genetic or biomarker tools, but this study elegantly demonstrates the power of clinical variables in personalized medicine. Moreover, it offers a simple and practical solution to a daily clinical problem for practicing cardiologists and physicians.
This completely revises my interpretation of the DAPT result. I considered the trial essentially null based on the tradeoff of risk and benefit and the importance of the bleeding complications. But we see now a much more clearly favorable benefit-to-risk profile for a substantial subset of patients who had PCI. It’s likely that the models in this score can be further optimized with additional study.
CANOA
Block: It is important to emphasize that the CANOA trial was not a trial that evaluated whether transcatheter atrial septal defect (ASD) closure reduced migraines. The trial evaluated the new onset of migraines in patients who had ASD closure, showing that patients who received dual antiplatelet therapy after closure had fewer new migraines than patients who received aspirin alone (number of monthly migraine days: DAPT group, 0.4; aspirin group, 1.4; incident risk ratio = 0.61; 95% CI, 0.41-0.91). The implication is that possibly small platelet thromboemboli from the left side of ASD closure devices may play a role in migraine development after ASD closure, and that this is reduced by aspirin and clopidogrel therapy. Does that mean that all patients should have aspirin and clopidogrel after their ASD closure? I doubt it. The incidence of new migraines seems to be quite low after ASD closure. It seems appropriate to treat initially with aspirin alone, reserving DAPT for patients who develop migraines.
CTO PCI AND DEPRESSION
Jaffer: My colleagues and I examined 45 patients undergoing clinically indicated chronic total occlusion PCI, and tried to understand whether depression was an important factor in this population. It is recognized that depression is a major source of morbidity and mortality, especially in patients with CAD. However, it was not yet known whether treating CTO patients with depression can improve their angina as well as their depression. We documented their baseline scores of angina and depression and their 30-day follow-up scores after the intervention.
People who presented with a symptomatic CTO were frequently depressed. Roughly 40% were depressed at baseline, and that was a bit of a surprise to us. The second thing we observed is that at baseline, angina scores of depressed patients were significantly higher than non-depressed patients as assessed by the Seattle Angina Questionnaire (SAQ7).
We then performed the CTO PCI with a success rate of about 90%. At 30 days, we saw two interesting phenomena. No. 1, their angina scores improved, but the angina scores improved more dramatically in patients who had depression. The delta SAQ score for improved angina was about twice as great for depressed patients (P < .001 for SAQ7 Summary; P = .01 for SAQ7 Angina Frequency). No. 2, what was really surprising was that the depression scores dramatically improved after CTO PCI. We now wonder whether CTO PCI might be an effective treatment for depression in some patients. It’s a small sample, and at 30 days it’s a little too early to say if the therapy will be durable. But we hope to study this in the near future in a larger population in the OPEN CTO registry, which has 1,000 patients.
Anecdotally, we noted that the one person who developed depression during the study was one of the patients in whom CTO PCI was not successful. With this foundational study, we now have an idea that depressed patients might substantially benefit from CTO PCI. Assessing depression scores in patients with CTO might help one realize that these patients are quite limited and that they have a lot to gain with PCI.
Disclosures: Bangalore reports consulting for Abbott Vascular and Gilead Sciences and serving on an advisory board for Abbott Vascular. Jaffer reports consulting for Abbott Vascular and Boston Scientific. Block, Bonow, de Lemos and Sellke report no relevant financial disclosures.