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The Take Home: AHA
The American Heart Association Scientific Sessions, featuring numerous presentations on a wide variety of topics in cardiology, was held Nov. 12-16, 2016, in New Orleans. Cardiology Today’s Intervention covered the sessions live and sought out comment from leading experts in interventional cardiology, including Vincent Bufalino, MD, from Advocate Health Care, Oakbrook Terrace, Illinois; C. Michael Gibson, MD, MS, from Beth Israel Deaconess Medical Center and Harvard Medical School; Cardiology Today’s Intervention Associate Medical Editor Roxana Mehran, MD, from Icahn School of Medicine at Mount Sinai; and Craig R. Smith, MD, from NewYork-Presbyterian Hospital/Columbia University Medical Center, for comment on the most important intervention-related findings
PIONEER AF-PCI
Gibson: Our population is aging. As it ages, more patients develop atrial fibrillation and CAD together. Approximately 5% to 10% of patients receiving a stent also have AF. To this point, we have given people full-dose warfarin at an INR of 2 to 3, a full-dose thienopyridine and aspirin, also known as triple therapy. This has resulted in major bleeding in about 15% of patients.
In the PIONEER AF-PCI study that I presented, our goal was to substitute rivaroxaban (Xarelto, Janssen Pharmaceuticals) for warfarin and to drop aspirin in an effort to make the regimen safer.
In the study of 2,124 patients, we found that if you use rivaroxaban at a dose of 15 mg per day with one thienopyridine and no aspirin, or use a baby dose of rivaroxaban of 2.5 mg twice daily with aspirin and a thienopyridine, you reduce bleeding by about 8 to 9 percentage points.
What this means for clinicians is that one would only need to treat 11 or 12 patients to prevent one clinically significant bleed. This did not come at a price of effectiveness. The rates of death, MI and stroke were very similar across all the different arms.
Another important take-home message is that one would only need to treat 10 to 15 patients with one of the rivaroxaban regimens to prevent one hospitalization, a very important driver from a cost-effectiveness perspective. The 2.5-mg dose is approved outside the United States for ACS. The 15-mg dose is in the FDA label for patients with impaired renal clearance and is the labeled dose in some countries, including Japan. Overall, this strategy represents a safer alternative for this patient population.
Mehran: The PIONEER AF-PCI study in patients with AF undergoing PCI showed that a rivaroxaban-based strategy was associated with a reduction in bleeding. This was a major finding because it points to a new way to deal with this complex patient population that is vulnerable to bleeding because of the medications required to treat AF and CAD.
Photo credit: Provided by the American Heart Association; printed with permission.
FUTURE
Mehran: The FUTURE study was very interesting. The study, conducted at a large number of centers in France, was supposed to enroll approximately 1,800 patients to compare fractional flow reserve-guided PCI with angiography-guided PCI in patients with multivessel disease. These results were highly anticipated because we want to know how FFR performs. Unfortunately, the trial was stopped prematurely after approximately 900 patients were enrolled due to increased mortality in the FFR arm. However, after the analysis was done and the findings were presented, the increased mortality was not statistically significant (HR at 1 year = 1.98; 95% CI, 0.85-4.6). The rate of the primary endpoint at 1 year — death, MI, stroke or revascularization — was also not significantly different between the two groups (HR = 1.09; 95% CI, 0.76-1.56). This means we still don’t know whether there are any differences between angiography-guided PCI and FFR-guided PCI.
In my opinion, based on the findings presented, I would not change a thing. I still believe that FFR-guided PCI is the right way to assess lesions when one is not sure of the significant narrowing of the lesion. We should not change our current practice based on these findings.
Bufalino: The results of FUTURE make one pause and ask the question if FFR is as beneficial to patients as standard care. Practically, we also have a concern that in an individual patient, FFR doesn’t always answer the question. The judgment of the interventionalist seems to sway the decision more often than not. This raises the issue that we have to be careful and not let FFR totally guide thinking. Having good judgment is still the most valuable thing in terms of managing these patients.
This is only one trial, so it may be too early for the findings to change how doctors use FFR in everyday practice. It will make those who have been a bit negative about FFR more energized. Overall, FFR has been very helpful and has changed practice patterns, helping us get better answers for cases that look borderline. It will still be utilized.
GARY
Smith: This was a registry of both surgical and transcatheter aortic valve replacement. The researchers performed a propensity-matched analysis of intermediate-risk patients with severe aortic stenosis who had TAVR or surgical AVR. They did a very good job of handling the problems that arise when trying to make sense of a real-world experience. They did a credible, defensible job of appropriately excluding, among others, patients who had confounding variables and accessory procedures, who would make it difficult to learn anything from the experience.
There were two groups, one treated with isolated surgical AVR and one treated with isolated TAVR. At 30 days, mortality was significantly lower with surgery. At 1 year, all-cause mortality was 16.6% in the TAVR group and 8.9% in the surgery group (P < .001). Patients who underwent TAVR were more likely to require a permanent pacemaker (19.1% vs. 5.3%), have more vascular complications (7.7% vs. 1.1%) and have more aortic regurgitation of grade 2 or higher (4.7% vs. 0.4%; P < .001 for all). In contrast, patients who underwent surgery had higher rates of bleeding complications with the need for transfusion (25% vs. 51.5%; P < .001), bleeding with the need for re-intervention (1.3% vs. 4.5%, P < .001) or the need for temporary dialysis after the procedure (2.3% vs. 3.6%, P = .024). The rates of stroke were about the same and the 19% pacemaker rate with TAVR was no surprise. The overall results in both groups were good, with an observed-to-expected ratio of 0.7 for both.
The big question is will this be the experience that patients are actually dealing with in the future? Should we be basing the choice on this kind of real-world experience, or should we be guided by selected experiences from clinical trials, for example the SAPIEN 3 intermediate-risk trial, in which TAVR had a 1% mortality rate and was very competitive with surgery?
Of interest, recent data from New York State’s registry showed that the mortality rate for isolated surgical AVR was 1.76%. That’s a difficult standard to beat, and that’s the kind of standard TAVR will have to meet to be equivalent to surgery. There is a lot to do.
Mehran: These findings are unlike anything we have seen before. I always caution people to be careful with interpreting registry data, taking the information with a few grains of salt, because registries are not as good as randomized studies. When we choose one strategy vs. another, there are confounders that we can never correct for in any propensity-matched analyses.
Therefore, I would say that the findings from the randomized trials still stand, and TAVR is the future of AVR. We are moving towards using TAVR more in patients at lower surgical risk. We will continue to use the registries to complement what we are learning from randomized studies.
Disclosures: Gibson reports receiving research grant support from Bayer and Janssen. Mehran reports financial ties with various device and pharmaceutical companies. Bufalino and Smith report no relevant financial disclosures.