The Take Home: TCT
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This year, Transcatheter Cardiovascular Therapeutics was held as a hybrid meeting Nov. 4 to 6, with some participants attending in person in Orlando and others attending virtually.
Healio spoke with numerous experts for their takes on the most important presentations. Offering their insights are Joseph Cleveland, MD, from the University of Colorado; Cardiology Today Editorial Board Member and American College of Cardiology President Dipti Itchhaporia, MD, FACC, FESC, from Hoag Memorial Hospital and University of California, Irvine; Gilbert H. Tang, MD, from Mount Sinai Health System; Oussama Wazni, MD, MBA, from Cleveland Clinic; and ACC Vice President-Elect B. Hadley Wilson, MD, FACC, from Sanger Heart & Vascular Institute/Atrium Health and UNC School of Medicine.
Editor’s Note: All coverage from TCT can be found here .
FAME 3
Cleveland: In patients with severe three-vessel coronary disease, CABG still appears to be the best revascularization strategy. For all the other groups in the FAME 3 study, it is still a question mark as to whether fractional flow reserve-guided PCI is noninferior to surgery.
The trial involved 1,500 patients with three-vessel CAD at 48 sites worldwide who were randomly assigned to undergo CABG or an FFR-guided PCI, in which all lesions were stented if FFR was 0.8 or less. The primary endpoint of death, MI, stroke or repeat revascularization at 1 year occurred in 10.6% of the FFR-guided PCI group compared with 6.9% of the CABG group (HR = 1.5; 95% CI, 1.1-2.2). The P value for noninferiority was .35, meaning that FFR-guided PCI was not found to be noninferior to CABG.
There are a lot of nuances in this trial. FFR-guided PCI is still an acceptable option for selected patients, provided there is also adherence to medical therapy; the trial does not condemn that as a strategy. The follow-up time of 1 year is short. Properly defining MI is still challenging, and there is a question of how the definition impacts the outcomes seen here. While the hard endpoints draw the most attention, other factors such as quality of life and cost-effectiveness are also important to address. The results allow us to sit with patients and give them yet another piece of counseling that FFR-guided PCI, while not meeting the noninferiority criteria, appears to be a viable option in some patients with less severe CAD, and some cardiologists believe it is the best option for those patients.
Things are likely to stay much the same in clinical practice. The event rates in the CABG group were lower than predicted, which is one reason why the results did not reach the noninferiority margin. The PCI results were better than in the SYNTAX trial, but the CABG results were a lot better. There is still a signal that when decisions are made with appropriate guidance, either strategy probably can be employed for patients with single- and two-vessel CAD. Even for patients with three-vessel-disease and lower SYNTAX scores, FFR-guided PCI produced decent results. As we saw in SYNTAX, for the more complex patients with three-vessel coronary disease, CABG stands out as the treatment of choice. That has been our approach since SYNTAX.
We need to see results out to 3 to 5 years. There also needs to be an analysis of the completeness of revascularization in both groups to see if that contributed to the results. Women and persons of color were underrepresented, and we need more information about how they may or may not fit the results.
RADIANCE-HTN TRIO
Itchhaporia: Past trials have not shown a significant difference between renal denervation and medical therapy. In a new analysis from RADIANCE-HTN , a sham-controlled trial of ultrasound renal denervation (Paradise, Recor Medical) in 989 patients with resistant hypertension, we may see a trend of benefit, but I am not sure if it is significant.
At 6 months, the number of antihypertensive medications in each group was similar (renal denervation, 3.8; sham, 4.1; P = .078), but the change in number of antihypertensive medications from baseline was greater in the sham group (0.7 vs. 1.1; P = .045).
The study s underpowered, but we see a positive on the second endpoint. So, we need to conduct a larger trial to see if this is a true trend.
We also need to know if renal denervation has durable results. The durability still has to be demonstrated.
It has been touted that these patients want to have fewer medications, and that may be true, but in this case, renal denervation led to only one less medication, the aldosterone antagonists, and the difference in medications was not significant at 6 months.
The door had been closed on renal denervation previously, and this study may have opened it a little, but we need to have a larger study before we can say we have true data that point the way to go.
FAVOR III China
Wilson: The FAVOR III China study represents the next stop on a journey that started with pressure wire-based techniques such as FFR for physiological assessment of coronary disease. This has progressed to FFR-CT and now to quantitative flow ratio (QFR). We are continuing to advance with less invasive techniques for assessing coronary artery blockages and determining how best to treat them. It has become less invasive and safer to assess coronary stenoses and select the right therapies to improve long-term outcomes.
These newer techniques also require less time and less resources to make these assessments accurately.
In the randomized trial of 3,825 patients with angina or recent MI (63.5% with ACS), the primary endpoint of 1-year MACE, defined as all-cause death, MI or ischemia-driven revascularization, occurred in 5.8% of the QFR group compared with 8.8% of the angiography group (difference, –3 percentage points; 95% CI, –4.7 to –1.4; HR = 0.65; 95% CI, 0.51-0.83; log-rank P = .0004).
QFR is used very little in the U.S. right now, but there has been growing interest. It will require an upgrading of technology in cath labs to perform QFR at the level seen in FAVOR III China. This can be done successfully, and QFR should be easier to implement than FFR-CT. It should also take less time to get up to speed with QFR than it took when we originally implemented FFR.
This is a very welcome, interesting and exciting study. We are going to see this technology come to the forefront. There is an ongoing trial in Europe to compare QFR with instantaneous wave-free ratio, which could further validate both of those technologies. If that happens, there will be an impetus to adopt this technology rapidly.
SURTAVI
Tang: In the 5-year results from the SURTAVI trial of 864 intermediate-risk patients assigned transcatheter aortic valve replacement with a balloon-expandable valve (Sapien 3, Edwards Lifesciences) and 796 patients assigned surgical AVR, the rate of the primary outcome of all-cause death or disabling stroke was 31.3% in the TAVR group compared with 30.8% in the surgery group (HR = 1.02; 95% CI, 0.85-1.22; P = .85).
There are no major surprises here. TAVR with a supra-annular self-expanding valve has durable performance at 5 years in intermediate-risk patients compared with surgery, given similar death and stroke, but better hemodynamics, at the expense of higher pacemaker rates and early valve reintervention.
TAVR in intermediate-risk patients appears to be a durable therapy up to 5 years with the supra-annular self-expanding valve. The reasons for aortic valve reintervention and increasing pacemaker rates need to be investigated.
PRAGUE-17
Wazni: The key take-home message from PRAGUE-17 is that after a long period of follow-up, left atrial appendage (LAA) closure (Amulet, Abbott; Watchman, Boston Scientific; or Watchman-FLX, Boston Scientific) was not inferior to oral anticoagulants. But there is nuance.
In the investigator-initiated trial of 402 patients with atrial fibrillation at high risk for stroke, after a median follow-up of 3.5 years, LAA closure remained noninferior to direct oral anticoagulation for the primary endpoint of cardioembolic events, CV death, clinically relevant bleeding or procedure/device-related complications, with 8.6 events per 100 patient-years in the LAA group and 11.9 events per 100 patient-years in the medical therapy group in the intention-to-treat analysis (subdistribution HR = 0.81; 95% CI, 0.56-1.18; P for noninferiority = .006).
LAA was also noninferior to direct oral anticoagulation for preventing CV death, all stroke or transient ischemic attack.
The primary composite endpoint included stroke, embolism and bleeding. The reassuring part is that the risk for stroke or thromboembolism was similar in both arms, and that the bleeding occurred more in the anticoagulant arm, which is expected.
However, because the study was not powered to look at stroke itself, we have to be careful in interpreting these results. It is reassuring to know that with long-term follow-up, the risk for stroke and thromboembolic events is not higher in the LAA closure group than in the oral anticoagulation group.
In clinical practice, we close the LAA to prevent stroke and avoid long-term oral anticoagulation. In that respect, the findings confirm our approach. Of concern, we do not know what the incidence and risks for device-related thrombosis or leaks were. The authors said they intended to look at that, but because of the COVID-19 pandemic, a lot of patients had their transesophageal echocardiography canceled.
A small number of patients in the LAA closure arm (approximately 8.5%) ended up with long-term blood thinners. We need to better understand the reasons for this. Was it due to device-related thrombosis or leaks, and if so, we need to better understand the risks for device-related thrombosis and if it can be avoided altogether. We also need to know if it is reasonable to resume oral anticoagulation in a subset of patients, and which subsets. Are they patients at high risk for stroke for other reasons? Are they patients whom we know may develop device-related thrombosis? It would be nice to understand what this 8.5% is about.
There are three large studies in progress that may help clarify some of these issues. OPTION, which I have been leading, randomly assigned patients with AF after ablation to oral anticoagulation or LAA closure with Watchman. We have enrolled 1,600 patients and will follow them for 3 years. This will better inform us on the risk for stroke and bleeding in low-risk patients who have already had ablation for AF. Then there is the CHAMPION study of Watchman vs. oral anticoagulation and the CATALYST study of Amulet vs. oral anticoagulation. These each have more than 3,000 patients each and follow-up of 3 to 5 years. These will be the seminal studies that will inform us more closely on whether LAA closure will replace oral anticoagulation in most patients.
We also have to consider if there is a subgroup of patients who should be treated with LAA closure plus oral anticoagulation because of high risk. The LAAOS III study showed that clipping the LAA during surgery plus oral anticoagulation is better than oral anticoagulation alone; the risk for stroke was much lower in the group that got LAA closure. We are now working on LAAOS IV, which will hopefully inform us regarding percutaneous strategies; it will be LAA closure with Watchman plus oral anticoagulation vs. anticoagulation alone.
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