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Source/Disclosures
Published by:
Healio Interviews
Disclosures:
Barbhaiya and Wilson report no relevant financial disclosures. Contreras reports consulting for Alnylam and Boehringer Ingelheim and giving lectures at events sponsored by Alnylam, AstraZeneca, Boehringer Ingelheim and Esperion. Lala reports giving lectures at events sponsored by Abbott and Zoll. Wei reports consulting and serving on an advisory board for Abbott Vascular, for which fees are paid to her institution.
The American College of Cardiology Scientific Session was held April 2 to 4 in Washington, D.C. For the first time since 2019, the meeting was held inperson, and Healio Cardiology Today w onsite to cover the latest in cardiology.
Healio spoke numerous experts to get their insights on important presentations. Among those were Chirag R. Barbhaiya, MD, FHRS, from NYU Grossman School of Medicine; Johanna Contreras, MD, MSc, FACC, FAHA, FASE, from Icahn School of Medicine at Mount Sinai; Anu Lala, MD, from Icahn School of Medicine at Mount Sinai; W.H. Wilson Tang, MD, from Cleveland Clinic; Cardiology Today Editorial Board Member Janet Wei, MD, FACC, from Smidt Heart Institute at Cedars-Sinai; and B. Hadley Wilson, MD, FACC, from Sanger Heart & Vascular Institute/Atrium Health and UNC School of Medicine.
Source: Adobe Stock
Editor’s Note: All coverage from the ACC Scientific Session can be found here .
VALOR-HCM
Johanna Contreras
Contreras: Mavacamten (Camzyos, Bristol Myers Squibb) is a game changer in obstructive hypertrophic cardiomyopathy, as seen in the VALOR-HCM trial. Mavacamten is a target inhibitor of cardiac myosin; thus, it decreases the excessive contractility that patients with obstructive HCM experience.
This trial of 112 patients with obstructive HCM assigned mavacamten or placebo showed in the mavacamten group significant improvement in symptoms, degree of left ventricular outflow tract gradient and cardiac markers, delaying or avoiding the need for septal reduction therapies by 16 weeks with really minor side effects. The primary endpoint of a decision to proceed with septal reduction therapy or guideline-based eligibility for septal reduction therapy at 16 weeks occurred in 17.9% of the mavacamten group compared with 76.8% of the placebo group (treatment difference, 58.93; 95% CI, 43.99-73.87; P < .0001).
Remember, septal reduction therapies are not available to everyone; they need to be performed at experienced centers by experienced performers. A lot of minority patients will not access to these centers. Thus, mavacamten will allow us to improve the health of many patients and select those who truly require septal reduction therapies.
Another point to consider is that a lot of these patients are young and receive a shocking diagnosis tha will change their lives. To require surgery and implantable cardioverter defibrillator placement may be a hard pill to swallow all at once. Maybe this therapy will also give time to patients to adjust better to their diagnosis.
CHAP
Janet Wei
Wei: We have had significant confusion regarding BP threshold for treatment of pregnant women with mild chronic hypertension, mainly due to the concern of fetal risk. Guidelines agree to treat BP > 140/90 mm Hg when there is superimposed preeclampsia, and the CHIPS trial demonstrated that more aggressive BP control prevented the development of severe hypertension but not preeclampsia. Other observational studies have also shown that lower BP levels during pregnancy have been associated with lower incidences of superimposed preeclampsia and preterm delivery, including in Black women. The 2019 American College of Obstetricians and Gynecologists’ (ACOG) practice bulletin on chronic hypertension in pregnancy stated that it is reasonable to continue to manage a chronic hypertensive patient in pregnancy similar to the ACC/American Heart Association guidelines for chronic hypertension, but the thresholds are not well defined.
In the CHAP trial of 2,408 pregnant women with mild chronic hypertension, researchers found that treating mild chronic hypertension in pregnancy to a goal of < 140/90 mm Hg decreased risk for preeclampsia with severe features and preterm birth compared to a goal of < 160/105 mm Hg (adjusted = 0.82; 95% CI, 0.74-0.92; P < .001), with no increase in the risk for smallforgestationalage birth weight (a = 1.04; 95% CI, 0.82-1.31; P = .76). Furthermore, there was no increased risk of severe neonatal complications. This is an important trial that will change clinical practice and improve maternal outcomes.
We need to understand the long-term effect of antihypertensive treatment on CV outcomes in pregnant women with hypertensive disorders of pregnancy and their offspring.
Although aspirin did not appear to influence the treatment effect in CHAP, less than half of the patients were taking aspirin by 23 weeks of gestation. ACOG recommends women with chronic hypertension to be initiated on aspirin for preeclampsia prevention optimally before 16 weeks’ gestation. Thus, it is possible that the combination of aspirin therapy and BP control < 140/90 mm Hg may have a greater effect on prevention of preeclampsia in pregnant women with mild chronic hypertension.
The difference in outcomes was seen despite a relatively small difference (3 mm Hg for systolic BP and 2 mm Hg for diastolic BP) in the overall achieved mean BPs between the active treatment group and control group. However, there appeared to be larger differences in BP over time.
SODIUM-HF
Anu Lala
Lala: The investigators of the SODIUM-HF trial enrolled over 800 patients who were randomly assigned to low sodium < 1,500 mg per day vs. unrestricted standard lowsodium diets and found no difference in all-cause mortality, hospitalizations, ED visits or 6-minute walk distance at 12 months, but there was a modest approximately 3.5-point improvement in Kansas City Cardiomyopathy Questionnaire quality of life score. Typically, a 5-point difference is considered clinically meaningful.
How are we to contextualize these findings? This was a large, multicenter, multinational study and the results challenge conventional wisdom and practice — so many of us HF clinicians ask our patients to refrain from salt under the assumption that excess sodium leads to excess congestion and thereby hospitalizations, but the relationship is likely more complex than just that. We are always humbled and reminded of why we do research. What you think is true may not be the case, hence the perpetual need for study and curiosity.
PROMPT-HF
W.H. Wilson Tang
Tang: The PROMPT-HF study is a fascinating pragmatic study 100 providers and more than 1,300 patients with HF with reduced ejection fraction that looked at an alert for guideline-directed medical therapy in a health system, both in cardiologists and noncardiologists, in the outpatient setting.
The prescription rate of an additional guideline-directed medical therapy class at 30 days, the primary outcome of PROMPT, was greater among providers who received an alert compared with no alert (RR = 1.41; 95% CI, 1.03-1.93; P = .03). This finding translated to a number needed to alert of 14 to improve guideline-directed medical therapy for one patient with HFrEF.
It seems that it did help, although there are interesting findings. The majority of help seems to have focused on beta-blockers and not necessarily as much in the ones that are low in prescription rate, like the newer drugs.
During the discussion, there was an interesting discussion of whether they were patient-related vs. clinician-related effects. In fact, an editorial published in the Journal of the American College of Cardiology even suggests that the majority of clinicians seem to find it helpful, although their actions don’t actually match with it. In fact, a lot of people did not do anything. Obviously, some important assessment is needed to figure out why clinicians act on what they do or do not act on what they do.
There’s still a lot to do, but this is a good illustration of how a learning health system can potentially improve care, because these are definitely guideline-directed medical therapies that have shown improvement in clinical outcomes, and effective use of it is important.
BIO | GUARD-MI
Chirag R. Barbhaiya
Barbhaiya: Incidence of significant arrhythmias increases along with increased comorbidity, and MI is a significant comorbidity. MI increases the risk for a number of clinically important arrhythmias.
In the BIO | GUARD-MI study of 790 patients with MI at high risk for stroke who were assigned to receive an implantable loop recorder (BioMonitor 2, Biotronik) plus usual care or usual care alone, there was no difference between the groups in the primary outcome of CV death or hospitalization for arrhythmia, ACS, worsening of HF, stroke, systemic embolism or major bleeding (HR = 0.84; 95% CI, 0.64-1.1; P = .21). However, the primary outcome favored the monitoring group in patients with non-STEMI (HR = 0.69; 95% CI, 0.49-0.98) but not in patients with STEMI (HR = 1.1; 95% CI, 0.72-1.69), with interaction barely missing significance (P for interaction = .09).
The study’s finding that patients with greater comorbidities were at greater risk significant arrhythmia makes a lot of sense. I look forward to seeing the full results of the trial to better understand exactly what arrhythmias were observed, and what were the key drivers of the primary endpoint. It seems that most of the events were related to detection of atrial fibrillation, and detection of arrhythmias that prompted pacemaker implantation. I would really like to see whether the events that drove the primary endpoint were hard clinical endpoints, or if they were hospitalization for asymptomatic bradycardia or AF that could likely have been managed without hospitalization.
Counterintuitively, the non-STEMI population appears to have been a more heterogenous population with more comorbidities. Thus, despite having a lower severity of MI, the non-STEMI population was a sicker population at greater risk for incident arrhythmia.
Arrhythmia monitoring using implantable and wearable devices is going to be an exciting and important area of research going forward. As the technology continues to improve to make it smaller, cheaper and more accurate, the level of risk needed to justify monitoring will continue to decrease.
FLAVOUR
B. Hadley Wilson
Wilson: For over a decade, we have known we can have better outcomes in PCI if guided by physiology via fractional flow reserve. The FLAVOUR trial of 1,682 patients with CAD with intermediate stenosis was looking to see if there were comparable results with using IVUS-guided PCI. After 2 years, major adverse CV effects (all-cause mortality, MI or any revascularization) were comparable (risk difference, –0.4 percentage points; P for noninferiority = .015), suggesting that FFR and IVUS are both good technologies to guide successful PCI, with low major adverse events over time.
The one caveat is that FFR-guided PCI had a lower rate of stent implantation than with IVUS, despite there being no difference in major outcomes.
When there is concern for the complexity of a coronary lesion, one can be guided by FFR or IVUS. FFR is used more often in the U.S. than IVUS, so IVUS is likely to be used in the minority of cases where the proceduralist wants to characterize the complexity of the lesion better than can be done with FFR alone.
American College of Cardiology
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