The 2018 in Orlando has wrapped up and the skeptical cardiologist has returned to patient care.
Of the thousands of abstracts presented, I think the three presentations that will impact my cardiology practice most are in the areas of dyslipidemia/CAD, wearable defibrillators, and prevention of chemotherapy related cardiotoxicity.
We now have outcomes data from a second PCSK9 inhibitor showing that driving LDL down to the range of 25-50 mg/dL on top of maximally tolerated statin therapy lowers cardiovascular event rates and overall mortality in high risk patients (post-ACS.)
This appears to come with no "safety signals" in that there was no difference in neurocognitive measures, diabetes development, cataracts, or hemorrhagic stroke on treatment versus placebo.
The patients with LDL >100 had a near 30% reduction in overall mortality.
For me, this means I will push harder to get my high risk CAD patients on a PCSK9 inhibitor if I cannot get their LDL <100. Price and pre-authorization are the major problems right now.
Interestingly, immediately after the presentation of ODYSSEY, according to ڴŮ, "Sanofi and Regeneron announced that they 'will offer payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent (alirocumab).'"
The drugmakers did not announce a specific price but, according to the ڴŮ report, promised it would be "'in alignment with' the Institute for Clinical and Economic Review's (ICER) new projection of cost-effectiveness at an annual price point of $4,500 to $8,000 in higher-risk patients with LDL cholesterol of ≥100 mg/dL despite intensive statin therapy."
This is great news and will reduce the biggest barrier to widespread use of the PCSK9 inhibitors.
This study also provides additional support for the LDL hypothesis and the safety of really low LDL levels on treatment.
I have been eagerly awaiting this RCT which after 10 years finally gathered enough patients to reach projected goals. This was a test (the first RCT) of whether the Zoll LifeVest wearable defibrillator would lower sudden cardiac death (SCD) or VT/VF death in patients with EF<35% after MI.
Strangely enough there was no difference in SCD (the primary endpoint) in the 90 days after MI but there was an overall significant reduction in mortality from any cause (a secondary endpoint) from 4.9% in those not wearing the LifeVest down to 3% in those wearing it.
This was somewhat baffling. The authors have suggested that the LifeVest could be functioning as an expensive cardiac monitor and perhaps false alarms led to earlier diagnosis of non-lethal arrhythmias like Afib or bradycardia or that there was misclassification of the causes of death.
We need more analysis of this study, clearly, and await the published paper.
I have previously been a skeptic and demanded RCT data supporting the device. Now I have a 10-year RCT showing a slightly significant drop (P=0.04) in overall mortality but not accomplished through preventing deaths from VT/VF.
Cardioprotection in Breast Cancer Tx
Two studies were presented looking at cardioprotection in breast cancer patients undergoing chemotherapy. The CECCY study found no benefit of carvedilol treatment in preventing reduced LVEF during anthracycline chemotherapy.
The second study randomized 468 HER2-positive breast cancer patients getting trastuzumab (Herceptin) who had had prior exposure to anthracycline chemotherapy. The risk of cardiac toxicity (losing at least 10% LVEF or at least 5% if to a level below 50%) was lowered by 50% in both lisinopril and carvedilol arms compared to placebo.
The second study provides good evidence to start breast cancer patients undergoing chemotherapy with both anthracyclines and trastuzumab on either lisinopril or carvedilol.
For more ACC coverage and a nice hour-long panel discussion of the major presentations led by Valentin Fuster check out the . This page also has the slidesets from the major presentations available for free download.
, is a private practice noninvasive cardiologist and medical director of echocardiography at St. Luke's hospital in St. Louis, Missouri. He blogs on nutrition, cardiac testing, quackery, and other things worthy of skepticism at , where a version of this post first appeared.