384 - COVID Vaccine, Colchicine for Heart Disease, CVD Risk Counseling
Take 3 – Practical Practice Pointers©
A “COVID-Quickie” From the CDC
1) Two Frequently Asked COVID Vaccine Questions
If I’ve already had COVID-19 and recovered, do I still need to get the vaccine?
COVID-19 vaccination should be offered to all patients regardless of whether they already had COVID-19 infection. They should not be required to have an antibody test before getting vaccinated. However, anyone currently infected with COVID-19 should wait to get vaccinated until after their illness has resolved and after they have met the CDC criteria to discontinue isolation. Additionally, current evidence suggests that reinfection with the virus that causes COVID-19 is uncommon in the 90 days after initial infection. Therefore, people with a recent infection may delay vaccination until the end of that 90-day period if desired.
When can I stop wearing a mask and avoiding close contact with others after I have received the vaccine?
There is not enough information currently available to say if or when CDC will stop recommending that people wear masks and avoid close contact with others to help prevent the spread of the COVID. Experts need to understand more about the protection that COVID vaccines provide before making that decision. Other factors, including how many people get vaccinated and how the virus is spreading in communities, will also affect this decision.
Sigh …. Confession time. It’s incredibly frustrating for me to think that “nothing will change” post vaccine, at least in the short run. This is because the initial vaccine research only looked at prevention of systemic disease, not whether the vaccine immunity included the nasopharynx or whether recipients could still harbor the virus in their nasal mucosa and become asymptomatic spreaders. At the least, I’m hoping we will thoughtfully question the need for “face shields” post vaccine, since they are for our protection, not to prevent our spreading virus to others. Stay tuned. The research is ongoing and hopefully we’ll soon have an answer.
CDC FAQ about COVID- 19 Vaccination. Updated 29 December 2020. Link
From the Literature and Question from a Colleague
2) Colchicine for Heart Disease?
“I recently received a practice alert in Up-to-Date regarding the use of colchicine for patients with known heart disease. What’s the story?”
Colchicine is a well-known and -tolerated medication that has been used to treat gout and pericarditis, so its anti-inflammatory credentials are solid. While we have known of a relationship of inflammation and coronary artery disease for years, several anti-inflammatory medications (anti-IL1b antibodies, methotrexate) have failed to pass RCT muster. Colchicine showed some early promise in a small, non-placebo-controlled study, and has been subsequently evaluated in two recent trials: one done just after myocardial infarction (MI) and one in stable coronary heart disease (CHD).
The Colchicine Cardiovascular Outcomes trial (COLCOT) randomized over 4700 patients within 30 days of MI to colchicine (0.5 mg per day) or placebo. Mean age was ~61, 81% were male, 20% had diabetes. There were a lot of exclusions in this study. The most relevant were moderate-severe CHF, chronic steroid use, recent stroke and cancer or bypass surgery within 3 years, severe renal disease (creatinine 2x normal), severe liver disease, and drug/alcohol abuse. The subjects were followed for just under 2 years on average and were assessed for a composite outcome that included any one of: MI, stroke, hospitalization for angina leading to percutaneous interventions, or cardiovascular death. An intention-to-treat analysis revealed a reduced risk of the composite outcome in the colchicine group compared to the placebo group (5.5% vs. 7.1%, respectively). Stroke and hospitalization were the two most significant individual outcome differences seen. While we can’t do an exact NNT calculation from this data (because of the differing lengths of time the subjects were enrolled in the trial), a rough estimate is ~63 patients needed to treat over 2 years to avoid any one of the outcomes. Significant adverse events with colchicine included nausea and flatulence (but not diarrhea), and pneumonia (0.9% vs. 0.4%, number needed to harm ~ 200, which bears monitoring).
The Low Dose Colchicine 2 trial (LoDoCo2) randomized just over 6500 subjects with chronic, stable CHD to colchicine (0.5 mg per day) vs placebo and followed them for an average of 28 months. CHD was defined in this trial by percutaneous angiography, CT angiography or coronary artery calcium score > 400 Agatston units (the highest category of results from this test). Exclusion criteria for this study focused on severe CHF, severe valvular disease, and severe renal impairment. Essentially the same composite outcome as in the COLCOT trial was used, and the colchicine group had a reduced risk of that outcome compared to placebo (6.8% vs. 9.6%, respectively). With the same caveat as above, the NNT is ~36 patients over 28 months to prevent one of the composite outcomes. Significant differences were seen in many more of the individual outcomes in secondary endpoint analysis than in the COLCOT trial. Significant adverse events included a small increase in myalgias in the colchicine group (22% vs 18.5% - likely a high overall rate due to statin use).
In these trials, patients were well-treated for their conditions (ASA, anti-platelet meds, and statins after MI, and ASA, statins, ACEs and beta-blockers for stable CHD) prior to adding the colchicine, so this therapy should be considered AFTER those therapies. Now that an anti-inflammatory treatment has been shown to help, I predict more such studies are forthcoming.
I reached out to Dr. Matt Schumaeker, Carilion Clinic Cardiology, for some additional context. He writes: “There have been several trials that suggest improvement of outcomes with low dose colchicine, including the LoDoCo2 trial…I have not seen this translate into significant practice changes yet. Unlike canakinumab, studied in the CANTOS trial, colchicine is a much less expensive anti-inflammatory therapy and potentially accessible to a much broader range of patients. Personally, I will wait to see this evolves into a guideline recommendation by ACC/AHA and for now, I continue to use colchicine only in treating patients with pericarditis.”
From the USPSTF
3) Behavioral Counseling for Adults with CVD Risk Factors
Cardiovascular disease (CVD) is the leading cause of death in the US. Known modifiable risk factors for CVD include smoking, overweight and obesity, diabetes, elevated blood pressure or hypertension, dyslipidemia, lack of physical activity, and unhealthy diet. It is known that adults who adhere to national guidelines for a healthy diet and physical activity have lower cardiovascular morbidity and mortality than those who do not. All persons, regardless of their CVD risk status, can gain health benefits from healthy eating behaviors and appropriate physical activity.
The USPSTF recently updated their 2014 recommendation regarding behavioral counseling interventions for adults with CVD risk factors including HTN, dyslipidemia, or ASCVD risk > 7.5%. The recommendation advocates offering or referring adults with CVD risk factors to behavioral counseling interventions to promote a healthy diet and physical activity. (B)
Behavioral counseling interventions usually combine counseling on a healthy diet and physical activity and are usually intensive, with multiple contacts that include either individual or group counseling sessions over extended periods. Interventions usually involve a median of 12 contacts, with an estimated 6 hours of contact time over 6 to 18 months. Interventions typically involve 1-on-1 time with an interventionist and include self-monitoring (cornerstone), motivational interviewing, and behavioral change techniques such as goal setting and problem solving to address barriers related to diet, physical activity, or weight change. Primary care clinicians as well as a wide range of specially trained professionals, including nurses, registered dietitians, nutritionists, exercise specialists, physical therapists, masters- and doctoral-level counselors trained in behavioral methods, and lifestyle coaches, can deliver these interventions.
Common dietary counseling advice includes reductions in saturated fats, sodium, and sweets/sugars and increased consumption of fruits, vegetables, and whole grains. The Dietary Approaches to Stop Hypertension (DASH) diet, low-sodium diet, and the Mediterranean diet are commonly recommended diets. Physical activity counseling focuses on patients achieving 90 to 180 minutes per week of moderate to vigorous activity.
I reached out to Laura Daniels, PhD, our residency Clinical Health Psychologist and Associate Program Director, for her insights into this recommendation. She responded: “Behavioral counseling that results in sustainable change and improves health outcomes is intensive, iterative, and tailored to individual factors, both static (e.g. health literacy, personality, cultural beliefs) and dynamic (e.g. motivation level, stressors, health status). Such change requires consistent empowerment through positive reinforcement and feedback.”
We’ll bring Laura back to highlight how to incorporate this in the midst of a busy clinical practice in a future Take 3.
Mark and John
Carilion Clinic Department of Family and Community Medicine
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