Optimal Vascular Care (Composite)

The Optimal Vascular Care (OVC) measure, a composite metric encompassing various aspects of vascular health management, reflects a critical shift in guidelines for hypertension diagnosis and management. The American College of Cardiology and American Heart Association's revised guidelines redefined hypertension thresholds, increasing the number of individuals classified as hypertensive. This change has prompted debate within the medical community, particularly concerning the appropriateness of lower blood pressure targets for all patients. Moreover, disparities in guideline endorsement among medical organizations have further complicated the landscape of hypertension management, leaving healthcare providers uncertain about the most effective approaches to care. Against this backdrop, the OVC measure serves as a vital tool for assessing and improving vascular health outcomes, albeit amidst ongoing controversies and challenges surrounding hypertension management.  

Informed by the evolving evidence and guideline recommendations, the development of the OVC measure involved extensive deliberation and consideration of various factors influencing vascular health outcomes. Notably, the measure targets modifiable risk factors, including blood pressure control, aspirin use, statin therapy, and tobacco cessation, which are crucial for reducing cardiovascular risk in high-risk populations. However, the implementation of these targets presents challenges, particularly in achieving optimal blood pressure control while balancing the risks and benefits of intensive treatment. Furthermore, disparities in care delivery across demographic and geographic lines underscore the need for targeted interventions to address inequities in vascular health outcomes. Overall, the OVC measure provides a comprehensive framework for evaluating and improving vascular care delivery, offering insights into areas for improvement and guiding efforts to optimize cardiovascular health outcomes for all patients.  

References:  

1. American College of Cardiology/ American Heart Association Guidelines for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults November 13, 2017 

2. Saiz LC, Gorricho J, Garjón J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5. PMID: 36398903; PMCID: PMC9673465. 

3. Averbeck, B., Ballard, S., Collins, D., & Detert, D. (2018, June). Hypertension work group: 2018 commentary | ICSI. ICSI Hypertension Work Group: 2018 Commentary. https://www.icsi.org/guideline/hypertension-work-group-2018-commentary/ 

4. Kruger J, O'Halloran A, Rosenthal AC, Babb SD, Fiore MC. Receipt of evidence-based brief cessation interventions by health professionals and use of cessation assisted treatments among current adult cigarette-only smokers: National Adult Tobacco Survey, 2009-2010. BMC Public Health. 2016 Feb 11;16:141. doi: 10.1186/s12889-016-2798-2. PMID: 26868930; PMCID: PMC4751655. 

5. Ridker PM, Mora S, Rose L; JUPITER Trial Study Group. Percent reduction in LDL cholesterol following high-intensity statin therapy: potential implications for guidelines and for the prescription of emerging lipid-lowering agents. Eur Heart J. 2016 May 1;37(17):1373-9. doi: 10.1093/eurheartj/ehw046. Epub 2016 Feb 24. PMID: 26916794; PMCID: PMC4852064. 

6. Arnett, Donna K., et al. "2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines." Circulation 140.11 (2019): e563-e595. 

The evidence is directly quoted and summarized below:   

 Reference One:  

ACC/ AHA Guidelines for the Diagnosis and Management of Hypertension-   

Review by MNCM Measure Development Workgroup  

Background:    

In November of 2017, the American Academy of Cardiology and American Heart Association released new guidelines for the prevention, diagnosis and management of hypertension in adults.^[1]  These guidelines redefined the diagnosis of hypertension moving from > 140/ 90 to a new definition of stage 1 hypertension (130-139/ 80-89).  With new definition, it is estimated that 46% of Americans will now be considered to have hypertension, up from 32% with a definition of > 140/90.  The release of the guidelines is not without controversy, and while most agree that a lower blood pressure is better, it is within the context of a patient’s individualized goal.  Less than 130/80 may not be an appropriate target for every patient.  The American College of Physicians and the American Academy of Family Practice has declined endorsement of the new guidelines.  They cite concerns with the methodology used in making recommendations and perceived conflict of interest. They are recommending reliance on 2014 JNC8 and ACP/AAFP guidelines for older adults.  

Patients with diabetes and cardiovascular disease represent two very high-risk subgroups; in an effort to reduce their modifiable risk factors, the blood pressure component target of the Optimal Diabetes Care (ODC) and Optimal Vascular Care (OVC) measures has reflected a goal that is below the hypertension definition cut-point.  

In similar measure development activities, the National Committee for Quality Assurance (NCQA) convened three expert panels (diabetes, cardiovascular and geriatric) for their evaluation of blood pressure targets for the HEDIS Controlling High Blood Pressure measure and concluded that for patients with hypertension ages 18 - 85 the blood pressure target is < 140/90.  

An MNCM convened measure development multi-stakeholder group met in April of 2018 to evaluate and discuss recent changes in guidelines and evidence surrounding blood pressure targets for patients with diabetes and vascular disease.  Based on this evaluation, determine the best BP component targets for the composite measures.  

Considerable time was devoted to the discussion of the evidence supporting guidelines, applicability of research studies into clinical practice, risk-harm benefit and need for individualized patient goals. After thoughtful and thorough discussion of current guidelines, evidence, and real-world practice implications, the work group gained consensus on the best BP targets for patients with diabetes and vascular disease.  

Key considerations included:  

• Evaluation of SPRINT (Systolic Blood Pressure Intervention Trial) demonstrates that for the primary outcome of mortality, there is only a 0.5% difference between the intensive treatment group and the standard treatment group.  Generalization of the SPRINT results to every day practice raised the issues of:  

1. SPRINT study design called for the withdrawal of treatment in asymptomatic patients in the conservative treatment arm, which does not match clinical practice   

2. Average systolic BP achieved was 121  

3. Best practice methods to obtain BP in a study (auto-BP machine, quiet setting, and resting 10 min) do not match current clinic practice.     

The SPRINT study excluded patients with diabetes, so its results are not transferable when there is direct evidence from the ACCORD study that is applicable. ACCORD (Action to Control Cardiovascular Disease in Diabetes) showed very little benefit for BP targets < 140/90.  

• Guidelines do not address treatment risks (hypotension, kidney function).  The main concern of the workgroup was that in setting a lower target for all patients to strive for, knowing that providers will want to meet that target and may be accountable for hitting that target, may put some patients at risk for serious and costly side effects of intensive treatment.  The workgroup would like to encourage individualized targets, knowing that a lower blood pressure is better for the patient, but only if it can be achieved safely.   

• There is not consensus at this time among the guideline writing groups about the definition of hypertension or appropriate targets for high risk populations like patients with diabetes or ischemic vascular disease, therefore not a clear direction for measurement to align with guidelines.  

Measure Development Workgroup Recommendation:  

American College of Cardiology/ American Heart Association Guidelines for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults November 13, 2017  

Reference Two: 

Cochrane Review 2022: Blood pressure targets for the treatment of people with hypertension and cardiovascular disease 

Background: This is the third update of the review first published in 2017. Hypertension is a prominent preventable cause of premature morbidity and mortality. People with hypertension and established cardiovascular disease are at particularly high risk, so reducing blood pressure to below standard targets may be beneficial. This strategy could reduce cardiovascular mortality and morbidity but could also increase adverse events. The optimal blood pressure target in people with hypertension and established cardiovascular disease remains unknown. 

Objectives: To determine if lower blood pressure targets (systolic/diastolic 135/85 mmHg or less) are associated with reduction in mortality and morbidity compared with standard blood pressure targets (140 mmHg to 160mmHg/90 mmHg to 100 mmHg or less) in the treatment of people with hypertension and a history of cardiovascular disease (myocardial infarction, angina, stroke, peripheral vascular occlusive disease). 

Search methods: For this updated review, we used standard, extensive Cochrane search methods. The latest search date was January 2022. We applied no language restrictions. 

Selection criteria: We included randomized controlled trials (RCTs) with more than 50 participants per group that provided at least six months' follow-up. Trial reports had to present data for at least one primary outcome (total mortality, serious adverse events, total cardiovascular events, cardiovascular mortality). Eligible interventions involved lower targets for systolic/diastolic blood pressure (135/85 mmHg or less) compared with standard targets for blood pressure (140 mmHg to 160 mmHg/90 mmHg to 100 mmHg or less). Participants were adults with documented hypertension and adults receiving treatment for hypertension with a cardiovascular history for myocardial infarction, stroke, chronic peripheral vascular occlusive disease, or angina pectoris. 

Data collection and analysis: We used standard Cochrane methods. We used GRADE to assess the certainty of the evidence. 

Main results: We included seven RCTs that involved 9595 participants. Mean follow-up was 3.7 years (range 1.0 to 4.7 years). Six of seven RCTs provided individual participant data. None of the included studies was blinded to participants or clinicians because of the need to titrate antihypertensive drugs to reach a specific blood pressure goal. However, an independent committee blinded to group allocation assessed clinical events in all trials. Hence, we assessed all trials at high risk of performance bias and low risk of detection bias. We also considered other issues, such as early termination of studies and subgroups of participants not predefined, to downgrade the certainty of the evidence. We found there is probably little to no difference in total mortality (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.91 to 1.23; 7 studies, 9595 participants; moderate-certainty evidence) or cardiovascular mortality (RR 1.03, 95% CI 0.82 to 1.29; 6 studies, 9484 participants; moderate-certainty evidence). Similarly, we found there may be little to no differences in serious adverse events (RR 1.01, 95% CI 0.94 to 1.08; 7 studies, 9595 participants; low-certainty evidence) or total cardiovascular events (including myocardial infarction, stroke, sudden death, hospitalization, or death from congestive heart failure (CHF)) (RR 0.89, 95% CI 0.80 to 1.00; 7 studies, 9595 participants; low-certainty evidence). The evidence was very uncertain about withdrawals due to adverse effects. However, studies suggest more participants may withdraw due to adverse effects in the lower target group (RR 8.16, 95% CI 2.06 to 32.28; 3 studies, 801 participants; very low-certainty evidence). Systolic and diastolic blood pressure readings were lower in the lower target group (systolic: mean difference (MD) -8.77 mmHg, 95% CI -12.82 to -4.73; 7 studies, 8657 participants; diastolic: MD -4.50 mmHg, 95% CI -6.35 to -2.65; 6 studies, 8546 participants). More drugs were needed in the lower target group (MD 0.56, 95% CI 0.16 to 0.96; 5 studies, 7910 participants), but blood pressure targets at one year were achieved more frequently in the standard target group (RR 1.20, 95% CI 1.17 to 1.23; 7 studies, 8699 participants). 

Authors' conclusions: We found there is probably little to no difference in total mortality and cardiovascular mortality between people with hypertension and cardiovascular disease treated to a lower compared to a standard blood pressure target. There may also be little to no difference in serious adverse events or total cardiovascular events. This suggests that no net health benefit is derived from a lower systolic blood pressure target. We found very limited evidence on withdrawals due to adverse effects, which led to high uncertainty. At present, evidence is insufficient to justify lower blood pressure targets (135/85 mmHg or less) in people with hypertension and established cardiovascular disease. Several trials are still ongoing, which may provide an important input to this topic in the near future.  

Saiz LC, Gorricho J, Garjón J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5. PMID: 36398903; PMCID: PMC9673465. (https://pubmed.ncbi.nlm.nih.gov/36398903/)  

 Reference Three: 

Institute for Clinical Systems Improvement Hypertension Workgroup Commentary 2018  

Excerpts-   

Background- Reception to the new ACC/AHA guideline has been mixed.  Differing interpretations of the same body of evidence has led to conflicting recommendations.  The American College of Physicians (ACP) and American Academy of Family Physicians (AAFP) did not endorse the new ACC/AHA guideline.   Notably, ACP and AAFP published a guideline in January 2017 recommending a goal of less than 150/90 mm Hg for adults over age 60.   The American Diabetes Association recommends treatment to a BP < 140/90 mm Hg for most patients with diabetes and consideration of a target < 130/80 for those at high cardiovascular risk if it can be achieved without undue burden.  As the controversy continues, providers are left wondering how to advise patients.  

Challenges Ahead- Measurement To understand blood pressure on a population level, it may be most useful to look at the distribution curve of blood pressures across the population.  This provides a more detailed picture of the problem, which then helps direct intervention. The work group agrees with a blood pressure goal of less than 130/80 mm Hg for the general population, to be adjusted as needed for the individual.  However, the group has significant concerns with using less than 130/80 mm Hg as an accountability target because it might result in pharmacologic therapy for some patients who are at low cardiovascular risk and should only be treated by lifestyle modifications.  The group agrees that because of the individualized nature of hypertension management, flexibility with measurement is critical.  

https://www.icsi.org/wp-content/uploads/2019/01/ICSI-HTN-Work-Group-2018-CommentaryUpdated071718.pdf  

 Averbeck, B., Ballard, S., Collins, D., & Detert, D. (2018, June). Hypertension work group: 2018 commentary | ICSI. ICSI Hypertension Work Group: 2018 Commentary. https://www.icsi.org/guideline/hypertension-work-group-2018-commentary/ 

 Reference Four: Receipt of evidence-based brief cessation interventions by health professionals and use of cessation assisted treatments among current adult cigarette-only smokers: National Adult Tobacco Survey, 2009-2010 

Background: Helping tobacco smokers to quit during a medical visit is a clinical and public health priority. Research suggests that most health professionals engage their patients in at least some of the '5 A's' of the brief cessation intervention recommended in the U.S. Public Health Service Clinical Practice Guideline, but information on the extent to which patients act on this intervention is uncertain. We assessed current cigarette-only smokers' self-reported receipt of the 5 A's to determine the odds of using optimal cessation assisted treatments (a combination of counseling and medication). 

Methods: Data came from the 2009-2010 National Adult Tobacco Survey (NATS), a nationally representative landline and mobile phone survey of adults aged ≥18 years. Among current cigarette-only smokers who visited a health professional in the past 12 months, we assessed patients' self-reported receipt of the 5 A's, use of the combination of counseling and medication for smoking cessation, and use of other cessation treatments. We used logistic regression to examine whether receipt of the 5 A's during a recent clinic visit was associated with use of cessation treatments (counseling, medication, or a combination of counseling and medication) among current cigarette-only smokers. 

Results: In this large sample (N = 10,801) of current cigarette-only smokers who visited a health professional in the past 12 months, 6.3 % reported use of both counseling and medication for smoking cessation within the past year. Other assisted cessation treatments used to quit were: medication (19.6 %); class or program (3.8 %); one-on-one counseling (3.7 %); and telephone quitline (2.6 %). Current cigarette-only smokers who reported receiving all 5 A's during a recent clinic visit were more likely to use counseling (odds ratio [OR]: 11.2, 95 % confidence interval [CI]: 7.1-17.5), medication (OR: 6.2, 95 % CI: 4.3-9.0), or a combination of counseling and medication (OR: 14.6, 95 % CI: 9.3-23.0), compared to smokers who received one or none of the 5 A's components. 

Conclusions: Receipt of the '5 A's' intervention was associated with a significant increase in patients' use of recommended counseling and medication for cessation. It is important for health professionals to deliver all 5 A's when conducting brief cessation interventions with patients who smoke. 

Kruger J, O'Halloran A, Rosenthal AC, Babb SD, Fiore MC. Receipt of evidence-based brief cessation interventions by health professionals and use of cessation assisted treatments among current adult cigarette-only smokers: National Adult Tobacco Survey, 2009-2010. BMC Public Health. 2016 Feb 11;16:141. doi: 10.1186/s12889-016-2798-2. PMID: 26868930; PMCID: PMC4751655. 

Reference Five: Percent reduction in LDL cholesterol following high-intensity statin therapy: potential implications for guidelines and for the prescription of emerging lipid-lowering agents 

Aims: Current statin guidelines in Europe and Canada advocate achieving a fixed LDL target or the attainment of a ≥50% reduction in low-density lipoprotein cholesterol (LDLC), while current US guidelines advocate the use of statin therapies that reduce LDLC by <50% (moderate intensity) or ≥50% (high intensity). Data are limited, however, linking the achievement of these % reduction thresholds to subsequent cardiovascular outcomes particularly for contemporary high-intensity regimens. 

Methods and results: In a randomized trial of 17 082 initially healthy men and women with median baseline LDLC of 108 mg/dL (interquartile range 94-119), we (i) used waterfall plots to assess the variability in LDLC response to rosuvastatin 20 mg daily and (ii) evaluated the impact of reaching ≥50% reductions in LDLC on risk of developing the first cardiovascular events. Among rosuvastatin allocated participants, 3640 individuals (46.3%) experienced an LDLC reduction ≥50%; 3365 individuals (42.8%) experienced an LDLC reduction >0 but <50%; and 851 individuals (10.8%) experienced no reduction or an increase in LDLC compared with baseline. These % LDLC reductions directly related to the risks of first cardiovascular events; at trial completion, incidence rates for the primary endpoint were 11.2, 9.2, 6.7, and 4.8 per 1000 person-years for those in the placebo, no LDLC reduction, LDLC reduction <50%, and LDLC reduction ≥50% groups, respectively. Compared with placebo, the multivariable adjusted hazard ratios for sequentially greater on-treatment per cent reductions in LDLC were 0.91 (95%CI 0.54-1.53), 0.61 (95%CI 0.44-0.83), and 0.43 (95%CI 0.30-0.60) (P < 0.00001). Similar relationships between % reduction and clinical outcomes were observed in analyses focusing on non-HDLC or apolipoprotein B. 

Conclusions: As documented for low- and moderate-intensity regimens, variability in % LDLC reduction following high-intensity statin therapy is wide yet the magnitude of this % reduction directly relates to efficacy. These data support guideline approaches that incorporate % reduction targets for statin therapy as well as absolute targets, and might provide a structure for the allocation of emerging adjunctive lipid-lowering therapies such as PCSK9 inhibitors should these agents prove broadly effective for cardiovascular event reduction. 

Ridker PM, Mora S, Rose L; JUPITER Trial Study Group. Percent reduction in LDL cholesterol following high-intensity statin therapy: potential implications for guidelines and for the prescription of emerging lipid-lowering agents. Eur Heart J. 2016 May 1;37(17):1373-9. doi: 10.1093/eurheartj/ehw046. Epub 2016 Feb 24. PMID: 26916794; PMCID: PMC4852064. 

Reference Six: 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary 

TOP 10 TAKE-HOME MESSAGES FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE  

1. The most important way to prevent atherosclerotic vascular disease, heart failure, and atrial fibrillation is to promote a healthy lifestyle throughout life.  

2. A team-based care approach is an effective strategy for the prevention of cardiovascular disease. Clinicians should evaluate the social determinants of health that affect individuals to inform treatment decisions.  

3. Adults who are 40 to 75 years of age and are being evaluated for cardiovascular disease prevention should undergo 10-year atherosclerotic cardiovascular disease (ASCVD) risk estimation and have a clinician–patient risk discussion before starting on pharmacological therapy, such as antihypertensive therapy, a statin, or aspirin. The presence or absence of additional risk-enhancing factors can help guide decisions about preventive interventions in select individuals, as can coronary artery calcium scanning.  

4. All adults should consume a healthy diet that emphasizes the intake of vegetables, fruits, nuts, whole grains, lean vegetable or animal protein, and fish and minimizes the intake of trans fats, red meat and processed red meats, refined carbohydrates, and sweetened beverages. For adults with overweight and obesity, counseling and caloric restriction are recommended for achieving and maintaining weight loss.  

5. Adults should engage in at least 150 minutes per week of accumulated moderate-intensity physical activity or 75 minutes per week of vigorous-intensity physical activity.  

6. For adults with type 2 diabetes mellitus, lifestyle changes, such as improving dietary habits and achieving exercise recommendations are crucial. If medication is indicated, metformin is first-line therapy, followed by consideration of a sodiumglucose cotransporter 2 inhibitor or a glucagonlike peptide-1 receptor agonist.  

7. All adults should be assessed at every healthcare visit for tobacco use, and those who use tobacco should be assisted and strongly advised to quit.  

8. Aspirin should be used infrequently in the routine primary prevention of ASCVD because of lack of net benefit.  

9. Statin therapy is first-line treatment for primary prevention of ASCVD in patients with elevated low-density lipoprotein cholesterol levels (≥190 mg/dL), those with diabetes mellitus, who are 40 to 75 years of age, and those determined to be at sufficient ASCVD risk after a clinician–patient risk discussion.  

10. Nonpharmacological interventions are recommended for all adults with elevated blood pressure or hypertension. For those requiring pharmacological therapy, the target blood pressure should generally be <130/80 mm Hg. 

Arnett, Donna K., et al. "2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines." Circulation 140.11 (2019): e563-e595.