VIVA: Overall Mortality Significantly Reduced Among Older Men Receiving Triple Vascular Screening

Overall mortality was reduced by 7 percent among a large population of men aged 65 to 74 years who received combined screening for abdominal aortic aneurysm (AAA), peripheral artery disease (PAD) and hypertension, compared with no screening, according to the results of the VIVA Trial, presented by Jes S. Lindholt, DMSci, PhD, on August 28 at ESC Congress 2017 in Barcelona and simultaneously published in The Lancet.

The VIVA Trial examined the effect and cost-effectiveness of combined screening for AAA, PAD and hypertension. All 50,168 men aged 65 to 74 living in the central region of Denmark were invited to participate and were randomized to the screening intervention or the control group. Only the control group was masked. The men in the intervention group were screened with abdominal ultrasound for AAA and Doppler-based ankle brachial index for PAD.

Men with suspected hypertension were referred to general practice. Those positive for AAA or PAD were confirmed and prescribed pharmacologic therapy. Participants diagnosed with AAA were referred for vascular surgery for repair or follow-up. The primary outcome was all-cause mortality. The secondary outcomes were cause-specific mortality, cardiovascular disease-related hospital admission, diabetes, intracerebral hemorrhage, renal failure, cancer, 30-day postoperative mortality, cost-effectiveness and quality of life.

The screening intervention was attended by 75 percent of the invited men. AAA was identified in 3.3 percent (n = 619) of participants, 49.6 percent of whom had repair within five years. PAD was diagnosed in 11 percent (n = 2,073) of participants and 4 percent had repair for intermittent claudication within five years. Men with AAA or PAD received a nurse-driven consultation for initiation of preventive treatment, including 75 mg aspirin, 40 mg statin, and instructions on diet, smoking cessation and exercise. Possible hypertension was found in 10 percent (n = 1,963) of the men.

At five years after randomization, significantly more men in the intervention group had survived compared with controls (hazard ratio [HR], 0.93; 95 percent confidence interval [CI], 0.88-0.98; p = 0.012). The number needed to screen was 169 (95 percent CI, 89-1811). No significant difference between the groups was reported for the secondary outcomes.

The censoring-adjusted incremental cost of screening was €148 per participant (95 percent CI, –215-512). The corresponding incremental life years (LY) gained and quality-adjusted life years (QALY) were estimated at 0.022 (95 percent CI, 0.006-0.038) and 0.019 (95 percent CI, 0.005-0.033), respectively. The cost of a LY gain was €6872 and of a QALY gain was €2148. At a threshold for willingness to pay of €40,000, the probability for cost effectiveness was estimated at 98 percent for LY gain and 99 percent for QALY.  All costs were based on the 2014 price year and 3.5 percent discounting.

VIVA demonstrated that combined vascular triple screening for AAA, PAD and hypertension reduced overall mortality in the study population without any observed serious negative side effects of screening. The investigators concluded this screening appears to be an effective and cost-effective prevention strategy and recommended that health policy makers should implement triple vascular screening for men aged 65 to 74 years.

In an accompanying editorial comment, Chadi Ayoub, MBBS, and M. Hassan Murad, MD, note that “the VIVA trial presents thought-provoking findings. However, implementation of this triple screening intervention requires more proof than presented in this study. The 10 criteria developed in the 1960s by WHO13 remain a valid framework for establishing whether screening should be implemented or scarce resources should be directed at individuals with increased risk of morbidity and mortality.”

Keywords: ESC Congress, ESC2017, Quality-Adjusted Life Years, Peripheral Arterial Disease, Ankle Brachial Index, Aortic Aneurysm, Abdominal, Cost-Benefit Analysis, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Intermittent Claudication, Smoking Cessation, Aspirin, Quality of Life, Denmark, Vascular Surgical Procedures, Hypertension, Diabetes Mellitus, Referral and Consultation, Cerebral Hemorrhage, Health Policy, Diet, Neoplasms, Renal Insufficiency

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