Original ArticleEvaluating Clinical Effectiveness of Pneumococcal Vaccination in Preventing Stroke: The CAPAMIS Study, 3-Year Follow-up
Introduction
The use of the 23-valent polysaccharide pneumococcal vaccine (PPV23) is commonly recommended for high-risk adults and elderly people.1 Protective effects of vaccination against invasive pneumococcal disease have been clearly proved, whereas a possible effectiveness in preventing other clinically relevant outcomes remains more controversial.2
In recent years, because some studies reported an increasing risk of thrombotic events among patients with acute respiratory infections (including influenza and pneumonia),3, 4 it has been suggested that pneumococcal vaccination would protect patients from acute thrombotic events.5, 6 In the last decade, several studies have investigated this issue with conflicting results.7, 8, 9, 10, 11, 12, 13
If we concretely consider cerebrovascular thrombotic events, 3 retrospective studies using distinct health databases have evaluated the relationship between pneumococcal vaccination and the risk of stroke with nondefinitive results.7, 9, 12 Thus, considering that a potential effect of pneumococcal vaccination in preventing cerebrovascular disease could have large clinical implications, a prospective study using validated clinical data to clarify whether a protective effect of vaccination is real would be greatly needed.
In the authors' study region (Southern Catalonia, Spain), the PPV23 is recommended and publicly funded for people older than 60 years since 2003. Considering this, we designed a 3-year prospective cohort study, known as CAPAMIS (Community Acquired Pneumonia, Acute Myocardial Infarction and Stroke),14 with the major aim of evaluating clinical benefits from PPV23 use. An interim analysis at 12-month follow-up and a summarized research letter have been published.15, 16 This article reports the analyses of PPV23 effectiveness against ischemic stroke at the end of 36-month follow-up, assessing possible vaccination effectiveness as in primary prevention (people without a history of cerebrovascular disease) and in secondary prevention (patients with a history of stroke).
Section snippets
Design, Setting, and Study Population
Study design has been extensively described elsewhere.14 In brief, this is a closed cohort study that included all people assigned to 9 Primary Care Centers (PCCs) in the region of Tarragona, Spain, who were 60 years or older on December 1, 2008 (N = 27,204 individuals). Cohort members were followed from the start of the study (December 1, 2008) until the occurrence of a first episode of stroke, disenrollment from the PCC, death, or until the end of the study (November 30, 2011). The study was
Results
The 27,204 cohort members were observed for a total of 76,033 person-years, of which 29,065 (38%) person-years corresponded to vaccinated subjects. At the study start, 8981 cohort members were classified as vaccinated and 18,223 as unvaccinated. Of the 18,223 subjects initially considered as unvaccinated, 2390 (13%) received PPV23 later (contributing to the analyses with 3472 person-years in the nonvaccinated group and 3597 person-years in the vaccinated group).
The mean age of study subjects
Discussion
We undertook a large cohort study to assess the clinical effectiveness of the PPV23 in preventing stroke in older adults (main target population where PPV23 is recommended). To our knowledge, this is the first prospective study using validated clinical data to evaluate the potential role of pneumococcal vaccination in cerebrovascular prevention. As the main findings, our data show no benefit of PPV23 against incident and/or recurrent ischemic stroke, death from stroke, and all-cause death. In
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Grant support: Funding for the study was provided by a grant from the “Fondo de Investigación Sanitaria” of the Instituto de Salud Carlos III (FIS 09/00043) of the Spanish Health Ministry.
This study sponsor had no role in the design or implementation of the study, analysis of data, or reporting of the results.
The work was performed at the Primary Care Service “Camp de Tarragona,” Institut Catala de la Salut, Tarragona, Spain.