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Published on: February 7, 2014
Pulse wave velocity as endpoint in large-scale intervention trial. The Complior study. Scientific, Quality Control,
R Asmar1, J Topouchian, B Pannier
1L'Institut CardioVasculaire, Paris, France. ra@icv.org
Insights
This study shows that antihypertensive therapy effectively reduces blood pressure and arterial stiffness in hypertensive patients. The Complior device demonstrated feasibility for large-scale trials measuring pulse wave velocity (PWV).
Area of Science:
- Cardiology
- Vascular Medicine
- Clinical Trials
Background:
- Arterial stiffness, a marker of cardiovascular risk, is often elevated in hypertensive patients.
- Measuring arterial stiffness using pulse wave velocity (PWV) can provide valuable prognostic information.
Purpose of the Study:
- To assess the impact of antihypertensive therapy on arterial stiffness, measured by carotid-femoral pulse wave velocity (PWV).
- To evaluate the feasibility of using PWV as an endpoint in a large-scale intervention trial for hypertension.
Main Methods:
- A 6-month intervention study involving 1,703 hypertensive patients across 19 countries.
- Patients received perindopril (ACE inhibitor) and indapamide (diuretic) as needed.
- Carotid-femoral PWV and blood pressure were measured at baseline, 2 months, and 6 months using the Complior device.
Main Results:
- Significant reductions in both systolic and diastolic blood pressure were observed.
- A statistically significant decrease in carotid-femoral PWV was achieved.
- The Complior device proved feasible for large-scale PWV measurements in hypertensive patients.
Conclusions:
- Antihypertensive therapy, including ACE inhibitors and diuretics, can improve arterial stiffness in hypertensive individuals.
- The Complior Study successfully demonstrated the feasibility of large-scale intervention trials utilizing PWV as a primary endpoint.
- Further long-term controlled studies are warranted to confirm these findings.
Objective:
To evaluate the ability of an antihypertensive therapy to improve arterial stiffness as assessed by aortic pulse wave velocity (PWV) in a large population of hypertensive patients.
Setting:
Sixty-nine healthcare centres, private and institutional (19 countries).
Patients:
Subjects aged 18-79 years, with essential hypertension. A total of 2,187 patients were enrolled; 1,703 (52% male) completed the study: mean age = 50 +/- 12 years; mean baseline systolic/diastolic blood pressure (S/D BP) = 158 +/- 15/98 +/- 7 mmHg; mean baseline carotid-femoral PWV = 11.6 +/- 2.4 m/s.
Interventions:
Patients were treated for 6 months, starting with perindopril (angiotensin converting enzyme (ACE) inhibitor) 4 mg once daily (OD), increased to 8 mg OD, and combined to diuretic (indapamide 2.5 mg OD) if BP was uncontrolled (> 140/90 mmHg).
Results:
It was feasible to measure carotid-femoral PWV using the automatic device Complior at inclusion, 2 and 6 months, along with conventional BP assessments in a population of 1,703 patients. Significant decreases (P < 0.001) in BP (systolic: -23.7 +/- 16.8, diastolic: -14.6 +/- 10 mmHg), and carotid-femoral PWV (-1.1 +/- 1.4 m/s) were obtained at 2 and 6 months.
Conclusions:
The Complior Study is the first study to show the feasibility of a large-scale intervention trial using PWV as the endpoint in hypertensive patients. Adequate results may be obtained using an automatic device and rigorous criteria for assessment. A long-term controlled intervention study is needed to confirm the results of the present uncontrolled trial.
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