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OUR MISSION: TO REDUCE THE BURDEN OF CARDIOVASCULAR DISEASE
Dr. Wolfgang Koenig
Prof. Stephen James Nicholls,
Presenter abstractDiscussant reportAll the Scientific resources on ESC Congress 365
By Stephen James NichollsOther authors: Dr George M Bakris (USA); Professor John JP Kastelein (The Netherlands); Dr Venu Menon (USA); Dr Bryan Williams (UK); Dr Maria Nicolaides (Switzerland); Dr Patrick Brunel (Switzerland); Dr Juergen Armbrecht (Switzerland); Dr Rishi Puri (USA); Ms Dianna Bash (USA); Ms Amy Hsu (USA); Dr Steven E Nissen (USA)Purpose:The renin-angiotensin-aldosterone system plays an important role in the pathogenesis of atherosclerosis. Yet, it is unknown whether direct renin inhibition with aliskiren slows progression of coronary atherosclerosis in patients who have already achieved currently recommended blood pressure (BP) targets. This study aimed to compare the rate of disease progression using intravascular ultrasound in pre-hypertensive patients treated with aliskiren 300 mg vs. placebo.
Study Design:A double-blind, randomized controlled trial of patients with angiographic coronary artery disease, in the prehypertensive range (systolic BP 125-139 mmHg, diastolic BP <90 mmHg) and at least two cardiovascular risk factors, treated for 24 months with aliskiren 300 mg/daily or matching placebo.
Sample Size:Of 1660 patients screened, 613 patients were randomized in 127 centers between 30-Mar-2009 and 14-Feb-2011.
Endpoints:The primary endpoint was the nominal change in percent atheroma volume in patients treated with aliskiren compared to placebo for at least 72 weeks. Additional objectives include changes in total atheroma volume, lipid and biochemical measurements, in addition to safety and tolerability over the 24-month treatment period.
Power Calculations:It was estimated that 222 patients would be required in each treatment group to provide 80% power to detect a 0.80 difference in progression of percent atheroma volume between the treatment groups, assuming a standard deviation of 3.0%. It was assumed that 25% of patients would discontinue or have non-evaluable imaging, requiring randomization of at least 592 patients.
Conclusion:The last patient received their final dose of treatment on 31-Jan-2013 and complete study results will be available before the ESC Congress. This study provides the first opportunity to evaluate the effect of direct renin inhibition with aliskiren on the rate of progression of coronary atherosclerosis.
Wolgang KoenigNicholls and colleagues investigated the role of renin inhibition on atherosclerosis using grey-scale IVUS in 613 patients with symptomatic CAD and blood pressure (BP) in the pre-hypertensive range, in whom the positive effect of additional BP lowering has not yet been established and therefore current guidelines do not recommend antihypertensive treatment.40% of all screened patients were randomized to either 300 mg aliskiren or placebo. After 24 months, 25% had either withdrawn or no evaluable final IVUS which is usually seen in these trials. Mean age was 60 years, 75% were male, and 29% had a history of diabetes. It is important to note that patients were intensively treated with statins (LDL-C < 100 mg/dL), antiplatelet drugs, beta-blockers, and CCBs. Approximately 60% were on ACEIs and 22% on ARBs. Diabetics on either of these drugs were withdrawn after results of ALTITUDE (1), a cardio-renal outcome trial of aliskiren in type 2 diabetes, became available. This may have potentially contributed to confounding of interpretation.After 2 years of treatment, systolic and diastolic BPs were modestly, although significantly lower in the aliskiren group. Using a well established IVUS efficacy parameter, change in percent atheroma volume (PAV), results were formally non-significant yet a trend in favor of aliskiren was seen with a P value of 0.08. A similar trend applied to the percentage of patients exhibiting regression. Change in total atheroma volume (TAV) was not different between groups. Surprisingly, although not powered for clinical outcomes, there was a statistically highly significantly lower rate of MACE in the aliskiren group, with significantly fewer deaths and MIs. Subgroup analysis showed that the reduction in MACE and the positive trend in PAV were only seen in patients without diabetes whereas no positive signal was seen in diabetic patients being in line with results from ALTITUDE, although for PAV the difference between groups was not significant. Regarding safety, discontinuation rate and hypotension were almost doubled in the aliskiren group but still less that 10%, yet other AEs were only slightly higher. In summary, although formally neutral, this study showed some interesting trends concerning regression of atherosclerosis and unexpectedly a lower MACE rate in an aggressively treated group of patients with CAD and pre-hypertensive BP values suggesting that this group may benefit from additional BP lowering. However, APOLLO (2), a clinical outcome trial with aliskiren + CCB or HCTZ in hypertensive elderly people has recently been terminated prematurely. This makes further clinical outcome trials investigating antiatherosclerotic effects of aliskiren unlikely.1 - Cardiorenal end points in a trial of aliskiren for type 2 diabetes. Parving HH, Brenner BM, McMurray JJ, de Zeeuw D, Haffner SM, Solomon SD, Chaturvedi N, Persson F, Desai AS, Nicolaides M, Richard A, Xiang Z, Brunel P, Pfeffer MA; ALTITUDE Investigators. N Engl J Med. 2012; 367:2204-13.
2 - 2013 ESH/ESC Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Authors/Task Force Members, Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Böhm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; ESH Scientific Council, Redon J, Dominiczak A, Narkiewicz K, Nilsson PM, Burnier M, Viigimaa M, Ambrosioni E, Caufield M, Coca A, Olsen MH, Schmieder RE, Tsioufis C, van de Borne P; ESC Committee for Practice Guidelines (CPG), Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers, Clement DL, Coca A, Gillebert TC, Tendera M, Rosei EA, Ambrosioni E, Anker SD, Bauersachs J, Hitij JB, Caulfield M, De Buyzere M, De Geest S, Derumeaux GA, Erdine S, Farsang C, Funck-Brentano C, Gerc V, Germano G, Gielen S, Haller H, Hoes AW, Jordan J, Kahan T, Komajda M, Lovic D, Mahrholdt H, Olsen MH, Ostergren J, Parati G, Perk J, Polonia J, Popescu BA, Reiner Z, Rydén L, Sirenko Y, Stanton A, Struijker-Boudier H, Tsioufis C, van de Borne P, Vlachopoulos C, Volpe M, Wood DA. Eur Heart J. 2013; 34:2159-219.
AQUARIUS: Effect of the Renin Inhibitor Aliskiren on Progression of Coronary Atherosclerosis: AQUARIUS Study Results