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2010 Late-Breaking Clinical Trial Abstracts and Clinical Science: Special Reports Abstracts


Author Disclosures: W.R. Hiatt: Research Grant; Significant; Sanofi Aventis. I.I. Baumgartner: Sanofi Aventis. S. Nikol: Sanofi Aventis. E. Van Belle: Sanofi Aventis. V.R. Driver: Sanofi Aventis. L. Norgren: Sanofi Aventis. J.J. Belch: Sanofi Aventis.

Author Disclosures: T. Investigators: None. O. Berwanger - Presenter: None.

21711 Late Cardiac Death and Myocardial Infarction Associated With Late Stent Thrombosis in Large Vessel Stenting After 1st or 2nd Generation Drug-Eluting Compared to Bare-Metal Stents: the BASKET PROspective Evaluation Examination (BASKET PROVE)

Matthias E Pfisterer, Christoph A Kaiser; Univ Hosp, Basel, Switzerland

Background: BASKET long-term outcome data suggested that patients with large native vessel stenting were at increased risk of late stent thrombosis and related cardiac death and myocardial infarction (MI) after 1st generation drug-eluting stent (DES) compared to bare-metal stent (BMS) implantation. We tested the hypothesis whether this could be confirmed in an adequately sized prospective randomized controlled trial and whether this was also true for 2nd generation DES. Methods: Thus, in a multicenter study, 2314 consecutive patients with

  • 3,0mm stents were randomized to receive a Cypher-Select or a Vision stent - as in BASKET

  • -

    or a XienceV stent. The primary endpoint was cardiac death or MI after two years. Late events,

months 7–24, and target-vessel revascularization (TVR) were main secondary safety and efficacy endpoints. Results: Patients presented with acute coronary syndrome in 65%; 76% had 1 “off-label” indication for drug-eluting stenting. Two-year cardiac death or non-fatal MI rate was 3.6%, not significantly different between the 3 study groups. Results were similar also for months 7–24 and there were no significant between-group differences for cardiac death, all-cause death, MI or stent thrombosis. However, compared to BMS, TVR rate was reduced by both DES by 50% (both p0.01 versus BMS), with similar 2-year TVR rates for both DES. Conclusions: Late safety problems of DES could not be confirmed in contemporary stenting of large coronary arteries. Between 1st and 2nd generation DES, no safety or efficacy differences could be detected. Both DES reduces TVR more than BMS.

Author Disclosures: M.E. Pfisterer: Speakers Bureau; Modest; Sanofi Aventis, Medtronic. Consultant/Advisory Board; Modest; Hoffmann La Roche Switzerland, Pfizer Switzerland, Eli Lilly Switzerland. C.A. Kaiser: Speakers Bureau; Modest; Biotronik, Abbott Vascular, Eli Lilly, Daiichi-Sankyo. Consultant/Advisory Board; Modest; Eli Lilly Switzerland, Astra Zeneca Switzerland.

21843 Acetylcystein for the Prevention of Contrast-Induced nephropaThy (ACT) Trial: a Pragmatic Multicenter Randomized Trial to Evaluate the Efficacy of Acetylcysteine for the Prevention of Renal Outcomes in Patients Undergoing Coronary and Vascular Angiography

The ACT Investigators, Rsch Institute - HCor - Coordinating Cntr, Sao Paulo, Brazil; Otavio Berwanger - Presenter; HCor (Sao Paulo Cardiac Hosp), Sao Paulo, Brazil

Late-Breaking Clinical Trials IV

Room S100a Abstracts 21685–21826


The Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT): Testing C-Reactive Protein at Baseline and on-Treatment as an Independent Predictor of Cardiovascular Outcomes

Peter S Sever, Neil R Poulter, Choon-Lan Chang, Simon A Thom, Alun D Hughes, Imperial College London, London, United Kingdom; Paul Welsh, Naveed Sattar; Univ of Glasgow, Glasgow, United Kingdom

Background Lowering C-reactive protein (hsCRP) by statins has been shown to independently predict cardiovascular (CV) outcomes. In a nested case- control study we explore the relationship between biomarkers prior to, and in-trial, with blood pressure and lipid lowering therapy, and CV outcomes. Methods In UK and Ireland, ASCOT randomised 9098 hypertensive adults to either calcium channel blocker- or beta blocker-based treatment. 4853 patients with total cholesterol 6.5 mmol/L (250mg/L) were further randomised to atorvastatin or placebo. Over 5.5 years, 485 CV cases (fatal coronary heart disease, non-fatal MI, coronary revascularization, fatal and non-fatal stroke), were age and sex matched with 1367 controls. Conditional logistic regression models were used to evaluate the association between CV events and LDL-cholesterol (LDL-c) and hsCRP. Results Baseline LDL-c and hsCRP were significantly correlated (r0.11, p0.0001) and predicted CV events (odds ratio[OR] 1.31 [CI 1.10–1.56, p0.002], and OR 1.19 [CI 1.05–1.34, p0.006]) respectively. Both ORs per 1-SD increase in log-transformed data. However, inclusion of hsCRP into the Framingham risk model only minimally improved prediction of CV events. At 6 months, atorvastatin reduced LDL-c by 40.3% and median hsCRP by 27.4%. In those randomised to atorvastatin, lower in trial LDL-c median (2.1 mmol/L) at 6 months was associated with a highly significant reduction in CV events (OR 0.41 [CI 0.22–0.75, p0.004] compared with those with median LDL-c, in a fully adjusted model incorporating other baseline risk factors. By contrast, in those randomized to atorvastatin, in the fully adjusted model, lower hs CRP at 6 months was not associated with CV events (OR 0.86 [0.49–1.51, p0.60]) comparing those with median(1.83mg/L) with those with median hsCRP levels. Consequently, addition of on-treatment hsCRP to on-treatment LDL-c did not improve prediction of statin efficacy. Conclusion These analyses do not support the hypothesis that hsCRP usefully improves risk factor prediction or indeed that a reduction in hsCRP associated with statin therapy is an independent predictor of CV outcomes.

Introduction: Aceltylcysteine has been evaluated in several small trials as a means of reducing the risk of contrast-induced nephropathy (CIN) in patients undergoing coronary angiographic procedures, however systematic reviews of these studies do not provide reliable answers. Thus, we planned the ACT Trial, the largest randomized clinical trial (RCT) testing the hypothesis that acetylcysteine reduces the risk of CIN in at-risk patients undergoing an intravascular angiography conducted to date (Clinicaltrials.gov NCT00736866). Methods: ACT is a RCT of acetylcysteine versus matching placebo in patients at-risk for CIN undergoing an intravascular angiographic procedure. The randomization list was concealed (central web- based randomization) and all analysis followed the intention-to-treat principle. The study drugs (acetylcysteine 1200 mg or placebo) were administered orally twice daily for two doses before and two doses after the procedure. The primary outcome was the occurrence of CIN, defined as a 25% elevation of serum creatinine above baseline between 48 and 96 hours after angiography. Results: A total of 2308 patients have been included in 46 centers in Brazil. Sixty seven percent of the procedures were coronary diagnostic angiographies, 29% were percutaneous coronary interventions and 4% were vascular procedures. Mean age was 6810 years, 15.7% had a baseline serum creatinine 1.5 mg/dL and 60.4% were diabetics. Compliance to study drugs was over 95% and intravenous hydration was given to 98% of the patients. The incidence of CIN was 12.7% in the acetylcysteine group and 12.7% in the control group (relative risk 1.00; 95% CI 0.81 — 1.25). Other clinical outcomes were also similar in the two groups (Table). Conclusion: Acetylcysteine does not reduce the risk of CIN nor other clinically relevant outcomes. These results may help to inform clinical practice and to update current guidelines.

Author Disclosures: P.S. Sever: Research Grant; Significant; Pfizer. Speakers Bureau; Significant; Pfizer, Servier, Novartis. Honoraria; Significant; Pfizer, Novartis. Consultant/Advisory Board; Significant; Pfizer, Servier. N.R. Poulter: Research Grant; Significant; Pfizer. Speakers Bureau; Significant; Pfizer, Servier, Novartis. Honoraria; Significant; Pfizer, Novartis. Consul- tant/Advisory Board; Significant; Pfizer, Servier. C. Chang: None. S.A. Thom: Research Grant; Significant; Pfizer. A.D. Hughes: Pfizer. P. Welsh: Pfizer. N. Sattar: Pfizer.


Primary Results of the DEFINE trial: Determining the EFficacy and Tolerability of CETP INhibition With AnacEtrapid

Christopher P Cannon, TIMI Study Group, Boston, MA; Sukrut Shah, Hayes M Dansky, Merck, Rahway, NJ; Michael Davidson, Univ of Chicago Med Cente, Chicago, IL; Eliot A Brinton, Univ of Utah Sch of Medicine, Salt Lake City, UT; Antonio M Gotto, Jr., Cornell Med Sch, New York, NY; Michael Stepanavage, Sherry Xueyu Liu, Patrice Gibbons, Tanya B Ashraf, Jennifer Zafarino, Yale B Mitchel, Merck, Rahway, NJ; Philip Barter; Heart Rsch Institute, Sydney, Australia

Background: New therapies to raise HDL-C are currently being investigated as a strategy to reduce residual cardiovascular risk. Anacetrapib is a cholesteryl ester transfer protein (CETP) inhibitor with robust HDL-C raising and LDL-C lowering effects and no adverse effects on blood pressure, electrolytes and aldosterone levels. Methods: Determining the EFficacy and

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