The Stabilization Of plaques using Darapladib (SOLID)-TIMI 52 trial: Primary Results
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1 The Stabilization Of plaques using Darapladib (SOLID)-TIMI 52 trial: Primary Results Michelle L. O Donoghue MD MPH, on behalf of the SOLID-TIMI 52 investigators European Society of Cardiology Congress Barcelona, Spain Sunday August 31, 2014
2 Lipoprotein- associated Phospholipase A 2 (Lp-PLA 2 ) activity: Background native LDL carrier of Lp-PLA 2 Lp-PLA 2 Leukocyte Lumen Atheroma Intima Lp-PLA 2 Sustained Inflammation Necrotic Core Expansion Oxidized LDL substrate for Lp-PLA 2 Macphee, Biochem J 1999; Zalewski and Macphee, ATVB 2005; Shi Atherosclerosis 2007; Kolodgie, ATVB 2006
3 Lp-PLA 2 activity and risk of CV outcomes: shape of association 79,036 participants, 32 prospective studies 2.5 Coronary heart disease* 5221 events, 17 studies Coronary Heart Disease* 2.5 All vascular death 2965 events, Vascular 13 Death studies Risk ratio (95% CI) Standardized Lp-PLA 2 activity Standardized Lp-PLA 2 activity Adjusted for age, sex, diabetes and baseline history of vascular disease Lp-PLA 2 Studies Collaboration. Lancet 2010;375:
4 Darapladib Phase 2 Results IBIS-2 Trial 330 patients with angiographic CAD 6 Change in necrotic core volume at follow-up 5 Change in necrotic core, % of total plaque mm 3. change from baseline P=0.012 Darapladib -0.5mm 3 p = 0.71, versus baseline +4.5mm 3 Placebo p = 0.009, versus baseline Change from baseline (%) P=0.047 Darapladib p = 0.45, versus baseline +0.5% Placebo p = 0.006, versus baseline +2.5% No significant change in: - Plaque deformability - C-reactive protein - Atheroma volume Primary endpoint Serruys et al., Circulation 2008;118:
5 Darapladib Phase III Clinical Program High risk* patients with chronic CHD High risk* patients with ACS (STEMI, NSTEMI, UA) Randomization to Darapladib or Placebo Randomization to Darapladib or Placebo within 30 days of index event n= 15,898 (3.7 year median f/u) n= 13,026 (2.5 year median f/u) * High-risk criteria ( 1 of the following): age >60 years, diabetes mellitus, (egfr ml/min/1.73 m 2 ), polyvascular disease, HDL <40 mg/dl (STABILITY only), tobacco use (STABILITY only), or prior MI (SOLID-TIMI 52 only)
6 STABILITY Trial 15,828 patients with stable CHD randomized to darapladib 160mg QD vs placebo Primary Endpoint HR (95% CI) CV death, MI or stroke 0.94 ( ) P=0.20 Selected Secondary Endpoints Major Coronary Events: (CHD death, MI or urgent coronary 0.90 ( ) revascularization for myocardial ischemia) P=0.045 Total Coronary Events (CHD death, MI, hospitalization for UA or 0.91 ( ) any coronary revascularization) P= Favors darapladib Favors placebo White et al., N Engl J Med 2014; 370:
7 SOLID-TIMI 52 Primary Trial Objective To demonstrate that the addition of darapladib to a background of optimal medical therapy would significantly reduce the risk of major coronary events in patients after an ACS.
8 Trial Organization Trial Leadership: TIMI Study Group Eugene Braunwald (Chair) Suzanne Morin (Director of Operations) Christopher P. Cannon (Global PI) Sabina A. Murphy (Statistics) Michelle L. O Donoghue (Co-PI) Kyungah Im (Statistics) Dylan P. Steen (Co-Investigator) Stephen D. Wiviott (CEC Chair) Sharon Crugnale (Senior Project Director) Marc P. Bonaca (SAE Chair) Executive Committee Eugene Braunwald Christoph Bode Christopher P. Cannon Judith S. Hochman P. Gabriel Steg Patrick W. Serruys Aldo P. Maggioni W. Douglas Weaver Harvey D. White Sponsor (GlaxoSmithKline) Elizabeth Tarka Richard Y. Davies Mary Ann Lukas Jennifer B. Shannon David F. Watson Katharine Edmonds Shruti Daga Independent Data Monitoring Committee Rory Collins (Chair) Jeffrey Anderson Peter Ganz David DeMets Peter Sandercock Michael Weber
9 National Lead Investigators ARGENTINA ( 159 ) GERMANY ( 510 ) ROMANIA ( 246 ) Ernesto Paolasso Christian Hamm Maria Dorobantu AUSTRALIA ( 210 ) GREECE RUSSIA ( 876 ) Phil Aylward John Lekakis Nikolay Gratsiansky BELGIUM ( 139 ) HUNGARY ( 350 ) SLOVAKIA ( 203 ) William Wijns Robert Kiss Tibor Duris BRAZIL ( 415 ) INDIA ( 345 ) SOUTH AFRICA ( 297 ) Jose Carlos Nicolau Atul Mathur/Krishna Reddy/ Sanjay Mittal/B. Soma Raju Anthony Dalby BULGARIA ( 284 ) ISRAEL ( 690 ) SPAIN ( 165 ) Assen Goudev Basil Lewis Jose Lopez-Sendon CANADA ( 327 ) ITALY( 229 ) SWEDEN ( 157 ) Pierre Theroux Diego Ardissino Mikael Dellborg G.B. John Mancini CHILE ( 155 ) JAPAN ( 211 ) TAIWAN( 132 ) Ramon Corbalan Takeshi Kimura Shih-Ann Chen CHINA ( 444 ) KOREA ( 119 ) THAILAND ( 114 ) Runlin Gao Ki-Bae Seung Piyamatr Sritara COLOMBIA ( 173 ) MEXICO TURKEY( 9 ) Daniel Isaza Guillermo Llamas Esperon Sema Guneri CZECH REPUBLIC ( 443 ) NETHERLANDS ( 622 ) UNITED KINGDOM ( 167 ) Jindrich Spinar Ton Oude-Ophuis/R.J. DeWinter Kausik Ray DENMARK ( 442 ) NEW ZEALAND ( 120 ) UKRAINE ( 306 ) Steen Husted Harvey White Alexander Parkhomenko ESTONIA PHILIPPINES ( 110 ) UNITED STATES ( 2476 ) Juri Voitk Noe Babilonia Christopher P. Cannon FRANCE ( 270 ) POLAND ( 1056 ) Gilles Montalescot Andrzej Budaj 36 Countries 868 Sites
10 SOLID-TIMI 52 Study Design Total N 13,026 High-risk* patients 30 days post-acs: UA, NSTEMI or STEMI Guideline-recommended background Rx, including statins and antiplatelet drugs * Must have met 1 enrichment criteria -Age 60y -DM req Rx -Polyvascular disease -Prior MI -egfr ml/min/1.73m 2 Darapladib (160mg daily) Randomized 1:1 Double-blind Placebo (daily) Median f/u 2.5y Primary Endpoint: CHD Death, Non-fatal MI, or Urgent Coronary Revascularization for Myocardial Ischemia
11 Enrollment Enrolled 12/ /2011: 36 countries, 868 sites, patients Sweden: 157 Canada: 327 United States 2479 Denmark: 442 Netherlands: 622 U.K. 168 Poland: 1056 Belgium: 138 Germany: 510 France: 270 Spain: 166 Ukraine: 306 Russia: 876 Romania: 246 Czech Rep: 443 Slovakia: 203 Hungary: 350 Bulgaria: 284 Turkey: 9 Israel: 690 S Korea: 119 Japan: 211 China: 445 Taiwan: 130 Thailand: 114 Philippines: 110 Colombia: 172 Italy: 229 India: 345 Peru: 55 Brazil: 414 Chile: 155 Argentina: 159 South Africa: 296 Australia: 209 New Zealand: 121
12 Characteristic Baseline Characteristics Placebo (n=6522) Darapladib (n=6504) Age (median, IQR) 64 (59-71) 64 (59-70) Female 26% 25% White race 84% 84% BMI (kg/m 2, median, IQR) 28 (25-31) 28 (25-31) Current smoker 19% 19% Diabetes mellitus req Rx 30% 30% Prior MI 31% 31% Index event STEMI NSTEMI UA 44% 44% 12% 46% 42% 12% Catheterization for QE 86% 86% PCI performed for QE 77% 77% Days from QE to rando (median, IQR) 14 (6-23) 15 (6-23) QE= qualifying event; IQR= interquartile range; PCI= percutaneous coronary intervention
13 Baseline Data Characteristic LDL cholesterol (mg/dl, median, IQR) HDL cholesterol (mg/dl, median, IQR) Triglycerides (mg/dl, median, IQR) Baseline medications Aspirin Statin Beta blocker P2Y 12 inhibitor ACE inhibitor or ARB Placebo (n=6522) 75 (57-97) [1.9 ( ) mm] 42 (36-50) [1.1 ( ) mm] 134 ( ) [1.5 ( ) mm] 96% 95% 87% 88% 82% Darapladib (n=6504) 75 (57-97) [1.9 ( ) mm] 42 (36-50) [1.1 ( ) mm] 135 ( ) [1.5 ( ) mm] 96% 94% 87% 88% 83% IQR=interquartile range
14 Trial Retention Metrics Placebo (n=6,522) Darapladib (n=6,504) Overall (n=13,026) Premature study drug discontinuation 1546 (9.5% per yr) 1854 (11.4% per yr) 3400 (10.4% per yr) Withdrawn consent VS known VS unknown 111 (1.7%) (1.7%) (1.7%) Lost to Follow Up VS known VS unknown Vital status at end of study was known in 99.6% of subjects. There were 31,167 total patient-years of follow-up. VS=vital status
15 18% 16% Primary Endpoint: CHD death, MI or urgent coronary revascularization Placebo Darapladib 14% 12% Event rate 10% 8% 6% HR 1.00 (95% CI ) P=0.93 4% 2% 0% Months No. at risk Placebo Darapladib
16 CV death, MI or stroke 18% 16% 14% Placebo Darapladib 12% Event Rate 10% 8% 6% HR 0.99 (95% CI ) P=0.78 4% 2% 0% Months No. at risk Placebo Darapladib
17 Total coronary events (CHD death, MI, UA or any coronary revascularization) 25% 20% Placebo Darapladib Event Rate 15% 10% HR 0.95 (95% CI ) P=0.20 5% 0% Months No. at risk Placebo Darapladib
18 Components of Primary Endpoint Outcome HR (95% CI) P value Primary endpoint: Major coronary events (CHD death, MI or urgent coronary revascularization for myocardial ischemia) 1.00 ( ) 0.93 CHD death 0.88 ( ) 0.16 MI (fatal and non-fatal) 0.97 ( ) 0.63 Urgent coronary revascularization for myocardial ischemia 1.09 ( ) 0.36
19 Subgroup Analyses CHD death, MI or Hazard Ratio P value for Subgroup Total # urgent revascularization (95% CI) interaction Overall 13, ( ) Age Age 60 years 9, ( ) 0.79 Age <60 years 3, ( ) Sex Men 9, ( ) 0.04 Women 3, ( ) White race Yes 10, ( ) 0.07 No 2, ( ) Region North America 2, ( ) 0.45 Eastern Europe 3, ( ) Western Europe 3, ( ) Asia Pacific 1, ( ) South America ( ) Current smoker Yes 2, ( ) 0.13 No 10, ( ) Favors darapladib Favors placebo
20 Subgroup Analyses (2) CHD death, MI or Hazard Ratio P value for Subgroup Total # urgent revascularization (95% CI) interaction Overall 13, ( ) Diabetes mellitus Yes 4, ( ) 0.55 No 8, ( ) Index diagnosis STEMI 5, ( ) 0.46 NSTEMI 5, ( ) Unstable angina 1, ( ) Statin use >8 weeks prior to randomization Yes 5, ( ) 0.39 No 6, ( ) Baseline LDL-C <70mg/dl 5, ( ) <100mg/dl 4, ( ) 100mg/dl 2, ( ) Baseline Lp-PLA 2 activity (nmol/min/ml) , ( ) , ( ) > , ( ) Favors darapladib Favors placebo
21 Additional Secondary and Exploratory Endpoints Outcome HR (95% CI) P value CHD death or MI 0.97 ( ) 0.55 CV death 0.91 ( ) 0.27 All-cause death 0.94 ( ) 0.40 Stroke (fatal and non-fatal) 1.12 ( ) 0.35 Any coronary revascularization 0.96 ( ) 0.33 Heart failure requiring hospitalization 0.97 ( ) 0.75
22 Event Safety Data Placebo (n=6465) Darapladib (n=6452) Any serious adverse event (SAE) 46.6% 45.5% Any adverse event leading to study drug discontinuation 12.0% 17.0% Any odor-related complaint* 2.5% 11.5% Diarrhea 5.6% 10.6% Renal failure (SAE) 1.0% 1.2% Renal failure (SAE or non-serious AE) 2.5% 2.5% Any reported cancer 4.5% 4.6% Any gastrointestinal cancer (adjudicated) 0.93% 0.88% * Including odor of feces, urine and skin, as well as dysgeusia
23 Conclusion In patients after ACS, direct inhibition of Lp-PLA 2 with darapladib on a background of optimal medical therapy did not reduce the risk of coronary events through 2.5 years of follow-up.
24 M. L. O Donoghue and coauthors Effect of Darapladib on Major Coronary Events After an Acute Coronary Syndrome: The SOLID-TIMI 52 Randomized Clinical Trial Published online August 31, 2014 Available at jama.com and on The JAMA Network Reader at mobile.jamanetwork.com jamanetwork.com
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