Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after TAXUS Liberté paclitaxel-eluting coronary stent placement.
BACKGROUND
The TAXUS Liberté Post Approval Study (TL-PAS) contributed patients treated with TAXUS Liberté paclitaxel-eluting stent and prasugrel to the Dual Antiplatelet Therapy Study (DAPT) that compared 12 and 30 months thienopyridine plus aspirin therapy after drug-eluting stents.


RESULTS
Outcomes for 2191 TL-PAS patients enrolled into DAPT were assessed. The DAPT coprimary composite end point (death, myocardial infarction [MI], or stroke) was lower with 30 compared with 12 months prasugrel treatment (3.7% versus 8.8%; hazard ratio [HR], 0.407; P<0.001). Rates of death and stroke were similar between groups, but MI was significantly reduced with prolonged prasugrel treatment (1.9% versus 7.1%; HR, 0.255; P<0.001). The DAPT coprimary end point, stent thrombosis, was also lower with longer therapy (0.2% versus 2.9%; HR, 0.063; P<0.001). MI related to stent thrombosis (0% versus 2.6%; P<0.001) and occurring spontaneously (1.9% versus 4.5%; HR, 0.407; P=0.007) were both reduced with prolonged prasugrel. MI rates increased within 90 days of prasugrel cessation after both 12 and 30 months treatment. Composite Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) moderate or severe bleeds were modestly increased (2.4% versus 1.7%; HR, 1.438; P=0.234) but severe bleeds were not more frequent (0.3% versus 0.5%; HR, 0.549; P=0.471) in the prolonged treatment group.


CONCLUSIONS
Prasugrel and aspirin continued for 30 months reduced ischemic events for the TAXUS Liberté paclitaxel-eluting stent patient subset from DAPT through reductions in MI and stent thrombosis. Withdrawal of prasugrel was followed by an increase in MI after both 12 and 30 months therapy. The optimal duration of dual antiplatelet therapy with prasugrel after TAXUS Liberté paclitaxel-eluting stent remains unknown, but appears to be >30 months.


BACKGROUND
http://www.clinicaltrials.gov. Unique identifier: NCT00997503.
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.). kgarratt@lenoxhill.net.
Kirk N
KN
Garratt
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
W Douglas
WD
Weaver
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
Ronald G
RG
Jenkins
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
Thomas K
TK
Pow
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
Laura
L
Mauri
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
Dean J
DJ
Kereiakes
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
Kenneth J
KJ
Winters
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
Thomas
T
Christen
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
Dominic J
DJ
Allocco
From Lenox Hill Hospital, New York, NY (K.N.G.); Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.); Kootenai Medical Center, Coeur d'Alene, ID (R.G.J.); Lakeland Hospitals at St. Joseph, St. Joseph, MI (T.K.P.); Brigham and Women's Hospital, Boston, MA (L.M.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center Heart & Vascular Center, Cincinnati, OH (D.J.K.); Eli Lilly and Co, Indianapolis, IN (K.J.W.); Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A.); and Stanford University Medical Center, Stanford, CA (D.P.L.).
David P
DP
Lee
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use*; D003327:Coronary Disease / Q000628:therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D015994:Incidence; D038622:Internationality; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D017239:Paclitaxel / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D000068799:Prasugrel Hydrochloride; D058921:Purinergic P2Y Receptor Antagonists / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use; D013876:Thiophenes / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D010879:Piperazines; D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D011725:Pyridines; D013876:Thiophenes; C446540:thienopyridine; D000068799:Prasugrel Hydrochloride; D017239:Paclitaxel; D001241:Aspirin
antiplatelet agents; drug-eluting stent; myocardial infarction; prasugrel; stent; thrombosis