Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents

NCT00638794 | Completed

• 1 other identifier: ADAPT-DES
• Study Type: observational
• Target: 8,575
• Locations: 1 country
• Sites: 8

Brief Summary

Prospective, multicenter, registry of at least 11,000 (and up to 15,000) consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.

Conditions

Coronary Artery Disease

Keywords

Myocardial Infarction; Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only.

  30 days, 1 year, 2 year

Secondary Outcomes (1)

• ARC definite, probable, possible or any stent thrombosis, utilizing primary only and then primary + secondary thromboses; death, MI, recurrent ischemia necessitating repeat target lesion and target vessel intervention and MACE.

  1 day, 30 days, 1 year, 2 year

Study Arms (2)

Surgical

Patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.

Observational

Consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications

Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)

Interventions

Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™) DEVICE

PCI using any FDA approved drug-eluting stent; Taxus Express2 - Paclitaxel-Eluting Coronary Stent System Cypher Sirolimus-eluting coronary stent Endeavor ABT-578 Eluting Coronary Stent System Xience V Everolimus Eluting Coronary Stent System

Also known as: Taxus™, Cypher®, Endeavor™, Xience V™

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient undergoing PCI in whom at least one DES is implanted and in whom PCI of all treated lesions is successful (diameter stenosis \<30% with TIMI 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intraprocedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery).

You may qualify if:

• Patients undergoing PCI in whom at least one DES is implanted and in whom PCI of all treated lesions is successful (diameter stenosis \<30% with TIMI 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intra-procedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery). One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting as long as at least one DES is implanted. However, the procedure must be successful and uncomplicated (as defined above) for all lesions (DES + BMS + non-stent).
• Aspirin use: Adequate aspirin loading given prior to PCI: at least 300 mg non enteric coated oral aspirin at least 1 hour prior to the procedure or 324 mg chewed or 250 mg IV aspirin at least 30 minutes prior to the procedure.
• Patient has Hematocrit between 30 and 52% and Platelet Count greater than 100,000/µl.
• For US sites: Only FDA-approved DES stents may be used in this study. For OUS sites: Only DES stents that are CE marked for approval may be used in this study.
• PCI performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin.
• Patient or guardian able to provide informed written consent.

You may not qualify if:

• Patients in whom blood for Accumetrics VerifyNow platelet function testing cannot be drawn after the minimum clopidogrel loading duration and Glycoprotein (GP) IIb/IIIa inhibitor washout duration as follows:
• Clopidogrel loading: Clopidogrel loading pre PCI is recommended, but post PCI clopidogrel loading is acceptable per standard of care. In all patients (whether or not clopidogrel is initiated pre or post PCI), prior to blood drawing for VerifyNow platelet function testing, a 600 mg loading dose must have been given at least 6 hours prior, or a 300 mg loading dose must have been given at least 12 hours prior, or the patient must have been maintained on at least 75 mg of clopidogrel daily for at least 5 days.
• GP IIb/IIIa inhibitor washout: Eptifibatide or tirofiban must have been discontinued for at least 24 hours prior to VerifyNow platelet function testing. Abciximab must have been discontinued for at 10 days prior to VerifyNow platelet function testing.
• Inability of the VerifyNow system to measure either Aspirin, P2Y12 or IIb/IIIa platelet responsiveness.
• Severe allergy to stainless steel, contrast dye, all anti-thrombin agents (unfractionated and low molecular weight heparin and bivalirudin), aspirin or clopidogrel that cannot be adequately pre-medicated.
• Patients in whom bypass graft surgery is planned within 2 years.
• Patients with stent thrombosis before the performance of pre-discharge VerifyNow platelet function testing.
• Patients unwilling or unable to complete clinical follow-up for the duration of the study.

Sponsors & Collaborators

• Cardiovascular Research Foundation, New York: lead
• Dickson Advanced Analytics Group: collaborator

Study Sites (8)

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Columbia University Medical Center & New York Presbyterian

New York, New York, 10027, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28202, United States

Location

LeBauer Cardiovascular Research

Greensboro, North Carolina, 27401, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Lehigh Valley Hospital and Health Network

Allentown, Pennsylvania, 18105, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Related Publications (21)

• Shahim B, Redfors B, Stuckey TD, Liu M, Zhou Z, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Srdanovic I, Madhavan MV, Mazzaferri EL Jr, Mehran R, Ben-Yehuda O, Kirtane AJ, Stone GW. On-Treatment Platelet Reactivity and Ischemic Outcomes in Patients With Diabetes Mellitus: Two-Year Results From ADAPT-DES. J Am Heart Assoc. 2023 Jan 3;12(1):e026482. doi: 10.1161/JAHA.122.026482. Epub 2022 Dec 24.

  PMID: 36565189 DERIVED

• Redfors B, Kirtane AJ, Liu M, Musikantow DR, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Ben-Yehuda O, Mehran R, Stone GW. Dual Antiplatelet Therapy Discontinuation, Platelet Reactivity, and Adverse Outcomes After Successful Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2022 Apr 25;15(8):797-806. doi: 10.1016/j.jcin.2022.01.300.

  PMID: 35450679 DERIVED

• Gupta R, Kirtane AJ, Liu Y, Crowley A, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Mehran R, Ben-Yehuda O, Stone GW. Impact of Smoking on Platelet Reactivity and Clinical Outcomes After Percutaneous Coronary Intervention: Findings From the ADAPT-DES Study. Circ Cardiovasc Interv. 2019 Nov;12(11):e007982. doi: 10.1161/CIRCINTERVENTIONS.119.007982. Epub 2019 Nov 1.

  PMID: 31672031 DERIVED

• Maehara A, Mintz GS, Witzenbichler B, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, McAndrew T, Genereux P, Mehran R, Kirtane AJ, Stone GW. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents. Circ Cardiovasc Interv. 2018 Nov;11(11):e006243. doi: 10.1161/CIRCINTERVENTIONS.117.006243.

  PMID: 30571206 DERIVED

• Giustino G, Redfors B, Kirtane AJ, Mehran R, Dangas GD, Witzenbichler B, Neumann FJ, Weisz G, Genereux P, Maehara A, McAndrew T, Farhan S, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Brodie BR, Stuckey TD, Gurbel P, Ben-Yehuda O, Stone GW. Platelet Reactivity and Risk of Ischemic Stroke After Coronary Drug-Eluting Stent Implantation: From the ADAPT-DES Study. JACC Cardiovasc Interv. 2018 Jul 9;11(13):1277-1286. doi: 10.1016/j.jcin.2018.01.263. Epub 2018 Jun 13.

  PMID: 29908967 DERIVED

• Redfors B, Genereux P, Witzenbichler B, Kirtane AJ, McAndrew T, Weisz G, Stuckey TD, Henry TD, Maehara A, Mehran R, Stone GW. Bleeding Severity After Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Mar;11(3):e005542. doi: 10.1161/CIRCINTERVENTIONS.117.005542.

  PMID: 29870382 DERIVED

• Redfors B, Genereux P, Witzenbichler B, McAndrew T, Diamond J, Huang X, Maehara A, Weisz G, Mehran R, Kirtane AJ, Stone GW. Percutaneous Coronary Intervention of Saphenous Vein Graft. Circ Cardiovasc Interv. 2017 May;10(5):e004953. doi: 10.1161/CIRCINTERVENTIONS.117.004953.

  PMID: 28495896 DERIVED

• Gupta R, Kirtane AJ, Ozan MO, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Mehran R, Ben-Yehuda O, Stone GW. Platelet Reactivity and Clinical Outcomes After Coronary Artery Implantation of Drug-Eluting Stents in Subjects With Peripheral Arterial Disease: Analysis From the ADAPT-DES Study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents). Circ Cardiovasc Interv. 2017 Mar;10(3):e004904. doi: 10.1161/CIRCINTERVENTIONS.116.004904.

  PMID: 28288963 DERIVED

• Yu J, Mehran R, Baber U, Ooi SY, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Brodie BR, Stuckey TD, Maehara A, Xu K, Ben-Yehuda O, Kirtane AJ, Stone GW. Sex Differences in the Clinical Impact of High Platelet Reactivity After Percutaneous Coronary Intervention With Drug-Eluting Stents: Results From the ADAPT-DES Study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents). Circ Cardiovasc Interv. 2017 Feb;10(2):e003577. doi: 10.1161/CIRCINTERVENTIONS.116.003577.

  PMID: 28193677 DERIVED

• Wang B, Mintz GS, Witzenbichler B, Souza CF, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Matsumura M, Yamamoto MH, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Predictors and Long-Term Clinical Impact of Acute Stent Malapposition: An Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) Intravascular Ultrasound Substudy. J Am Heart Assoc. 2016 Dec 22;5(12):e004438. doi: 10.1161/JAHA.116.004438.

  PMID: 28007741 DERIVED

• Kobayashi N, Mintz GS, Witzenbichler B, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Prevalence, Features, and Prognostic Importance of Edge Dissection After Drug-Eluting Stent Implantation: An ADAPT-DES Intravascular Ultrasound Substudy. Circ Cardiovasc Interv. 2016 Jul;9(7):e003553. doi: 10.1161/CIRCINTERVENTIONS.115.003553.

  PMID: 27402854 DERIVED

• Yun KH, Mintz GS, Witzenbichler B, Inaba S, Shimizu T, Metzger DC, Rinaldi MJ, Mazzaferri EL Jr, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Kirtane AJ, Stone GW, Maehara A. Relationship Between Platelet Reactivity and Culprit Lesion Morphology: An Assessment From the ADAPT-DES Intravascular Ultrasound Substudy. JACC Cardiovasc Imaging. 2016 Jul;9(7):849-854. doi: 10.1016/j.jcmg.2015.08.019. Epub 2016 Feb 17.

  PMID: 26897675 DERIVED

• Kirtane AJ, Parikh PB, Stuckey TD, Xu K, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Mazzaferri EL Jr, Parvataneni R, Maehara A, Genereux P, Mehran R, Stone GW. Is There an Ideal Level of Platelet P2Y12-Receptor Inhibition in Patients Undergoing Percutaneous Coronary Intervention?: "Window" Analysis From the ADAPT-DES Study (Assessment of Dual AntiPlatelet Therapy With Drug-Eluting Stents). JACC Cardiovasc Interv. 2015 Dec 28;8(15):1978-1987. doi: 10.1016/j.jcin.2015.08.032.

  PMID: 26738669 DERIVED

• Dohi T, Maehara A, Witzenbichler B, Rinaldi MJ, Mazzaferri EL Jr, Duffy PL, Weisz G, Neumann FJ, Henry TD, Cox DA, Stuckey TD, Brodie BR, Litherland C, Brener SJ, Kirtane AJ, Mintz GS, Stone GW. Etiology, Frequency, and Clinical Outcomes of Myocardial Infarction After Successful Drug-Eluting Stent Implantation: Two-Year Follow-Up From the ADAPT-DES Study. Circ Cardiovasc Interv. 2015 Dec;8(12):e002447. doi: 10.1161/CIRCINTERVENTIONS.114.002447.

  PMID: 26643737 DERIVED

• Brodie BR, Garg A, Stuckey TD, Kirtane AJ, Witzenbichler B, Maehara A, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Mehran R, Parvataneni R, Stone GW. Fixed and Modifiable Correlates of Drug-Eluting Stent Thrombosis From a Large All-Comers Registry: Insights From ADAPT-DES. Circ Cardiovasc Interv. 2015 Oct;8(10):e002568. doi: 10.1161/CIRCINTERVENTIONS.114.002568.

  PMID: 26415600 DERIVED

• Genereux P, Giustino G, Witzenbichler B, Weisz G, Stuckey TD, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri E, Yadav M, Francese DP, Palmerini T, Kirtane AJ, Litherland C, Mehran R, Stone GW. Incidence, Predictors, and Impact of Post-Discharge Bleeding After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2015 Sep 1;66(9):1036-45. doi: 10.1016/j.jacc.2015.06.1323.

  PMID: 26314532 DERIVED

• Petersen JE, Bouwens EA, Tamayo I, Turner L, Wang CW, Stins M, Theander TG, Hermida J, Mosnier LO, Lavstsen T. Protein C system defects inflicted by the malaria parasite protein PfEMP1 can be overcome by a soluble EPCR variant. Thromb Haemost. 2015 Nov;114(5):1038-48. doi: 10.1160/TH15-01-0018. Epub 2015 Jul 9.

  PMID: 26155776 DERIVED

• Baber U, Mehran R, Kirtane AJ, Gurbel PA, Christodoulidis G, Maehara A, Witzenbichler B, Weisz G, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Xu K, Parise H, Brodie BR, Stuckey TD, Stone GW. Prevalence and impact of high platelet reactivity in chronic kidney disease: results from the Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents registry. Circ Cardiovasc Interv. 2015 Jun;8(6):e001683. doi: 10.1161/CIRCINTERVENTIONS.115.001683.

  PMID: 26056248 DERIVED

• Kang SJ, Mintz GS, Witzenbichler B, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Shimizu T, Xu K, Kirtane AJ, Stone GW, Maehara A. Effect of obesity on coronary atherosclerosis and outcomes of percutaneous coronary intervention: grayscale and virtual histology intravascular ultrasound substudy of assessment of dual antiplatelet therapy with drug-eluting stents. Circ Cardiovasc Interv. 2014 Dec 31;8(1):e001392. doi: 10.1161/CIRCINTERVENTIONS.114.001392. Print 2015 Jan.

  PMID: 25552564 DERIVED

• Witzenbichler B, Maehara A, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, Xu K, Parise H, Mehran R, Mintz GS, Stone GW. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study. Circulation. 2014 Jan 28;129(4):463-70. doi: 10.1161/CIRCULATIONAHA.113.003942. Epub 2013 Nov 26.

  PMID: 24281330 DERIVED

• Stone GW, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri E, Gurbel PA, Xu K, Parise H, Kirtane AJ, Brodie BR, Mehran R, Stuckey TD; ADAPT-DES Investigators. Platelet reactivity and clinical outcomes after coronary artery implantation of drug-eluting stents (ADAPT-DES): a prospective multicentre registry study. Lancet. 2013 Aug 17;382(9892):614-23. doi: 10.1016/S0140-6736(13)61170-8. Epub 2013 Jul 26.

  PMID: 23890998 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Myocardial Ischemia

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Gregg W. Stone, MD

  CardioVascular Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 19, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2013
• Last Updated: January 23, 2013

Record last verified: 2012-08

Locations

US (8)