Clinical trial NCT02605447: EVOLVE Short DAPT Study
Official title: A Prospective, Multicenter, Single-arm Study Designed to Assess the Safety of 3-month Dual Antiplatelet Therapy (DAPT) in Subjects at High Risk for Bleeding Undergoing Percutaneous Coronary Intervention (PCI) With the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-11-16
Enrollment: 2009
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

Detailed description: The primary objective of the EVOLVE Short DAPT Study is to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent System.

The study will be conducted up to 120 sites worldwide in the United States, Europe, Japan, and Brazil with planned enrollment of up to 2,250 subjects. Clinical follow-up will be required at the following time points: 3 months, 6 months, 12 months and 15 months post index procedure.

Subjects must be treated with one of the following P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor) for 3 months following the index procedure. Subjects must be treated with aspirin for the duration of the trial. The minimum daily maintenance dose of aspirin should be 75-100 mg.

Subjects are eligible for discontinuation of P2Y12 inhibitor at 3 months if they meet both of the following criteria: subject was treated with 3 months of study required antiplatelet therapy post index procedure; and subject was free from events (stroke, MI, PCI, coronary artery bypass graft \[CABG\], and stent thrombosis) between the index procedure and the 3 month visit.

Subjects are not eligible for discontinuation of P2Y12 inhibitor at 3 months if any of the following criteria are met: subject who experiences a stroke, MI, PCI, CABG and/or stent thrombosis, during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject who is non-compliant with study required antiplatelet therapy during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months due to another condition requiring chronic P2Y12 inhibitor use.

All enrolled subjects who receive a SYNERGY stent must be followed at all milestones through 15-months, regardless of eligibility to discontinue P2Y12 inhibitor. Following the 3-month milestone, subjects who experience MI or stent thrombosis events should be treated per the investigator's discretion and should be followed through the 15-month visit.

Eligibility criteria: Inclusion Criteria:

1. Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:

   * ≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with \>3 months of DAPT outweighs the benefit,
   * need for chronic or lifelong anticoagulation,
   * history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
   * history of stroke (ischemic or hemorrhagic),
   * renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),
   * platelet count ≤100,000/μL
2. Subject must be at least 18 years of age
3. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days
4. Subject must be able to take study required antiplatelet therapy (as required per protocol)
5. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol
6. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed
7. For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:

1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
2. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
3. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
4. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
5. Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)
6. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
7. Subject previously treated at any time with intravascular brachytherapy
8. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
9. Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)
10. Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)
11. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
13. Subject is a woman who is pregnant or nursing
14. Subject with a current medical condition with a life expectancy of less than 15 months
15. Target lesion(s) is located in the left main
16. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
17. Subject has unprotected left main coronary artery disease ( \> 50% diameter stenosis)
18. Planned treatment of more than 3 lesion
19. Planned treatment of lesions in more than 2 major epicardial vessels
20. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
21. Target lesion(s) is restenotic from a previous stent implantation
22. Target lesion(s) is located within a saphenous vein graft or an arterial graft
23. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
24. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Primary outcomes:
measure: Number of Participants Who Experienced Death or Myocardial Infarction (MI)
timeFrame: 3 to 15 months
measure: Number of Participants Who Experienced Stent Thrombosis (ST)
timeFrame: 3 to 15 months
Secondary outcomes:
measure: Number of Participants Who Experienced Major Bleeding
timeFrame: 3 to 15 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Regional Medical Center
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Medical Center (Little Rock)
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars - Sinai Medical Center
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Riverside
country: United States
facility: HCA Riverside Community Hospital
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center, Sacramento
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital - San Francisco
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Mease Healthcare System
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Ocala
country: United States
facility: Mediquest Research at Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Sebring
country: United States
facility: Florida Hospital Heartland Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Augusta
country: United States
facility: University Hospital
state: Georgia
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
city: Coeur d'Alene
country: United States
facility: Kootenai Medical Center
state: Idaho
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Beech Grove
country: United States
facility: Franciscan St. Francis Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance - Lutheran Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Community Heart and Vascular Hospital
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Louisville
country: United States
facility: Jewish Hospital and St. Mary's Healthcare
state: Kentucky
city: Shreveport
country: United States
facility: Cardiovascular Research, LLC
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Regional Heart Center
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Centers
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Hospital
state: New Mexico
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Center for Research and Education at Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospital
state: South Carolina
city: Greenville
country: United States
facility: University Medical Center-Greenville Memorial Hospital
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Round Rock
country: United States
facility: St. David's Round Rock Medical Center
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Heart and Vascular Institute - Research and Education
state: Wisconsin
city: Sao Paulo
country: Brazil
facility: Instituto do Coração (InCor)
city: São Paulo
country: Brazil
facility: Instituto de Cardiologia Dante Pazzanese
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Segeberg
country: Germany
facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Jena
country: Germany
facility: Uni Jena
city: Fukuoka-shi
country: Japan
facility: Fukuoka Sanno Hospital
state: Fukuoka
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
state: Iwate-ken
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohama-City Eastern Hospital
state: Kanagawa
city: Chiyoda-ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
city: Riga
country: Latvia
facility: P. Stradins University Hospital
city: Falun
country: Sweden
facility: Falu Lasarett
city: Karlstad
country: Sweden
facility: Karlstadt Central Hospital
city: Malmo
country: Sweden
facility: Skane University Hospital
city: Fribourg
country: Switzerland
facility: Hospital Cantonal Fribourg
Study officials:
affiliation: Columbia University Medical Center/ NewYork Presbyterian Hospital
name: Ajay Kirtane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSELSPITAL - Universitätsspital Bern
name: Stephan Windecker, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirtane AJ, Stoler R, Feldman R, Neumann FJ, Boutis L, Tahirkheli N, Toelg R, Othman I, Stein B, Choi JW, Windecker S, Yeh RW, Dauerman HL, Price MJ, Underwood P, Allocco D, Meredith I, Kereiakes DJ. Primary Results of the EVOLVE Short DAPT Study: Evaluation of 3-Month Dual Antiplatelet Therapy in High Bleeding Risk Patients Treated With a Bioabsorbable Polymer-Coated Everolimus-Eluting Stent. Circ Cardiovasc Interv. 2021 Mar;14(3):e010144. doi: 10.1161/CIRCINTERVENTIONS.120.010144. Epub 2021 Mar 1.
citation: Balanescu DV, Aziz MK, Donisan T, Palaskas N, Lopez-Mattei J, Hassan S, Kim P, Song J, Ntim W, Cilingiroglu M, Marmagkiolis K, Iliescu C. Cancer treatment resumption in patients with new-generation drug-eluting stents. Coron Artery Dis. 2021 Jun 1;32(4):295-301. doi: 10.1097/MCA.0000000000000986.
citation: Mauri L, Kirtane AJ, Windecker S, Yeh RW, Dauerman HL, Price MJ, Christen T, Allocco DJ, Meredith IT, Kereiakes DJ. Rationale and design of the EVOLVE Short DAPT Study to assess 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention. Am Heart J. 2018 Nov;205:110-117. doi: 10.1016/j.ahj.2018.08.004. Epub 2018 Aug 17.