NCT02605447

EVOLVE Short DAPT Study

Completed Phase 4 Results posted Last updated 25 September 2020

What this trial tests

Phase 4 trial testing 3 months of dual antiplatelet therapy (DAPT) in Coronary Artery Disease in 2,009 participants. Completed in 17 July 2019.

Timeline

16 February 2016

Primary endpoint
17 July 2019

17 July 2019

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2,009
Start date	16 February 2016
Primary completion	17 July 2019
Estimated completion	17 July 2019
Sites	110 locations across Japan, Sweden, Germany, Switzerland, United States, Brazil, Latvia

Drugs / interventions tested

• 3 months of dual antiplatelet therapy (DAPT) — full drug profile →
• SYNERGY Stent System

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced Death or Myocardial Infarction (MI) Primary · 3 to 15 months

Rate of death or myocardial infarction

Group	Value	95% CI
SYNERGY Stent + 3 Month DAPT	84

Number of Participants Who Experienced Stent Thrombosis (ST) Primary · 3 to 15 months

Rate of stent thrombosis: definite + probable, using the Academic Research Consortium (ARC) definition Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed) Probable Clinical definition of probable stent thrombosis is considered to have occurred in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure and MI in the absence of any obvious cause which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis Possible

Group	Value	95% CI
SYNERGY Stent + 3 Month DAPT	3

Number of Participants Who Experienced Major Bleeding Secondary · 3 to 15 months

Rate of Bleeding, per Bleeding Academic Consortium definition (BARC2, 3a, 3b, 3c, 4, 5a and 5b) * Type 0: No Bleeding * Type 1: Bleeding that is not actionable and does not cause the patient to seek treatment * Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional * Type 3a: Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding * Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL (provided hemoglobin drop

Group	Value	95% CI
SYNERGY Stent + 3 Month DAPT	103

Adverse events — posted to ClinicalTrials.gov

Time frame: Study start to end of study (15 month). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SYNERGY Stent + 3 Month DAPT

Serious: 607/1487 (41%)

Deaths: 66/1487

Serious adverse events (417 terms)

Reaction	System	SYNERGY Stent + 3 Month DAPT
Total	Cardiac disorders	—
Total	Infections and infestations	—
Total	Gastrointestinal disorders	—
Total	General disorders	—
Total	Nervous system disorders	—
Total	Respiratory, thoracic and mediastinal disorders	—
Total	Injury, poisoning and procedural complications	—
Total	Renal and urinary disorders	—
Atrial fibrillation	Cardiac disorders	—
Total	Vascular disorders	—
Total	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Cardiac failure congestive	Cardiac disorders	—
Non-cardiac chest pain	General disorders	—
Total	Blood and lymphatic system disorders	—
Renal failure acute	Renal and urinary disorders	—
Pneumonia	Infections and infestations	—
Angina pectoris	Cardiac disorders	—
Total	Musculoskeletal and connective tissue disorders	—
Acute myocardial infarction	Cardiac disorders	—
Anaemia	Blood and lymphatic system disorders	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—
Sepsis	Infections and infestations	—
Coronary artery disease	Cardiac disorders	—
Total	Metabolism and nutrition disorders	—
Angina unstable	Cardiac disorders	—

Other adverse events (60 terms — click to expand)

Reaction	System	SYNERGY Stent + 3 Month DAPT
Total	Respiratory, thoracic and mediastinal disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Total	Injury, poisoning and procedural complications	—
Total	Gastrointestinal disorders	—
Haematuria	Renal and urinary disorders	—
Total	Renal and urinary disorders	—
Total	General disorders	—
Rectal haemorrhage	Gastrointestinal disorders	—
Catheter site haematoma	General disorders	—
Contusion	Injury, poisoning and procedural complications	—
Total	Vascular disorders	—
Gingival bleeding	Gastrointestinal disorders	—
Total	Skin and subcutaneous tissue disorders	—
Total	Cardiac disorders	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—
Haematochezia	Gastrointestinal disorders	—
Catheter site haemorrhage	General disorders	—
Laceration	Injury, poisoning and procedural complications	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	—
Myocardial infarction	Cardiac disorders	—
Melaena	Gastrointestinal disorders	—
Procedural haemorrhage	Injury, poisoning and procedural complications	—
Bleeding varicose vein	Vascular disorders	—
Haematoma	Vascular disorders	—
Anaemia	Blood and lymphatic system disorders	—
Total	Blood and lymphatic system disorders	—
Acute myocardial infarction	Cardiac disorders	—
Eye haemorrhage	Eye disorders	—
Total	Eye disorders	—
Diarrhoea haemorrhagic	Gastrointestinal disorders	—
Gastritis	Gastrointestinal disorders	—
Haemorrhoids	Gastrointestinal disorders	—
Implant site haematoma	General disorders	—
Total	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Anaemia postoperative	Injury, poisoning and procedural complications	—
Incision site haemorrhage	Injury, poisoning and procedural complications	—
Post procedural haematuria	Injury, poisoning and procedural complications	—
Skin abrasion	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Total, Total, Total, Total, Total, Total, Total, Total.

Data from ClinicalTrials.gov NCT02605447 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Evolving Concept of Dual Antiplatelet Therapy after Percutaneous Coronary Intervention: Focus on Unique Feature of East Asian and "Asian Paradox".
   Kang J, Kim HS. · · 2018 · cited 51× · PMID 29968428 · DOI 10.4070/kcj.2018.0166
2. Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents.
   Akinapelli A, Chen JP, Roy K, Donnelly J, et al · · 2017 · cited 22× · PMID 28017123 · DOI 10.2174/1573403x12666161222155230
3. Bleeding and Ischemic Risk Prediction in Patients With High Bleeding Risk (an EVOLVE Short DAPT Analysis).
   Mihatov N, Kirtane AJ, Stoler R, Feldman R, et al · · 2023 · cited 7× · PMID 37778226 · DOI 10.1016/j.amjcard.2023.06.036
4. Drug-coated stents versus bare metal stents in Academic Research Consortium-defined high bleeding risk patients.
   Marquis-Gravel G, Urban P, Copt S, Capodanno D, et al · · 2021 · cited 6× · PMID 32830645 · DOI 10.4244/eij-d-20-00749
5. High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial.
   Zocca P, Kok MM, van der Heijden LC, Danse PW, et al · · 2018 · cited 6× · PMID 30143879 · DOI 10.1007/s10557-018-6823-9
6. Dual Antiplatelet Therapy in Patients with High Cardiovascular Risk.
   Espinoza C, Mukherjee D. · · 2021 · cited 5× · PMID 36277317 · DOI 10.17925/hi.2021.15.1.26