Xience Versus Synergy in Left Main PCI

NCT02303717 | Unknown DMC

• 1 other identifier: IRAS Project ID162820
• Study Type: interventional
• Target: 818
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, randomized, multicenter study in patients with an indication for coronary artery revascularisation who have been accepted for percutaneous coronary intervention (PCI) of the left main coronary artery. Patients will undergo standard PCI of the left main coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the XIENCE stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after treatment.

Conditions

Coronary Artery Disease

Keywords

Left main; PCI; DES

Outcome Measures

Primary Outcomes (1)

• MACE

  The primary endpoint is the rate of MACE defined as death from any cause or MI or ischemia-driven target vessel revascularization (TVR) at 2 years after the procedure.

  2 years

Secondary Outcomes (7)

• All cause mortality

  2 years

• MI

  2 years

• Ischaemia driven target vessel revascularisation

  2 years

• Procedural success

  2 years

• Procedural success

  3 years

Other Outcomes (3)

• OCT derived healing score (no units)

  3 months

• Combined primary end-point in patients eligible for CABG vs patients considered inoperable

  2 years

• Angiographic late loss (mm)

  3 months

Study Arms (2)

Xience

ACTIVE COMPARATOR

Percutaneous coronary intervention utilising a cobalt chromium everolimus eluting stent with durable polymer (Xience) plus oral dual antiplatelet therapy (DAPT) for 12 months. DAPT will be aspirin 75-100mg daily plus either clopidogrel 75mg daily or prasugrel 5-10mg daily or ticagrelor 90mg twice daily.

Device: Percutaneous coronary intervention; Drug: Dual antiplatelet therapy

Synergy

EXPERIMENTAL

Percutaneous coronary intervention utilising a platinum chromium everolimus eluting stent with bioresorbable polymer (Synergy) plus oral dual antiplatelet therapy (DAPT) for 4 months. DAPT will be aspirin 75-100mg daily plus either clopidogrel 75mg daily or prasugrel 5-10mg daily or ticagrelor 90mg twice daily.

Device: Percutaneous coronary intervention; Drug: Dual antiplatelet therapy

Interventions

Percutaneous coronary intervention DEVICE

Percutaneous coronary stent implantation

Also known as: PCI

Synergy; Xience

Dual antiplatelet therapy DRUG

Dual antiplatelet therapy with aspirin and either clopidogrel, prasugrel or ticagrelor will be recommended for 12 months duration in the Xience stent arm but only 4 months duration in the Synergy stent arm.

Also known as: DAPT

Synergy; Xience

Eligibility Criteria

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

You may qualify if:

• Patients with an indication for coronary artery revascularisation by ESC guidelines and accepted for PCI of the left main coronary artery will be included in the study.
• Patient has an indication for coronary artery revascularisation of the left main artery in accordance with the ESC guidelines
• Patient has been discussed with the cardiac surgeon prior to PCI procedure
• Patient is accepted for PCI
• Patient is at least 18 years of age.
• The patient understands and accepts the meaning and the aims of the study and is willing to provide written informed consent
• The patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.

You may not qualify if:

• Not able to receive anti-platelet treatment due to contraindications
• Known allergy to acetylsalicylic acid, clopidogrel, prasugrel or ticagrelor
• Cardiogenic shock
• STEMI within the last 5 days
• Planned surgery within 12 months after stent introduction
• History of bleeding diathesis or active major bleedings
• Major surgery within previous 15 days
• Current participation in another trial which has not yet reached its primary endpoint
• Life expectancy \< 12 months
• Hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, platinum and fluoropolymers
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• Boston Scientific Corporation: collaborator
• Venn Life Sciences: collaborator
• Cardialysis B.V.: collaborator
• Diagram B.V.: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Keith G Oldroyd, MB ChB

CONTACT

+44 141 951 5180; keith.oldroyd@nhs.net

Catherine Sinclair, PhD

CONTACT

+44 141 951 5440; catherine.sinclair@gjnh.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 1, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: December 1, 2014

Record last verified: 2014-11