Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System compared with the PROMUS Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12608000582358
• Date of registration: 19/11/2008
• Primary sponsor: Commercial sector/Industry Boston Scientific Corporation
• Public title: Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System compared with the PROMUS Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions PLATINUM
• Scientific title: A Prospective, Randomised, Multicentre Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element) for the Treatment of up to two De Novo Coronary Artery Lesions
• Date of first enrolment: 1/01/2009
• Target sample size: 1532
• Recruitment status: Closed: follow-up continuing
• URL: http://www.anzctr.org.au/ACTRN12608000582358.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Countries of recruitment

Argentina, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Poland, Portugal, Singapore, Spain, Switzerland, United Kingdom, United States of America

Contacts

• Name: Mary Kennell

• Name: Ian T Meredith

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patient is eligible for percutaneous coronary intervention (PCI)
2. Patient has documented stable angina pectoris, or documented silent ischaemia, or unstable angina pectoris
3. Patient is acceptable candidate for Coronary Artery Bypass Graft (CABG)
4. Patient has left ventricular ejection fraction of >30%
5. Target lesion must be de novo and located within native coromary artery with diameter >2.50mm and <4.25mm
6. Target lesion must be <24mm in length
7. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >50% and <100%
Exclusion criteria: 1. Clinical symptoms or Electrocardiogram (ECG) changes consistent with Myocardial Infarction (MI)
2. Patient has known diagnosis of recent MI (within 30 days prior to index procedure) and has elevated enzymes at time of index procedure
3. Target vessel or side branch treated with any type of PCI within 12 months prior to index procedure
4. Patient is receiving chronic anticoagulation therapy for indications other than acute coronary syndrome

Age minimum: 18 Years
Age maximum: 150 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Atherosclerotic lesions in the coronary artery

Intervention(s)

The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. Up to two stents will be permanently implanted in the patient via use of a catheter inserted into the vasculature. The drug dosage depends on the size of the stent and varies from 57 micrograms (2.25x12mm stent) to 242 micrograms (4.0x38mm stent) and this drug is gradually eluted into the bloodstream following implantation of the stent. Stent size is selected by the investigator based on vessel diameter and length. Typically stent diameter is selected to be slightly larger than the vessel diameter (ie a 3.0mm stent would be used to treat a 2.8mm vessel). Typically stent length is selected so that the stent is 2-4mm longer than the lesion length (ie a 28mm stent would be used to treat a 22mm lesion)

Primary Outcome(s)

12-month target lesion failure (TLF) rate, defined as any ischaemia-driven revascularisation of the target lesion (TLR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel

Secondary Outcome(s)

Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:

* The patient has a positive functional study corresponding to the area served by the target lesion
* The patient has ischemic ECG changes at rest in a distribution consistent with the target vessel
* The patient has ischemic symptoms referable to the target lesion
A TLR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even in the absence of clinical or functional ischemia.

Any events must be reported to the sponsor within 24 hours. Source data regarding the event will be collected and sent to the Clinical Events Committee (CEC) for adjudication.

Target vessel revascularization (TVR) is defined as a TLR or a TVR remote. Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:
* The patient has a positive functional study corresponding to the area served by the target lesion
* The patient has ischemic ECG changes at rest in a distribution consistent with the target vessel
* The patient has ischemic symptoms referable to the target lesion
A TLR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even in the absence of clinical or functional ischemia



Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is 50% by QCA and any of the following are present:

* The patient has a positive functional study corresponding to the area served by the target lesion

* The patient has ischemic ECG changes at rest in a distribution consistent with the target vessel
* The patient has ischemic symptoms referable to the target lesion
A TVR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even in the absence of clinical or functional ischemia.

Any events must be reported to the sponsor within 24 hours. Source data regarding the event will be collected and sent to the CEC for adjudication.

Source(s) of Monetary Support

Boston Scientific Corporation