PROMUS Element™ Plus - Boston Scientific

• Abdominal pain (including upper abdominal pain)
• Anemia
• Angioedema
• Anorexia
• Asthenia
• Constipation
• Cough
• Delayed wound healing/fluid accumulation
• Diarrhea
• Dyslipidemia (including hyperlipidemia and
hypercholesterolemia)
• Dysgeusia
• Dyspepsia
• Dyspnea
• Dysuria
• Dry skin
• Edema (peripheral)
• Epistaxis
• Fatigue
• Headache
• Hematuria
• Hyperglycemia (may include new onset of diabetes)
• Hyperkalemia
• Hyperlipidemia
• Hypertension
• Hypokalemia
• Hypomagnesemia
• Hypophosphatemia
• Increased serum creatinine
• Infections and serious infections: bacterial, viral, fungal,
and protozoal infections (may include herpes virus
infection, polyoma virus infection which may be associated
with BK virus associated nephropathy, and/or other
opportunistic infections)
• Insomnia
• Interaction with strong inhibitors and inducers of CY3PA4
• Leukopenia
• Lymphoma and other malignancies (including skin cancer)
• Male infertility (azospermia and/or oligospermia)
• Mucosal inflammation (including oral ulceration and oral
mucositis)
• Nausea
• Neutropenia
• Non-infectious pneumonitis
• Pain; extremity, incision site and procedural, back, chest,
musculoskeletal
• Proteinuria
• Pruritus
• Pyrexia
• Rash
• Stomatitis
• Thrombocytopenia
• Thrombotic microangiopathy (TMA)/Thrombotic
thrombocytopenic purpura (TTP)/Hemolytic uremic
syndrome (HUS)
• Tremor
• Upper respiratory tract infection
• Urinary tract infection
• Vomiting
Live vaccines should be avoided and close contact with those
that have had live vaccines should be avoided. Fetal harm can
occur when administered to a pregnant woman. There may be
other potential adverse events that are unforeseen at this time.
10 CLiniCaL STUDiES
10.1 PLaTinUM workhorse (wH) randomized Controlled Trial
(rCT)
Primary Objective: The primary objective of the PLATINUM WH
RCT was to evaluate the safety and effectiveness of the PROMUS
Element Everolimus-Eluting Platinum Chromium Coronary Stent
System compared to the PROMUS® Everolimus-Eluting Cobalt
Chromium Coronary Stent System for the treatment of de novo
atherosclerotic lesions of up to 24 mm in length (by visual estimate)
in native coronary arteries of 2.50 mm to 4.25 mm in diameter (by
visual estimate).
Design: PLATINUM WH is a prospective, randomized, controlled,
single-blind, multi-center non-inferiority trial employing a 1:1
randomization to the PROMUS Element (test) or PROMUS (control)
everolimus-eluting stent. Eligible patients were those ≥18 years
old with left ventricular ejection fraction (LVEF) ≥30% and with
documented stable angina pectoris, silent ischemia, or unstable
angina pectoris. De novo target lesions in a native coronary artery
with diameter stenosis ≥50% and 1, reference vessel diameter
≥2.50 mm and ≤4.25 mm (visual estimate), and lesion length ≤24
mm (visual estimate) were eligible. Patients could have 1 or 2
target lesions treated. Patients with a single target lesion could
also have 1 de novo native coronary artery lesion within a different
epicardial vessel (non-target lesion) treated with a commerciallyavailable
treatment (e.g., stent, balloon angioplasty, excluding
brachytherapy) during the index procedure. The non-target lesion
had to be treated before the target lesion and the treatment had to
be a clinical angiographic success (defined as visually assessed
stenosis