TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

• Rate of TAXUS stent related cardiac events as classified by the CEC. [ Time Frame: within 30 days, 6 months and 2 years ] [ Designated as safety issue: Yes ]
• Rate of target vessel related cardiac events as classified by the CEC. [ Time Frame: 30 days, at 6 months, at 1 and 2 years post-implant procedure ] [ Designated as safety issue: Yes ]
• Rate of other TAXUS related events [ Time Frame: 30 days, 6 months, 1 and 2 years post-implant procedure ] [ Designated as safety issue: Yes ]

The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.

• Cardiovascular Disease
• de Novo Coronary Lesions

• Brilakis ES, Lasala JM, Cox DA, Berger PB, Bowman TS, Starzyk RM, Dawkins KD. Outcomes after implantation of the TAXUS paclitaxel-eluting stent in saphenous vein graft lesions: results from the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program. JACC Cardiovasc Interv. 2010 Jul;3(7):742-50.
• Lasala JM, Cox DA, Dobies D, Baran K, Bachinsky WB, Rogers EW, Breall JA, Lewis DH, Song A, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS; ARRIVE 1 and ARRIVE 2 Participating Physicians. Drug-eluting stent thrombosis in routine clinical practice: two-year outcomes and predictors from the TAXUS ARRIVE registries. Circ Cardiovasc Interv. 2009 Aug;2(4):285-93. Epub 2009 Jul 22.
• Lasala JM, Cox DA, Lewis SJ, Tadros PN, Haas RC, Schweiger MJ, Chhabra A, Untereker WJ, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS. Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme. EuroIntervention. 2009 May;5(1):67-77.

Appropriate Patient Criteria:

• Patient is eligible to receive a Boston Scientific TAXUS Stent

Inappropriate Patient Criteria:

• Known sensitivity to paclitaxel.
• Known allergy to stainless steel.
• Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
• Patients with unresolved vessel thrombus at the lesion site.
• Patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm.
• Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
• Patients with diffuse disease or poor overflow distal to the identified lesions.
• Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.
• Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.