RESUMO
BACKGROUND: The TriMaxx coronary stent system includes a novel trilayer metal stent having two outer layers of 316L stainless steel and with an inner 0.0007 inches layer of tantalum. This enables creation of a maximally flexible and thin device (0.0029 inches) while still maintaining the requisite strength and radiopacity for effective implantation. OBJECTIVES: The objective of this multi-center, single-arm prospective clinical trial was to assess the safety and performance of the TriMaxx stent for the treatment of single de novo coronary artery lesions. METHODS: One hundred patients with ischemic coronary occlusive disease because of single de novo obstructive lesions of native coronary arteries were treated with 3 x 15 or 3 x 18 mm TriMaxx stents in four hospitals in Brazil and Germany between May of 2004 and September of 2005. An independent core laboratory analyzed the quantitative coronary angiography (QCA) results immediately after stent implantation, and after six months. RESULTS: The lesion, procedure, and device-deployment success rates were 100, 99, and 100%, respectively. Eighty-eight patients underwent follow-up angiography at 6 +/- 1 months. After six months, 13 (13%) of patients had sustained major adverse cardiac events, including 9.0% that required target lesion revascularization (TLR). The follow-up angiographic studies revealed a binary in-stent restenosis rate of 25% with in-stent late lumen loss of 0.94 +/- 0.57 mm. CONCLUSIONS: These results demonstrate that the TriMaxx stent can be safely deployed for the treatment of single de novo coronary occlusive lesions with six-month clinical and angiographic results rates comparable to historical results using other bare metal stents.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Doenças Cardiovasculares/etiologia , Angiografia Coronária , Estenose Coronária/terapia , Stents Farmacológicos , Fosforilcolina/administração & dosagem , Aço Inoxidável , Tantálio , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Brasil , Doenças Cardiovasculares/diagnóstico por imagem , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Estenose Coronária/diagnóstico por imagem , Estudos de Viabilidade , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
Background: The TriMaxxTM coronary stent system includes a novel trilayer metal stent having two outer layers of 316L stainless steel and with an inner 0.0007 inches layer of tantalum. This enables creation of a maximally flexible and thin device (0.0029 inches) while still maintaining the requisite strength and radiopacity for effective implantation. Objectives: The objective of this multi-center, single-arm prospective clinical trial was to assess the safety and performance of the TriMaxx stent for the treatment of single de novo coronary artery lesions. Methods: One hundred patients with ischemic coronary occlusive disease because of single de novo obstructive lesions of native coronary arteries were treated with 3 3 15 or 3 3 18 mm TriMaxx stents in four hospitals in Brazil and Germany between May of 2004 and September of 2005. An independent core laboratory analyzed the quantitative coronary angiography (QCA) results immediately after stent implantation, and after six months. Results: The lesion, procedure, and device-deployment success rates were 100, 99, and 100%, respectively. Eighty-eight patients underwent follow-up angiography at 6 6 1 months. After six months, 13 (13%) of patients had sustained major adverse cardiac events, including 9.0% that required target lesion revascularization (TLR). The follow-up angiographic studies revealed a binary in-stent restenosis rate of 25% with in-stent late lumen loss of 0.94 6 0.57 mm. Conclusions: These results demonstrate that the Tri-Maxx stent can be safely deployed for the treatment of single de novo coronary occlusive lesions with six-month clinical and angiographic results rates comparable to historical results using other bare metal stents.