OBJECTIVE: A first-in-man evaluation of the safety, feasibility, deliverability, and efficacy of the new Medtronic S9 (Integrity) bare metal stent (BMS) in complex coronary diseases. BACKGROUND: Excellent deliverability remains an unmet clinical need among stents especially in complex lesions. The S9 (Integrity) BMS utilizes a new, continuous sinusoidal manufacturing technology to enhance stent flexibility and deliverability, without sacrificing radial strength. METHODS: This is a first-in-man, open label observational study in 15 patients treated with S9 (Integrity) BMS. Device success during implantation, clinical outcomes, 30-day and 12-month device-oriented and patient-oriented composite efficacy end-points, and 16-month angiographic restudy were evaluated (with amended protocols). RESULTS: Thirty-four stents were deployed to treat 30 complex lesions. Mean lesion length was 22.93 ± 11.78 mm, and mean percentage diameter stenosis was 78.59% ± 9.01%. Mean stent delivery time was 125 ± 68.3 sec. Acute device, lesion, and procedure success, as defined, were 100%. Device-oriented and patient-oriented composite end-points were zero at 30 days. Two patients had ischemic driven revascularization before 12 months. One patient had non-cardiac death at 13 months; all remaining 12 patients received 16 months angiographic restudy and only one had angiographic restenosis. The mean diameter of stenosis was 27.0% ± 18.3%, and mean late loss was 0.73 ± 0.50 mm. Total target vessel failure rate was 21.4% (3/14) at 16 months. CONCLUSION: The new S9 (Integrity) BMS exhibited excellent deliverability, flexibility, and conformability, contributing to good acute and 16 months outcomes in complex cases.
OBJECTIVE: A first-in-man evaluation of the safety, feasibility, deliverability, and efficacy of the new Medtronic S9 (Integrity) bare metal stent (BMS) in complex coronary diseases. BACKGROUND: Excellent deliverability remains an unmet clinical need among stents especially in complex lesions. The S9 (Integrity) BMS utilizes a new, continuous sinusoidal manufacturing technology to enhance stent flexibility and deliverability, without sacrificing radial strength. METHODS: This is a first-in-man, open label observational study in 15 patients treated with S9 (Integrity) BMS. Device success during implantation, clinical outcomes, 30-day and 12-month device-oriented and patient-oriented composite efficacy end-points, and 16-month angiographic restudy were evaluated (with amended protocols). RESULTS: Thirty-four stents were deployed to treat 30 complex lesions. Mean lesion length was 22.93 ± 11.78 mm, and mean percentage diameter stenosis was 78.59% ± 9.01%. Mean stent delivery time was 125 ± 68.3 sec. Acute device, lesion, and procedure success, as defined, were 100%. Device-oriented and patient-oriented composite end-points were zero at 30 days. Two patients had ischemic driven revascularization before 12 months. One patient had non-cardiac death at 13 months; all remaining 12 patients received 16 months angiographic restudy and only one had angiographic restenosis. The mean diameter of stenosis was 27.0% ± 18.3%, and mean late loss was 0.73 ± 0.50 mm. Total target vessel failure rate was 21.4% (3/14) at 16 months. CONCLUSION: The new S9 (Integrity) BMS exhibited excellent deliverability, flexibility, and conformability, contributing to good acute and 16 months outcomes in complex cases.
Authors: Wolfram Schmidt; Peter Lanzer; Peter Behrens; Christoph Brandt-Wunderlich; Alper Öner; Hüseyin Ince; Klaus-Peter Schmitz; Niels Grabow Journal: Eur J Med Res Date: 2018-01-08 Impact factor: 2.175