Methods and results
Sixty arteries in 54 subjects were enrolled into the PLUS-ONE Study. COBRA-P stents with bioabsorbable coating containing either 4 μg/18 mm ( n =30) or 8 μg/18 mm ( n =30) of paclitaxel were implanted in de novo coronary lesions in native coronary arteries. Visual reference vessel diameter was ≥3.0 and ≤3.75 and lesions up to 20 mm. The primary end point was major adverse cardiac events (MACE) at 4 months defined as cardiac death, myocardial infarction (MI) (Q wave and non-Q wave), and ischemia-driven target lesion revascularization (TLR). Secondary end points included MACE at 30 days and 4 months in-stent and in-segment angiographic late loss (millimeters) by quantitative coronary angiography (QCA). Reference vessel diameter (RVD) was similar in both groups: 2.58 and 2.57 mm. Late lumen loss was similar in both groups: 0.36 (±0.30) mm and 0.34 (±0.27) mm. Volume obstruction by IVUS at 4 months’ follow-up was 13.5% (±9.5) and 10.9% (±7.8). In-stent binary restenosis by QCA at 4 months was 7.1% vs. 0%; in-segment binary restenosis was 10.7% vs. 0%. One MACE (TLR: 3.3%; 1/30) occurred in the low-dose arm for ischemia-driven TLR and one TLR occurred for non-ischemia-driven operator-perceived binary restenosis (TLR: 3.3%; 1/30) in the high-dose arm resulting in a total of two TLRs (3.3%; 2/60 lesions) in the study. MACE rate remained unchanged at the 1-year follow-up.
Methods and results
Sixty arteries in 54 subjects were enrolled into the PLUS-ONE Study. COBRA-P stents with bioabsorbable coating containing either 4 μg/18 mm ( n =30) or 8 μg/18 mm ( n =30) of paclitaxel were implanted in de novo coronary lesions in native coronary arteries. Visual reference vessel diameter was ≥3.0 and ≤3.75 and lesions up to 20 mm. The primary end point was major adverse cardiac events (MACE) at 4 months defined as cardiac death, myocardial infarction (MI) (Q wave and non-Q wave), and ischemia-driven target lesion revascularization (TLR). Secondary end points included MACE at 30 days and 4 months in-stent and in-segment angiographic late loss (millimeters) by quantitative coronary angiography (QCA). Reference vessel diameter (RVD) was similar in both groups: 2.58 and 2.57 mm. Late lumen loss was similar in both groups: 0.36 (±0.30) mm and 0.34 (±0.27) mm. Volume obstruction by IVUS at 4 months’ follow-up was 13.5% (±9.5) and 10.9% (±7.8). In-stent binary restenosis by QCA at 4 months was 7.1% vs. 0%; in-segment binary restenosis was 10.7% vs. 0%. One MACE (TLR: 3.3%; 1/30) occurred in the low-dose arm for ischemia-driven TLR and one TLR occurred for non-ischemia-driven operator-perceived binary restenosis (TLR: 3.3%; 1/30) in the high-dose arm resulting in a total of two TLRs (3.3%; 2/60 lesions) in the study. MACE rate remained unchanged at the 1-year follow-up.
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