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Objective@#To evaluate the safety and feasibility of treating de novo coronary lesions with paclitaxel-eluting balloon.@*Methods@#This is a retrospective study, which enrolled 76 patients with 80 de novo coronary lesions treated with paclitaxel-eluting balloons(<30% residual stenosis and there was no blood flow limited dissection after pretreatment) from April 2015 to November 2016 in Guangdong general hospital. The data of basic characteristics,procedures,devices and follow-up information were retrieved and analyzed. The primary endpoint was the composite of cardiac death, recurrent myocardial infarction and target lesion revascularization.@*Results@#(1)The age was (63.3±10.3) years. There were 68.4%(52/76) acute coronary syndrome patients, prevalence of type 2 diabetes was 36.8%(28/76), and 64.5%(49/76)patients with at least one high bleeding risk. (2)The lesion length was (17.4±7.6)mm, and the stenosis was (88.1±8.2)%.The reference vessel diameter≥2.75 mm accounted for 51.2% (41/80), and bifurcation stenosis accounted for 67.5%(54/80). (3)53.7%(43/80) lesions were pretreated with scoring balloon to optimize plaque modification. The paclitaxel-eluting balloon length and diameter were (22.3±5.5)mm and (2.74±0.52)mm.The residual stenosis was (12.3±10.3)%. Procedural success was 88.8%(71/80).Bail-out stenting rate was 5.0%(4/80). (4)The median follow-up duration was 12(6, 25) months. Primary endpoint occurred in 3 cases (3.9%), including 2 cardiac deaths(1 patient died of recurrent myocardial infarction, and 1 patient died of acute heart failure induced by severe mitral insufficiency), and one patient receivedtarget lesion revascularization.@*Conclusion@#In case of no more than 30% residual stenosis and no blood flow limited dissection after lesion pretreatment,it is safe and feasible to treat de novo coronary lesionsusing paclitaxel-eluting balloon.
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Objective@#To evaluate the efficacy of paclitaxel-coated balloon for de novo coronary lesions with diameters ≥ 2.8 mm.@*Methods@#This prospective study included 215 consecutive patients with 238 de novo lesions, who received paclitaxel-coated balloon angioplasty in Beijing Hospital from May 2014 to June 2016. According to the reference vessel diameter, the patients were divided into large vessel disease (LVD) group (reference vessel diameter≥2.8 mm, 85 patients and 90 lesions) and small vessel disease (SVD) group (reference vessel diameter<2.8 mm, 130 patients and 148 lesions). Clinical characteristics, interventional procedures and major adverse cardiovascular events (includingall-cause mortality, non-fatal myocardial infarction and target lesion revascularization) after procedure were compared between the 2 groups.@*Results@#(1)Patients in LVD group were younger than SVD group ((60.1±11.1) years old vs. (65.0±10.6) years old, P<0.01), and less patients had diabetes (24.7% (21/85) vs. 43.1%(56/130), P<0.01).(2)Prevalence of three-vessel disease (35.5%(30/85) vs. 53.6%(67/130), P<0.05) and complex lesions (type B2/C,34.4% (31/90) vs. 50.0%(74/148), P<0.05) were significantly lower in LVD group than in SVD group.(3) During pre-dilation, the rate with plain balloons use was significantly higher in SVD group than in LVD group(76.4%(113/148) vs. 58.9%(53/90), P<0.01), while the proportion of additional use of non-compliant balloons was significantly higher in LVD groupthan in SVD group(20.0% (18/90) vs. 3.4% (5/148) , P<0.01). The ratio of paclitaxel-coated balloon diameter/RVD was significantly lower (0.87±0.12 vs. 0.96±0.15, P<0.01) and the duration of dilationwas significantly shorter ((41.5±9.5) seconds vs. (45.1±9.1) seconds, P<0.01) in LVD group than those in SVD group. Each group had 1 failure case that was bailout stented with drug-eluting stents. The success rate of paclitaxel-coated balloon treatment was similar in LVD group and SVD group (98.9% (89/90) vs. 99.3%(147/148), P>0.05).(4) At the fourth day of procedure, there was 1 acute myocardial infarction requiring emergent target lesion revascularization in SVD group. No major adverse cardiovascular event was observed in LVD group during hospitalization. Forty-two patients with 53 lesions, including 27 LVD lesions and 26 SVD lesions,underwent coronary angiography at (9.4±4.6) months after paclitaxel-coated balloon intervention. The quantitative coronary angiography analysis showed that minimal lumen diameter significantlyincreased during follow-up than that of post-procedurein SVD group ((1.71±0.36)mm vs. (1.52±0.30)mm, P<0.05) , while in LVD group the minimal lumen diameter was similar between during follow-up and post-procedure ((2.35±0.48)mm vs. (2.19±0.34)mm, P>0.05). Major adverse cardiovascular event rate was 0 in LVD group and 2.3%(3/130) in SVD group (P>0.05) during follow up. No death was observed in this patient cohort.@*Conclusion@#Treatment with paclitaxel-coated balloon for de novo coronary lesions with diameters≥2.8 mm is safe and effective.