Update on Cutting Balloon Angioplasty

Cutting balloon (CB) is a unique balloon catheter with 3 or 4 metal blades on its surface making controlled endovascular surgical incisions that show promise of causing less vessel wall injury and less intimai proliferation. Multicenter randomized trials have revealed that CB angioplasty with multiple inflations achieved better lumen enlargement than single inflation and reduced coronary dissection more than plain old balloon angioplasty (POBA). Follow-up results showed CB angioplasty had a smaller late loss and loss index, resulting in lessened restenosis and target lesion revascularization rates. The main indication of CB angioplasty is basically a noncalcified lesion with concentric plaque; however, it could be applied effectively to some lesions unsuitable for POBA including in-stent restenosis, small vessel, long diffuse lesion, or ostial lesion. Additional evaluation would be necessary to determine the role of CB angioplasty in the stent era.     

冠状动脉开口病变切割球囊成形术的预后

目的　评价切割球囊冠状动脉腔内成行术治疗开口病变的安全性及疗效。方法　 5 2例冠心病患者 5 2处开口病变行切割球囊扩张治疗 ,对其进行分析并短期临床随访。结果 5 2例病变血管直接切割球囊扩张治疗成功率98% ,切割球囊扩张后残余狭窄程度 (18.2± 17.1) % ,术终残余狭窄程度 (16 .8± 11.5 ) %。 1例对角支扩张后出现严重内膜撕裂安放支架 ,无急性闭塞、急诊冠状动脉旁路移植术及急性心肌梗死发生。随访期间无心脏事件发生。结论　切割球囊冠状动脉腔内成行术治疗冠状动脉开口病变安全、疗效良好。     

Effectiveness of cutting balloon angioplasty for small vessels less than 3.0 mm in diameter

The aim of this study was to evaluate the effectiveness of cutting balloon angioplasty (CBA) in small vessels < 3.0 mm in diameter. Included were 166 patients (175 lesions) treated with CBA (CBA group), and 215 patients (240 lesions) were treated with plain old balloon angioplasty (POBA group). No differences were observed in patient backgrounds or lesion characteristics between the two groups. Procedural success rates were similar: 98.3% (CBA) versus 95.8% (POBA). Coronary dissection rates were also similar: 7.4% in the CBA versus 5.8% in the POBA group. Severe dissections (types E and F) occurred in 2.5% of cases in the POBA group, whereas there was none observed in the CBA group. In-hospital complications occurred in 3.3% in the POBA group, and in only 0.6% in the CBA group. The restenosis rate was 37.5% (CBA group) versus 48.1% (POBA group); and in vessels < 2.75 mm, restenosis was significantly lower in the CBA group than in the POBA group (36.9% vs 62.7%, P < 0.05). CBA may be a useful therapeutic strategy for small vessels, given the absence of severe coronary dissection and the significantly lower rate of restenosis compared to POBA.     

Comparison of Restenosis Rate in Various Devices for Coronary Intervention: Analysis Using Vessel Diameter and Lesion Length

The purpose of this study was to retrospectively compare the restenosis rates related to vessel diameter and lesion length among plain old balloon angioplasty (POBA), cutting balloon (CB) angioplasty, Palmaz-Schatz (PS) stems, Gianturco-Roubin (GR) stents, and directional coronary atherectomy (DCA). In 909 consecutive successfully treated cases, target lesion dimensions were divided into diameters of ± 2.5 mm and lengths of ± 20 mm to compare the restenosis rates obtained by the individual devices. Quantitative angiographic analysis was performed before the procedure, after the procedure, and at FU angiography at a mean FU time of 6 ± 3 months. Restenosis was defined as %DS > 50 at FU angiography. Patients with acute myocardial infarction, chronic total occlusions, left main lesions, ostial as well as venous graft lesions, severe calcifications, severe coronary thrombosis, and bleeding complications were excluded. The overall restenosis rate was 32%, with the CB it was 29%, with the PS stent it was 27%, and with DCA it was 39%. Each of these restenosis rates was significantly lower than that with POBA. The overall restenosis rate with short lesions at small vessels was 35%, while CB angioplasty yielded 29%, being significantly lower compared to that obtained by POBA. The overall restenosis rate with long lesions at small vessels was 53%. With those lesions there was no significant difference among the devices. The overall restenosis rate with short lesions at large vessels was 27%, with CB angioplasty it was 24%, with the PS stent it was 22%, and with DCA it was 25%. These restenosis rates were significantly lower compared to POBA. With long lesions at large vessels, the overall restenosis rate was 44%. In this subgroup, there was again no significant difference among the devices. Our study suggests that restenosis rates with short lesions are lower after CB angioplasty, stenting, and DCA, when compared to POBA. However, in the presence of long lesions, no difference was found among the devices.     

普通球囊与切割球囊成形术对冠状动脉支架内再狭窄的近远期疗效

目的　对切割球囊成形术 (CBA)与普通球囊成形术 (POBA)支架内再狭窄病变的近远期血管造影结果比较 ,评价 CBA对支架内再狭窄病变的有效性。方法　 37例 ,共 39处病变 ,2 3处进入 CBA组 ,16处进入 POBA组。分别比较术后即刻及远期定量冠状动脉造影最小血管径 (ML D)、狭窄度 (DS)、再狭窄率、即刻管腔获得 (AL G)、即刻血管弹性回缩 (AR)及弹性回缩率 (ARR)。结果　术后即刻 ML D、DS、AL G两组差异无显著性。 CBA组最大扩张压、AR及 ARR均较 POBA组低 (P<0 .0 5或 P<0 .0 0 1)。随访造影结果 ,CBA组 ML D明显大于 POBA组 (P<0 .0 5 ) ;DS及再狭窄率均小于 POBA组 (P<0 .0 1)。结论　 CBA组的低压扩张治疗支架内再狭窄病变是有效的 ,对血管损伤小于 POBA,且获得较 POBA低的再狭窄率 ,值得进一步探讨     

Hemostatic and fibrinolytic activation is less following cutting balloon angioplasty of the coronary arteries

Recent studies have shown that percutaneous coronary intervention (PCI) activates systemic hemostatic activity, reflecting platelet activation and thrombin formation in the coronary arteries. The present study compared systemic levels of hemostatic markers induced by plain old balloon angioplasty (POBA), coronary stenting (STENT), and cutting balloon (CB) angioplasty. Sixty-one patients with stable angina pectoris, who underwent elective PCI or diagnostic coronary angiography (CAG) alone, were investigated. Patients who underwent PCI were divided into the POBA group (n = 11), the STENT group (n = 27), and the CB group (n = 11). Patients who underwent CAG alone were assigned to the CAG group (n = 12). Blood samples were collected before, 24 hours after, and 3 days after PCI or CAG. Plasma concentrations of prothrombin fragment 1+2 (F1+2), fibrinopeptide A (FPA), thrombin-antithrombin III complex (TAT), and plasminogen activator inhibitor-1 (PAI-1) were measured. In the CB group, the F1+2 (1.23 +/- 0.4 nmol/L) level 3 days after PCI was significantly smaller than that of the POBA group (2.37 +/- 0.5 nmol/L) (P < 0.05). The FPA (1.81 +/- 0.9 ng/mL), TAT (3.36 +/- 1.2 ng/mL) and PAI-1 (23.0 +/- 4.1 ng/mL) levels in the CB group 3 days after PCI were significantly smaller than those of the POBA group (P < 0.05, respectively) and STENT group (P < 0.05, respectively), but similar to the CAG group. Systemic hemostasis is activated to a greater extent after POBA and stenting than it is after CB angioplasty of the coronary arteries. This may contribute to the favorable long-term outcome of CB angioplasty.     

Bioresorbable vascular scaffold for coronary in-stent restenosis: A novel concept

The management of patients with significant in-stent restenosis (ISR) with drug-eluting stent is still not well defined. Various treatment modalities include plain old balloon angioplasty (POBA), metallic stent, cutting or scoring balloon and drug-eluting balloon (DEB). Bioresorbable vascular scaffold (BVS) is the latest technology for the treatment of de novo coronary artery lesions. The use of BVS in ISR is based on the rationale of local drug delivery as achieved by DEB without the permanent bi-layer of metal and also stabilizes dissection flaps and prevents acute recoil as provided by metallic stent. To the best of our knowledge this is the first case report of the use of BVS in patient with ISR.     

Effectiveness of a sirolimus-eluting stent (Cypher) for diffuse in-stent restenosis inside a bare metal stent

We estimated the benefit of a sirolimus-eluting stent (SES, Cypher) for diffuse (> 10 mm) in-stent restenosis (ISR) inside bare metal stents (BMS) because the feasibility of the SES was not confirmed after its recent approval in Japan. Clinical and angiographic outcomes after SES implantation to 93 diffuse ISR were compared with those of 3 groups treated by plain old balloon angioplasty (POBA, (n = 54)), cutting balloon angioplasty (CB, (n = 24)), and BMS (n = 41) in a series of 153 patients whose follow-up quantitative coronary angiography (QCA) evaluated 3-9 months after the treatments was obtained from January 2003 through December 2005. For 33 lesions in the SES group, 12-month follow-up QCA results were obtained and compared with those at 6 months. Ticlopidine (200 mg/day) was prescribed for at least 12 weeks after SES implantation and for 2 weeks after BMS in addition to aspirin (81-100 mg/day). Patient characteristics and the characteristics of previous implanted BMS in the SES group were not significantly different from those in the other groups. Death from cardiac causes and nonfatal myocardial infarction did not occur in any group. Stent thrombosis was not observed in the BMS and SES groups. The incidence of repeat target lesion revascularization (re-TLR) in the SES group (3.23%) was significantly lower compared with that of the POBA (37.0%), CB (25.0%), and BMS (29.3%) groups (P < 0.001, respectively). Late loss in the SES group (0.44 +/- 0.41 mm) was significantly smaller than that in the BMS group (1.34 +/- 0.74 mm) (P < 0.05). The rate of recurrent ISR (re-ISR) in SES (5.38%) was significantly lower than that in POBA (46.3%), CB (41.7%), and BMS (46.3%) (P < 0.001, respectively). The QCA variables at 6 months in the SES group were not significantly different from those at 12 months. Thus, SES implantation for diffuse ISR was far superior since it markedly reduced the incidence of re-TLR with re-ISR at up to 6-months follow-up. In addition, this angiographic patency after SES implantation continued until 12 months.     

切割球囊临床应用的有效性和安全性评价

目的 探讨切割球囊临床应用的安全性和有效性。方法 对131例患者142处狭窄病变进行切割球囊或切割球囊＋支架治疗。结果 142处狭窄病变行切割球囊治疗中4次失败，成功率为97.2%。切割球囊治疗支架内再狭窄、开口部病变、分叉病变和小血管弥漫性病变以及其他类型病变各为69处、16处、19处、7处和27处，7例切割球囊扩张后发生内膜撕裂，均为A型夹层，发生率为5.3%，术中无死亡和急性心肌梗死及其他严重血管并发症发生。失败原因与病变严重钙化以及切割球囊不能达到或通过狭窄部位有关。结论 切割球囊临床应用是安全面有效的。     

切割球囊血管成形术的作用机制及其在冠心病治疗中的应用

经皮腔内冠状动脉成形术后急性冠脉综合征和再狭窄等并发症是困扰冠心病介入治疗效果多年的难题 ,切割球囊血管扩张术是为解决这一难题出现的众多新技术中的一种。作者就切割球囊的结构、作用机制和临床应用等作一简要综述     

Safety and efficacy of cutting balloon angioplasty: the Mayo Clinic experience

A number of evolving clinical indications for cutting balloon angioplasty (CBA) have been described in the clinical literature, including angioplasty-resistant stenoses, in-stent restenosis, ostial lesions and small vessel disease. METHODS: We analyzed the Mayo Clinic PTCA registry and report procedural and in-hospital clinical outcomes in 100 patients (103 procedures, 114 lesions) undergoing CBA. RESULTS: CBA was successfully completed in 109 lesions (96%). The majority of lesions (73%) required additional treatment with either balloon angioplasty (39%) or stent implantation (34%). Severe intimal dissection resulting in at least 50% luminal obstruction occurred in 13 lesions (11%). A single incident of branch occlusion was documented, resulting in ST elevation myocardial infarction. There were no incidents of vessel perforation, urgent percutaneous or surgical target vessel revascularization, or in-hospital death. CONCLUSION: CBA is feasible and safe, with a low incidence of procedural complications and in-hospital adverse cardiac events when used primarily for in-stent restenosis.     

Self-expanding coronary stent (Radius) implantation with cutting balloon angioplasty

To evaluate the effect of cutting balloon (CB) angioplasty on the outcome of self-expanding coronary stent implantation, we compared the results of Radius stent implantation using two predilation strategies. Seventy de novo lesions in 70 patients (60 men) were included in the study. Stenting was performed after conventional angioplasty (n = 38, group 1) or CB angioplasty (n = 32, group 2). In-stent restenosis (ISR) rates of each group were 39 and 10% at 6-month follow-up (p = 0.02). Major adverse cardiac events occurred in 20 and 11%, respectively (p = 0.25). Multivariate analysis revealed that ISR was predicted only by lesion length > or = 20 mm. In conclusion, CB angioplasty did not reduce ISR after Radius stent implantation, when other independent risk factors, such as lesion length, were taken into consideration.     

Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty: Insights From the PEPCAD-DES Study (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter)

ObjectivesThe intention this PEPCAD-DES (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter) study update was to demonstrate the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in patients with DES-ISR at 3 years.BackgroundIn the PEPCAD-DES trial late lumen loss and the need for repeat target lesion revascularization (TLR) was significantly reduced with PCB angioplasty compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent in-stent restenosis (DES-ISR) at 6 months. We evaluated whether the clinical benefit of reduced TLR and major adverse cardiac events (MACE) was maintained up to 3 years.MethodsA total of 110 patients with DES-ISR in native coronary arteries with reference diameters ranging from 2.5 mm to 3.5 mm and lesion lengths ≤22 mm were randomized to treatment with either PCB or POBA in a multicenter, randomized, single-blind clinical study. With a 2:1 randomization, 72 patients were randomized to the PCB group and 38 patients to the POBA group. At baseline, there were lesions with at least 2 stent layers in PCB (52.8%, 38 of 72) and POBA (55.3%, 21 of 38) patients.ResultsAt 36 months, the TLR rates were significantly lower in the PCB group compared with the POBA control group (19.4% vs. 36.8%; p = 0.046). Multiple TLRs in individual patients were more frequent in the POBA group compared with the PCB group (more than 1 TLR: POBA, 13.2%; PCB, 1.4%; p = 0.021). The 36-month MACE rate was significantly reduced in the PCB group compared with the POBA group (20.8% vs. 52.6%, log-rank p = 0.001).ConclusionsPCB angioplasty was superior to POBA for the treatment of DES-ISR patients in terms of MACE and TLR for up to 36 months. There was no late catch-up phenomenon. (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter [PEPCAD-DES]; NCT00998439)     

Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial

The cutting balloon (CB) is a specialized device designed to create discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Such controlled dilatation theoretically reduces the force needed to dilate an obstructive lesion compared with standard percutaneous transluminal coronary angioplasty (PTCA). We report a multicenter, randomized trial comparing the incidence of restenosis after CB angioplasty versus conventional balloon angioplasty in 1,238 patients. Six hundred seventeen patients were randomized to CB treatment, and 621 to PTCA. The mean reference vessel diameter was 2.86 +/- 0.49 mm, mean lesion length 8.9 +/- 4.3 mm, and prevalence of diabetes mellitus in patients was 13%. The primary end point, the 6-month binary angiographic restenosis rate, was 31.4% for CB and 30.4% for PTCA (p = 0.75). Acute procedural success, defined as the attainment of <50% diameter stenosis without in-hospital major adverse cardiac events, was 92.9% for CB and 94.7% for PTCA (p = 0.24). Freedom from target vessel revascularization was slightly higher in the CB arm (88.5% vs 84.6%, log-rank p = 0.04). Five coronary perforations occurred in the CB arm only (0.8% vs 0%, p = 0.03). At 270 days, rates of myocardial infarction, death, and total major adverse cardiac events for CB and PTCA were 4.7% versus 2.4% (p = 0.03), 1.3% versus 0.3% (p = 0.06), and 13.6% versus 15.1% (p = 0.34), respectively. In summary, the proposed mechanism of controlled dilatation did not reduce the rate of angiographic restenosis for the CB compared with conventional balloon angioplasty. CB angioplasty should be reserved for difficult lesions in which controlled dilatation is believed to provide a better acute result compared with balloon angioplasty alone.     

Comparison of cutting balloon vs stenting alone in small branch ostial lesions of native coronary arteries.

Angioplasty of small vessels is associated with a higher rate of restenosis, even in the ostium. The present study compared the acute, late results of cutting balloon vs those of stenting alone in small branch ostial lesions of native coronary arteries and the effect on the parent vessel. The study group comprised 61 patients with successful angioplasty of smaller branch ostial lesions in native coronary arteries. The reference vessel diameter was between 2.5 and 3.0 mm. Patients were divided into 2 groups: group I (cutting balloon, n=30) and group II (stenting alone, n=31). After intervention, patients in group II achieved significant acute lumen gain, larger minimal lumen diameter (MLD) and less diameter stenosis. At 3-month follow-up, the MLD and diameter stenosis of the 2 groups were almost identical; however, late loss was lower in group I. At the 6-month follow up, the cumulative restenosis rate was 41% (11/27) in group I compared with 63% (19/31) in group II (p=0.05), and the target lesion revascularization was also lower in the cutting balloon group [29% (8/27) vs 53% (16/30) p=0.05]. In group 1, the MLD of the parent vessel did not change before, after cutting balloon or at follow-up. In contrast, there were significant reductions in parent vessel MLD following stenting alone and at follow-up. Plaque shift did not occur in the cutting balloon group. Cutting balloon angioplasty is a feasible approach for the treatment of small branch ostial lesions and does not cause significant narrowing of the parent vessel.     

Local delivery of argatroban for the prevention of restenosis after coronary balloon angioplasty: a prospective randomized pilot study.

BACKGROUND: Effective pharmacological prevention of restenosis using the systemic administration of various drugs that were effective for the prevention of restenosis in experimental studies has not been reported. The purpose of this study was to evaluate whether the local delivery of a potent thrombin inhibitor, argatroban, using a local drug delivery device would prevent restenosis after plain old balloon angioplasty (POBA). METHODS AND RESULTS: Seventy patients with chronic coronary artery disease requiring POBA were randomly assigned to wither the control group (n=35) or the argatroban group (n=35). In the argatroban group, argatroban was administered intravenously for 30 min before the POBA and intracoronarily into the dilated site using a Dispatch catheter immediately after the POBA, followed by a postoperative intravenous infusion for 4 h. The angiographical lesion restenosis and clinical restenosis rates at follow-up were significantly lower in the argatroban group (27% and 14%) than in the control group (56% and 37%; p=0.02 and p=0.03, respectively). There was no major complication during the procedure. CONCLUSION: The local delivery of argatroban is safe and effective in preventing restenosis after balloon angioplasty.     

Effect of intracoronary stenting on intimal dissection after balloon angioplasty: results of quantitative and qualitative coronary analysis

The effect of the Palmaz-Schatz stent on the angiographic appearance and residual luminal stenosis in patients with intimal dissection after balloon angioplasty was evaluated in 84 consecutive patients (90 lesions). Coronary angiography was performed before angioplasty, after conventional angioplasty and after stent implantation. The degree of intimal disruption was assessed as follows: grade 0, no dissection; grade 1, simple dissection (intraluminal linear defect or extraluminal cap extravasation); or grade 2, complex dissection (nonlinear spiral defect or luminal defect with multiple irregular borders). Quantitative coronary analysis of digitized cineangiograms was performed with use of a computerized automatic edge detection algorithm. After balloon angioplasty, 31 (34%) of 90 lesions demonstrated intimal dissection (18 simple, 13 complex). After stent implantation, intimal dissection improved by greater than or equal to 1 grade in 29 (94%) of the 31 lesions with 27 (87%) reduced to grade 0 (that is, no dissection). Dissection grade improved after stenting in 16 (89%) of 18 simple dissections and in all 13 complex dissections. Mean diameter stenosis was 77 +/- 17% before angioplasty, 47 +/- 17% after angioplasty and 14 +/- 10% after stenting (before angioplasty vs. after angioplasty and after angioplasty vs. after stenting, p less than 0.0001). In conclusion, intracoronary stenting is effective in reducing the residual luminal stenosis and in improving the angiographic appearance of intimal dissections after conventional balloon angioplasty.     

Comparison of Angiographic and Clinical Outcome After Cutting Balloon and Conventional Balloon Angioplasty in Vessels Smaller than 3 mm in Diameter: A Randomized Trial

OBJECTIVES: The purpose of the study was to evaluate and compare the immediate and six month follow-up angiographic and clinical outcome of cutting balloon angioplasty and conventional balloon angioplasty in small vessels (less than 3 mm in diameter). METHODS AND RESULTS: Between August 1995 and August 1996 a total of 71 eligible symptomatic patients with angiographically proven significant lesions in their coronary arteries smaller than 3 mm and requiring revascularization, were randomized to receive treatment by either cutting balloon angioplasty (CB) or conventional balloon angioplasty (BA). òStand-aloneó CB was performed on 51 lesions in 36 patients and BA on 47 lesions in 35 patients. Basic angiographic and clinical characteristics were similar in both groups. The overall procedural success rates for CB and BA groups were 92% and 97%, respectively. The immediate post-procedural minimal luminal diameter, residual stenosis and acute gain were similar in the CB and BA cohorts (1.93 +/- 0.36 mm, 24 +/- 12%, 1.18 +/- 0.45 mm vs. 2.01 +/- 0.34 mm, 22 +/- 9%, 1.26 +/- 0.35 mm, respectively). Total dissection rate and C-F dissections were fewer in the CB group (37%, 6% vs. 51%, 19%, respectively, p < 0.05). Six month follow-up angiographic restenosis rate was lower in the CB group (27% vs. 47%, p < 0.05). We also detected a significant difference of total number of all events at nine month clinical follow up (28% vs. 51%, p < 0.05). CONCLUSION: CB angioplasty can be performed with a comparable success rate to conventional BA in small vessels. Fewer bail-out procedures are needed as CB causes fewer and less severe dissections. There is also a significant reduction in six month restenosis rate. We suggest that CB might be a better option for revascularizing vessels smaller than 3 mm in diameter which are inherently more prone to immediate complications and late restenosis with BA.     

Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World

ObjectivesThis study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice.BackgroundA recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices.MethodsA retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed.ResultsOverall, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 ± 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007).ConclusionsIn this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.     

Cutting balloon angioplasty for treatment of calcified coronary lesions.

The aim of the study was to evaluate the feasibility, safety, and efficacy of cutting balloon angioplasty in treatment of angiographically moderate and severe calcified coronary lesions. Thirty-seven calcified coronary lesions (29 patients) detected by angiography were dilated with cutting balloon. Predilatation with plain balloon was performed in 27 (73.0%) lesions and stent was implanted in 23 (62.2%) lesions following cutting balloon. Acute gain following cutting balloon in predilated lesions was compared to the acute gain following plain balloon predilatation. For predilated lesions, acute gain after cutting balloon was significantly greater compared with plain balloon predilatation (1.51 +/- 0.49 vs. 0.77 +/- 0.42; P = 0.01). This result was achieved with larger size and lower pressure of cutting balloon compared with plain balloon (3.28 +/- 0.46 vs. 2.94 +/- 0.55, P = 0.01; 10.38 +/- 1.64 vs. 13.19 +/- 3.63, P = 0.001, respectively). The final gain following cutting balloon dilatation was significantly higher than the expected gain obtained by using a plain balloon of the same size (1.51 +/- 0.49 vs. 0.93 +/- 0.48; P < 0.0001), which was inflated at significantly higher pressure compared with cutting balloon. When we compared acute gain following cutting balloon in lesions with and without predilatation, we found no significant difference (P = 0.31). Angiographic success was achieved in 36 (97.3%) lesions and procedural success in 33 (89.1%) lesions. In-hospital major adverse cardiac event (MACE) occurred in three (10.3%) patients. Follow-up MACE was reported from three (10.3%) patients. In conclusion, cutting balloon angioplasty is feasible and safe in treatment of angiographically moderate and severe calcified lesions. Dilating efficiency of cutting balloon seems to be greater compared with a plain balloon of the same size, which was inflated at significantly higher pressure compared with cutting balloon. These results can be achieved with low in-hospital MACE and are associated with a good long-term outcome.