scholarly journals Percutaneous Mechanical Atherectomy Plus Thrombectomy Using the Rotarex®S Device Followed by a Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-stent Restenosis: A Prospective Single-Center, Single-Arm Efficacy Trial (PERMIT-ISR Trial)

2021 ◽  
Vol 8 ◽  
Author(s):  
Ming-Yuan Liu ◽  
Wenrui Li ◽  
Xiaobo Guo ◽  
Zhiwen Zhang ◽  
Bin Liu ◽  
...  
Keyword(s):  
De Novo ◽  
Ankle Brachial Index ◽  
Primary Patency ◽  
Secondary Patency ◽  
Single Center ◽  
Technical Success ◽  
Clinical Trial Registration ◽  
Technical Success Rate ◽  
Stent Restenosis ◽  
In Stent Restenosis

Background: Studies investigating debulking devices with drug-coated balloons (DCBs) in the treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) are limited. We aimed to evaluate the safety and midterm outcome of percutaneous mechanical atherectomy plus thrombectomy (MATH) using the Rotarex®S (Straub Medical, Wangs, Switzerland) catheter followed by a DCB in the treatment of FP-ISR.Methods: This study was a single-center single-arm trial. Patients with symptomatic (Rutherford category 2–5) de novo restenosis lesions of FP-ISR were treated with MATH and subsequent DCB. From June 2016 to May 2018, 59 patients with FP-ISR were enrolled. The primary endpoint was target lesion revascularization (TLR) and changes in the Rutherford category of the target limb at 12 months. Secondary endpoints included primary and secondary patency at 12 months, technical success rate, major adverse events, and ankle-brachial index (ABI). Risk factors for TLR were analyzed using Cox proportional hazard model.Results: The average follow-up time was 33 ± 8 months. The rate of technical success was 88.1% (52/59). Nine patients received bailout stenting. The rate of freedom from TLR was 84.7% (50/59) at 1 year, the Rutherford category changed at 12 months were significantly improved from baseline (p < 0.01). The primary patency rates and the secondary patency at the 12-month follow-ups were 82.5 and 92.5%, respectively. The ABI changed at 12 months were significantly improved from baseline (p < 0.01). Global limb anatomic staging system (GLASS) classification III [hazard ratio (HR) 18.44, 95% CI (1.57–215.99), p = 0.020] and postoperative Rutherford classification ≥4 [HR 8.28, 95% CI (1.85–37.06), p = 0.006] were identified as independent predictors of TLR.Conclusion: Our preliminary data suggested that MATH using a Rotarex®S catheter combined with DCB angioplasty is a safe, minimally invasive, and effective treatment for FP-ISR with favorable, immediate, and midterm outcomes.Clinical Trial Registration:http://www.chictr.org.cn, identifier [ChiCTR2000041380].

Rotational and aspiration atherectomy for infrainguinal in-stent restenosis

VASA ◽  
2013 ◽  
Vol 42 (2) ◽  
pp. 127-133 ◽  
Author(s):  
Ulrich Beschorner ◽  
Hans Krankenberg ◽  
Dierk Scheinert ◽  
Horst Sievert ◽  
Thilo Tübler ◽  
...  
Keyword(s):  
Ankle Brachial Index ◽  
Primary Patency ◽  
Study Endpoint ◽  
Primary Study ◽  
Lesion Length ◽  
Secondary Patency ◽  
Peripheral Vascular ◽  
Stent Restenosis ◽  
In Stent Restenosis

Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. Patients and methods: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex Results: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. Conclusions: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.

scholarly journals Comparison of Therapeutic Efficacy of Debulking Plus Drug-coated Balloon Angioplasty Versus Drug-coated Balloon Angioplasty Alone for Femoropopliteal Tosaka Class Iii in-stent Restenosis Lesions

2021 ◽  
Author(s):  
Liqiang Li ◽  
Zhu Tong ◽  
Shijun Cui ◽  
Lianrui Guo ◽  
Yongquan Gu
Keyword(s):  
Success Rate ◽  
Balloon Angioplasty ◽  
Primary Patency ◽  
Class Iii ◽  
Technical Success ◽  
Technical Success Rate ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Coated Balloon ◽  
In Stent Restenosis

Abstract Background: Femoropopliteal (FP) Tosaka Class III in-stent restenosis (ISR) Lesions remain a significant clinical problem and optimal revascularization management including the use of drug-coated balloon (DCB) and debulking devices have the potential to improve the outcomes for these patients. However, few studies have been published comparing the debulking plus DCB with DCB alone in Tosaka III FP-ISR treatment. This study was to compare debulking plus DCB versus DCB alone for the treatment of Tosaka III FP-ISR lesions in patients.Methods: This was a single-center retrospective study of patients Tosaka III FP-ISR who underwent endovascular interventions of debulking plus DCB or DCB alone for Tosaka III FP-ISR lesions. One-year primary patency was the main outcome. Other outcome measures are 12-month freedom from clinical-driven target lesion revascularization (f-CD-TLR), technical success rate, and periprocedural complications.Results: A total of 70 patients with Tosaka III FP-ISR were included; 29 were treated with debulking plus DCB, in which 13 were treated with laser atherectomy (LA) plus DCB and 16 were treated with rotational atherectomy (RA) plus DCB. 41 were treated with DCB alone. Lesions in the debulking plus DCB group were significantly longer (16.45±4.40mm vs. 14.04±3.67mm, p=0.015). the 12-month primary patency was not significant different in the comparison of debulking+DCB with DCB group (75.9% vs. 73.2%, p=0.798). in the subgroup comparison, no significant difference was found in the LA+DCB and RA+DCB group (69.2% vs. 81.3%, p=0.544). There were also no significant differences in the group and subgroup comparison of 12-month f-CD-TLR, technical success rate, and periprocedural complications.Conclusions: Debulking plus DCB or DCB alone are both safe and effective for Tosaka III FP-ISR lesions. Although no significant difference was seen, lesions in the debulking+DCB group were significantly longer, suggesting that debulking plus DCB treatment has possible superiority for longer lesions than DCB alone management.

Strecker Stents in the Femoropopliteal Arteries: Value of Duplex Ultrasonography in Restenosis Assessment

1995 ◽  
Vol 2 (2) ◽  
pp. 150-160 ◽  
Author(s):  
Alan E. Bray ◽  
Wei G. Liu ◽  
Warren A. Lewis ◽  
Catherine Harrison ◽  
Ann Maullin
Keyword(s):  
Ultrasound Imaging ◽  
Ankle Brachial Index ◽  
Duplex Ultrasound ◽  
Primary Patency ◽  
Secondary Patency ◽  
Stent Deployment ◽  
Stent Patency ◽  
Site Specific ◽  
Stent Restenosis ◽  
A Prospective Study

Purpose: Experience with Strecker stent implantation in the femoropopliteal arteries has been described; however, few of the reports were prospective studies, and none routinely used site-specific assessment methods for follow-up evaluation of stent patency. The purpose of this study was to evaluate 1-year Strecker stent patency using duplex ultrasound imaging to obtain a more precise delineation of stent restenosis than is possible with other noninvasive assessment modalities. Methods: A prospective study involved 52 patients with 57 sites treated by angioplasty and Strecker stent deployment in the femoropopliteal arteries. Assessment included clinical evaluation; ankle-brachial index (ABI) measurements at rest and after exercise; and duplex ultrasound imaging preprocedurally and at 3 and 12 months after the intervention. Results: All 74 stents were deployed successfully in the 35 occluded arteries and 22 stenotic lesions. Acute reocclusion occurred in 6 (10%). At 3 months, primary patency was 81% and secondary patency 84%. Mean (± SD) ABIs increased from 0.64 ± 0.15 at rest and 0.32 ± 0.17 after exercise to 0.89 ± 0.14 and 0.68 ± 0.23, respectively (p < 0.0001). At 12 months, primary patency was 79%, and secondary patency was 82%. Mean ABIs were 0.82 ± 0.15 at rest and 0.52 ± 0.22 after exercise at 12 months (p < 0.0001 compared with preprocedural ABIs). Analysis of the length of lesion treated showed better results with shorter diseased segments, but this was not statistically significant (p > 0.05). Better outcomes were also obtained when one stent was used rather than two stents at 12 months (p = 0.15), but there was no difference at 3 months (p = 0.3). Thirty-four percent of the stented segments progressed from < 20% stenosis at 3 months to > 50% stenosis at 12 months. Overall, 19 (43%) of 44 segments progressed from < 50% stenosis at 3 months to a > 50% stenosis at 12 months. Restenosis seen at 3 months generally was in the native artery just proximal or distal to the stent, but at 12 months, restenosis was mainly inside the stent. Conclusions: Strecker stents at 1-year demonstrated satisfactory patency in the femoropopliteal arteries when deployed for angioplasty salvage or recurrent disease. The 3- and 12-month evaluations obtained with duplex ultrasound provided site-specific hemodynamic data for stent assessment. Resting ankle pressures were a poor index of restenosis.

Rotational atherectomy with adjunctive balloon angioplasty in calcified chronic total occlusions of superficial femoral artery

Vascular ◽  
2020 ◽  
pp. 170853812097081
Author(s):  
Aysen Y Engin ◽  
Onur Saydam
Keyword(s):  
Balloon Angioplasty ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Primary Patency ◽  
Rotational Atherectomy ◽  
Secondary Patency ◽  
Technical Success ◽  
Technical Success Rate ◽  
The Mean ◽  
Drug Coated Balloon

Objectives The aim was to report the mid-term outcomes of Jetstream™ rotational atherectomy device in complex femoropopliteal lesions. Methods Between November 2016 and April 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned. Results Fifty-five patients who underwent endovascular treatment with rotational atherectomy for chronic total occlusive femoropopliteal lesions were included in the study. Technical success rate was 100%. The mean age was 63 (±10.5) years. The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers. The mean length of the lesions was 20.8 ± 11.2 cm. Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%). Thirty-three (60%) lesions were moderate or severely calcified. Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (POBA) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients. After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. The Kaplan–Meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%. No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and POBA as an adjunctive therapy, even though primary patency (83.3% vs. 61.3%, p = .06) and secondary patency (91.7% vs. 71%, p = .56) rates of drug-coated balloon angioplasty were slightly higher than POBA. Patients with claudication had better primary patency (90.5% vs. 58.8%, p = .001) and secondary patency (100% vs. 67.6%, p = .004) rates than patients with critical limb ischemia at 24 months. Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs. 88%, p = .007) and secondary patency (67% vs. 96%, p = .007). Six patients underwent unplanned amputation. There were eight (14.5%) mortalities during follow-up. Conclusions Rotational atherectomy with adjunctive balloon angioplasty has satisfactory technical success rates and mid-term outcomes. As an adjunctive method, there was no difference between drug-coated balloon angioplasty s and POBAs. Smoking cessation is always the first-step treatment to improve mid-term patency results. Patients with critical limb ischemia have worse patency results compared to the patients with claudication.

One-Year Results of ZBIS Iliac Branch Device With an Off-Label Connection Limb

2021 ◽  
pp. 152660282110547
Author(s):  
Jose Torrealba ◽  
Giuseppe Panuccio ◽  
Fiona Rohlffs ◽  
Thomas Gandet ◽  
Catharina Gronert ◽  
...  
Keyword(s):  
Primary Patency ◽  
Main Body ◽  
Secondary Patency ◽  
Technical Success ◽  
Technical Success Rate ◽  
Off Label ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
One Year

Purpose: The purpose of this article is to study 1-year results of Zenith branch iliac endovascular graft (ZBIS) with the off-label use of a 13 mm spiral Z limb to connect to the aortic main body. Materials and Methods: A retrospective review from 2015 to 2019 of all iliac branch devices (IBDs) was performed at 1 institution that were connected to an aortic main body with a 13 mm spiral Z limb and had at least 1-year follow-up with computed tomography (CT). Primary endpoints are freedom from ZBIS separation from the connection limb, endoleak (EL), or reintervention at 1 year. Secondary endpoints are primary and secondary ZBIS patency, presence of any EL, and aortic reinterventions. Results: Of 149 IBDs implanted in this period, 45 ZBIS in 35 patients were connected with a 13 mm limb and had a 1-year CT; 97% of patients had common iliac artery (CIA) aneurysms, 7% of patients had hypogastric artery (HA) aneurysms, and 30% of patients had bilateral ZBIS implantation. Technical success was 98%. In 84% of cases, the Advanta V12 was used as the HA mating stent; 56% of patients had an EL, mostly type II, which resolved spontaneously in 70% at 1 year, and 9% of ZBIS required reinterventions at 1 year (2 for thrombosis, 2 for type Ic EL from HA mating stent). One-year ZBIS primary patency and secondary patency were 96% and 100%, respectively. No EL was noted to be related to the 13 mm connection limb. No migration or separation of the devices occurred. Conclusions: The use of 13 mm spiral Z limb to connect a ZBIS with the main body in our series yields a high technical success rate and good 12-month outcomes without device separation or migration.

scholarly journals Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Isolated Popliteal Artery Lesions

2016 ◽  
Vol 24 (2) ◽  
pp. 181-188 ◽  
Author(s):  
Konstantinos Stavroulakis ◽  
Arne Schwindt ◽  
Giovanni Torsello ◽  
Arne Stachmann ◽  
Christiane Hericks ◽  
...  
Keyword(s):  
Popliteal Artery ◽  
Patency Rate ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Technical Success ◽  
Primary Patency Rate ◽  
Technical Success Rate ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

scholarly journals Drug-Coated Balloon for the Treatment of Femoropopliteal Tosaka Class III In-stent Restenosis Lesions

2021 ◽  
Vol 7 ◽  
Author(s):  
Bihui Zhang ◽  
Guochen Niu ◽  
Ziguang Yan ◽  
Yinghua Zou ◽  
Xiaoqiang Tong ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Ankle Brachial Index ◽  
Primary Patency ◽  
Lesion Length ◽  
Efficacy And Safety ◽  
Class Iii ◽  
Stent Restenosis ◽  
Drug Coated Balloon ◽  
In Stent Restenosis

Background: To date, there have been few studies examining the efficacy and safety of drug-coated balloon (DCB) angioplasty in the treatment of Tosaka class III in-stent restenosis (ISR) lesions in the clinical setting. Therefore, this study aimed to investigate the clinical efficacy and safety of DCBs in patients with Tosaka class III ISR femoropopliteal lesions.Methods: This single-center study enrolled 28 femoropopliteal ISR Tosaka III patients who were treated by DCB angioplasty from September 2016 to September 2018. The patency, the freedom from target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints were analyzed during a 14-month follow-up period.Results: Out of the 28 patients, 32.1% presented with critical limb ischemia. The mean lesion length was 250.4 ± 93.9 mm. Technical success was achieved in all lesions (100%). Debulking devices were used in 50% of lesions, and bailout stents were performed in 3.6% of patients. Kaplan Meier estimates that the 14-month primary patency was 79.2% (95% CI 60.6–97.8%), whereas the freedom from TLR rate was 91.5% (95% CI 80.1–100%). Clinical symptoms improved by at least 1 Rutherford category in 82.1% of limbs. The ankle-brachial index (ABI) values improved from 0.51 ± 0.30 to 1.05 ± 0.22 at the final follow-up (P &lt; 0.001). The rate of freedom from 30-day major adverse limb events (MALEs) was 100%. The mortality rate was 7.1%.Conclusion: These results suggested that the use of DCBs is safe and effective in treating femoropopliteal Tosaka class III ISR lesions.

Hybrid treatment of multilevel revascularization in patients with peripheral arterial disease – a multi-centre study in Korea

VASA ◽  
2018 ◽  
Vol 47 (3) ◽  
pp. 235-241 ◽  
Author(s):  
Soon Cheon Lee ◽  
Jin Hyun Joh ◽  
Jeong-Hwan Chang ◽  
Hyung-Kee Kim ◽  
Jang Yong Kim ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Combined Treatment ◽  
Ankle Brachial Index ◽  
Primary Patency ◽  
Limb Ischaemia ◽  
University Hospitals ◽  
Multi Centre Study ◽  
Free Survival ◽  
Technical Success Rate ◽  
Hybrid Treatment

Abstract. Background: Endovascular treatment is an alternative first-line management for peripheral artery disease (PAD). Hybrid treatment (HT) is defined as a combined treatment for patients with PAD using endovascular and open surgery, simultaneously performed in an operating room. The results of HT are reportedly good for multilevel revascularization (MR) in patients with chronic limb ischaemia, and even in older high-risk patients. The goal of this study was to examine the clinical and haemodynamic outcomes of HT in patients who need MR. Patients and methods: Nine university hospitals in Korea participated in this multicentre study. A total of 134 patients with multilevel PAD underwent HT and MR. Patients were enrolled from July 2014 to June 2015 and were followed for 18 months. Results: The mean age of the patients was 68.8 ± 9.93 years and 88.1 % were men. Patients with Rutherford category 2 to 3 and 4 to 6 comprised 59.0 % and 42.0 % of the group, respectively. The technical success rate was 100 %. The primary patency rates at 12 and 18 months were 77.6 % and 63.9 %, respectively. The primary-assisted patency rates at 12 and 18 months were both 90.0 %. The pre-operative mean ankle brachial index (0.43 ± 0.23) increased to 0.87 ± 0.23 at six months post-operatively (t-test, p < 0.05). The amputation free survival rate was 97.1 %. Conclusions: Although outcomes of multilevel PAD are reportedly poor when endovascular treatment alone is used, we have shown that HT is a feasible alternative modality for patients with multilevel PAD, with satisfactory amputation-free survival and freedom from re-intervention rates.

scholarly journals Safety and efficacy of the treatment of in-stent restenosis and de novo complex lesions with the novel paclitaxel-coated scoring balloon (Angiosculpt X)

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.P Agip Fustamante ◽  
S Ortiz Cruces ◽  
S Camacho Freire ◽  
A Gutierrez Barrios ◽  
A Gomez Menchero ◽  
...  
Keyword(s):  
Real World ◽  
Cardiac Death ◽  
De Novo ◽  
Funding Source ◽  
The Novel ◽  
Safety And Efficacy ◽  
Stent Restenosis ◽  
Scoring Balloon ◽  
In Stent Restenosis ◽  
Complex Lesions

Abstract Background The AngioSculpt X (Spectranetics) is a novel paclitaxel-coated scoring balloon with encouraging preliminary data for the treatment of in-stent restenosis or de novo complex lesions. Purpose To assess the safety and efficacy of real-world patients with in-stent restenosis (ISR) or de novo complex lesions (vessels &lt;2.5 mm, calcified lesions, bifurcation lesions...) treated with the novel paclitaxel-coated scoring balloon. Methods A “real-world”, prospective registry from two centers was performed including consecutive patients presenting with ISR or de novo complex lesions and treated with AngioSculpt X. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, stent thrombosis, nonfatal myocardial infarction, target lesion revascularization (TLR) and target vessel revascularization (TVR). Results Overall, 87 real-world patients and 93 lesions (73% male, 68±10 years, 46% smoker, 83% hypertensive, 62% diabetic, 71% hyperlipidemic, 35% LVEF &lt;60% impairment) were enrolled in the study. Clinical presentation was stable angina in 19%, unstable angina in 33%, NSTEMI in 29% and STEMI in 5%. Radial access account 84%. The median fluoroscopy time was 17 (IQ range 10,0 - 37.5) min. De novo complex lesions were treated in 35% (n=32) while ISR in 63% (n=57), (Prior BMS 19%; Sirolimus DES 9%; Everolimus DES 26%; Biolimus/Anfilimus DES 20%; Zotarolimus DES 26%) with a median time to ISR of 3.6 (IQ range 1.1 - 10.7) years. Total stent length was 28±18 mm, with an overlap spot affected in 18%, and 27% had &gt;1 treatment for ISR. The most frequent artery treated was left anterior descending (41%) followed by left circumflex (35%) and right coronary artery (17%). Quantitative coronary angiography reference diameter of lesions was 2.7±0.5 mm and length 9.0±4.8 mm, with a % stenosis of 75±20. Predilatation/postdilatation was performed in 60/24% respectively. Device diameter was 2.9±0.4 mm and length 13.6±3.9 mm, deployed at 16±3 atmospheres, with an inflation time of 33±16 seconds. The balloon/artery ratio was 0.99±0.03. Crossover was decided on 18 cases (19%) due to remaining intimal flap, but the success rate (residual stenosis &lt;30%) was 100%. Intracoronary imaging technique was performed in 12% (OCT=7, IVUS=4). At 7±6 month follow-up, there were 10 MACE (cardiac death=1, nonfatal myocardial infarction =4, TLR=4 and TVR=1). Conclusions Paclitaxel-coated scoring balloon offers a safe and valuable treatment option for ISR and de novo complex lesions. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Juan Ramόn Jiménez University Hospital

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