Long-Term Follow-Up After Treatment of Drug-Eluting Stent Restenosis and De Novo Lesions Using SeQuent Please Paclitaxel-Coated Balloons

Angiology ◽  
2018 ◽  
Vol 70 (5) ◽  
pp. 414-422
Author(s):  
Dai Zhang ◽  
Yan Sun ◽  
Xiaoli Liu ◽  
Fang Liu ◽  
Yujing Cheng ◽  
...  

Managing patients with in-stent restenosis (ISR) remains an important clinical challenge. In particular, large, randomized trials assessing the effect of drug-eluting balloons (DEB) in patients with de novo lesions are warranted. We investigated the effect of DEB on procedural complications, target lesion revascularization (TLR), and major adverse cardiac and cerebrovascular events in patients with drug-eluting stent ISR and de novo lesions. The clinical profiles of 238 consecutive patients treated for coronary ISR (n = 174) and de novo lesions (n = 64) using SeQuent Please paclitaxel-coated balloon were analyzed. Study end points were major adverse cardiac events (MACEs). At 1-year follow-up, TLR and MACEs occurred with acceptably low rates (5.0% and 6.3%, respectively). At 2.00 (0.74) years of follow-up, there was a significant difference in the rates of TLR between the ISR and the de novo lesions groups (14.4% [ISR] vs 3.1% [de novo], P = .028), and the occurrence of MACEs distinctly increased in the ISR group compared to the de novo lesions group (21.8% vs 6.2%, P = .009). The long-term outcomes of the ISR group were inferior to those of the de novo group (TLR, log-rank P = .019; MACEs, log-rank P = .010). Drug-eluting balloon for ISR and de novo lesions of small coronary vessels is effective and safe.

2019 ◽  
Vol 2019 ◽  
pp. 1-13
Author(s):  
Chengbin Zheng ◽  
Jeehoon Kang ◽  
Kyung Woo Park ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  

Objectives. The aim of our study was to investigate the predictors of target lesion revascularization (TLR) and to compare the in-stent restenosis (ISR) progression rates of different 2nd-generation drug-eluting stents (DES). Background. The predictors of early and late TLR after 2nd-generation DES implantation have not been fully evaluated. Methods. We analyzed 944 stented lesions from 394 patients who had at least two serial follow-up angiograms, using quantitative coronary angiography (QCA) analysis. The study endpoints were TLR and the velocity of diameter stenosis (DS) progression. Results. TLR occurred in 58 lesions (6.1%) during the first angiographic follow-up period and 23 de novo lesions (2.4%) during the following second interval. Independent predictors for early TLR were diabetes mellitus (DM) (HR 2.58, 95% CI 1.29–5.15, p=0.007), previous percutaneous coronary intervention (PCI) (HR 2.41, 95% CI 1.03–5.65, p=0.043), and postprocedure DS% (HR 1.08, 95% CI 1.05–1.11, p<0.001, per 1%), while predictors of late TLR were previous PCI (HR 9.43, 95% CI 2.58-34.52, p=0.001) and serum C-reactive protein (CRP) (HR 1.60, 95% CI 1.28-2.00, p<0.001). The ISR progression velocity (by DS%) was 12.1 ±21.0%/year and 3.7 ±10.1%/year during the first and second follow-up periods, respectively, which had no significant difference (p>0.05) between the four types of DESs. Conclusions. Our data showed that predictors for TLR may be different at different time intervals. DM, pervious PCI, and postprocedure DS could predict early TLR, while previous PCI and CRP level could predict late TLR. Contemporary DESs had similar rates of ISR progression rates. Trial Registration. This study was retrospectively registered and approved by the institutional review board of Seoul National University Hospital (no. 1801–138-918).


2013 ◽  
Vol 26 (3) ◽  
pp. 271-277
Author(s):  
BALAZS BERTA ◽  
ZOLTAN RUZSA ◽  
GYORGY BARCZI ◽  
DAVID BECKER ◽  
LASZLO GELLER ◽  
...  

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Eric Schampaert ◽  
Joachim Schofer ◽  
Guenther Breithardt ◽  
Eric A. Cohen ◽  
Michael Schlüter ◽  
...  

Background : NEW-SIRIUS is the pooled analysis of the E-SIRIUS (n=352) and C-SIRIUS (n=100) studies, respectively, performed in Europe and Canada. Identical in design, these are multicenter randomized, double-blind trials examining the safety and efficacy of the sirolimus-eluting stent (SES) vs. an identical bare-metal stent (BMS) in 452 patients to treat de novo native long lesions in small coronary arteries, with adjunctive clopidogrel for only 2 months. Methods : The primary endpoint was in-stent minimum lumen diameter (MLD) at 8-month follow-up. Among the secondary endpoints were major adverse cardiac events(MACE) at 1, 6, 9 and 12 months, and annually up to 5 years post-procedure, as well as target lesion revascularization (TLR), target vessel revascularization (TVR) and protocol-defined stent thrombosis. Results : At 8 months, the MLD was 2.27±0.47mm in the SES vs. 1.36±0.66 mm in the BMS (p < 0.001). The binary in-lesion restenosis rate was 5.1% in the SES vs. 44.2% in the BMS (p < 0.001). At 4 years, there was a significantly lower incidence of MACE (SES: 15.1% vs BMS: 33.9%, p < 0.001), primarily driven by a significant difference in clinically-driven TLR rates (SES: 7.1% vs. BMS: 26.0%, p < 0.001). A subgroup analysis in diabetic patients (45 SES, 60 BMS) demonstrated that the in-stent MLD was larger in SES than in BMS (2.20±0.47 vs 1.14±0.64 mm, p < 0.001) and the binary in-lesion restenosis rate was reduced from 56.1% (BMS) to 10.0% (RRR: 82.2%, p < 0.001) at 8 months. At 4 years, the freedom from MACE in diabetic patients was 80.0% in the SES vs. 61.7% in the BMS (p = 0.031), again mainly driven by an improved freedom from clinically driven-TLR (SES: 90.8% vs. BMS: 66.9%, p=0.005), with no evidence of a late catch-up effect. Conclusion : Up to 4 years, SES were superior to BMS in the total cohort as well as in the diabetic subgroup without evidence of a late catch-up. Five-year follow-up data, including antiplatelet therapies utilization and a diabetic subgroup analyses will be available by July 2007 and presented.


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Jung-Sun Kim ◽  
Byung Ho Lee ◽  
Jae-Deok Kim ◽  
Hyun-Soo Kim ◽  
Sungha Park ◽  
...  

Background : The aim of this study is to identify the association of hsCRP with neointimal plaque volume at 9 month follow-up IVUS after implantation of Sirolimus eluting stent (SES) and Paclitaxel-eluting stent (PES). Methods: A total of 127 patients (M:F = 78:49, age 62 ± 8 years), who underwent the elective coronary stenting for a de-novo lesion were prospectively enrolled and randomized according to type of stents (64 SES, 63PES). Infarct-related lesions within 7 days were excluded. Among them, hsCRP was serially measured in 104 patients (50 SES and 54 PES) at baseline, 48 hr after and 9 month follow-up after coronary stenting. IVUS was simultaneously performed at initial, after coronary stenting and 9 month follow-up. Neointimal volume index (neotintimal volume/stent length) at 9 month follow-up was obtained using INDEC system. Result : Baseline clinical, angiographic and IVUS parameters after stenting of both groups showed no significant differences. hsCRP was significantly increased at 48 hrs after coronary stenting but there was no significant difference between two groups (baseline: 2.9 ± 8.7 vs. 3.6 ± 7.6 mg/L, 48 hr: 10.7 ± 21.3 vs. 13.0 ± 15.3 mg/L, 9 month: 1.0 ± 1.6 vs. 1.2 ± 1.8 mg/L). At 9 month follow-up, SES showed a significantly lower neointimal volume index (0.22 ± 0.41 vs. 1.0 ± 0.9 mm 2 , p < 0.001) and lower tendency of in-stent restenosis [1 (2.2 %) vs. 6 (12.5 %), p = 0.111] than PES. Neointimal plaque volume at 9 month was significantly correlated with hsCRP at 48 hr (r= 0.426, p = 0.004) and increase of hsCRP between baseline and 48 hr (r = 0.512, p < 0.001). Also, higher increase of hsCRP between baseline and 48 hr (β = 0.469, p = 0.006) and PES (β = - 0.345, p = 0.024) were independently associated with increased neointimal volume index at 9 month follow-up after adjusting the clinical and angiographic parameters. Conclcusion: Increase of hsCRP at 48 hr after coronary stenting was significantly associated with neointimal volume in drug eluting stent (DES) era. Thus, control of acute inflammation after implantation of DES, especially PES might be beneficial for reducing neointimal plaque volume.


2010 ◽  
Vol 5 (6) ◽  
pp. 703-708 ◽  
Author(s):  
Francesco Tagliareni ◽  
Alessio La Manna ◽  
Francesco Saia ◽  
Antonio Marzocchi ◽  
Corrado Tamburino

2011 ◽  
Vol 18 (6) ◽  
pp. 654-661 ◽  
Author(s):  
Orhan Dogdu ◽  
Mikail Yarlioglues ◽  
Mehmet G. Kaya ◽  
Erol Tulumen ◽  
Bahadir Sarli ◽  
...  

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Higaki ◽  
K Nishioka ◽  
K Suruga ◽  
H Takemoto ◽  
T Nakano ◽  
...  

Abstract Background Drug-eluting stent restenosis (DES-ISR) is associated with poorer outcomes than those of bare-metal stent restenosis after treatment with paclitaxel-coated balloon (PCB), and late restenosis after PCB angioplasty for DES-ISR is a residual problem. Excimer laser coronary angioplasty (ELCA) is thought to be advantageous for ISR treatment by removing neointima. However, whether the combination of ELCA and PCB angioplasty is more effective than the use of PCB only angioplasty in DES-ISR has not been studied so far. Purpose We evaluated the efficacy of ELCA and PCB combination therapy for DES-ISR at mid-and late-term after revascularization. Methods From January 2014 to March 2016, 166 DES-ISR lesions were treated with ELCA and no-ELCA prior to PCB. Two serial angiographic follow-ups were planned for the patients (at 6–12 and 18–24 months after procedure). Acute procedural and follow-up angiographic results were assessed by quantitative coronary angiography. ELCA and no-ELCA group included 74 lesions and 92 lesions, respectively. Results There was no significant difference between the two groups in the clinical characteristics except the prevalence of hemodialysis, the rate of first-generation DES (37.9% vs 36.8%, p=0.897), previous stent size (2.90±0.39 mm vs 2.77±0.39 mm, p=0.063), and reference vessel diameter (2.65±0.46 mm vs 2.60±0.65 mm, p=0.593). Early follow-up angiography was performed in 66 lesions (89.1%) of ELCA group, and was done in 76 lesions (82.6%) of no-ELCA group. In the ELCA group, percentage diameter stenosis (%DS) just after procedure and at 6–12 months later were significantly smaller than those of no-ELCA group. Besides, target lesion revascularization (TLR) rate at 6–12 months after procedure was tended to be lower in the ELCA group. Late follow-up angiography was performed for 93 lesions (81.6%) of the remaining 114 lesions (excluding TLR lesion), late restenosis was found 9 lesions (18.6%) in the ELCA group and 11 lesions (24.4%) in the no-ELCA group (p=0.504). Late luminal loss was similar in both groups (0.37±0.71 mm vs 0.24±0.82 mm, p=0.438), and %DS at 12–18 months after revascularization was not different between the two groups. Changes of %DS and TLR rate Conclusions %DS in the ELCA group was smaller at just after procedure and the advantage was kept even after 1-year. However, late restenosis and TLR at 2-year after revascularization for DES-ISR could not be reduced by ELCA and PCB combination therapy.


2012 ◽  
Vol 6 ◽  
pp. CMC.S8959 ◽  
Author(s):  
Ibrahim Akin ◽  
Steffen Pohlmann ◽  
Christoph A. Nienaber ◽  
Hüseyin Ince

Calcified coronary lesions are challenging to deal with, as they require optimal lesion preparation. Direct stenting in this scenario is associated with risk of stent-underexpansion, which is related to in-stent restenosis, target lesion revascularization and stent-thrombosis. We report on the interventional management of an underexpanded bare-metal stent not amenable to high-pressure balloon dilation and cutting-balloon. By using rotablation we could abrade the underexpanded stent struts and the calcification with subsequent implantation of a drug-eluting stent. Follow-up of 6 months revealed good results without evidence of significant restenosis. Our clinical experience and case reports in the literature suggest that this strategy might be an option for underexpanded stents not amenable to conventional techniques.


Sign in / Sign up

Export Citation Format

Share Document