scholarly journals Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry)

2021 ◽  
Author(s):  
Wojciech Wańha ◽  
Jacek Bil ◽  
Rafał Januszek ◽  
Natasza Gilis-Malinowska ◽  
Tomasz Figatowski ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Death ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Target Vessel ◽  
End Point ◽  
Stent Restenosis ◽  
Drug Eluting ◽  
In Stent Restenosis

Background: Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis. Methods: Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%). Results: Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41–0.83], P =0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45–0.84], P =0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50–0.94], P =0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55–1.51], P =0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55–1.36], P =0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58–1.42], P =0.667) between the thin-DES and DEB group, respectively. Conclusions: This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04415216.

Abstract 17459: Drug Eluting Balloon Angioplasty is a Safe Treatment Option for In-stent Restenosis: Meta-analysis of Current Evidence

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Sainath Gaddam ◽  
Bhavi Pandya ◽  
Mustafain Meghani ◽  
Vratika Agarwal ◽  
Armaghan Soomro ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Current Evidence ◽  
Stent Restenosis ◽  
Number Of Patients ◽  
Drug Eluting ◽  
Drug Eluting Balloon ◽  
Plain Old Balloon Angioplasty ◽  
In Stent Restenosis

Introduction: Drug eluting balloons (DEB) were recently approved by FDA for peripheral artery interventions only. For coronary in-stent restenosis (ISR), the ACC/AHA/SCAI 2011 PCI guidelines have no recommendations on role for DEB. While ESC/EACTS 2010 PCI guidelines, have level IIa recommendation for DEB for ISR after a bare metal stent. The drug delivery kinetics with DEB allows shorter duration of dual anti-platelet therapy and has a potential role in ballooning side branches of a bifurcating lesion after stenting. Aim: To compare safety and efficacy of DEB angioplasty vs. plain old balloon angioplasty (BA) or drug eluting stent (DES) for treating coronary ISR. Methods and Results: A thorough search was performed on Pubmed, Embace and Google scholar databases for randomized control trials (RCT) comparing DEB vs. BA or DES for ISR. We compared target lesion revascularization (TLR) and MACE events for these groups. We also pooled data from registries and observation studies on DEB for outcome analysis. Total number of patients with DEB’s in our study was 3465, with 693 DEB’s in 8 RCT’s. Mean follow up period was 11 months. Pooled analysis showed significant benefit for DEB compared to plain old BA, for events of target lesion revascularization (OR= 0.25, p<0.0001), and death (OR=0.31, p<0.0001). Comparing DEB to DES, there was no statistical difference in outcomes comparing TLR (OR=1.4, p=0.14), MI or death (OR=0.65, p=0.39). Cumulative incidence of target lesion revascularization (TLR) with DEB was 6.7%. Conclusions: For coronary ISR, drug eluting balloon angioplasty is superior to plain old balloon angioplasty in terms of safety and outcomes. However, comparing drug eluting balloons vs. drug eluting stents in ISR, the outcomes are comparable and will need larger studies powered to make definitive recommendation.

scholarly journals Comparison of new-generation drug-eluting stents versus drug-coated balloon for in-stent restenosis: a meta-analysis of randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017231 ◽  
Author(s):  
Jin-Zan Cai ◽  
Yong-Xiang Zhu ◽  
Xin-Yu Wang ◽  
Christos V Bourantas ◽  
Javaid Iqbal ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Death ◽  
Meta Analysis ◽  
Drug Eluting Stents ◽  
Stent Restenosis ◽  
Drug Eluting ◽  
New Generation ◽  
Drug Coated Balloon ◽  
In Stent Restenosis

ObjectiveThe study sought to compare angiographic and clinical outcomes of new-generation drug-eluting stents (DES) versus drug-coated balloon (DCB) in patients with coronary in-stent restenosis (ISR).DesignMeta-analysis using data from randomised trial found by searches on PubMed, the Cochrane Library, ClinicalTrials.gov and websites of major cardiovascular congresses.SettingOnly randomised trials comparing DES with DCB were included.ParticipantsPatients with ISR in the included trials.InterventionsNew-generation DES versus DCB.OutcomesThe angiographic and clinical outcomes including cardiac death, all-cause death, myocardial infarction, target lesion revascularisation (TLR), target vessel revascularisation (TVR), major adverse cardiac events (MACE) and stent thrombosis were investigated.ResultsFive trials including 913 patients were eligible and included. Pooled analysis in angiographic results identified that new-generation DES were associated with higher acute luminal gain (−0.31 mm, 95% CI −0.42 to −0.20, P<0.001) and lower per cent diameter stenosis (risk ratio (RR): 0.28, 95% CI 0.02 to 0.55, P=0.04). DES significantly reduced the risk of TLR (RR: 1.96, 95% CI 1.17 to 3.28, P=0.01) compared with DCB; however, there was no statistical differences for MACE (RR: 1.21, 95% CI 0.67 to 2.17, P=0.53), myocardial infarction (RR: 1.16, 95% CI 0.55 to 2.48, P=0.69) and cardiac death (RR: 1.80, 95% CI 0.60 to 5.39, P=0.29).ConclusionsInterventions with new-generation DES appear to be associated with significant reduction in per cent diameter stenosis and TLR at short-term follow-up, but had similar MACE, myocardial infarction and cardiac death for patients with coronary ISR compared with DCB. Appropriately powered studies with longer term follow-up are warranted to confirm these findings.

scholarly journals The Predictors of Target Lesion Revascularization and Rate of In-Stent Restenosis in the Second-Generation Drug-Eluting Stent Era

2019 ◽  
Vol 2019 ◽  
pp. 1-13
Author(s):  
Chengbin Zheng ◽  
Jeehoon Kang ◽  
Kyung Woo Park ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  
Keyword(s):  
Target Lesion ◽  
University Hospital ◽  
Target Lesion Revascularization ◽  
Drug Eluting Stent ◽  
2Nd Generation ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Eluting ◽  
In Stent Restenosis

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).

scholarly journals Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer‐Generation Drug‐Eluting Stents

2021 ◽  
Author(s):  
Rayyan Hemetsberger ◽  
Mohammad Abdelghani ◽  
Ralph Toelg ◽  
Nader Mankerious ◽  
Abdelhakim Allali ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Target Vessel ◽  
Durable Polymer ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
Bioresorbable Polymer ◽  
Sirolimus Eluting Stent

Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare‐metal and first‐generation drug‐eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer‐generation drug‐eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable‐polymer sirolimus‐eluting stent or a durable‐polymer everolimus‐eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target‐lesion failure (TLF) (cardiac death, target‐vessel myocardial infarction, or target‐lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P =0.003) and stent thrombosis rates (2.1% versus 0.2%; P <0.0001), whereas target‐lesion revascularization was not different between the groups (5.0% versus 3.9%; P =0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89–2.08; P =0.148) but did for target‐vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03–2.68; P =0.037). TLF rates were similar between bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent (12.6% versus 15.4%, P =0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable‐polymer sirolimus‐eluting stent showed lower TLF (7.5% versus 10.3%, P =0.045). Conclusions With newer‐generation drug‐eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target‐vessel myocardial infarction was higher. The bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

scholarly journals Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study)

2019 ◽  
Vol 41 (38) ◽  
pp. 3715-3728 ◽  
Author(s):  
Daniele Giacoppo ◽  
Fernando Alfonso ◽  
Bo Xu ◽  
Bimmer E P M Claessen ◽  
Tom Adriaenssens ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Target Lesion ◽  
Drug Eluting Stent ◽  
Stent Restenosis ◽  
All Cause Mortality ◽  
Drug Eluting ◽  
In Stent Restenosis

Abstract Aims Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited. Methods and results The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02–1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58–1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71–1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53–1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80–2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments. Conclusions In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.

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