Aneurysm formation after drug‐eluting balloon treatment of drug‐eluting in‐stent restenosis: First case report

A 55‐year‐old male underwent paclitaxel‐eluting stent implantation in a bifurcation lesion of his left anterior descending artery (LAD) during an episode of unstable angina in 2008. A late in‐stent restenosis developed 15 months after implantation of the drug‐eluting stent (DES) and was treated with paclitaxel eluting balloon. Two months later, during angiography for functional assessment of the significance of lesions in the circumflex artery, an aneurysm at the place of drug‐eluting balloon (DEB) inflation was observed. The patient was left on double antiplatelet therapy and scheduled for clinical observation after 3 months and control coronary angiography after 6 months for aneurysm progression follow‐up. © 2012 Wiley Periodicals, Inc.     

Vascular brachytherapy for patients with drug-eluting stent restenosis

Background: The rate of drug‐eluting stent (DES) in‐stent restenosis (ISR) exceeds 10% in complex subsets of patients and lesions. The optimal management of DES ISR remains undetermined. Vascular brachytherapy (VBT) is proven to be effective for the treatment of bare metal stent ISR but its outcome for DES ISR has not been established. Methods: Ninety‐nine consecutive patients who presented with ISR following DES implantation in 122 lesions were subjected to conventional percutaneous coronary intervention with adjunct VBT using either beta radiation (Beta Rail in 74 patients [82.2%] and the Galileo system in 13 patients [14.4%]) or gamma radiation (Checkmate system in 3 patients [3.3%]). Patients were followed clinically for major adverse cardiac events (MACE) during 1‐year follow‐up. Results: A high proportion of patients in this cohort presented with complex ISR; 31.1% had recurrences of ISR to the same site, 55% had diffuse or proliferate pattern of restenosis, and 23 lesions (18.9%) were located in a saphenous vein graft. Procedural success and uneventful in‐hospital course were documented in all patients post VBT. At 12 months' follow‐up, the target lesion revascularization (TLR) rate was 11% and the overall MACE rate was 26%. Patients with multiple episodes of ISR to the same site had a TLR of 16% and MACE rate of 35.5%. Conclusions: VBT for the treatment of DES ISR was found to be effective and safe and should be considered for the treatment of DES ISR, in particular in complex patients with multiple recurrences.     

Assessment of Efficacy and Safety of Combining “Paclitaxel” Eluting Balloon and “Limus” Eluting Stent in the Same Lesion

Objectives

To assess the safety and efficacy of combining drug‐eluting balloon (DEB) and drug‐eluting stents (DES) in the same coronary lesion.

Background

Use of DEB may not always produce optimal results or even result in dissection, compelling the operators to consider bailout stenting with bare metal stents (BMS). However, BMS may not be ideal in patients who have significant risk‐profile for restenosis. We have opted for DES over BMS in such situations and present our follow‐up data.

Methods

Between 2009 and 2011, 46 patients (57 lesions) requiring bailout stenting following DEB use were treated with second‐generation DES. All patients had at‐least one or more risk‐factors that made them vulnerable for restenosis (diabetes, chronic kidney disease, previous in‐stent restenosis [ISR], and/or long diffuse lesions ≥30 mm).

Results

Of the 57 lesions, 34 (60%) were previous ISR. The mean length of the DEB was: 36.2 ± 5.6 mm. All patients had TIMI‐3 flow post PCI with no in‐lab complications. At median follow‐up of 12.3 months (interquartile range [IQR]: 7.5–18.1), the rates target lesion revascularization (TLR) and target vessel revascularization (TVR) were 3 (5.3%) and 4 (7%), respectively. One patient had died 3 months following treatment. There were no episodes of myocardial infarction, definite or probable stent thrombosis. The major adverse cardiovascular events (MACE) rate defined as cardiac‐death, MI, and TVR occurred in 11% of patients.

Conclusion

The results from this novel strategy of combining “Paclitaxel” eluting balloon and “Limus” eluting stent in a same lesion are encouraging. Dual drug‐elution acting on two different pathways may provide potential synergy that may explain the favorable outcome. (J Interven Cardiol 2013;26:259–263)

     

End of the bare metal stent era?

• Second‐generation drug eluting stents (2g‐DES) have lower rates of stent thrombosis (ST) than bare metal stents (BMS).
• Second‐generation DES have exceedingly low rates of very late ST, significantly improving on first‐generation drug eluting stents (1g‐DES) and similar to BMS.
• Emerging drug‐coated stent (DCS) technology appears superior to BMS in patients unable to tolerate prolonged dual antiplatelet therapy (DAPT).

     

One-year outcomes with angiographic follow-up of paclitaxel-eluting balloon for the treatment of in-stent restenosis: insights from Spanish multicenter registry

Introduction: Even in the drug‐eluting stent (DES) era treatment of in‐stent restenosis (ISR) is still a relatively common problem for which a satisfactory solution is yet to be found. We wished to assess the efficacy of a new paclitaxel‐coated drug‐eluting balloon (DEB) in the treatment of these lesions. Methods: In this prospective multicenter registry 126 patients with ISR, treated with a new paclitaxel‐eluting balloon (3.0 μg/m² balloon surface area), were included. All lesions were predilated using conventional balloon angioplasty. The DEB was inflated for a minimum of 60 seconds. Dual antiplatelet therapy was recommended for at least 1 month. The only exclusion criteria were acute STEMI and cardiogenic shock. Results: Thirty‐three percent of patients were diabetic and 51% presented acutely. Interestingly, 48% had ISR of DES, 54% had ISR in a small vessel, and 29% involved bifurcation lesions. The pattern of ISR was focal in 59% and the most treated artery was the left anterior descending artery (LAD). Angiographic success was 96%. In 2 centers, repeat angiography was performed in 79% and restenosis observed in 6 patients (17.6%). MACE rate at a median of 12 (6–13) months was 16.7% (4.0% cardiac death, 4.0% MI, and 12.0% TLR). There was only 1 probable thombotic event (ARC). As compared with BMS‐ISR, patients with DES‐ISR were more often diabetic (40 vs. 28%) and had more re‐restenosis (TLR 14.8 vs. 9.2%). Conclusion: In a real‐world population, treatment of ISR (including 48% DES‐ISR) with this DEB provides good mid‐term results with 12% TLR at 1 year, especially in ISR pattern IC (9% MACE). (J Interven Cardiol 2011;24:518–528)     

Patient preferences prompt a peek at priorities

• Patients rate the downsides of bare metal stents (higher restenosis rates) as being of similar magnitude to the downsides of drug eluting stents (longer dual anti‐platelet therapy).
• Patient preferences regarding choice of bare metal versus drug eluting stents should be elicited before coronary stenting.
• This article does not study actual patient preferences for stent type. Future studies should assess how personalized discussions of trade‐offs of stent types affect patient preferences.

     

Comparison of Clinical Results Following the Use of Drug‐Eluting Balloons for a Bare‐Metal Stent and Drug‐Eluting Stent Instent Restenosis

Background

Drug‐eluting balloons (DEBs) have emerged as a potential alternative to current treatments of instent restenosis (ISR). The study aims to investigate the clinical outcomes of a DEB angioplasty to treat bare‐metal stent (BMS) ISR and drug‐eluting stent (DES) ISR at 1‐year clinical follow‐up period.

Methods

Between November 2011 and December 2014, 312 patients were diagnosed with coronary artery ISR at our hospital. A total of 426 coronary ISR lesions were treated with DEBs. The clinical outcomes, including target lesion revascularization (TLR), myocardial infarction, stroke, cardiovascular mortality, and all‐cause mortality were compared between the BMS‐ISR group and DES‐ISR group. Propensity score matched analysis was used to minimize bias.

Results

The average age of the patients was 64.99 ± 10.35 years, and 76.9% of the patients were male. After multivariate Cox regression analyses about 1‐year recurrent restenosis in DES‐ISR group, only end stage renal disease (ESRD) (P = 0.047) and previous DEB failure (P < 0.001) were identified with significant difference. After propensity score matched analysis, the bias of baseline characteristics showed no significant difference. The DES‐ISR group experienced more myocardial infarctions (2.8% vs 8.3%, P = 0.075), more TLR (8.1% vs 15.4%, P = 0.051), especially at nonostial lesion (5.7% vs 14.9%, P = 0.030) than the BMS‐ISR group. Higher incidence of major cardiac cerebral adverse events happened in the DES‐ISR group. (11.7% vs 22.1 %, P = 0.038)

Conclusion

During the 1‐year follow‐up period, DEBs angioplasty for BMS‐ISR had better clinical outcomes and less TLR than DES‐ISR. ESRD and previous DEB failure were associated to TLR in DES‐ISR group.

     

Paclitaxel‐eluting balloon: From bench to bed

Since the first clinical angioplasty by Gruntzig in 1977, restenosis has been the primary drawback of percutaneous coronary intervention (PCI). In the balloon era. restenosis was correlated with elastic recoil and negative remodeling of the arterial wall. Later, introduction of stents proved to be a significant advance in reducing the elastic recoil and negative remodeling at the treatment site but stimulated proliferation, migration of smooth muscle cells, and neointimal hyperplasia, thereby generating a new type of restenosis, in‐stent restenosis. Brachytherapy and drug‐eluting stents (DES) may be considered the two breakthroughs against neointimal hyperplasia. However, concerns about stent thrombosis and incomplete elimination of in‐stent restenosis with DES in complex lesions and patients justify the pursuit of research in this field. Non‐stent based local drug delivery and particularly the use of paclitaxel‐eluting balloons could be one of these strategies. We aimed to review the concept, preclinical‐, and clinical data available with non‐stent based local drug delivery and, in particular, with paclitaxel‐eluting balloons. © 2009 Wiley‐Liss, Inc.     

Duration of dual anti‐platelet therapy following drug eluting stents

• This meta‐analysis suggests that abbreviated DAPT (<6 months) could be considered in patients undergoing PCI with current generation drug eluting stents (DES).
• Extended DAPT strategy (>1 year) may be appropriate in those patients in whom prevention of stent and non‐stent‐related coronary events are likely to offset the bleeding complications.
• Additional randomized trials are needed to evaluate the optimum duration of DAPT in patients with the latest generation DES and current antiplatelet drugs.

     

Evaluation of re-endothelization extent at mid-term follow-up after drug eluting balloon plus bare metal stent implantation during primary coronary angioplasty: insight from OCT imaging

One quarter of patients with STEMI submitted to primary percutaneous coronary intervention (PCI) need repeated target vessel revascularization (TVR) because of stent restenosis or thrombosis. Introduction of DES has effectively reduced the incidence of these complications but the safety of this type of stent in the setting of AMI is limited due to the unpredictable risk of stent malapposition and vessel remodelling in the long term follow-up. Recently, treatment with drug eluting balloon (DEB) in association with bare metal stenting (BMS) has been reported to have an excellent efficacy and safety profile. However, little is known regarding the extent of stent coverage in BMS after DEB utilization.     

Leave nothing behind: Promising results for coronary drug‐coated balloons in clinical practice

• 1,025 patients with de novo coronary artery disease (66.9%) or in‐stent restenosis (ISR) (33.1%) underwent treatment with paclitaxel drug‐coated balloons in a multinational single‐arm registry. Bail‐out stenting rate was only 4.8%.
• One‐year target lesion revascularization was 2.3% for de novo lesions, 2.9% for bare metal stent ISR, and 5.8% for drug‐eluting stent ISR.
• Short‐term results with coronary drug‐coated balloons are promising. Nonetheless, long‐term data, preferably from randomized trials are necessary to confirm their safety and efficacy.

     

Implantation of everolimus‐eluting bioresorbable scaffolds in a diabetic all‐comers population—the future is now?

• This article describes a single‐center experience of Everolimus‐eluting bioresorbable scaffolds as an alternative to drug eluting stents in diabetic patients with various presentations of coronary artery disease.
• The results suggest the possibility of a paradigm shift for treatment in this population as ultimately no metallic remains are left to act as a nidus for inflammation.
• The study suggests the benefits as well as technical limitations of the current bioresorbable scaffold (BRS) technology, such as increased strut thickness, decreased deliverability, and increase in major cardiovascular events compared to current drug eluting stent (DES) technology.

     

Markedly different tissue types on optical coherence tomography imaging in a patient with multiple lesion drug‐eluting stent in‐stent restenosis

The treatment of in‐stent restenosis after drug‐eluting stent (DES) implantation remains a major clinical challenge. Optical coherence tomography (OCT) imaging at the time of presentation can provide important information on mechanical factors contributing to stent failure as well as on tissue characteristics of the in‐stent neointimal tissue. We report a case of markedly different tissue types—characterized by heterogeneous and homogeneous signal intensity—observed in a patient with multiple lesion DES in‐stent restenosis. Although both lesions were initially successfully treated with drug‐coated balloon angioplasty, the patient presented with recurrent in‐stent restenosis in the lesion with homogeneous tissue characteristics. Future studies should evaluate whether OCT tissue characterization can guide optimal treatment strategy in patients with DES restenosis. © 2016 Wiley Periodicals, Inc.     

Application of transcatheter valves for aortic valve replacement in pediatric patients: A case series

• Diabetic patients are frequently affected by coronary artery disease (CAD) and are at increased risk of CAD‐related adverse events, even after drug‐eluting stent (DES) implantation. If currently available DES have similar safety and efficacy in diabetic and nondiabetic patients is still debated.
• This prospective, multicenter registry showed similar 3‐year outcome in patients undergoing different DES implantation, although diabetic patients, especially those requiring insulin treatment, had significantly higher risk of adverse events than nondiabetic patients.
• Specific efforts to improve the performance of DES in diabetic patients are mandatory to adequately address the unsolved issue of diabetic patients affected by CAD.

     

An intravascular ultrasound analysis of the mechanisms of restenosis comparing drug-eluting stents with brachytherapy

There are treatment failures after de novo drug-eluting stent (DES) implantation and after treatment with DESs or vascular brachytherapy (VBT) of in-stent restenosis (ISR) lesions. We studied 38 patients who presented with DES failure (26 patients after de novo DES implantation and 12 patients after DES treatment of ISR) and 30 patients who presented with VBT failure (all after treatment of ISR). Standard clinical data were collected and volumetric intravascular ultrasound was measured. Patients who presented with DES failures were 58.8 +/- 9.6 years of age and those who presented with VBT failures were 59.8 +/- 8.7 years of age; 60.5% of DES and 58.6% of VBT failures were in men; 31.5% of DES failures and 46.6% of VBT failures occurred in diabetic patients; and times to presentation were 210 +/- 101 days in DES failures and 510 +/- 527 days in VBT failures (p = 0.001). Minimal stent area was significantly larger in VBT than in the 2 DES failure groups (de novo DES implantation and DES treatment of ISR, p <0.0001); this was associated with more neointimal hyperplasia in VBT failures (p <0.0001). After it was normalized to stent length, intimal hyperplasia was diffusely distributed in VBT failures; conversely, DES failures were associated with less intimal hyperplasia and the intimal hyperplasia was mostly focal, with greater accumulation in the proximal and mid segments. In conclusion, VBT failures were caused by significant, recurrent, and diffuse intimal hyperplasia in the setting of adequate stent expansion, whereas DES failures were caused by only modest, but focal, intimal hyperplasia in the setting of DES underexpansion.     

Angiographic and intravascular ultrasound follow up of paclitaxel‐ and sirolimus‐eluting stent after poststent high‐pressure balloon dilation: From the poststent optimal stent expansion trial

Objectives : The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug‐eluting stent (DES) and compare paclitaxel‐eluting stent (PES) to sirolimus‐eluting stent (SES). Background : Although poststent high‐pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES. Methods : Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9‐month follow‐up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in‐stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months. Results : At 9‐month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm²) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm² and 0.21 ± 0.37, P < 0.001 in PES and SES]. Conclusions : OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high‐pressure balloon dilatation. © 2010 Wiley‐Liss, Inc.     

冠状动脉支架置入术后不同类型支架再狭窄形式分析

目的通过分析冠状动脉支架置入后造影复查的影像资料,寻找不同支架再狭窄的特点。方法入选行冠状动脉病变介入治疗后造影复查的846处病变,对再狭窄病变行再狭窄形式分析。结果裸支架和药物支架再狭窄中支架近端局限性再狭窄分别占5.69%和33.67%(P=0.000),而支架内弥漫性再狭窄分别占29.27%和9.18%(P=0.000),弥漫性狭窄累及支架两端的分别为20.33%和6.12%(P=0.003),闭塞性再狭窄发生率分别为9.76%和10.20%(P=0.912)。雷帕霉素及其衍生物释放支架和紫杉醇释放支架再狭窄支架边缘局限性再狭窄分别为47.06%和25.00%(P=0.037),支架内弥漫性狭窄分别为1.96%和16.67%(P=0.018)。结论药物支架改变了支架再狭窄模式,弥漫型转为局限型;闭塞性再狭窄时药物支架以支架近端闭塞为主,裸支架以支架内闭塞为主;紫杉醇药物释放支架弥漫性再狭窄发生率较雷帕霉素释放支架有所增加。     

A completely fractured zotarolimus‐eluting stent in an aortocoronary saphenous vein bypass graft

Drug‐eluting stents (DES) have significantly improved the rate of target vessel revascularization in comparison with bare metal stents. DES fracture was not reported in multicenter randomized clinical trials, but several case reports of DES fracture have been published, mostly with sirolimus‐eluting stents. DES fracture is associated with stent restenosis and thrombosis. We report a zotarolimus‐eluting stent fracture in an aortocoronary saphenous vein graft (SVG) bypass. The patient presented with chest pain and a non‐ST‐elevation myocardial infarction. He underwent cardiac catheterization that showed a complete fracture of a zotarolimus‐eluting stent in the ostium of a sequential SVG to the diagonal and obtuse coronary arteries. His management included coronary angioplasty and retrieval of the proximal fractured segment. We discuss the potential causes for this stent fracture and suggest caution when using a DES in an ostial location of a SVG bypass, especially in a highly mobile vessel. © 2012 Wiley Periodicals, Inc.     

Drug‐Eluting vs. Conventional Balloon for Side Branch Dilation in Coronary Bifurcations Treated by Provisional T Stenting

Objective

The origin of the side branch (SB) is the most common site for restenosis in coronary bifurcations. The end‐point is to compare the results of SB dilation with drug‐eluting balloon (DEB group) versus conventional balloon (BAL group) in bifurcations treated with provisional T stenting.

Methods and Results

Each group included 50 patients. In DEB, the origin of SB was dilated with a Sequent^® Please balloon. In both groups, a Taxus Liberté^® stent was implanted in the main vessel, with kissing balloon postdilation. If the outcome for the SB was suboptimal, a Taxus stent was implanted in BAL and a bare stent in DEB group. An angiographic follow‐up and IVUS were scheduled for 12 months later. Adverse events (MACE) were 24% in BAL versus 11% in DEB (P = 0.11), with greater revascularization (TLR) in the BAL group (22% vs. 12%, P = 0.16). At angiographic follow‐up, there was a lower percentage of SB restenosis in the DEB group (20% vs. 7%, P = 0.08), with less late loss (0.40 mm vs. 0.09 mm, P = 0.01).

Conclusion

Side branch dilation with a drug‐eluting balloon resulted in better angiographic outcomes than with a conventional balloon, with less late loss and restenosis at the 12‐month follow‐up. (J Interven Cardiol 2013;26:454‐462)

     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, Inc.