Late Restenosis After Paclitaxel-Coated Balloon Angioplasty Occurs in Patients With Drug-Eluting Stent Restenosis

Habara, Seiji; Kadota, Kazushige; Shimada, Toshio; Ohya, Masanobu; Amano, Hidewo; Izawa, Yu; Kubo, Shunsuke; Hyodo, Yusuke; Otsuru, Suguru; Hasegawa, Daiji; Tada, Takeshi; Tanaka, Hiroyuki; Fuku, Yasushi; Goto, Tsuyoshi; Mitsudo, Kazuaki

doi:10.1016/j.jacc.2015.05.002

Cited by 62 publications

(44 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

Section: Alfonso Et Al Everolimus-eluting Stents For In-stent Restenosismentioning

confidence: 99%

“…[5][6][7][8][9] Indeed, long-term clinical and angiographic results of patients treated for DES-ISR are significantly poorer than those seen in patients treated for BMS-ISR. [5][6][7][8][9] These findings have been demonstrated in patients with ISR treated with first-generation DES. 5,6 Recent studies suggest that drug-eluting balloons (DEB), another well-established therapy in this scenario, are also associated with poorer long-term clinical and angiographic outcomes in patients with DES-ISR than in those with BMS-ISR.…”

Section: Alfonso Et Al Everolimus-eluting Stents For In-stent Restenosismentioning

confidence: 99%

“…5,6 Recent studies suggest that drug-eluting balloons (DEB), another well-established therapy in this scenario, are also associated with poorer long-term clinical and angiographic outcomes in patients with DES-ISR than in those with BMS-ISR. [7][8][9] The reasons accounting for the adverse results in patients with DES-ISR remain unsettled. Patients with ISR after DES may be more complex from a clinical and anatomic stand point and, therefore, prone to recurrences.…”

Section: Alfonso Et Al Everolimus-eluting Stents For In-stent Restenosismentioning

confidence: 99%

“…[5][6][7][8][9] Patients treated for DES-ISR tend to have higher rates of clinical and angiographic recurrences compared with those treated with DES-ISR. [5][6][7][8][9] The reasons explaining these findings are not fully understood. Patients presenting DES-ISR represent a highly selected subset that developed ISR in spite of the use of a potent antiproliferative agent.…”

mentioning

confidence: 99%

See 3 more Smart Citations

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Alfonso

Pérez-Vizcayno

Blanco³

et al. 2016

Circ: Cardiovascular Interventions

View full text Add to dashboard Cite

S tent implantation constitutes the default strategy during coronary interventions.1,2 Drug-eluting stents (DES) are widely used because of their unique ability to inhibit neointimal proliferation and reduce the restenosis risk.1,2 However, although rare, in-stent restenosis (ISR) still occurs after DES implantation. 3,4 Of concern, several studies have suggested that treatment Background-Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. Methods and Results-A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-ElutingBalloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at followup remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. Conclusions-This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EESprovide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940. Current address for A. of patients with DES-ISR is more challenging than treatment of patients with bare-metal stent (BMS) ISR. 5-9 Indeed, long-term clinical and angiographic results of patients treated for DES-ISR are significantly poorer than those seen in patients treated for BMS-ISR. [5][6][7][8][9] These findings have been demonstrated in patients with ISR treated with first-generation DES. 5,6 Recent studies suggest that drug-eluting balloons (DEB), another well-established therapy in this scenario, are also associated with poorer long-term clinical and ang...

show abstract

Section: Alfonso Et Al Everolimus-eluting Stents For In-stent Restenosismentioning

confidence: 99%

Section: Alfonso Et Al Everolimus-eluting Stents For In-stent Restenosismentioning

confidence: 99%

Section: Alfonso Et Al Everolimus-eluting Stents For In-stent Restenosismentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Alfonso

Pérez-Vizcayno

Blanco³

et al. 2016

Circ: Cardiovascular Interventions

View full text Add to dashboard Cite

show abstract

“…But the most successful approaches were vascular brachytherapy, restenting with same or different DES, and drug-coated balloons (DCB), [5][6][7] which are supported by the European guidelines with similar levels of evidence.…”

Section: See Article By Alfonso Et Almentioning

confidence: 95%

In-Stent Restenosis?

Waksman

Steinvil

2016

Circ: Cardiovascular Interventions

View full text Add to dashboard Cite

T he introduction of bare metal stents (BMS) over 30 years ago was a significant milestone in the evolution of percutaneous coronary intervention. Soon after, it was apparent that these stents led to a troubling phenomenon of in-stent restenosis (ISR), which requires repeat revascularization, was associated with increased morbidity and mortality, and posed a therapeutic challenge. The quest for optimal therapy for ISR has begun, but in parallel, continued efforts were devoted to improve the stent technology. These iterations included design and alloy modification, reducing strut thickness, and adding a polymer to elute an antiproliferative drug. Drug-eluting stents (DES) significantly reduced the occurrence of exuberant neointimal proliferation.1 However, in spite of the wide use and experience gained with novel stent technologies and implantation techniques, the rates of ISR in both BMS and DES are still relatively high.2 In a contemporary report on a large cohort (n=10 004), routine angiographic surveillance 6 to 8 months after stent implantation has revealed ISR rates of 30.1%, 14.6%, and 12.2% for BMS, first-generation DES, and second-generation DES, respectively. 3 See Article by Alfonso et alTo optimize the treatment of ISR, it is imperative to identify and understand the major etiologies for ISR that have been traditionally classified and characterized as (1) operator or technique dependent, including stent undersizing, incomplete lesion coverage, stent under expansion, and malapposition; (2) mechanical and design properties of stents that may lead to recoil because of loss of radial force, stent fractures, and altering increase in shear stress; (3) patient-and biologically related conditions, such as metal allergy, local hypersensitivity reactions with immunologic and inflammatory response to the drug or the polymer, often characterized with inflammatory cells and smooth muscle cells that transformed to rigid scar tissue within the stent. This local inflammation can lead to the development of neoatherosclerosis characterized by accumulation of lipid-laden foamy macrophages within the neointima with or without a necrotic core formation and calcification, which can occur years after stent placement. 4 With the introduction of DES, it was apparent that there are differences with respect to the time course and the phenotypic appearance of ISR across the BMS and DES generations, exhibiting a more diffuse and proliferative pattern for BMS versus more focal and soft lesions for the DES, however, more resistant to treatment. 4 Neoatherosclerosis occurs more frequently and at an earlier time in the first-and second-generation DES when compared with BMS.2 These mechanistic complexities make the treatment of ISR even more challenging because both mechanical and biological factors can influence treatment outcomes.Over the years, there were many attempts to find an optimal therapy for ISR; among them there were the high-pressure balloons, scoring balloons, ablative therapy with laser and rotational atherectomy device...

show abstract