MyMedR

OBJECTIVE: The objective of this study was to compare the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug eluting stent (PF-SES) to its uncoated bare-metal stent (BMS) platform of identical stent architecture.

BACKGROUND: Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis (ST) and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES).

METHODS: Data of previously published large-sale, international, single-armed, multicenter, observational studies of ultra-thin PF-SES, and BMS were propensity score (PS) matched for selected lesion morphological and cardiovascular risk factors to compare target lesion revascularization (TLR), myocardial infarction, cardiac death, major adverse cardiac events (MACE), bleeding complications and ST rates. Primary endpoint in both studies was TLR at 9 months.

RESULTS: At 9 months the rates of TLR was significantly lower in the PF-SES group as compared with patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, P = 0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, P = 0.001) whereas there were no differences in the accumulated ST rates (0.5% vs. 1.5%, P = 0.109). Overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p = 0.388).

CONCLUSIONS: PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies given the currently favored postprocedural comedication (ClinicalTrials.gov Identifier NCT02629575).

Matched MeSH terms: Drug-Eluting Stents*

Fulltext Early and aggressive ISR with a polymer- and carrier-free drug-coated stent system

Loch A, Bewersdorf JP, Veeriah RS

Indian Heart J, 2017 03 17;69(5):651-654.

PMID: 29054192 DOI: 10.1016/j.ihj.2017.03.002

The LEADERS FREE trial concluded that the polymer free drug-coated BioFreedom™ stent appeared to be both safer and more effective than bare-metal stents (BMS) with an ISR rate comparable to traditional DES without the need for prolonged DAPT. We implanted 45 BioFreedom™ stents in 34 patients over a 4-month period. 4 patients represented early (106-238 days after the implant procedure) with angina symptoms and severe ISR was detected in all patients. The rate of severe and early ISR detected in our patient population of 11.8% is comparable to that of traditional BMS. Further studies are warranted.

Matched MeSH terms: Drug-Eluting Stents*

Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus

Ali RM, Degenhardt R, Zambahari R, Tresukosol D, Ahmad WA, Kamar Hb, et al.

EuroIntervention, 2011 May;7 Suppl K:K83-92.

PMID: 22027736 DOI: 10.4244/EIJV7SKA15

Coronary lesions in diabetics (DM) are associated with a high recurrence following percutaneous coronary intervention (PCI), even after drug-eluting stent (DES) deployment. Encouraging clinical data of the drug-eluting balloon catheter (DEB) SeQuent Please warrant its investigation in these patients.

Matched MeSH terms: Drug-Eluting Stents*

Fulltext Different vascular healing process between bioabsorbable polymer-coated everolimus-eluting stents versus bioresorbable vascular scaffolds via optical coherence tomography and coronary angioscopy (the ENHANCE study: ENdothelial Healing Assessment with Novel Coronary tEchnology)

Wan Ahmad WA, Nakayoshi T, Mahmood Zuhdi AS, Ismail MD, Zainal Abidin I, Ino Y, et al.

Heart Vessels, 2020 Apr;35(4):463-473.

PMID: 31587103 DOI: 10.1007/s00380-019-01516-9

Recent clinical trials have raised concerns about the safety and efficacy of ABSORB™ bioresorbable vascular scaffolds (BVS). The difference in the vascular healing process between SYNERGY™ bioabsorbable polymer-coated everolimus-eluting stents (BP-EES) and BVS remains unclear. The aim of the ENHANCE study was to compare vascular healing on BP-EES versus BVS by optical coherence tomography (OCT) and coronary angioscopy (CAS) at 4- and 12-month follow-ups. This is a prospective, non-randomized, single center clinical trial. Thirteen eligible patients with multivessel disease were enrolled. BP-EES and BVS were simultaneously implanted in the same patients, but in different coronary vessels. Imaging follow-up with both OCT and CAS was completed in 11 patients at 12 months. Neointimal coverage rates were similar between the two groups based on OCT measurements. The neointimal thickness of BP-EES was significantly thicker at the 12th month than at the 4th month, whereas the neointimal thickness of BVS did not change between the measurements taken at the 4th and 12th month. Existence of intra-stent thrombus was significantly higher in the BVS group, compared to the BP-EES group. On the other hand, CAS revealed that red-thrombi and yellow-plaque were more frequently observed in BVS at 4 months and up to 12-month follow-ups than in BP-EES. These findings suggested that the evidence of instability remained up to 12 months in the vascular healing with BVS, compared to that with BP-EES. Vascular healing of the stented wall was recognized at the very early phase after BP-EES implantation. However, vascular healing with BVS was still incomplete after 12 months.

Matched MeSH terms: Drug-Eluting Stents*

Fulltext Gene Polymorphisms of the Renin-Angiotensin-Aldosterone System as Risk Factors for the Development of In-Stent Restenosis in Patients with Stable Coronary Artery Disease

Azova M, Timizheva K, Ait Aissa A, Blagonravov M, Gigani O, Aghajanyan A, et al.

Biomolecules, 2021 05 20;11(5).

PMID: 34065198 DOI: 10.3390/biom11050763

This study investigated the renin-angiotensin-aldosterone system (RAAS) gene polymorphisms as possible genetic risk factors for the restenosis development in patients with drug-eluting stents. 113 participants had coronary artery disease and underwent stenting. The control group consisted of 62 individuals with intact coronary arteries. Patients were divided into two groups: with in-stent restenosis (ISR) and without it. The patients with ISR were classified into subgroups by the terms of the restenosis development and age. Real-time PCR and Restriction Fragment Length Polymorphism-PCR were used to genotype the study participants for RAAS gene polymorphisms. We found that the development of restenosis is generally associated with the minor A allele for renin (REN) rs2368564 and the major TT genotype for angiotensinogen (AGT) rs699. The heterozygous genotype for AGT rs4762 acts as a protective marker. A minor A allele for angiotensin II type 2 receptor (AGTR2) rs1403543 is associated with a risk of restenosis in people under 65 years old. Among patients with the early ISR, heterozygotes for angiotensin II type 1 receptor (AGTR1) rs5186 are more frequent, as well as A allele carriers for AGTR2 rs1403543. A minor homozygous genotype for REN rs41317140 and heterozygous genotype for aldosterone synthase (CYP11B2) rs1799998 are predisposed to the late restenosis. Thus, to choose the effective treatment tactics for patients with coronary artery disease, it is necessary to genotype patients for the RAAS polymorphisms, which, along with age and clinical characteristics, will allow a comprehensive assessment of the risk of the restenosis development after stenting.

Matched MeSH terms: Drug-Eluting Stents/adverse effects*

Fulltext Provisional drug-coated balloon treatment guided by physiology on de novo coronary lesion

Shin ES, Bang LH, Jun EJ, Her AY, Chung JH, Garg S, et al.

Cardiol J, 2021;28(4):615-622.

PMID: 32789835 DOI: 10.5603/CJ.a2020.0105

Although drug-eluting stents (DES) have become the mainstay of percutaneous coronary intervention, late and very late stent thrombosis remains a concern. Drug-coated balloons (DCB) have the advantage of preserving the anti-restenotic benefits of DES while minimizing potential long-term safety concerns. Currently the two methods to ensure successful DCB treatment of a stenotic lesion are angiography or physiology-guided DCB application. This review will evaluate these two methods based on previous evidence and make suggestions on how to perform DCB treatment more efficiently and safely.

Matched MeSH terms: Drug-Eluting Stents*

Unravelment of Medtronic Onyx stent during bifurcation stenting using the jailed wire technique; An adverse effect of helical stent structure?

Leenders GE, Liew HB, Stella PR

Cardiovasc Revasc Med, 2018 12;19(8S):58-59.

PMID: 30115559 DOI: 10.1016/j.carrev.2018.03.016

A 62-year old male underwent treatment of a bifurcation lesion in the left anterior descending coronary artery using provisional stenting with a jailed wire technique. Severe longitudinal stent deformation and unravelment of the stent part proximal of the bifurcation occurred when we tried to pull the jailed wire from the side branch. The described case poses a caution on the use of this specific stent(-design) in bifurcation lesions.

Matched MeSH terms: Drug-Eluting Stents*

Effects of different polyaniline emeraldine compositions in electrodepositing ginsenoside encapsulated poly(lactic-co-glycolic acid) microcapsules coating: Physicochemical characterization and in vitro evaluation

Lukman SK, Saidin S

J Biomed Mater Res A, 2020 05;108(5):1171-1185.

PMID: 31994824 DOI: 10.1002/jbm.a.36891

Even though drug-eluting stent (DES) has prominently reduced restenosis, however, its complication of delayed endothelialization has caused chronic side effect. A coating of ginseng-based biodegradable polymer could address this issue due to its specific therapeutic values. However, deposition of this type of stable coating on metallic implant often scarce. Therefore, in this study, different polyaniline (PANI) emeraldine compositions were adopted to electrodeposit ginsenoside encapsulated poly(lactic-co-glycolic acid) microcapsules coating. The coating surfaces were analyzed using attenuated total reflectance-Fourier transform infrared spectroscopy, X-ray photoelectron spectroscopy, scanning electron microscopy, contact angle, and atomic force microscopy instruments. A month coating stability was then investigated with an evaluation of in vitro human umbilical vein endothelial cell analyses consisted of cytotoxicity and cells attachment assessments. The 1.5 mg PANI emeraldine has assisted the formation of stable, uniform, and rounded microcapsules coating with appropriate wettability and roughness. Less than 1.5 mg PANI emeraldine was not enough to drive the formation of microcapsules coating while greater than 1.5 mg caused the deposition of melted microcapsules. The similar coating also has promoted greater cells proliferation and attachment compared to other coating variation. Therefore, the utilization of electrodeposition to deposit a drug-based polymer coating could be implemented to develop DES, in accordance to stent implantation which ultimately aims for enrich endothelialization.

Matched MeSH terms: Drug-Eluting Stents

Recurrent in-stent restenosis with total occlusion remedied with drug-eluting balloon angioplasty

Azarisman SM, Sabruddin MZ, Rosli MA

Int Heart J, 2011;52(1):61-3.

PMID: 21321471

We report a 69 year old female who presented with chest pain to the Emergency Department of the National Heart Institute Malaysia. Her history revealed that she had had 2 separate episodes of chest pain beginning in 2002, resulting in total occlusion of her mid left anterior descending artery (LAD) requiring percutaneous coronary intervention and stenting on both occasions. Cine angiogram on her current admission revealed recurrent target lesion in-stent restenosis with total occlusion of the distal LAD. Intravascular ultrasound revealed multilayered suboptimally deployed stents in the LAD. Successive drug-eluting balloon deployments resulted in sustained patency of the LAD after 1 year.

Matched MeSH terms: Drug-Eluting Stents*

1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the COMBO collaboration

Chandrasekhar J, Kalkman DN, Aquino MB, Sartori S, Hájek P, Atzev B, et al.

Int J Cardiol, 2020 05 15;307:17-23.

PMID: 32111358 DOI: 10.1016/j.ijcard.2020.01.045

BACKGROUND: The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization.

OBJECTIVE: We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans.

METHODS: The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR).

RESULTS: This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant.

CONCLUSIONS: In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. CLINICALTRIAL.

GOV IDENTIFIER-NUMBERS: NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

Matched MeSH terms: Drug-Eluting Stents*

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