Ultrathin Strut Research Articles

TCT-432 Long-Term Outcomes of Ultrathin Struts Biodegradable Polymer Sirolimus-Eluting Stent for Percutaneous Coronary Interventions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

TCT-432 Long-Term Outcomes of Ultrathin Struts Biodegradable Polymer Sirolimus-Eluting Stent for Percutaneous Coronary Interventions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry

ObjectiveWe evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary...

Comparative effectiveness of ultrathin vs. standard strut drug-eluting stents: insights from a large-scale meta-analysis with extended follow-up

BackgroundNewer generation ultrathin strut stents are associated with less incidence of target lesion failure (TLF) in patients undergoing percutaneous coronary intervention (PCI) in the short term. However, its long-term effect on different cardiovascular outcomes remains unknown.ObjectivesWe aim to identify the effects of newer-generation ultrathin-strut stents vs. standard thickness second-generation drug-eluting stents (DES) on long-term outcomes of revascularization in coronary artery disease.MethodsWe searched PubMed, Web of Science, Cochrane Library databases, and Scopus for randomized controlled trials (RCTs) and registries that compare newer-generation ultrathin-strut (< 70 mm) with thicker strut (> 70 mm) DES to evaluate cardioprotective effects over a period of up to 5 years. Primary outcome was TLF, a composite of cardiac death, target vessel myocardial infarction (TVMI) or target lesion revascularization (TLR). Secondary outcomes included the components of TLF, stent thrombosis (ST), and all-cause death were pooled as the standardized mean difference between the two groups from baseline to endpoint.ResultsWe included 19 RCTs and two prospective registries (103,101 patients) in this analysis. The overall effect on the primary outcome was in favor of second-generation ultrathin struts stents in terms of TLF at ≥ 1 year, ≥ 2 years, and ≥ 3 years (P value = 0.01, 95% CI [0.75, 0.96]), P value = 0.003, 95% CI [0.77, 0.95]), P value = 0.007, 95% CI [0.76, 0.96]), respectively. However, there was no reported benefit in terms of TLF when we compared the two groups at ≥ 5 years (P value = 0.21), 95% CI [0.85, 1.04]). Some of the reported components of the primary and secondary outcomes, such as TLR, target vessel revascularization (TVR), and TVMI, showed the same pattern as the TLF outcome.ConclusionUltrathin-strut DES showed a beneficial effect over thicker strut stents for up to 3 years. However, at the 5-year follow-up, the ultrathin strut did not differ in terms of TLF, TLR, TVR, and TVMI compared with standard-thickness DES, with similar risks of patient-oriented composite endpoint (POCE), MI, ST, cardiac death, and all-cause mortality.

Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents: Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial.

The efficacy and safety of each third-generation drug-eluting stent with ultrathin struts and advanced polymer technology remain unclear. We investigated the clinical outcomes of percutaneous coronary intervention using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. The HOST-IDEA trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy), initially designed with a 2×2 factorial approach, sought to randomize patients undergoing percutaneous coronary intervention based on dual antiplatelet therapy duration (3 versus 12 months) and stent type (Coroflex ISAR versus Orsiro). Despite randomizing 2013 patients for dual antiplatelet therapy duration, the stent arm transitioned to a registry format during the trial. Among these, 328 individuals (16.3%) were randomized for Coroflex ISAR or Orsiro SES, while 1685 (83.7%) underwent percutaneous coronary intervention without stent-type randomization. In this study, the Coroflex ISAR (n=559) and Orsiro groups (n=1449) were matched using a propensity score. The prespecified primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 12 months. The baseline patient and procedural characteristics were well balanced between the Coroflex ISAR and Orsiro groups after propensity score matching (n=559, each group). The Coroflex ISAR group was significantly associated with a higher rate of target lesion failure, mainly driven by clinically driven target lesion revascularization, compared with the Orsiro group (3.4% versus 1.1%; hazard ratio, 3.21 [95% CI, 1.28-8.05]; P=0.01). A higher risk of target lesion failure in the Coroflex ISAR group was consistently observed across various subgroups. The rates of any bleeding (hazard ratio, 0.85 [95% CI, 0.51-1.40]; P=0.52) and major bleeding (hazard ratio, 1.58 [95% CI, 0.61-4.08]; P=0.34) were comparable between the 2 groups. In this propensity score-matched analysis of the stent arm registry from the HOST-IDEA trial, the Orsiro SES was associated with significantly better outcomes in terms of 1-year target lesion failure, mainly driven by clinically driven target lesion revascularization, than the Coroflex ISAR SES. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02601157.

A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).

The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

Evaluation of Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents in an All-Comers Patient Population: 1-Year Results of the S-FLEX Slovakia Registry.

Supraflex (Sahajanand Medical Technologies Limited, Surat, India) is a new-generation, biodegradable polymer-coated sirolimus-eluting stent (SES) designed on an ultrathin (60 µm) cobalt-chromium platform with a flexible 'S-link.' The S-FLEX Slovakia registry aimed to assess the safety and effectiveness of Supraflex SES in an all-comers population, with a subgroup of diabetic patients. This was a prospective, observational, multi-center, post-market registry conducted between February 2018 and May 2019. All consecutive patients with symptomatic coronary artery disease scheduled for percutaneous coronary intervention with Supraflex SES were enrolled. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR) by percutaneous or surgical methods at 1-year follow-up. Stent thrombosis was a safety endpoint. A total of 413 patients was assessed (145 diabetics and 268 nondiabetics). At 1-year follow-up, the primary endpoint of TLF occurred in 5.1% patients, comprised of 3.9% cardiac deaths, 0.5% TV-MI, and 0.7% CI-TLR. Overall stent thrombosis occurred in 0.5% patients at 1-year follow-up. In the subgroup analysis, TLF occurred in 6.2% diabetics and 4.5% nondiabetics (P =.433) and comprised 4.8% and 3.4% cardiac deaths (P =.447), 0.7% and 0.4% TV-MI (P =.653), and 0.7%, and 0.7% CI-TLR (P =.952) in diabetics and non-diabetics, respectively. Overall stent thrombosis occurred in 0.7% diabetic and 0.4% non-diabetic patient (P =.659). This registry demonstrates favourable clinical outcomes after the implantation of the ultrathin biodegradable polymer coated Supraflex SES in an all-comers population, with event rates that were similar in diabetic and nondiabetic patients.

Comparison of endothelial shear stress between ultrathin strut bioresorbable polymer drug-eluting stent vs durable-polymer drug-eluting stent post-stent implantation: An optical coherence tomography substudy from BIOFLOW II

BackgroundRecent clinical data indicate a different performance of biodegradable polymer (BP)-drug eluting stent (DES) compared to durable polymer (DP)-DES. Whether this can be explained by a beneficial impact of BP-DES stent design on the local hemodynamic forces distribution remains unclear. ObjectivesTo compare endothelial shear stress (ESS) distribution after implantation of ultrathin (us) BP-DES and DP-DES and examine the association between ESS and neointimal thickness (NIT) distribution in the two devices at 9 months follow up. Methods and resultsWe retrospectively identified patients from the BIOFLOW II trial that had undergone OCT imaging. OCT data were utilized to reconstruct the surface of the stented segment at baseline and 9 months follow-up, simulate blood flow, and measure ESS and NIT in the stented segment. The patients were divided into 3 groups depending on whether DP-DES (N = 8, n = 56,160 sectors), BP-DES with a stent diameter of >3 mm (strut thickness of 80 μm, N = 6, n = 36,504 sectors), or BP-DES with a stent diameter of ≤3 mm (strut thickness of 60 μm, N = 8, n = 50,040 sectors) were used for treatment. The ESS, and NIT distribution and the association of these two variables were estimated and compared among the 3 groups. ResultsIn the DP-DES group mean NIT was 0.18 ± 0.17 mm and ESS 1.68 ± 1.66 Pa; for the BP-DES ≤3 mm group the NIT was 0.17 ± 0.11 mm and ESS 1.49 ± 1.24 Pa and for the BP-DES >3 mm group 0.20 ± 0.23 mm and 1.42 ± 1.24 Pa respectively (p < 0.001 for both NIT and ESS comparisons across groups). A negative correlation between NIT and baseline ESS was found, the correlation coefficient for all the stented segments was −0.33, p < 0.001. ConclusionIn this OCT sub-study of the BIOFLOW II trial, the NIT was statistically different between groups of patients treated with BP-DES and DP-DES. In addition, regions of low ESS were associated with increased NIT in all studied devices.

Interim prediction of two-year all-cause mortality in patients with de novo multivessel coronary artery disease undergoing intended multivessel PCI

Abstract Background/Introduction coronary revascularization in patients with de novo three-vessel coronary artery disease (3VD) without Left Main disease can be performed by either PCI or CABG after objective Heart Team consensus. In the ongoing Multivessel TALENT trial (NCT04390672)1, the intended multivessel PCI is performed using DES with ultrathin struts and biodegradable polymers under the guidance of quantitative flow ratio (QFR) and intracoronary imaging with IVUS or OCT. Purpose The Logistic Clinical SYNTAX score (logSYNTAX) to predict 2-year all-cause mortality after PCI was developed in 15,883 patients treated in the GLOBAL LEADERS trial and externally validated in 10,100 patients. This study aims to predict 2-year all-cause mortality after intended multivessel PCI in the currently enrolled trial population to identify patients who should be considered high risk. Methods and results We performed an interim analysis in the first consecutive 781 patients of the ongoing Multivessel TALENT Trial aimed to enrol 1550 patients. Thirteen clinical predictors are used in the logSYNTAX score: SYNTAX I-score, presence of 3VD and/or LM disease, age, creatinine clearance in mL/min, LVEF, BMI, serum hemoglobin level(g/dL), the White Blood Cell Count (WBC, in 109 cells/L) and the presence of COPD, PVD, diabetes mellitus, current smoking and/or a history of stroke. LVEF and BMI have additional squared terms to adjust for non-linear associations with all-cause mortality. The predicted mortality was estimated using the survival function developed in the GLOBAL LEADERS trial. We considered patients high-risk if the estimated risk was above the 3rd quartile. In 563 patients, all thirteen predictors necessary for 2-year mortality prediction were available. Median 2-year all-cause mortality of 1.9% (1.09-3.82; IQR2.73). 142 patients (25%) with an increased estimated 2-year mortality risk (&amp;gt;3.8%) due to higher prevalence of the aforementioned predictors; higher median age [75 (9.0) vs. 67 (12.0), p &amp;lt;0.001], a lower median LVEF [55% (20) vs. 94% (35.5), p &amp;lt;0.001] and a higher median SYNTAX score [26.0 (13.5) vs. 20.0(11.0), p &amp;lt;0.001]. A complete overview of predictors can be found in table 1. High age, an impaired LVEF, and an increased anatomical SYNTAX-I score were the main contributors to high mortality in this study cohort (see figure 1). Conclusion(s) In 563 patients, the median predicted 2-year all-cause mortality was 1.9%. Nevertheless, a non-neglectable amount of patients were estimated to be at increased risk for all-cause 2-year mortality. Accurate prediction by knowledge of aforementioned predictors is pivotal for appropriate mortality risk prediction to segregate high-risk patients with 3VD for individual decision-making on coronary revascularization, even if surgical revascularization is no option, and guide optimal treatment with use of intravascular imaging to achieve an optimal PCI result.Table 1Figure 1

Abstract 15324: Biodegradable Polymer Ultrathin Sirolimus-Eluting Stent is Associated With Better Outcomes Compared With Polymer-Free Ultrathin Sirulimus-Eluting Stent in Complex Percutaneous Coronary Intervention: A Post Hoc Analysis of the HOST-IDEA Randomized Clinical Trial

Introduction: Third generation drug-eluting stents with ultrathin struts and advanced polymer technology have been introduced. However, their safety and efficacy have not been fully elucidated, particularly in complex percutaneous intervention (PCI). Aim To investigate the clinical outcomes of complex PCI using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. Methods: This study was a post-hoc analysis of the HOST-IDEA trial that randomly assigned 2,013 patients undergoing PCI with Orsiro or Coroflex ISAR into either 3-month dual antiplatelet therapy (DAPT) or 12-month DAPT arms from January 2016 to May 2021 at 37 centers in South Korea. We compared a 1:1 propensity score (PS)–matched cohort balanced by patient and procedural characteristics. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization at 1 year. Complex PCI was defined as any of the following features: ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length ≥ 60 mm, left main PCI, or heavy calcification. Results: After PS matching, baseline patient and procedural characteristics were balanced between Coroflex ISAR and Orsiro groups (n=542 in each). Complex PCI was significantly associated with a higher rate of TLF compared with non-complex PCI (5.3% vs. 1.1%, hazard ratio (HR) 5.12 [95% confidence interval (CI) 2.21-11.86], P&lt;0.001). Compared with the Coroflex ISAR SES, the better outcomes of TLF associated with the Orsiro SES was more pronounced in the complex PCI group (HR 0.14 [95% CI 0.03-0.60], P =0.008 in complex PCI; HR 0.99 [95% CI 0.25-3.98], P =0.993 in non-complex PCI; P for interaction 0.054). Conclusion In patients undergoing complex PCI with third-generation DES, the Orsiro SES was associated with significantly better outcomes in terms of TLF than the Coroflex ISAR SES.

Ultrathin, biodegradable polymer-coated everolimus-eluting stents for patients undergoing percutaneous coronary intervention: Final three-year results of the PERFORM-EVER registry

The registry reports 3-year safety and clinical performance of the ultrathin strut (60 μm) biodegradable polymer-coated Tetrilimus, an everolimus-eluting stent (EES) (Sahajanand Medical Technologies Limited, India), in ‘real-world’ patients with coronary artery disease. A total of 815 Tetrilimus EES were implanted in 735 lesions in 594 patients. At 3-year follow-up, primary endpoint (target lesion failure, TLF) was reported in 8.6 % patients, including 2.6 % cardiac deaths, 3.5 % myocardial infarction and 2.6 % target lesion revascularization. At three-year, no cases of definite stent thrombosis were reported. The final three-year results of PERFORM-EVER registry endorse the continuous safety and effectiveness Tetrilimus EES.

TCT-418 Impact of Diabetes on Clinical Outcomes After Percutaneous Coronary Intervention: 5-Year Results of the SORTOUT IX Trial Comparing the Polymer-Free Biolimus A9-Coated Stent to the Ultra-Thin Strut Biodegradable Polymer Sirolimus-Eluting Stent

TCT-418 Impact of Diabetes on Clinical Outcomes After Percutaneous Coronary Intervention: 5-Year Results of the SORTOUT IX Trial Comparing the Polymer-Free Biolimus A9-Coated Stent to the Ultra-Thin Strut Biodegradable Polymer Sirolimus-Eluting Stent

TCT-664 Long-Term Outcomes of Ultrathin Strut Sirolimus-Eluting Stent for Percutaneous Coronary Intervention: A Systematic Review, Meta-Analysis, and Meta-Regression of Randomized Controlled Trials

TCT-664 Long-Term Outcomes of Ultrathin Strut Sirolimus-Eluting Stent for Percutaneous Coronary Intervention: A Systematic Review, Meta-Analysis, and Meta-Regression of Randomized Controlled Trials

Comparison of Supraflex Cruz 60 μm Versus Ultimaster Tansei 80 μm Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial

Up to 45% of patients who underwent percutaneous coronary intervention (PCI) may have a high bleeding risk (HBR), depending on the bleeding risk definition.1 This condition is often associated with an enhanced risk of thrombotic events with a negative impact on short- and long-term outcomes,2-8 making the choice of an appropriate antithrombotic regimen after PCI particularly challenging. Advances in stent technologies, in which the introduction of newer generations of thinner strut drug-eluting stents (DES), have significantly reduced the rate of thrombotic complications and may justify a shorter dual antiplatelet therapy (DAPT) duration. Both in vitro and in vivo studies have shown that local hemodynamic factors may critically affect the natural history of atherosclerosis. Strut thickness correlates with flow disturbances and endothelial shear stress. Flow separation within struts determines areas of recirculation with low endothelial shear stress which promotes local concentration of activated platelets.9 By mitigating inflammation, vessel injury, and neointimal proliferation, thin and streamlined struts have been associated with faster vascular healing and re-endothelization and have resulted in lower rates of thrombotic events after PCI.10,11 The use of thin strut and ultra-thin strut stents may lead to a favorable trade-off in bleeding and ischemic events in patients with HBR. However, dedicated studies evaluating the performance of thin strut versus ultrathin strut stents in patients with HBR are lacking.

Safety and Efficacy of Post-Dilation in Percutaneous Coronary Intervention Using Polymer-Free Ultrathin Strut Sirolimus-Probucol Coated Drug-Eluting Stents.

Background and Objectives: Polymer-free ultrathin strut sirolimus- and probucol-eluting stents (PF-SES) are recognized as safe and effective in diverse patient populations, although the implications of post-dilation during stent implantation remain underexamined. Materials and Methods: In this study, patients implanted with PF-SES at Gachon University Gil Medical Center between December 2014 and February 2018 were evaluated. Major adverse cardiovascular events (MACE), encompassing nonfatal myocardial infarction (MI), nonfatal stroke, and cardiovascular death were identified as primary outcomes, with secondary outcomes including target vessel revascularization (TVR), target lesion revascularization (TLR), and in-stent restenosis (ISR). Results: Of the 384 initial patients, 299 were considered eligible for analysis. The groups, delineated by those undergoing post-dilation (143 patients) and those not (156 patients), exhibited comparable rates of primary outcomes [hazard ratio (HR), 2.17; 95% confidence interval (CI), 0.40 to 11.87; p = 0.37]. The outcomes remained consistent irrespective of the post-dilation status and were similarly unaffected in multivariate analyses (HR, 2.90; 95% CI, 0.52 to 16.34; p = 0.227). Conclusions: These results suggest that the clinical outcomes of patients with post-dilation were similar to that of those without post-dilation in those with the polymer-free sirolimus- and probucol-eluting stents.

Long-term safety of ultrathin bioabsorbable-polymer sirolimus-eluting stents versus thin durable-polymer drug-eluting stents in acute coronary syndrome: A systematic review and meta-analysis.

Because of the advancement of bioabsorbable polymers and thinner struts, bioabsorbable-polymer sirolimus-eluting stents (BP-SES) with ultrathin struts may be related to superior performance when compared to durable-polymer drug-eluting stents (DP-DES) with thin struts. Nonetheless, the long-term safety of ultrathin BP-SES in acute coronary syndrome (ACS) remains unknown. We sought to assess the long-term safety of ultrathin BP-SES in ACS patients, conducting a thorough meta-analysis of all relevant trials drawing a comparison between ultrathin BP-SES and contemporary thin DP-DES. Target lesion failure (TLF), which includes cardiac death (CD), target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CD-TLR) was considered the primary endpoint. Multiple databases comprising Embase, MEDLINE, Cochrane Library, and Pubmed were all thoroughly searched. There were seven randomized controlled trials included in our study with 7522 randomized patients with ACS (BP-SES = 3888, DP-DES = 3634). TLF occurred in 371 (9.5% in BP-SES) and 393 (10.8% in DP-DES) patients, respectively, across a 40.7-month weighted mean follow-up, with no statistically significant group differences (risk ratio [RR]: 0.87; 95% confidence interval [CI]: 0.73-1.04; p = .12). Furthermore, no significant differences in cardiac death (RR: 0.96; 95% CI: 0.68-1.35; p = .81), TV-MI (RR: 0.63; 95% CI: 0.36-1.10; p = .10) and CD-TLR (RR: 0.77; 95% CI: 0.46-1.29; p = .32) were detected between two groups. During a follow-up of 40.7 months, ultrathin BP-SES and thin DP-DES had a comparable risk of TLF and its individual components (CD, TV-MI, and CD-TLR), indicating that ultrathin BP-SES held at least the same safety and efficiency as thin DP-DES presented in patients with ACS.

Features of re-endothelialization process during implantation of coronary stents (review of literature)

Method of endovascular treatment for coronary artery lesions has made its way from balloon angioplasty to implantation of drug-eluting stents. Today, drug-eluting stents are widely used for coronary artery revascularization and have significantly reduced the incidence of restenosis compared to bare metal stents. Delayed or incomplete re-endothelialization is a very specific problem for most drug-eluting stents, as after their implantation, there is a risk of developing late thrombosis associated not only with incomplete endothelialization of the stent struts or impaired endothelial function, but also with chronic inflammatory reaction of the vascular wall. The development of stents with ultrathin struts, the abluminal coating of the struts with polymer and drug contribute to the decrease of vascular wall trauma and of the inflammatory response and provide faster stent endothelialization. Keywords: coronary heart disease, coronary stents, re-endothelialization, microporous coating, polymer-free antiproliferative coating, Yukon stent

A Randomized Controlled Trial Comparing BioMime Sirolimus-Eluting Stent With Everolimus-Eluting Stent: Two-Year Outcomes of the meriT-V Trial.

Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16). The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.

Stent expansion in calcified coronary chronic total occlusions: The impact of different stent platforms.

To evaluate the stent expansion of the durable-polymer Zotarolimus-eluting stent (dp-ZES), the durable-polymer Everolimus-eluting stent (dp-EES), and the bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in calcified coronary chronic total occlusions (CTO). The newer generation stents with ultrathin struts might raise concerns regarding reduced radial strength and higher stent recoil (SR) when implanted in calcified CTOs. Between January 2017 and June 2021 consecutive patients with CTO undergoing percutaneous coronary intervention with dp-ZES, dp-EES, or bp-SES were evaluated. The analysis was performed in calcific and in noncalcific CTOs. Quantitative coronary angiography analysis was used to assess diameter stenosis (DS), absolute and relative SR, absolute and relative focal SR, absolute and relative balloon deficit (BD), and absolute and relative focal BD. The primary endpoint was DS. A total of 213 CTOs were evaluated, 115 calcific CTOs (dp-ZES:25, dp-EES:29, bp-SES:61) and 98 non-calcific CTOs (dp-ZES:41, dp-EES:11, bp-SES:46).In calcific CTOs, residual DS was lower in dp-ZES than in dp-EES and bp-SES (-1.00% [-6.50-6.50] vs. 13.00% [7.0-19.00] vs. 15.00% [5.00-20.00]; p < 0.001). Dp-ZES was also an independent predictor of residual DS ≤ 10% (OR 11.34, 95% CI 2.6-49.43, p = 0.001). Absolute and relative focal SR and absolute and relative SR were similar between dp-ZES, dp-EES, and bp-SES (p = 0.913, p = 0.890, p = 0.518, p = 0.426, respectively). In noncalcified CTOs, the residual DS was similar in the three groups (p = 0.340). High relative focal SR was less frequent in dp-ZES than in dp-EES and in bp-SES (19.5% vs. 54.5% vs. 37.0%; p < 0.048). The three stent platforms demonstrated an overall low residual DS when implanted in CTOs. However, dp-ZES was associated with the lowest residual DS and identified as independent predictor of residual DS ≤ 10% in patients with calcific CTOs. Dp-ZES was associated with a lower incidence of high relative focal stent recoil, in noncalcific CTOs. Balloon deficit might be considerate as a surrogate for stent expansion in calcified CTOs.

Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stents: Patient-Level Pooled Analysis From Two Indian Registries.

Background Despite significant evolution in stent technology, female gender, and patients with diabetes mellitus, multivessel disease, total occlusions, long lesions, and small vessels represent the "Achilles' heel" of contemporary percutaneous coronary intervention (PCI). We performed a pooled analysis of high-risk subgroup on patient-level data from the T-Flex registry (1,203 patients) and a real-world Indian registry (1,269 patients), with the aim of assessing one-year safety and clinical performance of ultrathin strut biodegradable polymer-coated Supra family of sirolimus-eluting stents (SES) (Sahajanand Medical Technologies Limited, Surat, India) in the real-world, all-comer population. Method We pooled the following high-risk subgroups data from two all-comer registries: female gender (n=678), diabetes mellitus (n=852), multivessel disease (n=406), total occlusions (n=420), long lesions (≥28 mm) (n=1241), and small vessels (≤2.5 mm) (n=726). Both the registries included patients with coronary artery disease who underwent implantation of at least one SES belonging to the Supra family of stents from May 2016 until March 2018, irrespective of lesion complexity and comorbidities. The primary endpoint was the inci-dence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revas-cularization by percutaneous or surgical methods up to one year. The safety endpoint was stent thrombosis. Results According to prespecified high-risk subgroups, one-year rates of TLF and overall stent thrombosis, respectively, were as follows: female gender (4.9% and 0.6%), diabetes mellitus (6.9% and 1.0%), multivessel disease (6.4% and 0.8%), total occlusions (5.2% and 0.5%), long lesions (≥28 mm) (6.6% and 0.8%), and small vessels (≤2.5 mm) (6.1% and 1.3%). Conclusion This present pooled analysis demonstrated the one-year safety and clinical performance of ultrathin strut biodegradable polymer-coated Supra family of SES in a real-world, all-comer population, with considerably low rates of TLF and stent thrombosis.

Comprehensive mechanical performance characteristics of newly developed ultra-thin coronary stents

Endovascular technologies such as percutaneous transluminal coronary angioplasty and stenting are widely used due to being minimally invasive procedures. One of the endovascular devices, a drug-eluting stent (DES), proved to be a safe and effective therapeutic option for cardiologists, substantially reducing in-stent restenosis (ISR) rates. DES consists of thin (< 200 µm) or ultra-thin (< 70 µm) struts made of Cobalt-Chromium (CoCr) or other alloys. The DES with ultra-thin struts exhibits higher longitudinal flexibility and improved trackability. It also reduces vascular injury and promotes more rapid endothelization, substantially decreasing the risk of ISR. This study evaluates comprehensive mechanical performances of two different structural designs of newly developed ultra-thin CoCr stents (i.e., strut width of 75 µm or 65 µm). These two stent designs are engineered with distinct bridge size and distribution patterns, prioritizing enhanced flexibility irrespective of the strut thickness. Computational modeling results show anticipated stress distribution with maximum local stresses, which are compared with experimental outcomes conducted in this study. ASTM guideline based in vitro experimental studies have been conducted to assess the stents’ longitudinal flexibility, radial strength, recoil and shortening, as well as crushability through this study. Three-point bending experiments have demonstrated that the stent design 1 requires less bending force compared to the design 2, showing better longitudinal flexibility of the stent design 1 in the collapsed state for the new ultra-thin DES devices. The design 1 also showed superior radial strength and recoiling phenomena, as well as smaller shortening. In short, the stent design 1 shows better mechanical performance needed for the coronary artery DES.