Sirolimus-eluting Stent Research Articles

Comparison of Clinical Outcomes Among Various Percutaneous Coronary Intervention Strategies for Small Coronary Artery Disease

It remains unclear which percutaneous coronary intervention (PCI) strategy is the most preferable in patients with small-vessel coronary artery disease (CAD). We sought to evaluate the clinical efficacy of various PCI strategies for patients with small-vessel CAD through a network meta-analysis of randomized controlled trials (RCTs). We searched multiple databases for RCTs investigating the efficacy of the following PCI strategies for small-vessel CAD (<3mm in diameter): drug-coated balloons (DCB), early-generation paclitaxel-eluting stents and sirolimus-eluting stents (SES), newer-generation drug-eluting stents (DES), bare-metal stents (BMS), cutting balloon angioplasty, and balloon angioplasty (BA). The primary outcome was the trial-defined major adverse cardiovascular events (MACE), mostly defined as a composite of death, myocardial infarction, and revascularization. The secondary outcomes included each component of MACE and angiographic binary restenosis. We performed a sensitivity analysis for RCTs without BMS or first-generation DES. Our search identified 29 eligible RCTs, including 8,074 patients among the 8 PCI strategies. SES significantly reduced MACE compared with BA (hazard ratio 0.23, 95% confidence interval 0.10 to 0.54) with significant heterogeneity (I2=55.9%), and the rankogram analysis showed that SES was the best. There were no significant differences between DCB and newer-generation DES in any clinical outcomes, which was consistent in the sensitivity analysis. BMS and BA were ranked as the worst 2 for most clinical outcomes. In conclusion, SES was ranked as the best for reducing MACE. There were no significant differences in clinical outcomes between DCB and newer-generation DES. BMS and BA were regarded as the worst strategies for small-vessel CAD.

Ten-year major clinical outcomes between first- and second-generation Drug-Eluting Stents in unstable angina patients underwent Percutaneous Coronary Intervention

Abstract Background There are very limited long-term clinical outcome data comparing first-generation (1G) versus second-generation (2G) drug-eluting stents (DES) in unstable angina (UA) patients. The authors sought to compare the efficacy and safety 2G-DES with 1G-DES in dyslipidemia patients who underwent percutaneous coronary intervention (PCI) during ten-year clinical follow-up periods. Methods Finally, a total of 878 eligible UA patients who underwent PCI with 1G-DES (paclitaxel-, sirolimus-eluting stent, n = 333) or 2G-DES (zotarolimus [endeavor, endeavor resolute]- or everolimus-eluting stent [promus element, xience], n = 545) were enrolled. The study endpoints were individual and composite clinical outcomes up to ten-year. Results After PSM, two propensity-matched (PSM) groups (216 pairs) were generated. During the ten-year follow-up period, the 2G-DES group had a lower incidence of target lesion revascularization (TLR; hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.22 – 0.84; p = 0.013), target vessel revascularization (TVR; HR, 0.40; 95% CI, 0.23 – 0.71; p = 0.002), any revascularization (HR, 0.48; 95% CI, 0.31 – 0.75; p &amp;lt; 0.001), total major adverse cardiac events (MACE; HR, 0.54; 95% CI, 0.37 – 0.81; p = 0.003), TLR MACE (HR, 0.54; 95% CI, 0.30 – 0.97; p = 0.038), and MACCE (HR, 0.62; 95% CI, 0.42 – 0.90; p = 0.012, table). Conclusion In our single-center, all-comer registry, 2G-DES had better efficacy especially repeat revascularization compared with 1G-DES in UA patients during 10-year follow-up periods.

Long-term PCI outcomes in chronic versus acute coronary syndromes: 5-year results of the TARGET All Comers trial

Abstract Introduction In the TARGET AC trial, the biodegradable-polymer sirolimus-eluting Firehawk stent was non-inferior to the everolimus-eluting XIENCE stent with respect to target lesion failure (TLF) at 12 months; however, long-term safety and efficacy in the setting of an acute coronary syndrome (ACS) are not known. Purpose To assess the long-term outcomes in ACS vs chronic coronary syndromes (CCS) with the Firehawk stent vs the XIENCE stent Methods The TARGET AC study was a multicentre, open label, noninferiority trial of all comer patients randomised 1:1 (stratified by STEMI) to Firehawk or XIENCE stents. In this substudy, outcomes were compared based on clinical presentation (ACS vs CCS) and treatment allocation. Results A total of 1653 patients were enrolled (728 with ACS and 922 with CCS) with 94% completing 5-year follow-up. Baseline characteristics were well matched. Target lesion failure (TLF) (15.5% vs 17.7%; p=0.24), patient-oriented composite endpoint (death, any myocardial infarction, or any revascularization) (32.0% vs 34.4%; p=0.31), and stent thrombosis (4.1% vs 3.3%; p=0.40) were similar between ACS and CCS patients (Table 1). Among the ACS cohort, outcomes at 5 years for Firehawk vs XIENCE were not different for TLF (16.0% vs 14.9%; p=0.70), ischemia-driven target lesion revascularisation (ID-TLR) (5.6% vs 8.3%; p=0.17), or definite/probable stent thrombosis (2.7% vs 4.6%; p=0.18). The same was true for the CCS cohort, with 5-year outcomes for Firehawk vs XIENCE for TLF (18.0% vs 17.4%; p=0.82), ID-TLR (6.4% vs 5.0%; p=0.37), and definite/probable stent thrombosis (3.0% vs 1.8%; p=0.26) similar between groups. Conclusions One in three patients presenting with CCS or ACS had a major adverse event at 5 years. Long-term, the Firehawk stent was as safe and effective as the XIENCE stent irrespective of clinical presentation.

Physiological phenotype of coronary artery disease on short-term angina status in patients with CCS after PCI: perspective from PIONEER IV trial

Abstract Background The hemodynamic impact of PCI on major epicardial conductance vessels is the results of a complex interplay between diffuseness and focality of coronary artery atherosclerosis. The pre-procedural identification of these two phenotypes (diffuseness vs. focality) may have important implication on the angina relief after PCI. Purpose The aim of this study was to determine the differential improvement in patient-reported outcomes after PCI in focal and diffuse CAD as defined by the pullback pressure gradient index (PPGi) derived from angiography. Methods The PIONEER IV trial is a prospective, all-comers, multi-center trial, randomizing patients to PCI guided by angiography-derived physiology or usual care, with both arms using the Healing-Targeted Supreme sirolimus-eluting stent. Pre-procedural PPGi derived from angiography was documented. The 7-item Seattle Angina Questionnaire (SAQ-7) was administered at baseline and 30 days after PCI. The median PPG value was used to define focal and diffuse CAD. Residual angina was defined as a SAQ-AF score ≤ 90. Results A total of 203 patients were analyzed, in which 105 patients with focal CAD and 98 diffuse. Focal disease had larger pre-procedure QFR and post-procedure QFR value than patients with diffuse disease (0.71 ± 0.13 vs 0.59 ± 0.19, P &amp;lt; 0.001; 0.96 ± 0.04 vs 0.91 ± 0.08, P &amp;lt; 0.001). The median of PPGi was 0.73 (Figure 1A). In the restricted cubic spline model, the risk of residual angina rises substantially when the pre-procedural PPGi was below 0.74 (Figure 1B). Patients with focal disease who underwent PCI for focal CAD had significantly higher angina frequency score and quality of life score at follow-up than those with diffuse CAD (94.10 ± 11.58 vs 89.80 ± 16.31, P = 0.031; 75.77 ± 26.01 vs 67.17 ± 25.86, P=0.024; Figure 2). After PCI, residual angina was present in 35.0% but was significantly less in those with treated focal CAD (26.7 % vs 43.9 %; P = 0.015; Figure 1C-D). Conclusion Residual angina after PCI was higher in patients with diffuse CAD, whereas patients with focal CAD reported greater improvement in angina and quality of life. Whether pre-procedural physiological phenotyping should alter the therapeutic decision making to perform PCI, and could influence the procedure planning warrants further study.Figure 1Figure 2

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.

Selection criteria in the era of perfect competition for drug-eluting stents - a survey of interventional cardiologists in Japan: the selection-DES study

ABSTRACT Background More than 20 years have passed since the first company introduced drug-eluting stent (DES) in 2002, but competing companies still have improved their DESs under regulatory approval. This study aimed to investigate the criteria for interventional cardiologists performing percutaneous coronary intervention (PCI) in selecting a DES. Research design and methods From 10 April 2023, to 30 April 2023, 3,422 cardiologists were requested to complete a questionnaire, of whom 126 responded to the survey. Results Overall, 86.5% of the respondents used Xience cobalt-chromium everolimus-eluting stent (Xience) in > 10% of PCI procedures. For Xience, brand loyalty and calcified lesions were important independent variables for the DES selection criteria. Ultimaster sirolimus-eluting stent (Ultimaster) was not affected by the clinical data delivered by the company, whereas the respondents were shown to seek support for their activities from the Ultimaster supplier. The relationship with the company and/or sales representative and the planned surgical procedure affected the use of Coroflex ISAR NEO sirolimus-eluting polymer-free stent. Conclusions Patient background and lesion characteristics had little impact on the DES selection criteria, suggesting that DES performance has already reached its physical limitations to the extent that respondents may not value further improvements in performance or characteristics of DES.

48-Month Clinical Outcomes and Prognostic Factors in an All-Comers Population with Acute Coronary Syndrome and Chronic Coronary Syndrome Undergoing Percutaneous Coronary Intervention with a Sirolimus-Eluting Stent.

We characterized the performance as well as safety of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), deployed in the acute coronary syndrome (ACS) setting. We enrolled patients who were subjected to percutaneous coronary intervention (PCI) between July 2015 and March 2016 and took into consideration demographics, clinical and laboratory data, and clinical outcomes. We defined the primary endpoint as the 48-month rate of major cardiovascular adverse events (MACE), including cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were all-cause death, cardiac death, MI, and TLR rates at 12-, 24-, 36-, and 48 months. We enrolled 232 patients in whom 282 stents were implanted, including 88 ACS and 144 chronic coronary syndrome (CCS) patients. The mean age of the ACS population was 67 ± 13 years old, and 32% of it consisted of females. Patients with ACS were characterized by lower rates of arterial hypertension (85.2% vs. 95.8%, p = 0.004), dyslipidemia (67% vs. 81.9%, p = 0.01), prior MI (34.1% vs. 57.6%, p < 0.001), and prior PCI (35.2% vs. 68.8%, p < 0.001). At 48 months, among the ACS patients, the rates of MACE, death, cardiac death, MI, and TLR were 23.9%, 11.4%, 7.9%, 9.1%, and 10.2%, respectively. No stent thrombosis cases were reported. Multivariable Cox regression revealed that the statistically significant MACE predictors were massive calcifications in coronary arteries (HR 9.0, 95% CI 1.75-46.3, p = 0.009), post-dilatation (HR 3.78, 95% CI 1.28-11.2, p = 0.016), prior CABG (HR 6.64, 95% CI 1.62-27.1, p = 0.008), vitamin K antagonist use (HR 5.99, 95% CI 1.29-27.8, p = 0.022), and rivaroxaban use (HR 51.7, 95% CI 4.48-596, p = 0.002). The study findings show that Alex Plus was effective and safe in a contemporary cohort of real-world ACS patients undergoing primary PCI. The outcomes were comparable between the ACS and chronic coronary syndrome patients, with a trend of lower TLR in ACS patients at 4 years.

Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial

Biodegradable polymer sirolimus-eluting stents improve early stent-related clinical outcomes compared to durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The long-term advantages of biodegradable polymer sirolimus-eluting stents after complete degradation of its polymer coating in patients with STEMI remains however uncertain. BIOSTEMI Extended Survival (BIOSTEMI ES) was an investigator-initiated, follow-up extension study of the BIOSTEMI prospective, multicentre, single-blind, randomised superiority trial that compared biodegradable polymer sirolimus-eluting stents with durable polymer everolimus-eluting stents in patients with STEMI undergoing primary percutaneous coronary intervention at ten hospitals in Switzerland. All individuals who had provided written informed consent for participation in the BIOSTEMI trial were eligible for this follow-up study. The primary endpoint was target lesion failure, defined as a composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target lesion revascularisation, at 5 years. Superiority of biodegradable polymer sirolimus-eluting stents over durable polymer everolimus-eluting stents was declared if the Bayesian posterior probability for a rate ratio (RR) of less than 1 was greater than 0·975. Analyses were performed according to the intention-to-treat principle. The study was registered with ClinicalTrials.gov, NCT05484310. Between April 26, 2016, and March 9, 2018, 1300 patients with STEMI (1622 lesions) were randomly allocated in a 1:1 ratio to treatment with biodegradable polymer sirolimus-eluting stents (649 patients, 816 lesions) or durable polymer everolimus-eluting stents (651 patients, 806 lesions). At 5 years, the primary composite endpoint of target lesion failure occurred in 50 (8%) patients treated with biodegradable polymer sirolimus-eluting stents and in 72 (11%) patients treated with durable polymer everolimus-eluting stents (difference of -3%; RR 0·70, 95% Bayesian credible interval 0·51-0·95; Bayesian posterior probability for superiority 0·988). In patients undergoing primary percutaneous coronary intervention for STEMI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 5 years of follow-up. The difference was driven by a numerically lower risk for ischaemia-driven target lesion revascularisation. Biotronik.

Randomized clinical trial of abluminus DES+ sirolimus-eluting stent versus everolimus-eluting DES for percutaneous coronary intervention in patients with diabetes mellitus: An optical coherence tomography study.

Diabetic patients are at higher risk of recurrent adverse events following percutaneous coronary intervention (PCI) than the nondiabetics. Despite the introduction of new generation drug-eluting stents, their efficacy in the diabetics is still limited. To evaluate the efficacy of the Abluminus DES+ biodegradable polymer sirolimus-eluting stent in reducing neointimal hyperplasia in diabetic patients, compared to a durable polymer everolimus-eluting stent (DP-EES). A total of 131 patients with diabetes and coronary artery disease were enrolled in six Italian centers and randomized in a 2:1 fashion to PCI with Abluminus DES+ or DP-EES: 85 were assigned to Abluminus DES+ and 46 to DP-EES. The primary endpoint was optimal coherence tomography (OCT)-derived neointimal volume at 9-12 months. Secondary endpoints included OCT-derived neointimal area, neointimal volume obstruction and adverse clinical events. The primary endpoint, neointimal volume, did not differ between Abluminus DES+ and DP-EES (29.11 ± 18.90 mm3 vs. 25.48 ± 17.04 mm3 , p = 0.40) at 9-12-month follow-up. This finding remained consistent after weighing for the sum of stents lengths (1.14 ± 0.68 mm3 vs. 0.99 ± 0.74 mm3 for Abluminus DES+ and DP-EES, respectively, p = 0.38). Similarly, other OCT-derived and clinical secondary endpoints did not significantly differ between the two groups. Rate of target lesion failure was high in both groups (21.2% for Abluminus DES+ and 19.6% for DP-EES). This preliminary study failed to demonstrate the superiority of the Abluminus DES+ over the DP-EES in diabetic patients in terms of neointimal proliferation.

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial.

Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing. We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention. The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR). A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups. At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years. gov: NCT03216733.

A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial.

Third generation drug-eluting stents (DES) potentially offer better technical performance and reduced neointimal proliferation than previous generation DES. The XLIMIT non-inferiority trial evaluated the performance of the Xlimus (a novel sirolimus-eluting coronary stent system) in terms of endothelialization and tissue healing compared to the bioresorbable polymer Synergy DES. A total of 177 patients undergoing percutaneous coronary intervention (PCI) were randomized in a 2:1 ratio (2 Xlimus: 1 Synergy). The primary endpoints, defined as the in-stent neointimal volume weighted by the sum of the lengths of the implanted stent (ISNV) and the in-stent neointimal percent volume obstruction (%VO) were evaluated at 6-9 months by means of optical coherence tomography (OCT). Additional OCT parameters as well as clinical endpoints were also collected. Most of the patients were males (77.4%), and the mean age was 64 years. One third of the population had stable angina/silent ischemia. A total of 300 stents (237 lesions) were analyzed: 198 (152 lesions) were in the Xlimus group, and 102 (85 lesions) in the Synergy group. The ISNV in the Xlimus group was 30.7 ± 24.5 mm3 while in the Synergy group it was 26.5 ± 26.7 mm3: the difference between the two means was 0.08 (-0, 04-0, 45), p = 0.018, thus meeting the non-inferiority hypothesis. The %VO was 16.3% ± 10.4% and 13.3% ± 10.8% in the Xlimus and Synergy groups, respectively: the difference between the two means was 3.0 (-0, 06-4, 2), (p = 0.01), thus meeting the non-inferiority hypothesis. No difference was found with respect to the secondary OCT endpoints as well as for clinical endpoints. The study results confirm that the biological interaction of the Xlimus and Synergy DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the Xlimus is non-inferior to the Synergy. ClinicalTrials.gov, identifier (NCT03745053).

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.

Safety and efficacy of anovel 3D-printed bioresorbable sirolimus-eluting scaffold in aporcine model.

The effect of 3D-printed bioresorbable vascular scaffolds (BRS) in coronary heart disease has not been clarified. We aimed to compare the safety and efficacy of 3D-printed BRS with that of metallic sirolimus-eluting stents (SES). Thirty-two BRS and 32 SES were implanted into 64 porcine coronary arteries. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were performed at 14, 28, 97, and 189 days post-implantation. Scanning electron microscopy (SEM) and histopathological analyses were performed at each assessment. All stents/scaffolds were successfully implanted. All animals survived for the duration of the study. QCA showed the two devices had asimilar stent/scaffold-to-artery ratio and acute percent recoil. OCT showed the lumen area (LA) and scaffold/stent area (SA) of the BRS were significantly smaller than those of the SES at 14 and 28 days post-implantation (14-day LA: BRS vs SES 4.52±0.41 mm2 vs 5.69±1.11 mm2; p=0.03; 14-day SA: BRS vs SES 4.99±0.45 mm2 vs 6.11±1.06 mm2; p=0.03; 28-day LA: BRS vs SES 2.93±1.03 mm2 vs 4.82±0.74 mm2; p=0.003; 28-day SA: BRS vs SES 3.86±0.98 mm2 vs 5.75±0.71 mm2; p=0.03). Both the LA and SA of the BRS increased over time and were similar to those of the SES at the 97-day and 189-day assessments. SEM and histomorphological analyses showed no significant between-group differences in endothelialisation at each assessment. The novel 3D-printed BRS showed safety and efficacy similar to that of SES in aporcine model. The BRS also showed along-term positive remodelling effect.

1247 A Vascular Surgeon's Dilemma - Biodegradable Versus Non-Biodegradable Drug Releasing Stents: A Systematic Review and Meta Analysis

Abstract Aim Vascular stents are the best-known interventional treatment for cardiovascular disease, and variation in available stents has increased significantly over time. Despite the rapidity of new prototype releases, critical cross-comparisons fail to maintain the same rate, therefore causing confusion for vascular surgeons. Research is most notably lacking between biodegradable-polymer sirolimus-eluting stents (BP-SES) and permanent-polymer sirolimus-eluting stents (PP-SES). Consequently, a systematic review with meta-analysis was conducted evaluating clinical outcomes. Method Medline, Embase, and Scopus databases were searched using relevant synonyms of “biodegradable”, “sirolimus” and “stent”, with the final search being conducted on the 4th of November 2022. Reference lists were also screened. The clinical outcomes investigated were stent thrombosis (ST), myocardial infarction (MI), target vessel revascularisation (TVR), target lesion revascularisation (TLR), and death. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Results Five clinical trials directly comparing clinical outcomes between BP-SES and PP-SES were ultimately identified for inclusion. For all five outcomes investigated, no statistically significant difference (p&amp;gt;0.05) was found between the BP-SES and the PP-SES recipients. Pooled odds ratios of 0.86 (95% CI:0.44-1.65), 0.75 (95% CI:0.32-1.74), 1.12 (95% CI:0.54-2.32), 1.14 (95% CI:0.38-3.38) and 0.95 (95% CI:0.51-1.77) were calculated for ST, MI, TVR, TLR and death respectively. Conclusions Although there is some evidence to suggest BP-SES are noninferior to PP-SES, concrete conclusions cannot yet be drawn due to the paucity of research in this field. Further clarity from randomised control trials will aid additional examination and improvement in stent materials and outcomes.

SP11.9 A Vascular Surgeon's Dilemma - Biodegradable Versus Non-Biodegradable Drug Eluting Stents: A Systematic Review and Meta Analysis

Abstract Aims Vascular stents are the best-known interventional treatment for cardiovascular disease, with variation in available stents increasing significantly over time. Despite the rapidity of new prototype releases, critical cross-comparisons fail to maintain the same rate, therefore causing confusion for vascular surgeons. Research is most notably lacking between biodegradable-polymer sirolimus-eluting stents (BP-SESs) and permanent-polymer sirolimus-eluting stents (PP-SESs). Therefore, a systematic review with meta-analysis was conducted evaluating clinical outcomes. Methods Using relevant synonyms of “biodegradable”, “sirolimus” and “stent”, the databases Medline, Embase, and Scopus were searched, with the final search being conducted on the 4th of November 2022. Reference lists were also screened. The clinical outcomes investigated were stent thrombosis (ST), myocardial infarction (MI), target vessel revascularisation (TVR), target lesion revascularisation (TLR), and death. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Results Five clinical trials directly comparing clinical outcomes between BP-SESs and PP-SESs were ultimately identified for inclusion. For all five outcomes investigated, no statistically significant difference (p&amp;gt;0.05) was found between the BP-SES and the PP-SES recipients. Pooled odds ratios of 0.86 (95% CI:0.44-1.65), 0.75 (95% CI:0.32-1.74), 1.12 (95% CI:0.54-2.32), 1.14 (95% CI:0.38-3.38) and 0.95 (95% CI:0.51-1.77) were calculated for ST, MI, TVR, TLR and death respectively. Conclusions Although there is some evidence to suggest BP-SESs are noninferior to PP-SESs, concrete conclusions cannot yet be drawn due to the paucity of research in this field. Further clarity from randomised control trials will aid additional examination and improvement in stent materials and outcomes.

Clinical Outcomes and Prognostic Factors in Complex, High-Risk Indicated Procedure (CHIP) and High-Bleeding-Risk (HBR) Patients Undergoing Percutaneous Coronary Intervention with Sirolimus-Eluting Stent Implantation: 4-Year Results.

We aimed to characterize the performance and safety of percutaneous coronary intervention (PCI) in complex, high-risk indicated procedure (CHIP) and high-bleeding-risk (HBR) patients at a 4-year follow up. We included all consecutive patients who underwent PCI with the sirolimus-eluting coronary stent Alex Plus (Balton, Poland) between July 2015 and March 2016. We analyzed various baseline demographic and clinical characteristics, laboratory data, and clinical outcomes. We enrolled 232 patients in whom 282 stents were implanted, including 81 patients meeting the CHIP criteria and 76 patients meeting the HBR criteria. In the whole population, the mean age was 68 ± 11 years, and 23.7% were females. Most procedures were performed from radial access (83.2%) using a 6F guiding catheter (95.7%). The lesions were mostly predilated (61.6%), and postdilatation was performed in 37.9%. The device success was 99.6% (in one case, a second stent was required due to heavy calcifications). Additional stents were deployed in 39% of cases due to edge dissection (6.9%), side branch stenting (5.2%), or diffuse disease (26.9%). Myocardial infarction (MI) type 4a was revealed in 2.2% of cases. At 4 years, the MACE rates for the whole population and for CHIP and HBR patients were 23.3%, 29.6%, and 27.6%, respectively. CHIP patients had a higher risk of MACEs (29.6% vs. 19.9%, HR 1.69, p = 0.032) and cardiac death (11.1% vs. 4.6%, HR 2.50, p = 0.048). There were no differences for MI (7.4% vs. 6.6%, p = 0.826) and TLR (18.5% vs. 12.6%, p = 0.150). HBR patients were also characterized by a higher risk of MACEs (27.6% vs. 21.2%, HR 1.84, p = 0.049) and cardiac death (17.1% vs. 1.9%, HR 9.61, p < 0.001). There were no differences for MI (7.9% vs. 6.4%, p = 0.669) and TLR (11.8% vs. 16.0%, p = 0.991). PCI in CHIP and HBR patients is feasible with a low rate of periprocedural complications. Nevertheless, CHIP and HBR patients are at a high risk of future adverse events and require strict surveillance to improve outcomes.

Clinical implication of ticagrelor monotherapy in patients with small vessel coronary artery disease: results from the TICO randomized trial.

The aim of this study was to evaluate the efficacy and safety of ticagrelor monotherapy in patients with small vessel disease compared with ticagrelor-based DAPT within the Ticagrelor Monotherapy after 3 Months in the Patients Treated with New Generation Sirolimus Eluting Stent for Acute Coronary Syndrome (TICO) trial population. Reference vessel diameter ≤2.5 mm was considered as small vessel disease. We conducted a comparison of the incidence of target lesion failure (TLF) and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. TLF was defined as a composite of cardiac death, target lesion myocardial infarction, stent thrombosis, and target lesion revascularization. 652 patients among 3,056 TICO population (21.3%) had small vessel disease. Patients with small vessel disease showed a higher rate of TLF compared to those without small vessel disease (2.9% vs. 1.0%, log-rank p < 0.001). The presence of small vessel disease emerged as an independent predictor for 1-year TLF (HR 2.84, 95% CI 1.54-5.25), while it did not show a significant association with bleeding complications. The 12-month TLF rate was 1.6% for ticagrelor monotherapy after 3-month DAPT, and 4.2% for ticagrelor-based 12-month DAPT (p = 0.059) in patients with small vessel disease (HR 0.38, 95% CI 0.14-1.04, p for interaction = 0.261). The incidence of BARC type 3 or 5 bleeding rate 2.5% for ticagrelor monotherapy after 3-month DAPT, and 5.6% for ticagrelor-based 12-month DAPT (p = 0.052) in patients with small vessel disease (HR 0.44, 95% CI 0.19-1.01, p for interaction = 0.322). In the 3-month landmark analysis, ticagrelor monotherapy significantly reduced BARC type 3 or 5 bleeding in patients with small vessel disease (HR 0.09, 95% CI 0.01-0.69, log-rank p = 0.005) while demonstrating a similar incidence of TLF compared to ticagrelor based 12-month DAPT during the 3-12 months period. There are no significant interactions between the antiplatelet strategy regarding the 12-month incidence of ischemic and bleeding complications. Ticagrelor monotherapy demonstrated a reduction in bleeding complications after a 3-month period of DAPT without increasing the rate of TLF, when compared to ticagrelor-based 12-month DAPT, specifically in patients with small vessel disease. Clinical Trial Registration: www.ClinicalTrials.gov, identifier, NCT02494895.

Ten-year clinical outcomes from a randomized trial comparing new-generation everolimus-eluting stent versus first-generation Sirolimus-eluting stent: Results from the RESET extended study.

New-generation drug-eluting stents (DES) achieved technological innovations and reported clinical advantages as compared with first-generation DES in clinical trials with 3-5 years follow-up. However, detailed clinical outcome data in very long-term follow-up is still scarce. To evaluate 10-year clinical outcomes after first- and new-generation DES implantation. In this extende follow-up study of the RESET, which is a largest randomized trial comparing everolimus-eluting stent (EES) with Sirolimus-eluting stent (SES), the study population consisted of 2892 patients from 84 centers. The primary efficacy and safety endpoints were target lesion revascularization (TLR) and a composite of death or myocardial infarction (MI), respectively. Complete 10-year follow-up was achieved in 87.9% of patients. Cumulative 10-year incidences of TLR and non-TLR were not significantly different between EES and SES (13.9% vs. 15.7%, Log-rank p = 0.20, and 33.4% vs. 31.3%, Log-rank p = 0.30). The cumulative 10-year incidence of death/MI was also not significantly different between the groups (32.5% vs. 34.4%, Log-rank p = 0.18). Cumulative 10-year incidence of definite stent thrombosis was numerically lower in EES than in SES (1.0% vs. 1.7%, Log-rank p = 0.16). The lower risk of EES relative to SES was significant for a composite endpoint of target lesion failure (TLF: 19.6% vs. 24.9%, Log-rank p = 0.001) and target vessel failure (TVF: 26.7% vs. 31.4%, Log-rank p = 0.006). During 10-yearof follow-up, the risks for primary efficacy and safety endpoints were not significantly different between new-generation EES and first-generation SES, although EES compared with SES was associated with a lower risk for composite endpoints such as TLF and TVF.

Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials.

In patients with peripheral arterial disease (PADs), who underwent percutaneous coronary intervention (PCI), little is known about the potential impact of using different new-generation drug-eluting stents (DES) on outcome. In PCI all-comers, the results of most between-stent comparisons-stratified by strut thickness-suggested some advantage of coronary stents with ultrathin-struts. The current post-hoc analysis aimed to assess outcomes of PCI with ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) vs. thin-strut durable polymer zotarolimus-eluting stents (DP-ZES) in patients with PADs. We pooled 3-year patient-level data from two large-scale randomized all-comer trials to compare Orsiro ultrathin-strut BP-SES vs. Resolute-type thin-strut DP-ZES in trial participants with concomitant PADs. BIO-RESORT (December 2012 to August 2015) and BIONYX (October 2015 to December 2016) included all-comer patients who were aged 18 years or older, capable of providing informed consent, and required a PCI. The trials had web-based randomization, with block sizes of 4 and 8, performed in a 1:1:1 or 1:1 fashion. Assessors, research staff, and patients were blinded to the type of stent used. We assessed the composite main clinical endpoint target vessel failure [TVF: cardiac death, target vessel related myocardial infarction (MI), or clinically indicated target vessel revascularization (TVR)], its components, and stent thrombosis. Of 4,830 trial participants, 360 had PADs: 177 (49.2%) were treated with BP-SES and 183 (50.8%) with DP-ZES. Baseline characteristics were similar. For BP-SES, the 3-year TVF rate was 11.0% and for DP-ZES 17.9% [hazard ratio (HR): 0.59, 95% CI: 0.33-1.04; P=0.07]. For BP-SES, the TVR rate was lower than for DP-ZES (4.1% vs. 11.0%; HR: 0.36, 95% CI: 0.15-0.86; P=0.016), but this did not translate into between-group differences in cardiac death or MI. In small vessels (<2.75 mm), the TVR rate was also lower in BP-SES (5.6% vs. 13.9%; HR: 0.32, 95% CI: 0.11-0.91; P=0.024). Definite-or-probable stent thrombosis rates were 1.2% and 2.3% (P=0.43). In PCI patients with PADs, the 3-year TVF incidence was numerically lower in the ultrathin-strut BP-SES vs. the thin-strut DP-ZES group. Furthermore, TVR risk was significantly lower in ultrathin-strut BP-SES, mainly driven by a lower TVR rate in small vessels. BIO-RESORT trial: clinicaltrials.gov (NCT01674803); BIONYX trial: clinicaltrials.gov (NCT02508714).

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.