Sirolimus-eluting Coronary Stent Research Articles

Coronary bifurcation lesion treatment with the BioMime™ branch sirolimus-eluting coronary side-branch stent system: A single-center experience

BackgroundCoronary bifurcation lesions (CBL) comprise 15 %–20 % of percutaneous coronary procedures and remain a challenge despite advances in stent and interventional techniques. The BioMime™ Branch sirolimus-eluting coronary side-branch stent (BBSES) is specifically designed for CBL treatment in conjunction with a standard drug-eluting stent (DES). We report the first single-center experience of treating complex CBL with the novel BBSES. MethodsThis is a retrospective, single-center study involving consecutive prospectively identified patients who underwent treatment of true CBL with the BBSES. The protocol included BBSES+DES implantation in the CBL and simultaneous final kissing balloon inflation. ResultsFifty-eight CBL were treated in 58 consecutive patients (89.6 % men, mean age 69 ± 9.5 years) presenting primarily with stable angina (84.4 %) and true (Medina 1,1,1,) CBL. Procedural success was 100 % without major adverse cardiac events (MACE). At a median follow-up of 18 months, one sudden death was reported that was accounted as possible late stent thrombosis. One patient had spontaneous myocardial infarction due to subacute thrombosis of a DES implanted in the main vessel proximally to the BBSES before the index procedure. Another patient was hospitalized for atrial fibrillation. ConclusionsThis is the first clinical experience to date of true CBL treatment with the BBSES demonstrating high procedural success, no in-hospital MACE and sustained clinical results at a median follow-up of 18 months.

One-Year Outcomes of Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stent in Acute Coronary Syndrome: A Patient-Level Pooled Analysis from Two Indian Registries.

This pooled analysis was conducted to assess the clinical safety and performance of the Supra family (Sahajanand Medical Technologies Ltd., Surat, India) of sirolimus-eluting stents (SES) in patients with acute coronary syndromes (ACSs) including ST-segment elevation myocardial infarction (STEMI) from two real-world all-comers Indian registries at 1 year. We evaluated 1,824 patients with ACS who underwent percutaneous coronary intervention with the Supra family of SES from two real-world Indian registries (891 patients from T-Flex registry and 933 patients from Tetriflex real-world registry). The primary endpoint was the incidence of target lesion failure (TLF) defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR) at 1-year follow-up. The safety endpoint was stent thrombosis at 1-year follow-up. Among a total of 1,824 patients with ACS, 689 (37.8%) patients presented with STEMI. In ACS and STEMI groups, 47.6% and 41.8% patients had multivessel disease, respectively. Of 2,128 lesions in ACS group, 76.7% lesions were type B2/C and 16.2% lesions were totally occluded. In the STEMI group, out of 784 treated lesions, 76.7% were type B2/C lesions and 21.9% were totally occluded. At 1-year follow-up, incidence of TLF was 5.3% (cardiac death: 0.9%, TV-MI: 2.5%, TLR: 1.9%) in patients with ACS and 6.2% (cardiac death: 1.4%, TV-MI: 2.1%, TLR: 2.7%) in patients with STEMI. The 1-year rate of definite/probable stent thrombosis was 0.3% and 0.7% in patients with ACS and STEMI, respectively. This patient-level pooled analysis provides evidence for the safe and effective use of the Supra family of SES in complex patient populations such as ACS and even in STEMI with favorable rates of TLF and stent thrombosis at 1-year follow-up.

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).

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.

Nasolacrimal Duct Coronary Stent Recanalization (NCR): First Cadaver Experience and Its Potential as an Alternative to DCR.

To investigate the feasibility of implanting a drug-eluting cobalt-chromium alloy coronary stent in the nasolacrimal ducts (NLDs) of human cadavers. The pilot study was carried out in 5 NLDs of 4 adult human cadavers. Sirolimus-eluting coronary stents of 2 mm in width and lengths of 8 and 12 mm, which were mounted on balloon catheters, were used. Following dilatation of the NLDs, the balloon catheters were introduced into the NLDs under direct endoscopy guidance. The stents were delivered following dilatation of the balloon to 12 ATMs and secured in a locked (spring out) position. The balloon is then deflated and securely extubated. The dacryoendoscopy confirmed the stent position. The lacrimal system was then dissected to assess several key parameters like the uniformity of the NLD expansion, anatomical interactions of the NLD mucosa with the stent rings and struts, integrity of the soft and bony NLD, stent movement on mechanical push and pull, and ease of manual removal. The cobalt-chromium alloy coronary stents could be delivered with ease and secured in the cadaveric NLDs. Its position was confirmed by a dacryoendoscopy and later by the direct NLD dissection. The NLD was uniformly dilated 360° with a wide and uniform lumen. NLD mucosa was noted to be uniformly distributed in spaces between the stent rings without influencing the expanded lumen. Following the lacrimal sac's dissection, the NLD stent showed significant resistance to downward movement but could be easily retrieved with forceps. The 12-mm stents could reach the near total length of the NLD with good luminal expansion. The integrity of the bony and soft-tissue NLD was maintained. The learning curve is shallow if the surgeon is adept with the techniques of balloon dacryoplasty. Drug-eluting cobalt-chromium alloy coronary stents can be precisely deployed and secured within the human NLDs. The study is the first of its kind to demonstrate the technique of NLD coronary stent recanalization in human cadavers. It is a step forward in the journey to evaluate their use in patients with primary acquired NLD obstructions and other NLD disorders.

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents: BIOFLOW V Final 5-Year Outcomes.

Randomized trials have demonstrated the superiority of ultrathin strut drug-eluting stents compared with alternative stent designs. Whether these differences persist over late-term follow-up is uncertain. This study sought to compare late-term (5-year) clinical outcomes among patients treated with ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81 µm) durable polymer everolimus-eluting stents (DP EES). BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international, 2:1 randomized trial comparing percutaneous coronary intervention with ultrathin strut BP SES versus thin strut DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Prespecified outcomes through 5 years were assessed. Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 5-year rates of TLF were 12.3% for BP SES and 15.3% for DP EES (P = 0.108). Revascularization with BP SES was associated with a significantly lower target vessel-related myocardial infarction (6.6% vs 10.3%, P = 0.015) and late/very late definite/probable stent thrombosis (0.3% vs 1.6%, P = 0.021). Ischemia-driven target lesion revascularization was numerically but not significantly lower with BP SES (5.9% vs 7.7%, P = 0.202). Cardiac death rates were 2.6% versus 1.9% (P=0.495) for BP SES and DP EES, respectively. In a large, randomized trial, TLF and the individual outcomes of cardiac death and target lesion revascularization at 5 years were similar among patients treated with BP SES versus DP EES. Both target vessel-related myocardial infarction and late/very late definite/probable stent thrombosis were significantly lower with BP SES. These results confirm the durability of safety and the effectiveness of percutaneous coronary intervention with ultrathin BP SES.

Outcomes of Supraflex Sirolimus-eluting Coronary Stents

Background: The development of a sirolimus-eluting coronary stent (SES) was a big step forward in interventional cardiology. SES has been demonstrated in large, randomized clinical studies to reduce angiographic restenosis and target vessel revascularization (TVR) when compared to bare-metal stents and other drug-eluting stents (DESs). However, there is little information on the outcomes of Indian patients treated with Drug-eluting stents (DES). As a result, the study's goal was to assess the efficacy of Supraflex sirolimus-eluting coronary stents in the treatment of coronary artery disease and to identify severe adverse cardiovascular and cerebrovascular events. Methods: This single-center, observational, nonrandomized study enrolled unselected real-world patients at a tertiary care center who had undergone implantation with Supraflex sirolimus-eluting stents. The primary endpoint of the study was major adverse cardiovascular and cerebrovascular events (MACCE), which is a conglomeration of cardiac death, target lesion revascularization, TVR, cerebrovascular accident (CVA), and heart failure at 1-year follow-up. Results: A total of 100 patients were intervened successfully with sirolimus-eluting stents. Out of total patients, diabetes and hypertension were observed in 38% and 35% of patients, respectively. According to the American College of Cardiology/American Heart Association classification, there were 68% of type B lesions and 32% of type C lesions. At 1-year follow-up, major adverse cardiovascular events were 11%, a composite of 4% target lesion revascularization, 3% target vessel revascularization, 1% CVA, and 5% heart failure. Diabetes (P = 0.02), hypertension (P = 0.01), kidney dysfunction (P = 0.002), and left ventricular (LV) function (P = 0.01) strongly correlated with outcome (MACCE). Conclusion: There was an acceptable rate of adverse events after implantation of the Supraflex sirolimus-eluting stents, although slightly higher than in other studies. Diabetes, hypertension, kidney dysfunction, and LV function strongly correlate with the outcome (MACCE).

Five-Year Impacts of Antithrombotic Therapy Based on 10-Year Clinical Outcomes of Cypher™ Stent Implantation.

IntroductionFew researchers have investigated the optimal long-term antithrombotic therapy regimen, especially after first-generation drug-eluting stent (DES) use. This study aimed to evaluate the impact of mid-term antithrombotic therapy on long-term outcomes in patients treated with the first sirolimus-eluting coronary stent (Cypher™).MethodsBetween 2004 and 2009, 1021 patients underwent Cypher™ implantation at our institute; among them, 567 patients had available data on antithrombotic therapy at year 5. We assessed patients’ antithrombotic therapy at year 5 post Cypher™ implantation and examined their association with adverse events from year 5 to year 10 post Cypher™ implantation.ResultsPatients with dual-antiplatelet therapy (DAPT) at year 5 had significantly lower risk of stent thrombosis (ST) than those with single-antiplatelet therapy (SAPT) (hazard ratio [HR] 0.24, p = 0.034). The HR of major bleeding in DAPT, compared to SAPT, was high, but the difference was not significant (HR 1.72, p = 0.26). Risk of major bleeding was significantly higher in patients on oral anticoagulants (OAC) than in those in other groups (OAC/SAPT; HR 5.31, p = 0.0048, OAC/DAPT; HR 3.08, p = 0.022), without significant reduction in the risk of cardiovascular events.ConclusionsThe incidence of ST after Cypher™ implantation in patients with DAPT at year 5 was significantly lower than that in SAPT. However, the risk of bleeding was higher with DAPT than with SAPT. Moreover, the risk of major bleeding was significantly higher in patients on anticoagulant therapy than in other patients. New options for the use of antithrombotic drugs after percutaneous coronary intervention warrant further studies on the optimal antithrombotic therapy for first-generation DES.

Clinical follow-up of long nontapered sirolimus-eluting coronary stent in real-world patients with de novo lesions. The Billar registry

Clinical follow-up of long nontapered sirolimus-eluting coronary stent in real-world patients with de novo lesions. The Billar registry

Twelve-month clinical outcomes of "nano-crush technique" for the treatment of bifurcation lesions using ultra-thin (60 µm) sirolimus-eluting coronary stents.

Provisional stenting is preferred for bifurcation lesion; however, certain anatomical substrate does require two stents as a part of dedicated stent technique. Here, the present study evaluated outcomes of ultra-thin (60 µm) Supra family sirolimus-eluting stent (SES) (Sahajanand Medical Technologies Limited, Surat, India) for dedicated bifurcation lesions using nano-crush technique at 12 months angiographic follow-up. This was prospective, single-center observational study which enrolled patients with de novo bifurcation lesion and underwent angioplasty with Supra family SES using nano-crush technique at a tertiary care center in India, between March-2017 and February-2019. Primary endpoint at 12 months was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included patient-oriented composite endpoint (POCE), all-cause death, any revascularization, clinically driven target vessel revascularization, stent thrombosis, periprocedural and spontaneous MI, and device failure. The study enrolled total 63 patients with a mean age of 62.5±4.9 years and had male dominance (89%). Left main (LM) bifurcation and non-LM bifurcation were observed in 21 (33%) and 42 (67%) patients, respectively. Total 50 (80%) patients had Medina class- 1,1,1. At 12 months, TLF occurred in 4 (6%) patients which included one cardiac death (1.5%), two (3.0%) TV-MI, and one CD-TLR (1.5%). POCE was observed in 6 (9.6%) patients. Stent failure was seen in 2 (3.1%) patient and one patient (1.5%) developed late stent thrombosis. Twelve months angiographic follow-up indicated intact stent patency in all other patients. On multivariate analysis, LM bifurcation, renal dysfunction, LM bifurcation with renal dysfunction, ejection fraction (<35%) and calcified lesion were found as predictors of TLF. Dedicated stenting with ultra-thin Supra family SES for complex bifurcation lesion using nano-crush technique reported acceptable clinical outcomes among real-world patients and can be performed safely with ease without any procedural complications.

Outcomes and regional differences in practice in a worldwide coronary stent registry

ObjectiveThe primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to...

Outcomes of supraflex sirolimus eluting coronary stents

Background: The introduction of Sirolimus Eluting Coronary Stents (SES) was a major breakthrough in interventional cardiology. The large, randomized, clinical trials using SES have shown a remarkable reduction in angiographic restenosis and target vessel revascularization (TVR) compared with bare-metal stents as well as other drug-eluting stents (DESs). However, there is only limited data on the outcome of Indian patients treated by DES of Indian origin. The purpose of the study was to evaluate the outcomes of the supraflex sirolimus-eluting coronary stents for the treatment of coronary artery disease and to determine major adverse cardiovascular and cerebrovascular events (MACCE). Materials and Methods: This was a single-centre, observational, nonrandomized study that enrolled unselected real-world patients at a tertiary care center who had undergone implantation with supraflex sirolimus-eluting stents. The primary end-point of the study was MACCE, which is a conglomeration of cardiac death, target lesion revascularization (TLR), TVR, cerebrovascular accident (CVA), and heart failure at 1-year follow-up. Results: A total of 100 patients were intervened successfully with sirolimus-eluting stents. Out of total patients, diabetes and hypertension were observed in 38% and 35% of patients. According to ACC/AHA classification, there were 68% Type B lesions and 32% Type C lesions. At 1-year follow-up, MACE was found to be 11%, which is a composite of 4% TLR, 3% TVR, 1% CVA, and 5% heart failure. Diabetes (P = 0.02), hypertension (P = 0.01), kidney dysfunction (P = 0.002), and LV function (P = 0.01) strongly correlate with outcome (MACCE). Conclusion: There was an acceptable rate of adverse events after implantation of the supraflex sirolimus-eluting stents, although it was slightly higher compared to other studies. Diabetes, hypertension, kidney dysfunction, and LV function strongly correlate with outcome (MACCE).

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk

BackgroundThe appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear.MethodsOne month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population.ResultsAmong the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, −0.23 percentage points; 95% confidence interval [CI], −1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, −1.29 to 1.51; P=0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, −2.82 percentage points; 95% CI, −4.40 to −1.24; P<0.001 for superiority).ConclusionsOne month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding. (Funded by Terumo; MASTER DAPT ClinicalTrials.gov number, NCT03023020.)

Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study

[Figure: see text].

Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.

This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.

Twelve-months clinical outcomes of biodegradable polymer-coated sirolimus-eluting coronary stent in real-world patients: A single-center experience.

This study was designed to evaluate the safety and performance of Metafor™ SES in real-world patients with coronary artery disease. This was retrospective, single-centre, post-marketing, observational study. The primary endpoint was the occurrence of major adverse cardiac event (MACE). A total of 141 patients (187 lesions) were treated with the study device. The average stent length and diameter was 24.75 ± 9.50 mm and 2.93 ± 0.38 mm, respectively. The cumulative incidence of MACE was 1.42%. No incidence of stent thrombosis was observed at 12-months follow-up. This retrospective study demonstrated favourable safety and performance of Metafor™ SES.

The Bioengineered Combo Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent in Patients with Chronic Total Occlusion Evaluated by Clinical Outcome and Optical Coherence Tomography Imaging Analysis.

We sought to determine the effects of the use of a Bioengineered Combo Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent (Combo® DTS) in patients with chronic total occlusion (CTO) by evaluating clinical outcomes and by performing an optical coherence tomography (OCT) analysis. We retrospectively analyzed data from 39 patients who had successfully undergone OCT-guided revascularization of a CTO being treated with a Combo® DTS. Clinical assessment, angiography (with quantitative coronary angiography analysis) and OCT examination were performed at baseline and at follow-up. The median follow-up period was 189 days, ranging from 157 to 615 days. At follow-up, revascularization was required due to angiographic restenosis in 40% (14 of 35) of patients. OCT analysis detected neointima proliferation in 23 (76.6%) patients. Neointima formation was often associated with microvessels in 18 patients (60%). Neoatheroslcerosis was observed in 2 (6.6%) patients. Malapposition was found in 4 patients (13.3%), and stent fractures were found in 11 patients (36.6%). Rate of strut coverage was 96.3% at follow-up. In conclusion, the implantation of a Combo® DTS after successful CTO recanalization was associated with a restenosis rate of 40% despite good stent implantation at baseline, proven by OCT. Neointima formation was found as a main contributor to restenosis. Nevertheless, we observed a low rate of major cardiovascular events in our follow-up.

A prospective multicentre randomized all-comers trial to assess the safety and effectiveness of the ultra-thin-strut sirolimus-eluting coronary stent Supraflex: 2-year results of the TALENT trial

Abstract Background and purpose Supraflex is a sirolimus-eluting stent with a biodegradable polymeric coating and 60um ultra-thin struts. In the TALENT study, we found the Supraflex stent was non-inferior to the Xience stent for a device-oriented composite endpoint (DOCE, defined as cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation) at 12 months in an all-comer population. Additionally, per-protocol analysis showed a significantly lower clinically indicated target lesion revascularisation (CI-TLR) in the Supraflex group than in the Xience group. We now present the 2-year follow-up results. Methods The TALENT study was a prospective, randomised, single-blind, multicentre study across 23 centres in Europe. Eligible participants underwent percutaneous coronary intervention in an all-comers fashion in vessels of 2.25–4.5 mm. Patients were randomized (1:1) to implantation of either Supraflex or Xience (NCT02870140). Results Between October 21, 2016 and July 3, 2017, 720 patients with 1046 lesions were randomly assigned to Supraflex, and 715 patients with 1030 lesions to Xience. At 24 months, DOCE had occurred in 49 patients (6.9%) in the Supraflex group and in 56 patients (7.9%) in the Xience group (absolute difference −1.0% [95% CI: −3.7 to 1.7], Plog-rank=0.491). Per-protocol analysis at 24 months showed CI-TLR occurred in 21 and 30 patients in the Supraflex and Xience, respectively (3.3% versus 4.5%, absolute difference −1.2%, [95% CI: −3.3 to 0.9], Plog-rank=0.267). Conclusion In an all-comer population, at 2-year follow-up, the use of Supraflex stent was at least as safe and efficacious as Xience stent. However, the significantly lower rate of CI-TLR shown in patients treated with Supraflex at 1-year was no longer retained in the 2-year results. Whether theoretical advantage of ultra-thin strut drug eluting stents Supraflex can translate into clinical benefit or not will be further elucidated through a total of 3 years of follow-up. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): SMT

Long term safety and efficacy of the yukon choice flex sirolimus-eluting coronary stent- a real world data from india

Long term safety and efficacy of the yukon choice flex sirolimus-eluting coronary stent- a real world data from india