Zotarolimus-eluting Stent Research Articles

Comparison of long-term clinical outcomes among zotarolimus-, everolimus-, and biolimus-eluting stents in acute myocardial infarction patients with renal impairment.

It is important to determine the best drug-eluting stent (DES) for acute myocardial infarction (AMI) in patients with renal impairment. In this studythe outcomes of everolimus-eluting stents (EESs), zotarolimus-eluting stents (ZESs) and biolimus-eluting stents (BESs) were evaluated. From the Korea Acute Myocardial Infarction-National Institutes of Health registry, a total of 1,470 AMI patients with renal impairment undergoing percutaneous coronary intervention (PCI) were enrolled (816 with EES, 345 with ZES, and 309 with BES). Renal impairment was defined as creatinine clearance < 60 mL/min/1.73 m² estimated by the Cockcroft-Gault method. Major adverse cardiac and cerebrovascular events were determined as the composite of all-cause death, non-fatal myocardial infarction (MI), cerebrovascular accident, any revascularization, rehospitalization and stent thrombosis. All clinical outcomes were analyzed. The baseline characteristics of the patients revealed no significant difference between the three groups, except for Killip classification > 2, beta-blockers, lesion type, vascular approach, staged PCI, left main coronary artery (LMCA) complex lesions, LMCA PCI, and the number and length of implanted stents. In the Kaplan-Meier analysis, similar clinical outcomes were derived from the unadjusted data between the three DES groups. However, after the inverse probability of treatment weighting, a statistically significant difference was found in non-fatal MI, which implied a higher incidence of non-fatal MI in the ZES group than in the other two DES groups. In AMI patients with renal impairment, there was no significant difference between the three stent groups in terms of long-term clinical outcomes, except for non-fatal MI.

B-16 | The RESOLUTE ONYX Bifurcation Study: 3-Year Outcomes in Patients With Coronary Bifurcation Lesions

Coronary bifurcation lesions are challenging to treat, with higher risk of procedural complications and adverse events than non-bifurcation lesions. In this study, we evaluated the 3-year clinical outcomes in patients with bifurcation lesions treated with the Resolute Onyx zotarolimus-eluting stent (ZES). Patients with a single bifurcation target lesion undergoing planned treatment using the provisional stenting technique were enrolled at 25 centers in the United States and Europe. Inclusion criteria included main branch reference vessel diameter (RVD) 2.25-5.0 mm, lesion length ≤35 mm, stenosis ≥50%, side branch ≥2.0 mm, and TIMI flow ≥2. The primary endpoint was target vessel failure (TVF) at 1-year. Follow-up was for 3 years. Between Apr 2017 to Dec 2019, 205 patients with 209 bifurcation lesions (of 267 total) were enrolled. Patients were 66.6 ± 10.7yrs, 21.5% female, 26.3% type II diabetic, 35.1% had previous PCI. Core lab analysis showed that 32.5% of lesions were true bifurcation lesions per Medina classification (1.1.1, 1.0.1, 0.1.1). Target vessel RVD was 2.65 ± 0.47 mm and lesion length was 17.03 ± 9.64 mm. 12.1% of patients had TVF through 3 years. There were no instances of stent thrombosis (Figure). Patients with coronary bifurcation lesions treated with the Resolute Onyx ZES had favorable long-term clinical outcomes at 3 years, with only 6% of target lesion revascularization and no cases of stent thrombosis. These results support the use of Resolute Onyx ZES to treat complex coronary bifurcation lesions using a planned provisional stenting technique, safely and effectively.

Long-term follow-up of contemporarydrug-eluting stent implantation in diabetic patients: Subanalysis of a randomized controlled trial.

The elevated risk of adverse events following percutaneous coronary intervention in diabetic patients persists with newer-generation DES. The polymer-free amphilimus-eluting stent (PF-AES) possesses characteristics with a potentially enhanced performance in patients with diabetes. Data from the 1-year follow-up period has been previously published. The aim of this subanalysis was to assess long-term performance of two contemporary drug-eluting stents (DES) in a diabetic population. In the ReCre8 trial, patients were stratified for diabetes and troponin status, and randomized to implantation of a permanent polymer zotarolimus-eluting stent (PP-ZES) or PF-AES. The primary endpoint was target-lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization. Clinical outcomes between discharge and 3 years follow-up were assessed. A total of 302 patients with diabetes were included in this analysis. After 3 years, TLF occurred in 12.5% of PP-ZES patients versus 10.0% in PF-AES patients (p = 0.46). Similarly, the separate components of TLF were comparable between the two study arms. The secondary composite endpoint of NACE was higher in the PP-ZES arm with 45 cases (29.6%) versus 30 cases (20.0%) in the PF-AES arm (p = 0.036). In the insulin-dependent diabetic population, TLF occurred in 19.1% of PP-ZES patients versus 10.4% of PF-AES patients (p = 0.21). NACE occurred in 40.4% of PP-ZES patients versus 27.1% of PF-AES patients (p = 0.10). This subanalysis shows that the use of PF-AES results in similar clinical outcomes as compared to PP-ZES, yet some benefits of use of PF-AES in diabetic patients may prevail. Future dedicated trials should confirm these findings.

Coronary Stenting in High Bleeding Risk Patients With Small Coronary Arteries Followed by One-Month Dual Antiplatelet Therapy: Onyx ONE Clear.

Small reference vessel diameters (RVDs) are a predictor of ischemic events after coronary stenting. Among patients at high bleeding risk (HBR) precluding long-term dual antiplatelet therapy (DAPT), those with small vessel disease (SVD) constitute an especially high-risk subgroup. Here, we evaluated the results of a durable-polymer, coronary zotarolimus-eluting stent (ZES) for the treatment of patients with SVD at HBR with 1-month DAPT. In the prospective, multicenter Onyx ONE (One-Month DAPT) Clear study, 1506 patients at HBR treated with a ZES that discontinued DAPT at 30 days were included. The clinical outcomes of patients undergoing treatment of lesions with an RVD of ≤2.5 mm (SVD group, as determined by the angiographic core laboratory) were compared with patients without SVD. The primary end point was the composite of cardiac death or myocardial infarction between 1 and 12 months. Small vessel diameter treatment was performed in 489 (32.5%) patients. Patients with SVD were more likely to be women, have undergone a previous percutaneous intervention, and have multivessel coronary artery disease than patients without SVD. There were no significant differences in lesion, device, or procedural success between the groups. The Kaplan-Meier rate estimate of the primary end point was 8.5% and 6.8% in patients with SVD and those without SVD, respectively (P = .425). No significant differences were found in any secondary end point. The Kaplan-Meier rate of stent thrombosis was 0.6% and 0.8% in patients with SVD and those without SVD, respectively (P = .50). Among patients at HBR treated with a ZES and 1-month DAPT, those with SVD had favorable 12-month ischemic and bleeding outcomes, which were comparable with those of patients with larger caliber vessels.

Procedural Performance of Ultrathin, Biodegradable Polymer-Coated Stents Versus Durable Polymer-Coated Stents Based on Intracoronary Imaging.

Thinner stent struts might lead to a higher risk of recoil and subsequently a smaller minimal stent area (MSA), which is known to be the strongest predictor of stent failure. We compared procedural performance between an ultrathin-strut biodegradable-polymer sirolimus-eluting stent (BP-SES) and a durable-polymer zotarolimus-eluting stent (DP-ZES) using intracoronary imaging. A consecutive cohort of patients underwent percutaneous coronary intervention (PCI) with either BP-SES or DP-ZES in a pseudorandomized fashion between July 2018 and October 2019. In the present subanalysis, we included cases in which post-PCI imaging with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was performed. The primary endpoint of the study was MSA. Secondary endpoints included percentage stent expansion and presence of residual edge disease, malapposition, tissue protrusion, submedial edge dissections, or edge hematoma. A total of 141 treated lesions (78 BP-SES and 63 DP-ZES) in 127 patients were analyzed. Median age was 69.3 years (interquartile range [IQR], 57.3-75.6) and 74.0% of patients were male. All baseline and procedural characteristics were comparable between both groups. Median MSA was 5.80 mm² (IQR, 4.40-7.24) for BP-SES and 6.35 mm² (IQR, 4.76-8.31) for DP-ZES (P=.15). No significant differences in stent expansion, residual edge disease and presence of malapposition, tissue protrusion, submedial edge dissections, or edge hematomas were found. Stent diameter and stent length were found to be independent predictors of MSA. No significant differences in MSA were found between lesions treated with BP-SES vs DP-ZES. BP-SES and DP-ZES were comparable in terms of procedural performance.

One-year outcomes of polymer-free amphilimus-eluting stents versus durable polymer zotarolimus-eluting stents in patients with diabetes mellitus: a meta-analysis

BackgroundDiabetes mellitus (DM) and cardiovascular diseases often co-exist. Today, percutaneous coronary intervention (PCI) is the preferred revascularization procedure for majority of patients with coronary artery disease. Polymer-free amphilimus-eluting stents (AES) represent a novel elution technology in the current era of drug-eluting stents. In this analysis, we aimed to systematically compare the cardiovascular outcomes which are associated with polymer-free amphilimus-eluting stents (AES) versus the durable polymer zotarolimus-eluting stents (ZES) for the treatment of patients with DM.MethodsHttp://www.ClinicalTrials.gov, EMBASE, Web of Science, MEDLINE, Cochrane database and Google Scholar were searched for publications comparing polymer-free AES versus durable polymer ZES in patients with DM. Selective cardiovascular outcomes were assessed. Statistical analysis was carried out by the latest version of the RevMan software. Risk ratio (RR) with 95% confidence interval (CI) was used to represent the data analysis.ResultsFour studies with a total number of 1795 participants with DM whereby 912 patients were assigned to be revascularized by the polymer-free AES and 883 patients were assigned to be revascularized by the durable polymer ZES were included in this analysis. In patients with DM, at one year, polymer-free AES were associated with significantly lower risk of major adverse cardiac events (MACEs) (RR: 0.69, 95% CI: 0.54–0.88; P = 0.002) and target lesion failure (TLF) (RR: 0.66, 95% CI: 0.48–0.91; P = 0.01) compared to durable polymer ZES. However, there was no significant change in all-cause mortality (RR: 0.79, 95% CI: 0.51–1.22; P = 0.28), cardiac death and the other cardiovascular outcomes. Similar risk of total stent thrombosis (RR: 1.13, 95% CI: 0.60–2.13; P = 0.70), including definite stent thrombosis (RR: 1.12, 95% CI: 0.38–3.31; P = 0.84), probable stent thrombosis (RR: 0.87, 95% CI: 0.37–2.09; P = 0.76), possible stent thrombosis (RR: 1.19, 95% CI: 0.50–2.87; P = 0.69) and late stent thrombosis (RR: 1.00, 95% CI: 0.17–5.72; P = 1.00) as between polymer-free AES and durable polymer ZES in patients with DM.ConclusionsAt 1 year follow-up, polymer-free AES were associated with significantly lower MACEs and TLF compared to durable polymer ZES in these patients with DM, without any increase in mortality, stent thrombosis and other cardiovascular outcomes. However, this analysis is only based on a follow-up time period of one year, therefore, future research should focus on the long term follow-up time period.

Clinical outcomes of percutaneous coronary intervention and rotational atherectomy using second generation drug eluting stents: a Korean multicentre analysis

Abstract Background The aim of this study was to compare the clinical outcomes of different second generation drug-eluting stents (DES) in patients with calcified coronary lesions who underwent percutaneous coronary intervention using rotational atherectomy. Methods This study was based on a multicentre registry which enrolled patients with calcified coronary artery disease who received RA during between January 2010 and October 2019 from 9 tertiary centres in Korea. The primary outcome was target-vessel failure (TVF), defined as the compositae of cardiac death, target-vessel myocardial infarction (MI), and target-vessel revascularisation (TVR). The secondary outcomes were all-cause death, cardiac death, target vessel MI, TVR, cardiovascular accident, stent thrombosis, and total bleeding. Results 540 patients who underwent PCI after RA were enrolled and followed up for a median period of 16.1 months. From this registry, 439 patients who were treated using second generation DES were selected for further analysis. They were divided into four groups based on the characteristics of the stents used during the procedure. [Group I cobalt-chromium sirolimus eluting stent (CoCr-SES): Ultimaster 48 &amp; Orsiro 30, Group II platinum-chromium everolimus eluting stent (PtCr-EES): Synergy 93 &amp; Promus 70, Group III cobalt-chromium everolimus eluting stent (CoCr-EES): Xience 105, Group IV zotarolimus eluting stent (ZES): Resolute 93] There was no inter-group difference in procedural success rates, and the primary outcome of TVF showed no difference across the four groups (I: 10.3%, II: 13.5%, III: 13.3%, IV: 15.1%, log-rank p=0.922). Even after multivariate Cox regression analysis, there was no significant difference in TVF, or the secondary outcomes of all-cause death, cardiac death, target vessel MI, TVR, cardiovascular accident, stent thrombosis, and total bleeding. Conclusions There was no difference in procedural success rates and clinical outcomes between four different types of second-generation DES (CoCr-SES, PtCr-EES, CoCr-EES, ZES) in patients who underwent PCI using RA. Funding Acknowledgement Type of funding sources: None.

Patients With Diabetes at High Bleeding Risk With 1-Month Dual Antiplatelet Therapy: Onyx ONE Clear Results.

Patients with diabetes mellitus (DM) are at a higher risk of ischemic events compared with patients without DM. Percutaneous coronary intervention (PCI) with the Resolute Onyx zotarolimus-eluting stent (ZES) followed by 1-month dual antiplatelet therapy (DAPT) is safe and effective in patients with high bleeding risk. However, outcomes in patients with DM are not fully understood. Onyx ONE Clear was a prospective, multicenter study that included patients receiving the Resolute Onyx ZES during PCI and 1-month DAPT. The primary end point was a composite of cardiac death (CD) or myocardial infarction from 1 month to 12 months. Among the Onyx ONE Clear population (N = 1506), 39% had DM. Patients with DM had a higher incidence of hypertension, hyperlipidemia, and previous PCI and a higher body mass index than patients without DM. Patients with diabetes were also younger, more likely to be anemic, and experience renal failure. After adjusting for baseline differences between the groups, the Kaplan-Meier rates of CD or myocardial infarction (9.3% vs 6.1%; P = .122, unadjusted P = .010) and target lesion failure (10.2% vs 7.7%; P = .294, unadjusted P = .056) between 1 month and 12 months were not significantly different in patients with and without DM. The rates of target lesion revascularization were also similar in both groups, and stent thrombosis was very low and comparable in both arms after adjusting for baseline differences. Non-CD and bleeding were more frequent in patients with DM. Patients with diabetes treated with the Resolute Onyx ZES followed by 1-month DAPT had favorable 12-month ischemic outcomes after accounting for baseline differences between patients with and without DM, supporting the safety and efficacy of the treatment in selected patients with DM at high bleeding risk.

Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions.

Outcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions. This study sought to compare the relative performance of different types of DES for de novo long (≥25mm) coronary artery lesions. Using a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9months. The primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES. In this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120).

Procedural Performance of Ultrathin, Biodegradable-Polymer-Coated Stents Versus Durable-Polymer-Coated Stents Based on Intracoronary Imaging

Thinner stent struts might lead to a higher risk of recoil and subsequently a smaller minimal stent area (MSA), which is known to be the strongest predictor of stent failure. We compared procedural performance between an ultrathin-strut biodegradable-polymer sirolimus-eluting stent (BP-SES) and a durable-polymer zotarolimus-eluting stent (DP-ZES) using intracoronary imaging.A consecutive cohort of patients underwent percutaneous coronary intervention (PCI) with either BP-SES or DP-ZES in a pseudorandomized fashion between July 2018 and October 2019. In the present subanalysis, we included cases in which post-PCI imaging with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was performed. The primary endpoint of the study was MSA. Secondary endpoints included percentage stent expansion and presence of residual edge disease, malapposition, tissue protrusion, submedial edge dissections, or edge hematoma.A total of 141 treated lesions (78 BP-SES and 63 DP-ZES) in 127 patients were analyzed. Median age was 69.3 years (interquartile range [IQR], 57.3-75.6) and 74.0% of patients were male. All baseline and procedural characteristics were comparable between both groups. Median MSA was 5.80 mm² (IQR, 4.40-7.24) for BP-SES and 6.35 mm² (IQR, 4.76-8.31) for DP-ZES (P=.15). No significant differences in stent expansion, residual edge disease and presence of malapposition, tissue protrusion, submedial edge dissections, or edge hematomas were found. Stent diameter and stent length were found to be independent predictors of MSA.No significant differences in MSA were found between lesions treated with BP-SES vs DP-ZES. BP-SES and DP-ZES were comparable in terms of procedural performance.

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.

Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. This study reports the final 2-year results of the randomized Onyx ONE trial. The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95%CI: -3.1% to 4.2%; P=0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95%CI: -2.5% to 4.8%; P=0.54). Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).

Safety and Efficacy of Contemporary Drug-Eluting Stents in Patients With ST-Segment Elevation Myocardial Infarction and a High Ischemic Risk.

BackgroundIn patients with ST-elevation myocardial infarction (STEMI) with a high risk of ischemic events, the safety and efficacy of drug-eluting stent (DES) are unclear.MethodsBased on the nationwide, multicenter, prospective registry, we selected 1,592 patients who underwent primary percutaneous coronary intervention (PCI) with everolimus-(EES) and zotarolimus-eluting stent (ZES) for STEMI with a high risk of an ischemic event. The occurrence of target lesion failure (TLF) for 3 years, defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR), was evaluated.ResultsThe prevalence of high ischemic risk features was observed in 43.4% (2,744/6,325) of overall patients with STEMI. Among them, a total of 1,078 and 514 patients were treated with EES and ZES, respectively. At 3 years, the risk of TLF was not significantly different between the two groups (p = 0.93). In addition, the incidence of cardiac death, TV-MI, ID-TLR, and definite/probable stent thrombosis (ST) were also not different between the two groups. Moreover, elderly patients (age > 75 years) and PCI for the left main disease were identified as independent predictors of TLF.ConclusionImplantation of EES or ZES provided comparable clinical outcomes in STEMI patients and high ischemic risks.

Experience with zotarolimus eluting stent in left main percutaneous coronary intervention at a very long-term follow-up

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Drug eluting stents (DES) has improved the results of percutaneous coronary intervention (PCI) in terms of safety and effectiveness in left main coronary artery (LMCA) disease. Zotarolimus is a second-generation drug with excellent clinical outcomes but nowadays their results are unclear in this subgroup of high-risk coronary lesions. Purpose The main objective of this study was to evaluate the efficacy and safety of zotarolimus eluting stent (ZES) in LMCA disease at 14-year follow-up. Methods We prospectively included 432 consecutive patients (69 ± 12 years, 75.5% male) with LMCA disease treated with PCI and ZES between June 2006 and June 2020. We evaluated the presence of major adverse cardiovascular events (MACE) defined as cardiac death, nonfatal myocardial infarction, target lesion revascularization (TLR) and stent thrombosis, after 14-year clinical follow-up (median 61 months). Results 52.8% of patients had stable coronary disease and 47.2% acute coronary syndrome (38.2% Non-STEMI and 9% STEMI). 40.7% were diabetic patients and 40.8% presented moderate-severe left ventricular systolic dysfunction. 5.8% were protected LMCA and 81.7% bifurcated lesions. An intra-aortic balloon pump was needed in 4.9% of the cases. Mean logistic EuroSCORE was 6.7% and Syntax score was ≥ 23 in 73.1% of patients. The most frequently bifurcation technique employed in LMCA was "provisional stenting" in 67.1% of cases with an angiographic success of 99.3%. Complication rate in the procedure was 4.6% with one intraoperative death. During follow-up, MACE rate at 14 years was 17.4% (12.5% cardiac death, 3.5% nonfatal myocardial infarction, 4.2% TLR and thrombosis rate 0.5%). We observed significant differences in the occurrence of MACE in diabetic patients (p=0.002), chronic kidney insufficiency (p&amp;lt;0.001), severe left ventricular systolic dysfunction (p&amp;lt;0.001) and patients in which we didn´t perform final kissing balloon (p=0.03). 21.07% of patients had an angiographic follow-up. Conclusions PCI treatment with ZES in LMCA disease is safe and effective with a low rate of immediate complications and a low rate of mayor cardiac events at very long-term follow-up. Patients with diabetes mellitus or chronic kidney insifficiency, severe left ventrcular systolic dysfinction or those in wich didn´t performe a final kissing balloon have worse prognosis.

Real-world clinical outcomes of left main percutaneous coronary intervention in diabetic patients at a long-term follow-up

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Coronary artery disease in diabetic patients has more aggressivity and tends to be a more complex disease characterized by small, diffuse, calcified, multivessel involvement that it presents higher in-stent restenosis rates after percutaneous coronary intervention (PCI). Besides, left main coronary artery (LMCA) disease has poor prognosis and it usually associates more severe lesions in other coronary arteries. Currently, the PCI in LMCA disease in these patients is controversial. Purpose The main objective of this study was to evaluate the efficacy and safety of PCI in LMCA disease in diabetic patients at a 14-year follow-up. Methods We prospectively included 228 consecutive patients (71 ± 11 years, 70.2% male) with LMCA disease treated with PCI between June 2006 and June 2020. We evaluated the occurrence of major adverse cardiovascular events (MACE) defined as cardiac death, nonfatal myocardial infarction, target lesion revascularization (TLR) and stent thrombosis after a 14-year clinical follow-up (median 66 months). Results 53.1% of patients had stable coronary disease and 46.9% acute coronary syndrome (42.1% Non-STEMI and 4.8% STEMI). 40.3% of patients presented moderate-severe left ventricular systolic dysfunction. 63.6% had LMCA and ≥ 2 vessels disease and 43% had a SYNTAX score ≥ 33. Mean Logistic Euroscore was 7.2%. The most frequent bifurcation technique employed in LMCA was "provisional stenting" in 65.4% and zotarolimus-eluting stent was used in 75.8% of cases. Angiographic success rate was 99.6% and complication rate intra-procedure was 3.1% without intraoperative death. During follow-up, MACE rate at 14 years was 19.8% (14.4% of cardiac death, 6.6% of nonfatal myocardial infarction, 5.7% of TLR and thrombosis rate 0.4%). Higher MACE rate was significantly associated to left ventricular systolic dysfunction (p=0.04) and chronic kidney insufficiency (p=0.02). 22.2% of patients had angiographic follow-up. Conclusions PCI on LMCA in diabetic patients is safe and effective, with low complication rate and a low rate of long-term follow-up events. Left ventricular systolic dysfunction and chronic kidney insufficiency showed a significantly worse outcome.

Clinical results at a long-term follow-up of percutaneous coronary intervention in ostial left main coronary artery disease

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left main coronary ostial lesions are notable for being found more commonly among middle-aged women with fewer conventional coronary artery risk factors and for lower long-term patency of internal thoracic grafts. Isolated ostial left main coronary artery (LMCA) disease is involved in the 18% of lesions and have a management approach do well either with percutaneous coronary intervention (PCI) or cardiac surgery. Continuous improvement in the devices and the emergence of better drug-eluting stents (DES) has improved the results of PCI in these high-risk lesions. Purpose The main objective of this study was to evaluate the efficacy and safety of PCI in ostial LMCA disease at a 14-year follow-up. Methods We prospectively included 109 consecutive patients (72± 12 years, 72.5% male) with ostial LMCA disease treated with PCI between June 2006 and June 2020. We evaluated the presence of major adverse cardiovascular events (MACE) defined as cardiac death, non-fatal myocardial infarction, target lesion revascularization (TLR) and stent thrombosis after a 14-year clinical follow-up (median 63.6 months). Results 55.9% had stable coronary disease and 44.1% had acute coronary syndrome (35.9% Non-STEMI and 8.2% STEMI). 45% were diabetic patients and 36.6% presented moderate-severe left ventricular systolic dysfunction. The mean logistic EuroSCORE was 8.1 % and SYNTAX score was ≥ 23 in 72.5% of the patients. We implanted second-generation DES in the 83.5% of patients (76% zotarolimus-eluting stent) and post-dilatation was performed in the 68.8%. The angiographic success rate was 99%. Complication rate in the procedure was 5.5% without intra-procedure deaths. During follow-up, MACE rate at 14 years was 18.3% (13.7% of cardiac death, 4.6% of nonfatal myocardial infarction, 7.3% of TLR and thrombosis rate of 0.9%). 24.2% of patients had an angiographic follow-up. Conclusions In spite of high surgical risk, complex coronary anatomy and older aged patients, PCI in ostial LMCA disease is safe and effective with a low rate of major cardiovascular events at long-term follow-up.

B-25 | Two-Year Outcomes in Patients with Bifurcation Lesions treated with Resolute ONYX ZES: Final Results from the RESOLUTE ONYX Bifurcation Study

Bifurcations are a challenging lesion subset for percutaneous coronary intervention. In the RESOLUTE ONYX Bifurcation study, we evaluated the 2-year clinical outcomes of patients with bifurcation lesions treated with the Resolute Onyx zotarolimus-eluting stent (ZES).

A-13 | One Month DAPT in High Bleeding Risk ACS Patients: 2-year Subgroup Analysis from Onyx ONE Clear

The safety and efficacy of Resolute Onyx zotarolimus-eluting stents in high bleeding risk (HBR) patients with 1-month dual antiplatelet therapy (DAPT) was previously demonstrated. This subgroup analysis examines 2-year outcomes in ACS and non-ACS patients in the Onyx ONE Clear study.

Comparison of Contemporary Drug-Eluting Stents in Patients Undergoing Complex High-Risk Indicated Procedures.

Limited data are available on the relative performances of diverse contemporary drug-eluting stents (DES) in patients undergoing complex high-risk indicated procedures (CHIP). The purpose of this study was to evaluate the comparative effectiveness of contemporary second-generation DES for CHIP patients in "real-world" settings. Of 28,843 patients enrolled in the IRIS-DES registry, a total of 6,645 patients with CHIP characteristics who received 5 different types of contemporary DES were finally included: 3,752 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 1,258 with Resolute zotarolimus-eluting stents (Re-ZES), 864 with platinum-chromium EES (PtCr-EES), 437 with ultrathin strut biodegradable-polymer sirolimus-eluting stents (UT-SES), and 334 with bioresorbable polymer SES (BP-SES). The primary outcome was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 12months. At 12months, the rate of target-vessel failure was highest in the CoCr-EES (7.1%) group; intermediate in the Re-ZES (5.0%), PtCr-EES (4.6%), and BP-SES (4.2%) groups; and lowest in the UT-SES (3.8%) group (overall long-rank P=0.001). In multiple-treatment propensity-score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were significantly lower in the Re-ZES (HR: 0.71; 95% confidence interval [CI]: 0.52-0.97), the UT-SES (HR: 0.52; 95%CI: 0.29-0.95), and BP-SES (HR: 0.33; 95%CI: 0.16-0.70) groups than in the CoCr-EES group (referent). In this contemporary PCI registry, we observed the differential risks of target-vessel failure according to various types of contemporary DES in patients with CHIP characteristics. However, owing to inherent selection bias, the results should be considered hypothesis-generating, highlighting the need for further randomized trials. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study.

In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type. In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation. Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariate-adjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications. As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.

Platinum chromium everolimus-eluting stent versus cobalt chromium zotarolimus-eluting stent in very late stent thrombosis: a meta-analysis of randomized controlled trials

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Very late stent thrombosis is a rare but potentially lethal outcome for drug-eluting stents used in percutaneous coronary intervention. There is limited research currently on the occurrence of very late stent thrombosis as a complication of two most used second-generation drug-eluting stents, i.e. platinum chromium everolimus-eluting stent (PtCR-EES) and cobalt chromium zotarolimus-eluting stent (CoCr-ZES). Purpose The study provides comparative information on the formation of very late stent thrombosis as a long-term outcome of PtCr-EES and CoCr-ZES. Results of this study may guide interventional cardiologists in decision-making regarding the choice of stent. Methods Randomized controlled trials (RCTs) which compared stent thrombosis end point of PtCr-EES and CoCr-ZES were identified through Pubmed. Results Data from three RCTs analyzed a total of 7,911 participants, with 4,574 in the PtCr-EES and 3,324 in the CoCr-ZES. Treatment with either stent showed no significant difference in the incidence of very late stent thrombosis. Conclusion Both stents showed comparable incidence of very late stent thrombosis. Additional RCTs are recommended to further establish the results for very late stent thrombosis. Longer follow-up is also suggested to discover more long-term outcomes.