Second-generation Drug-eluting Stents Research Articles

Abstract 4142793: Development of an Angiography-Based Multimodal AI Model for Predicting the risk of In-Stent Restenosis

Background: Despite advances in Second-generation drug-eluting stents (DES), 5-10% of patients still experience in-stent restenosis (ISR) after percutaneous coronary intervention (PCI), which generates significant financial burden and elevates the risk of acute coronary syndrome (ACS) and rehospitalization. Thus, early identification of patients at high risk for ISR is crucial for guiding clinical stratification and early intervention. Aims: To develop and validate a multimodal artificial intelligence (AI) model based on coronary angiography images for predicting ISR risk in patients post-DES implantation. Methods: To establish an accurate predictive model, our approach begins with the pre-training on 100,000 angiographic images to enhance the model’s capability in recognizing image features. Subsequently, we employ the DenseNet architecture as the primary deep learning model, incorporating angiographic images from 2,000 cases of DES-treated de novo lesions—1,000 from patients who did not experience ISR within two years and 1,000 from those who did. A multivariate logistic regression analysis, including radiomic features, clinical baselines, and functional information, constructs the predictive model. Additionally, a separate prospective cohort of 300 cases was assembled for validation to simulate real-world application and to verify the model's reliability and accuracy. Results: Our study successfully developed an AI prediction model for ISR, utilizing a large cohort of coronary angiography images, which effectively predicts ISR with high accuracy. Leveraging the DenseNet architecture and finely tuned machine learning algorithms, the model achieved a sensitivity and specificity of 90% in the validation cohort. The ROC curve from the test phase demonstrated an AUC above 0.90, underscoring the model’s exceptional diagnostic capabilities. Furthermore, the implementation of this model in a prospective cohort confirmed its reliability and practical utility in real-world clinical settings. Conclusions: This study introduces the first multimodal AI model using angiographic imaging to predict ISR. By demonstrating high diagnostic accuracy and reliability in real-world settings, this model serves as an essential tool for early ISR detection and intervention, ultimately helping to reduce the incidence of major adverse cardiac events (MACEs) and mortality.

Abstract 4114293: Impact of stent length on long-term clinical outcomes in acute myocardial infarction patients treated with second-generation drug-eluting stents

Background: Stent length has been considered an important predictor of adverse events in stable patients undergoing percutaneous coronary intervention (PCI). However, there are few data in acute myocardial infarction (AMI) patients treated with very long drug-eluting stents (DES). We conducted this study to evaluate the impact of stent length on the long-term clinical outcomes. Method: The study included a total of 9,021 AMI patients who underwent PCI with 2 nd generation DESs. The patients were categorized into 3 groups according to the stent length: group A (<38mm, n=6821), group B (38 – 59mm, n=1735) and group C (≥60mm, n=465) and compared using the inverse probability of treatment-weighted (IPTW) method. The primary outcome was the incidence of major adverse cardiac events (MACEs) up to 3years. Results: After adjustment for baseline differences, stent length was still significantly associated with higher cumulative rates of MACE [Odd ration(OR) :1.15 for 38 -59mm group, 95% confidence interval (CI): 1.06-1.26, p= 0.001, OR 1.23 for ≧ 60mm group, 95% CI: 1.13 -1.34, p< 0.001], especially, non-target vessel revascularization (TVR), not TVR, (table). In subgroup analysis, 3-year TVR according to stent length, Biolimus A9 stent was associated with TVR in patient with more than 38-59mm stent (OR 6.50, 95% CI: 2.60 to 16.26, p 〈 0.001). Conclusion: Even in the 2 nd generation DES era, stent length was associated with adverse long-term clinical outcomes in patients with AMI. Interestingly, long stent implantation did not affect target vessel failure but non-TVR.

Ten-year major clinical outcomes between first- and second-generation drug-eluting stents in hypertensive 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 patients with hypertension. The authors sought to compare the efficacy and safety 2G-DES with 1G-DES in hypertension patients who underwent percutaneous coronary intervention (PCI) during ten-year clinical follow-up periods. Methods Finally, a total of 1,631 eligible hypertensive patients who underwent PCI with 1G-DES (paclitaxel-, sirolimus-eluting stent, n = 715) or 2G-DES (zotarolimus [endeavor, endeavor resolute]- or everolimus-eluting stent [promus element, xience], n = 916) were enrolled. The study endpoints were individual and composite clinical outcomes up to ten-year. Results After PSM, two propensity-matched (PSM) groups (452 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], 0.54; 95% confidence interval [CI], 0.35 – 0.82; p = 0.004), target vessel revascularization (TVR; HR, 0.66; 95% CI, 0.46 – 0.94; p = 0.022), any revascularization (HR, 0.65; 95% CI, 0.48 – 0.88; p = 0.006), total major adverse cardiac events (MACE; HR, 0.70; 95% CI, 0.55 – 0.90; p = 0.005), TLR MACE (HR, 0.69; 95% CI, 0.49 – 0.98; p = 0.037), and MACCE (HR, 0.69; 95% CI, 0.54 – 0.88; p = 0.002, table). Conclusion In our single-center, all-comer registry, 2G-DES had better efficacy especially repeat revascularization and MACE as compared with 1G-DES in hypertensive patients during 10-year follow-up periods.

Comparative outcomes of drug-coated balloon angioplasty versus second-generation drug-eluting stent for in-stent restenosis: a real-world data analysis

Abstract Background Coronary in-stent restenosis (ISR) poses a significant challenge in interventional cardiology, with optimal treatment strategies being the subject of ongoing debate. Current clinical guidelines offer a choice between drug-coated balloon angioplasty (DCB) and repeat stenting with second-generation drug-eluting stents (DES), each with distinct implications for long-term patient outcomes. Purpose The aim of this study is to compare 1-year outcomes between DCB angioplasty and second-generation DES in the treatment of ISR. Longitudinal real-world data are used from the OBSERVABLE database, which comprises German health claims data between 2012 and 2021. Methods A total of 10,440 ISR individuals undergoing DCB or DES intervention were identified. After exclusion of bare-metal stents, first generation stents and non-DCBs, 3,810 propensity score-matched individuals remained. The primary outcome was the composite of all-cause mortality and myocardial infraction (MI). Secondary outcomes included all-cause death, MI, and bleeding as a safety outcome. Results At 1-year follow-up, the primary outcome of all-cause mortality and MI was observed in 246 individuals (12.9%) in the DES group, compared with 201 individuals (10.6%) in the DCB group (HR, 1.27; 95% CI, 1.06-1.53). Sensitivity analysis confirmed the robustness of these findings. Secondary outcomes revealed higher all-cause mortality in the DES group (7.9%) compared to the DCB group (6.3%) (HR, 1.31; 95% CI, 1.03-1.66), with no difference in MI. Bleeding events were comparable between the two treatments, with 244 individuals (12.8%) in the DES group and 206 individuals (10.8%) in the DCB group (HR, 1.17; 95% CI, 0.89-1.53). Conclusion This real-world data analysis demonstrated a higher incidence of the primary composite endpoint of all-cause mortality and MI within one year, after treatment with DES compared to DCB. Our results support prior findings about the safety profile of repeated DES implantation and strengthen DCB as a potential superior alternative to DES in ISR management.

Long-term clinical outcomes of acute myocardial infarction based on a center's experience with IVUS in the contemporary drug-eluting stent era

Abstract Introduction Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) is recognized for improving patient prognosis. However, how a center's experience with IVUS affects clinical outcomes remains unclear. Purpose This study aims to elucidate the impact of a center's expertise in IVUS on clinical outcomes, emphasizing the value of institutional experience. Methods In this retrospective cohort study from the Korean AMI Registry (KAMIR), we analyzed 9,752 patients diagnosed with acute myocardial infarction (AMI) who underwent intervention with second-generation drug-eluting stents. The primary outcome was major adverse cardiovascular events (MACE) at 3 years, defined as the composite of all-cause deaths, any myocardial infarction, and any coronary revascularization. The secondary outcome was target-lesion failure (TLF), defined as the composite endpoint of all cardiac deaths, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 3 years. Results In this study, the median frequency of IVUS usage across 20 institutions was 10.3%. Hospitals were categorized as centers with extensive experience in IVUS or those with limited experience, based on the median frequency of IVUS usage. In centers with extensive experience in IVUS, IVUS-guided PCI consistently showed a reduction in MACE (18.5% vs. 15.3%, p=0.016) and TLF (8.3% vs. 6.3%, p=0.039) within propensity-score matched populations. Furthermore, multivariate Cox regression analysis revealed that IVUS-guided PCI was associated with decreased risks of MACE (HR 0.80, 95% CI [0.69-0.93], p=0.003) and TLF (HR 0.75, 95% CI [0.59-0.95], p=0.01). However, from propensity matched population in centers with limited experience in IVUS, there were no significant reductions in the incidences of MACE (18.6% versus 15.7%, p=0.422) and TLF (10.4% versus 8.9%, p=0.644). Conclusion This comprehensive, nationwide cohort study shows that outcomes of IVUS-guided PCI are more favorable in centers with extensive IVUS experience compared to those with limited experience. These results indicate that the clinical advantages of IVUS-guided PCI are more pronounced in centers with extensive experience than in those with limited experience.

Drug-coated balloon versus drug-eluting stent revascularization in the treatment of de novo acute myocardial infarction

Abstract Objective To assess the efficacy and safety of a drug-coated balloon (DCB) revascularization on percutaneous coronary intervention (PCI) in patients with de novo acute myocardial infarction (AMI). Background Data on DCB-only treatment in the context of AMI are limited. Methods A total of 96 patients with de novo AMI successfully treated with DCB alone were retrospectively enrolled. Visual residual stenosis ≤ 30% without flow-limiting dissection was considered a satisfactory pre-balloon angioplasty and followed by DCB treatment. We compared it with 96 propensity-matched patients treated with second-generation drug-eluting stent (DES) from the PTRG-DES registry (n = 13,160 patients). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent or target lesion thrombosis, target vessel revascularization, and major bleeding (Bleeding Academic Research Consortium bleeding type 3 or greater) at 1 year. Results Baseline clinical characteristics were comparable between the groups. The mean device diameter was larger in DES group (2.7 ± 0.3 mm vs. 3.1 ± 0.4 mm, P < 0.001). No abrupt vessel closure requiring treatment occurred after treatment with DCB. The MACE was comparable in both groups (6.2% in DCB group vs. 7.3% in DES group, P = 0.790) at 1-year follow-up. Conclusions In de novo AMI patients, DCB-only treatment approach had comparable clinical outcomes at 1-year follow-up. DCB-only treatment may be a safe and effective alternative to DES in carefully selected patients who had satisfactory pre-dilation results.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention for acute myocardial infarction with cardiogenic shock

Abstract Background Intravascular ultrasound (IVUS) potentially improves short and long-term clinical outcomes of percutaneous coronary intervention (PCI). However, evidence regarding its efficacy in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI) is limited. Objectives This study investigated the impact of IVUS-guided PCI in patients with AMI and CS. Methods From the pooled data based on a series of Korean AMI registries during 2011–2020, we identified 1,418 consecutive patients who underwent PCI with second generation drug-eluting stent (DES) for AMI and CS. The primary endpoint was the 1-year rate of target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction, and ischemic-driven target lesion revascularization. Results Among the patients, 294 (20.7%) and 1,124 (79.3%) underwent IVUS-guided and angiography-guided PCI with second generation DES implantation, respectively. No significant difference was observed in the 1-year TLF between both groups after IPTW analysis (hazard ratio 0.93, 95% confidence interval 0.65–1.34, p=0.70) (Figure A). Additionally, the adjusted landmark analysis for TLF at 30 days and between 30 days and 1 year after PCI demonstrated no significant difference between the groups (Figure B). Conclusions In patients with AMI and CS who underwent PCI with second-generation DES, IVUS-guided PCI did not improve clinical outcomes with respect to 1-year TLF compared with angiography-guided PCI.Figure

The long-term clinical impact of high-intensity statin therapy in older patients with acute myocardial infarction

Abstract Introduction Despite substantial clinical evidence supporting the benefits of high-intensity statins for acute myocardial infarction, the clinical implications of their use in elderly populations have yet to be fully elucidated. Purpose This study aims to clarify the importance of high-intensity statin therapy at discharge for patients aged over 65 with acute myocardial infarction (AMI). Methods In this retrospective cohort analysis conducted with data from the Korean Acute Myocardial Infarction Registry (KAMIR), we evaluated 4,147 patients aged 65 and above who experienced acute myocardial infarction (AMI), underwent coronary interventions utilizing second-generation drug-eluting stents, and were prescribed statins at the time of discharge. The primary outcome was major adverse cardiovascular events (MACE) at 3 years, defined as the composite of all-cause deaths, any myocardial infarction, and any coronary revascularization. The secondary outcome was target-lesion failure (TLF), defined as the composite endpoint of all cardiac deaths, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 3 years. Results In this study, 1,268 patients (30.5%) were treated with high-intensity statins at discharge. The patients were stratified into two groups using an age threshold of 78 years. In the propensity-matched cohort aged 65 to 78, the use of high-intensity statins was associated with a significant reduction in MACE (19.1% versus 14.5%, p=0.011). In the propensity score-matched cohort aged over 78, however, treatment with high-intensity statins did not lead to a reduction in MACE (24.8% versus 24.5%, p>0.99). Additionally, multivariate analysis revealed that high-intensity statin therapy was associated with a reduced risk of MACE (HR 0.69, 95% CI [0.57-0.85], p<0.001) in patients aged 65 to 78. However, the effects of high-intensity statins on TLF were not significant in matched patients aged 65 to 78 (7.9% versus 6.5%, p=0.269) and in those aged over 78 (13.7% versus 12.1%, p=0.638). Conclusion This extensive, nationwide cohort study suggests that treatment with high-intensity statins upon discharge may not offer clinical benefits in reducing MACE and TLF in patients with AMI aged over 78, compared to those aged 65 to 78.

Long-term efficacy of drug-coated balloon-based treatment for de novo left anterior descending artery disease

Drug-coated balloons (DCB) are increasingly utilized in percutaneous coronary intervention (PCI), but their effectiveness in coronary artery disease (CAD) needs further exploration. This study investigates the efficacy and safety of a DCB-based strategy for de novo left anterior descending artery (LAD) disease. Patients with de novo LAD lesions treated with DCB alone or combined with drug-eluting stents (DES) and were retrospectively enrolled from 2010 to 2023 (n = 268). The comparator group consisted of patients treated with second-generation DES from a Korean multicenter registry (n = 4,147). The primary endpoint was three-year major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction, target vessel revascularization, target lesion thrombosis, and major bleeding. In the DCB-based group (n = 268), 218 (81.3%) received DCB-only, while 50 (18.7%) underwent a hybrid approach. After propensity score-matching of 243 paired subjects, baseline characteristics were balanced. The DCB-based PCI reduced overall stent burden by 86.7% and significantly lowered the risk of MACE at three years compared to DES-only PCI (4.5% vs. 7.6%, HR 0.50, 95% CI 0.28–0.90; p = 0.020). The most significant reduction was in major bleeding. The DCB-based approach offers an alternative to DES-only strategy for LAD PCI by reducing three-year MACE risk, supporting its use in treating de novo CAD.

Ostial left main disease tackled with a percutaneous coronary intervention using a second-generation drug-eluting stent: A case report

Abstract: The hospital emergency admitted a middle-aged male who had previously undergone stenting in the left anterior descending (LAD) and right coronary arteries due to severe central chest pain radiating to both arms. A two-dimensional color Doppler echocardiogram showed septal hypokinesia, and coronary angiography showed a 70% ostial left main (LM) stenosis. The LAD coronary artery had a patent stent, but the mid-right coronary artery had a totally occluded stent. The chest pain increased during coronary angiography, and the patient consented to percutaneous coronary intervention (PCI) with a second-generation drug-eluting stent. The patient was discharged in a stable condition. The evolution and the current approach of PCI compared to coronary artery bypass grafting surgery for LM coronary disease based on randomized trials are discussed.

TCT-261 Comparison of Clinical Outcomes Between First- and Second-Generation Drug-Eluting Stents in Single-Vessel Disease Patients: Up to 10-Year Follow-up Results

TCT-261 Comparison of Clinical Outcomes Between First- and Second-Generation Drug-Eluting Stents in Single-Vessel Disease Patients: Up to 10-Year Follow-up Results

Randomized Comparison of NovelLow-Dose Sirolimus-Eluting Biodegradable Polymer Stent vsSecond-Generation DES: TARGET-IV NA Trial.

Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs. We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs. The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12months (composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss). A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). Atotal of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5%CI: 2.03, Pnoninferiority< 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263mm for BP-SES and 0.327 ± 0.463mm for control (least squares mean difference:-0.178; 90%CI:-0.2943 to-0.0632; Pnoninferiority< 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13months (Pnoninferiority=0.01). The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (Firehawk® Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532).

Prior coronary stent does not exclude major pulmonary resection regardless of antiplatelet therapy.

We assessed the safety of general thoracic surgery in patients with prior coronary stents undergoing lung resection, based on differences in perioperative antiplatelet therapy management. We retrospectively examined 150 patients with coronary artery stents who underwent pulmonary resection between July 2009 and July 2018. The impact of the antiplatelet agent on thoracic surgery safety was assessed by comparing perioperative outcomes, including major adverse cardiac and cerebrovascular events, among the discontinued antiplatelet therapy (group D), heparin bridging (group H), and continuous antiplatelet therapy (group C) groups. Groups D, H, and C included twenty-four, eighty-four, and forty-two patients, respectively. Second-generation drug-eluting stents were used in > 50% of the patients. No significant differences were found in the estimated blood loss, transfusion rate, or operative duration. Major adverse cardiac and cerebrovascular events occurred in four (2.7%) patients, which was comparable among the groups. In group H, postoperative heart failure and transient ischemic attack with stroke occurred in one patient each. Major bleeding occurred in two (4.7%) patients in group C. Pulmonary resection surgical outcomes in patients with coronary artery stents were feasible regardless of antiplatelet therapy continuation. However, discontinuing dual-antiplatelet or single-antiplatelet therapy in such patients may be reasonable because this generation of drug-eluting stents has a higher safety profile than bare-metal and first-generation drug-eluting stents.

Impact of acute coronary syndrome on early in-stent neoatherosclerosis as shown by optical coherence tomography.

Patients with acute coronary syndrome (ACS) have a higher risk of requiring target vessel revascularisation after percutaneous coronary intervention (PCI) than patients with stable angina. Neoatherosclerosis is a significant risk factor for very late stent thrombosis, and the presence of neoatherosclerosis is independently associated with major adverse cardiac events. In this study, we used optical coherence tomography (OCT) to investigate the impact of ACS on neoatherosclerosis within 1 year after PCI. We investigated 102 patients (122 lesions) who had undergone PCI using a second-generation drug-eluting stent (DES) from March 2017 to November 2020 and were followed up with OCT within 1 year. The patients were categorised into the ACS group or non-ACS group according to their clinical findings at the time of target lesion treatment. We used OCT to investigate the presence of neoatherosclerosis. The ACS group comprised 23 (22.5%) patients. There were no differences in the patients' clinical characteristics between the groups. The total stent length tended to be shorter in the ACS group than in the non-ACS group (24 mm vs 32 mm, respectively; p=0.09), but this difference was not statistically significant. The median duration from PCI was 290 days. Neoatherosclerosis was more frequent in ACS lesions (39% vs 4%; p<0.01), and implantation of a DES in ACS lesions was an independent predictor of neoatherosclerosis occurrence (odds ratio 9.70; p<0.01). This observational study using OCT indicates that stenting for ACS lesions is associated with early in-stent neoatherosclerosis.

Technological Advances Are Associated With Better Clinical Outcomes of Percutaneous Coronary Intervention inPatients With Unprotected Left MainDisease.

Few large-scale studies have evaluated the effectiveness of percutaneous coronary intervention (PCI) technological advances in the treatment of patients with unprotected left main coronary artery disease (LM-CAD). We aim to identify independent factors that affect the prognosis of PCI in patients with unprotected LM-CAD and to assess the impact of PCI technological advances on long-term clinical outcomes. A total of 4512 consecutive patients who underwent unprotected LM-CAD PCI at Fuwai Hospital from 2004 to 2016 were enrolled. Multivariable Cox proportional hazards model was used to identify which techniques can independently affect the incidence of major adverse cardiac events (MACEs; a composite of cardiac death, myocardial infarction, or target vessel revascularization). The incidence of 3-year MACEs was 9.0% (406/4512). Four new PCI techniques were identified as the independent protective factors of MACEs, including second-generation drug-eluting stents (hazard ratio [HR], 0.61 [95% CI, 0.37-0.99]), postdilatation (HR, 0.75 [95% CI, 0.59-0.94]), final kissing balloon inflation (HR, 0.78 [95% CI, 0.62-0.99]), and using intravascular ultrasound (HR, 0.78 [95% CI, 0.63-0.97]). The relative hazard of 3-year MACEs was reduced by ≈50% with use of all 4 techniques compared with no technique use (HR, 0.53 [95% CI, 0.32-0.87]). PCI technological advances including postdilatation, second-generation drug-eluting stent, final kissing balloon inflation, and intravascular ultrasound guidance were associated with improved clinical outcomes in patients who underwent unprotected LM-CAD PCI.

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

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

Impact of Drug-Coated Balloon-Based Revascularization in Patients with Chronic Total Occlusions.

Background: Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) for chronic total coronary occlusions (CTOs) improves clinical symptoms and quality of life. However, data on drug-coated balloon (DCB)-based PCI in CTO lesions are limited. Methods: A total of 200 patients were successfully treated for CTO lesions, either with DCB alone or in combination with DES (DCB-based PCI). They were compared with 661 patients who underwent second-generation DES implantation for CTO from the PTRG-DES registry (DES-only PCI). The endpoint was major adverse cardiovascular events (MACEs), which included a composite of cardiac death, myocardial infarction, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years. Results: In the DCB-based PCI group, 49.0% of patients were treated with DCB only and 51.0% underwent the hybrid approach combining DCB with DES. Bailout stenting was performed in seven patients (3.5%). The DCB-based PCI group exhibited fewer stents (1.0; IQR: 0.0-1.0 and 2.0; IQR: 1.0-3.0, p < 0.001), shorter stent lengths (6.5 mm; IQR: 0.0-38.0 mm and 42.0 mm; IQR: 28.0-67.0 mm, p < 0.001), and lower usage of small stents with a diameter of 2.5 mm or less (9.8% and 36.5%, p < 0.001). Moreover, the DCB-based PCI group had a lower rate of MACEs than the DES-only PCI group (3.1% and 13.2%, p = 0.001) at 2-year follow-up. Conclusions: The DCB-based PCI approach significantly reduced the stent burden, particularly in the usage of small stent diameters, and resulted in a lower risk of MACEs compared to DES-only PCI in CTO lesions.

Long-term clinical outcomes of image-guided percutaneous coronary intervention in acute myocardial infarction from the Korea Acute Myocardial Infarction Registry.

Imaging modalities for percutaneous coronary intervention (PCI), such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT), have increased in the current PCI era. However, their clinical benefits in acute myocardial infarction (AMI) have not been fully elucidated. This study investigated the long-term outcomes of image-guided PCI in patients with AMI using data from the Korean Acute Myocardial Infarction Registry. A total of 9,271 patients with AMI, who underwent PCI with second-generation drug-eluting stents between November 2011 and December 2015, were retrospectively examined, and target lesion failure (TLF) at 3 years (defined as the composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was evaluated. From the registry, 2,134 patients (23.0%) underwent image-guided PCI (IVUS-guided: n = 1,919 [20.6%]; OCT-guided: n = 215 patients [2.3%]). Based on propensity score matching, image-guided PCI was associated with a significant reduction in TLF (hazard ratio: 0.76; 95% confidence interval: 0.59-0.98, p = 0.035). In addition, the TLF incidence in the OCT-guided PCI group was comparable to that in the IVUS-guided PCI group (5.3% vs 4.7%, p = 0.903). Image-guided PCI, including IVUS and OCT, is associated with favorable clinical outcomes in patients with AMI at 3 years post-intervention. Additionally, OCT-guided PCI is not inferior to IVUS-guided PCI in patients with AMI.

Glycemic Control and Coronary Stent Failure in Patients With Type 2 Diabetes Mellitus

BackgroundThe impact of glycemic control in the risk of stent failure in subjects with type 2 diabetes (T2D) is currently unknown. ObjectivesThis study sought to study whether poor glycemic control is associated with a higher risk of stent failure in subjects with T2D. MethodsThis observational study included all patients in Sweden with T2D who underwent implantation of second-generation drug-eluting stents (DES) during 2010 to 2020. The exposure variable was the updated mean of glycated hemoglobin (HbA1c). Individuals were stratified by glycemic control, with HbA1c 6.1% to 7.0% (43-53 mmol/mol) as the reference group. The primary endpoint was the occurrence of stent failure (in-stent restenosis and stent thrombosis). The main result was analyzed in a complete cases model. Sensitivity analyses were performed for missing data and a model with death as a competing risk. ResultsThe study population consisted of 52,457 individuals (70,453 DES). The number of complete cases was 24,411 (29,029 DES). The median follow-up was 6.4 years. The fully adjusted HR was 1.10 (95% CI: 0.80-1.52) for HbA1c of ≤5.5% (≤37 mmol/mol), 1.02 (95% CI: 0.85-1.23) for HbA1c of 5.6% to 6.0% (38-42 mmol/mol), 1.25 (95% CI: 1.11-1.41) for HbA1c of 7.1% to 8.0% (54-64 mmol/mol), 1.30 (95% CI: 1.13-1.51) for HbA1c of 8.1% to 9.0% (65-75 mmol/mol), 1.46 (95% CI: 1.21-1.76) for HbA1c of 9.1% to 10.0% (76-86 mmol/mol), and 1.33 (95% CI: 1.06-1.66) for HbA1c of ≥10.1% (≥87 mmol/mol). Sensitivity analyses did not change the main result. ConclusionsWe found a significant association between poor glycemic control and a higher risk of stent failure driven by in-stent restenosis.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention for acute myocardial infarction with cardiogenic shock.

The benefits of intravascular ultrasonography (IVUS)-guided percutaneous coronary intervention (PCI) in the clinical context of cardiogenic shock (CS) complicating acute myocardial infarction are lacking. We aimed to investigate the impact of IVUS-guided PCI in patients with AMI and CS. From the pooled data based on a series of Korean AMI registries during 2011-2020, we identified 1418 consecutive patients who underwent PCI with second generation drug-eluting stent (DES) for AMI and CS. The primary endpoint was the 1-year rate of target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction, and ischemic-driven target lesion revascularization. In total, 294 (20.7%) and 1124 (79.3%) underwent IVUS-guided and angiography-guided PCI with second generation DES implantation, respectively. The 1-year TLF was not significantly different between groups after IPTW analysis (hazard ratio 0.93, 95% confidence interval 0.65-1.34, p = 0.70). Additionally, the adjusted landmark analysis for TLF at 30days and between 30days and 1year after PCI demonstrated no significant difference between the groups. In conclusion, in patients with AMI and CS who underwent PCI with second-generation DES, IVUS-guided PCI did not improve the 1-year TLF compared with angiography-guided PCI.Registration: URL: http://cris.nih.go.kr . KCT0000863 and KCT0008355.