Drug-eluting Stents In Patients Research Articles

Drug-coated balloons versus drug-eluting stents in patients with in-stent restenosis: An updated meta-analysis with trial sequential analysis.

Drug-coated balloons (DCB) have promising results in the management of in-stent restenosis (ISR), still their role remains a major challenge, and not well established in contemporary clinical practice. To provide a comprehensive appraisal of the efficacy and safety of DCBs in patients with in-stent restenosis (ISR). We searched PubMed, Scopus, web of Science, Ovid, and Cochrane Central from inception until 30 March, 2023. We included randomized controlled trials (RCTs) that compared DCB versus DES in ISR patients. Our primary endpoints were major adverse cardiac events (MACE) and late lumen loss (LLL). Secondary clinical endpoints were all-cause death, cardiac death, MI, TLR, TVR, and stent thrombosis, and angiographic outcomes were MLD, and in-stent binary restenosis. Ten RCTs comprising 1977 patients were included in this meta-analysis. The incidence of MACE was 15.57% in the DCB group compared to 14.13% in the DES group, with no significant difference in the risk of MACE following DCB (odds ratio [OR] 1.04, 95% confidence interval [CI]: 0.87 to 1.44). Compared with the DES intervention, the risk of LLL was comparable to the DCB intervention (mean difference [MD] -0.08, 95% CI: -0.18 to 0.02), while the incidence of TLR was increased in the DCB intervention (OR: 1.54, 95% CI: 1.2 to 1.99). DCB was comparable to DES implantation is ISR patients regarding clinical outcomes, however it showed an increase in TLR events. Moreover, a RCT with large sample size and longer follow-up duration is warrened to validate these results.

Use of Onyx Frontier™ for intracranial stenting in stroke patients: A multicenter retrospective study.

Acute ischemic stroke (AIS) due to intracranial atherosclerotic disease (ICAD) carries a high risk of recurrence despite aggressive medical management. The aim of our study is to present our initial experience with the Onyx Frontier™ balloon-mounted drug-eluting stent (Medtronic, Santa Rosa, CA) for AIS due to ICAD. We conducted a multicenter retrospective cohort study describing the technical feasibility, safety, and performance of using the Onyx Frontier™ balloon-mounted drug-eluting stent in patients with acute intracranial vessel occlusion due to ICAD across three comprehensive stroke centers in the United States. We included 23 patients in our study (mean age 67.3 [10.7]; females: n = 13/23, 56.5%). Most patients were Black (n = 14/23, 60.9%). The most common site of vessel occlusion was the M1 branch of the middle cerebral artery (MCA) (n = 14/23, 60.9%), followed by the vertebrobasilar system (n = 5/23, 21.7%), and the internal carotid artery (n = 3/23, 13.0%). Treatment with the Onyx Frontier™ stent was associated with a final mTICI score ≥2b for 100% of patients, with no vessel perforations or distal embolization. None of the patients had any restenosis or re-treatment over a median follow-up of 3.5 months (interquartile range [IQR] 7.8). All cases required a single stent except for one, where two were deployed. Transfemoral access was used in most cases (n = 18/23, 78.3%), with one in-hospital death due to access site complication (n = 1/23, 4.3%). This is the largest multicenter cohort study demonstrating the feasibility and safety of using the Onyx Frontier™ balloon-mounted zotarolimus-eluting stent to treat symptomatic AIS due to ICAD.

TCT-449 Long-Term Outcomes of Drug-Coated Balloons vs Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease

TCT-449 Long-Term Outcomes of Drug-Coated Balloons vs Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease

Comparison of Clinical Outcomes between Drug-Eluting Balloons and Drug-Eluting Stents in Patients with Small Coronary Artery Disease

Background/Aims: Drug-eluting balloons (DEBs) represent a novel therapeutic approach for patients with small coronary artery disease. However, further studies are needed to compare the clinical efficacy of DEBs versus drug-eluting stents (DESs).Methods: In total, 492 patients (age, 67.9 ± 11.0 years; 339 men) with small coronary artery lesions (diameter < 2.75 mm) were randomly assigned to group I (DEB) (n = 104; age, 67.2 ± 10.7 years; 83 men) and group II (DES) (n = 388; age, 68.0 ± 11.1 years; 254 men). For inverse probability of treatment weighting (IPTW) analysis, the study population was stratified into groups I (n = 269) and II (n = 280). We compared the incidences of major adverse cardiac events (MACE) between the two groups during 12 months of clinical follow-up.Results: Group I had shorter device lengths (22.4 ± 5.8 mm) compared with group II (27.4 ± 9.3 mm; p < 0.001). Additionally, devices in group I were smaller in diameter (2.4 ± 0.1 mm) compared with those in group II (2.6 ± 0.1 mm; p < 0.001). Left ventricular ejection fraction (LVEF) was lower in group I (53.8% ± 12.6%) than in group II (58.6% ± 11.9%; p < 0.001). After IPTW, no significant differences in LVEF were observed between groups I and II. During 12 months of follow-up, the incidence of total MACE did not differ between the two groups.Conclusions: No significant differences were observed in clinical efficacy between DEB and DES for the treatment of small coronary artery disease. Therefore, DEB can be considered a viable alternative to DES in patients with small coronary artery disease.

Clinical Comparison of Drug-Coated Balloon and Drug-Eluting Stent for Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia With Wounds.

Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions.Methods and Results: This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4. No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.

Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention

BackgroundThere are limited clinical data on drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) compared with drug-eluting stent (DES)-only PCI in patients with complex coronary artery lesions. ObjectivesThe goal of the current study was to investigate the efficacy of DCB in patients undergoing PCI for complex coronary artery lesions. MethodsFrom an institutional registry of patients with de novo complex coronary artery lesions, 126 patients treated with DCB-based PCI were compared with 234 propensity score–matched patients treated with DES-only PCI. Complex coronary artery lesions were defined as the presence of at least 1 of the following: bifurcation, chronic total occlusion, unprotected left main disease, long lesion ≥38 mm, multivessel disease, lesion requiring ≥3 devices, or severe calcification. The primary endpoint was target vessel failure (TVF) at 2 years, a composite of cardiac death, target vessel–related myocardial infarction, and target vessel revascularization. ResultsBaseline characteristics were comparable between the 2 groups. DCB-based PCI showed a comparable risk of TVF vs DES-based PCI (7.6% vs 8.1%; HR: 0.81; 95% CI: 0.33-1.99; P = 0.638). The risks of cardiac death (5.0% vs 5.7%; HR: 0.78; 95% CI: 0.24-2.49), target vessel–related myocardial infarction (0.9% vs 1.3%; HR: 2.65; 95% CI: 0.26-27.06), and target vessel revascularization (3.5% vs 2.0%; HR: 1.30; 95% CI: 0.30-5.67) were also comparable between the 2 groups. ConclusionsDCB-based PCI showed comparable risks of TVF vs those of DES-only PCI in patients with complex coronary artery lesions. DCB might be considered as a suitable alternative device to DES in patients undergoing complex PCI. (Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI; NCT03870815)

Outcomes of Drug-Eluting Stents in comparison to Bare Metal Stents in Cancer Patients with Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

Background. Studies have demonstrated poor prognosis in cancer patients who undergo percutaneous coronary intervention (PCI) for coronary artery disease (CAD). Cancer patients receiving PCI are at increased risk of in-stent thrombosis, bleeding, hospital readmissions, and cardiovascular and noncardiovascular mortality when compared to patients without cancer. It is unclear if the poor outcomes in cancer patients are related to the stent type utilized for PCI. This meta-analysis attempts to identify differences in efficacy and safety outcomes when comparing drug-eluting stents (DESs) with bare metal stents (BMSs) in cancer patients. Methods. This meta-analysis is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Medline, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched to identify relevant studies. Risk of bias was assessed using the Modified Newcastle-Ottawa scale and Cochrane risk of bias tool. The primary outcomes of interest were in-stent thrombosis, bleeding, and mortality. Results. Four studies comprising of 54,414 patients met the inclusion criteria. There was no difference in in-stent thrombosis (odds ratio (OR): 0.79; 95% confidence interval (CI): 0.58–1.07), bleeding events (OR: 1.38; 95% CI: 0.77–2.49), or in-hospital mortality (OR: 1.92; 95% CI: 0.83–4.43) when comparing cancer patients who underwent PCI with DES vs BMS. Conclusions. This meta-analysis demonstrates no difference in mortality, bleeding, or in-stent thrombosis between revascularization with BMS vs DES in patients with cancer and CAD. Cancer patients included in this meta-analysis experienced higher rates of mortality, bleeding, and in-stent thrombosis after PCI compared to all-comers described in the literature.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial

Intravascular ultrasound-guided percutaneous coronary intervention has been shown to result in superior clinical outcomes compared with angiography-guided percutaneous coronary intervention. However, insufficient data are available concerning the advantages of intravascular ultrasound guidance for patients with an acute coronary syndrome. This trial aimed to investigate whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome. In this two-stage, multicentre, randomised trial, patients aged 18 years or older and presenting with an acute coronary syndrome at 58 centres in China, Italy, Pakistan, and the UK were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention or angiography-guided percutaneous coronary intervention. Patients, follow-up health-care providers, and assessors were masked to random assignment; however, staff in the catheterisation laboratory were not. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularisation at 1 year after randomisation. This trial is registered at ClinicalTrials.gov, NCT03971500, and is completed. Between Aug 20, 2019 and Oct 27, 2022, 3505 patients with an acute coronary syndrome were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention (n=1753) or angiography-guided percutaneous coronary intervention (n=1752). 1-year follow-up was completed in 3504 (>99·9%) patients. The primary endpoint occurred in 70 patients in the intravascular ultrasound group and 128 patients in the angiography group (Kaplan-Meier rate 4·0% vs 7·3%; hazard ratio 0·55 [95% CI 0·41-0·74]; p=0·0001), driven by reductions in target vessel myocardial infarction or target vessel revascularisation. There were no significant differences in all-cause death or stent thrombosis between groups. Safety endpoints were also similar in the two groups. In patients with an acute coronary syndrome, intravascular ultrasound-guided implantation of contemporary drug-eluting stents resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularisation compared with angiography guidance alone. The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. For the Mandarin translation of the abstract see Supplementary Materials section.

One-Year Outcome of Drug-Coated Balloon vs. Drug-Eluting Stent in Patients Undergoing Initial Percutaneous Coronary Intervention (PCI) for De Novo Lesion.

Drug-eluting stents (DES) are the major treatment option in percutaneous coronary intervention (PCI). Recently, drug-coated balloon (DCB) utilization has been increasing globally, leading to the expected new strategy of "stent-less PCI." This study aimed to evaluate the one-year outcome of DCB compared to DES. Patients who underwent initial PCI for de novo lesions in our institution from January 2018 to December 2021 (n=337) were subjected to retrospective analysis. Among them, 75 patients were treated with DCB, while 262 patients were treated with DES. Target lesion failure (TLF) was evaluated during the follow-up period. The proportion of PCIs for ACS was significantly lower in the DCB group (DCB, n=23, 30.7% vs. DES, n=143, 54.6%; p=0.001). The median device diameter and length in the DES group were larger than those in the DCB group (DCB, 2.60 mm vs. DES, 2.98 mm; p<0.001; DCB, 19.1 mm vs. DES, 25.2 mm; p<0.001). There was no significant difference between the DCB and DES groups in lesion calcification. The proportion of ostial lesions was significantly higher in the DCB group (DCB, n=13, 17.3% vs. DES, n=21, 8.0%; p=0.018). The cumulative rate of TLF (DCB, n=5, 6.7% vs. DES, n=18, 6.9%; p=0.951) did not significantly differ between the DCB and DES groups. DCB may be as effective a strategy as DES in the patient who underwent initial PCI for a de novo lesion.

Efficacy and safety of durable versus biodegradable polymer drug-eluting stents in patients with acute myocardial infarction complicated by cardiogenic shock

The clinical impact of different polymer technologies in newer-generation drug-eluting stents (DESs) for patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains poorly understood. We investigated the efficacy and safety of durable polymer DESs (DP-DESs) compared with biodegradable polymer DESs (BP-DESs). A total of 620 patients who underwent percutaneous coronary intervention with newer-generation DESs for AMI complicated by CS was divided into two groups based on polymer technology: the DP-DES group (n = 374) and the BP-DES group (n = 246). The primary outcome was target vessel failure (TVF) during a 12-month follow-up, defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Both the DP-DES and BP-DES groups exhibited low stent thrombosis rates (1.3% vs. 1.6%, p = 0.660). The risk of TVF did not significantly differ between the two groups (34.2% vs. 28.5%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.69–1.29, p = 0.721). This finding remained consistent after adjustment with inverse probability of treatment weighting (28.1% vs. 25.1%, HR 0.98, 95% CI 0.77–1.27, p = 0.899). In AMI patients complicated by CS, the risk of a composite of cardiac death, myocardial infarction, or target vessel revascularization was not significantly different between those treated with DP-DESs and those treated with BP-DESs.Trial registration: RESCUE registry, https://clinicaltrials.gov/ct2/show/NCT02985008, NCT02985008.

Clinical outcomes with biodegradable versus durable polymer drug-eluting stents in patients with ST-elevation myocardial infarction

BackgroundCoronary drug-eluting stents (DES) built with either durable (DP) or biodegradable (BP) polymeric coatings have been largely tested and are extensively available for routine use. However, their comparative performance remains an open question, particularly in more complex subsets of patients. AimsWe evaluated the outcomes of patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI) using DP-DES versus BP-DES in a large multicenter real-world registry. MethodsThe population comprised patients with STEMI treated with pPCI within 12 h of symptoms onset. Those treated with more than one DES who received different polymer types were excluded. The final cohort for analysis was selected after propensity score matching (PSM), computed to generate similar groups of DP DES versus BP DES. Primary endpoint was the incidence of major adverse cardiac events (MACE), defined as the composite of total death, myocardial infarction and target lesion revascularization at 2 years. ResultsFrom January 2017 to April 2022, a total of 1527 STEMI patients underwent pPCI with a single DES type (587 DP-DES; 940 BP-DES). After PSM, 836 patients (418 patients in the DP-DES and 418 patients in the BP-DES groups), comprised the final study population. Both study groups had a similar baseline profile. Patients treated with BP-DES group had similar rates of MACE (15.3 % vs. 19.4 %, HR 0.69, 95 % CI 0.50–0.94, p = 0.022). Rates of target lesion revascularization was lower in BP DES group (0.7 % vs. 3.8 %, HR 0.17, 95 % CI 0.05–0.51, p = 0.006). ConclusionIn a cohort of STEMI patients submitted to pPCI, BP and DP DES had similar rates of the primary outcome. Patients treated with BP DES, however, had a decreased incidence of TLR at after 2-year follow-up.

The Efficacy of Drug-Coated Balloons and Drug-Eluting Stents in Infrapopliteal Revascularization: A Meta-analysis.

The study aimed to compare the effectiveness of drug-coated balloon (DCB) and drug-eluting stents (DESs) to standard endovascular techniques like percutaneous transluminal angioplasty (PTA) and bare metal stent (BMS) for treating infrapopliteal artery disease. Including 8 DCB trials and 4 DES trials, this meta-analysis of 12 recent randomized controlled trials (RCTs) is comprehensive. We searched MEDLINE, EMBASE, Science of Web, Cochrane, and PubMed for this meta-analysis. We searched these databases for papers from their inception to February 2023. We also analyzed the references given in the listed studies and any future study that cited them. No language or publication date restrictions were applied to the 12 RCTs. The experimental group includes 8 DCB studies and 4 DES investigations, the DCB group is primarily concerned with the paclitaxel devices, whereas the DES group is preoccupied with the "-limus" devices. Key clinical outcomes in this study were primary patency and binary restenosis rates. This study's secondary outcomes are late lumen loss (LLL), clinically-driven target lesion revascularization (CD-TLR), limb amputation, and all-cause mortality. The evidence quality was assessed using Cochrane risk-of-bias. The PROSPERO registration number for this study is CRD42023462038. Only 108 of 1152 publications found satisfied qualifying criteria and contained data. All 13 RCTs have low to moderate bias. Drug-coated balloons and DESs were compared in the excluded study. The analysis comprised 2055 participants from 12 RCTs that met the inclusion criteria, including 1417 DCB patients and 638 DES patients. Drug-coated balloons outperform traditional methods in short-term monitoring of primary patency, binary restenosis, and CD-TLR. The benefits fade over time, and the 2 techniques had similar major amputation rates, mortality rates, and LLL. Drug-eluting stents outperform conventional procedures in primary patency, binary restenosis, and CD-TLR during medium-term to short-term follow-up. Comparing the 2 methods, major and minor amputations, death rate, and LLL were similar. Comparison of DES and DCB with PTA or BMS shows that DES had better follow-up results. DCB has positive short-term results, but long-term effects differ, however, more research is needed to determine when DES and DCB should be used in medical procedures. The provision of additional evidence to substantiate the advancement of drug-coated balloon (DCB) therapy in the treatment of lower limb arteriosclerosis obliterans, particularly in the below-the-knee area characterized by high calcium load and significant occlusion, is comparable in efficacy to conventional procedures. This finding is advantageous for the progress of interventional revascularization. The advancement and efficacy of DCB have resulted in improved treatment outcomes for medical practitioners in clinical settings. Our research incorporates the most recent randomized experiments.

Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease

BackgroundAlthough target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) disease is not rare, its timing of occurrence and prognostic impact on long-term mortality is uncertain. ObjectivesThis study sought to investigate TLR incidence over time and its impact on mortality after PCI with drug-eluting stents (DES) for LMCA disease. MethodsUsing a pooled data from 4 multicenter observational registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents], IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization], MAIN-COMPARE [Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization], and PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease]), we evaluated 1,397 patients with LMCA disease treated with DES and available long-term mortality data. The association between TLR and the 10-year risk of mortality was examined by multivariable Cox proportional hazards regression, with TLR as a time-varying covariate. ResultsDuring maximum follow-up of 10 years (median 6.8 years), TLR occurred in 118 patients and its 10-year cumulative incidence was 10.8%. TLR mostly occurred within 2 years after initial PCI and decreased over time: early-stage TLR (within 2 years) in 73 (61.9%) patients and late-stage TLR (beyond 2 years) in 45 (38.1%) patients. Among all TLR patients, 23 patients underwent coronary artery bypass grafting and 95 underwent repeat PCI. In the time-varying multivariable Cox model, the presence of TLR was not significantly associated with an increased risk of mortality (adjusted HR: 0.90; 95% CI: 0.50-1.63; P = 0.73). ConclusionsAlthough the incidence of ischemia-driven TLR was mostly common within 2 years after left main PCI, TLR occurred steadily during the 10-year follow-up period. However, given that such patients were optimally revascularized, the prognostic impact of TLR on mortality was not substantial. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133; Observational Study for Left Main Disease Treatment [IRIS-MAIN]; NCT01341327; Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease [MAIN COMPARE]; NCT02791412; Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968)

First-in-Human Evaluation of a Polymer-Free Everolimus-Eluting Stent Using a Titanium Dioxide Film.

In patients with coronary artery disease treated with permanent polymer-coated drug-eluting stents (DES), the persistent presence of a less biocompatible polymer might delay arterial healing. Thin strut polymer-free DES have the potential to improve clinical outcomes and reduce the duration of dual antiplatelet therapy (DAPT). The purpose of this first-in-human study was to assess the safety and effectiveness of a novel polymer-free DES in patients with de novo coronary lesions. The TIGERevolutioN® stent (CG Bio Co., Ltd., Seoul, Korea) consists of a cobalt chromium platform with a strut thickness of 70 μm and a surface treated with titanium dioxide onto which everolimus-eluting stent (EES) is applied abluminally (6 µg/mm of stent length) without utilization of a polymer. A total of 20 patients were enrolled, with de novo coronary lesions (stable or unstable angina) and > 50% diameter stenosis in a vessel 2.25 to 4.00 mm in diameter and ≤ 40 mm in length for angiographic, optical coherence tomography (OCT), and clinical assessment at 8 months. All patients received DAPT after stent implantation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at 8 months. Twenty patients with 20 lesions were treated with TIGERevolutioN®. At 8 months, in-stent LLL was 0.7 ± 0.4 mm. On OCT, percent area stenosis was 29.2 ± 9.4% and stent strut coverage was complete in all lesions. No adverse cardiovascular event occurred at 8 months. The new polymer-free EES was safe and effective with low LLL and excellent strut coverage at 8 months of follow-up. Trial Registration: Clinical Research Information Service Identifier: KCT0005699.

Sex-based differences in ischemic cardiovascular and bleeding outcomes following implantation of drug-eluting stent in patients at high bleeding risk

BackgroundPatients with high bleeding risk (HBR) may exhibit uncertain adherence to dual antiplatelet therapy (DAPT) following drug-eluting stent (DES) implantation. The current population-based cohort study aimed to investigate the sex-based differences in adverse outcomes among the HBR population by analyzing the National Health Insurance Research Database in Taiwan. MethodsPatients who had HBR features defined by the Academic Research Consortium (ARC) and received DES implantation between January 1, 2007, and December 31, 2017, were enrolled. Propensity score matching was adopted to select 3,981 pairs with similar clinical cardiovascular risks but different sexes. A competing risk model was performed to evaluate the risk of adverse ischemic events (cardiac death, nonfatal myocardial infarction, and ischemic stroke) and any bleeding events in both sexes. Noncardiac death was considered a competing risk. ResultsWithin a 5-year follow-up, the incidence rates (per 1,000 person-year (95% confidence interval (CI)) of composite ischemic events and any bleeding events in males were respectively 44.09 (40.25–48.30) and 42.55 (38.79–46.68), while those in females were respectively 40.18 (36.51–44.23) and 42.35 (38.57–46.51). After adjustment for clinical variables, male patients had a marginally increased risk in the composite ischemic events (adjusted subdistribution hazard ratio (SHR) = 1.15 (1.00–1.31), p = 0.045) and a similar risk of any bleeding events (adjusted SHR = 1.00 (0.88–1.15), p = 0.946) compared with female patients. ConclusionsOf the HBR population, males had an increased risk of ischemic outcomes but a similar risk of bleeding compared with females following DES implantation.

Efficacy and Safety of Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention With Drug-Eluting Stent in Patients With Diabetes Mellitus: A Systematic Review and Meta- analysis

BACKGROUND: Dual-antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the standard for the prevention of thrombotic events in patients undergoing percutaneous coronary intervention (PCI). Type 2 diabetes mellitus (DM) patients are a subgroup with a higher risk of bleeding and thrombotic events after PCI. OBJECTIVES: This meta-analysis aimed to determine whether ticagrelor monotherapy after an initial short-course DAPT is an effective and safe option in preventing thrombotic events among DM patients undergoing PC. METHODS: A systematic review and meta-analysis was done on randomized controlled trials (RCT) comparing ticagrelor monotherapy following short-course DAPT versus conventional DAPT in T2DM patients who underwent PCI. Outcome measures for major bleeding, myocardial infarction, and all-cause mortality were extracted and analyzed using a random-effects model via RevMan version 5.3. RESULTS: A total of three RCTs, with 7482 patients, were analyzed. There were no significant differences in major bleeding (P = 0.26) and myocardial infarction (P = 0.66) events between the ticagrelor and DAPT groups. However, there was a higher rate of all-cause mortality in the DAPT group, which was statistically significant (risk ratio, 0.76; 95% confidence interval, 0.59–0.98; P = 0.03). CONCLUSION: Ticagrelor monotherapy following short-course DAPT and conventional DAPT have similar rates of major bleeding and myocardial infarction among DM patients undergoing PCI with DES. However, conventional DAPT has a higher incidence of all-cause mortality, which suggests that ticagrelor monotherapy after short-course DAPT may be a preferable antiplatelet strategy in DM patients undergoing PCI. KEYWORDS: bleeding, diabetes mellitus, dual-antiplatelet therapy, percutaneous coronary intervention, thrombosis, ticagrelor

Drug-coated balloons versus drug-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention: an updated meta-analysis with trial sequential analysis

BackgroundDrug-coated balloons (DCBs) are an established strategy for coronary artery disease. However, the new generation drug-eluting stent (DES) is recommended for patients with Acute myocardial infarction (AMI) for coronary artery revascularization. Our aim is to provide a comprehensive appraisal of the efficacy of DCBs in patients with AMI undergoing PCI.MethodsWe searched the WOS, PubMed, Scopus, and Cochrane CENTRAL till March 2023, for studies that compared DCBs versus DES in patients with AMI undergoing PCI. We used a random-effects model to compare major adverse cardiac events (MACE), cardiac death, all-cause death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis, Late lumen Loss (LLL), and minimum lumen diameter (MLD) between the two groups.ResultsThirteen studies comprising 2644 patients were included. The pooled OR showed non-inferiority of DCB over DES in terms of MACE (OR = 0.89, 95% CI [0.57 to 1.40], p = 0.63). When we defined MACE as a composite of cardiac death, MI, and TLR; the pooled OR favored DCB over DES (OR = 0.50, 95% CI [0.28 to 0.9], p = 0.02). Moreover, DCB was not inferior to DES in terms of all-cause mortality (OR = 0.88, 95% CI: 0.43 to 1.8, p = 0.73), cardiac mortality, (OR = 0.59, 95% CI: 0.22 to 1.56, p = 0.29), MI (OR = 0.88, 95% CI: 0.34 to 2.29, p = 0.79), stent thrombosis (OR = 1.21, 95% CI: 0.35 to 4.23, p = 0.76), TLR (OR = 0.9, 95% CI: 0.43 to 1.93, p = 0.8), LLL (MD = -0.6, 95% CI: -0.3 to 0.19, p = 0.64), or MLD (MD = -0.4, 95% CI: -0.33 to 0.25, p = 0.76).ConclusionOur meta-analysis indicated that DCB intervention was not inferior to DES in the PCI setting in patients with AMI, and can be recommended as a feasible strategy in AMI.PROSPERO registrationCRD42023412757.

Resultados tras 5 años de cirugía o abordaje percutáneo en coronariopatía grave. Metanálisis de ensayos aleatorizados con reconstrucción del tiempo hasta el evento

Introduction and objectivesThere is controversy about the optimal revascularization strategy in severe coronary artery disease (CAD), including left main disease and/or multivessel disease. Several meta-analyses have analyzed the results at 5-year follow-up but there are no results after the fifth year. We conducted a systematic review and meta-analysis of randomized clinical trials, comparing results after the fifth year, between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) using drug-eluting stents in patients with severe CAD. MethodsWe analyzed all clinical trials between January 2010 and January 2023. The primary endpoint was all-cause mortality. The databases of the original articles were reconstructed from Kaplan-Meier curves, simulating an individual-level meta-analysis. Comparisons were made at certain cutoff points (5 and 10 years). The 10-year restricted median survival time difference between CABG and PCI was calculated. The random effects model and the DerSimonian-Laird method were applied. ResultsThe meta-analysis included 5180 patients. During the 10-year follow-up, PCI showed a higher overall incidence of all-cause mortality (HR, 1.19; 95%CI, 1.04-1.32; P=.008)]. PCI showed an increased risk of all-cause mortality within 5 years (HR, 1.2; 95%CI, 1.06-1.53; P=.008), while no differences in the 5–10-year period were revealed (HR, 1.03; 95%CI, 0.84-1.26; P=.76). Life expectancy of CABG patients was slightly higher than that of PCI patients (2.4 months more). ConclusionsIn patients with severe CAD, including left main disease and/or multivessel disease, there was higher a incidence of all-cause mortality after PCI compared with CABG at 10 years of follow-up. Specifically, PCI has higher mortality during the first 5 years and comparable risk beyond 5 years.

Long term safety of paclitaxel coated balloon for de novo non-small coronary lesions

Abstract Background The efficacy of drug-coated balloons (DCB) for treating de novo coronary stenoses in non-small lesions remains unclear. Purpose To evaluate the long-term efficacy of DCB to second-generation drug eluting stent (DES) in de novo, non-small coronary lesions. Methods Patients treated with paclitaxel-DCB were compared with patients from two second-generation drug eluting stent (DES) registries. Only patients having DES-only or DCB-only strategies were included; those with in-stent restenosis, a device diameter&amp;lt;2.5mm, DES bailout post-DCB treatment, or combined use of DES and DCB were excluded. The primary endpoint was a patient-oriented composite endpoint (PoCE) defined as all-cause death, any non-fatal myocardial infarction (MI), any stroke, and any revascularization at 2-year. Differences in the risk of PoCE between cohorts were compared and adjusted by inverse probability of treatment weighting (IPTW). Results The study included 6,284 patients with 5,399 treated with DES and 885 with DCB. The mean device diameters were 3.05 mm and 2.88 mm in the DES and DCB cohort, respectively. At 2-year follow-up, the primary endpoint occurred in 531 (9.8%) patients receiving DES and 92 (10.4%) patients treated with DCB (HRcrude:1.10, 95%CI:0.88-1.37, P=0.418; HRIPTW:1.08, 95%CI:0.79-1.47, P=0.639; Figure 1). All-cause death occurred in 230 (4.3%) patients in the DES group and 11 (1.2%) patients in the DCB group (HRIPTW:0.27, 95%CI: 0.12-0.57), any non-fatal MI occurred in 56 (1.0%) patients in the DES group and 13 (1.5%) patients in the DCB group (HRIPTW:0.94, 95%CI:0.39-2.25), any stroke occurred in 108 (2.0%) patients in the DES arm and 8 (0.9%) patients in the DCB group (HRIPTW:0.63, 95%CI: 0.29-1.39), and any repeat revascularization occurred in 199 (3.7%) patients in the DES arm and 69 (7.8%) patients in the DCB group (HRIPTW:2.10, 95%CI: 1.43-3.11). Conclusion We did not observe DCB to be associated with a higher rate of PoCE than DES in patients with de novo coronary lesions which were ≥2.5mm in diameter. However, DCB was associated with significantly lower mortality and significantly higher rates of repeat revascularization than DES.Figure 1

Abstract 13590: Comparative Efficacy and Safety of Bare-Metal versus Drug-Eluting Stents in Managing Saphenous Venous Graft Disease: A Meta-Analysis and Systematic Review

Introduction: Current understanding of the relative safety and efficacy of bare metal stents (BMS) vs. drug eluting stents (DES) in patients with saphenous venous graft disease (SVGD) relies on analysis of small datasets. Methods: Literature search was performed using PubMed, Embase and Web of Science to identify relevant articles on outcomes of BMS vs. DES in patients with SVGD. A random effects model was used to calculate odds ratios (ORs) for several safety and efficacy outcomes including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), total vessel revascularization (TVR), in-stent restenosis, and stent thrombosis. Results: Of 3644 total citations on the initial search, 40 studies comprising 83,151 (33,306 BMS, 49,845 DES) patients qualified for quantitative analysis. The mean age was 72 years, and the mean ejection fraction was 47%. The inter group proportion of hypertension was 78% vs. 83%, diabetes mellitus was 37% vs. 14%, and hyperlipidemia was 69% vs. 78% in patients with BMS vs. DES, respectively (Table). Patients receiving DES had significantly lower odds of MACE (OR 0.63, 95% CI 0.52-0.77), and its components; TLR (OR 0.67, 95% CI 0.49-0.92), TVR (OR 0.61, 95% CI 0.46-0.81); and stent restenosis (OR 0.61, 95% CI 0.45-0.84) compared with BMS (Figure). The risk of stent thrombosis (OR 0.84, 95% CI 0.61-1.15) was similar between the two groups. Conclusions: Compared with BMS, patients receiving DES for SVGD demonstrated a lower risk of adverse events, stent stenosis, and need for revascularization.