Drug-eluting Stent Implantation Research Articles

High Non-Cardiac Death Incidence Should Be a Limitation of Drug-Eluting Stents Implantation? Insights from Recent Randomized Data.

Despite the introduction of drug-eluting stents (DES) significantly improved the efficacy and safety of percutaneous coronary interventions (PCI), particularly in a high-risk group of patients, the gap between PCI with his competitor's coronary artery bypass surgery (CABG) and/or optimal medical treatment alone was not reduced. In this revision, we highlighted the fact that in recent years landmark randomized studies reported at mid and long-term follow-ups a high incidence of non-cardiac death, cancer incidence, or both in the DES group of patients. The overall incidence of non-cardiac death was significantly higher in the DES vs. the comparator arm: 5.5% and 3.8%, respectively, p = 0.000018, and non-cardiac death appears to be more divergent between DES vs. the comparator at the extended follow-up to expenses of the last one. One of these trials reported five times greater cancer incidence in the DES arm at late follow-up, 5% vs. 0.7% p < 0.0018. We review the potential reason for these unexpected findings, although we can discard that DES biology could be involved in it. Until all these issues are resolved, we propose that DES implantation should be tailored accorded patient age, life expectancy, and lesion complexity.

Long-term clinical outcomes of percutaneous coronary intervention for ostial left main coronary artery disease.

There are limited data regarding the long-term prognosis of percutaneous coronary intervention treatment for left main (LM) ostial stenosis. The present study sought to investigate the long-term clinical outcomes and risk factors for adverse events in LM ostial lesions following drug-eluting stent implantation (DES) in a large cohort of an LM registry database. Patients presenting with LM coronary disease from January 2004 to December 2016 at Fuwai Hospital were included. The primary endpoint was target vessel failure (TVF), a composite endpoint of cardiac death, target vessel myocardial infarction and target vessel revascularisation. Cox proportional hazards models were constructed to identify independent predictors. Among 4,625 LM patients, 627 (13.6%) patients were identified with LM ostial lesions. There were more female patients in the ostial group (31.3%), compared with the shaft (18.1%) and bifurcation groups (19.9%) (p<0.0001). Among patients with DES implantation, 3-year TVF occurred in 44 patients (7.5%) in the ostial group, which is comparable with the other two groups. Myocardial infarction (MI) was significantly lower in the ostial group (2.0%) compared with the bifurcation group (4.2%) (p=0.02), especially for MI events originating in the LM vessel (p=0.02). For patients with ostial LM disease who received percutaneous coronary intervention (PCI) treatment, procedural complications were an independent risk factor for long-term cardiac death or MI, while a more recent PCI proved to be a protective factor. PCI treatment for ostial LM lesions achieved favourable long-term outcomes, with a similar MI risk compared with the mid-shaft group but a significantly lower risk of MI compared with the distal group.

Ischemic and Bleeding Outcomes in Patients Who Underwent Percutaneous Coronary Intervention With Chronic Kidney Disease or Dialysis (from a Japanese Nationwide Registry)

The relation between chronic kidney disease (CKD) and outcomes in patients receiving percutaneous coronary intervention (PCI) is thought to be bidirectional; these patients are at a higher risk of ischemic and bleeding events. From a Japanese nationwide PCI registry, ischemic (cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke) and bleeding events (fatal or nonfatal major bleeding) 1 year after discharge among patients who had second- or newer-generation drug-eluting stent implantation were analyzed. Patients on oral anticoagulants were excluded. Patients were stratified according to their preprocedural renal function: CKD stages 1 to 2 (estimated glomerular filtration rate [eGFR] ≥60ml/min/1.73m2), 3 (eGFR 30 to 59), or 4 to 5 (eGFR <30), or those receiving dialysis. Overall, 23,349 patients, including 2,798 patients with CKD 3 to 5 (12.0%) and 1,464 patients on dialysis (6.3%), were investigated. One-year ischemic events were observed in 1.5%, 5.2%, 9.7%, and 5.3% in the CKD stages 1-to-2, 3, 4-to-5, and dialysis groups, respectively; patients with CKD stages 3 or 4 to 5 and those receiving dialysis were associated with higher risks of ischemic events after adjustment of covariates than were patients without CKD. Compared with ischemic events, 1-year bleeding events were low, with incidence rates of 1.5%, 2.0%, 3.4%, and 2.3%, respectively. Furthermore, the presence of CKD or dialysis was not associated with a higher risk of bleeding events after adjustment of covariates. In conclusion, in the contemporary nationwide PCI registry, the presence of CKD and dialysis was independently associated with a higher risk of ischemic events but not with bleeding events, and this suggests a need to alter the models of care delivery in these patients.

Association between triglyceride glucose-body mass index and cardiovascular outcomes in patients undergoing percutaneous coronary intervention: a retrospective study

BackgroundThe triglyceride glucose-body mass index (TyG-BMI index) has been considered a reliable surrogate measure of insulin resistance; however, its ability to predict the incidence of cardiovascular disease in individuals with coronary artery disease (CAD) remains uncertain. The aim of this study was to demonstrate the correlation between the TyG-BMI index and cardiovascular incidence.MethodsA total of 2533 consecutive participants who underwent percutaneous coronary intervention (PCI) and drug-eluting stent (DES) implantation were included. Data from 1438 patients was analyzed in the study. The endpoint was defined as a composite of acute myocardial infarction, repeat revascularization, stroke, and all-cause mortality (major adverse cardiac and cerebrovascular events, MACCEs) at 34-month follow-up. The formula for calculating the TyG-BMI index is ln [fasting triglyceride (mg/dL) × fasting blood glucose (mg/dL)/2] × BMI.ResultsAmong the 1438 participants, 195 incident patient cases of MACCEs were ascertained. The incidence of MACCEs showed no statistically significant differences in the TyG-BMI index tertiles in the overall population. Further exploratory subgroup analysis and multivariable logistic regression analysis revealed a linear relationship between the TyG-BMI index (per 1 SD increased) and MACCEs in the elderly patients (OR = 1.22, 95% CI 1.011–1.467, p = 0.038) and in the female patients (OR = 1.33, 95% CI 1.004–1.764, p = 0.047). The addition of the TyG-BMI index to traditional risk factor models in elderly and female patients did not improve risk prediction for MACCEs.ConclusionA higher TyG-BMI index was proportionally related to an increased incidence of MACCEs in the elderly or female patients. However, the inclusion of the TyG-BMI index did not provide better predictive performance for MACCEs in the elderly, specifically in female patients.

Rotational atherectomy treatment before drug-eluting stent implantation in severe calcific coronary lesion

Rotational atherectomy can effectively destroy calcified plaques and facilitate stent insertion and expansion in many cases. In this article, we present a successful application of rotational atherectomy with rotablator and drug-eluting stent implantation treatment in a 43-year-old male patient with severe calcific stenosis in the right coronary artery that could not be dilated with a high-pressure balloon. During the follow-up, the patient did not have any complaints as long as he was hospitalized, and no recent adverse events, such as acute stent thrombosis and bleeding, were observed.

Comparison of Early and Late Surgeries after Coronary Stent Implantation in Patients with Normal Preoperative Troponin Level: A Retrospective Study

Current guidelines recommend delaying noncardiac surgery for 6 months after drug eluting stent implantation. However, this recommendation is largely based on limited evidence and various event definitions. Whether early surgery within 6 months of coronary stent implantation increases myocardial injury in patients with normal preoperative high-sensitivity cardiac troponin I (hs-cTnI) has not yet been investigated. This retrospective study assessed patients who received coronary stent implantation and underwent noncardiac surgery (vascular, abdominal, or thoracic) between 2010 and 2017 with normal preoperative hs-cTnI (n = 186). Patients were divided into early (within 6 months of PCI) and late (after 6 months of PCI) groups. The primary endpoint was the incidence of myocardial injury as diagnosed by hs-cTnI within 3 days post-operation. The secondary outcomes were myocardial infarction, stent thrombosis, emergent coronary revascularization, major bleeding (bleeding requiring transfusion or intracranial bleeding), stroke, renal failure, heart failure, or death within 30 days post-operation. Inverse probability treatment weighting (IPTW) was carried out to adjust for the intergroup baseline differences. Myocardial injury occurred in 28.6% (8/28) and 27.8% (44/158) of the early and late groups, respectively, with no difference between groups (odds ratio [OR] 1.067, 95% confidence interval [CI] 0.404, 2.482; p = 0.886). Secondary outcomes did not differ between the groups. IPTW analysis also showed no differences in myocardial injury and secondary outcomes between the groups. In conclusion, early surgery within 6 months after coronary stent implantation did not increase the incidence of myocardial injury in patients with normal preoperative hs-cTnI.

Drug-coated balloons for the treatment of stent edge restenosis.

Drug-coated balloon (DCB) is a device for treating patients with in-stent restenosis; however, there are scant data on its efficacy for stent edge restenosis (SER). This study aimed to investigate the clinical outcomes of DCB use for treating SER compared with new-generation drug-eluting stent (DES) implantation. From December 2013 to January 2019, patients who underwent DES implantation or DCB for SER were enrolled. Clinical outcomes were analyzed, and propensity score with matching was conducted. The primary outcome was target-vessel revascularization (TVR). The secondary outcomes were the incidence of all-cause mortality, major adverse cardiovascular events (MACE), and target lesion revascularization (TLR). A total of 291 patients with SER were included: 160 were treated with DCB, and 131 with new-generation DES. DCB treatment for SER treatment was associated with a lower risk of TVR than DES [hazard ratio, 0.549; 95% confidence interval (CI), 0.339-0.891] at a median follow-up of 1080 days (interquartile range; 729-1080 days). Propensity score matching (PSM) was performed to adjust for baseline clinical and lesion characteristics. After PSM, no significant difference in the risk of TVR was observed (hazard ratio, 0.965; 95% CI, 0.523-1.781). Similarly, the risk for all-cause death (hazard ratio, 0.507; 95% CI, 0.093-2.770), MACE (hazard ratio: 0.812; 95% CI, 0.451-1.462), and TLR (hazard ratio: 0.962; 95% CI, 0.505-1.833) were comparable between the two groups. DCB treatment efficacy for SER was similar to that of new-generation DES after PSM. DCB is a significant alternative to obtain comparable results with new-generation DES for the treatment of SER.

Effects of delayed hospitalization on the 3-year clinical outcomes of patients with or without diabetes who had non-ST-segment-elevation myocardial infarction and underwent new-generation drug-eluting stent implantation.

Clinical outcomes after non-ST-segment-elevation myocardial infarction (NSTEMI) in patients with (symptom-to-door time [SDT] ≥ 24 h) or without (SDT < 24 h) delayed hospitalization among patients with or without diabetes were compared. From the Korea Acute Myocardial Infarction Registry-National Institute of Health, a total of 4517 patients with NSTEMI who underwent new-generation drug-eluting stents implantation were recruited and they were classified into the diabetes mellitus (DM) and non-DM groups. These two groups were subdivided into groups with and without delayed hospitalization. The primary clinical outcome was the occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, recurrent myocardial infarction, repeat coronary revascularization, and stroke. The secondary clinical outcome was the occurrence of individual components of MACCE and stent thrombosis. Although after multivariable and propensity score-adjusted analyses in the DM group, the primary and secondary clinical outcomes between the SDT < 24 h and SDT ≥ 24 h groups were similar; in the non-DM group, all-cause (p = 0.003 and p = 0.007, respectively) and cardiac (p = 0.001 and p = 0.008, respectively) death rates were significantly higher in the SDT ≥ 24 h group than in the SDT < 24 h group. Our results suggested that there was no significant difference in prognosis between diabetic patients with and without delayed SDT, but delayed SDT was associated with poor prognosis in nondiabetic patients.

Risk investigation of in-stent restenosis after initial implantation of intracoronary drug-eluting stent in patients with coronary heart disease.

To analyze the risk factors of in-stent restenosis (ISR) after the first implantation of drug-eluting stent (DES) patients with coronary heart disease (CHD) and to establish a nomogram model to predict the risk of ISR. This study retrospectively analyzed the clinical data of patients with CHD who underwent DES treatment for the first time at the Fourth Affiliated Hospital of Zhejiang University School of Medicine from January 2016 to June 2020. Patients were divided into an ISR group and a non-ISR (N-ISR) group according to the results of coronary angiography. The least absolute shrinkage and selection operator (LASSO) regression analysis was performed on the clinical variables to screen out the characteristic variables. Then we constructed the nomogram prediction model using conditional multivariate logistic regression analysis combined with the clinical variables selected in the LASSO regression analysis. Finally, the decision curve analysis, clinical impact curve, area under the receiver operating characteristic curve, and calibration curve were used to evaluate the nomogram prediction model's clinical applicability, validity, discrimination, and consistency. And we double-validate the prediction model using ten-fold cross-validation and bootstrap validation. In this study, hypertension, HbA1c, mean stent diameter, total stent length, thyroxine, and fibrinogen were all predictive factors for ISR. We successfully constructed a nomogram prediction model using these variables to quantify the risk of ISR. The AUC value of the nomogram prediction model was 0.806 (95%CI: 0.739-0.873), indicating that the model had a good discriminative ability for ISR. The high quality of the calibration curve of the model demonstrated the strong consistency of the model. Moreover, the DCA and CIC curve showed the model's high clinical applicability and effectiveness. Hypertension, HbA1c, mean stent diameter, total stent length, thyroxine, and fibrinogen are important predictors for ISR. The nomogram prediction model can better identify the high-risk population of ISR and provide practical decision-making information for the follow-up intervention in the high-risk population.

Clinical Impact of CYP2C19 Genotype on Clopidogrel-Based Antiplatelet Therapy After Percutaneous Coronary Intervention

BackgroundAlthough there is a growing body of evidence that CYP2C19 genotyping can be beneficial when considering treatment with clopidogrel after percutaneous coronary intervention (PCI), whether a genotype-guided strategy can be generally adopted in routine practice remains unclear among East Asians. ObjectivesThis study sought to investigate long-term outcomes of patients undergoing clopidogrel-based antiplatelet therapy after drug-eluting stent (DES) implantation according to CYP2C19 genotypes. MethodsFrom the nationwide multicenter PTRG-DES (Platelet function and genoType-Related long-term proGnosis in DES-treated patients) consortium, patients who underwent CYP2C19 genotyping were selected and classified according to CYP2C19 loss-of-function allele: rapid metabolizers (RMs) or normal metabolizers (NMs) vs intermediate metabolizers (IMs) or poor metabolizers (PMs). The primary outcome was a composite of cardiac death, myocardial infarction, and stent thrombosis at 5 years after the index procedure. ResultsOf 8,163 patients with CYP2C19 genotyping, 56.7% presented with acute coronary syndrome. There were 3,098 (37.9%) in the RM or NM group, 3,906 (47.9%) in the IM group, and 1,159 (14.2%) in the PM group. IMs or PMs were associated with an increased risk of 5-year primary outcome compared with RMs or NMs (HRadj: 1.42; 95% CI: 1.01-1.98; P = 0.041), and the effect was more pronounced in the first year (HRadj: 1.67; 95% CI: 1.10-2.55; P = 0.016). The prognostic implication of being an IM and PM was significant in acute coronary syndrome patients (HRadj: 1.88; 95% CI: 1.20-2.93; P = 0.005) but not in those with stable angina (HRadj: 0.92; 95% CI: 0.54-1.55; P = 0.751) (interaction P = 0.028). ConclusionsAmong East Asians with clopidogrel-based antiplatelet therapy after DES implantation, CYP2C19 genotyping could stratify patients who were likely to have an increased risk of atherothrombotic events. (Platelet Function and genoType-Related Long-term progGosis in DES-treated Patients: A Consortium From Multi-centered Registries [PTRG-DES]; NCT04734028)

Comparison Of 3-6 Month Versus 12 Month Dual Antiplatelet Therapy After Coronary Intervention Using the Contemporary Drug-eluting Stents With Ultrathin Struts: The HOST-IDEA Randomized Clinical Trial.

Background: Limited data are available on short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) using third-generation drug-eluting stents (DES) with ultrathin struts and advanced polymer technology. We investigated whether 3-6 month DAPT was non-inferior to 12 month one after implantation of DES with ultrathin struts and advanced polymer technology. Methods: We performed an open-label, randomized trial at 37 centers in South Korea. We enrolled patients undergoing PCI using the Orsiro biodegradable-polymer sirolimus-eluting stents (SES) or the Coroflex ISAR polymer-free SES. Patients with ST-segment elevation myocardial infarction were excluded. Patients were randomized to receive either 3-6 month or 12 month DAPT after PCI. The choice of antiplatelet medications was at the physician's discretion. The primary outcome was a net adverse clinical event (NACE), a composite of cardiac death, target vessel myocardial infarction (TVMI), clinically driven target lesion revascularization (CD-TLR), stent thrombosis, or major bleeding, defined as Bleeding Academic Research Consortium type 3 or 5 at 12 months. The major secondary outcomes were target lesion failure (TLF), a composite of cardiac death, TVMI, CD-TLR, and major bleeding. Results: A total of 2,013 patients (mean age 65.7±10.5, 1,487 male [73.9%], 1,110 [55.1%] presented with acute coronary syndrome) were randomized to 3-6 month DAPT (n=1,002) or 12 month DAPT (n=1,011). The primary outcome occurred in 37 (3.7%) patients in the 3-6 month DAPT group and 41 (4.1%) in the 12 month DAPT group. The non-inferiority of the 3-6 month DAPT group to the 12 month DAPT group was met (absolute risk difference, -0.4% [1-sided 95% confidence interval (CI), -∞% to 1.1%; P<0.001 for non-inferiority]). There were no significant differences in TLF (hazard ratio [HR] 0.98, 95% CI 0.56-1.71, P=0.94) or major bleeding (HR 0.82, 95% CI 0.41-1.61, P=0.56) between the two groups. Across various subgroups, the treatment effect of 3-6 month DAPT was consistent for NACE. Conclusions: Among patients undergoing PCI using third-generation DES, 3-6 month DAPT was non-inferior to 12 month DAPT for NACE. Further research is needed to generalize this finding to other populations and to determine the ideal regimen for 3-6 month DAPT.

Sex Differences in Delayed Hospitalization in Patients with Non-ST-Segment Elevation Myocardial Infarction Undergoing New-Generation Drug-Eluting Stent Implantation

We compared the effects of sex differences in delayed hospitalization (symptom-to-door time [SDT], ≥24 h) on major clinical outcomes in patients with non-ST-segment elevation myocardial infarction after new-generation drug-eluting stent implantation. A total of 4593 patients were classified into groups with (n = 1276) and without delayed hospitalization (SDT < 24 h, n = 3317). Thereafter, these two groups were subdivided into male and female groups. The primary clinical outcomes were major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, recurrent myocardial infarction, repeat coronary revascularization, and stroke. The secondary clinical outcome was stent thrombosis. After multivariable- and propensity score-adjusted analyses, in-hospital mortalities were similar between the male and female groups in both the SDT < 24 h and SDT ≥ 24 h groups. However, during a 3-year follow-up period, in the SDT < 24 h group, all-cause death (p = 0.013 and p = 0.005, respectively) and cardiac death (CD, p = 0.015 and p = 0.008, respectively) rates were significantly higher in the female group than those in the male group. This may be related to the lower all-cause death and CD rates (p = 0.022 and p = 0.012, respectively) in the SDT < 24 h group than in the SDT ≥ 24 h group among male patients. Other outcomes were similar between the male and female groups and between the SDT < 24 h and SDT ≥ 24 h groups. In this prospective cohort study, female patients showed higher 3-year mortality, especially in the SDT < 24 h, compared to male patients.

Impact of calcified nodule on target lesion failure after stent implantation in hemodialysis patients.

Little is known about intravascular imaging predictors of cardiac events after drug-eluting stent (DES) implantation in hemodialysis (HD) patients. We aimed to reveal the association between calcified nodules (CN) and target lesion failure (TLF) in HD patients after DES implantation. We enrolled 114 HD patients who underwent DES implantation between October 2016 and October 2020. The patients were divided into a CN group (39%, 44 patients) and a non-CN group (61%, 70 patients). The primary endpoint was the incidence of TLF, including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization. HD duration was longer, and the calcium burden was higher in the CN group than in the non-CN group. Over a median follow-up of 607 days [interquartile range: 349-965 days], the cumulative incidence curve showed that the CN group had a significantly higher incidence of TLF than the non-CN group (31.8% vs. 11.4% within 3 years, p = 0.008). On Fine-Gray sub-distribution hazard model analysis, the CN group was associated with an increased rate of TLF (hazard ratio[HR]: 2.86; 95% confidence interval[CI]: 1.21-6.75, p = 0.016). An in-stent CN was observed in 73% of the lesions with target lesion revascularization in the CN group, whereas no in-stent CN was observed in the non-CN group (p = 0.026). CN was an independent predictor of TLF in patients undergoing HD. In-stent CN was an important cause of TLF after DES implantation in CN lesions in HD patients;therefore, a different strategy should be considered for treating the lesions.

Early vascular healing after neXt-generation drug-eluting stent implantation in Patients with non-ST Elevation acute Coronary syndrome based on optical coherence Tomography guidance and evaluation (EXPECT): study protocol for a randomized controlled trial.

There is limited evidence about vessel wall healing response following implantation of next-generation drug-eluting stents (DES) in patients admitted with a non-ST elevation acute coronary syndrome (NSTE-ACS). Cumulative data indicate that optical coherence tomography (OCT) imaging can optimize percutaneous coronary intervention results and expedite stent endothelialization in the general population but there is lack of data in NSTE-ACS patients. The EXPECT study is an investigator-initiated, prospective, randomized trial to assess early vascular healing response following next-generation DES implantation in patients admitted with NSTE-ACS based on OCT guidance and evaluation. Sixty patients are randomized at 1:1:1 ratio to OCT-guided percutaneous coronary intervention (PCI) with 3-month follow-up OCT imaging (O3 group, n = 20), to angiography-guided PCI with 3-month follow-up OCT imaging (A3 group, n = 20) and to angiography-guided PCI with 6-month follow-up OCT imaging (A6 group, n = 20). The primary endpoint of the study is stent strut coverage rate at 3- or 6- month follow-up in the studied groups. The secondary endpoints of the study include OCT imaging endpoints, clinical endpoints, and molecular biology endpoints at the different time points. The clinical endpoints comprised of major cardiovascular adverse events and individual components. The molecular biology endpoints comprised of lipid levels and the levels of inflammatory indicators. The findings of the EXPECT study are anticipated to provide novel insights into vessel wall healing in NSTE-ACS population following implantation of next-generation DES, underscore the value of OCT imaging in expediting strut coverage in this setting, and explore the potential of an early discontinuation of dual antiplatelet therapy (DAPT) in this population. ClinicalTrials.gov, NCT04375319.

Clinical Implications of Fractional Flow Reserve Measured Immediately After Percutaneous Coronary Intervention.

The purpose of the present study was to find the independent predictors of Fractional Flow Reserve (FFR) measured immediately after percutaneous coronary intervention with drug-eluting stent implantation (post-PCI FFR) and investigate if applying vessel-specific post-PCI FFR cut-off values to predict target vessel failure (TVF), a composite of cardiac death (CD), non-fatal myocardial infarction (MI) and target vessel revascularization (TVR), or a composite of CD and MI ameliorated its predictive power. Consecutive patients with post-PCI FFR measurement at our center between 2009 and 2021 were included in this analysis. A total of 434 patients with 500 vessels were included. Median pre-PCI FFR was 0.72 with no difference between LAD and non-LAD vessels. Median post-PCI FFR was 0.87. LAD location, male gender, smaller stent diameter, and lower pre-PCI FFR proved to be significant predictors of a lower post-PCI FFR. On a vessel-level, post-PCI FFR, stent length, and diabetes mellitus proved to be significant predictors of TVF and the composite of CD and MI. The best post-PCI FFR cut-off to predict TVF or a composite of CD and MI was 0.83 in the LAD and 0.91 in non-LAD vessels. LAD location is a predictor of a lower post-PCI FFR. Post-PCI FFR is an independent predictor of TVF as well as of the composite of CD and MI. No uniform target post-PCI FFR value exists; different cut-off values may have to be applied in LAD as opposed to non-LAD vessels.

Impact of the ultra-long 48 mm drug-eluting stent on procedural and clinical outcomes in patients with diffuse long coronary artery disease.

Diffuse coronary artery disease (CAD) is a prognostic factor after percutaneous coronary intervention (PCI) and requires multiple overlapping stent implantations. We investigated the impact of ultra-long 48 mm drug-eluting stent (DES) on procedural and clinical outcomes in real-world practice. Patients who underwent DES implantation for a lesion length of >40 mm were selected from a prospective registry between 2019 and 2021. Patients treated with one or more ultra-long 48 mm DES were in the ultra-long DES group (n = 221). The others comprised the conventional DES group (n = 428). Procedural and clinical outcomes were compared after propensity score matching (PSM). The primary endpoint was a device-oriented composite outcome (DOCO) consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 1-year follow-up. After PSM, 158 matched pairs of patients showed no differences in the baseline clinical and angiographic characteristics. The stent delivery failure rate, the use of guide-extension catheter or anchor balloon technique, and the procedural success rate were similar for both groups. Approximately two-thirds of lesions could be treated with one DES in the ultra-long DES group. At 1-year follow-up, the DOCO was similar for both groups (2.5% vs. 0.6%, p = .168). In daily clinical practice, ultra-long DES implantation is as safe and effective as multiple overlapping conventional DES implants in treating diffuse long CAD. However, ultra-long DES can reduce the number of stents. (Trial Registration: ClinicalTrials.gov Identifier: NCT02038127).

Use of stents with medication coating for the treatment of occlusive-stenotic lesions of the superficial femoral artery

Objective ‒ to analyze the results of endovascular revascularization of the femoropopliteal segment with drug-eluting stents. Materials and methods. Endovascular intervention was performed in 23 patients with stenotic lesions of the superficial femoral artery (SFA). Paclitaxel-eluting stents were used. There were 10 men (43.5 %), 13 women (56.5 %). The mean age of the patients was (66.0 ± 3.5) years. There were 16 (69.6 %) patients with diabetes mellitus type 2 and diabetic angiopathy, and 7 (23.4 %) patients had obliterating atherosclerosis of the arteries of the lower limbs. Critical ischemia of the lower extremities was diagnosed in 18 (56.5 %) cases, intermittent claudication ‒ in 5 (21.7 %). Isolated lesions of the femoral-popliteal segment were noted in 3 (13.4 %) patients, lesions of the iliac and femoral-popliteal segments ‒ in 4 (17.4 %), lesions of the femoral-popliteal and ankle segments ‒ in 16 (69.6 %). Results. Twenty (86.6 %) scheduled procedures for stenting of the SFA were technically successful. Among postoperative complications, 3 (13.04 %) patients had puncture site hematomas that did not require surgical evacuation. In 6 (26.1 %) patients, signs of reperfusion syndrome were observed, which were treated with conservative treatment. During follow-up period (3 months), there were no cases of reocclusion or clinically significant restenosis at the stented level. In 1 (5.0 %) case, a hemodynamically significant stenosis of the SFA was observed outside the implanted stent. The patient successfully underwent angioplasty of SFA stenosis. There were no «major» amputations during follow-up period. «Small» ankle amputations were performed in 7 (35.0 %) patients with diabetic gangrene, where endovascular revascularization of the femoro-popliteal and ankle segments was the stage of surgical treatment. Conclusions. Implantation of drug-eluting stents is an effective method of endovascular revascularization in patients with SFA lesions. To compare the results of implantation of drug-eluting stents with other methods of revascularization of the lesions of the femoro-popliteal segment, it is necessary to accumulate more data and increase the duration of the follow-up period.

Optical coherence tomography factors for adverse events in patients with severe coronary calcification

BackgroundSevere coronary calcification is a factor for worse outcomes after percutaneous coronary intervention. AimsTo identify factors of pre- and post-stent optical coherence tomography (OCT) for device-oriented clinical endpoints (DoCE) in patients with severely calcified lesions requiring drug-eluting stent (DES) implantation. MethodsA total of 237 consecutive patients with stable coronary disease who underwent OCT imaging of severe coronary lesions were included. Lesions with a maximum calcium angle >180°, maximum calcium thickness > 0.5 mm, and calcium length > 5 mm were defined as having severe calcification. ResultsThe prevalence of eruptive calcified nodules (41% vs. 18%, p = 0.002) and medial dissection with calcified flaps (59% vs. 26%, p < 0.001) was significantly higher in patients with DoCE (n = 34) than those without DoCE (n = 203). Multivariate analyses demonstrated that the presence of a medial dissection with calcified flap within the DES-implanted segment was independently associated with a higher incidence of DoCE (odds ratio, 3.367; 95% confidence interval, 1.503–7.543; p = 0.003). The combined presence of eruptive calcified nodules and medial dissection with calcified flaps was associated with a higher incidence of DoCE (p < 0.001) during a median of 756 days after DES implantation. ConclusionsOCT-defined severely calcified lesions with eruptive calcified nodules and medial dissection with calcified flaps were associated with a higher incidence of DoCE after DES implantation.

Sex Differences in 10-Year Outcomes After Percutaneous Coronary Intervention With Drug-Eluting Stents: Insights From the DECADE Cooperation.

Although some studies have investigated sex-related outcomes up to 5 years after percutaneous coronary intervention (PCI), analyses at longer follow-up (ie, to 10 years) in large cohorts treated exclusively with drug-eluting stent (DES) platforms are lacking. Therefore, this study aimed to define whether sex-related differences in long-term outcomes after PCI persist both in the DES era and at longer-term follow-up. Individual data of patients treated with DES in 5 randomized controlled trials with 10-year follow-up were pooled. Patients were divided into 2 groups by sex. The analysis of individual participant data was performed using a 1-stage approach by entering a clustering effect by parent study in all univariable and multivariable models focusing on sex. The main outcomes of interest for this analysis included cardiovascular death, myocardial infarction, repeat revascularization, and definite stent thrombosis to 10 years after PCI. Survival was analyzed by the Kaplan-Meier method to estimate the time to first event, and differences between the 2 groups were tested with the log-rank test. Hazard ratios (HRs) and 95% CIs were calculated with a Cox proportional hazards model. Conventional multivariable analyses with adjustment for relevant variables were performed. Among 9700 patients undergoing PCI with DES implantation included in the present analysis, 2296 were women and 7404 were men. Through to 10 years, cardiovascular death occurred in 407 of the 2296 female patients and 1012 of the 7404 male patients (adjusted HR [HRadj], 0.94 [95% CI, 0.80-1.11]). Female sex was associated with a lower risk of repeat revascularization of the target lesion (HRadj, 0.80 [95% CI, 0.74-0.87]), target vessel (HRadj, 0.81 [95% CI, 0.76-0.87]), and nontarget vessels (HRadj, 0.69 [95% CI, 0.62-0.77]). Compared with male patients, female patients displayed an increased risk of myocardial infarction in the first 30 days after PCI with DES (HRadj, 1.65 [95% CI, 1.24-2.19]) but a comparable risk of myocardial infarction thereafter. The risk of definite stent thrombosis was not significantly different between female and male patients (HRadj, 1.14 [95% CI, 0.89-1.47]). Through to 10-year follow-up after PCI with DES, female patients are at increased risk of early myocardial infarction, receive fewer repeat revascularizations, and have no difference in cardiovascular mortality compared with male patients.

Impact of Endothelial Dysfunction on Long-Term Clinical Outcomes in Patients With Chronic Coronary Syndromes Treated With Second Generation Drug-Eluting Stent Implantation

BackgroundStudies investigating clinical outcomes of patients with or without endothelial disfunction (ED) treated with percutaneous coronary intervention (PCI) for stable coronary artery disease (CAD) using second generation drug eluting stents (DES) are lacking. MethodsWe prospectively collected data from 109 patients undergoing PCI with second generation DES due to stable CAD between December 2014 and September 2016. ED was evaluated evaluating the flow mediated dilation (FMD) at the brachial artery level and defined by an FMD < 7 %. Primary outcome were major adverse cardiovascular events (MACE), secondary outcomes were target vessel failure (TVR), myocardial infarction (MI) and all-cause death. ResultsFive-year follow-up was available in all patients. Median FMD didn't significantly differ between patients who experienced the outcome and those who didn't [no TVR vs. TVR: p = 0.358; no MI vs. MI: p = 0.157; no death vs. death: p = 0.355; no MACE vs. MACE: p = 0.805]. No association between ED and an increased risk for the primary outcome as well as for the secondary ones was evident [MACE: 17.0 % vs. 14.3 %, HR 0.87 (0.33–2.26), log rank p = 0.780; TVR: 9.4 % vs. 5.4 %, HR 0.53 (0.12–2.24), log rank p = 0.384; MI: 3.7 % vs. 8.9 %, HR 2.46 (0.47–12.76), log rank p = 0.265; death: 7.5 % vs. 3.6 %, HR 0.53 (0.09–2.90), log rank p = 0.458]. These findings were confirmed using a lower threshold of FMD to define ED and at one-year landmark analysis. ConclusionsED is not associated with an increased risk of adverse events at long-term follow-up in a contemporary cohort of patients undergoing PCI with second generation DES.