Generation Drug-eluting Stents Research Articles

Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3Trial.

Outcomes in women after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown. This study sought to evaluate differences in clinical outcomes according to sex after FFR-guided PCI with current generation DES compared with CABG. The FAME 3 trial was an investigator-initiated, randomized controlled trial, comparing FFR-guided PCI with current generation DES or CABG in patients with 3-vessel coronary artery disease. This prespecified subgroup analysis compared the incidence of major adverse cardiac and cerebrovascular events (MACCE) according to sex, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years. Of 1,500 patients included in the FAME 3 trial, 265 (17.7%) were women. Women had a significantly higher risk of MACCE at 3 years compared with men after CABG (18.1% vs 11.7%; adjusted HR: 2.07; 95%CI: 1.19-3.60), whereas women had a similar risk of MACCE at 3 years compared with men after PCI (18.2% vs 19.1%; adjusted HR: 1.27; 95%CI: 0.79-2.03). Regarding treatment effects by sex, women undergoing PCI had a similar risk of MACCE at 3 years compared with CABG (adjusted HR: 1.15; 95%CI: 0.62-2.11). By contrast, men undergoing PCI had a higher risk of MACCE at 3 years compared with CABG (adjusted HR: 1.68; 95%CI: 1.25-2.25; Pinteraction=0.142), which was mainly driven by a higher risk of myocardial infarction (adjusted HR: 2.11; 95%CI: 1.26-3.56; Pinteraction=0.102) and repeat revascularization (adjusted HR: 2.26; 95%CI: 1.47-3.47; Pinteraction=0.071). In the FAME 3 trial, at 3 years, women had similar outcomes with FFR-guided PCI compared with CABG, whereas men had improved outcomes with CABG. (A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease [FAME 3]; NCT02100722).

Abstract 4120583: Long term Safety and Efficacy of Ultrathin Bioabsorbable polymer sirolimus eluting Stents Versus Thin Durable polymer everolimus eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: A systematic review and meta analysis

Background: First generation drug eluting stents (DES) with thick polymers may contribute to local vascular inflammation and late stent thrombosis. Thinner-strut DES (ultrathin), particularly those with biodegradable polymers, aim to reduce this risk by minimizing flow disturbance and vascular injury. However, the long-term safety and efficacy of ultrathin biodegradable polymer sirolimus eluting stents (BP-SES) compared to durable polymer everolimus eluting stents (DP-EES) are still uncertain. Thus, we performed a meta analysis to compare outcomes of these two stents. Methods: Inclusion criteria comprised randomized controlled trials comparing ultrathin BP SES and thin DP EES in patients undergoing percutaneous coronary interventions with long term follow-up of at least 3 years. We excluded cohort studies, case reports, editorials, conference abstracts, and animal studies. Primary outcomes were target lesion failure (TLF), cardiac death (CD), target-vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). We systematically searched PubMed, Cochrane CENTRAL, and Scopus. Cochrane’s ROB 2.0 tool assessed trial quality, and RevMan software (5.4) performed the meta-analysis. Results: Our analysis included ten RCTs, totaling 16,216 patients, with 9,108 in the BP SES group and 7,108 in the DP EES group. TLF occurred in 905 patients (9.94%) in the BP-SES group and 821 patients (11.55%) in the DP-EES group, with no statistically significant differences between the groups (RR = 0.92, 95% CI = 0.85 to 1.01, p = 0.08). Additionally, there were no significant differences in cardiac death (RR = 1.00, 95% CI = 0.84 to 1.19, p = 1.00), TV-MI (RR = 0.91, 95% CI = 0.78 to 1.05, p = 0.19), and CI-TLR (RR = 0.88, 95% CI = 0.78 to 1.01, p = 0.06) between the two groups. Conclusion: The use of BP-SES did not result in higher rates of TLF, CD, TV-MI, or CI-TLR compared to DP-DES. These findings suggest that both BP-SES and DP-DES are viable options for PCI procedures, with comparable long-term safety profiles. However, some trials used strut thicknesses exceeding 70µm in cases requiring wider diameters, similar to the strut thickness in the DP-EES group. This makes it challenging to assess whether, in addition to biodegradable polymers, lower strut thickness contributes to reducing target lesion-related events. Further research may be needed to explore other relevant outcomes and to confirm these findings in diverse patient populations.

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.

Abstract 4124335: Ticagrelor monotherapy the way forward after Percutaneous Coronary Interventions : An updated meta-analysis

Background: With the advent of newer generation drug eluting stents, the chorus for shortening the duration of dual antiplatelet therapy (DAPT) after percutaneous coronary interventions (PCI) is getting louder and louder. Ticagrelor monotherapy after a short course of DAPT has been studied in a few randomized controlled trials with promising results. We conducted a systematic review and meta-analysis comparing the ticagrelor monotherapy with DAPT after short duration DAPT in patients undergoing PCIs. Methods: PubMed, Embase and Cochrane databases were searched for RCTs comparing ticagrelor monotherapy to DAPT after PCI and reported the outcomes of Major Adverse Cardiac Events including death, myocardial infarction or stroke (MACE); Major Adverse Cardiac and Cerebrovascular Events including death, myocardial infarction, stroke, stent thrombosis or target vessel revascularization (MACCE); Major bleeding; Death from any cause; CV death; Stent thrombosis and Target vessel revascularization (TVR). Data were extracted from published reports and quality assessment was performed per Cochrane recommendations. Statistical analysis was performed using Review Manager Web (Cochrane Collaboration). Heterogeneity was examined with I 2 test. Results: Out of 3208 database results, 5 RCTs with 32,393 patients were included; 16,188 (50%) received Ticagrelor monotherapy. Studies had mean follow-up ranging from 12 months to 24 months. Baseline characteristics are as per Table 1. Safety endpoints of major bleeding (HR 0.50; 95% CI 0.38-0.66; p < 0.0001; I 2 = 23 %; Figure 1A), was significantly less with ticagrelor monotherapy. Efficacy endpoints of MACE, MACCE, Death from any cause, CV Death, target vessel revascularization (TVR) and stent thrombosis were not significantly different between ticagrelor and DAPT (Figure 1 and 2). Conclusion: Ticagrelor monotherapy reduces major bleeding as compared to continued DAPT for 12 months after PCI. Major ischemic outcomes were similar in both groups. Ticagrelor monotherapy may be the way forward after short duration of DAPT in patients undergoing PCI.

Overview of Stent Thrombosis: Mechanisms and Clinical Implications

Stent thrombosis (ST) is a major complication after percutaneous coronary intervention. There have been many basic research and clinical studies to identify the exact pathophysiology of ST and also, many efforts were made to overcome and to prevent this catastrophic event which is associated with desperate clinical situations including death and myocardial infarction. Although the risk factors, underlying pathophysiology and mechanisms of ST are not fully investigated, newer generation drug eluting stents, and high resolution intra-vascular imaging modalities are important for prevention of ST.

The prognosis of acute myocardial infarction due to stent thrombosis after 2nd generation drug eluting stents era (comparative study with acute myocardial infarction due to plaque rupture or erosion)

Abstract Backgrounds Stent thrombosis (ST) is a rare complication after percutaneous coronary intervention (PCI), and more than 70% of ST cases result in acute myocardial infarction (AMI). Although a new generation of drug-eluting stents (DES) and newer antiplatelet therapies have been shown to reduce the incidence of ST, ST-related AMI continues to be observed in contemporary practice. The prevalence and prognosis of ST results in AMI have not been well evaluated after the 2nd generation DES (G2-DES) era. Purpose The purpose of this study was to evaluate the prevalence and prognosis of AMI due to ST after the G2-DES era compared with AMI due to plaque rupture or erosion. Methods Among 6601 AMI patients enrolled in the Mie ACS registry from January 2013 to November 2022, 6273 AMI patients with AMI due to ST(ST) and AMI due to plaque rupture and erosion (AMI:P) were included for this analysis after excluding other types of AMI. ST was confirmed by angiography. The primary endpoint was defined as all-cause mortality, and revascularization after PCI for AMI was also evaluated. Results Seventy-eight patients, or 1.2% of all AMI in this study, had AMI due to ST, including early ST n=13 (16.7%), late ST n=4 (5.1%), and very late ST n=61 (78.2%). Stent types were G2-DES n=35 (44%), G1-DES n=18 (23.1%), bare metal stent (BMS) n=12 (15.4%), and unknown n=13 (16.7%). According to the KM survival curve, the 30-day mortality rate of ST was 2.6%, while the AMI:P rate was 6.7%, which was not statistically significant, but the ST was half the mortality rate. Furthermore, in the landmark analysis, the 2-year mortality rates were 6.2% for ST and 7.0% for AMI:P (P=0.66, Figure 1). ST was not an independent predictor of poor prognosis by multivariate Cox regression analysis. Even after the propensity score matching analysis as a sensitivity analysis, ST was not an independent predictor of poor prognosis in AMI patients. Among ST patients, 82.2% were treated with balloon angioplasty (without additional stenting) at the time of AMI, whereas 9.7% of AMI:P patients were treated with balloon angioplasty (P<0.001). Compared to patients with AMI:P, patients with ST had a higher incidence of revascularization after PCI for AMI within 2 years (21.8% vs. 11.2%; P=0.02, Figure 2A). Multivariate Cox regression analysis also showed that ST was an independent predictor of revascularization after PCI for AMI with a hazard ratio of 2.00 (P<0.01, Figure 2B). Conclusion The prognosis of ST patients tended to be better than that of AMI:P patients. The proportion of ST in AMI has decreased in the G2-DES era, and the higher proportion of VLST in ST suggests that its prognosis may be better than that of AMI:P . However, the rate of revascularization is higher in ST patients because stenting was not performed in the acute phase of PCI for AMI, and the appropriate use of stents depending on the type of ST may lead to a reduction in revascularization.Figure1Figure2

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

Short versus conventional DAPT in patients undergoing PCI with ultra-thin DES by renal function: an analysis from the HOST-IDEA trial

Abstract Background Patients with impaired renal function are known to have an elevated risk of both ischemic and bleeding events following percutaneous coronary intervention (PCI). However, there is insufficient data available on the optimal duration of dual antiplatelet therapy (DAPT), especially with the latest generation of drug-eluting stent (DES)s. Objective We investigated to assess the efficacy and safety of abbreviated duration of DAPT in patients undergoing PCI with 3rd generation DESs based on their renal function. Methods In this prespecified subgroup analysis of the HOST-IDEA trial, a total of randomized 1997 patients with available baseline estimated glomerular filtration rate (eGFR) were categorized into three groups: high eGFR (>90 mL/min), intermediate eGFR (60 to 90 mL/min), and low eGFR (<60 mL/min). The primary outcome assessed during the 1-year follow-up period was net adverse clinical events (NACE). Ischemic and bleeding endpoints were also evaluated. Results Compared to intermediate or high eGFR groups, the low eGFR group resulted in significantly worse outcomes (P < 0.001). 3-6 month DAPT was associated with similar risk of NACE across all eGFR groups (High eGFR: HR: 0.91; 95% CI: 0.38-2.20; Intermediate eGFR: HR: 0.76; CI: 0.33-1.73; Low eGFR: HR: 0.99; CI: 0.51-1.92). There was also no significant difference in target lesion failure (HR: 0.95; CI: 0.32-2.83, HR: 0.77; CI: 0.29-2.06, and HR: 1.14; CI: 0.47-2.75) and major bleeding (HR: 0.84; CI: 0.19-3.74, HR: 0.59 CI: 0.14-2.48; and HR 0.83 CI: 0.34-2.05) among all stratified eGFR groups. This effect was also consistent in patients of end stage of renal disease (eGFR <15 mL/min). Conclusions In patients undergoing PCI with third generation DESs, short DAPT was comparable to conventional DAPT regardless of their baseline renal function.

Impact of the distribution of calcification around the left main coronary artery bifurcation on prognosis after percutaneous coronary intervention

Abstract Backgrounds The presence of true bifurcation lesions (TBL) by Medina classification at the left main coronary artery (LMCA) bifurcation is known to be associated with cardiovascular events after percutaneous coronary intervention (PCI). However, the prognostic impact of the distribution of calcification at LMCA bifurcation has not been adequately investigated. Methods This retrospective study consisted of consecutive patients who were implanted with a second or subsequent generation drug-eluting stent for LMCA bifurcation at a single center from 2014 to 2018. We excluded patients with a protected LMCA and those in whom calcification or stenosis of the LMCA bifurcation could not be assessed. With reference to the Medina classification, the region was divided into three segments (LM, LAD, and LCX). Each segment was assigned a value of 0 (for less than moderate calcification) or 1 (for more than moderate calcification) and expressed as calc (X.X.X). Calc (1.1.1), calc (1.0.1), and calc (0.1.1) were defined as true bifurcation calcification (TBC). The primary endpoint was 3-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Results Of 498 patients in this analysis, the mean age was 73 years, males accounted for 78% overall, acute coronary syndrome 31% overall, and TBL 42% overall. Moderate or severe calcification at any site around the LMCA bifurcation was observed in 184 (37%). In order of frequency, calc (1.1.0) in 70 (14%), calc (1.1.1) in 58 (12%), calc (0.1.0) in 43 (9%), calc (0.1.1) in 11 (2%), and calc (1.0.1) in 2 (0.4%), while calc (1.0.1) and calc (1. 0.0) were not present. TBC accounted for 14% overall. Patients with TBC at LMCA bifurcation had a higher incidence of 3-year TLF (Log-rank P <0.001; Figure1). Multivariable logistic regression, including age, acute coronary syndrome, maintenance hemodialysis, SYNTAX score ≥33, TBL, and TBC in the model as covariates, TBC was significantly associated with the primary endpoint (adjusted odds ratio 3.4, 95% confidence interval 1.6-7.2, P=0.013). In contrast, a significant association between TBL and the primary endpoint was not observed (adjusted odds ratio 1.5, 95% confidence interval 0.8-2.8, p=0.206). Conclusion Even after adjusting the presence of TBL at LMCA bifurcation, the presence of TBC at LMCA bifurcation was significantly associated with the 3-year TLF.

Long-term clinical impact of routine follow-up coronary angiography of asymptomatic patients after complex percutaneous coronary intervention in the drug-eluting stent era

Abstract Background Drug-eluting stent (DES) implantation has become the standard for treating coronary artery disease (CAD). While routine follow-up coronary angiography (FUCAG) post-percutaneous coronary intervention (PCI) is not recommended in the 2nd generation DES era, its efficacy and necessity in complex PCI remains unclear. This study aims to investigate the utility of FUCAG after complex PCI. Methods From 2014 to 2020, a study was conducted on patients at our university medical center who underwent complex PCI. Out of a total of 4,098 individuals, after excluding 848 individuals with a follow-up period of less than 4 years and 288 individuals who experienced an event within a year, a total of 2,962 was enrolled. Follow-up coronary angiography (FUCAG) was defined as angiography performed between 6- and 18-months post-index PCI for lesion evaluation. To adjust for any differences in baseline characteristics between the groups, propensity score matching (PSM) was implemented. The primary outcome was defined as Major Adverse Cardiac Events (MACE), comprising all-cause death, myocardial infarction, and target-lesion revascularization. Results PSM was conducted to correct the difference in baseline characteristics between the two groups. In the Kaplan-Meier analysis, there was no difference between FUCAG and clinical follow-up for MACE (Log-rank: P=0.410). Cox proportional regression analysis revealed a hazard ratio (HR) of 0.55 with a 95% confidence interval (CI) of 0.64-1.27, indicating no statistically significant difference. Conclusions In our study, FUCAG did not demonstrate a clinical benefit in patients who underwent complex PCI compared to clinical follow-up. Therefore, clinical follow-up may be considered post-PCI surveillance after complex PCI.

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.

Immediate Destiny of Bifurcation Lesions Treated with Biomatrix Alpha Stents.

About 15% of coronary artery interventions are performed on coronary artery bifurcation. Managing these lesions presents a significant therapeutic obstacle in the context of coronary artery issues. Addressing both immediate and lasting side effects of these lesions demands ongoing monitoring and action. The introduction of drug-eluting stents has raised hopes for better outcomes in patients experiencing cardiovascular events. In this study, we selected 51 patients (out of 850) who had received ≥1 cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) Biomatrix Alpha stent. Immediately after stenting, thrombolysis in myocardial infarction (TIMI) flow score in the coronary artery and its bypass branch, plaque shift, and lateral dissection immediately after angioplasty were evaluated. The mean age for patients was 65 (±10.35) years, where 49.02% of them were male and 45.1% had diabetes. No lateral dissection and death were reported in any of the patients. Also, the TIMI flow grade was 3 for the main branch in all patients. Plaque shifts were compared at different degrees of the TIMI flow coronary artery bypass graft. A statistical study revealed a noteworthy distinction between the groups. There was no discernible change when gender, diabetes, systolic and diastolic blood pressure with plaque changes were all controlled for. We discovered that the Biomatrix Alpha stents' instant clinical results are admissible. Our findings confirm the clinical utility of the recently developed biolimus-eluting (BES) stent technology, which combines the BA-9 medication, a thin-strut CoCr stent platform, and a biodegradable polymer. This aligns with the existing body of research on the most recent generation of drug-eluting stents (DES).

Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.

Efficacy and Outcomes of Stenting Versus Balloon Angioplasty for Chronic Limb-Threatening Ischemia in Infrapopliteal Peripheral Arterial Disease: A Meta-Analysis of Randomized Controlled Trials.

Peripheral arterial disease (PAD) and its severe complication, chronic limb-threatening ischemia (CLTI) are associated with significant morbidity and mortality worldwide. Conventionally, balloon angioplasty has been regarded as superior to stenting in CLTI associated with infrapopliteal PAD. Stenting is often considered a "rescue" or "bail-out" procedure in managing CLTI. However, stenting using newer generation stents coated with antiproliferative drugs such as paclitaxel has demonstrated noninferior results compared with balloon angioplasty in terms of risk of restenosis. However, the current data comparing stenting to balloon angioplasty for other outcomes is rather inconsistent. Major bibliographic databases were searched systematically to identify randomized controlled trials (RCTs) comparing stenting to balloon angioplasty in CLTI in infrapopliteal PAD patients. Risk ratios (RR) with 95% confidence intervals (CI) were pooled in a random-effects model with statistical significance considered at P < 0.05. 9 RCTs with 1125 patients (634, stenting; 491, balloon angioplasty) were included. Stenting was associated with a statistically significant reduction in the risk of binary restenosis (RR, 0.61; 95% CI, 0.38-0.97; P = 0.04] compared with balloon angioplasty. However, no statistically significant difference in technical success, all-cause mortality, clinically driven target lesion revascularization, major limb amputation, and primary patency was observed between the 2 groups. In infrapopliteal PAD associated with CLTI, stenting is noninferior to balloon angioplasty. Future large multicentric RCTs are warranted, particularly evaluating the newer generation drug-eluting stents, in a diverse patient population with longer follow-up periods to corroborate the results of this meta-analysis.

Smoking and 10-year risk of cardiovascular and non-cardiovascular events after contemporary coronary stenting

The impact of smoking cessation on long-term clinical outcomes after contemporary percutaneous coronary intervention (PCI) is not well known. We estimated the association of smoking and smoking cessation on the 10-year risk of cardiovascular and non-cardiovascular events in patients after contemporary PCI in a multicenter retrospective cohort of all patients having PCI with second generation drug-eluting stents in the VA Healthcare System between 2008 and 2016. Smoking status, comorbidities and clinical outcomes were extracted from the medical record and the National Death Index. Hazard ratios and 95 % confidence intervals (HR, 95 %CI) were derived from Cox Proportional Hazards Models. Estimates of events prevented from smoking cessation were derived from the differences in absolute risks between subjects who smoked and had stopped smoking. Among 29,001 patients, 10,598 (36.5 %) were current smoking patients, 13,093 (45.1 %) were former smoking patients, and 5,310 (18.3 %) never smoked. Over 10 years, 7,806 (26.9 %) subjects died with non-cardiovascular deaths exceeding cardiovascular deaths. In multivariable models, current smoking was significantly associated with increased long-term risks of all-cause death (HR = 1.27, 95 %CI = 1.19, 1.36), myocardial infarction (HR = 1.32, 95 %CI = 1.21–1.43), cancer death (HR = 2.55, 95 % CI = 2.10, 3.08), and pulmonary death (HR = 4.07, 95 % CI = 2.85, 5.83). Smoking cessation may prevent 18.5 % (95 %CI = 16.0 %, 20.9 %) all-cause deaths, 14.8 % (95 %CI = 9.8 %, 19.6 %) cardiovascular deaths, 42.6 % (95 %CI = 37.7 %, 47.2 %) cancer deaths, and 48.3 % (95 %CI = 41.8 %, 54.2 %) pulmonary deaths among smokers. Stopping smoking will likely have major impacts on non-cardiovascular events as well as cardiovascular events in patients after PCI with second generation drug-eluting stents.

Hybrid coronary revascularization: position paper of the European Society of Cardiology Working Group on Cardiovascular Surgery and European Association of Percutaneous Cardiovascular Interventions.

Myocardial revascularization in coronary artery disease via percutaneous coronary intervention or coronary artery bypass graft (CABG) surgery effectively relieves symptoms, significantly improves prognosis and quality of life when combined with guideline-directed medical therapy. Hybrid coronary revascularization is a promising alternative to percutaneous coronary intervention or CABG in selected patients and is defined as a planned and/or intended combination of consecutive CABG surgery using at least 1 internal mammary artery to the left anterior descending (LAD), and catheter-based coronary intervention to the non-LAD vessels for the treatment of multivessel disease. The main indications for hybrid coronary revascularization are (i) to achieve complete revascularization in patients who cannot undergo conventional CABG, (ii) to treat patients with acute coronary syndromes and multivessel disease with a non-LAD vessel as the culprit lesion that needs revascularization and (iii) in highly select patients with multivessel disease with complex LAD lesions and simple percutaneous coronary intervention targets for all other vessels. Hybrid coronary revascularization patients receive a left internal mammary artery graft to the LAD artery through a minimal incision along with percutaneous coronary intervention to the remaining diseased coronary vessels using latest generation drug-eluting stents. A collaborative environment with a dedicated heart team is the optimal platform to perform such interventions, which aim to improve the quality and outcome of myocardial revascularization. This position paper analyses the rationale of hybrid coronary revascularization and the currently available evidence on the various techniques and delves into the sequence of the interventions and pharmacological management during and after the procedure.

Percutaneous coronary intervention for unprotected left main distal bifurcation lesions in elderly people.

In the elderly people with unprotected left main distal bifurcation lesions (ULMD), percutaneous coronary intervention (PCI) is often selected as first choice treatment strategy because of perioperative high risk of coronary artery bypass graft surgery due to their large number of comorbidities. Also, some recent papers reported that geriatric nutritional risk index (GNRI) is also strongly associated with clinical outcomes after interventional procedures in elderly patients. We assessed clinical outcomes after PCI for ULMD and the impact of GNRI in elderly patients. We identified 669 non dialysis patients treated with current generation drug-eluting stent for ULMD from MITO registry. We divided the patients to the following 2 groups; elderly group (n = 240, age ≥75) and young group (n = 429, age <75). Additionally, we could calculate GNRI and divided elderly group into 2 group based on the median value of the GNRI. The primary endpoint was all-cause mortality. All-cause mortality was significantly higher in elderly group [adjusted hazard ratio (HR) 2.37; 95% confidence interval (CI), 1.40-4.02; p = 0.001]. All-cause mortality was significantly higher in low GNRI elderly group compared to other 2 groups (Adjusted HR of elderly with low GNRI: 3.56, 95%CI (1.77-7.14), p < 0.001). Cardiovascular mortality was comparable between two groups. TLR rate was significantly lower in elderly group (adjusted HR 0.57; 95% CI, 0.34-0.97; p = 0.035). The elderly had higher all-cause mortality after PCI for ULMD compared to young people. Especially, the elderly with low GNRI were extremely associated with poorer outcomes.

Determinants of One-Year Outcome After Successful Percutaneous Coronary Intervention for Chronic Total Occlusion; Insight from Japanese CTO-PCI Expert Registry

Although outcomes have improved with new-generation drug-eluting stents (DES), few reports have analyzed the risk factors associated with chronic outcomes of chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). This study aimed to investigate the independent risk factors for target lesion revascularization (TLR) and major adverse cardiac and cerebrovascular events (MACCEs) after CTO-PCI using Japanese multicenter data. A total of 3,666 patients, who underwent CTO-PCI and completed a 1-year follow-up, registered at the Japanese CTO-PCI Expert Registry, from 2014 to 2019 were examined. The primary outcome was defined as TLR, and the secondary outcome was MACCEs at the 1-year follow-up. TLRs and MACCEs occurred in 175 (4.8%) and 524 (14.3%) patients, respectively. Multivariate logistic regression analysis demonstrated that in-stent occlusion (ISO) (odds ratio [OR] 2.604; 95% confidence interval [CI], 1.695-4.001), hemodialysis (OR 1.784; 95% CI, 1.062-2.997), diabetes mellitus with insulin use (OR 1.741; 95% CI, 1.060-2.861), moderate-to-severe calcification (OR 1.726; 95% CI, 1.197-2.487), and the right coronary artery as the target vessel (OR 1.468; 95% CI, 1.018-2.117) were significantly associated with TLR. Hemodialysis (OR 2.214; 95% CI, 1.574-3.113), ISO (OR 1.499; 95% CI, 1.127-1.993), arteriosclerosis obliterans (OR 1.414; 95% CI, 1.074-1.863), and multivessel disease (OR 1.356; 95% CI, 1.117-1.647) were significantly associated with MACCEs. One-year outcomes of new generation DES for CTO-PCI were favorable, and ISO as a lesion factor and hemodialysis as a patient factor were strongly associated with TLR and MACCEs, respectively.

Thrombogenicity of biodegradable metals

Biodegradable metals offer a promising means to ameliorate many of the long-term risks associated with vascular devices made of conventional biostable stent metals. While numerous biodegradable metal alloys have been developed and characterized in animal models, knowledge of their blood reactivity and thrombogenicity remains unknown. Metal hemocompatibility is particularly valuable because current generation drug-eluting stents pose a significant long-term thrombosis risk. In this study, four pure metals, widely used as degradable base materials (Fe, Zn, Mg, and Mo), and three alloys commonly used in cardiovascular devices [NiTi, CoCr, and stainless steel (SS)] were evaluated. This work examined how each of these metals activate platelets, coagulation factors, and inflammation using in vitro hemocompatibility assays and a clinically relevant ex vivo non-human primate arteriovenous shunt model. Testing found that while all metals promoted a downstream activation of platelets and coagulation in flowing whole blood, platelet and fibrin attachment to Mg was markedly reduced. Additionally, Fe and Mo trended toward higher platelet attachment and contact pathway activation. Overall, the results suggest that Mg may delay clot initiation, but not eliminate clot formation, indicating the importance of understanding thrombosis in Mg alloys that are currently being developed for clinical use as biodegradable stents.

Outpatient PCI - early discharge PCI, single center experience

Abstract Funding Acknowledgements None. Background Percutaneous coronary intervention (PCI) has undergone rapid evolution over the last years and is currently a widely generalized therapeutic option. In the past, it was associated with a significant rate of complications, yet, with the improvement of new generation drug eluting stents, and the radial access (RA) development, PCI has become safer and simpler, with a minimum rate of complications. This allows patient’s faster discharge. Besides the pressure from the limited number of beds in wards, the improvement of PCI has given the confidence to urge outpatient PCI programs. However, there are still centers where there is no ambulatory PCI. Purpose This study aims to describe our center experience of ambulatory PCI program, in terms of safety and efficacy. Methods We analyzed our center’s retrospective cohort of 723 PCI, in 2022. Ambulatory PCI was defined as PCI with same day hospital discharge. Our inclusion criteria were patients submitted to PCI. We excluded patients with acute coronary syndromes and patients needing hospital admission for other non-coronary reasons. Results 467 (65%), of the 723 PCI were performed in ambulatory setting. Patients mean age was 67,8±11 years and 23% (n=107) were female. In 12% (n=55) of the cases, the coronary anatomy was previously known, from a differed procedure. 63% (n=298) had a normal left ventricle ejection fraction (LVEF), 6% (n=26) had a moderate depression of LVEF and 3% (n=13) had LVEF severe depression. RA was possible in 82% of the cases (n=384), and 18% (n=83) of PCI was done by femoral access (FA). The access size was 6 Fr in 77% (n=359) of the cases, 7Fr in 22% (n=105) and 8Fr in 1% (n=2). The RA hemostasis was by compression (either manually or by external device) and FA hemostasis was first intended by closing device, however in 17% of the transfemoral PCI (n=14) had to be compressed, due to device hemostasis failure. PCI was successful in 97% of the cases (n=449), with revascularization of the goal lesion. The unsuccessful PCI (3% n=18) were because uncrossable lesion in 2% (n=14), and no reflow after PCI in 1% (n=4). 6 patients had to be admitted, after planned outpatient PCI, 5 due to peripheral access complication with hemorrhage of FA (after closing device and manual compression failure) and 1 due to PCI complication, with small coronary perforation. There was a higher probability of admission in patients submitted to transfemoral PCI (p&amp;lt;0,05), and there was no statistically significant relation between unplanned admission and patient’s LVEF. There were no episodes of death, MACE, non-planned hospital readmission and stent failure in the ambulatory PCI population. PCI has become a predictable and reliable technique, capable to treat outpatients. Patients undergoing successful non-complex PCI, without events, can safely be discharged on the same day. Outpatient PCI helps with the functioning of inpatient care, allowing beds to be freed up for other situations.