Endovascular community response to mortality data in use of paclitaxel devices for peripheral vascular disease.

OBJECTIVE: We examined the endovascular community response to data demonstrating increased mortality in paclitaxel devices for the treatment of peripheral arterial disease in femoropopliteal lesions. METHODS: A retrospective observational study using the Vascular Quality Initiative Peripheral Vascular Intervention registry dataset was performed to examine paclitaxel device use for peripheral arterial disease in femoropopliteal arteries treated from 2017 to 2019. A total of 41,707 patients and 52,208 procedures were analyzed during the study period. A post hoc analysis was performed to examine paclitaxel device use during selected periods in 2019. RESULTS: The total number of femoropopliteal procedures in 2017, 2018, and 2019 were 17,458, 21,140, and 21,322, respectively. Paclitaxel devices were used for 8852 arteries in 2017, 10,691 in 2018, and 6732 in 2019, which was significantly reduced in 2019 compared with 2017 or 2018 (P < .0001) and 2019 compared with the 2018 and 2017 volumes combined (P < .0001). Post hoc analysis of selected periods in 2019 demonstrated variable use throughout 2019. CONCLUSIONS: After the report of data with concerns of mortality associated with paclitaxel device use in 2018, a rapid reduction in overall paclitaxel device use was observed in 2019.

10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. OBJECTIVES: The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial. METHODS: The EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis. RESULTS: Complete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years. CONCLUSIONS: At 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315).

Durable polymer everolimus-eluting stents: history, current status and future prospects.

INTRODUCTION: Coronary percutaneous interventions have evolved from plain old balloon angioplasty (POBA) to stent implantation, which itself evolved from bare-metal stents (BMS) to the new biodegradable stents which try to restore endothelial function. Currently, the most commonly used stent is the everolimus-eluting stent. AREAS COVERED: This review will cover the current status of durable polymer everolimus-eluting stent, its history, and future perspectives. Nowadays, the everolimus-eluting stent is the most used device in the acute and chronic settings due to its safety and efficacy. EXPERT OPINION: Durable polymer everolimus-eluting stent, supported by much evidence, has demonstrated its efficacy and safety, not only in de novo artery lesions, but in multiples scenarios, such as the acute setting and diabetic population, becoming one of the most polyvalent stents available. Nowadays, research is focused on the reduction of antiplatelet treatment duration. Similar rates of stent thrombosis with short dual antiplatelet treatment regimens of 1 to 3 months compared to pronged treatment have been observed. However, specific studies should be performed to evaluate this possibility.

Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis.

BACKGROUND: Paclitaxel-containing devices (PTXDs) significantly reduce reintervention in patients with symptomatic femoropopliteal peripheral artery disease. A recent aggregate-data meta-analysis reported increased late mortality in patients with peripheral artery disease treated with PTXDs. We performed an individual patient data meta-analysis to evaluate mortality. METHODS: Manufacturers of US Food and Drug Administration-approved and commercially available devices in the United States provided deidentified individual patient data for independent analysis. Cox proportional hazards 1-stage meta-analysis models using intention-to-treat methods were used for the primary analysis. A secondary analysis of recovered missing vital status data was performed. The impact of control crossover to PTXDs, cause-specific mortality, and drug dose mortality were assessed. RESULTS: A total of 2185 subjects and 386 deaths from 8 PTXD trials with 4-year median follow-up were identified. The primary analysis indicated a 38% (95% CI, 6% to 80%) increased relative mortality risk, corresponding to 4.6% absolute increase, at 5 years associated with PTXD use. Control and treatment arm loss to follow-up and withdrawal were 24% and 23%, respectively. With inclusion of recovered vital status data, the excess relative mortality risk was 27% (95% CI, 3%-58%). This observation was consistent across various scenarios, including as-treated analyses, with no evidence of increased risk over time with PTXDs. Mortality risk tended to be increased for all major causes of death. There were no subgroup differences. No drug dose-mortality association was identified. CONCLUSIONS: This individual patient data meta-analysis, based on the most complete available data set of mortality events from PTXD randomized controlled trials, identified an absolute 4.6% increased mortality risk associated with PTXD use.

New Innovations and Devices in the Management of Chronic Limb-Threatening Ischemia.

As the number of patients afflicted by chronic limb-threatening ischemia (CLTI) continues to grow, new solutions are necessary to provide effective, durable treatment options that will lead to improved outcomes. The diagnosis of CLTI remains mostly clinical, and endovascular revascularization remains mostly balloon-based. Multiple innovative techniques and technologies are in development or in early usage that may provide new solutions. This review categorizes areas of advancement, highlights recent developments in the management of CLTI and looks forward to novel devices that are currently under investigation.

2-Year Outcomes After Stenting of Lipid-Rich and Nonrich Coronary Plaques.

BACKGROUND: Autopsy studies suggest that implanting stents in lipid-rich plaque (LRP) may be associated with adverse outcomes. OBJECTIVES: The purpose of this study was to evaluate the association between LRP detected by near-infrared spectroscopy (NIRS) and clinical outcomes in patients with coronary artery disease treated with contemporary drug-eluting stents. METHODS: In this prospective, multicenter registry, NIRS was performed in patients undergoing coronary angiography and possible percutaneous coronary intervention (PCI). Lipid core burden index (LCBI) was calculated as the fraction of pixels with the probability of LRP >0.6 within a region of interest. MaxLCBI4mm was defined as the maximum LCBI within any 4-mm-long segment. Major adverse cardiac events (MACE) included cardiac death, myocardial infarction, definite or probable stent thrombosis, or unplanned revascularization or rehospitalization for progressive angina or unstable angina. Events were subcategorized as culprit (treated) lesion-related, nonculprit (untreated) lesion-related, or indeterminate. RESULTS: Among 1,999 patients who were enrolled in the COLOR (Chemometric Observations of Lipid Core Plaques of Interest in Native Coronary Arteries Registry), PCI was performed in 1,621 patients and MACE occurred in 18.0% of patients, of which 8.3% were culprit lesion-related, 10.7% were nonculprit lesion-related, and 3.1% were indeterminate during 2-year follow-up. Complications from NIRS imaging occurred in 9 patients (0.45%), which resulted in 1 peri-procedural myocardial infarction and 1 emergent coronary bypass. Pre-PCI NIRS imaging was obtained in 1,189 patients, and the 2-year rate of culprit lesion-related MACE was not significantly associated with maxLCBI4mm (hazard ratio of maxLCBI4mm per 100: 1.06; 95% confidence interval: 0.96 to 1.17; p = 0.28) after adjusting clinical and procedural factors. CONCLUSIONS: Following PCI with contemporary drug-eluting stents, stent implantation in NIRS-defined LRPs was not associated with increased periprocedural or late adverse outcomes compared with those without significant lipid.

Slicing parameter optimization for 3D printing of biodegradable drug-eluting tracheal stents.

In 3D printing, the schematic representation of an object must be converted into machine commands. This process is called slicing. Depending on the slicing parameters, products with different properties are obtained. In this work, biodegradable drug-eluting tracheal stents consisting of a medical grade poly(lactic-co-glycolic acid) and a drug were printed by fused deposition modeling. A slicing parameter optimization method was proposed with the aim of obtaining a particularly low stent porosity and high mechanical strength while maintaining the stent dimensions, which is essential regarding patient-tailored implants. Depending on the three slicing parameters printing pattern, lateral strand distance and spatial fill, porosities of approximately 2-5% were obtained. The tensile strength was used as a measure for the mechanical strength of the implants and was found to be dependent on the porosity as well as the strand orientation relative to the load direction. Strand orientations in load direction yielded the highest tensile strengths of 40-46 MPa and the bonding between individual layers yielded the lowest tensile strengths of 20-24 MPa. In vitro dissolution tests of successfully printed stents were used to predict sustained release of the drug over several months.

Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice.

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.

Intravascular ultrasound-guided stent implantation reduces cardiovascular mortality - Updated meta-analysis of randomized controlled trials.

BACKGROUND: The use of intravascular ultrasound (IVUS) guidance to facilitate stent implantation has been demonstrated to reduce major adverse cardiovascular events (MACE), predominantly due to a reduction in target lesion revascularization (TLR). The objectives of our meta-analysis are to assess the effect of IVUS on clinical outcomes, including cardiovascular mortality. METHODS: RCTs comparing drug-eluting stent (DES) implantation using IVUS plus angiography versus angiography alone were identified from a comprehensive search in PubMed, Embase, and Cochrane library. Pooled relative risks (RR) were obtained using DerSimonian and Laird estimator for the random effects model. RESULTS: The search yielded 10 RCTs (5007 participants) in which the relevant data were available. Two trials were performed in patients with chronic total occlusion (CTO), whereas other trials included patients that either had stable ischemic heart disease (22-64%) or presented as an acute coronary syndrome (ACS) (36-78%). Routine use of IVUS was effective in reducing TLR (risk ratio (RR) 0.59, 95% confidence interval (CI) 0.44, 0.80; p < 0.01), target vessel revascularization (TVR) (RR 0.59, 95% CI 0.43, 0.81; p < 0.01), and MACE (RR 0.63, 95% CI 0.51, 0.77; p < 0.01). Cardiovascular mortality was also significantly reduced (RR 0.51, 95% CI 0.27, 0.96; p = 0.04). CONCLUSION: During DES implantation, the routine use of IVUS in addition to angiography improves clinical outcomes, including cardiovascular mortality. These findings reinforce the need for a broader implementation of IVUS-guidance during PCI. Since a significant proportion of patients studied presented as ACS, future trials should assess the benefit of IVUS-guidance in a more focused presentation setting.

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials.

BACKGROUND: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. METHODS: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. RESULTS: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ±â€¯10.8 and 62.7 ±â€¯10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. CONCLUSION: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

Clinical and procedural characteristics of persons living with HIV presenting with acute coronary syndrome.

OBJECTIVES: Persons living with HIV (PLWH) are at greater risk for acute coronary syndrome (ACS). Practice patterns of ACS management by HIV serostatus are unknown. We examined the presentation and management of ACS in PLWH. DESIGN: Retrospective case-control study. METHODS: We included 86 PLWH and 263 sex-matched and race-matched HIV-negative controls hospitalized with ACS between 2004 and 2013. We performed multivariable conditional logistic regression to determine the associations between HIV serostatus and ACS type and management. RESULTS: Both groups were predominantly of black race and male sex. PLWH were significantly younger (53 vs. 60 years) and more likely to smoke (48 vs. 31%). Among PLWH, 30% had CD4 cell count less than 200 cells/µl and 58% had undetectable HIV RNA. PLWH had more single-vessel disease and a higher median Gensini score among those with single-vessel disease (32 vs. 4.25) than controls. HIV serostatus was positively associated with ST-elevation myocardial infarction (STEMI) [adjusted odds ratio (aOR) (95% confidence interval (CI)):5.05 (1.82-14.02)], and any revascularization procedure after ACS [aOR (95% CI): 2.90 (1.01-8.39)] and negatively associated with non-STEMI [aOR (95% CI): 0.33 (0.14-0.79)] presentation. PLWH who underwent stent placement had a higher likelihood of bare metal stent placement compared with controls [70 vs. 15%, aOR (95% CI): 5.94 (1.33-26.55)]. Among PLWH, ACS characteristics were not significantly associated with CD4 cell count, HIV RNA, or antiretroviral therapy. CONCLUSION: PLWH hospitalized with ACS were more likely to have severe single-vessel disease, present with STEMI rather than non-STEMI, and undergo revascularization, and less likely to have a drug-eluting stent placed than matched HIV-negative controls, suggesting that coronary plaque morphology and/or distribution is different with HIV infection and warrants further investigation.

The Current Literature on Bioabsorbable Stents: a Review.

PURPOSE OF REVIEW: The purpose of this review is to explore the evolution of the coronary stent, from the advent of bare-metal stents, to the newest adopted technology of bioresorbable vascular scaffolds (BVS) used in bioresorbable stents. To date, there have been conflicting data regarding the safety and efficacy of BVS stents, especially when compared to current-generation drug-eluting stents (DES). This review will cover the data that exist regarding current BVS stents, as well as the active clinical trials for future iterations of BVS. RECENT FINDINGS: The ABSORB BVS, the most widely circulated stent of its class, was promised to decrease rates of stent thrombosis and target vessel revascularization. Several randomized control trials, however, found the opposite to be true, with the ABSORB BVS demonstrating higher rates of thrombosis, target vessel revascularization, and even target lesion myocardial infarctions when compared to current-generation DES. These data caused the product to be pulled from all markets, leaving the field with uncertainty as to the role of BVS in coronary interventions. Coronary stents have evolved significantly from 1977, when they were first introduced. The original bare-metal stent was later fitted with a drug-eluting polymer, to prevent restenosis and thrombosis over time. Subsequent iterations of the stent attempted to further mitigate that risk by replacing the durable polymer to one that is bioresorbable. The final step in this progression was to create a stent that was fully bioresorbable, which Abbott did with the creation of their ABSORB BVS stent. The product, however, was found to perform poorly when compared to current-generation drug-eluting stents, with several trials showing high rates of stent thrombosis (ST), late stent thrombosis (LST), target-lesion myocardial infarction, and target vessel revascularization. Observational studies of BVS stents have proposed several mechanisms for their thrombogenicity, including higher stent-strut profiles leading to turbulent flow, low radial strength leading to strut disruption, and a higher propensity for neoatherosclerosis. Given the failure of the first-generation BVS stent, but the lingering desire for fully bioresorbable scaffolds, various manufacturers have proposed their solutions with new stents. Until data from their clinical trials emerge, it remains unclear whether fully bioresorbable stents will play any role in coronary interventions.

Twelve-month angiographic and clinical outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold and a metallic stent in patients with coronary artery disease.

BACKGROUND: Recent studies showed bioresorbable scaffold (BRS) increased risks of late target lesion failure (TLF) and thrombosis. XINSORB scaffold is a poly-L-lactic acid based BRS. METHODS: The study included randomization and registry parts. Eligible patients with one or two de novo lesions were randomly 1:1 assigned to XINSORB scaffold and sirolimus-eluting stent (SES) in randomization part. These patients were clinically and angiographically assessed. In registry part, patients were treated with XINSORB scaffold only and were clinically assessed. The primary endpoint was in-segment late luminal loss (LLL) at 12-month in randomization part. The secondary endpoint was 12-month TLF in all XINSORB-treated patients. RESULTS: Total 395 and 798 patients were enrolled in randomization and registry part, respectively. Device success was 98.0% (1069/1091) in all XINSORB-treated and 100% (221/221) in SES-treated lesions. The primary endpoint of in-segment LLL at 12-month was 0.19 ±â€¯0.32 mm in XINSORB and 0.31 ±â€¯0.41 mm in SES (P = 0.003), which met the noninferior margin of 0.195 mm (95% CI: -0.20, -0.04, P ≪ 0.0001). No difference was found in TLF between two devices. In all XINSORB-treated patients, 12-month TLF was 0.8% (8/998), which also met the noninferior margin of 9.0% (95% CI: 0.3%, 1.4%, P ≪ 0.0001). Only one device thrombosis was recorded in all XINSORB-treated patients while none in SES. CONCLUSIONS: In the multicenter clinical trial, XINSORB BRS was noninferior to sirolimus-eluting stent for the primary endpoint of in-segment LLL at 12-month in patients with simple and moderate complex de novo coronary lesions. TLF at 12-month was low and comparable.

Risk of new-onset atrial fibrillation after drug-eluting stent implantation in patients with stable coronary artery disease.

BACKGROUND: New-onset atrial fibrillation (NOAF) is associated with adverse outcomes in patients with coronary artery disease (CAD). Although newer generation drug-eluting stents (NG-DESs) are more beneficial than bare-metal stents (BMSs) in reducing the risk of in-stent restenosis and revascularization, whether NG-DES implantation in patients with stable CAD reduces NOAF risk compared with BMS implantation remains unknown. METHODS: This population-based cohort study was conducted using data from Taiwan's National Health Insurance Research Database. Propensity score matching was used to select 18,423 pairs of patients with stable CAD receiving NG-DES implantation and BMS implantation with similar baseline characteristics for evaluation. A competing risk model was used to evaluate the risk of NOAF between the NG-DES and BMS groups in which death was considered a competing risk. RESULTS: After adjustment for patients' clinical variables, the use of NG-DESs was associated with a decreased risk of NOAF at 1-year follow-up (adjusted subdistribution hazard ratio [SHR] = 0.79, 95% confidence interval [CI] = 0.68-0.93, P = 0.005) compared with the use of BMSs. Similar results indicated that NG-DESs were beneficial for reducing the risk of NOAF (adjusted SHR = 0.81, 95% CI = 0.67-0.97, P = 0.020) in patients with a CHA2DS2-VASc score of ≥2. These findings were also consistent with those for patients who received dual antiplatelet therapy for an undefined duration of >1 month following stent implantation. CONCLUSIONS: Our findings suggest that NG-DESs might reduce the risk of NOAF in patients with stable CAD.

Abluminal biodegradable polymer biolimus-eluting versus durable polymer everolimus-eluting stent in patients with diabetes mellitus: 5 years follow-up from the COMPARE II trial.

BACKGROUND: Drug eluting stents with biodegradable polymers have been developed to address the risk of very late adverse events. Long-term comparison data between the biodegradable polymer-coated biolimus-eluting stent (BES; Nobori®) and the second-generation durable polymer-coated everolimus-eluting stent (EES; XIENCE V® or XIENCE PRIME® or PROMUS™) in diabetic patients are scarce. METHODS: The COMPARE II trial was an investigator-initiated, multicenter, open-label, randomized, all-comers trial which assigned patients undergoing percutaneous coronary intervention (PCI) in a 2:1 fashion to either BES or EES. We analyzed the safety and efficacy outcomes in diabetic patients at 5 year follow-up. The primary pre-specified composite endpoint major adverse cardiac event (MACE) was defined as cardiac death, non-fatal target-vessel myocardial infarction (TV-MI), or clinically indicated target vessel revascularization (CD-TVR). RESULTS: Out of 2707 study patients, 588 were diabetics (21.7%) of whom 391 were treated with BES and 197 with EES. At 5 years follow-up, MACE occurred in 87 patients (22.2%) in the BES group and in 34 patients (17.2%) in the EES group (p = .34). Other safety and efficacy endpoints did not differ between stent groups. CONCLUSIONS: At 5 years follow-up, no differences in terms of MACE as well as all analyzed safety and efficacy measures, including stent thrombosis, between the biodegradable polymer-coated BES and the durable polymer-coated EES in diabetic patients were observed.

[Femoral-popliteal Arteriosclerosis Obliterans:Review of Evidence-based Studies on Drug-eluting Endovascular Treatment].

Atherosclerosis-related diseases have increasingly become health concerns with the increased living conditions and aging.Globally,about 200 million people have suffered from arteriosclerosis obliterans(ASO),which can even be life-threatening in some cases.The past seven decades have witnessed the rapid advances in the treatment of ASO,which has developed from surgery to endovascular interventions including plain balloon angioplasty,bare metal stent placement,drug-coated balloon,and drug-eluting stent.However,the roles of these new techniques for femoral-popliteal lesions,especially their real-world clinical outcomes and indications,remain unclear.This article reviews the latest evidences on the use of drug-eluting devices in treating femoral-popliteal arteriosclerosis obliterans.

Two-year clinical outcomes of the "Italian diffuse/multivessel disease absorb prospective registry" (IT-DISAPPEARS).

BACKGROUND: Large prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. METHODS: We enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. RESULTS: Clinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47 ±â€¯22 mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5 mm scaffolds were independent predictors of DOCE. CONCLUSIONS: The 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.

Daily risk of adverse outcomes in patients undergoing complex lesions revascularization: A subgroup analysis from the RAIN-CARDIOGROUP VII study (veRy thin stents for patients with left mAIn or bifurcatioN in real life).

INTRODUCTION: Percutaneous coronary intervention (PCI) for complex lesions, including unprotected left main (ULM) and bifurcations, is gaining a relevant role in treating coronary artery disease with good outcomes, also thanks to new generation stents. The daily risk of adverse cardiovascular events and their temporal distribution after these procedures is not known. METHODS: All consecutive patients presenting with a critical lesion of ULM or bifurcation treated with very thin struts stents, enrolled in the RAIN-Cardiogroup VII study, were analyzed. The daily risk of major acute cardiovascular events (MACE), target lesion revascularization (TLR) and stent thrombosis (ST) and their temporal distribution in the first year of follow-up was the primary endpoint. Differences among subgroups (ULM, patient presentation, kind of stent polymer) were the secondary endpoint. RESULTS: 2745 patients were included, mean age 68 ±â€¯11 years, 33.3% diabetics, 54.5% had an acute coronary syndrome (ACS); 88.5% of treated lesions were bifurcations, 27.2% ULM. Average daily risk was 0.022% for MACE, 0.005% for TLR and 0.004% for ST, in the first year. Bimodal distribution of adverse events, especially TLR, with an early peak in the first 50 days and a late one after 150 days, was observed. Patients with ULM presented a significantly higher daily risk of events, and ACS patients presented higher MACE risk. No difference emerged according to the type of stent polymer. CONCLUSIONS: The daily risk of adverse events in the first year after complex PCI in our study is acceptably low. PCI on ULM carries a higher risk of complications.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. RESULTS: 82 patients (5%) were discharged with ≤3-month DAPT (57 ±â€¯27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ±â€¯75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). CONCLUSIONS: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.

Long-term trends of treatment effect of stenting or bypass surgery in patients with ostial or shaft left main coronary artery disease.

BACKGROUND: Little is known about how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG) on clinical outcomes in ostial or shaft left main coronary artery (LMCA) disease has evolved over time. METHODS: This study included 2,112 patients with ostial or shaft LMCA disease from IRIS-MAIN registry who underwent PCI (n = 1,329) or CABG (n = 783). Patients were stratified by time period based on stent type availability: wave 1 (1995-2002, bare-metal stent [BMS] era); wave 2 (2003-2006, first-generation drug-eluting stent [DES] era); and wave 3 (2007-2014, second-generation DES era). RESULTS: Compared to CABG, PCI has been used more frequently from wave 1 to wave 3. PCI showed substantial improvements over time with respect to death (P for trend = 0.012); the composite of death, myocardial infarction (MI), or stroke (P for trend = 0.047); repeat revascularization (P for trend < 0.001); and major adverse cardiac and cerebrovascular events (MACCE; a composite of death, MI, stroke, or repeat revascularization) (P for trend < 0.001). By contrast, outcomes of CABG remained relatively stable over time. The gap between the treatment effects of CABG vs PCI for MACCE has narrowed over time; the adjusted hazard ratios for CABG compared to PCI during wave 1, 2, and 3 were 0.41 (95% confidence interval [CI]: 0.22-0.76), 0.47 (95% CI: 0.31-0.71), and 0.78 (95% CI: 0.50-1.20), respectively. CONCLUSIONS: In patients with ostial or shaft LMCA disease, significant improvements in PCI outcomes resulted in a progressive decline in the gap between the outcomes of CABG and PCI.