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.

[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.

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.

New-generation drug-eluting stents for left main coronary artery disease according to the EXCEL trial enrollment criteria: Insights from the all-comers, international, multicenter DELTA-2 registry.

BACKGROUND: Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear. METHODS: We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models. RESULTS: Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p < 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002). CONCLUSIONS: In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.

Arterial occlusions increase the risk of in-stent restenosis after vertebral artery ostium stenting.

OBJECTIVE: The study was designed to investigate if vascular occlusion in the internal carotid artery (ICA) or the contralateral vertebral artery (VA) contribute to developing in-stent restenosis (ISR) in patients with vertebral artery ostium stenosis (VAOS). METHODS: 420 consecutive patients treated with VAOS stents (from a population of 8145 patients with VAOS) from January 2013 to December 2014 were analyzed in this retrospective study; 216 with drug eluted stents and 204 with bare metal stents. Based on pre-stent DSA findings, patients were divided into four groups: both carotid and vertebral arteries patent (PAT), ICA occlusion (ICA-OCC), contralateral VA occlusion (CVA-OCC), and combined occlusions (C-OCC). The incidence of ISR (stenosis >50%) was compared between groups using Cox regression analysis. RESULTS: Of the 420 patients, the mean incidence of ISR was 36.4%, with a median 12 months of follow-up (IQR 3-12). Logistic regression analysis showed that drug eluting stent had less ISR than bare metal stent (OR=0.38, 95% CI 0.19 to 0.75, P=0.01). Cox regression analysis showed that CVA-OCC (HR=1.63, P=0.02) and C-OCC (HR=3.30, P=0.001) were risk factors for ISR but not ICA-OCC (P=0.31). In the CVA-OCC and C-OCC groups, in-stent peak systolic velocity (PSV) ≥140 cm/s, 1 day after successful stenting, was associated with subsequent development of ISR (OR=2.81, 95% CI 1.06 to 7.43, P=0.04). CONCLUSION: Contralateral VA occlusion at the time of stenting increased the risk of ISR, especially if stent PSV on day 1 was >140 cm/s. Bare metal stents had more ISR than drug eluting stents.

Comparison of the Cost of Drug-Eluting Stents versus Bare Metal Stents in the Treatment of Critical Limb Ischemia in the United States.

BACKGROUND: Despite significant technical advancement in the last decade, the durability of endovascular management of critical limb ischemia (CLI) remains highly debatable. Drug-eluting stents (DESs) are being popularized for the management of CLI after its precedent success in coronary intervention. Initial reports on the durability of DES are promising. However, little is known on the additional cost of this relatively newer technology. The aim of this study is to compare the cost of the traditional bare metal stents (BMSs) to the newly introduced DES in a large cohort of CLI patients. METHODS: Using the Premier database (2009-2015), we identified all patients with CLI undergoing DES and BMS. A multivariable generalized linear model was implemented to examine in-hospital cost adjusting for patients' characteristics, comorbidities, and regional characteristics. RESULTS: A total of 20,702 patients with CLI underwent peripheral artery revascularization using BMS (18,924 [91.41%]) or DES (1,778 [8.6%]). Majority of patients were males (53%) and whites (71%). Patients undergoing BMS were slightly younger (median age [interquartile range]: 70 [62-79] versus 71 [63-80]) and were more likely to be smokers (46% vs. 39%) and have a history of cerebrovascular disease (10% vs. 8%) and chronic pulmonary disease (24.5% vs. 20.9%) as compared with those undergoing DES (all P < 0.05). On the other hand, DES patients had a high prevalence of diabetes (4% vs. 3%) and renal disease (25% vs. 22%) (both P < 0.05). There was also a significant increase in the proportion of patients undergoing DES and a corresponding decrease in BMS (P < 0.001) over the study period. Median total in-hospitalization cost (BMS: $13,342 [8,574 to 21,166], DES: $13,243 [8,560-20,232], P = 0.76) was similar for both approaches. After adjusting for potential confounders, DES was associated with $407 higher cost than BMS (adjusted mean difference [95% confidence interval]: 407 [17 to 798], P = 0.04). In addition, the cost was $672 higher in teaching hospitals, $1,153 higher in Rural areas, and increased in all regions compared with the Midwest (adjusted mean difference [95% confidence interval]-South: $293 [31 to 555], Northeast: $2,006 [1,517 to 2,495], West: $3,312 [2,930 to 3,695], all P < 0.05). CONCLUSIONS: In this large cohort of CLI patients, after controlling for potential confounders, we demonstrated that the cost of endovascular revascularization is significantly higher in patients undergoing DES than those undergoing BMS. Regional disparities in cost were also observed. Further studies looking at the long-term durability and costs of DES versus BMS are needed.

Comprehensive analysis of common safety profiles and their predictive factors in 520 records of liver cancer patients treated by drug-eluting beads transarterial chemoembolization.

This study aimed to investigate the difference of common adverse events (AEs) between patients experienced first drug-eluting beads transarterial chemoembolization (DEB-TACE; FD) and second or higher DEB-TACE (SHD), and the factors influencing AEs.Five hundred twenty DEB-TACE records were retrospectively reviewed in this cohort study, among which 284 and 236 records were in FD and SHD groups, respectively. The incidence and/or severity of pain, fever, vomiting, and increased blood pressure (BP) were collected.Pain numerical rating scale (NRS) score, pain severity, body temperature, fever severity, and fever lasting days were higher in FD group than in SHD group, while no difference of vomiting and increased BP between 2 groups were disclosed. Age ≥65 years was associated with decreased high fever and less possibility of vomiting in FD group, and lower pain and fever severity in SHD group; Male decreased the possibility of vomiting in both the groups, and reduced increased BP incidence in SHD group; diabetes history correlated with decreased pain degree and less fever in FD group.In conclusion, SHD was better tolerated compared with FD in liver cancer patients, and older age as well as male were correlated with less occurrence or severity of common AEs in DEB-TACE operation.

Safety and Effectiveness of Second-Generation Drug-Eluting Stents in Patients With Left Main Coronary Artery Disease.

BACKGROUND: Limited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD). OBJECTIVES: This study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice. METHODS: Among 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents] registry, the IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization] registry, and the PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease] study) treated between July 2007 and July 2015, the authors identified 2,692 patients with significant LMCAD who received second-generation DES; 1,254 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 232 with biodegradable polymer biolimus-eluting stents (BP-BES), 616 with platinum-chromium EES (PtCr-EES), and 590 with Resolute zotarolimus-eluting stent (Re-ZES). The primary outcome was target-vessel failure. RESULTS: The observed 3-year rates of target-vessel failure were not significantly different for the different types of DES (16.7% for the CoCr-EES, 13.2% for the BP-BES, 18.7% for the PtCr-EES, and 14.7% for the Re-ZES; p = 0.15). In multiple treatment propensity score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were similar in between-group comparisons of the different DES, except for the PtCr-EES versus the BP-BES (reference; HR: 1.60; 95% confidence interval: 1.01 to 2.54; p = 0.046). There were no significant differences in risk of composite of all-cause death, any myocardial infarction, or any revascularization and its individual components according to the different types of DES. Although the 3-year incidence of stent thrombosis was considerably low (≤1.0%) for all types of DES, between-group differences were observed, generally favoring the EES platforms. CONCLUSIONS: In this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Management and predictors of outcome in unselected patients with cardiogenic shock complicating acute ST-segment elevation myocardial infarction: results from the Bremen STEMI Registry.

INTRODUCTION: Patients with ST-segment elevation myocardial infarction (STEMI) and consecutive cardiogenic shock (CS) represent a challenge in clinical practice. Only few 'real-world' data on therapeutic management and outcome exist. METHODS: The present analysis focuses on changes of clinical management of STEMI-patients with CS and analyzes predictors of outcome using the Bremen-STEMI registry. RESULTS: Out of 7865 patients with STEMI, 981 patients (13%) presented with CS. Most CS patients (88%) underwent an early percutaneous intervention (PCI). Intraaortic balloon pumps (IABP) were less implanted since 2013 (p < 0.001), the rate of drug-eluting stents and periprocedural prasugrel or ticagrelor therapy increased over the years. Overall in-hospital mortality of patients with CS was 37%, 1 year mortality was 50%. A significantly reduced 1-year mortality (2006-2009: 55%, 2010-2013: 50%; 2014-2015: 43%, p = 0.027) was observed. In a multivariate analysis significant predictors of an increased 1-year mortality were acute renal failure (OR 3.6; 95% CI 1.9-7.0), atrial fibrillation (OR 2.8; 95% CI 1.3-6.0), three-vessel disease (OR 2.5; 95% CI 1.3-4.7), age ≥ 75 years (OR 2.4, 95% CI 1.3-4.4) and anemia (OR 1.9; 95% CI 1.1-3.3). A successful performed PCI (OR 0.5, 95% CI 0.2-0.9) was associated with a significantly reduced 1-year mortality. CONCLUSION: management of patients with CS changed with a steep decrease of IABP implantations. Mortality of patients with CS decreased over the last 10 years. Especially, performance of successful PCI was associated with a reduction of mortality, indicating the crucial role of early revascularization to improve prognosis in this high-risk cohort of STEMI-patients.

Drug-coated versus bare-metal stents for elderly patients: A predefined sub-study of the LEADERS FREE trial.

BACKGROUND: The randomized, LEADERS FREE trial showed superior safety and efficacy of a polymer-free DCS vs. a bare metal stent in high-bleeding risk patients with only one month dual antiplatelet treatment. We report characteristics and outcomes of the pre-specified group of elderly patients (aged ≥75). METHODS: Age >75 was one of the trial's inclusion criteria. The main additional criteria were: need for oral anticoagulants, recent bleeding, anemia, chronic renal failure and cancer. All patients received 1month DAPT only. Both primary endpoints (efficacy: clinically driven TLR and safety: composite of cardiac death, MI and stent thrombosis) as well as bleeding were recorded up to 390days. RESULTS: 1564 elderly patients (63.4% of the population) were enrolled with a mean of 2 inclusion criteria/patient. The primary safety endpoint was reached less frequently in DCS than BMS patients (10.7 vs. 14.3%, p=0.03), as was the primary efficacy endpoint (5.8 vs. 10.8% p=0.0003). Major bleeding rates were high and similar in both groups (7.3 vs. 8.2%, p=0.55). For the 562 (23.4%) patients with age as sole entry criterion, trends were similar for DCS and BMS patients respectively: safety endpoint (7.3%vs.11.4% p=0.10) and Cd TLR (4.7 vs. 13.2% p=0.0003), but for both groups, major bleeding occurred less frequently than for elderly patients with more comorbid conditions (3.6%vs. 2.8%). CONCLUSION: Compared to a BMS, use of a DCS together with a short one-month DAPT course was associated with significant safety and efficacy benefits for the elderly patients enrolled in LEADERS FREE.

Coronary artery bypass graft surgery versus percutaneous coronary intervention with drug-eluting stents for left main coronary artery disease: A meta-analysis of randomized trials.

BACKGROUND: Despite several clinical studies, efficacy of coronary artery bypass grafting (CABG) surgery versus percutaneous coronary intervention (PCI) in patients with left main (LM) disease remains controversial. The objective of this meta-analysis of randomized trials was to evaluate the clinical outcome of CABG versus PCI with drug-eluting stents in LM coronary disease. METHODS: We systematically searched online databases up to March 2017 for randomized trials comparing CABG to PCI with drug-eluting stents. We calculated odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: We included data from 5 randomized trials and 4595 patients. At 30days, CABG was associated with higher stroke (OR 2.54 [95% CI, 1.02-6.31]) and periprocedural myocardial infarction (OR 1.45 [95% CI, 1.00-2.10]), with no other significant differences compared to PCI. At 1year, CABG reduced repeat revascularization (OR 0.56 [95% CI, 0.40-0.77]), but increased stroke (OR 5.11 [95% CI, 1.62-16.12]). At 3-5years, CABG reduced repeat revascularization (OR 0.55 [95% CI, 0.45-0.67]) and non-periprocedural myocardial infarction (OR 0.45 [95% CI, 0.29-0.70]), without significant differences on other outcomes. CONCLUSIONS: From the present updated meta-analysis of available studies on LM coronary disease treatment, there were no differences in mortality, myocardial infarction, and stroke rate at 3-5years follow-up after CABG or PCI, but CABG decreased the rate of repeat revascularization and non-periprocedural infarction. However, at short-term follow-up, CABG showed higher rate of stroke and periprocedural myocardial infarction, but these effects attenuated over time. These findings merit further investigation at longer follow-up.

Long-term comparative effectiveness of Endeavor zotarolimus-eluting and everolimus-eluting stents in New York.

BACKGROUND: Endeavor zotarolimus-eluting stents (E-ZES) and everolimus-eluting stents (EES) as second-generation stents were approved for use in percutaneous coronary interventions (PCIs) in 2008. We aimed to evaluate the long-term outcomes of E-ZES vs. EES using New York State (NYS) cardiac registries and to compare long-term effectiveness of E-ZES vs. EES in six "off-label" and two "high-risk" subgroups. METHODS: We created a longitudinal database by linking the NYS cardiac registries, the statewide hospital discharge data, the National Death Index, and the U.S. Census file (2010) for patients receiving either E-ZES or EES from July 2008 through December 2010. We examined outcome measures of all-cause mortality, acute myocardial infarction (AMI), target lesion PCI (TLPCI), and target vessel coronary artery bypass graft (TVCABG) surgery for 13,663 propensity score matched pairs in the 6-year follow-up period. We applied Kaplan-Meier methods and Cox proportional hazards regression for further adjustment of propensity-matched pairs. RESULTS: Compared with patients receiving EES, patients receiving E-ZES had a significantly higher rate of 6-year all-cause mortality (adjusted hazard ratio (AHR): 1.10, 95% confidence interval (CI): 1.04-1.17, P=0.003), AMI (AHR: 1.12, 95% CI: 1.02-1.23, P=0.01), TLPCI (AHR: 1.28, 95% CI: 1.18-1.39, P<0.001), and TVCABG (AHR: 1.47, 95% CI: 1.26-1.71, P<0.001). EES had better or similar long-term outcomes than E-ZES for the subgroups that were examined. CONCLUSION: At 6years, patients receiving EES generally had better or comparable mortality, AMI, TLPCI, and TVCABG outcomes compared with patients receiving E-ZES.

Trends in the Use of Stents and Drug-Eluting Stents in Sinus Surgery.

Stenting has long been used in the paranasal sinuses with the goals of maintaining a patent sinus cavity during the postoperative healing process and preventing restenosis from inflammation or scarring. More recently, drug-eluting stents have been introduced. Steroid-impregnated dressings and implants appear to be safe, although likely have increased systemic absorption compared with topical nasal steroid sprays and rinses. There is evidence to support the use of steroid-releasing implants in the ethmoid cavity in the postoperative period; however, more study is needed to truly define the role of these implants.

Verapamil eluting stents as a possible treatment for vasospasm after subarachnoid hemorrhage.

OBJECTIVE: The only pharmacologic prophylaxis for cerebral vasospasm after subarachnoid hemorrhage is oral nimodipine. A novel way to mitigate this risk may be to design a drug eluting stent that elutes verapamil over the time period typically associated with vasospasm. In this study, we explore different methods of coating nitinol stents with a bioabsorbable polymer and determine the release profile of various verapamil coated stents for the potential treatment of vasospasm. METHODS: Nitinol stents were coated with different concentrations of poly(lactic acid-co-glycolic acid) (PLGA) in chloroform solution and using three coating techniques: dip coating, spin coating, and electrospinning. Morphology of the coatings were studied with scanning electron microscopy. 12 verapamil eluting stents were then prepared using different verapamil concentrations and coatings with different numbers of layers. Drug release behaviors were studied using UV spectroscopy for 21 days. RESULTS: Electrospinning at 20% w/v resulted in a smooth uniform coating without significant surface irregularities, and may be the most effective technique to coat stents. Stents with a single layer of PLGA/verapamil coating showed a two phase release profile (initial burst release followed by a slow rate of release) whereas stents with a bilayer coating showed a lower level of initial release followed by a slower sustained release phase. CONCLUSIONS: Development of verapamil eluting stents that elute drug over the time course typical of cerebral vasospasm, and for either immediate or prophylactic treatment, is technically feasible. Further in vitro and in vivo studies are required to determine whether this can improve the outcome of patients after subarachnoid hemorrhage.

Second vs. first-generation drug-eluting stents in complex lesions subsets: 3 years' follow-up of ERACI IV study.

BACKGROUND: Although percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES-1) did not show a benefit in terms of death rate and myocardial infarction (MI) compared to bypass surgery (coronary artery bypass graft [CABG]), DES platforms have seen a remarkable improvement in the last few years, and a significant increase in their safety and efficacy was observed in randomized controlled trials and observational studies in comparison with DES-1 in patients with coronary artery disease (CAD). One-year results from the ERACI IV registry using a second-generation DES (DES-2) demonstrated significantly greater efficacy and safety in patients with multiple vessel CAD, including diabetics, compared to DES-1. Long-term results are yet unknown. METHODS: The ERACI IV registry was a multicenter, prospective and controlled open-label study conducted in 9 sites in Argentina during 2013 and 2014, which evaluated a DES-2 for the treatment of patients with multiple vessel CAD including unprotected left main disease (ULMD) and diabetes. The primary endpoint was to compare the composite of death of any cause, MI and cerebrovascular accident (CVA) as hard endpoints with ERACI III DES-1 arm. Secondary endpoints included each component of the primary endpoint and target vessel revascularization (TVR) as major adverse cardiovascular events (MACCE) and stent thrombosis. We include a modified Syntax Score (SS) taking in account functional revascularization, treating lesions ≥70% in vessels ≥ 2.00 mm, whereas severe lesions in vessels < 2.0 mm and intermediate lesions were not rated. RESULTS: Baseline characteristics were similar between groups, with higher numbers of diabetics and 3-vessel/ULMD (P=0.02 and P=0.003, respectively) in ERACI IV. At 34.7 months' follow-up, the incidence of the composite of death/MI/CVA between ERACI IV and ERACI III (4.9% vs. 13.7%, P<0.001); unplanned new revascularization (5.3% vs. 14.2%, P<0.001) and MACCE (9.3% vs. 22.7%, P<0.001), were significantly lower in ERACI IV DES-2. MACCE rate was similar in diabetics, (5.8%) and nondiabetics (7.0%). After performing a matched propensity score, MACCE remain significantly lower in ERACI IV (P = 0.005). Incidence of stent thrombosis was lower although not significantly between groups, (0.9% vs. 3.1% in ERACI IV and III, respectively; P=0.13). CONCLUSIONS: The use of DES-2 in patients with complex lesions subsets together with a functional PCI strategy were associated with a remarkable low incidence of adverse events at 3 years' follow-up and the benefit was also seen in in diabetic population. Late outcome of this study strongly validated our lesion PCI scoring and assessment.

[Coronary interventions : Current developments for improved long-term results]. / Koronarinterventionen : Aktuelle Entwicklungen für bessere Langzeitergebnisse.

Based on solid scientific evidence, new generation drug-eluting stents (DES) have become established as the standard of care in interventional cardiology. With at least similar safety and superior efficacy over uncoated bare metal stents (BMS) in various scenarios and including patients with increased bleeding risk, there are probably no remaining indications favoring the use of BMS. Additional developments regarding the platform, drug elution characteristics and polymer design were aimed at optimizing DES with even better outcomes. Although there is no lack of new variations, none has proven to be superior and several non-inferiority trials lacked statistical power, which precludes the label third generation (over second generation or new generation DES). While it is recognized that potential long-term advantages of bioresorbable scaffolds cannot be expected at this stage from the current ABSORB III trial, the safety and efficacy are encouraging. Beyond procedural aspects, such as intracoronary imaging, variations in duration of antiplatelet therapy should help to improve outcomes but still require careful individual weighting of ischemic vs. bleeding risk.

State of the art in coronary revascularization: Everolimus eluting stents versus multiple arterial grafting.

BACKGROUND: Contemporary comparisons on coronary revascularization should take into account the state of the art percutaneous coronary intervention (PCI) with new generation everolimus-eluting stents (EESs) and coronary artery bypass grafting (CABG) with multiple arterial grafts (MAGs). We aimed to compare early outcomes and late survival after EES versus MAG in patients with multivessel coronary artery disease using a single centre institutional database. METHODS: In an observational registry study, we identified 3787 patients with multivessel coronary disease. Of these 696 (18.3%) underwent PCI with EES and 3091 (81.7%) CABG with MAG. With the use of propensity-score matching, we identified 483 pairs for final comparison (C-statistic: 0.91). RESULTS: The two groups were comparable for 30-day mortality (1.6% versus 0.8% in the EES and MAG group respectively, P=0.38). Stroke was not observed in the EES group and it was 0.8% in the MAG group (P=0.13). After a mean follow-up of 3.1years, PCI with EES was associated with a higher risk of late death (HR 2.2; 95% CI 1.18-4.16; P=0.01). CONCLUSIONS: In patients with multivessel coronary disease, CABG with multiple arterial grafts when compared with PCI with new generation drug eluting stent, was associated with significantly improved long-term survival. Further randomized studies are warranted to identify the best revascularization strategies in the current era.