Safety and efficacy of everolimus-eluting stents compared with first-generation drug-eluting stents in patients undergoing primary percutaneous coronary intervention

ObjectiveTo assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation drug-eluting stents (DES) in patients with acute myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI).BackgroundEES have been associated with improved clinical outcomes compared to paclitaxel-eluting stents (PES) and with similar outcomes compared to sirolimus-eluting stents (SES).MethodsA total of 520 patients who presented with ST-elevation myocardial infarction (STEMI) from 2003 to 2013, who underwent primary PCI with DES, were retrospectively analyzed. Of these, 247 received SES, 136 PES, and 137 EES. Patients were followed up to 2 years for major adverse cardiac events (MACE). Univariate and multivariate models detected correlates to outcome.ResultsEES implantation, compared with PES and SES, resulted in comparable rates of MACE (8.8% vs. 16.2%, p = 0.06 and 8.8% vs. 12.6%, respectively, p = 0.26), stent thrombosis, MI, and target lesion revascularization. Patients who received EES had lower rates of all-cause mortality (3.7% vs. 12.6% vs. 9.4%, p = 0.03) at 1-year follow up. However, in the univariate and multivariate analyses, stent type was not independently associated with the primary outcome or with all-cause mortality. Diabetes mellitus and number of stents implanted were independently associated with the primary outcome.ConclusionWhile EES seem to be associated with better outcome when compared to PES, the main correlates of STEMI patients are the presence of diabetes and number of stents implanted, and not the type of stent used for intervention.     

Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: A meta-regression from 31 randomized trials

BackgroundThe use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised.ObjectiveThis study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases.MethodsA meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated.ResultsThe clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR = 31.1–1.2 (TLR for bare-metal stents); p < 0.001. The use of DES was safe regardless of the risk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, ? 0.12 to 0.19, and ? 0.03 to?0.15 for mortality, myocardial infarction, and stent thrombosis, respectively).ConclusionsThe clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety.     

The Japanese experience with sirolimus-eluting stent implantation in the infarct-related artery: Five years of observation from the J-PMS study

BackgroundLong-term outcome and safety concerns regarding drug-eluting stents (DES) for acute myocardial infarction (AMI) treatment is still debated.Methods and resultsWe analyzed data from 1937 patients with complete 5-year follow-up (94.5%) from a multicenter registry of sirolimus-eluting stents (J-PMS). The patients were divided into 2 groups: AMI (n = 133) and non-AMI (n = 1804) by clinical presentation of index procedure, and compared the outcomes. At 5-year follow-up, there were no significant differences in major adverse cardiac events (MACE), death, MI, or stent thrombosis between the groups. However, target vessel related events (TVF; revascularization, cardiac death, MI, thrombosis) were higher in the non-AMI group (p = 0.03). In the early phase (0–6 months), MACE and death/MI were higher in the AMI group (6.0% vs. 3.0%; p = 0.02 and 6.8% vs. 2.1%; p < 0.001). However, in the late phase (6–60 months), there was a difference in TVF between the 2 groups, with a steady increase in the non-AMI group (p = 0.03). Over 60% of patients with AMIs were started on dual antiplatelet therapy after stent implantation or on the same day. However, dual anti-platelet therapy duration was similar (867 ± 18 days in the AMI and 727 ± 57 days in the non-AMI group, p = 0.5). Frequency of bleeding was similar.ConclusionFive-year observation of AMI treatment using drug-eluting stent compared with non-AMI has no clinical disadvantage.     

First- versus second-generation drug-eluting stents for the treatment of coronary bifurcations

BackgroundRandomized controlled trials have demonstrated that second-generation drug-eluting stents (DESs) for the treatment of obstructive coronary artery disease are associated with comparable, if not improved, clinical outcomes as compared to those of their first-generation counterparts. The aim of this study was to compare the long-term clinical outcomes associated with first- versus second-generation DESs for the treatment of coronary bifurcation lesions.Methods and MaterialsThis was a retrospective study of consecutive de novo bifurcation lesions, excluding those at the left main, treated with either second-generation DES (everolimus-eluting or resolute zotarolimus-eluting stents) between October 2006 and October 2011 (199 bifurcation lesions in 192 patients) or first-generation DES (sirolimus-eluting or paclitaxel-eluting stents) between April 2002 and December 2005 (289 bifurcation lesions in 273 patients).ResultsSecond-generation DES use in this setting was associated with less major adverse cardiac events (MACE) (23.1% vs. 14.4%, p = 0.02) as well as lower target vessel revascularization (TVR) rates (15.5% vs. 8.3%, p = 0.01) at 2-year follow-up. Target lesion revascularization, both per patient (12.6% vs. 7.4%, p = 0.02) and per bifurcation (11.8% vs. 7.0%, p = 0.03), was also improved with second-generation DES over the same follow-up period. Propensity-score adjusted analysis suggested that second-generation DES was associated with a lower incidence of MACE (HR, 0.53; 95% CI, 0.33–0.85; p = 0.01) and TVR (HR, 0.44; 95% CI, 0.24–0.83; p = 0.01).ConclusionsOur results suggest that the use of second-generation DES for the treatment of bifurcation lesions is associated with better clinical outcomes as compared to first-generation DES, largely due to a lower need for repeat revascularization.     

One-year outcome of patients with diabetes mellitus after percutaneous coronary intervention with three different revascularization strategies: Results from the DiabEtic Argentina Registry (DEAR)

AimsPercutaneous coronary interventions (PCI) in patients with diabetes mellitus (DM) are associated with a high incidence of coronary restenosis, myocardial infarction (MI) and death. This study was to assess the potential role of a paclitaxel-eluting balloon (PEB) treatment in patients with DM with coronary lesions compared to those treated either with bare-metal stents (BMS) or drug-eluting stents (DES).Methods and ResultsThe Diabetic Argentina Registry (DEAR) was an observational, prospective, non-randomised, open-label study that enrolled 92 patients with diabetes mellitus in three centers from Buenos Aires, Argentina, between April 2009 and March 2011, to be treated with PEB. Results were compared with previous outcome data in all patients with DM treated with DES (n = 129 pts) or BMS (n = 96 pts) in clinical studies conducted at our institutions. At one-year follow-up, patients with DM who received PEB followed by BMS implantation (96%) had a significantly lower incidence of major adverse cardiac events (MACE) compared to the BMS group (BMS 32.3%, PEB 13.2%; P = .003). The incidence of target-vessel failure (TVF) was 30.2% (BMS) and 11% (PEB) (P = .003), that of target-vessel revascularization (TVR) was 22.9% (BMS) and 8.3% (PEB) (P = .005) and the composite of death/MI occurred in 13.5% (BMS) and in 2.2% for PEB (P = .05). These positive results are persistent even after subgroups analysis. When comparing with previous DES patients, TVF was 18.6% in DES vs. 11.0% in PEB (P = .13), MACE was 18.6% in DES vs. 13.2% in PEB (P = .29), TVR rate was 14.0% in DES vs. 8.3% in PEB (P = .14) and the composite death/MI was 9.3% in DES vs. 4.4% in PEB (0.18)ConclusionsDiabetic patients treated with PEB followed by BMS resulted in a significantly better outcome than BMS alone and appeared to be comparable to DES treatment.     

Drug-eluting stents in patients on chronic hemodialysis: Paclitaxel-eluting stents vs. limus-eluting stents

BackgroundPatients requiring chronic hemodialysis (HD) are at high risk for restenosis after percutaneous coronary intervention (PCI) with bare metal stents. Outcome data on drug-eluting stent (DES) implantation in HD patients are limited and suggest superiority of paclitaxel-eluting stents (PES) over limus-eluting stents (LES).MethodsIn total, 218 consecutive patients were prospectively enrolled. A comparison of post-PCI outcomes up to 2 years was carried out between patients receiving PES (n = 62) and LES (n = 156; SES n = 112, EES n = 44). The primary end point was 2-year major adverse cardiac events [MACE; death, Q-wave myocardial infarction and target lesion revascularization (TLR)].ResultsBaseline characteristics were comparable. The overall prevalence of diabetes mellitus was 71%. On clinical follow-up to 2 years, MACE rates were similar [PES 32/51 (62.7%) vs. LES 77/132 (58.3%), p = 0.59]; however, clinically-driven revascularization occurred more than twice as frequently in LES patients: TLR [PES 4/36 (11.1%) vs. LES 24/93 (25.8%), p = 0.07] and target vessel revascularization [5/37 (13.5%) vs. 33/96 (34.4%), p = 0.02]. Given that overall mortality was nominally higher for PES patients [31/50 (62.0%) vs. 61/127 (48.0%), p = 0.09], a competing outcome analysis was implemented for TLR against mortality, which demonstrated that the trend for increased TLR with LES was no longer apparent (p = 0.282). On multivariable adjustment, only diabetes mellitus was independently associated with TLR (use of PES was not).ConclusionsPatients on chronic HD experience high rates of clinically driven TLR despite DES implantation. Use of PES does not demonstrate a significant advantage over LES in this population.     

Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: The PLUS-ONE first-in-man study

BackgroundThe Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES.MethodsA total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18 mm, n = 30) or group B (8 μg/18 mm, n = 30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization.ResultsPatient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P = 1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30 mm and 0.34 ± 0.20 mm P = .773).ConclusionsIn this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol–gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year.     

Resultado del tratamiento percutáneo de la reestenosis de stents farmacoactivos: ¿depende de si el stent tenía o no recubrimiento polimérico?

Introduction and objectivesOutcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES.MethodsPatients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups.ResultsA total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P = .38; P_adjusted = .29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR = 1.04, 95%CI, 0.70-1.55; P = .83; P_adjusted = .79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR = 0.91, 95%CI, 0.60-1.39; P = .68; P_adjusted = .62).ConclusionsIn patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES.     

Función endotelial y microvascular distal a stents farmacoactivos sin polímero y captadores de células endoteliales. Estudio aleatorizado FUNCOMBO

Introduction and objectivesThe vasomotor function of new-generation drug-eluting stents designed to enhance stent healing and reendothelialization is unknown. This study aimed to compare the endothelial function of the infarct-related artery (IRA) treated with bioactive circulating endothelial progenitor cell-capturing sirolimus-eluting stents (COMBO) vs polymer-free biolimus-eluting stents (BioFreedom) in ST-segment elevation myocardial infarction patients at 6 months. Secondary objectives were to compare the microcirculatory function of the IRA and stent healing at 6 months.MethodsSixty patients were randomized to bioactive sirolimus-eluting stent vs polymer-free biolimus-eluting stents implantation. At 6 months, patients underwent coronary angiography with vasomotor, microcirculatory and optical coherence tomography examinations. Endothelial dysfunction of the distal coronary segment was defined as ≥ 4% vasoconstriction to intracoronary acetylcholine infusion.ResultsEndothelial dysfunction was similarly observed between groups (64.0% vs 62.5%, respectively; P = .913). Mean lumen diameter decreased by 16.0 ± 20.2% vs 16.1 ± 21.6% during acetylcholine infusion (P = .983). Microcirculatory function was similar in the 2 groups: coronary flow reserve was 3.23 ± 1.77 vs 3.23 ± 1.62 (P = .992) and the index of microcirculatory resistance was 24.8 ± 16.8 vs 21.3 ± 12.0 (P = .440). Optical coherence tomography findings were similar: uncovered struts (2.3% vs 3.2%; P = .466), malapposed struts (0.1% vs 0.3%; P = .519) and major evaginations (7.1% vs 5.6%; P = .708) were observed in few cases.ConclusionsEndothelial dysfunction of the IRA was frequent and was similarly observed with new-generation drug-eluting stents designed to enhance stent reendothelialization at 6 months. Endothelial dysfunction was observed despite almost preserved microcirculatory function and complete stent coverage. Larger and clinically powered studies are needed to assess the role of residual endothelial dysfunction in ST-segment elevation myocardial infarction patients.Registered in ClinicalTrials.gov: NCT04202172Full English text available from:www.revespcardiol.org/en     

Comparison of sirolimus-, paclitaxel-, and everolimus-eluting stent in unprotected left main coronary artery percutaneous coronary intervention

ObjectivesThis retrospective study evaluated the outcomes of patients who underwent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with different types of drug-eluting stents (DES).BackgroundThe standard of care for patients with ULMCA is coronary artery bypass surgery. However, current guidelines recommend PCI in clinical conditions where there is an increased risk of adverse surgical outcomes. Clinical outcomes of patients undergoing ULMCA PCI with different types of drug-eluting stents (DES) are unknown.MethodsData from a multicenter international registry, which included 239 consecutive patients from four institutions who ULMCA PCI with DES, were collected.ResultsThere were 42 patients receiving paclitaxel-eluting stent (PES), 158 patients receiving sirolimus-eluting stent (SES), and 39 patients receiving everolimus-eluting stent (EES). There was no statistical difference in major adverse cardiovascular events, cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis among PES, SES, and EES at 30 days and 1 year.ConclusionsThere are no differences in clinical events among patients receiving PES, SES, and EES for ULMCA disease.     

Everolimus-eluting stents compared with paclitaxel-eluting stents for treatment of coronary in-stent restenoses

BackgroundEverolimus-eluting stent (EES) implantation was superior to paclitaxel-eluting stent (PES) implantation for treatment of de-novo coronary artery disease. We evaluated the outcome of EES compared with PES for treatment of restenosis in bare-metal and drug-eluting stents (DES).Methods and MaterialsIn a prospective observational study patients with in-stent restenosis (ISR) were treated with EES (N = 91) or PES (N = 107). Dual antiplatelet therapy was given for 6 months. Patients were scheduled for 6 months angiographic follow-up and 24 months clinical follow-up. Primary outcome measure was the occurrence of major adverse cardiac events (MACE) defined as a composite of cardiac death, any myocardial infarction and target lesion revascularization (TLR).ResultsBaseline data showed some differences between groups including frequency of DES restenosis, length of stented segment and reference vessel diameter. For EES versus PES occurrence of MACE (18.7% vs. 15.0%, p = 0.48) and need for TLR did not differ (13.2% vs. 9.3%, p = 0.39). In-stent late loss was similar with 0.20 ± 0.39 mm for EES and 0.18 ± 0.31 mm for PES (p = 0.34). Binary angiographic restenosis rate for the total segment was 18.0% and 16.7% (p = 0.85), respectively. In multivariable analysis the stented length (p = 0.014), minimal lumen diameter post stenting (p < 0.01) and repeated restenosis (p < 0.001) were risk factors for a higher late loss but not type of DES or presence of diabetes mellitus.ConclusionsIn this observational registry treatment of DES and BMS restenosis with EES versus PES implantation resulted in similar clinical and angiographic outcome.     

Stent thrombosis is not increased following percutaneous coronary intervention in patients with non-insulin dependent diabetes mellitus taking metformin

Objective

Recent studies have suggested that metformin may inhibit endothelialization following limus-eluting stent (LES) placement and may increase the risk of stent thrombosis. Therefore, we assessed the impact of metformin on stent thrombosis and major adverse cardiovascular events (MACE) in non-insulin-dependent diabetes mellitus (NIDDM) patients who receive drug-eluting stents (DES).

Methods

We assessed the impact of metformin and stent type on stent thrombosis, MACE, and death in NIDDM patients following DES placement. Of the 1201 patients included, 74.8% received LES, 25.2% received paclitaxel-eluting stents (PES), and 55% were taking metformin.

Results

There was no difference in stent thrombosis, regardless of stent type or metformin use. While Kaplan–Meier curves demonstrated reduced MACE (p = 0.007) and death (p = 0.006) with metformin use, multivariate analysis demonstrated that stent type and metformin use were not associated with outcome.

Conclusion

In NIDDM patients, metformin use or stent type following DES placement did not increase stent thrombosis and MACE rates.     

Two-year follow-up of percutaneous coronary intervention using EucaTax or Cypher

BackgroundThe EucaTax stent (EUPES) is a coronary stent with biodegradable polymer and camouflage coating that has been developed to promote the complete elution of drugs and decrease the risk of late complications. The aim of this study was to evaluate the efficacy and safety of the double-coated EUPES in patients with stable angina versus sirolimus-eluting stent CYPHER (SES) with permanent polymer coating.Methods and MaterialsThe study included consecutive patient with at least 70% de novo coronary lesions in one or two native coronary arteries and who had undergone the coronary stenting using either EUPES or SES. We evaluated the 2-year major adverse cardiac events (MACE) rates, including total death (cardiac, non-cardiac), myocardial infarction (MI), target lesion revascularisation (TLR) and stent thrombosis.ResultsBetween 2006 and 2009 this observational, prospective, single centre study included 602 patients (282 with EUPES and 320 with SES). At 2 years, the rates of TLR (16.3% versus 6.25%; p = 0.0001) and MACE (18.4% versus 7.8%; p = 0.001) were significantly higher in the EUPES than in the SES group. The rate of TLR was significantly higher in the EUPES group compared with SES group in stenting of artery with a diameter less than 3 mm, using stent length more than 18 mm, as well as when the residual stenosis was more than 12%.ConclusionsWe found that EUPES was inferior to SES during the 2-year follow-up with respect to rates of MACE and TLR that were significantly higher in the EUPES than in the SES group.     

Clinical outcomes of everolimus- and zotarolimus-eluting stents in patients with acute myocardial infarction for small coronary artery disease

Background and purposeThere were limited data about comparison of zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES) in patients with small coronary artery disease (CAD), especially in patients with acute myocardial infarction (AMI). The objective of this study was to compare the clinical outcomes of ZES and EES in patients with AMI for small CAD.Methods and subjectsA total 1565 AMI patients treated with Endeavor-ZES (n = 651) (Medtronic CardioVascular, Santa Rosa, CA, USA) or Xience V/Promus-EES (n = 914) (Abbott Vascular, Temecula, CA/Boston Scientific, Natick, MA, USA) for small CAD (stent diameter ≤2.75 mm) in KAMIR (Korea Acute Myocardial Infarction Registry) were enrolled. After propensity score matching to adjust for baseline clinical and angiographic characteristics, we compared a total 1302 patients (651 ZES and 651 EES) about major adverse cardiac events (MACE) at 1-year. Subgroup analysis about 1-year clinical outcomes was undertaken in patients who were discharged alive.ResultsBaseline clinical and angiographic characteristics were similar between the two groups after propensity score matching. Total MACE did not differ between the two groups before (9.8% vs. 8.2%, p = 0.265) and after (9.8% vs. 9.4%, p = 0.778) propensity score matching. The EES group showed lower rate of 1-year cardiac death (5.4% vs. 3.3%, p = 0.041), target lesion failure (TLF; 6.9% vs. 4.3%, p = 0.022), and stent thrombosis (1.4% vs. 0.4%, p = 0.042) compared with the ZES group. However, there were no differences in 1-year cardiac death, TLF, and stent thrombosis in propensity score matched populations. Other various 1-year clinical outcomes showed no difference between the two groups. Subgroup analysis in patients who were discharged alive showed similar outcomes between the two groups at 1-year follow-up.ConclusionIn-this propensity score matched analysis, EES and ZES showed no significant difference in clinical outcomes at 1-year follow-up in patients with AMI for small CAD.     

Predictors of major adverse cardiac events following elective stenting of large coronary arteries

ObjectiveDiameter of the affected coronary artery is an important predictor of restenosis and need for revascularization. In the present study, we investigated the frequency and potential risk factors for major adverse cardiac events following elective percutaneous coronary intervention (PCI) and stenting of large coronary arteries.MethodsWe reviewed the data of elective candidates of PCI on a large coronary artery who presented to our center. Demographic, clinical, angiographic and follow-up data of the eligible patients were retrieved from our databank. The study characteristics were then compared between the patients with and without MACE in order to find out the probable risk factors for MACE in patients with large stent diameter.ResultsData of 3043 patients who underwent single vessel elective PCI with a stent diameter of ≥3.5 mm was reviewed. During a median follow up period of 14 months, 64 (2.1%) patients had MACE. TVR was the most common type of MACE that was observed in 29 patients, while 5 patients had cardiac death. Higher serum levels of creatinine, history of cerebrovascular accident (CVA), and use of a drug eluting stent (DES) were significantly associated with MACE. In the multivariate model, history of CVA (odds ratio = 5.23, P = 0.030) and use of DES (odds ratio = 0.048, P = 0.011) were the independent predictors of MACE in patients underwent large coronary artery stenting.ConclusionThis study showed that prior CVA and the use of BMS were the potential risk factors for MACE in patients who were stented on their large coronary arteries.     

Angioplasty of unprotected left main coronary stenosis: Real world experience of a single-operator group from eastern India

BackgroundCoronary artery bypass graft surgery is the standard treatment of unprotected left main coronary stenosis (ULMCA). However, in the real world scenario, many of these patients are unfit for CABG or prefer angioplasty as an alternative when offered the choice.MethodsA total of 86 clinically stable patients with ULMCA stenosis who were unfit or unwilling for CABG underwent PCI with DES at two tertiary care centers in Kolkata. Patients were followed up prospectively for a median of 34.6 months for major adverse cardiovascular events. Angiographic follow-up was done after 1 year of index procedure or earlier, if indicated.ResultsFifty-five patients (64%) had distal left main stenosis. Two-stent technique was used in 19 patients (22%) and single-stent technique in 36 patients (42%) with distal left main lesion. Thirteen patients (15.1%) had left ventricular ejection fraction (LVEF) of ≤45%. There was no in-hospital death, MI, or stent thrombosis. During follow-up, major adverse cardiac event (MACE) occurred in 9 patients (10.5%). Our study revealed significantly greater MACE in patients with distal left main lesion with LVEF ≤45% (50% vs 6.38%, p = 0.0002), high SYNTAX score (36.36% vs 6.82%, p = 0.008), and diabetes (17.95% vs 0.00%, p = 0.07). Overall, also patients with Diabetes, LVEF ≤ 45%, and SYNTAX score >32 had significantly higher MACE. Use of IC Stent, IVUS, or procedural strategy in distal lesion did not affect MACE.ConclusionIn selective patients with low-intermediate SYNTAX score and without diabetes and LV dysfunction, ULMCA PCI with DES is feasible.     

Clinical Outcomes after Treating Acute Coronary Syndrome Patients with a Drug-Eluting Stent: Results from REWARDS-EMI (Endeavor® for Myocardial Infarction Registry)

BackgroundDrug-eluting stents have shown promising clinical results in the treatment of acute coronary syndrome (ACS) patients. We aimed to evaluate the long-term outcome of Endeavor® zotarolimus-eluting stent (EZES) implantation in an ACS population and to compare these results with those obtained in patients treated with sirolimus-eluting (SES) and paclitaxel-eluting stents (PES).MethodsThis prospective study included 1481 consecutive ACS patients (72% myocardial infarction, age 65 ± 13 years, 62% male) treated with a drug-eluting stent: (SES, n = 925; PES, n = 417; EZES, n = 139). The primary end point was major adverse cardiac events (MACE) at 2 years, defined as the composite of death, myocardial infarction, and target vessel revascularization. Two-year follow-up was obtained in all patients.ResultsBaseline clinical and angiographic characteristics were mostly similar. Unadjusted 2-year MACE and death rates were lower in the EZES group than in the SES and PES groups (MACE: 18.7% vs. 25.3% vs. 30.2%, p = 0.02; death: 10.1% vs. 16.4% vs. 22.2%, p = 0.002, respectively). The rate of definite stent thrombosis at 2 years was lower in the EZES group without statistically significant difference (0.7% vs. 2.9% SES vs. 1.7% PES, p = 0.16). After adjusting for differences in baseline characteristics, EZES use was an independent correlate for 2-year MACE (vs. SES, hazard ratio 0.65, p = 0.049; vs. PES, hazard ratio 0.57, p = 0.01).ConclusionIn an ACS patient population, a lower long-term MACE rate was observed in patients treated with an EZES when compared to treatment with first-generation drug-eluting stents. The use of EZES in contemporary practice has excellent long-term outcome in terms of low rates of revascularization and clinical events.     

Angioscopic assessments and clinical outcomes one year after polymer-free biolimus A9-coated coronary stent implantation

BackgroundPolymer-free biolimus A9-coated coronary stent (DCS) has novel features which lead to the expectation of better arterial healing. However, comparisons of intravascular status between DCS and drug-eluting stents (DES), and robust real-word clinical assessments of DCS have been lacking to date.MethodsFrom September 2017 to September 2018, we evaluated the intra-vascular status of 74 DCS implanted in 55 lesions from 43 patients using coronary angioscopy (CAS) approximately one year after implantation from a cohort of 219 lesions in 158 patients. We set 239 second-generation durable-polymer DES (DP-DES) implanted in 211 lesions from 180 patients from a cohort of 2652 lesions in 1914 patients as the control. Angioscopic images were analyzed to determine (1) the dominant degree of neointimal coverage (NIC) over the stent; (2) the heterogeneity of NIC; (3) yellow color grade of the stented segment; and (4) the presence of intra-stent thrombus. The primary outcome was the incidence of thrombus and secondary outcomes were the other CAS findings, and the 1-year clinical outcomes which included target lesion revascularization (TLR) and major adverse cardiac events (MACE). To minimize inter-group differences in baseline characteristics, propensity score matching was performed for clinical outcomes.ResultsIncidence of thrombus adhesion was similar in DCS and DP-DES groups (28.4% versus 22.6%, p = 0.31). However, the dominant NIC grade was significantly higher in DCS (p < 0.001), while NIC was more heterogeneous in DCS than in DP-DES (p = 0.001). Maximum yellow color grade was similar (p = 0.22). After propensity score matching, 202 lesion pairs from 146 patient pairs were retained for analysis. The cumulative incidence of TLR (4.6% versus 3.8%, p = 0.38) and MACE (11.6% versus 11.7%, p = 0.84) was similar for DCS and DP-DES.ConclusionsDCS showed thrombus adhesion and clinical outcomes at 1 year similar to DP-DES. DCS can thus be used with similar safety and efficacy as DP-DES.     

Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography

BackgroundDifferences in early arterial healing patterns after stent implantation between biodegradable and durable polymer based new generation drug-eluting stents are not well understood. The aim of this study was to compare the healing patterns of a novel rapid breakdown (≤ 8 weeks) biodegradable polymer sirolimus-eluting stent (BP-SES) with a durable polymer everolimus-eluting stent (EES) using intravascular optical coherence tomography (OCT) at 4 months.MethodsA total of 20 patients were randomly assigned to stenting with BP-SES (n = 11) or EES (n = 9). Overall intravascular imaging was available for 15 (75%) patients. The primary endpoint was the difference in rate of uncovered struts between BP-SES and EES. To account for strut-level clustering, the results in both treatment groups were compared using a generalized linear mixed model approach.ResultsRegarding the primary endpoint, BP-SES as compared to EES showed similar rates of uncovered struts (37 [6.8%] versus 167 [17.5%], odds ratio (OR) 0.45 (95% CI 0.09-2.24), p = 0.33). There were no malapposed struts in BP-SES group and 14 malapposed struts in EES group (p = 0.97). No difference in percent neointimal volume (14.1 ± 8.2% vs. 11.4 ± 6.4%, p = 0.56) was observed.ConclusionsAlthough rapid-breakdown BP-SES as compared to EES showed signs of improved early tissue coverage, after adjustment for strut-level clustering these differences were not statistically significant. No differences in ability to suppress neointimal hyperplasia after stent implantation between 2 stents were observed.     

Paclitaxel-coated balloon for the treatment of drug-eluting stent restenosis: subanalysis results from the Valentines I trial

ObjectivesTo analyze the effect of paclitaxel-coated balloon (PCB) treatment on patients with drug-eluting stent (DES) restenosis.BackgroundIn the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR® PCB.MethodsValentines I prospectively enrolled 250 patients with in-stent restenosis (ISR); 76 patients (30.4%) had restenosis of a previous paclitaxel or limus DES. Patients underwent balloon angioplasty followed by PCB treatment. Clinical outcomes of patients with paclitaxel-eluting DES restenosis (n = 34; 41 lesions) and limus-eluting (sirolimus, everolimus and zotarolimus) DES restenosis (n = 42; 43 lesions) treated with DIOR® PCB were compared.ResultsBaseline characteristics were similar. There were more diffuse lesions > 20 mm treated in paclitaxel- compared to limus-eluting DES restenosis (50% vs. 26.8%, p = 0.032). Number of PCB used per patient (1.08 ± 0.31 overall), mean PCB diameter (2.99 ± 0.42 mm overall), mean PCB length (24.4 ± 11.9 mm overall), and bailout stenting (2.4% vs. 4.7%) were similar (p = NS). At mean follow-up of 231 ± 43 days, major adverse cardiac events was 0% vs. 23.8% in paclitaxel- vs. limus-eluting DES restenosis (p = 0.002), driven mainly by less target vessel revascularization (0% vs. 21.4%, p = 0.004). Target lesion revascularization was 0% vs. 16.7% for paclitaxel- vs. limus-eluting DES restenosis (p = 0.015).ConclusionIn Valentines I, PCB use was more effective in patients with paclitaxel DES restenosis compared to limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not limus resistance due to different mechanisms of DES failure.