Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions

Objective: The ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) for the treatment of de novo calcified coronary lesions. Background: Severely calcified coronary arteries pose an ongoing treatment challenge. Stent placement in calcified lesions can result in stent under expansion, malapposition, and procedural complications. OAS treatment may change calcified lesion compliance to reduce procedural complications and facilitate stent placement. Methods: The ORBIT I trial, a prospective, nonrandomized study, was conducted in two centers in India. Fifty patients with de novo calcified coronary lesions were enrolled. Patients were treated with the OAS followed by stent placement. Results: The average age of the patients was 57.4 years and 90% were male. Mean lesion length was 13.4 mm. The average number of OAS devices used per patient was 1.3. Device success was 98%, and procedural success was 94%. The cumulative major adverse cardiac event rate was 4% in‐hospital (two non–Q‐wave myocardial infarctions), 6% at 30 days (one additional non–Q‐wave myocardial infarction leading to target lesion revascularization), and 8% at 6 months (one additional event of cardiac death). Angiographic complications were observed in seven patients (six dissections and one perforation). Conclusion: The ORBIT I trial suggests that the OAS may offer an effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult to treat patients. A larger trial is required to establish safety and overall effectiveness of the OAS in treating calcified coronary lesions. © 2012 Wiley Periodicals, Inc.     

Deliverability of the Resolute Integrity stent and a post hoc comparison of radial and femoral access: The DELIVER study

Background/PurposeDELIVER (DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER stenting) was a prospective, multicenter, all-comers registry to assess the deliverability of the Resolute Integrity™ zotarolimus-eluting stent (R-ZES).Methods/MaterialsPatients (n = 7740 patients, 10449 lesions) undergoing percutaneous coronary intervention and deemed suitable for R-ZES implantation were enrolled and treated according to standard practice of the participating centers in 30 countries. Outcomes included delivery success and in-hospital target lesion failure (TLF), major adverse cardiac event (MACE), and Academic Research Consortium definite/probable stent thrombosis. We performed a post hoc analysis comparing deliverability, in-hospital clinical outcomes and resource utilization with radial vs. femoral access.ResultsA high proportion of the population had complex disease (71%): mean lesion length was 26.7 ± 17.5 mm, 35% of lesions were moderately/severely calcified and 17% were bifurcated. Femoral and radial accesses were used in 53% and 46% of patients, respectively. Patients treated using femoral access had more complex coronary artery disease. Primary delivery success was 98.9% and did not differ by approach. Radial access was associated with lower stent and balloon utilization, but higher guide catheter utilization, lower procedure duration, and contrast administered compared with femoral access. In-hospital TLF and MACE occurred in 1.6% of patients; definite or probable stent thrombosis occurred in 0.2%. Clinical outcomes did not differ by vascular access.ConclusionsR-ZES was found to be highly deliverable in a complex, all-comers, international population, regardless of whether radial or femoral access was used. In-hospital outcomes were excellent with very low risk of complications.     

Orbital Atherectomy for the Treatment of Long (≥25–40 mm) Severely Calcified Coronary Lesions: ORBIT II Sub-Analysis

BackgroundOrbital atherectomy (OA) is an effective method of lesion preparation of severely calcified vessels prior to stent deployment. Long calcified lesions may lead to higher risk of post-procedural complications, yet the optimal treatment strategy has not been established. In this study we sought to determine the safety and efficacy of OA in patients with long (≥25–40 mm) calcified target lesions.MethodsORBIT II was a single-arm trial that enrolled 443 patients at 49 U.S. sites. De novo, severely calcified coronary lesions were treated with OA prior to stenting. Patients treated with the OA device were stratified into two groups according to target lesion length as visually estimated by the investigator: those with short (<25 mm; N = 314) vs. long (≥25–40 mm; N = 118) lesions. Lesions >40 mm were excluded per protocol. The primary endpoint was the 3-year major adverse cardiac event (MACE) rate, defined as a composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).ResultsThe 3-year MACE rates in patients with short (<25 mm) vs. long (≥25–40 mm) lesions were 21.1% vs. 29.9% respectively (p = 0.055). The rate of cardiac death (6.5% vs. 7.8%, p = 0.592) and TVR (8.5% vs. 13.7%, p = 0.153) did not significantly differ. The rate of MI (CK-MB > 3× ULN) at 3 years was significantly higher in patients with long (≥25–40 mm) lesions (9.0% vs. 17.0%, p = 0.024), with the majority occurring in-hospital (7.0% vs. 13.6%, p = 0.037).ConclusionsPatients with long (≥25–40 mm) calcified target lesions had similar outcomes in terms of MACE at 3 years despite higher rates of MI, which mostly occurred in-hospital. Using the more contemporary SCAI definition of MI, there was no significant difference in rates of MI between the short (<25 mm) and long (≥25–40 mm) groups. Further studies are warranted to determine how OA compares to focal force balloon angioplasty, rotational atherectomy and other novel treatment options for long severely calcified lesions.Summary for annotated table of contentsPercutaneous coronary intervention of long calcified lesions is inherently more complex and higher risk and may require more intensive lesion preparation. This sub-analysis of ORBIT II revealed that orbital atherectomy treatment of longer (≥25–40 mm) lesions was associated with a higher rate of MACE at 30 days, but not at 3 years. This difference, however, was driven primarily by a higher in-hospital non-Q-wave MI rate; using the more contemporary SCAI definition of MI, there was no significant difference in rates of MI between the short (<25 mm) and long (≥25–40 mm) groups.     

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.     

Prospective,multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

BackgroundNovel bare metal stents with improved stent design may become a viable alternative to drug-eluting stents in certain patient groups, particularly, when long-term dual antiplatelet therapy should be avoided.PurposeThe ENERGY registry aimed to assess the safety and benefits of a cobalt–chromium thin strut bare metal stent with a passive coating in a large series of patients under real-world conditions.Methods and materialsThis prospective registry recruited 1016 patients with 1074 lesions in 48 centers from April to November 2010. The primary endpoint was the rate of major adverse cardiac events (MACEs), a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization.ResultsMore than half of the lesions (61.0%) were type A/B1 lesions, mean lesion length was 14.5 ± 6.5 mm and mean reference vessel diameter 3.2 ± 0.5 mm. MACE rates at 6, 12 and 24 months were 4.9%, 8.1% and 9.4%, target lesion revascularization rates 2.8%, 4.9% and 5.4% and definite stent thrombosis rates 0.5%, 0.6% and 0.6%. Subgroups showed significant differences in baseline and procedural characteristics which did not translate into significantly different clinical outcomes. Specifically, MACE rates at 24 months were 13.5% in diabetics, 8.6% in small stents and 9.6% in acute coronary syndrome patients.ConclusionThe population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt–chromium thin strut bare metal stent with a passive coating showed very good results up to 24 months. (ClinicalTrials.gov:NCT01056120)Summary for annotated table of contentsThe ENERGY international registry evaluated the safety and benefits of a cobalt–chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2 years. Results were encouraging with a low composite rate of cardiac death, myocardial infarction and clinically driven target lesion revascularization, even in the pre-defined high risk groups of diabetes, stents ≤ 2.75 mm and acute coronary syndrome.     

Long-term clinical outcome of elderly patients with acute coronary syndrome treated with early percutaneous coronary intervention: Insights from the BASE ACS randomized controlled trial: Bioactive versus everolimus-eluting stents in elderly patients

BackgroundThe BASE ACS trial demonstrated an outcome of titanium–nitride–oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial.MethodsWe randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Follow-up was planned at 12 months and yearly thereafter for up to 7 years. Elderly age was defined as ≥ 65 years.ResultsOf the 827 patients enrolled in the BASE ACS trial, 360 (43.5%) were elderly. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in elderly versus younger patients (19.7% versus 12.0%, respectively, p = 0.002), probably driven by more frequent cardiac death and non-fatal MI events (5.3% versus 1.5%, and 9.7% versus 4.5%, p = 0.002 and p = 0.003, respectively). The rates of ischemia-driven TLR were comparable (p > 0.05). In propensity score-matched analysis (215 pairs), only cardiac death was more frequent in elderly patients (6% versus 1.4%, respectively, p = 0.01). Diabetes independently predicted both MACE and cardiac death in elderly patients.ConclusionsElderly patients treated with stent implantation for ACS had worse long-term clinical outcome, compared with younger ones, mainly due to a higher death rate.     

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.     

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.     

Five-Year Clinical Outcomes of the COBRA Polyzene F NanoCoated Coronary Stent System

Background/purposeThe COBRA Polyzene F™ NanoCoated Coronary Stent System (PzF coated stent) stent demonstrated favorable clinical outcomes at 9 months but late results have not been reported. We sought to assess the late safety and effectiveness of the PzF coated stent for treatment of de novo coronary artery lesions.MethodsPatients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a non-randomized, prospective clinical trial and followed for 5 years. The primary endpoint was target vessel failure (TVF, cardiac death, myocardial infarction [MI], or clinically-driven target vessel revascularization [TVR]) at 9 months. Secondary endpoints included major adverse clinical events (MACE, cardiac death, MI, or clinically driven TLR), clinically driven target lesion revascularization (TLR) and definite or probable stent thrombosis during 5-year follow-up. Endpoints at 5 years were analyzed as cumulative incidence accounting for competing risk of death.ResultsOf 296 enrolled patients, 290 (98%) were evaluable at 5 years. By 5 years, MACE had occurred in 61 (21.3%), cardiac death in 11 (4.2%), MI in 25 (8.6%), and TLR in 34 (12.0%) subjects. Between follow-up years 1 and 5, a first MACE occurred in 17 (6.2%), including 10 (4.0%) cardiac death, 4 (1.6%) MI, and 7 (2.9%) TLR events. There were no definite or probable stent thromboses.ConclusionsThe PzF coated stent demonstrated continued safety and effectiveness through 5 years with low to very low incident rates of MACE, MI, TLR and stent thrombosis between 1 and 5 years after stent placement.     

Litoplastia coronaria en lesiones calcificadas: registro multicéntrico de la práctica clínica

Introduction and objectivesCoronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population.MethodsThis was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5 mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory.ResultsThis registry included 57 patients (66 lesions). The population was elderly (72.6 ± 9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization.ConclusionsThis is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results.     

Procedural and Long-Term Ischemic Outcomes of Tight Subtotal Occlusions Treated with Orbital Atherectomy: An ORBIT II Subanalysis

Background/purposeOrbital atherectomy is an effective treatment strategy to modify severely calcified coronary lesions prior to stent placement. Traversing a severely calcified subtotal occlusion with the crown may be more challenging compared with a less severely stenotic lesion. The purpose of this ORBIT II subanalysis was to evaluate outcomes post-orbital atherectomy (OA) treatment of lesions with ≥95% stenosis.Methods/materialsORBIT II, a single-arm, prospective, multicenter trial, enrolled 443 subjects with severely calcified coronary lesions. Patients with chronic total occlusions were excluded from the trial. Subjects with the OA device activated were stratified based on pre-procedure percent stenosis: ≥95% stenosis (N = 91) and <95% stenosis (N = 341). Procedural success and 3-year major adverse cardiac event (MACE) rates were compared.ResultsThe severe angiographic complications rates were 6.6% and 6.7% in the ≥95% and <95% stenosis groups, respectively. There was no significant difference in procedural success (94.5% vs. 88.3%, p = 0.120). 3-year MACE rates were similar (27.1% vs. 22.5%, p = 0.548), as were the rates of cardiac death (5.7% vs. 7.1%, p = 0.665) and MI (7.9% vs. 12.1%, p = 0.244). The TVR rate was higher in the ≥95% stenosis group (19.1% vs. 7.5%, p = 0.004).ConclusionsIn ORBIT II, OA treatment of lesions with ≥95% stenosis resulted in a high rate of procedural success. Although the 3-year revascularization rate was higher in the ≥95% stenosis group, it is not unexpected given the challenge of treating such complex lesions. The results of this analysis suggest that OA may be a reasonable treatment strategy for tight, severely calcified subtotal occlusions.SummaryThe purpose of this ORBIT II subanalysis was to evaluate outcomes post-orbital atherectomy (OA) treatment of lesions with ≥95% stenosis. In ORBIT II, OA treatment of lesions with ≥95% stenosis resulted in a high rate of procedural success. Although the 3-year revascularization rate was higher in the ≥95% stenosis group, it is not unexpected given the challenge of treating such complex lesions. The results of this analysis suggest that OA may be a reasonable treatment strategy for tight, severely calcified subtotal occlusions.     

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.     

Safety and efficacy of biodegradable polymer-coated biolimus-eluting stents

BackgroundUsing drug eluting stents with a biodegradable polymer ensures that both the drug and coating are absorbed from the stent surface after completing their functions, which may reduce the need for prolonged antiplatelet therapy and decrease the risk of late stent thrombosis.ObjectivesOur study sought to compare the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a well-established sirolimus- or paclitaxel-eluting stent (with durable polymers).MethodsWe undertook a prospective, randomized, comparative study that included 145 patients with chronic stable coronary artery diseases or acute coronary syndromes. The patients were randomized for treatment with either biolimus-eluting (n = 62) or sirolimus/paclitaxel-eluting (n = 83) stents. The study endpoint was a composite of major adverse cardiac events (MACE) within 2 years. Angiographic follow-up was scheduled at the end of the study or earlier if clinically indicated.ResultsAt the two-year follow-up, a biodegradable polymer biolimus-eluting stent showed comparable safety and efficacy to permanent polymer DES(5[8.1%] patients in the biolimus group vs.8[9.6%] in the sirolimus/paclitaxel group, p = 0.7). The incidence of mortality, myocardial infarction, cerebrovascular accident and target lesion revascularization was similar for both stent types. Furthermore, the incidence of stent thrombosis was statistically non-significant between both the groups.ConclusionThe use of a biodegradable polymer-based DES (biolimus-eluting) demonstrated satisfactory efficacy and safety profiles with low MACE and stent thrombosis rates up to 2 years compared with other non-biodegradable polymer-based DES.     

Safety and Efficacy of the cobalt chromium PRO-Kinetik coronary stent system: Results of the MULTIBENE study

BackgroundThe aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions.Methods and MaterialsThis prospective international multicenter study included 202 patients at 10 European sites. Analysis was performed on the per protocol population of 197 patients. Patients were followed until 12 months, a subset of patients (n = 72) underwent additional coronary angiography at 6 months. Primary endpoint was 6-months rate of target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR).ResultsAt 6 months, rate of TVF was 10.9% and rate of major adverse cardiac events, a composite of cardiac death, MI, target lesion revascularization (TLR) and coronary artery bypass graft, was 11.4%, both being mainly attributed to TVR respective TLR. No cardiac death or stent thrombosis occurred. In-segment late lumen loss was 0.66 ± 0.61 mm and binary restenosis was 20.8%, as determined by core laboratory in the angiographic subgroup.ConclusionBased on these data, the PRO-Kinetik coronary stent system was found to be safe and effective.     

The long-term efficacy of sirolimus-eluting stent for small vessel disease—Subanalysis of Cypher Stent Japan Post-Marketing Surveillance Registry

BackgroundPercutaneous coronary intervention for lesions with small vessel diameter may have high event rates. Although drug-eluting stents reduce the risk of restenosis, the long-term efficacy of drug-eluting stent implantation in small vessels is unclear.Methods and resultsWe reviewed the data of Cypher Stent Japan Post-Marketing Surveillance Registry including 2356 lesions of 1959 patients, and retrospectively investigated the angiographic outcomes at 8 months, and the clinical outcomes at 1800 days after sirolimus-eluting stent (SES) implantation in vessels with diameter less than 2.5 mm (small vessel group) compared to that with diameter of 2.5 mm or more (non-small vessel group). The rate of major adverse cardiac events (MACE) at 1800 days was slightly higher in the small vessel group than in the non-small vessel group, but not statistically significant (24.4% vs 21.0%, p = 0.086). The rate of target lesion revascularization was higher in the small vessel group than in the non-small vessel group (10.2% vs 6.4%, p = 0.004). The rate of stent thrombosis was almost the same in the two groups. Multivariate Cox hazard model analysis revealed that a vessel diameter less than 2.5 mm was not an independent risk factor for MACE.ConclusionSES implantation for vessels with diameter less than 2.5 mm is safe and provides good long-term outcomes.     

Residual SYNTAX score can predict short- and long-term outcomes in patients with STEMI

ObjectivesThe prognostic value of residual SYNTAX score (rSS) has been observed in different patient groups. However, its prognostic value has not been compared in patients with ST segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).MethodsA total of 208 patients meeting the eligibility criteria were included in the study. Complete revascularisation (CR) was defined as rSS = 0 and incomplete revascularisation (IR) was defined as rSS ≥ 1.ResultsAmong the sample, 78 patients (33.3%) were included in the CR group and 130 patients (67.7%) in the IR group. One patient (1.3%) in the CR group and 8 patients (6.2%) in the IR group died by day 30 (P < 0.01). The incidence of stent thrombosis, recurrent myocardial infarction (MI) and target lesion revascularisation (TLR) was similar between the two groups. During follow-up (mean 28.8 ± 7.1 months), 2 patients (2.6%) from the CR group and 10 (7.7%) patients from the IR group died (P > 0.05). The incidence of recurrent MI (18.5% vs. 7.7%; P < 0.01) and major adverse cardiovascular events (MACE) (24.6% vs. 7.7%; P < 0.01) were significantly higher in the IR group.ConclusionrSS, which is an indirect marker of incomplete revascularisation, was independently correlated with recurrent MI and MACE after STEMI.     

Should Proximal LAD be treated differently? Insights from a large DES stent registry

BackgroundThe current revascularization treatment recommendation is different according to lesion location and a higher recommendation is given to surgery for proximal LAD (pLAD) lesions over PCI. This is based on previous studies and expert opinion. We aimed to investigate whether indeed there is a difference in outcome with respect to LAD lesion location while using a drug eluting stent (DES).MethodsThe NOBORI-2 trial, enrolled 3067 consecutive patients in 125 centers who were treated with DES for single and multivessel disease. We compared 834 [27.2%] patients who underwent PCI of the pLAD as part of their revascularization, to 2203 [71.8%] patients in which stenting to other lesion(s) but not the pLAD was performed.ResultsThe pLAD group had lower incidence of hypertension, peripheral vascular disease, prior PCI and CABG, but had more lesions treated [1.55 ± 0.8 vs. 1.35 ± 0.6], more stents implanted [1.98 ± 1.2 vs. 1.66 ± 1.0] and longer overall stent length [31.8 ± 20.2 vs. 28.2 ± 17.8 mm].There was no difference in the occurrence of the primary endpoint [cardiac death, myocardial infarction and target lesion revascularization] at 1 or 2 years of follow up between the pLAD and non pLAD [6.0% vs. 4.6%, p = 0.14 and 7.7% vs. 6.6%; p = 0.22, respectively]. The relief from anginal symptoms was similar. Multivariate analysis showed that pLAD location was not a variable that predicted MACE or TLF. Stent thrombosis rate was similar.ConclusionWhen considering PCI with DES, there is no difference in outcome between patients with and without proximal LAD lesions.     

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.     

Radial approach and single wiring as first intentional strategies in chronic total occlusions of the left anterior descending coronary artery

BackgroundPercutaneous coronary intervention (PCI) for chronic total occlusion (CTO) of the left anterior descending coronary artery (LAD) specifically is associated with improved long-term 5 years survival as compared to PCI failure. Simpler PCI techniques may be successful and safer than complex techniques which are perceived to have high failure rates and technical complexity.We aimed to describe the safety and effectiveness of first intentional single wiring and radial approach in the treatment of patients with a CTO of the native LAD coronary artery at Toulouse Rangueil university hospitals.Patients and methodsThe study was a single center prospective registry. All patients showed evidence of myocardial viability in LAD territory. The operators’ initial strategy was to start by a radial access as a first choice whenever feasible; if not, a femoral access was chosen. The initial strategy for lesion crossing in either antegrade or retrograde approaches was single wiring by lesion crossing using one guidewire (GW) as a simple technique.ResultsA total of 30 patients with 30 LAD CTO lesions (100%) were recorded. Mean age was 71.6 + 15 years, 77% were males and 23% were females. The access route was radial 66% of the time and femoral 54% of the time and with double access for contralateral injection in 40% of the patients. Sheaths and catheters sizes 6F were used in 53% of the patients, and 7F in 73% of the patients.Overall lesion success rate was 83% of lesions. Single wiring was the prevailing technique used in 97% of successful lesions (83% of total cases), while only 3% were by multiple wiring techniques. Successful single antegrade wiring represented 63% of our total study cases with a GW success rate of 92% of cases. Successful single retrograde wiring represented 13% of our cases with a GW success rate of 67%. Q-wave myocardial infarction (MI), stent thrombosis, stroke, emergency coronary artery bypass graft (CABG), major bleeding, radiation dermatitis, cardiac tamponade or clinical perforation requiring any hemostatic maneuvers did not occur. There was a post-procedural Troponin rise of 3x normal levels in 30% of patients, and contrast induced nephropathy in 7%. Intra-aortic balloon counterpulsation (IABCP) was used in 3% of patients and cardiac death occurred in 3% of patients.ConclusionSingle wiring and radial access as initial strategies in PCI for LAD-CTO lesions in either approaches antegrade or retrograde are associated with a high procedural success rate and an acceptable incidences of adverse 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.