Clinically-driven Target Lesion Revascularization Research Articles

Real-life data regarding acute procedural success and 1-year clinical outcome of desolve bioresorbable scaffolds.

We aimed to evaluate the peri-procedural success of DESolve bio-resorbable scaffolds (BRSs) and analyzed real-life data about major cardiac events during 1-year follow-up. There is little information about real-life data of DESolve BRS which is a novel stent technology offering various advantages over drug eluting stents and commonly used in daily cardiology practice. We conducted this single-center and non-randomized cross-sectional study from June 2015 through August 2016 in Medipol University Department of Cardiology and included 117 patients undergoing single or multivessel percutaneous coronary interventions (PCI) with novolimus-eluting BRS devices (152 scaffolds) (Elixir Medical Corporation). Study end points were acute device and procedural success, scaffold thrombosis and major adverse cardiac event (MACE) rates of DESolve BRS. Device success was 96.7% and procedural success was 99.3%. We detected MACE rate as 0.9% while clinical-driven target lesion revascularization was performed in one patient. None of the patients experienced scaffold thrombosis or death. Peri-procedural complications were reported in three patients. High rates of successful scaffold implantations, low rates of peri-procedural complications, and major cardiac events in long-term suggest that DESolve scaffolds can safely and effectively be used in daily intervention practice by particularly experienced operators.

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months

Purpose: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Methods: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2–4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Results: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Conclusion: Nine-month results of the VISIBILITY Iliac stent study (ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

Combining clinical and angiographic variables for estimating risk of target lesion revascularization after drug eluting stent placement

Drug-eluting stents (DES) reduce restenosis but require prolonged antiplatelet therapy, when compared with bare metal stents. Ideally, the patient should be involved in this risk:benefit assessment prior to selecting DES, to maximize the benefits and cost-effectiveness of care, and to improve medication adherence. However, accurate estimation of restenosis risk may require angiographic factors identified at cardiac catheterization. In a large PCI registry, we used logistic regression to identify clinical and angiographic predictors of clinically-driven target lesion revascularization (TLR) over the first year after stent placement. Discrimination c-statistic and integrated discrimination improvement (IDI) were used to calculate the incremental utility of angiographic variables when added to clinical predictors. Of 8501 PCI patients, TLR occurred in 4.5%. After adjusting for DES use, clinical TLR predictors were younger age, female sex, diabetes, prior PCI, and prior bypass surgery (model c-statistic 0.630). Angiographic predictors were vein graft PCI, in-stent restenosis lesion, longer stent length, and smaller stent diameter (c-statistic 0.650). After adding angiographic factors to the clinical model, c-statistic improved to 0.680 and the average separation in TLR risk among patients with and without TLR improved by 1% (IDI=0.010, 95% CI 0.009-0.014), primarily driven by those experiencing TLR (from 5.9% to 6.9% absolute risk). Among unselected PCI patients, the incidence of clinically-indicated TLR is <5% at 1-year, and standard clinical variables only moderately discriminate who will and will not experience TLR. Angiographic variables significantly improve TLR risk assessment, suggesting that stent selection may be best performed after coronary anatomy has been delineated. Although several recent studies have challenged traditional expectations regarding the duration of dual antiplatelet therapy, current guidelines recommend at least 6 to 12months of treatment after implantation of a drug eluting stent, with a shorter course for bare metal stents. Stent selection ideally should involve input from the patient receiving these stents, but multiple studies have suggested that angiographic factors - obtained after the patient has received sedation during the diagnostic catheterization - are important predictors of repeat revascularization. In this analysis from a large registry of patients receiving coronary stents, angiographic characteristics were found to significantly improve risk assessment for target lesion revascularization, when added to clinical variables alone.

Long term follow-up of “full metal jacket” of de novo coronary lesions with new generation Zotarolimus-eluting stents

BackgroundDiffuse coronary artery disease treatment still remains a challenge for interventional cardiologists and cardiac surgeons. There are few data on full metal jacket (FMJ) stenting, especially with new-generation drug-eluting stents. We aimed to assess the efficacy and safety of FMJ with new-generation Zotarolimus-eluting stents (n-ZES). Methods and resultsAll patients who underwent FMJ with n-ZES (≥60mm stent length) in eleven Italian interventional centers participating in the Clinical Service® project were included in this analysis.The project population consisted of 120 patients and 122 lesions. Mean age was 67±10years and 95 (79.2%) patients were male. A chronic total occlusion was present in 34 lesions (27.9%). The number of stents implanted per lesion was 2.9±0.8, and the diameter of the stents was 3.0±0.5mm. Predilation and post-dilatation were performed in 107 (87.7%) and 92 (75.4%) patients, respectively.At 41±21month follow-up there were 2 patients with subacute definite stent thrombosis, 6 patients (5.0%) had cardiac death and 5 patients (4.2%) had non-fatal myocardial infarction. Seven patients (5.8%) underwent clinically-driven target lesion revascularization. Fourteen patients (11.7%) had at least one major adverse cardiac event. ConclusionThe treatment of diffuse coronary artery disease with FMJ stenting with n-ZES appears to be effective and safe. Late and very-late ST does not seem to be an issue and the rate of restenosis and of major cardiac adverse events after more than 3-year follow-up is rather low.

Impact of total stent length after cobalt chromium everolimus-eluting stent implantation on 3-year clinical outcomes.

The objective was to assess whether total stent length (TSL) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation was associated with long-term clinical outcomes. The impact of TSL after CoCr-EES implantation on long-term clinical outcomes remained unclear. A total of 1,007 consecutive patients with 1,382 lesions treated only with CoCr-EES were analyzed. Patients and lesions were divided into tertile group: TSL per patient (TSL-P) (PA [8-23 mm], n = 382; PB [23-46 mm], n = 312; and PC [46-204 mm], n = 313), and TSL per lesion (TSL-L) (LA [8-18 mm], n = 486; LB [18-28 mm], n = 475; and LC [28-140 mm], n = 421). The cumulative 3-year incidence of clinically driven target-lesion revascularization (CD-TLR) and definite stent thrombosis (ST) based on TSL-P and TSL-L groupings were accessed. After inverse probability of weighted adjustment, the cumulative 3-year incidence of CD-TLR for the TSL-P and TSL-L were higher in the PC and LC groups than in the other groups (hazard ratio [HR] 2.92, 95% confidence intervals [CI] 1.66-5.15, P < 0.001 vs. PA; HR 2.49, 95% CI 1.47-4.20, P < 0.001 vs. PB; HR 1.94, 95% CI 1.15-3.28, P = 0.01 vs. LA; HR 2.80, 95% CI 1.73-4.54, P < 0.001 vs. LB, respectively). No significant differences in the cumulative 3-year incidence of definite ST were observed in both TSL-P and TSL-L groups. TSL after CoCr-EES implantation has significantly impact on CD-TLR rate through 3 years, but it is not associated with an increased incidence of definite ST. © 2016 Wiley Periodicals, Inc.

Two-year clinical outcomes of the NOBORI biolimus-eluting stents versus XIENCE/PROMUS everolimus-eluting stents in small vessel disease.

Biolimus-eluting stents (BES) have similar efficacy and safety compared with cobalt chromium everolimus-eluting stents (CoCr-EES), whereas it is unclear whether the same applies to small vessel disease. We sought compare clinical outcomes between BES and CoCr-EES in patients with small vessel disease. A total of 1,132 patients treated only with BES (612 patients) or EES (520 patients) in small vessel disease (stent size 2.5-mm) were retrospectively analyzed. We assessed the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiac death, myocardial infarction (MI), definite stent thrombosis (ST), and clinically driven target lesion revascularization (CD-TLR). The cumulative 2-year incidence of MACE was similar between the two groups (12.1% vs. 11.8%, P = 0.77). The cumulative incidence of cardiac death, CD-TLR, and definite ST were also not significantly different between both groups (3.2% vs. 3.6%, P = 0.78; 8.3% vs. 8.4%, P = 1.00; 0.33% vs. 0.21%, P = 0.66, respectively). After multivariate adjusting, the adjusted risk of BES group relative to CoCr-EES group for MACE was not significantly different (hazard ratio [HR]: 0.78, 95% confidential interval [CI]: 0.53-1.15, P = 0.20). Similarly, no significant difference in the adjusted risks for cardiac death and CD-TLR were observed between the two groups (HR: 0.62, 95% CI: 0.28-1.37, P = 0.24; HR: 0.81, 95% CI: 0.51-1.29, P = 0.38). Two-year clinical outcomes of BES are similar to those of CoCr-EES in patients with small vessel disease. The use of BES is acceptable for small coronary artery disease. © 2015 Wiley Periodicals, Inc.

Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease.

BackgroundClinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently.MethodsThis retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up.ResultsMost of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50–782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis.ConclusionsDespite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment.

Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA

BackgroundEvidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. ObjectivesThis study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. MethodsWe enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. ResultsAt 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. ConclusionsThe 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461)

Favorable outcomes in octogenarians treated with bioresorbable polymer drug-eluting stent.

As a result of a higher prevalence of comorbidities, elderly adults are often underrepresented in clinical trials, and more often experience complications during percutaneous coronary intervention. Our aim was to evaluate clinical outcomes of patients older than 80 years, compared with their younger counterparts, when bioresorbable polymer biolimus A9 drug-eluting stent is used for their treatment. The prospective, observational e-Nobori registry was created to validate the safety and efficacy of bioresorbable polymer drug-eluting stent in unselected patients. The primary end-point of the study was freedom from target lesion failure defined as a composite of cardiac death, target vessel-related myocardial infarction and clinically-driven target lesion revascularization at 1 year. There were 781 (7.8%) octogenarians, they were less frequently male (62% vs 77%; P < 0.0001) and more often presented as acute coronary syndrome (44% vs 39%; P = 0.0182). The index percutaneous coronary intervention success was lower in the elderly patients (98% vs 99%; P = 0.0398). One-year follow up was completed for 97% of the elderly patients and 99% of the younger patients. The difference in target lesion failure (3.33% vs 2.83%; log-rank P = 0.0114) was mainly driven by increased mortality in octogenarians (3.73% vs 1.47%; P < 0.0001). Elderly patients had more bleeding and vascular complications (2.67% vs 1.05%; P = 0.0001). Despite advanced age, multiple comorbidities and complexity of treated lesions, clinical outcomes are favorable in octogenarians treated by bioresorbable polymer biolimus A9 drug-eluting stent. Geriatr Gerontol Int 2016; 16: 1246-1253.

Two-year clinical outcome in patients with small coronary artery disease treated with everolimus- versus paclitaxel-eluting stenting

BackgroundPercutaneous coronary interventions involving small coronary vessels represent a true challenge because of the increased risk of restenosis and adverse outcomes. We evaluated the 2-year clinical outcomes between single everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in small coronary artery disease. MethodsFrom the data of SACRA (SmAll CoronaRy Artery treated by TAXUS Liberté) and PLUM (PROMUS/Xience V Everolimus-ELUting Coronary Stent for sMall coronary artery disease) registries, 245 patients with 258 lesions and 264 patients with 279 lesions, respectively, were enrolled in this study. ResultsThe 2-year clinical driven target lesion revascularization (4.5% vs. 10.6%, p=0.01) and target vessel revascularization (8.0% vs. 13.9%, p=0.03) rates were significantly lower in the EES group compared with the PES group. Major adverse cardiac events in the EES group tended to be lower than those in the PES group (8.7% vs. 14.3%, p=0.05). On the other hand, all new lesions for remote target vessel revascularization were observed at the proximal site of target lesions in both groups and those rates were not different between the two groups (3.4% vs. 3.3%, p>0.99). ConclusionEES showed better clinical results at 2-year follow-up compared with PES in small coronary artery diseases, however, new lesions at the proximal remote site of the target lesion remain problematic.

Comparison of Bare-Metal Stent and Drug-Eluting Stent for the Treatment of Patients Undergoing Percutaneous Coronary Intervention for Unprotected Left Main Coronary Artery Disease - Long-Term Result from a Single Center Experience.

Percutaneous coronary intervention (PCI) has become an alternative treatment for left main (LM) coronary artery disease. The aim of our study was to compare long-term clinical outcomes of patients undergoing unprotected LM PCI with bare-metal stent (BMS) or drug-eluting stent (DES) in a high-risk population. We enrolled 223 consecutive patients with unprotected LM coronary artery disease undergoing PCI (mean age: 71.1 ± 11.2 years, 187 male), including 94 patients receiving BMS and 129 patients receiving DES. The patients receiving DES had a significantly higher SYNTAX score (p = 0.05). During the mean follow-up period of 2.5 years, there were 31 cardiovascular deaths (BMS: 21 cases, DES: 10 cases, p = 0.04 by log-rank test), 56 major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction (MI) and clinical-driven target lesion revascularization; BMS: 33 cases, DES: 23 cases, p = 0.03 by log-rank test) and 6 cases with definite/probable stent thrombosis (BMS: 5 cases, DES: 1 cases, p = 0.09). In multivariate Cox analysis, the use of DES was identified as an independent protective factor against cardiovascular death [hazard ratio (HR) = 0.34, 95% confidence interval (Cl) = 0.15-0.79, p = 0.01] and MACE (HR = 0.50, 95% CI = 0.28-0.88, p = 0.02). The clinical outcome analyses in propensity-score matched the cohort (87 matched pair of patients receiving BMS and DES) and yielded similar results. In the general practice among a high-risk population undergoing unprotected LM PCI, the use of DES appeared to be beneficial in reducing the risk of long-term cardiovascular death and MACE. Bare-mental stent; Drug-eluting stent; Left main coronary artery disease; Percutaneous coronary intervention.

Evaluation of clinical outcomes in patients undergoing dual vessel percutaneous coronary intervention using sirolimus-eluting coronary stent system in India.

Coronary artery disease is the most common catastrophic disease in India. The safety and effectiveness of dual vessel sirolimus-eluting stent (SES) implantation (used as an intervention in CAD) is currently unknown in Indian population. The purpose of this study was to investigate one year clinical outcomes of patients with dual vessel coronary artery disease after implantation of the Supralimus-Core SES, in a "real-world" setting. We evaluated 60 patients between April-2011 and August-2012, who underwent dual vessel percutaneous coronary intervention (PCI) with the Supralimus-Core SES implantation at the same index procedure. Dual vessels were defined as involvement of two major epicardial vessels (right, left anterior descending, circumflex, or left main coronary arteries) or one major epicardial vessel and a branch (≥2.5 mm in diameter) originating from another major epicardial vessel. The primary endpoint was target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR) at one year. Secondary endpoint included combined (definite, probable and possible) stent thrombosis (ST). A total of 120 lesions were treated in 60 enrolled patients (mean age 56.0±9.2 y; 80.0% male) with average stent length of 23.1±8.5 mm. Among 60 patients, diabetes, hypertension and hypercholesterolemia were present in 15 (25.0%), 22 (36.7%) and 25 (41.7%) patients respectively. Indications for PCI were unstable angina in 30 (50.0%) patients and stable angina in 11 (18.3%) patients. Overall, 40 (33.3%) lesions were classified as complex (American College of Cardiology/American Heart Association type B2/C). The cumulative TLF rate was 5.0% (n=3) at one year. Cardiac death, MI and clinically-driven TLR occurred in 1 (1.7%), 0 (0%) and 2 (3.3%) patients, respectively at one year follow-up. The Kaplan-Meier curve of the freedom from overall events at one year was 95.0%. According to the Academic Research Consortium definition, there were no events of stent thrombosis during one year. Our study shows that, dual vessel Supralimus-Core SES implantation allows safe and effective treatment with low rates of TLF at one year follow-up in Indian population.

Helical-centreline (BioMimics 3D) stent offers long term patency protection in patients with femoropopliteal disease

Arterial stents are subject to obstruction and failure by intimal hyperplasia (IH). Arterial curvature is physiologically commonly non-planar, or helical, encouraging us to develop a nitinol, self-expanding, bare-metal, helical-centreline stent. On implantation in the common carotid arteries of healthy pigs, this deformed the vessels helically, generating swirling and mixing of intraluminal flow and (compared with findings with a straight-centreline stent) suppressed the development of IH1. Encouraged by these findings, a prospective, randomised, controlled trial was conducted, involving 76 patients, randomised 2:1, undergoing femoropopliteal artery intervention (patients were implanted with the BioMimics 3D (n=50) helical-centreline stent and control subjects were treated with a straight-centreline stent, primarily the Bard LifeStent (24/26 cases). At two years, two key findings were the Kaplan Meier (KM) survival estimate of freedom from loss of primary patency of 72% for BioMimics 3D subjects, versus 55% for the control group (p=0.0497 by log-rank test). Secondly, there was no decrease in the KM estimate of freedom from clinically driven target lesion re-vascularisation (CDTLR) in the BioMimics 3D arm between 12 and 24 months, compared to a decrease of 16% (92% at 12 months and 76% at 24 months) in the control arm. Enhanced wall shear and possibly improved blood-wall mass transport, including of oxygen, may explain the longer-term patency protective effect seen with the BioMimics 3D stent. (1J R Soc Interface, 2013, Vol:10, 1742-5689)

Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapopliteal Arterial Revascularization in Critical Limb Ischemia: 12-Month Results From the IN.PACT DEEP Randomized Trial

BackgroundDrug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation. ObjectivesThe goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI). MethodsWithin a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR. ResultsClinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080). ConclusionsIn patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733)

TCT-184 Late Adverse Events After Implantation of Sirolimus-eluting Stent and Bare-metal Stent: 4-7 years follow-up of the CREDO-Kyoto Registry Cohort-2

Background: Late adverse events such as very late stent thrombosis (VLST) or late target-lesion revascularization (TLR) have emerged as new problems after drugeluting stent implantation. However, there is a paucity of data from long-term followup studies evaluating late adverse events after sirolimus-eluting stents (SES) implantation in comparison with bare-metal stent (BMS) implantation. Methods: Among 13058 consecutive patients undergoing first percutaneous coronary intervention in the CREDO-Kyoto registry Cohort-2, 5078 patients were treated with SES only and 5392 patients were treated with BMS only. Median follow-up duration was 1974 (inter-quartile range: 1700-2225) days. Results: During 4-7 years follow-up after SES implantation, VLST and late TLR beyond 1-year occurred constantly and without attenuation at 0.24%/year, and 2.0%/ year, respectively. Cumulative 7-year incidence of VLST was significantly higher in the SES group than in the BMS group (1.43% vs. 0.68%, P<0.0001). However, there was no excess of all-cause death beyond 1-year in the SES group as compared with the BMS group (20.8% vs. 19.6%, P1⁄40.91), although the cumulative incidence of sudden death beyond 1-year was slightly but significantly higher in the SES group than in the BMS group (3.0% vs. 1.8%, P1⁄40.02). Cumulative 7-year incidences of late TLR and clinically-driven late TLR were also significantly higher in the SES group than in the BMS group (12.0% vs. 4.1%, P<0.0001 and 8.5% vs. 2.6%, P<0.0001, respectively), leading to significant late catch-up of the SES group to the BMS group regarding the cumulative incidence of over-all and clinically-driven TLR through 7-year (18.8% vs. 25.2%, and 10.6% vs. 10.2%, respectively). Clinical indication of late TLR in the SES group included acute myocardial infarction (13.1%), unstable angina (8.1%), stable angina (34.0%), asymptomatic ischemia (7.9%) and non-clinically driven (36.9%). Conclusions: During 4-7 years follow-up after SES implantation, late adverse events including VLST and late TLR continued to occur without attenuation of their incidences. Late catch-up phenomenon of SES relative to BMS in terms of TLR was real and should be the target for the development of drug-eluting stents.

Everolimus and paclitaxel-eluting stents for small coronary artery diseases: insight from the one year results of PLUM and SACRA registries

Purpose: Percutaneous coronary interventions involving small coronary vessels represent a true challenge because of the increased risk of restenosis and adverse outcomes. The aim of this study is to evaluate the one-year clinical results following small coronary stenting between everolimus- (EES) and paclitaxel-eluting stent (PES). Methods: PLUM (PROMUS/Xience V Everolimus-ELUting Coronary Stent for sMall coronary artery disease: 264 patients with 279 lesions) and SACRA (SmAll CoronaRy Artery treated by TAXUS Liberte: 245 patients with 258 lesions) registries are prospective, multicenter registries to assess the efficacy of single EES and PES in patients with small coronary artery diseases. Inclusion criteria were 1) Lesions >75% diameter stenosis in vessels <2.5mm in diameter, 2) lesion length <28mm. The primary endpoint is clinical driven target lesion revascularization (TLR) rate at one year. Results: Major adverse cardiac events between the two groups were similar, however, one year TLR rate was significantly lower in EES group (Table). View this table: Clinical and angiographic results Conclusion: EES showed better clinical and angiographic results for treatment of small coronary artery diseases.

First-in-human evaluation of a sirolimus-eluting coronary stent on an integrated delivery system: the DIRECT study

The DIRECT study is a first-in-human evaluation of the safety and efficacy of the Svelte sirolimus-eluting coronary stent mounted on a fixed-wire, "all-in-one" integrated delivery system (IDS) in patients with de novo coronary artery lesions. The system permits easy delivery, deployment and post-dilatation of a cobalt-chromium stent eluting sirolimus from a fully bioabsorbable amino acid coating. The stent on its IDS has a very low profile, and is designed specifically to facilitate direct stenting. Patients with symptomatic ischaemic heart disease and a single de novo native coronary lesion suitable for percutaneous coronary intervention were prospectively enrolled at four New Zealand sites. The lesion length had to be <23 mm and the vessel reference diameter 2.5-3.5 mm. The primary safety and efficacy endpoints were target vessel failure (TVF) and angiographic in-stent late lumen loss (LLL) at six months, respectively. Twenty-nine of 30 enrolled patients completed six-month follow-up. TVF occurred in two patients (7%). The in-stent LLL was 0.22 ± 0.27 mm. No patient had clinically-driven target lesion revascularisation. Intravascular ultrasound neointimal volume was 3.3 ± 4.4 mm3 and volume obstruction was 2.7 ± 4.5% at six months. Optical coherence tomography showed 98 ± 4% strut coverage at a depth of 0.12 ± 0.06 mm. No patient developed stent thrombosis. Percutaneous coronary intervention using the Svelte sirolimus-eluting coronary stent mounted on an IDS appears safe and effective in de novo coronary artery lesions, with minimal in-stent proliferation and excellent stent strut coverage at six months.

Sustained Patency and Clinical Improvement Following Treatment of Atherosclerotic Iliac Artery Disease Using the Assurant Cobalt Iliac Balloon-Expandable Stent System

To report the outcome of the ACTIVE (Use of the Assurant Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) study (ClinicalTrials.gov Identifier: NCT00753337), which was designed to determine the safety and effectiveness of the next-generation Assurant cobalt chromium balloon-expandable stent in symptomatic patients with iliac occlusive disease. This prospective, multicenter, single-arm study enrolled 123 symptomatic (Fontaine class II or III) patients (69 men; mean age 65.5±10.6 years) with 159 de novo or restenotic lesions (length ≤100 mm) in the common or external iliac arteries. Objective measures of outcome were ankle or toe-brachial indexes, Fontaine class, and duplex ultrasound evaluations collected before the procedure and at 1 and 9 months. The primary endpoint of major adverse events (MAE) at 9 months was defined as device- and procedure-related death, target limb loss, or clinically-driven target lesion or target vessel revascularization (TLR/TVR). At 9 months, the rate of MAE was 0.8% with 1 TLR and 99.2% primary patency. There were no device- or procedure-related deaths or target limb amputations. The ankle-brachial index increased by 0.2±0.2 at 1 and 9 months. There was an improvement in the Fontaine classification of claudication for the majority of patients, accompanied by significant and sustained improvements in walking speed, distance, and stair climbing. The balloon-expandable Assurant cobalt chromium iliac stent demonstrated an excellent safety profile and sustained patency associated with marked improvements in objective and functional measures of patency.

TCT-647 Value Of High-Density Lipoprotein Cholesterol In Predicting Future Cardiovascular Events Of Patients With Low-Density Lipoprotein Cholesterol At The Time Of Percutaneous Coronary Intervention

Background: Implantation of drug-eluting stents in long coronary artery lesions is associated with a higher risk for restenosis and stent thrombosis related to the need for multiple and overlapping stents. The Resolute zotarolimus-eluting stent (R-ZES) is manufactured in a 38 mm length to accommodate longer lesions but clinical data to demonstrate efficacy and safety of the longer stent have not been reported. Methods: A substudy of 2 prospective, multicenter clinical trials; RESOLUTE–US and RESOLUTE-Asia enrolled patients with de novo coronary artery lesions amenable to treatment with the 38-mm-length R-ZES. The target lesion had to be 35 mm long and the primary endpoint was target lesion failure (TLF) defined as the composite of cardiac death, target vessel myocardial infraction (TVMI), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. The rate of TLF at 1 year was compared to a performance goal of 19.0% based on literature suggesting an expected TLF rate of 15.1%. All patients were prescribed dual antiplatelet therapy for a minimum of 6 months. Results: There were 223 patients treated with a 38 mm R-ZES; mean age was 61 years, 78.9% were men, 44.6% were white, 3.6% were black, and 50.9% were Asian. Prior PCI was noted in 27.4% of patients, 37.7% had diabetes mellitus and 53.8% had multivessel disease. Lesions were located in the LAD (52.0%), LCX (20.2%) and RCA (44.4%) and 3.4% were moderately or severely torturous. TIMI flow was 0 or 1 in 6.1% of lesions and 47.9% were branch vessel disease with mean sidebranch stenosis of 30.4%; 91.2% were lesion class B2/C. The primary endpoint was met with a 12-month TLF rate of 4.5% (upper one-sided 95% confidence interval 7.5%). Rates of cardiac death, TVMI, and TLR at 12 months were 0.9%, 3.6%, and 1.4% respectively. Early stent thrombosis ( 30 days) was 0.9% and there were no stent thrombosis events after 30 days. Conclusions: At 12 months the rate of TLF was significantly less than the performance goal of 19% and clinical events rates were low with no late stent thrombosis. The 38 mm length R-ZES was safe and effective in this selected population of long lesion patients.

194 Three year clinical outcomes associated with the use of the zotarolimus-eluting stent in an unrestricted contemporary practice

BACKGROUND: Drug eluting stents (DES) have improved clinical outcomes by reducing the need for target vessel revascularization. However, the randomized trials from which this data originated included only patients with single, non-complex lesions and excluded patients with acute coronary syndromes. There has been a suggestion in the literature that DES may be associated with late ( 1 year) stent thrombosis. The objective of this study was to evaluate clinical outcomes associated with the use of the Endeavor stent in a single center unrestricted clinical practice over a three-year period. METHODS: Percutaneous coronary intervention was performed at the discretion of the Interventional Cardiologist. Telephone follow-up and review of hospital and clinic records were conducted 2 years post procedure. At three years, hospital and clinic records were re-reviewed and patients living outside the immediate Ottawa area were re-contacted by telephone. The primary outcome was clinically driven target vessel revascularization (TVR), target lesion revascularization (TLR) and stent thrombosis (ST) at one, two and three years. Secondary endpoints included acute myocardial infarction (MI), cardiac death and non-cardiac death. RESULTS: Four hundred ninety four consecutive patients treated with Endeavor stents from June 2005 to Feb 2007 were followed. 717 stents were used to treat 625 lesions. Clinicallydriven TLR rates were 6.2%, 1.1% and 0.3% at 1, 2 and 3 years respectively. TVR rates were 8.1%, 2.4% and 0.5% for the same time periods. The cumulative rates of TLR and TVR for the three-year period were 7.7% and 11.0%, respectively. There were 4 cases of ARC definite stent thrombosis involving 3 patients and 1 case of ARC probable stent thrombosis, all occurring within 12 months, with a rate of 0.7%. The cumulative rate of MI was 6.1% with rates at 1, 2 and 3 years were 4.0%, 1.4% and 0.6%, respectively. All cause mortality was 2.8%, 2.4% and 0.6%, whereas cardiac mortality was 1.6%, 1.8 % and 0.6% at 1, 2 and 3 year followup, respectively. CONCLUSIONS: The rates of the clinical outcomes of TVR and TLR in this study were relatively low and were similar to those reported in earlier randomized studies, despite use of the Endeavor stent in an unrestricted population. Our results do not suggest an increased rate of late stent thrombosis.