Higher Rate Of Target Lesion Revascularization Research Articles

Prevalence, Management and Outcomes of Percutaneous Coronary Intervention for Coronary In-Stent Restenosis: Insights From the France PCI Registry

BackgroundDespite the evolution of stent technology, there is a non-negligible risk of in-stent restenosis (ISR) after Percutaneous coronary intervention (PCI). Large-scale registry data on the prevalence and clinical management of ISR is lacking. MethodsThe aim was to describe the epidemiology and management of patients with ≥1 ISR lesions treated with PCI (ISR PCI). Data on characteristics, management and clinical outcomes were analyzed for patients undergoing ISR PCI in the France-PCI all-comers registry. ResultsBetween January 2014 and December 2018, 31,892 lesions were treated in 22,592 patients, 7.3 % of whom underwent ISR PCI. Patients undergoing ISR PCI were older (68.5 vs 67.8; p < 0.001), and more likely to have diabetes (32.7 % vs 25.4 %, p < 0.001), chronic coronary syndrome or multivessel disease. ISR PCI concerned drug eluting stents (DES) ISR in 48.8 % of cases. Patients with ISR lesions were more frequently treated with DES than drug eluting balloon or balloon angioplasty (74.2 %, 11.6 % and 12.9 %, respectively). Intravascular imaging was rarely used. At 1 year, patients with ISR had higher target lesion revascularization rates (4.3 % vs. 1.6 %; HR 2.24 [1.64–3.06]; p < 0.001). ConclusionsIn a large all-comers registry, ISR PCI was not infrequent and associated with worse prognosis than non-ISR PCI. Further studies and technical improvements are warranted to improve the outcomes of ISR PCI.

Predictors and outcomes of ischemia-driven target lesion revascularization in deferred lesion based on fractional flow reserve: a multi-center retrospective cohort study.

BackgroundFractional flow reserve (FFR) has become the gold standard for diagnosing ischemia in angiographically intermediate epicardial coronary artery stenosis. This study investigated the clinical outcomes and predictors of revascularization deferral based on FFR.MethodsIn this retrospective cohort study, we assessed 474 lesions (440 patients) where revascularization was deferred based on the FFR value. Minimum lumen diameter and %-diameter stenosis were measured. Calcification was graded as none, mild, moderate, or heavy. The synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) score I was also determined. The primary outcome was ischemia-driven target lesion revascularization (TLR) in deferred lesions within 3 years. Patients were also assigned into two groups based on FFR value.ResultsThe average age of the patients was 69.7±10.4 years. The average FFR value was 0.86±0.05. Stable angina pectoris was noted in 298 (67.7%) cases, and in-stent restenosis (ISR) was present in 28 (5.9%). The average SYNTAX score was 7.2±4.2. The 3-year ischemia-driven TLR was 18 lesions (3.8%). Cox proportional hazard model revealed that the SYNTAX score and ISR were independent predictors for TLR in deferred lesions [hazard ratio (HR) =1.10, 95% confidential interval (CI): 1.01–1.19, P=0.03; HR =6.33; 95% CI: 2.25–17.8, P<0.01, respectively]. The deferral group, with a low FFR value, tended to have higher TLR rates than other groups.ConclusionsLesions with lower FFR values were associated with a higher incidence of ischemia-driven TLR than those with higher FFR values. SYNTAX score and ISR were predictors for ischemia-driven TLR at 3 years in the deferred lesions.

Impact of diabetes on clinical outcomes after revascularization with the dual therapy CD34 antibody-covered sirolimus-eluting Combo stentand the sirolimus-eluting Orsiro stent.

ObjectivesTo compare the efficacy and safety of the dual therapy CD34 antibody‐covered sirolimus‐eluting Combo stent (DTS) and the sirolimus‐eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study.BackgroundThe incidence of target lesion failure (TLF) after treatment with modern drug‐eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown.MethodsIn total 3146 patients were randomized to stent implantation with DTS (n = 1578; DM: n = 279) or SES (n = 1568; DM: n = 271). The primary end point, TLF, was a composite of cardiac death, target‐lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.ResultsAt 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02–3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15–2.42). The differences were mainly explained by higher rates of TLR.ConclusionCompared to the SES, the DTS was associated with an increased risk of TLF at 12 months in patients with and without DM. The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without DM.

Drug-Eluting versus Bare-Metal Stents in Saphenous Vein Grafts Compared to Native Coronary Vessels: The Norwegian Coronary Stent Trial Study

Background: Drug-eluting stents (DES) reduce target lesion revascularization (TLR) with no effect on mortality or myocardial infarction (MI) compared to bare-metal stents (BMS) in native vessels. Randomized stent studies in saphenous vein grafts (SVG) are few and the reported effects are ambiguous. The Norwegian Coronary Stent Trial study is the first to randomize lesions to percutaneous coronary intervention in native vessels and SVG. Aims: The aim of this study was to compare the rate of mortality, MI, and TLR across stent and vessel types. Methods: In this substudy, 6,087 patients with a single lesion in native vessels and 164 in SVG were followed for 5 years. Results: MI was more frequent in SVG (subdistributional hazard ratio [SHR] 4.95 (3.75–6.54, p < 0.001), but not affected by stent type. In the first 500 days, DES reduced TLR in native vessels (SHR 0.21 (0.15–0.30) p < 0.001) and SVG (SHR 0.18 (0.04–0.80) p = 0.02). Thereafter, DES and BMS were equivalent in native vessels, but DES had a higher TLR rate than BMS in SVG (SHR 3.31 (1.23–8.94) p = 0.02). After 5 years, the TLR rate was still significantly lower for DES in native vessels (3.2% vs. 7.8%, p < 0.001) but not in SVG (21.4% vs. 18. 4%). Conclusion: In SVG, no difference in TLR between DES and BMS was observed after 5 years in contrast to persistent benefit in native vessels. The high rate of TLR and MI in SVG makes treatment of native vessels a preference whenever feasible and better treatment options for SVG are warranted.

Clinical outcomes following percutaneous coronary intervention for bifurcation lesions: kissing balloon inflation vs. sequential dilation.

Percutaneous coronary intervention for bifurcation lesions remains challenging, with there being several debatable issues, including the requirement for kissing balloon inflation (KBI). The objective of this study was to assess the clinical outcomes following single crossover stent implantation with KBI or sequential dilation alone. Data were examined for 255 non-left main bifurcation lesions (246 patients) treated with single crossover stent implantation, followed by side branch (SB) strut dilation with KBI (n = 74 lesions) or sequential dilation (n = 181 lesions) in three hospitals. Target lesion revascularization (TLR) was the primary endpoint. There was no significant difference in the pre-procedural reference diameter of both the main vessel (MV) and SB between the KBI and sequential dilation groups. However, MV post-dilation balloon size was smaller with lower pressure and post-procedural minimal lumen diameter was significantly smaller in the KBI group. During the median follow-up period of approximately 3years, TLR incidence was significantly higher in the KBI group than in the sequential dilation group; in particular, the TLR rate at the distal MV was higher in the former. For bifurcation lesions treated with single crossover stent implantation, the TLR rate was higher after KBI than after sequential dilation; this was mainly due to higher revascularization in the distal MV. For bifurcation lesions treated with KBI, MV post-dilation balloon diameter tended to be smaller with lower pressure, which might lead to poorer stent expansion and a higher TLR rate.

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry

To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS). CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP. This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST). Data from 130 patients were analyzed (mean age 72.5± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2± 12.8month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion. The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.

Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study.

IntroductionScoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty.MethodsWe studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292).ResultsA total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901).ConclusionsThe routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

Prospective, large-scale multicenter trial for the use of drug-coated balloons in coronary lesions: The DCB-only All-Comers Registry.

This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions. Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited. This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months. A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates. Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.

TCT-188 Culprit Lesion Harbouring Calcified Nodule Predicts A Higher Target Lesion Revascularization Rate after PCI with 2ndGeneration Drug-eluting Stent in ACS Patients: Findings from Serial Coronary Angiography Study

TCT-188 Culprit Lesion Harbouring Calcified Nodule Predicts A Higher Target Lesion Revascularization Rate after PCI with 2ndGeneration Drug-eluting Stent in ACS Patients: Findings from Serial Coronary Angiography Study

Midterm Outcomes After Endovascular Intervention for Occluded vs Stenosed External Iliac Arteries

Purpose: To evaluate the association between a chronic total occlusion (CTO) and long-term outcomes among patients undergoing endovascular intervention to the external iliac artery (EIA). Methods: A 2-center retrospective study was conducted of 331 patients (mean age 64.7±12.7 years; 221 men) who underwent endovascular intervention for 481 EIA atherosclerotic lesions between 2006 and 2016. A quarter of the lesions (115, 23.9%) were CTOs. The majority of patients (184, 60.9%) were treated for claudication; 172 (38%) lesions were TransAtlantic Inter-Society Consensus type C or D. Target lesion revascularization (TLR) and major adverse limb event (MALE) rates were compared between lesions with or without an EIA CTO. A Cox proportional hazard model was subsequently developed to determine baseline variables associated with long-term outcomes after successful endovascular intervention of stented EIAs; outcomes are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: The mean lesion length was longer (84 vs 50 mm, p<0.001) among patients treated for CTOs. While overall the target lesion failure rates were very low (2.8%), vessel perforation (2.7% vs 0.3%, p=0.02) and distal embolization (2.7% vs 0.9%, p=0.02) were more common in the CTO group. Among 377 successfully crossed and stented lesions (93 CTOs), the overall 1-year primary patency was 78% and secondary patency was 92%. One-year and 5-year TLR rates were 8.2% and 15.4%, respectively. CTO intervention was associated with higher 5-year TLR rates in the unadjusted analysis (HR 1.72, 95% CI 1.00 to 2.56, p=0.050), but the association did not remain significant after multivariable adjustment. Conclusion: Intervention to EIA CTOs is associated with increased intraprocedural complexity but with similar midterm outcomes, including high patency and low rates of TLR to 5 years.

Intracoronary Brachytherapy in the Era of Drug-Eluting Stents

Intracoronary brachytherapy (ICBT) is an effective percutaneous trans-luminal solution for in-stent restenosis (ISR). Our objective is to assess the feasibility, safety, and efficacy of ICBT as a treatment option for ISR. We retrospectively identified adult patients who underwent ICBT for ISR in our institution, between March 2015 and January 2017 in an IRB approved database. All lesions were treated with Y-90 source, with an activity of 1.66 gigabecquerel to a prescription depth of 2mm. Lesions were prescribed 18.4 Gy (n=35), for reference vessel diameter (RVD) of < 3.35 mm or 23 Gy (n=36) for RVD of ≥ 3.35mm. Demographic variables, rates of peri-procedural complications and incidence of target lesion revascularization (TLR) were collected. Predictors of TLR were determined using Cox proportional hazards modelling. We identified 60 patients treated to a total of 71 lesions with 11 patients undergoing a second ICBT procedure. The median age of patients was 66 years with a median follow-up of 5 months. All patients had hyperlipidemia, 63% were male, 98.3% were hypertensive, and 58.3% had diabetes. Never smokers, former smokers, and current smokers represented 49.3%, 39.4%, and 11.3% respectively. The number of previous ISR at the site of ICBT was known for 47 treatments with < 4 prior ISR in 56.8% and ≥4 in 43.2%. Number of stent layers at the site of ICBT was known for 58 lesions and was < 2 layers in 65.5% and ≥3 in 34.5%. Left anterior descending artery (LAD) was the most commonly treated vessel (32.4% of ICBT). The median true vessel diameter (TVD) was 3.4 mm (range, 2.5-4.5), median injury length was 32 mm (range, 5-120mm) and median number of dwell positions was 1 (range, 1-4). Fifteen lesions (21.1%) required TLR resulting in 6 and 12-month actuarial rates of ISR of 9% and 30.3% respectively. No peri-procedural myocardial infarctions, arrhythmias, vessel perforations or dissections were observed. Univariate analysis revealed an association between TLR and history of prior ICBT HR = 3.24 (95% CI 0.93 - 12.7 p = 0.065), fewer stent layers HR = 3.13 (95% CI 0.70 – 14.0 p = 0.14) and a higher number of previous ISR at the ICBT site HR = 2.25 (95% CI 0.71 to 7.14 p = 0.17). There was no statistically significant association between TLR and age (p = 0.36), sex (p = 0.57), DM (p = 0.46), smoking (p = 0.97), TVD (p = 0.76), radiation dose (p = 0.77) or number of dwell positions (p = 0.71). One patient has died resulting in an actuarial overall survival rate of 83.3% at 24 months. ICBT in the era of drug-eluting stents is a feasible and safe treatment option for patients with ISR with low rates of severe peri-procedural complications. This preliminary report suggests a history of prior ICBT may be associated with a higher rate of TLR after ICBT. For patients with in-stent restenosis in the era of drug-eluting stents, ICBT should be considered to minimize the risk of ISR.

Nitinol stent implantation for femoropopliteal disease in patients on hemodialysis: results of the 3-year retrospective multicenter APOLLON study.

The clinical outcomes of nitinol stents for femoropopliteal arterial (FP) disease in patients on hemodialysis were assessed. Endovascular therapy (EVT) is accepted for symptomatic FP disease. However, the clinical outcomes of patients on dialysis are not well known. A multicenter retrospective study was conducted with data between November 2010 and August 2013. A total of 484 consecutive patients who successfully underwent EVT for FP disease with nitinol stents were recruited and analyzed. Patients were categorized into the hemodialysis group (N=161) and non-hemodialysis group (N=323). The primary measure was primary patency verified by duplex ultrasound at a rest peak systolic velocity (PSVR) of >2.5, and secondary measures were freedom from target lesion revascularization (TLR) and major amputation-free survival (AFS). Average follow-up duration was 19.5±13.5months. The primary patency rate at 3years was significantly lower in the hemodialysis group than the non-hemodialysis group (33.8 vs. 43.7%; p=0.036). Freedom from TLR at 3years was 55.0% in the hemodialysis group and 66.1% in the non-hemodialysis group (p=0.032). The hemodialysis group showed a significantly lower AFS rate at 3years than the non-hemodialysis group (86.4 vs. 58.2%; p<0.001). In hemodialysis patients, nitinol stent use resulted in a lower patency rate, higher TLR rate, and lower AFS rate compared to non-hemodialysis patients. These data suggest that nitinol stent implantation for FP arteries in hemodialysis patient needs to be reconsidered.

Comparison of 2‐year clinical outcomes between zotarolimus‐, sirolimus‐, and paclitaxel‐eluting stents in real life clinical practice

There are few studies comparing the long-term efficacy and safety of the zotarolimus-eluting stent (ZES) with sirolimus- (SES) and paclitaxel-eluting stents (PES) in the unselected cohorts that were subject to real life clinical practice. Total 2,769 patient who underwent successful percutaneous coronary intervention (PCI) with the three drug-eluting stents (DES) between April 2006 and July 2008 were analyzed retrospectively. A total of 1,152 patients were treated with SES, 810 with PES, and 807 with ZES. The primary analysis endpoint was cumulative rate of target-lesion failure (TLF) at 24 months, defined as the composite of cardiac death, target-vessel-related myocardial infarction (MI), and target-lesion revascularization (TLR). At 24 months, the incidence of TLF was significantly lower in the SES group compared with the ZES (7.6% vs. 11.3%, HR = 0.66, CI = 0.49–0.88, P = 0.005) or the PES group (7.6% vs. 10.2%, HR = 0.74, CI = 0.55–0.99, P = 0.048), while similar between the PES and the ZES groups (HR = 0.89, CI = 0.66–1.20, P = 0.443). The difference was mostly driven by higher rate of TLR in the ZES and PES groups compared with the SES group, mostly within the first year post-PCI. However, the rate of hard endpoints (cardiac death or nonfatal MI) was similar among the three groups. These results were reproduced in the propensity score-matched cohort. This observational study shows that the use of SES is superior to PES or ZES for the TLF in the overall and matched analysis.

TCT-539 Differences in Patients' Selection and Outcomes of SilverHawk Atherectomy versus Laser Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: A Retrospective Analysis from a Single Center

Background: Treatment of in-stent restenosis (ISR) of the femoropopliteal (FP) artery remains a challenge to the endovascular specialist. Silverhawk (SA) and excimer laser atherectomy (ELA) use different mechanisms in restenotic tissue reduction. We report data on FP ISR treatment with SA and ELA in an unselected cohort of patients treated at a single center. Methods: Demographic, clinical, angiographic and procedural data was collected on all patients that underwent SA and ELA (laser Elite 83.3%, Booster or Tandem 16.7%) for FP ISR from January 2005 until June 2010. Major adverse events and oneyear target lesion revascularization (TLR) were obtained by review of medical records and phone calls. Univariate analysis was used to compare the 2 groups. Cox Regression analysis for TLR over time was performed to adjust for differences between the 2 cohorts and modeled for the following variables: SA vs. ELA, lesion length, TASC D lesions (versus A-C), diabetes, age, gender and bail out stenting. Results: 81 consecutive patients (41 SA, 40 ELA) were included in the analysis. ELA was utilized more frequently in longer lesions, subacute presentation, TASC D lesions, and in patients with more angiographic thrombus. Percent stenosis post ELA was 56.6% 0.7% vs SA 33.8% 7.5% (p1⁄40.015). Percent stenosis post ELA was 56.6% 0.7% vs SA 33.8% 7.5% (p1⁄40.015). Final angiographic success (< 30% residual narrowing post final treatment) was similar between ELA and SA respectively (92.5% vs. 100%, p1⁄40.12). Embolic filter protection was used equally in both modalities (ELA 57.5% vs. SA 56.1%, p1⁄41.00). DE requiring treatment occurred in 2.5% in ELA vs 7.3% of SA (p1⁄40.2). There were no device related complications. The primary outcome of TLR at 1 year occurred in 48.7% and 31.7% of ELA and SA respectively (p1⁄40.171). ELA had a steeper failure rate than SA in the first 6 months post treatment and to a lesser extent after 6 months, whereas SA showed lesser TLR initially but a higher TLR after 6 months. Cox Regression analysis showed that SA was a predictor of TLR at 1 year. Conclusions: Both SA and ELA continued to have high TLR rates in treating ISR of the FP arteries. SA appears to be a predictor of TLR at 1 year.

Comparison of 5-Year Outcomes in Patients With and Without Unprotected Left Main Coronary Artery Disease After Treatment With Sirolimus-Eluting Stents: Insights From the j-Cypher Registry

This study assessed 5-year outcomes after implantation of sirolimus-eluting stents (SES) for unprotected left main coronary artery (ULMCA) disease in comparison with that for non-left main disease. More information on long-term outcomes after ULMCA stenting is needed. The j-Cypher is a multicenter prospective registry of consecutive patients undergoing SES implantation in Japan. Among 12,812 patients enrolled in the j-Cypher registry, the unadjusted mortality rate at 5 years was significantly higher in patients with ULMCA stenting than in patients without ULMCA stenting (22.8% vs. 14.1%; p < 0.0001); however, the risk for death with ULMCA stenting was no longer significant after adjusting for confounders (hazard ratio: 1.18, 95% confidence interval: 0.95 to 1.46; p = 0.14). In the lesion-level comparison, the nonbifurcation ULMCA lesions treated exclusively with SES had a significantly lower rate of target lesion revascularization (TLR) than those in non-ULMCA nonbifurcation lesions (2.4% vs. 12.7%; p = 0.04). Among bifurcation lesions, those treated with a provisional 2-stent approach had similar rates of TLR (12.1% vs. 11.4%; p = 0.79) between the ULMCA and non-ULMCA groups. Lesions treated with an elective 2-stent approach had higher TLR rates in the ULMCA group as compared with the non-ULMCA group (33.5% vs. 19.7%; p = 0.002). The safety of ULMCA stenting relative to non-LMCA stenting was maintained through 5 years follow-up. In terms of efficacy, SES implantation in nonbifurcation ULMCA lesions was associated with an extremely low cumulative incidence of TLR, whereas the elective 2-stent approach for ULMCA bifurcation lesions was associated with a markedly higher cumulative incidence of TLR as compared with that for non-ULMCA bifurcation lesions.

Clinical outcomes after bare‐metal stenting in diabetic patients with lesions carrying a low risk of restenosis

To evaluate the clinical results of diabetic patients undergoing percutaneous coronary intervention (PCI) for coronary artery lesions carrying a low risk of restenosis treated with a bare-metal stent (BMS). There is a discrepancy between current international guidelines on the use of BMS in diabetics with low risk of restenosis coronary artery lesions. Registry data from diabetic patients who underwent non-urgent PCI in a high-volume tertiary referral hospital in the Netherlands was used. The main outcomes were target lesion revascularization (TLR) and the composite of cardiac death, myocardial infarction, and target vessel revascularization at 1-year of follow-up. A total of 1,951 patients were included, of which 1,596 non-diabetics (non-DM), 231 non-insulin requiring diabetics (NIRDM), and 124 insulin requiring diabetics (IRDM).TLR rates in non-DM versus NIRDM were similar (6.3% vs. 5.6%; P = 0.68), whereas TLR in IRDM was higher (6.3% vs. 11.3%; P = 0.03). The composite of cardiovascular clinical outcomes was not significantly different in non-DM versus NIRDM (9.5% vs. 13.4%; P = 0.07), though in IRDM the incidence was higher (9.5% vs. 17.7%; P < 0.01). No differences were observed in TLR or composite clinical endpoint at 1-year between non-DM and NIRDM after BMS placement in coronary artery lesions carrying a low risk of restenosis. The presence of IRDM was associated with higher TLR rates when treated with BMS. These results imply that BMS placement may be considered in patients with NIRDM but further work is required to define treatment strategies and, more importantly, improve the outcomes in diabetics.

Comparison of Drug-Eluting Stents in Acute Myocardial Infarction Patients with Chronic Kidney Disease

Background/AimsTo determine which drug-eluting stents are more effective in acute myocardial infarction (MI) patients with chronic kidney disease (CKD).MethodsThis study included a total of 3,566 acute MI survivors with CKD from the Korea Acute Myocardial Infarction Registry who were treated with stenting and followed up for 12 months: 1,845 patients who received sirolimus-eluting stents (SES), 1,356 who received paclitaxel-eluting stents (PES), and 365 who received zotarolimus-eluting stents (ZES). CKD was defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m2 calculated by the modification of diet in renal disease method.ResultsAt the 12-month follow-up, patients receiving ZES demonstrated a higher incidence (14.8%) of major adverse cardiac events (MACEs) compared to those receiving SES (10.1%) and PES (12%, p = 0.019). The ZES patients also had a higher incidence (3.9%) of target lesion revascularization (TLR) compared to those receiving SES (1.5%) and PES (2.4%, p = 0.011). After adjusting for confounding factors, ZES was associated with a higher incidence of MACE and TLR than SES (adjusted hazard ratio [HR], 0.623; 95% confidence interval [CI], 0.442 to 0.879; p = 0.007; adjusted HR, 0.350; 95% CI, 0.165 to 0.743; p = 0.006, respectively), and with a higher rate of TLR than PES (adjusted HR, 0.471; 95% CI, 0.223 to 0.997; p = 0.049).ConclusionsOur findings suggest that ZES is less effective than SES and PES in terms of 12-month TLR, and has a higher incidence of MACE due to a higher TLR rate compared with SES, in acute MI patients with CKD.

Long-Term Outcomes After the Percutaneous Treatment of Drug-Eluting Stent Restenosis

This study sought to evaluate the long-term angiographic and clinical outcomes after the treatment of drug-eluting stent in-stent restenosis (DES-ISR) based on the angiographic pattern of restenosis. Long-term outcomes after percutaneous treatment of DES-ISR are unclear. This study performed a retrospective analysis of 481 consecutive de novo DES-ISR lesions (n = 392) treated percutaneously between August 2002 and July 2007. The lesions were divided based on the pattern of restenosis: focal (305; 63.4%), diffuse (120; 24.9%), and occlusive (56; 11.6%). The majority (65%) of patients had angina or ischemia on presentation and 13% had an acute coronary syndrome. Angiographic follow-up after treatment of DES-ISR was available in 65.5% of lesions. A second angiographic restenosis occurred in 29.1% of the focal group, 45.8% (p = 0.007) of the diffuse, and 65.6% (p < 0.0001) of the occlusive. The pattern of DES-ISR predicted the pattern of recurrence: occlusive reoccluded in 66.7%; diffuse recurred as diffuse or occlusive in 57.9%; focal as focal in 67.2%. During a median follow-up of 2.97 years (interquartile range: 2.37 to 3.89), major adverse cardiac events occurred in 32.8% of patients with no significant differences among the focal, diffuse, and occlusive groups (30.9%, 38.7%, 31.1%; p = 0.38). Diffuse restenosis was associated with a significantly higher target lesion revascularization rate compared with focal (27.1% vs. 15.8%; p = 0.008). A disparity between restenosis (65.6%) and target lesion revascularization (18.5%) rates for occlusive DES-ISR suggests that as many recurrent restenoses were occlusive, they were not retreated. DES-ISR identifies a high-risk cohort that is at an increased risk of events, in particular repeat revascularization, during long-term follow-up. The initial pattern of restenosis is the most important predictor of recurrent restenosis or the need for subsequent reintervention.

Inter- and Intra-Observer Variability for Assessment of the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) Score and Association of the SYNTAX Score With Clinical Outcome in Patients Undergoing Unprotected Left Main Stenting in the Real World

The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) score was proposed as a method to evaluate the complexity of coronary anatomy. However, the reproducibility of assessment for the SYNTAX score in unprotected left main coronary artery (ULMCA) disease has not yet been adequately evaluated. The purpose of this study is to assess inter- and intra-observer variability for the assessment of the SYNTAX score in patients undergoing ULMCA stenting in daily clinical practice. The SYNTAX score of 101 consecutive patients who underwent ULMCA stenting with sirolimus-eluting stent was independently assessed by 2 experienced interventional cardiologists. One of the 2 cardiologists evaluated all the cases again 6 months after the initial assessment. The κ value for inter-observer variability in estimating the SYNTAX score was 0.62 according to the dichotomized analysis (≥ 33, < 33) and 0.58 according to the tertile analysis (< 23, 23 ≤ - < 33, ≥ 33), while the intra-observer variability was 0.78 and 0.69, respectively. Patients with a high SYNTAX score (≥ 33, n = 55) compared with those with low or intermediate score (< 33, n = 46) had a significantly higher rate of target-lesion revascularization (TLR) of the ULMCA lesion at 2 years (24% vs. 4.4%, P = 0.01). Both inter- and intra-observer variability for estimating the SYNTAX score were within an acceptable range and a high SYNTAX score showed a higher rate of TLR in patients undergoing ULMCA stenting in daily clinical practice.

Influence of Sex on Long-Term Outcomes After Percutaneous Coronary Intervention With the Paclitaxel-Eluting Coronary Stent: Results of the “TAXUS Woman” Analysis

We conducted the "TAXUS Woman" analysis to assess the influence of sex on long-term outcomes after percutaneous coronary intervention using paclitaxel-eluting stents (PES) in a broad spectrum of patients. Previous studies indicate that the sex gap suggesting worse outcomes in women has narrowed. However, limited data are available on long-term sex-based outcomes with drug-eluting stents despite their extensive use in current practice. We analyzed 2,271 PES-treated patients (women = 665), from 5 randomized trials and 7,492 PES-treated patients (women = 2,449) from 2 "real-world" registries. The trial and registry datasets were stratified by sex to compare long-term outcomes. Additionally, the outcomes in PES-treated women were compared with bare-metal stent-treated women (n = 395) in the randomized trials. In the randomized trials, PES-treated women had a lower target lesion revascularization (TLR) rate (11.5% vs. 22.6%, p < 0.001) than bare-metal stent-treated women, with no significant sex-based differences in death, myocardial infarction, stent thrombosis, or TLR through 5 years. In both the trials and the registries, although women had more adverse baseline characteristics including advanced age, hypertension, and diabetes, they had similar outcomes to men. In expanded-use patients, however, women showed significantly higher rates of death and TLR, although only the higher TLR rate was confirmed by multivariate analysis. This study of nearly 10,000 patients including more than 3,000 women demonstrates that despite their higher-risk profile, women have comparable benefits to men from percutaneous coronary intervention with PES except for a slightly higher revascularization rate in the high-risk cohort.