Predictors Of Target Lesion Revascularization Research Articles

Restenosis Predictors after Carotid Angioplasty and Stenting and Its Influence on Procedure Durability, Single-Center Experience

This article reports our experience regarding in-stent restenosis in the carotid arteries with special focus was given to angiographic morphology and clinical predictors of in-stent restenosis. Between July 2008 and August 2011, 245 carotid angioplasty and stenting procedures were performed in 243 patients (172 men and 71 women). Stenting for de novo stenoses was performed in 214 (87.3%) carotid arteries, and 31 (12.7%) vessels were treated because of postsurgical restenosis. Symptomatic lesions were detected in 187 patients (76.3%). Angiography confirmed any significant recurrent lesion detected on the ultrasound scan. Symptomatic or significant (70%) recurrent lesions detected on the ultrasound scan were an indication for retreatment. During the follow-up period of 821 days (range: 62-1750 days), there were 10 deaths, all non-procedure related. Stent restenosis was defined as greater than 30% narrowing of the vessel lumen diameter and could be detected in 35 (14.3%) patients. Retreatment was indicated in 16 (6.5%) patients. Three types of restenosis were differentiated: tandem type restenosis (n = 5 of 35); "in-stent" restenosis (n = 18 of 35); and "end-stent" restenosis (n = 12 of 35). Interventions, either dilation alone (n = 12) or dilation with restenting (n = 4) for restenosis, were performed with 1 procedure-related dysphasia that resolved in 30 days. Female gender, hypercholesterolemia, peripheral vascular disease (PVD), initial stenosis, and surgical graft were predictors of target lesion revascularization. In our cohort, history of surgical endarterectomy, female gender, hypercholesterolemia, PVD, and initial stenosis were predictors of in-stent restenosis. Three types of restenosis were identified in our cohort.

Incidence and predictors of early and late target lesion revascularization after everolimus-eluting stent implantation in unselected patients in japan.

The objective of this study was to clarify the incidence and predictors of early and late target lesion revascularization (TLR) after everolimus-eluting stent (EES) implantation in actual clinical practice. Several clinical studies have reported the incidence and predictors of TLR after EES implantation. However, detailed features of early and late TLR are unknown. We analyzed the clinical data of patients who underwent EES implantation between January 2010 and December 2011 at 22 institutions in Japan (Tokyo-MD PCI study). Patients who underwent ischemia-driven TLR (ID-TLR) were grouped according to the number of years elapsed since stent placement, and incidence and correlations between clinical factors were analyzed. Statistical analysis was performed for 1,899 patients and 2,305 lesions. The mean age was 70.0 ± 9.9 years, and the median follow-up period was 1,281 days (IQR: 762-1,440 days). The incidence of ID-TLR was 2.7% at 1 year and 5.4% at 4 years. After 2 years, the ID-TLR rates plateaued. The independent predictors of ID-TLR occurring within 2 years were hemodialysis, triple vessel disease, restenotic lesion, and ostial lesions. The independent predictors of ID-TLR between 2 and 4 years were diabetes mellitus and peripheral artery disease. The ID-TLR rates leveled off after 2 years. Furthermore, the predictors of ID-TLR that occurred within 2 years of EES implantation differed from those that occurred later than 2 years. © 2017 Wiley Periodicals, Inc.

Impact of Routine Fractional Flow Reserve Evaluation During Coronary Angiography on Management Strategy and Clinical Outcome: One-Year Results of the POST-IT.

Penetration of fractional flow reserve (FFR) in clinical practice varies extensively, and the applicability of results from randomized trials is understudied. We describe the extent to which the information gained from routine FFR affects patient management strategy and clinical outcome. Nonselected patients undergoing coronary angiography, in which at least 1 lesion was interrogated by FFR, were prospectively enrolled in a multicenter registry. FFR-driven change in management strategy (medical therapy, revascularization, or additional stress imaging) was assessed per-lesion and per-patient, and the agreement between final and initial strategies was recorded. Cardiovascular death, myocardial infarction, or unplanned revascularization (MACE) at 1 year was recorded. A total of 1293 lesions were evaluated in 918 patients (mean FFR, 0.81±0.1). Management plan changed in 406 patients (44.2%) and 584 lesions (45.2%). One-year MACE was 6.9%; patients in whom all lesions were deferred had a lower MACE rate (5.3%) than those with at least 1 lesion revascularized (7.3%) or left untreated despite FFR≤0.80 (13.6%; log-rank P=0.014). At the lesion level, deferral of those with an FFR≤0.80 was associated with a 3.1-fold increase in the hazard of cardiovascular death/myocardial infarction/target lesion revascularization (P=0.012). Independent predictors of target lesion revascularization in the deferred lesions were proximal location of the lesion, B2/C type and FFR. Routine FFR assessment of coronary lesions safely changes management strategy in almost half of the cases. Also, it accurately identifies patients and lesions with a low likelihood of events, in which revascularization can be safely deferred, as opposed to those at high risk when ischemic lesions are left untreated, thus confirming results from randomized trials. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01835808.

Abstract 16152: Utility of Peak Systolic Velocity Ratio in Asymptomatic Patients With Restenosis After Endovascular Therapy for Femoro-Popliteal Lesion

Introduction: The predictive factor of whether asymptomatic restenosis needs reintervention after initial therapy remains unclear. Objective: The aim of this study was to evaluate whether peak systolic velocity ratio (PSVR) is effective to predict target lesion revascularization (TLR) after endovascular therapy (EVT) for femoropopliteal (FP) lesion. Methods: From April 2007 to September 2013, 120 restenotic limbs without ischemic symptoms (mean age: 73.1±9.0, men: 75.0%, stent implantation: 57.5%) were selected and analyzed, 73 limbs underwent reintervention. Median follow-up period was 33.7 months (5.1-110.4 months). They were followed by serial duplex ultrasound (DUS). Restenosis was defined as peak systolic velocity (PSV) > 250cm/s or PSVR > 2.4 by using DUS. We divided them into two groups (High PSVR group (PSVR ≧3.63)and low PSVR group (PSVR < 3.63)). The ratio of TLR was compared between two groups by Kaplan-Meier survival curve. We also analyzed the TLR between balloon angioplasty (POBA) alone and stent implantation on initial EVT. Each cut off value of PSVR were 4.19 and 3.63. Results: At 1, 3 and 5 years after initial EVT, Freedom from TLR were significantly different between two groups (76.5%, 33.2% and 18.3% vs 90.7%, 75.4%, and 58.0%, p<0.001). Moreover, two groups were significantly different when analyzed about limbs performed POBA (86.9%, 67.0% and 35.7% vs 69.2%, 29.0% and 14.5%, p =0.048 ) and stenting on initial EVT (92.3%, 77.6% and 51.7% vs 83.8%, 35.2% and 12.0%, p < 0.01). After adjustment for use of cilostazol, use of proton pomp inhibitor , chronic total occlusion, history of EVT for aortoiliac disease, PSVR was an independent predictors of TLR. Conclusions: PSVR may be a predictive factor of performing reintervention for asymptomatic patient with restenosis after EVT of FP lesion.

Photoablation Using theTurbo-Booster andExcimer Laser for In-Stent RestenosisTreatment: Twelve-Month Results From the PATENT Study

To evaluate the performance of the Turbo Elite laser catheter in combination with the Turbo-Booster guiding catheter for the treatment of femoropopliteal in-stent restenosis (ISR). The PATENT study (Photoablation Using the Turbo-Booster and Excimer Laser for In-Stent Restenosis Treatment) was a multicenter prospective industry-sponsored registry involving 5 European centers. Patients with symptomatic femoropopliteal ISR (Rutherford categories 2-5) and an ankle-brachial index ≤0.8 were treated with excimer laser atherectomy (ELA). Ninety patients (65 men; mean age 69.5±9.3 years) were enrolled. The majority of patients were Rutherford category 3 (63, 71.6%), and 32 (35.6%) patients had previous treatment for ISR. The average lesion length was 123±95.9 mm, and 30 (34.1%) lesions were total occlusions. The main efficacy outcome was primary patency at 12 months as measured by duplex ultrasonography. The primary safety outcome was freedom from major adverse events (MAE) during hospitalization and at 30-day follow-up to include all death, unplanned major amputation, or target lesion revascularization (TLR). The Turbo Elite laser catheter created a pilot channel in 87 (96.7%) of 90 lesions, with a mean of 1.5 passes, followed by the Turbo Booster with a mean of 5.7 passes. Adjunctive balloon dilation was performed in 79 (87.8%) lesions. Procedure success (<30% residual stenosis without stenting) was 96.7%. The mean percentage stenosis improved from a baseline of 87.0% to 32.3% after laser atherectomy and to 7.4% after final treatment. The MAE rate through 30 days was 2.2%. Nine (10.0%) patients experienced distal embolization. Estimates of freedom from TLR at 6 and 12 months were 87.8% and 64.4%, respectively. Primary patency at 6 and 12 months was 64.1% and 37.8%, respectively. Only a history of prior intervention for ISR (p<0.01) was a predictor of TLR at 12 months. The PATENT study has established excimer laser atherectomy as safe for the treatment of femoropopliteal ISR, achieving high procedure success. Recurrence of restenosis indicates that removing hyperproliferative tissue alone does not solve the problem of ISR. New concepts, such as the combination of ELA with drug-eluting balloons, may prove beneficial.

Differences in Patient Selection and Outcomes Between SilverHawk Atherectomy and Laser Ablation in the Treatment of Femoropopliteal In-Stent Restenosis: A Retrospective Analysis From a Single Center

To analyze differences in the application and outcomes of SilverHawk atherectomy (SH) and excimer laser ablation (ELA) in the treatment of femoropopliteal in-stent restenosis (ISR) in an unselected cohort of patients treated at a single center. Between January 2005 and June 2010, 81 consecutive patients (46 men; mean age 69.1 years, range 43-86) underwent directional atherectomy (41 SH, 40 ELA) for femoropopliteal ISR lesions. Data were reviewed retrospectively on procedural outcomes, major adverse events, and 1-year target lesion revascularization (TLR) obtained from medical records and supplemented with telephone calls. The primary endpoint was symptom-driven TLR at 1 year; secondary endpoints were death and amputation. ELA was utilized more frequently than SH in longer lesions (210.4±104 vs. 126.2±79.3 mm, respectively; p=0.001), subacute presentation (55% vs. 14.6%, p=0.001), TASC D lesions (47.5% vs. 12.2%), and in patients with more angiographic thrombus (42.5% vs. 4.9%, p=0.001). Final angiographic success (<30% residual narrowing post final treatment) was similar between ELA and SH (92.5% vs. 100%, respectively, p=0.12). Bailout stenting was significantly higher with ELA vs. SH (50.0% vs. 24.4%, p=0.022). At 1 year, TLR had occurred in 48.7% of the ELA patients vs. 31.7% of the SH cases (p=0.171). Regression analysis confirmed that SH was a predictor of TLR at 1 year (hazard ratio 2.679, 95% CI 1.015 to 7.073, p=0.047). Both SH and ELA continue to have a high TLR rate in treating ISR of the femoral and popliteal arteries. A higher rate of delayed failure is seen with SH and an earlier, steeper loss of TLR-free survival is seen with ELA.

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.

Single-stent crossover technique from distal unprotected left main coronary artery to the left circumflex artery

Objectives: To report the clinical outcomes of single-stenting from distal unprotected left main coronary artery (LMCA) to the left circumflex artery (LCx). Background: Percutaneous coronary intervention of distal LMCA is usually performed by stenting into the left anterior descending artery (LAD). In some cases, stenting from LMCA to LCx alone is performed. Methods: Between April 2002 and April 2011, single-stenting with drug-eluting stent for distal unprotected LMCA disease was performed in 584 patients. Thirty-one patients underwent LMCA-LCx stenting, who were compared with the remaining 553 LMCA-LAD stented patients. Results: At 3-year follow-up, there were no significant differences between LMCA-LCx and LMCA-LAD stenting groups in major adverse cardiac events (24.1% vs. 19.6%, p=0.540), cardiac death and myocardial infarction. A trend towards higher target lesion revascularization (TLR) in the LMCA-LCx stenting group was noted. This was significant when the stented-branch was only considered (18.2% vs. 3.0%, p<0.001). In both TLR-subgroups, LCx-ostium was frequently involved (83.3% in LMCA-LCx vs. 66.2% in LMCA-LAD TLR-subgroups, p=0.39). The LAD-ostium was more frequently involved in LMCA-LCx TLR-subgroup (83.3% vs. 21.0%, p<0.001). On the multivariable Cox regression analysis, LMCA-LCx stenting was an independent predictor of TLR for restenosis at the ostium of the stented-branch (HR 6.49, 95% CI 2.27-18.53, p<0.001). Conclusions: TLR rate at the LCx-ostium is high irrespective of LMCA-LCx or LMCA-LAD stenting. The former also seems to be associated with high TLR at the LAD-ostium. It may therefore be important to evaluate alternative strategies for treating distal LMCA disease that extends into the LCx but not LAD.

High disturbed flow in stent-implanted region predicts target lesion revascularization after everolimus-eluting stent implantation in hemodialysis

Background: High disturbed coronary blood flow was reported to increase the risk of adverse events. The purpose of this study was to assess predictive values of coronary flow velocity (CFV) and an index of disturbed flow for target lesion revascularization (TLR) after everolimus-eluting stent (EES) implantation in hemodialysis (HD) patients. Methods and results: The study group consisted of 81HD patients with 100 coronary lesions (age 69.9±9.1 years, mean ± SD, 59 male) who underwent successful percutaneous coronary intervention (PCI) with EES implantation. The TIMI frame count method and quantitative digital angiographic analysis were performed based on the post-PCI angiogram. CFV (vessel length/TIMI frame count/15) and an index of disturbed flow (Reynolds number: velocity/diameter/density/viscosity) were measured both throughout the target vessel and in the stent-implanted region. Target lesion revascularization (TLR) occurred in 12 lesions (12.0%) at the follow-up period of 20.9±10.4 months. There were no significant differences between TLR group (12 lesions) and Non-TLR group (88 lesions) in terms of CFV and Reynolds number throughout the target vessel (195.4±66.8mm/sec vs. 159.8±56.6, p=0.17, 153.4±75.4 vs. 119.7±59.4, p=0.08, respectively). However, in the stent-implanted region, CFV and Reynolds number of the TLR group were significantly higher than the Non-TLR group (222.8±70.7mm/sec vs. 160.5±77.2, p=0.006, 186.1±65.7 vs. 132.4±71.2, p=0.01, respectively). Multivariate analysis showed that Reynolds number in the stent-implanted region after EES was an independent predictor of TLR in the HD patients (OR: 1.01, 95% CI: 1.00-1.023, p=0.02). Conclusion: In the stent-implanted region, CFV and Reynolds number were significantly higher in the TLR group than the Non-TLR group. High disturbed flow in stent-implanted region after EES may predict the risk of TLR in HD patients.

Repeat Revascularization After Contemporary Percutaneous Coronary Intervention

Although drug-eluting stents and intensive secondary prevention have contributed to improved outcomes after percutaneous coronary intervention (PCI), repeat revascularization remains relatively common in contemporary practice. We used data from the multicenter Evaluation of Drug-Eluting Stents and Ischemic Events registry to evaluate the relative frequency and timing of staged revascularization, target lesion revascularization (TLR), and other nontarget revascularization during the first year after contemporary PCI. Patients with staged revascularization, TLR, and other unplanned procedures (elsewhere in the target vessel or in other coronary arteries) were evaluated in time-dependent models using Kaplan-Meier life-table estimation. Predictors of TLR and unplanned revascularization at nontarget sites were identified using logistic regression. Between July 2004 to June 2007, 10 144 patients undergoing PCI were enrolled at 55 US hospitals, of whom 86% were treated with at least 1 drug-eluting stent. Twelve percent required repeat revascularization within the first year (3% staged; 9% unplanned). More than 75% of staged revascularizations were performed <30 days after index PCI, although there was significant variation in this practice across hospitals (range, 0%-54%). TLR occurred in 4.5% of patients, with higher hazard rates between 2 to 9 months after PCI, whereas the risk of unplanned non-TLR (4.4% cumulative incidence) was constant over time. Among unselected patients undergoing PCI in the drug-eluting stent era, the incidence of repeat revascularization at 1 year is ≈12%. Among unplanned procedures, only half are performed for TLR. To achieve further improvements in PCI outcomes, future efforts should concentrate as much on identifying ischemia-producing lesions and intensifying secondary prevention therapies as on the prevention of restenosis.

Clinical usefulness of the Driver® stent in a retrospective, collaborative, multicenter, open-label study in Japanese real-world patients with coronary artery disease and the drug-eluting stent era

The objectives of the present study were to determine predictors for target lesion revascularization (TLR) and to examine the clinical usefulness of the Driver(®) stent (a cobalt alloy, modular-type) in Japanese patients with coronary artery disease. Data on 631 Japanese patients including 241 with stable angina and 361 with acute coronary syndrome-who had been implanted with the Driver(®) stent (805 lesions) between August 2004 and February 2005-were collected retrospectively; 95.0 and 81.7% of these lesions were de novo and ACC/AHA classification B2/C type, respectively. Early angiography of 622 patients revealed 1) the preprocedural minimal lumen diameter (MLD) of 0.80±0.51mm, with lesion lengths of 17.1±7.3mm, and 2) the postprocedural MLD of 2.95±0.55mm, with MLD gains of 2.14±0.68mm. At 270days of clinical follow-up, the incidences of major adverse cardiac events (MACE), TLR, and early stent thrombosis (ST) were 18.8, 14.7, and 0.2%, respectively; the TLR rate decreased statistically significantly to 5.3 and 5.9% when implanting the Driver(®) stent (3.5 and 4.0mm) and by IVUS, respectively. Absence rate of diabetes mellitus, presence rate of AMI, presence rate of stent diameters of ≥3.5mm, and presence rate of IVUS-guided PCI showed lower TLR rates, with statistically significant differences. Uni- and multivariate analyses revealed that AMI and stent diameter (≥3.5mm) are significant predictors for TLR (0.048 and 0.047, respectively), indicating that physicians are recommended to consider these variables when selecting candidate real-world patients for IVUS-guided PCI.

Impact of Acute Gain on Clinical Outcomes of Patients Treated With Sirolimus-Eluting Stent - A Sub-Analysis Study From the STLLR Trial -

Geographical miss (GM), representing suboptimal drug-eluting stent deployment, is associated with an increased risk of target lesion revascularization (TLR) and myocardial infarction. The impact of suboptimal stenting techniques on clinical outcomes in diabetics remains unknown. Stent deployment Techniques on cLinicaL outcomes of patients treated with the cypheR(TM) stent (STLLR) is the first multicenter, large trial to prospectively evaluate outcomes associated with sirolimus-eluting stent (SES) deployment techniques. Axial GM and longitudinal GM (LGM), defined as a balloon injured segment or a diseased segment not covered by a SES, were assessed by an independent core laboratory. One-year outcomes between diabetics and non-diabetics and their relationship with GM were assessed. This substudy included 1,336 patients, 28.8% with diabetes. In non-LGM patients, TLR was similarly low in both diabetics and non-diabetics (2.0% vs. 2.0%, P=NS). However, TLR increased 4.1 times in diabetics (8.0%) and 1.9 times in non-diabetics (3.8%) in the presence of LGM (P=0.03). Axial GM had no impact on outcomes. By univariate analysis, stent length, acute gain, and LGM were the predictors of TLR in the total cohort. However, by multivariate analysis, acute gain was the only predictor of TLR (P=0.03), independently of LGM or diabetes. Acute gain is the exclusive predictor of TLR after SES implantation. Particularly in diabetics, the negative impact of LGM on TLR seems to be amplified. Diligent SES deployment for larger acute gain is critical to improve clinical outcomes.

Comparing Two-Stent Strategies for Bifurcation Coronary Lesions: Which Vessel Should be Stented First, the Main Vessel or the Side Branch?

This study compared two-stent strategies for treatment of bifurcation lesions by stenting order, 'main across side first (A-family)' vs 'side branch first (S-family). The study population was patients from 16 centers in Korea who underwent drug eluting stent implantation with two-stent strategy (A-family:109, S-family:140 patients). The endpoints were cardiac death, myocardial infarction (MI), stent thrombosis (ST), and target lesion revascularization (TLR) during 3 years. During 440.8 person-years (median 20.2 months), there was 1 cardiac death, 4 MIs (including 2 STs), and 12 TLRs. Cumulative incidence of cardiac death, MI and ST was lower in A-family (0% in A-family vs 4.9% in S-family, P = 0.045). However, TLR rates were not different between the two groups (7.1% vs 6.2%, P = 0.682). Final kissing inflation (FKI) was a predictor of the hard-endpoint (hazard ratio 0.061; 95% CI 0.007-0.547, P = 0.013), but was not a predictor of TLR. The incidence of hard-endpoint of S-family with FKI was comparable to A-family, whereas S-family without FKI showed the poorest prognosis (1.1% vs 15.9%, retrospectively; P = 0.011). In conclusion, 'A-family' seems preferable to 'S-family' if both approaches are feasible. When two-stent strategy is used, every effort should be made to perform FKI, especially in 'S-family'.

Predicting Restenosis of Drug-Eluting Stents Placed in Real-World Clinical Practice

Background— Prediction of restenosis after percutaneous coronary intervention (PCI) remains challenging, and existing risk assessment algorithms were developed before the widespread adoption of drug-eluting stents (DES). Methods and Results— We used data from the EVENT registry to develop a risk model for predicting target lesion revascularization (TLR) in 8829 unselected patients undergoing DES implantation between 2004 and 2007. Using a split-sample validation technique, predictors of TLR at 1 year were identified from two thirds of the subjects (derivation cohort) using multiple logistic regression. Integer point values were created for each predictor, and the summed risk score (range, 0 to 10) was applied to the remaining sample (validation cohort). At 1 year, TLR occurred in 4.2% of patients, and after excluding stent thrombosis and early mechanical complications, the incidence of late TLR (more likely representing restenosis-related TLR) was 3.6%. Predictors of TLR were age &lt;60, prior PCI, unprotected left main PCI, saphenous vein graft PCI, minimum stent diameter ≤2.5 mm, and total stent length ≥40 mm. Comparison of observed versus predicted rates of TLR according to risk score demonstrated good model fit in the validation set. There was more than a 3-fold difference in TLR rates between the lowest risk category (score=0; TLR rate, 2.2%) and the highest risk category (score ≥5; TLR rate, 7.5%). Conclusions— The overall incidence of TLR remains low among unselected patients receiving DES in routine clinical practice. A simple risk model incorporating 6 readily available clinical and angiographic variables helps identify individuals at extremely low (&lt;2%) and modestly increased (&gt;7%) risk of TLR after DES implantation.

Incidência e preditores de revascularização da lesão-alvo no seguimento clínico de longo prazo: análise crítica do Registro DESIRE

INTRODUÇÃO: Reportamos a incidência e preditores de nova revascularização da lesão-alvo (RLA) numa coorte de pacientes do mundo real tratados com stents farmacológicos (SF) MÉTODO: Entre maio de 2002 e fevereiro de 2010, 3.320 pacientes de único centro foram submetidos a intervenção percutânea (ICP), eletiva ou de urgência, com implante de 5.320 SF (Cypher, 83%; Taxus, 9%; Xience V/Promus, 3%; Endeavor, 4%; BioMatrix, 1%). O seguimento clínico de até oito anos (mediana, 3,4 anos) foi completo em 98% do grupo e 129 pacientes (3,88%) foram submetidos a RLA RESULTADOS: Entre os pacientes com RLA, 33% tinham diabetes, 10% eram portadores de insuficiência renal e 61%, de doença em múltiplos vasos. A artéria descendente anterior foi o vaso mais frequentemente tratado (33%), e 72,3% das lesões eram de alta complexidade (tipo B2/C). Nesse grupo, foram implantados 214 SF em 191 lesões e 45% dos pacientes receberam múltiplos stents. Na análise univariada, os preditores de RLA foram: diabetes melito [razão de risco (RR) 1,88, intervalo de confiança (IC) de 95% 1,08-3,27; P = 0,025), uso do stent Taxus (RR 1,73, IC 95% 1,20-2,50; P = 0,003), lesão ostial (RR 1,82, IC 95% 1,1-2,98; P = 0,018), ponte de safena (RR 2,36; IC 95% 1,55-3,50; p = 0,0001), e lesões reestenóticas (RR 1,95, IC 95% 1,17-3,24; P = 0,009). Após análise multivariada, permaneceram como preditores independentes: diabetes melito, uso do stent Taxus e tratamento de lesões em pontes de safena (RR 1,64, IC 95% 1,14-2,35; P = 0,008) CONCLUSÃO: No registro DESIRE, a RLA em pacientes complexos tratados com SF foi baixa, e o diabetes melito, o tratamento de lesões em ponte de safena e o uso de SF Taxus foram os únicos preditores de RLA no acompanhamento clínico de até oito anos.

In‐Hospital and 12‐Month Postprocedural Clinical Outcome of Coronary Bifurcational Lesion Treatment with the Endeavor Stent

The zotarolimus-eluting stent (ZES) has been documented as significantly reducing restenosis and target lesion revascularization (TLR) requirement compared to bare metal stents (BMS). In this single-centered, prospective study we sought to evaluate the short- and medium-term outcomes of ZES placement in bifurcated coronary artery lesions. Between August 2006 and December 2007, 107 consecutive patients (110 bifurcations) were recruited to have ZES placement in the lesion. The provisional T stenting (PTS) technique was used in 96.3%. Angiographic success was 100% in main vessel (MV) cases and 97.2% in that of side branch (SB). With a mean follow-up of 12.4 +/- 1.77 (mean +/- SD) months there were four deaths, three from cardiac cause (2.85%). There were 18 patients (19 bifurcations) requiring TLR (17.59%) for clinical reasons. The only predictor of TLR was the use diameter of ZES <or=3 mm. ZES can be used for bifurcation lesions using the PTS technique with a high rate of intraprocedural success; however, frequency of TLR is high, especially for stents with a diameter <or=3 mm.

Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy

Lesion length remains a predictor of target lesion revascularisation and results of long lesion stenting remain poor. Sirolimus-eluting stents have been shown to perform better than paclitaxel eluting stents in long lesions. In this substudy of the LEADERS trial, we compared the performance of biolimus biodegradable polymer (BES) and sirolimus permanent polymer stents (SES) in long lesions. A total of 1,707 'all-comer' patients were randomly allocated to treatment with BES and SES. A stratified analysis of angiographic and clinical outcomes at nine months and one year, respectively was performed for vessels with lesion length <20 mm versus >20 mm (as measured by quantitative angiography).Of 1,707 patients, 592 BES patients with 831 lesions and 619 SES patients with 876 lesions had only short lesions treated. One hundred and fifty-three BES patients with 166 lesions and 151 SES patients with 162 lesions had long lesions. There were no significant differences in baseline clinical characteristics, except for higher number of patients with long lesions presenting with acute myocardial infarction in both stent groups. Long lesions tended to have lower MLD and greater percent diameter stenosis at baseline than short lesions. Late loss was greater for long lesions than short lesions. There was no statistically significant difference in late loss between BES and SES stents (0.32+/-0.69 vs 0.24+/-0.57, p=0.59). Binary in-segment restenosis was present in 23.2% versus 13.1% of long lesions treated with BES and SES, respectively (p=0.042). In patients with long lesions, the overall MACE rate was similar for BES and SES (17% vs 14.6%; p=0.62). There was a trend towards higher overall TLR rate with BES (12.4 % vs 6.0%; HR=2.06; p=0.07) and clinically driven TLR (10.5% vs 5.3%: HR 1.94; p=0.13). Rates of definite stent thrombosis were 3.3% in the long lesion group and 1.3-1.7 % in the short lesion group. BES and SES appear similar with respect to MACE in long lesions in this "all-comer" patient population. However, long lesions tended to have a higher rate of binary in-segment restenosis and TLR following BES than SES treatment.

Evaluation of a Strategy for Treating Bifurcated Lesions by Single or Double Stenting Based on the Medina Classification

The Medina bifurcated lesion classification has been widely adopted because of its simplicity. However, no data are available on its use in helping select the best stenting technique for bifurcations. Consecutive patients with bifurcated lesions (side branch >or=2.25 mm) were prospectively assessed using the Medina classification. The treatment strategy studied involved implanting two stents in lesions with a Medina classification of 1,1,1 (M3 group) and one stent in only the main vessel in lesions with other Medina classifications (OM group). Clinical endpoints were a major adverse cardiac event (MACE) and target lesion revascularization (TLR) during hospitalization and at 12-month follow-up. The study included 120 patients: 25 in the M3 group and 95 in the OM group. There was no difference in baseline characteristics between the groups. The treatment strategy was successfully implemented in 97% of the OM group and 68% of the M3 group (P< .001). No death or TLR was recorded during hospitalization, though three myocardial infarctions occurred postoperatively (2.1% in the OM group vs 4.0% in the M3 group; P=.6). At 12 months, there was no difference in clinical outcome between the two groups (MACE: 12.6% in the OM group vs 8% in the M3 group; P=.4; TLR: 13.7% in the OM group vs 8% in the M3 group; P=.5). Multivariate analysis showed that bare metal stent implantation (only in patients receiving a single stent) was the only independent predictor of TLR. The planned treatment strategy of implanting a single stent in patients with bifurcated lesions not classified as Medina 1,1,1 lesions was associated with a very low rate of second stent implantation. Moreover, bare metal stent use was a predictor of TLR, suggesting that drug-eluting stents should be used routinely to treat bifurcated lesions regardless of their angiographic complexity.

AS-23: Comparison of Subsequent Vascular Response in Diabetic Patients after Coronary Stenting between Sirolimus- and Paclitaxel-Eluting Stents: Optical Coherence Tomography Analysis

Diabetes mellitus (DM) remains a major predictor of target lesion revascularization, even in drug-eluting stent era. The aim of this study was to evaluate the differences of chronic vascular response in patients with DM following coronary stenting between sirolimus-eluting (SES) and paclitaxel-eluting (PES) stents using optical coherence tomography (OCT).

Impact of the Metabolic Syndrome on Angiographic and Clinical Events After Coronary Intervention Using Bare-Metal or Sirolimus-Eluting Stents

Patients with metabolic syndrome (MS) are at increased risk for cardiovascular events. Although the number of patients with MS requiring coronary revascularization is increasing rapidly, the impact of MS on clinical events and restenosis in patients who undergo stent placement is not well defined. Seven hundred thirty-four consecutive patients with 734 de novo coronary lesions (<50 mm lesion length, reference vessel diameter <3.5 mm) were enrolled in this study. Four hundred thirty-seven patients were treated with bare-metal stents, and 297 patients were treated with sirolimus-eluting stents. Patients with bifurcation lesions, left main lesions, and ST-segment-elevation myocardial infarctions were excluded from the study. Patients were categorized into 3 groups: those with (1) diabetes mellitus (DM), (2) MS without DM, and (3) no MS and no DM. MS was defined according to American Heart Association and National Heart, Lung, and Blood Institute criteria (the presence of > or =3 of the following criteria: obesity, hypertension, hypertriglyceridemia, low high-density lipoprotein cholesterol, and increased fasting glucose). Clinical follow-up was performed for > or =1 year (mean 27.5 +/- 18.1 months). One hundred sixty-four patients (22%) had DM, 180 patients (25%) had MS without DM, and 390 patients (53%) had no MS and no DM. Baseline clinical and angiographic parameters were comparable among the 3 groups, including lesion length and reference vessel diameter. In patients treated with bare-metal stents, the rates of major adverse cardiac events (MACEs) at 12 months were 14% in patients without DM or MS, 18% in those with MS but no DM, and 33% in those with DM (p = 0.046). In patients treated with sirolimus-eluting stents, the MACE rates were 3% in patients without DM or MS, 4% in those with MS, and 13% in those with DM (p = 0.034). DM (odds ratio 2.14, 95% confidence interval 1.48 to 3.07, p <0.001) and bare-metal stent (odds ratio 2.51, 95% confidence interval 1.49 to 4.22, p <0.001) implantation were independent predictors of MACEs during follow-up, whereas MS was not predictive. Similarly, MS was not a predictor of target lesion revascularization. In conclusion, patients with MS did not have an increased risk for target lesion revascularization or a greater MACE rate compared with control patients during a 12 month follow-up period after bare-metal or drug-eluting stent placement. In contrast, DM is associated with significantly increased event rates.