Late Target Lesion Revascularization Research Articles

Impact of statin therapy on late target lesion revascularization after everolimus-eluting stent implantation according to pre-interventional vessel remodeling and vessel size of treated lesion

Clinical evidence demonstrating the impact of statins for preventing late target lesion revascularization (TLR) after newer-generation drug-eluting stent implantation and differences in the effect of statins on late TLR according to pre-interventional vessel remodeling and vessel size is limited. We retrospectively evaluated 1193 de novo lesions in 720 patients who underwent everolimus-eluting stent implantation using intravascular ultrasound from January 2010 to December 2012. The primary endpoint was late TLR. Lesions were divided into the statin group (n = 825) and non-statin group (n = 368). The incidence of late TLR was significantly lower in the statin than non-statin group (1.7% vs. 5.2%, respectively; p = 0.001), and within the statin group, it was significantly lower in the follow-up low-density lipoprotein cholesterol (LDL-C) < 100 than ≥ 100 mg/dL level subgroup (1.0% vs. 3.6%, respectively; p = 0.006). Furthermore, in positive remodeling lesions and non-small vessel size lesions, the incidence of late TLR was significantly lower in the statin than non-statin group (1.6% vs. 8.5% and 1.3% vs. 5.3%, respectively; p = 0.001 and p = 0.004). Lowering the LDL-C level using statins was more effective for preventing late TLR after everolimus-eluting stent implantation. Evaluating pre-interventional vessel remodeling patterns and vessel size might be helpful to stratify lesions at high risk of late TLR.

＜Editors' Choice＞ Very long-term clinical outcomes after percutaneous coronary intervention for complex vs non-complex lesions: 10-year outcomes following sirolimus-eluting stent implantation.

ABSTRACTFew studies have reported the long-term outcomes (>10 years) following first-generation drug-eluting stent implantation. In this single-center retrospective study, we investigated the very long-term clinical outcomes after first-generation sirolimus-eluting stent (SES) implantation in patients with complex lesions. The study included 383 consecutive patients who underwent initial SES implantation between July 2004 and January 2006; 84 and 299 of these patients reported a history of percutaneous coronary intervention (PCI) for complex and noncomplex lesions, respectively. Complex PCI was defined as having at least one of the following features: left main trunk PCI, implantation of ≥3 stents, bifurcation lesions with implantation of 2 stents, total stent length >60 mm, or chronic total occlusion. The target lesion revascularization (TLR) rate was significantly higher in the complex PCI than in the noncomplex PCI group (29.4% vs 13.0%, P=0.001), and we observed a significant intergroup difference in the late TLR (>1 year) rates (21.6% vs 9.5%, P=0.008). Late TLR continued over 10 years at a rate of 2.4%/year in the complex PCI and 1.1%/year in the noncomplex PCI group. Cox regression analysis revealed that complex PCI was related to TLR both over 10 years (hazard ratio 2.29, P=0.003) and beyond 1 year (hazard ratio 2.32, P=0.01). Cardiac death was more common in the complex PCI than in the noncomplex PCI group, particularly 4 years after PCI (15.8% vs 7.5%, P=0.031). Sudden death was the major cause of cardiac death beyond 4 years in the complex PCI group. These data indicate that long-term careful follow-up is essential for patients implanted with SES, especially those treated for complex lesions.

Long-term (beyond 5 years) clinical impact of Xience everolimus-eluting stent implantation.

ObjectsWe aim at examining the long‐term clinical outcome after Xience everolimus‐eluting stent (X‐EES) implantation.BackgroundLong‐term clinical outcomes beyond 5 years after X‐EES implantation remain unclear.MethodsThis retrospective study has collected data from 1184 consecutive patients, corresponding to 1463 lesions, who were treated with X‐EES alone in the Nagoya Heart Center between January 2010 and December 2013. The primary endpoint was the 10‐year cumulative incidence of target lesion failure (TLF), defined as cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Definite/probable stent thrombosis (ST) was evaluated as a secondary outcome.ResultsAt 10 years, the cumulative incidence of TLF was recorded to be 12.4%, whereas that of cardiac death, target vessel MI, and clinically indicated TLR was at 4.4%, 4.1%, and 7.8%, respectively. The cumulative rate of definite/probable ST was observed to remain low (0.3% at 30 days; 0.3% at 1 year; 0.6% at 5 years; and 1.1% at 10 years). In the multivariate analysis, the risk factors of TLF were insulin‐treated diabetes (hazard ratio (HR), 1.93; 95% confidence interval (CI), 1.13‐3.29; P = .02), left ventricular dysfunction (HR, 2.28; 95% CI, 1.43‐3.62; P < .01), hemodialysis (HR, 2.22; 95% CI, 1.39‐3.56; P < .01), prior percutaneous coronary intervention (HR, 1.68; 95% CI, 1.18‐2.41; P < .01), peripheral vascular disease (HR, 1.70; 95% CI, 1.07‐2.69; P < .01), severe calcification (HR, 2.08; 95% CI, 1.36‐3.09; P < .01), and in‐stent restenosis (HR, 2.93; 95% CI, 1.64‐4.89; P < .01).ConclusionsThe incidence rates of the long‐term adverse effects after X‐EES implantation, such as late TLR and ST, were determined to be low in this study; however, they increased over time until 10 years after stent implantation.

Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes - A Single-Center Observational Study.

Background: Few studies have investigated the importance of glycemic control in patients with diabetes mellitus (DM) for reducing the incidence of late target lesion revascularization (TLR) after implantation of new-generation drug-eluting stents (DES).Methods and Results: We retrospectively identified 1,568 patients who underwent new-generation DES implantation. Patients were divided into 3 groups based on diabetic status and glycemic control 1 year after the procedure: those without DM (non-DM group; n=1,058) and those with DM at follow-up with either good (HbA1c <7%; n=328) or poor (HbA1c ≥7%; n=182) control. The cumulative 5-year incidence of clinically driven late TLR after the index procedure was significantly higher in DM with poor control at follow-up than in those with good control at follow-up or non-DM (14%, 4.8%, and 2.9%, respectively; P<0.0001). Multivariate analysis revealed that poor control at follow-up was significantly associated with a higher risk of clinically driven late TLR compared with the non-DM group (hazard ratio [HR] 4.58, 95% confidence interval [CI] 2.50–8.16, P<0.0001). However, good control at follow-up group was not associated with a higher risk of clinically driven late TLR compared with the non-DM group (HR 1.35, 95% CI 0.68–2.56, P=0.38).Conclusions: DM patients with poor glycemic control at follow-up had a significantly higher risk of clinically driven late TLR than non-DM patients.

P2693Late catch-up phenomenon and late-term target lesion revascularization of two-stenting for coronary bifurcation lesions between first and second generation drug-eluting stents

Abstract Background The second generation drug-eluting stent (G2-DES) has been reported as superior to the first generation drug-eluting stent (G1-DES) in mid-term outcomes. However, the late-term outcomes between G1-DES and G2-DES in two-stenting for coronary bifurcation lesions are not well studied. Purpose To evaluate the late catch-up phenomenon and late-term target lesion revascularization (TLR) of two-stenting for coronary bifurcation lesions between G1-DES and G2-DES. Methods This study included 1133 lesions in 1089 patients undergoing drug eluting stent implantation with two stenting from 2004 to 2016. These consisted of 496 G1-DES implanted lesions and 637 G2-DES implanted lesions. Late-term follow-up angiography was performed without in-stent restenosis (ISR) and TLR at mid-term follow-up in 582 lesions (242 G1-DES lesions and 340 G2-DES lesions). ISR was defined as more than 50% restenosis. Late catch-up phenomenon was defined as ISR without ISR within 1 year following index stent implantation. Late-term TLR was defined as from 1 to 5 year TLR. Bifurcation lesions were defined as the main branch ranging from the proximal stem to the distal main branch with boundaries defined by 5 mm proximal and distal to the stent-implanted area, and the side branch ranging from the bifurcation carina to the distal side branch with boundaries defined by the carina and 5 mm distal to the stent-implanted area. Results The median follow-up duration was 5.1 years (the first and third quarters, 3.2 and 7.1 years). The late-catch up phenomenon rate significantly differed between the G1-DES and G2-DES groups (16.9% vs 8.4%, p=0.001). A significant difference in late catch-up between the same two groups was also observed in bifurcation lesions of the main branch (5.0% vs 0.6%, p=0.001) and side branch (10.3% vs 5.6%, p=0.033), respectively. The 5-year cumulative rates also differed between the two groups in TLR (8.2% vs 3.7% log-rank p=0.001), and late-term TLR (7.0% vs 3.6% log-rank p=0.001). Conclusion Two-stenting using G2-DES, compared with G1-DES, significantly reduced late-term restenosis and TLR. The restenosis rate in bifurcation area may be associated with differences between two groups in late-term outcome.

The Predictors of Target Lesion Revascularization and Rate of In-Stent Restenosis in the Second-Generation Drug-Eluting Stent Era.

Objectives The aim of our study was to investigate the predictors of target lesion revascularization (TLR) and to compare the in-stent restenosis (ISR) progression rates of different 2nd-generation drug-eluting stents (DES). Background The predictors of early and late TLR after 2nd-generation DES implantation have not been fully evaluated. Methods We analyzed 944 stented lesions from 394 patients who had at least two serial follow-up angiograms, using quantitative coronary angiography (QCA) analysis. The study endpoints were TLR and the velocity of diameter stenosis (DS) progression. Results TLR occurred in 58 lesions (6.1%) during the first angiographic follow-up period and 23 de novo lesions (2.4%) during the following second interval. Independent predictors for early TLR were diabetes mellitus (DM) (HR 2.58, 95% CI 1.29–5.15, p=0.007), previous percutaneous coronary intervention (PCI) (HR 2.41, 95% CI 1.03–5.65, p=0.043), and postprocedure DS% (HR 1.08, 95% CI 1.05–1.11, p<0.001, per 1%), while predictors of late TLR were previous PCI (HR 9.43, 95% CI 2.58-34.52, p=0.001) and serum C-reactive protein (CRP) (HR 1.60, 95% CI 1.28-2.00, p<0.001). The ISR progression velocity (by DS%) was 12.1 ±21.0%/year and 3.7 ±10.1%/year during the first and second follow-up periods, respectively, which had no significant difference (p>0.05) between the four types of DESs. Conclusions Our data showed that predictors for TLR may be different at different time intervals. DM, pervious PCI, and postprocedure DS could predict early TLR, while previous PCI and CRP level could predict late TLR. Contemporary DESs had similar rates of ISR progression rates. Trial Registration This study was retrospectively registered and approved by the institutional review board of Seoul National University Hospital (no. 1801–138-918).

CLINICAL OUTCOMES OF NEWER-GENERATION VERSUS SECOND-GENERATION DRUG-ELUTING STENT IMPLANTATION IN PATIENTS WITH CORONARY ARTERY DISEASE: RETROSPECTIVE ANALYSIS OF REAL-WORLD DATA

Late adverse events such as very late stent thrombosis (ST) and late target lesion revascularization are still concern issues. Newer-generation drug-eluting stent (DES) is expected to reduce these events. The aim of this study was to investigate clinical outcomes in patients after newer-generation

TCT-240 Long-Term (5 to 7 Years) Clinical Outcomes After Cobalt-Chromium Everolimus-Eluting Stent Implantation

The cobalt-chromium everolimus-eluting stent (CoCr-EES) is the second-generation DES demonstrating the improved safety and efficacy as compared with first-generation drug-eluting stents. Late adverse events such as very late stent thrombosis (VLST) or late target lesion revascularization (TLR) after

P6118Impact of progressive luminal narrowing in the chronic phase on various types of very late target lesion revascularization after sirolimus-eluting stent implantation

P6118Impact of progressive luminal narrowing in the chronic phase on various types of very late target lesion revascularization after sirolimus-eluting stent implantation

Difference in clinical presentations and related angiographic findings among early, late, and very late sirolimus-eluting stent failures requiring target lesion revascularization

BackgroundsThe difference in clinical presentations (acute coronary syndrome [ACS] and stable coronary artery disease [SCAD]) and related angiographic morphologies of sirolimus-eluting stent (SES) failure requiring target lesion revascularization (TLR) during early-term (<1year), late-term (1–5years), and very late-term periods (>5years) remains unknown. MethodsAmong 4484 lesions undergoing SES implantation, clinically-driven TLR was performed on 105 lesions during early-term, 169 lesions during late-term, and 147 lesions during very late-term period. Angiographic morphological patterns were divided into focal or non-focal patterns and stent-edge or stent-body patterns. ResultsThe proportion of ACS substantially increased in very late TLR lesions (57.1%) from early (40.0%, p=0.01) and late TLR lesions (36.7%, p<0.001). The proportions of both stent-edge and non-focal patterns were higher in very late TLR lesions than in early and late TLR lesions. Although the stent-edge pattern tended to be more prevalent in SCAD lesions than in ACS lesions during the early- and late-term periods, it was more frequently observed in ACS lesions than in SCAD lesions during the very late-term period (65.5% vs. 47.6%, p=0.04). The non-focal pattern was more frequent in ACS lesions than in SCAD lesions during all 3 periods. However, the proportion of the non-focal pattern in ACS lesions was extremely high during the very late-term (90.5%) compared with the early- (47.6%, p<0.001) and late-term periods (48.4%, p<0.001). ConclusionsStent-related ACS became more common beyond 5years after SES implantation. Stent-edge and non-focal patterns were the main angiographic morphologies of very late SES failure, particularly causing ACS.

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.

TCT-492 Serial Angiographic Changes in Lesions with and without Very Late Target Lesion Revascularization after Sirolimus-Eluting Stent Implantation

TCT-492 Serial Angiographic Changes in Lesions with and without Very Late Target Lesion Revascularization after Sirolimus-Eluting Stent Implantation

Ten-year clinical outcomes after sirolimus-eluting stent implantation: Impact of an in-stent restenosis target lesion

Little is known about the long-term outcomes after first-generation sirolimus-eluting stent (SES) implantation. We aimed to investigate the clinical outcomes up to 10 years after SES implantation. The study population comprised 342 patients (504 lesions) who underwent SES implantation between January 2002 and December 2004. The median duration of follow-up was 3816 days (interquartile range [Q1-Q3], 3,705-3,883 days). The cumulative event rate of definite stent thrombosis was 3.9%. The cumulative rate of target lesion revascularization (TLR) at 1, 5, and 10 years was 8.7%, 18.8%, and 31.1%, respectively, and the annual rate of TLR was 3.1%. Clinically driven TLR occurred at relatively constant rate during 10 years (2.0% per year). In a multivariate analysis, higher body mass index, hemodialysis, in-stent restenosis (ISR) target lesion, and total stent length >30 mm were independent risk factors of TLR within 5 years. An independent risk factor of TLR beyond 5 years was ISR target lesion. Late TLR after SES implantation is a long-term hazard, lasting up to 10 years. The ISR target lesion is a risk factor of TLR during 10 years.

Mechanism of in-stent restenosis after second-generation drug-eluting stents (DES): is it different from bare-metal stents and first-generation DES?

First-generation drug-eluting stents (DES) have dramatically reduced the rate of in-stent restenosis (ISR) and subsequent target lesion revascularization (TLR) compared with bare-metal stents (BMS) (1). However, widespread use of first-generation DES has drawn attention to several unresolved, clinically relevant issues such as late stent thrombosis (ST) and late restenosis (2). Histopathological studies of first-generation DES have revealed that a chronic reaction to components of the permanent polymer reaction may lead to the delayed arterial healing, which is associated with increased risks of late DES failure (3,4). In addition, neoatherosclerosis is suggested as another cause of very late ST and late TLR (5). To overcome these limitations, biocompatible and biodegradable polymers have been developed and equipped with second-generation DES. Recent clinical trials demonstrated that second-generation DES has the improved efficacy and safety compared with those of first-generation DES (6,7). Nevertheless, second-generation DES, as well as first-generation DES, are not immune to ISR. In fact, Cassese et al. reported a large cohort of patients with angiographic surveillance that ISR rate of second-generation DES remains higher than 10% (8). Therefore, it is important to elucidate the mechanism of ISR after second-generation DES compared with that of BMS and first-generation DES, which may play a crucial role in the newly developed DES.

Abstract 12822: Continuous Smoking Promotes Neoatherosclerosis Formation in Stent Restenotic Neointimal Tissue After Drug-Eluting Stent Implantation

Introduction: Despite the advance of drug-eluting stents (DES), late adverse events such as very late stent thrombosis (VLST) and late target lesion revascularization are of concern. Although continuous smoking is an independent risk factor of VLST, the pathogenic impact on in-stent restenotic neointimal tissue components after DES implantation remains unclear. Hypothesis: We assessed the hypothesis that continuous smoking after DES implantation might promote neoatherosclerosis formation in restenosis lesions. Methods: We enrolled 47 consecutive patients with in-stent restenosis requiring revascularization after DES implantation between January 2008 and March 2015. In advance, we excluded the patients with recurrent restenosis, thrombotic lesions, and total occlusion. For evaluation of in-stent tissue components, integrated backscatter intravascular ultrasound (IB-IVUS) was performed. Patients were divided into current smokers and nonsmokers including both previous smokers and never-smokers. Results: Of these patients, 12 (25.5%) were current smokers. On volumetric IB-IVUS analyses, current smokers had a significantly higher percentage of lipid tissue volume within the neointima and a significantly lower percentage of fibrous tissue volume than nonsmokers (42.9 ± 19.4 vs. 26.3 ± 12.8%; p = 0.03, and 55.1 ± 19.2 vs. 70.9 ± 11.9%; p = 0.04, respectively). Moreover, continuous smoking was positively correlated with the percentage of lipid volume on multiple linear regression analysis after adjustment for confounding factors (β = 0.35, p = 0.03). Interval from stent implantation was similar between current smokers and nonsmokers (44.6 ± 38.2 vs. 37.5 ± 29.1 months; p = 0.58). Conclusions: Continuous smoking was associated with larger lipid tissue volume within the neointima after DES placement, suggesting the development of neoatherosclerosis and vulnerable neointima. Thus continuous smoking might lead to future adverse coronary events.

Abstract 13724: Intravascular Ultrasound and Angiographic Predictors for 5-Year Target Lesion Revascularization After Second Generation Drug-Eluting Stent Implantation

Background: Late target lesion revascularization (TLR) remains an unresolved problem in drug-eluting stents (DES). This study aimed to evaluate whether angiography and IVUS at mid-term can predict late-TLR in lesions treated with 2nd generation DES. Methods: Clinical outcomes were followed for 5 years in 1265 lesions with no TLR within the 1st year after Endeavor zotarolimus- (E-ZES, n=748), Resolute zotarolimus- (R-ZES, n=195), and everolimus-eluting stent (EES, n=322) implantation. Quantitative coronary angiography (QCA) and IVUS were performed at baseline and mid-term (8-12 months) follow-up. Results: During 1 to 5 years, R-ZES and EES showed equivalent late-TLR rates, while E-ZES demonstrated significantly less late-TLR than other stents (4.6%, 4.3% and 1.5%, respectively. Log Rank p=0.002). In E-ZES, no QCA or IVUS variables predicted late-TLR. In contrast, the late-TLR group in R-ZES and EES had smaller minimum lumen diameter (MLD), greater neointima and more late-acquired incomplete stent apposition (LISA) at mid-term follow-up, as well as greater increases of vessel and peri-stent plaque volumes during the follow-up. Multiple logistic regression analysis determined follow-up MLD, LISA and the increase of peri-stent plaque at mid-term as independent predictors of late-TLR in R-ZES and EES. In particular, with ROC-determined cutoff values, lesions with ≥2 predictors had a relative risk of 14.4 for late-TLR. Conclusion: The incidence and determinants of late-TLR can vary depending on the drug, carrier and release kinetics. Despite a trend for more TLR within the 1st year, E-ZES with phosphorylcholine coating was associated with an extremely low incidence of late-TLR and stable vessel response surrounding the stent. R-ZES and EES with durable polymer and longer release kinetics showed similar rates of late-TLR, possibly related to pathological responses of the stented artery that may be detectable by IVUS within the 1st year after implantation.

Abstract 18600: Very Long-term Clinical Outcome After Sirolimus-eluting Stent Implantation

Background: Late adverse events such as stent thrombosis (ST) or late target-lesion revascularization (TLR) after sirolimus-eluting stents (SES) implantation remain an important concern. However, there is little data regarding clinical outcome beyond 5 years after SES implantation. We sought to assess very long-term clinical outcome after SES implantation. Methods: Between April 2004 and December 2006, a total of 686 patients with 894 lesions underwent percutaneous coronary intervention only with SES. We assessed the major adverse cardiac events (MACE), defined as a composite of cardiac death, TLR, definite ST. Results: At 10 years, cumulative incidence of MACE and cardiac death were 50.8% and 8.2%, respectively. Cumulative incidence of TLR within 1 year was 12.6%. However, late TLR beyond 1 year continued to occur without attenuation up to 10 years (2.3%/year) (5 years, 22.8%; 10 years, 33.3%). Cumulative incidence of definite ST was low (30 days, 0.3%; 1 year, 0.9%; 5 years, 1.8%; and 10 years, 3.3%), whereas definite ST also continued to occur without attenuation (0.27%/year). The predictors of MACE were hemodialysis (hazard ratio [HR] 2.87, 95% confidence intervals [CI]:1.76-4.53, p &lt;0.001) and age ≥75 years (HR 1.72, 95% CI: 1.31-2.26, p &lt;0.001). Conclusions: Late catch-up phenomenon regarding ST and TLR continued up to 10 years without attenuation. Careful clinical follow-up is required in patients treated with SES beyond 5 years.

Incidence and Characteristics of Late Catch‐Up Phenomenon Between Sirolimus‐Eluting Stent and Everolimus‐Eluting Stent: A Propensity Matched Study

We evaluated and compared the incidence and characteristics of late catch-up phenomenon (LCU) between everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) implantations. Late catch-up phenomenon after everolimus-eluting stent (EES) implantation has not yet been evaluated sufficiently. Between April 2007 and May 2011, 1,234 patients with coronary artery disease were treated with SES and 502 patients with EES. Following propensity score matching, we evaluated 495 SES-treated patients and 495 ESS-treated patients. The incidences of LCU (i.e., late target lesion revascularization [TLR] [1-3 years]) were compared. The cumulative incidence of TLR at 3 years was 11.9% in the SES group and 6.1% in the EES group (P = 0.001). The incidence of late TLR was 7.5% in the SES group and 3.4% in the EES group (P = 0.004). Even though not statistically significant, intravascular ultrasound showed a higher tendency of stent fracture (SF) in late restenosis lesions in the SES group than in the EES group (37.0% vs 7.7%; P = 0.052). Moreover, the SF rate tended to increase in late restenosis compared with early restenosis (within 1 year) in the SES group compared with the EES group (SES: 37.0% vs 22.2%; P = 0.293, EES: 7.7% vs 10.0%; P = 0.846), although the increase was not significantly different. EES was superior to SES in terms of LCU. SF may be associated with LCU after SES implantation.

Meta-Analysis of Drug-Eluting Balloon Angioplasty and Drug-Eluting Stent Placement for Infrainguinal Peripheral Arterial Disease

PurposeTo perform a meta-analysis of randomized controlled trials (RCTs) of drug-eluting balloon (DEB) angioplasty and drug-eluting stents (DESs) for infrainguinal peripheral arterial disease. Materials and MethodsSystematic searches were performed for all relevant RCTs. ResultsEight RCTs for DEB angioplasty and 12 RCTs for a DES in peripheral arterial disease were identified. Meta-analysis demonstrated statistically significant superiority of DEB over plain balloon angioplasty of femoral-popliteal disease for late lumen loss, restenosis, and target lesion revascularization, with no benefit in major amputation or mortality. Statistically significant superiority of DEB over percutaneous transluminal angioplasty (PTA) was demonstrated for infrapopliteal disease for restenosis and target lesion revascularization. Drug-eluting stents showed statistically significant superiority over bare metal stents (BMSs) of femoral-popliteal disease for late lumen loss and restenosis, with no benefit in mortality or amputation. Drug-eluting stents showed statistically significant superiority over BMSs of infrapopliteal disease restenosis and target lesion revascularization, with no benefit in amputation or mortality. ConclusionsDrug-eluting balloon angioplasty and DESs demonstrated superior outcomes compared to PTA and BMS, with no difference in amputation or mortality.

Bioresorbable scaffolds for percutaneous coronary interventions.

Innovations in drug-eluting stents (DES) have substantially reduced rates of in-segment restenosis and early stent thrombosis, improving clinical outcomes following percutaneous coronary interventions (PCI). However a fixed metallic implant in a vessel wall with restored patency and residual disease remains a precipitating factor for sustained local inflammation, in-stent neo-atherosclerosis and impaired vasomotor function increasing the risk for late complications attributed to late or very late stent thrombosis and late target lesion revascularization (TLR) (late catch-up).The quest for optimal coronary stenting continues by further innovations in stent design and by using biocompatible materials other than cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding, local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics have been recently developed. These devices have been utilized in selected clinical applications so far providing preliminary evidence of safety showing comparable performance with current generation drug-eluting stents (DES).Herein we provide a comprehensive overview of the current status of these technologies, we elaborate on the potential benefits of transient coronary scaffolds over permanent stents in the context of vascular reparation therapy, and we further focus on the evolving challenges these devices have to overcome to compete with current generation DES. Condensed :: The quest for optimizing percutaneous coronary interventions continues by iterative innovations in device materials beyond cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding; local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics were recently developed. These devices have been utilized in selected clinical applications providing preliminary evidence of safety showing comparable intermediate term clinical outcomes with current generation drug-eluting stents.