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One strategy to improve the effectiveness of intravascular brachytherapy (IVBT) is to study its failures. Previous investigations described mostly discrete, focal recurrences, typically at the proximal or distal edges of the irradiated segment after plain angioplasty or bare metal stents. We reviewed failure patterns of 30 unselected drug-eluting stent (DES) patients who had follow-up angiograms for recurrence within their IVBT-treated vessel.Records of 53 unselected IVBT patients treated between 2016 and 2021 were reviewed. Thirty of the 53 patients had at least one subsequent percutaneous intervention (PCI) for in-stent restenosis (ISR) after IVBT. Angiographic findings of those 30 patients with ISR within their previously irradiated vessel are reported here.Of the 30 patients, 21 (70%) developed recurrent ISR within the irradiated segment. Six of the 21 patients who failed within the irradiated segment also experienced ISR proximal or distal to the irradiated segment. Only 15 patients (50%) failed exclusively within the irradiated segment. In nine patients (30%), restenosis occurred proximally and/or distally to the irradiated segment, but not inside of the irradiated segment itself.We have shown here that 50% of failures after coronary IVBT for DES ISR occur exclusively within the irradiated segment. An additional 20% of patients had failure within and outside of the irradiated segment. These percentages suggest that a higher radiation dose might improve the long-term patency rates, a conclusion that should be tempered by the lack of universal follow-up.

In-stent restenosis (ISR) remains a challenge in the treatment of vertebral artery V1 segment stenosis. The aim of this meta-analysis is to identify the risk factors of ISR.Studies eligible for inclusion criteria were found in PubMed, Embase, and Cochrane Library databases. Data related to risk factors of ISR were extracted from the included studies, and pooled analysis was performed when data of the same factor were available in ≥2 studies. Dichotomous outcomes were analyzed with odds ratios (OR) and continuous outcomes were analyzed with a weighted mean difference (WMD). The Stata 14.0 program was used for the meta-analysis.A total of 11 studies involving 1356 patients were included in our analysis. Pooled analyses showed that younger age (p = 0.01; WMD= -1.958; 95% confidence interval [CI], -3.453 to -0.463) and V1 tortuosity (p = 0.004; OR = 4.145; 95% CI, 1.56-11.012) significantly associated with higher risk of ISR in V1 segment stenting. While bare-metal stents, stent diameter and length, diabetes mellitus, coronary artery disease, and smoking were not found to increase ISR rates.This meta-analysis showed that young age and V1 tortuosity increase the ISR rates after vertebral V1 segment stenting.

In-stent restenosis is a common complication after percutaneous coronary intervention (PCI) for coronary heart disease requiring revascularization. We performed a retrospective analysis to assess the value of inflammatory biomarker albumin to globulin ratio (AGR) in clinical prognosis of PCI. In total, 992 patients with coronary heart disease who underwent the first drug-eluting stent implantation and re-examination angiography in our hospital were enrolled in this study. The AGR was measured. At mean follow-up of 11.2 ± 4 months, the in-stent restenosis (ISR) and revascularization events (including target lesion revascularization, target vessel revascularization, and revascularization of de novo lesions) occurred in 127 and 284 patients, respectively. Compared with the non-ISR or non-event group, AGR was significantly lower in the ISR group and the events group. Beyond that, albumin was significantly lower, whereas urea nitrogen, glucose, and Gensini score, as well as the proportions of a history of diabetes and peripheral vascular diseases were significantly higher in the ISR group and the events group. Age, heart rate, white blood cell, neutrophils, lymphocyte, monocyte, and incidence of ischemic stroke were significantly higher in the events group. Multivariate Cox regression analysis showed that AGR was independently associated with ISR (p = 0.032) and events (p = 0.024). Besides, Kaplan-Meier analysis indicated that the higher quartile of AGR had a lower rate of ISR (p = 0.038) and events (p ≤ 0.001). Finally, the receiver operating characteristic curve for AGR in diagnosing ISR and events indicated that the area under the curve were 0.56 and 0.57, respectively. Therefore, AGR is one of the most important factors that independently associate with the ISR and revascularization events after PCI.

We evaluated the association between plasma levels of mac-2 binding protein (M2BP) with the risk of in-stent restenosis (ISR) after percutaneous coronary intervention (PCI).Plasma M2BP levels were compared between 258 patients who experienced ISR at 12-months post-PCI and 258 patients, matched for age and sex, without angiographic evidence of ISR.The plasma M2BP level was significantly higher in the ISR than in the non-ISR group. On multivariate analysis, adjusted for potential clinical, biochemical, and angiography characteristics, M2BP remained as an independent significant predictor of ISR.M2BP may be an important predictive biomarker of ISR and may be useful in identifying at-risk patients.

Objectives To investigate the outcomes of deferred coronary revascularization in patients with non-significant in-stent restenosis (ISR) by physiological assessment. Background The pathophysiology and natural history of ISR is markedly different from de-novo stenoses. There is a paucity of data on the safety of deferral of revascularization of ISR using physiological assessment. Methods In this single centre study, using a propensity-score matched analysis, we compared the long-term clinical outcomes of patients with ISR and de-novo disease deferred based on intracoronary physiology. Matching was on a 1:2 basis of ISR to de-novo stenosis. The primary end point was major adverse cardiovascular events (MACE) a composite of all-cause mortality, target lesion revascularization or target vessel myocardial infarction at 36 months. Results Matched cohorts of 56 ISR and 112 de-novo stenoses were analyzed. The median percentage stenosis was 50% in both groups (p = 0.403). Deferral was based on fractional flow reserve (FFR). The mean FFR was 0.86 across both groups (p = 0.942). At 36-months, freedom from MACE was similar between groups; 86.2% versus 92.8% log rank p=0.180 for ISR and de-novo lesions, respectively. Neither were there differences in the individual components of MACE. Conclusions Deferral of coronary revascularization in patients with ISR based on its functional impact is associated to similar long-term safety as in de-novo coronary stenosis.

This study sought to compare the efficacy and clinical safety of the LONGTY drug-coated balloon (DCB) with those of SeQuent Please DCB in patients with in-stent restenosis (ISR).Although DCB technologies have evolved, little is known about the clinical efficacy of the new-generation LONGTY DCB.This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow-up.A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow-up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow-up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups.In this multicenter, head-to-head, randomized trial, the new-generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.

Background The Cobra PzF coronary stent is cobalt chromium with flat thin struts, nano-coated with Polyzene-F that enhance rapid reendothelialization and reduce the risk of stent thrombosis and restenosis. It is designed to overcome shortfalls of BMS and DES in patients requiring short DAPT duration. Aims To report procedural and 1-year clinical outcomes following Cobra PzF stent implantation in routine practice PCI. Methods e-Cobra registry is a multicenter prospective study to evaluate Cobra PzF stent in routine practice in patients deemed appropriate for short DAPT after PCI. The primary endpoint was MACE rate at 12 months (Cardiac death, MI, TLR). The secondary endpoint was definite stent thrombosis at 12 months. Results Among 940 patients (72% men, 72.8 ± 13.4 years) with multiple co-morbidities, 47% had acute coronary syndromes, and 62% were defined as high bleeding risk. A total of 1,229 lesions were treated with 1,314 stents. 36% of patients had lesion type B2 or C classification. Angiographic success was achieved in all cases. One-year follow-up was available for 97% of patients. The primary endpoint occurred in 9.0% of patients, including cardiac death 3.7%, MI 4.8%, and TLR 4.3%. Definite stent thrombosis occurred in six out of 915 (0.7%). Conclusion The Cobra PzF stent was safe and effective in routine practice patients and seems feasible in situations when short DAPT or Mono Antiplatelet Therapy (MAPT) is needed. One-year follow-up was associated with satisfactory clinical outcomes and validate previously reported data.

Background and purpose Drug-eluting balloons (DEBs) have been proposed as an option for the treatment of in-stent restenosis (ISR) following carotid artery stent placement. We report our experience and review of literature to provide additional data. Methods For literature review, PubMed search was conducted to identify studies published between 2005 and 2019, reporting data on management of carotid ISR with DEBs. Two cases with carotid ISR, which were successfully treated with DEB at our facility, were also included in the final compilation of results RESULTS: A total of seven studies demonstrating the use of the DEBs for treatment of carotid ISR were identified. They encompassed 31 patients, 11 (35.5%) of whom presented with symptomatic ISR, with the remaining 20 patients (64.5%) asymptomatic. DEB angioplasty followed by stent placement was performed in 3 patients, whereas DEB alone was utilized in 28 patients. Periprocedural complications included asymptomatic dissection from DEB inflation in 1 patient and transient neurological deficits in another patient. Follow-up period was variable and ranged from 1 month to 5 years. Three patients were noted to develop recurrent asymptomatic stenosis, whereas 1 patient developed an episode of symptomatic restenosis post procedural on follow-up. In our two cases, both patients were noted to have protracted period of hypotension postprocedure without any new or recurrent neurological symptoms. Conclusion The use of DEBs is a promising development and a viable alternative for management of severe and recurrent carotid ISR.

Background There are limited data on the clinical value of routine postdilatation using noncompliant balloons after contemporary drug‐eluting stent implantation. Hypothesis Additional postdilatation using noncompliant balloons after everolimus‐eluting stent implantation could provide better clinical outcomes. Methods We randomly assigned 1774 patients with coronary artery disease to undergo additional high‐pressure postdilatation using noncompliant balloons and moderate‐pressure dilatation using stent balloons after everolimus‐eluting stent implantation. The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization. Results The study was discontinued early owing to slow enrollment. In total, 810 patients (406 patients in the high pressure group and 404 in the moderate pressure group) were finally enrolled. At 2 years, the primary endpoint occurred in 3.6% of patients in the high pressure group and in 4.4% of those in the moderate pressure group (P = .537). In addition, no significant differences were observed between the two groups in the occurrence of an individual end point of death (0.8% in the high pressure group vs 1.5% in the moderate group, P = .304), MI (0.2% vs 0.5%, P = .554), stent thrombosis (0% vs 0.2%, P = .316), or TVR (2.8% vs 2.6%, P = .880). Conclusions The strategy of routine postdilatation using noncompliant balloons after everolimus‐eluting stent implantation did not provide incremental clinical benefits.

BACKGROUND Whether left atrial (LA) expansion index is associated with coronary restenosis, and exercise capacity (EC) reduction in coronary artery disease has not been established. METHODS This study analyzed 342 consecutive patients who had received a coronary stent implant. A treadmill exercise test (TET) was administered in all participants. The LA expansion indices were measured immediately before and after TET. Maximal EC measured on a breath-by-breath basis by a metabolic cart with gas analyzers and recorded as metabolic equivalent task. All patients with positive TET results received angiography, and those with restenosis received complete revascularization by either percutaneous coronary intervention (PCI) or bypass surgery. The LA expansion index and EC before and 1 month after PCI were then compared. RESULTS Out of 342 patients, 74 had positive TET results, and 54 had restenosis in angiography. Low LA expansion index was associated with poor EC. In patients with LA expansion index > 200%, only 5% had restenosis with 38.5% positive predictive value (PPV) of TET. In patients with LA expansion index

Self-reporting implantable medical devices are the future of cardiovascular healthcare. Cardiovascular complications such as blocked arteries that lead to the majority of heart attacks and strokes are frequently treated with inert metal stents that reopen affected vessels. Stents frequently re-block after deployment due to a wound response called in-stent restenosis (ISR). Herein, an implantable miniaturized sensor and telemetry system are developed that can detect this process, discern the different cell types associated with ISR, distinguish sub plaque components as demonstrated with ex vivo samples, and differentiate blood from blood clot, all on a silicon substrate making it suitable for integration onto a vascular stent. This work shows that microfabricated sensors can provide clinically relevant information in settings closer to physiological conditions than previous work with cultured cells.

Antegrade dissection reentry with Stingray device (Boston Scientific, Marlborough, MA) accounts for 20–34% of the chronic total occlusion (CTO) cases in the various hybrid operators' CTO registries and is an important component of CTO crossing algorithms. The Stingray device can facilitate antegrade dissection and reentry, however its use is low outside North America and Europe. The Asia Pacific CTO Club along with three experience Stingray operators from the US, Europe and India, created an algorithm guiding use of the CrossBoss and Stingray catheter. This APCTO Stingray algorithm defines when to use the CrossBoss and Stingray device recommending a reduction in CrossBoss use except for in‐stent restenosis lesions and immediate transition from knuckle wiring to the Stingray device. When antegrade wiring fails, choice of Stingray‐facilitated reentry versus parallel wiring depends on operator experience, device availability, cost concerns, and anatomical factors. When the antegrade wire enters the subintimal space, we recommend using a rotational microcatheter to produce a channel and deliver the Stingray balloon—so called the “bougie technique.” We recommend early switch to Stingray rather than persisting with single wire redirection or parallel wire. We recommend choosing a suitable reentry zone based on preprocedural computer tomography or angiogram, routine use of stick and swap, routine use of Subintimal TRAnscatheter Withdrawal (STRAW) through the Stingray balloon, and the multi stick and swap technique. We believe these techniques and algorithm can facilitate incorporation of the Stingray balloon into the practice of CTO interventionists globally.

Objectives We sought to evaluate the efficacy of plaque debulking by directional coronary atherectomy (DCA) prior to second-generation drug-eluting stent (DES) implantation for bifurcated coronary lesions. Background Percutaneous coronary intervention (PCI) for bifurcated lesions still remains complex and challenging in terms of restenosis or stent thrombosis regardless of whether simple or complex stenting is used. Methods Patients with bifurcated lesions were enrolled in this prospective multicenter registry. Pre-second-generation DES plaque debulking with a novel DCA catheter (ATHEROCUT®, Nipro Co., Osaka, Japan) was conducted. All patients were scheduled to perform a follow up angiography (9-12 month coronary angiography or coronary computed tomography). The primary end point was target vessel failure (TVF) at follow up. Secondary end points were procedure-related events and major adverse cardiac events at 1 year. Results A total of 77 patients with bifurcated lesions were enrolled. PCI with DCA was performed successfully in all cases without any major procedure-related event and only one case required complex stenting. The TVF rate at 9-12 month follow up was 3.9% (3 of 77) and those were all associated with revascularization of the target vessel. Restenosis was only observed at the ostium of the main-branch in three cases. No death, coronary artery bypass grafting, or myocardial infarction were reported for any patients within the first year. Conclusion DCA before second-generation DES implantation can possibly avoid complex stenting and provide a good mid-term outcome in patients with bifurcated lesions.

In-stent restenosis (ISR) is seriously affecting the long-term prognosis of vascular interventional therapy and leading to enormous medical burdens. Great efforts have been devoted to developing functional vascular stents with desired features and properties for effective ISR prevention. Here, a multifunctional bionic vascular stent with designed coatings prepared using microfluidic electrospinning technology is presented. Such stents are composed of biocompatible, drug-loaded methylacrylated gelatin-polyethylene glycol diacrylate (GelMA-PEGDA) and polycaprolactone composite nanofibers on 316L stainless steel stents by an easy-to-operate step-by-step spraying method. Benefitting from the addition of polydopamine during the fabrications, the drug-loaded composite nanofibers can adhere well to both the stent and the vascular wall. Furthermore, as the inner fibrous layer of the stent contacting the lumen is equipped with heparin-vascular endothelial growth factor (Hep-VEGF), it plays an anticoagulation role and promotes the growth of endothelial cells; while the outer layer contacts the vascular wall and releases rapamycin slowly, which can restrain smooth muscle proliferation. By implanting this into the rabbit carotid artery, the multi-functional bionic demonstrates that the vascular stent can achieve good anti-thrombosis and in-stent restenosis effects, which indicates its potential values in vascular intervention and other biomedical fields.

Background This study aimed to explore the associations of common inflammatory cytokine levels with restenosis and rapid angiographic stenotic progression (RASP) risk in coronary artery disease (CAD) patients underwent percutaneous coronary intervention (PCI) with drug‐eluting stents (DES). Methods Two hundred and ten CAD patients underwent PCI with DES were consecutively recruited, then pre‐operative serum levels of TNF‐α, IL‐1β, IL‐4, IL‐6, IL‐8, IL‐10, IL‐17A, IL‐21, and IL‐23 were determined by ELISA. The 12‐month in‐stent restenosis and RASP of non‐intervened lesion were assessed by quantitative coronary angiography analysis. Results The pre‐operative TNF‐α, IL‐6, IL‐17A, and IL‐23 expressions were increased while IL‐4 expression was decreased in restenosis patients compared with non‐restenosis patients. Further analysis revealed that IL‐6, IL‐8, hypercholesteremia, diabetes mellitus, and HsCRP could independently predict restenosis risk, and subsequent ROC curve revealed that their combination was able to differentiate restenosis patients from non‐restenosis patients with an AUC of 0.951 (95%CI: 0.925‐0.978). Meanwhile, the pre‐operative TNF‐α, IL‐6, IL‐17A, IL‐21, and IL‐23 expressions were increased whereas IL‐4 level was decreased in RASP patients compared with non‐RASP patients. Further analysis revealed that TNF‐α, IL‐6, IL‐23, hypercholesteremia, SUA, HsCRP, and multivessel artery lesions could independently predict RASP risk, and subsequent ROC curve disclosed that their combination could discriminate RASP patients from non‐RASP patients with an AUC of 0.886 (95%CI: 0.841‐0.931). Conclusions This study unveils the potentiality of pre‐operative circulating inflammatory cytokines as markers for predicting restenosis and RASP risk in CAD patients underwent PCI with DES.

OBJECTIVES We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. BACKGROUND Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. METHODS We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. RESULTS Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). CONCLUSIONS In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

Objectives The clinical implications of subintimal stenting (SS) of the recanalized chronic total occlusion (CTO) segment have not been characterized. We evaluated the in-hospital and the long-term clinical and angiographic outcomes of drug-eluting stents (DESs) deployed in true vs. false lumen of successfully recanalized CTO. Methods and results Two independent reviewers analyzed the intravascular ultrasound (IVUS) images of 173 successfully recanalized CTO lesions (157 patients), between August 2011 and October 2012. After successful guidewire (GW) crossing, lesions were classified according to IVUS evaluation into two groups: (1) true lumen (TL) stenting group and (2) SS group; and compared with regards to in-hospital and long-term clinical outcomes. In 154 lesions, DESs were deployed in the TL; and in 19 (11%) lesions, DESs were deployed in the subintimal space (95% confidence interval: 6.3-15.6%). False GW tracking in the SS group resulted in increased rates of IVUS-detected dissection flaps (84% vs. 42.6%, P ≤ 0.001), intramural hematoma (32 vs. 11%, P = 0.01), and minor perforations 6/19 (31.6% vs. 8.4%, P = 0.002). At 1-year follow-up, both groups had similar cumulative rates of binary restenosis and target lesion revascularization (P = 0.73 and P = 0.97, respectively). Six patients (4.6%, 6/129 patients) in the TL group and none in the subintimal group died at 1 year. Conclusions Acknowledging some limitations, our observations may suggest that, subintimal stent deployment in a recanalized CTO segments, using second generation DES and IVUS guidance, might have a comparable success rate and long-term angiographic and clinical outcomes as TL stenting.

OBJECTIVES The objective of this study was to determine the long-term major adverse cardiac events (MACE) in patients treated with intracoronary brachytherapy (ICBT) for coronary in-stent restenosis (ISR). BACKGROUND ICBT was commonly used to treat coronary ISR prior to the availability of drug-eluting stents (DES). The long-term outcomes of ICBT for ISR remain unknown. METHODS Six hundred and eighty consecutive patients who underwent ICBT treated for ISR between September 1998 and April 2005 were included in the study. Clinical and angiographic data were collected and the long-term MACE were measured for all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR) at 10-year follow-up. RESULTS Patients were 63 ± 11 years old (66% male). The majority of patients were treated with a bare metal stent 670/680 (99%) prior to ICBT. Significant baseline clinical findings include high incidence of smokers 479/680 (70%), hyperlipidemia 638/680 (94%), and multivessel disease 526/680 (77%). The majority of target lesions were diffuse 407/680 (60%), and either in the left anterior descending 258/680 (38%) or right coronary artery 215/680 (32%). At 10-year follow-up, the rate of death was 25%, MI was 22.4%, and TVR was 48%. CONCLUSION MACE at 10-year follow-up following ICBT for ISR indicates steady rate of death and MI and declining rate of TVR after 5 years.

Objectives This study aimed to evaluate the outcomes of patients with in-stent restenosis (ISR) who underwent rotablation (RA) followed by balloon angioplasty (BA), drug-eluting stent (DES) implantation, or drug-coated balloon (DCB) angioplasty. Background Interventional treatment of ISR is occasionally challenging. Despite the availability of various percutaneous treatments, the optimal solution remains unclear. Methods and results A total of 200 patients with ISR who underwent RA were retrospectively identified from our institutional database. Clinical outcomes at 12 months and independent predictors of target lesion revascularization (TLR) were assessed. Of patients, 90, 55, and 55 underwent BA, DES implantation, and DCB angioplasty, respectively. The incidence of all-cause death, cardiac death, and hospitalization due to heart failure was low in all groups. Moreover, no definite stent thrombosis was observed in the three groups. The TLR rate of BA, DES implantation, and DCB angioplasty following RA for ISR were 40.7%, 35.0%, and 27.3%, respectively. The adjusted outcomes for TLR using the inverse probability of treatment weighting method based on propensity scores indicated that DCB angioplasty following RA was superior to BA after RA. Intraprocedural complications, which could be successfully managed with interventional treatment, were identified in only three cases. Conclusions TLR at 12 months is dismal. RA is not effective for ISR requiring RA. In unfavorable settings, DCB angioplasty following RA is the most effective treatment option in patients with ISR requiring debulking strategy.

Curcumin, the main ingredient of Curcuma longa L., has been used as a spice and as a herbal medicine with different therapeutic characteristics for centuries in Asian countries. This phytochemical has been shown to possess beneficial antiplatelet activity that has introduced it as a promising candidate for the treatment of thromboembolism, atherothrombosis, and inflammatory diseases. Platelet dysfunction under different circumstances may lead to cardiovascular disease, and curcumin has been shown to have beneficial effects on platelet dysfunction in several studies. Therefore, this narrative review is aimed to summarize available evidence on the antiplatelet activity of curcumin and related molecular mechanisms for this activity.

Background The efficacy of paclitaxel-eluting balloon catheters (PEB) and drug-eluting stents for treatment of bare-metal stent restenosis (BMS-ISR) have been demonstrated in several studies with follow-up times of 9 to 12 months; however, the long-term outcomes of ISR treatment are less defined. Objectives We aimed to compare the long-term efficacy of PEB and everolimus-eluting stents (EES) for the treatment of BMS-ISR. Methods We analyzed 3-year clinical follow-up data from patients included in the TIS randomized clinical study. A total of 136 patients with BMS-ISR were allocated to receive treatment with either PEB or EES (68 patients with 74 ISR lesions per group). Results The PEB and EES groups did not significantly differ in major adverse cardiac events-free survival (MACE; P = .211; including individual events: CV death: P = .622; myocardial infarction: P = .650 or target vessel revascularization: P = .286) at 3-year clinical follow-up. No event-free survival differences were found between the groups regarding overall mortality (P = .818), definite stent thrombosis (P = .165) or the second MACE (P = .270). Conclusions At the 3-year follow-up, no significant differences in clinical outcomes were found between iopromide-coated PEB and EES for the treatment of BMS-ISR. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825).

Aims: Long-term comparisons between Drug-eluting stent and bare metal stent are not well-studied. The aim of this study was to compare two stents that were previously frequently used in regard to long-term risk of restenosis and stent thrombosis (ST). Methods and results: We used data from the SCAAR registry. Consecutive procedures performed between 2004 and 2014 for stable angina, UA/NSTEMI and STEMI were included. We compared two different stents: Cordis Cypher Select (C-CS), and Boston Scientific Liberte (BS-L), modeling data with multilevel Cox proportional-hazards regression. The primary endpoint was time to first occurrence of either ST or restenosis. During the study period 2210 C-CS and 6941 B-SL were implanted in 5,314 patients. Mean follow-up time was 2,288 days for C-CS and 2,297 days for BS-L. Treatment with C-CS was associated with lower risk for restenosis or ST up to one year from index procedure (HR 0.41; 95% CI 0.32-0.52; P

OBJECTIVES: To perform detailed analysis of stent expansion, vessel wall stress, hemodynamics, re-endothelialization, restenosis, and repeat PCI in the simultaneous kissing stents (SKS) technique of bifurcation left main stem (LMS) stenting. BACKGROUND: The SKS technique is useful to treat patients with true bifurcation disease of the LMS but remains controversial. METHODS AND RESULTS: Computational structural analysis of SKS expansion demonstrated undistorted and evenly expanded stents. Computational fluid dynamics modelling revealed largely undisturbed blood flow. 239 PCI procedures were performed on 217 patients with unprotected bifurcation LMS disease with SKS using DES (2004-2017). We electively studied 13 stable patients from baseline to 10 years post-SKS with repeat angiography and optical coherence tomography, and demonstrated tissue coverage of the stent struts at the carina, with no evidence of lacunae behind the stents. We studied all patients with symptomatic recurrence. Target lesion revascularization rate was 3.2% at 1 year and 4.6% at 2 years. Of all 20 patients with restenosis, the site was the LMS-Cx stent in 7, the LMS-LAD stent in 2 and both in 11. Two-year recurrence rate was 7/32 (5.3%) for first, and 4/108 (3.7%) for second generation DES. Treatment with repeat kissing techniques was undertaken in 19/20, with sustained clinical results with re-SKS. CONCLUSION: The SKS technique for treating unprotected LMS bifurcation disease does not distort the stents, is associated with favorable hemodynamics, tissue coverage of the exposed struts, and a low restenosis rate when performed with contemporary stents. Re-PCI with repeat SKS appears feasible, safe, and durable.

Objectives The objective of this study was to assess the 12-month clinical outcomes in patients with drug-eluting stent in-stent restenosis (DES-ISR) who were either pre-dilated with non-compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty. Methods This monocentric, retrospective study included patients with DES-ISR who were routinely treated over a 2-year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES-ISR lesion were analyzed. The primary endpoint was the clinically driven target-lesion revascularization (TLR) rate at 12 months. Secondary endpoints included post-interventional lumen gain and late lumen loss (LLL) at 6 months. Results The 12-month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs 0.40 ± 0.46 mm, P = 0.468). Conclusions Scoring Balloon Angioplasty can safely and effectively prepare DES-ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

OBJECTIVES To investigate the impact of stent deformity induced by final kissing balloon technique (KBT) for coronary bifurcation lesions on in-stent restenosis (ISR). BACKGROUND In experimental models, the detrimental effects of KBT have been clearly demonstrated, but few data exists regarding the impact of proximal stent deformity induced by KBT on clinical outcomes. METHODS We examined 370 coronary lesions where intravascular ultrasound (IVUS)-guided second-generation drug-eluting stent (DES) implantation for coronary bifurcation lesions was performed. Based on IVUS analysis, the stent symmetry index (minimum/maximum stent diameter) and stent overstretch index (the mean of stent diameter/the mean of reference diameter) were calculated in the proximal main vessel. RESULTS The stent symmetry index was significantly lower (0.75 ± 0.07 vs 0.88 ± 0.06, P

Objectives We aimed to test a novel stent-less revascularization strategy using a combination of excimer laser coronary angioplasty (ELCA) and drug-coated balloon (DCB) for patients with acute coronary syndrome (ACS). Background Percutaneous coronary intervention with drug eluting stents is a standard invasive treatment for ACS. Some unsolved issues however remain, such as stent thrombosis and bleeding risks associated with dual antiplatelet therapy. Methods Consecutive ACS patients were planned to receive either a DCB application following ELCA without a stent implantation or conventional revascularization with a coronary stent. The endpoints were (i) major cardiac adverse events (MACEs), defined as the composite of cardiac death, myocardial infarctions, and target lesion revascularization; (ii) target vessel revascularization (TVR); and (iii) angiographic outcome. Results Since a greater than expected number of patients allocated to the stent-less treatment arm eventually received a bailout stenting, the following 3 as-treated groups were compared; DCB with ELCA group (N = 60), Stent with ELCA group (N = 23), and Stent without ELCA group (N = 85). During a mean follow-up period of 420 ± 137 days, and with angiographic 6- and 12-month-follow-up rates of 96.7%, 87%, and 81.2%, and 50%, 65.2%, and 45.9%, respectively, the MACE rate did not differ across the groups (10%, 4.3%, and 3.5%; P = 0.22) while an incidence of TVR was more common (15%, 0, and 4.7%; P = 0.02) and the diameter stenosis at 6-months of follow-up was greater (25.7 ± 18.2, 14.9 ± 13.1 and 16.2 ± 15.4%; P = 0.002) in the DCB with ELCA group. Conclusions The stent-less revascularization strategy with DCB and ELCA was associated with a higher occurrence of restenosis in ACS patients.

Objectives We aimed to compare the long-term outcomes of the novel biodegradable polymer cobalt-chromium sirolimus-eluting stent (BP-SES) versus the durable polymer sirolimus-eluting stent (DP-SES) in the I-LOVE-IT2 trial. Backgrounds Comparisons of the long-term safety and efficiency of the BP-DES versus the DP-DES are limited. Methods A total of 2,737 patients eligible for coronary stenting were randomized to the BP-SES or DP-SES group at a 2:1 ratio. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization. Results A three-year clinical follow-up period was available for 2,663 (97.3%) patients. There were no significant differences in TLF (8.9% vs. 8.6%, P = 0.81), patient-oriented composite endpoint (PoCE) (15.2% vs.14.5%, P = 0.63), or individual components between the BP-SES and DP-SES. Definite/probable stent thrombosis (ST) was low and similar at 3 years (0.8% vs. 1.0%, P = 0.64). Landmark analysis of 1-3 years showed that the TLF (2.7% vs. 2.6%, P = 0.81), PoCE (6.2% vs. 5.1%, P = 0.28), and definite/probable ST (0.4% vs. 0.4%, P = 1.00) were comparable between the 2 arms. Conclusions In this prospective randomized trial, the BP-SES showed similar clinical results versus the DP-SES in terms of safety and efficacy outcomes over a 3-year follow-up period.

Objectives To investigate the efficacy of drug-coated balloon (DCB) for calcified coronary lesions. Background Calcified coronary lesions is associated with poor clinical outcomes after revascularization. Recently, DCB is emerging as an alternative strategy for de novo coronary lesions. However, reports describing the efficacy of DCB for calcified coronary lesions are limited. Methods A total of 81 patients (96 lesions) who electively underwent DCB treatment for de novo coronary lesions were enrolled: 46 patients (55 lesions) in the calcified group and 35 patients (41 lesions) in the non-calcified group. Angiographic follow-up data and clinical outcomes after the procedure were evaluated. Results The diameter of the DCB used was 2.5 ± 0.5 mm. No bail-out stenting was observed after DCB treatment. Rotational atherectomy was used in 82% of lesions in the calcified group. Follow-up angiography (median, 6.5 months after intervention) was performed for 59 patients (30 in the calcified group and 29 in the non-calcified group). Late lumen loss and rates of restenosis were comparable between the groups (0.03 mm in the calcified group vs -0.18 mm in the non-calcified group, P = 0.093 and 13.9% vs 3.03%, P = 0.095, respectively). The survival rates for target lesion revascularization free survival and major adverse cardiac events at 2 years were comparable between the groups (85.3% vs 93.4%, P = 0.64 and 81.4% vs 88.5%, P = 0.57, respectively). Conclusion Calcified coronary lesions might dilute the effect of DCB. However, clinical outcomes in the calcified group were similar to those in the non-calcified group.

Purpose The benefit of drug-eluting stents (DES) versus drug-coated balloons (DCB) in coronary artery in-stent restenosis (ISR) for the prevention of target lesion revascularization (TLR), stent thrombosis, and mortality remains uncertain. Our aim was to synthesize the available evidence from randomized clinical trials (RCTs) and observational studies that directly compare second-generation drug-eluting stents (SG-DES) and DCB for the treatment of coronary ISR. Methods Medline, Embase, and Cochrane Central were searched for RCTs or observational studies, published up to March 15, 2017. A random effects model meta-analysis investigating clinical and angiographic outcomes was conducted for RCTs and observational studies that compared SG-DES versus DCB for the treatment of ISR. Results Ten studies and 2,173 patients were included in this meta-analysis. The two treatment strategies were proven equal with regards to TLR, myocardial infarction, stent thrombosis, and cardiac mortality in both randomized and observational studies. No difference was found among RCTs for all-cause mortality, while in observational studies, patients who were treated with SG-DES had a lower mortality compared to DCB (OR: 0.47; 95% CI: 0.27–0.83). In the pooled analysis also (RCTs and observational studies), SG-DES were associated with lower all-cause mortality compared to DCB. Patients treated with SG-DES were also superior in terms of minimal lumen diameter (standardized mean difference: 0.39; 95% CI: 0.12–0.66). Conclusions The two treatment strategies are equal for the treatment of ISR, while the difference in all-cause mortality might be potentially explained by baseline differences in the two groups among real-world studies.

Background Prior reports have suggested that the design of the Promus Element stent is prone to longitudinal stent deformation (LSD). However, little is known about the clinical and angiographic outcomes of Promus Element stent axial deformations when implanted in unrestricted coronary lesions. Method and results Two independent reviewers retrospectively evaluated the procedure steps of 961 Promus Element stent (833 de novo lesions in 494 consecutive patients) implanted in unrestricted coronary lesions, between February 2012 and March 2013, and compared the prevalence, predictors, and the mid-term clinical and angiographic outcomes between lesions with and without stent deformation. Fifteen stents (1.56%) with LSD were observed (95% confidence interval [CI]: 0.78-2.34%). The proximal edge of the stent was deformed in 13 stents (86.6%). Ostial stenting (Adjusted Odds ratio [OR]: 9; 95%CI: 2.27-33.3; P = 0.002), and bifurcation lesions (Adjusted OR: 3; 95%CI: 1.03-8.8; P = 0.04) were independently associated with the occurrence of stent deformation. LSD led to unplanned stenting in (53%, 8 of 15) of the deformed stents, which consumed larger contrast volume and longer fluoroscopy time. At 8-month follow-up, there was no significant difference in binary restenosis rate and target lesions revascularization between both groups (P = 0.98, and P = 0.56, respectively), while death occurred in six patients of the non-LSD group (1.36%, 6 of 440) and none in the LSD group. All patients of the LSD group had no major adverse clinical events at 8-month follow-up. Conclusions Axial stent deformation in Promus Element platform is an infrequent event, occurs following manipulation of the interventional tools. Other than unplanned stenting, the LSD was not associated with any adverse clinical events at 8-month follow-up.

Objectives This study aimed at assessing the performance of a new generation polymer-free biolimus-eluting stent (BES) in real-world patients with ST-segment elevation myocardial infarction (STEMI). Background Polymers components of early-generation drug-eluting stents have been implicated in the pathogenesis of delayed arterial healing, vessel remodeling, and delayed stent thrombosis. Recently, a novel polymer-free BES has shown excellent clinical performance in clinical trial setting. Methods Overall, 175 consecutive patients (64 ± 14 years, 141 men) treated with the BioFreedom (Biosensors Europe, Morges, Switzerland) polymer-free BES because of STEMI were included in this study. The primary endpoint was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction, and ischemia-driven target vessel revascularization at 1 year follow-up. A subgroup of patients underwent 6-month angiographic follow-up. Dual antiplatelet therapy was prescribed for 12 months after STEMI. Results At 1 year, the cumulative rate of MACE was 4.6%. One patient (0.6%) had an arrhythmic cardiac death and five (2.9%) had ischemia-driven target vessel revascularization, although only three (1.7%) had target lesion revascularization. Two (1.1%) patients had acute stent thrombosis yielding nonfatal myocardial infarction. In 70 patients (63 ± 14 years, 61 men), quantitative coronary angiography at 6-month follow-up revealed diameter stenosis of 24.1 ± 13.7% and minimal lumen diameter of 2.29 ± 0.56 mm, yielding a late lumen loss of 0.13 ± 0.14 mm. Conclusions In real-world setting, implantation of a new-generation polymer-free BES during STEMI is associated with favorable clinical and angiographic results, pointing toward the overall efficacy and safety of the device in complex clinical scenarios.

BACKGROUND Differences in stent platform, polymer coatings, and antirestenotic drugs among the current in use second-generation drug-eluting stents (G2-DESs) may induce significant variations in neointimal response and vascular healing, which may impact the prevalence of neoatherosclerosis (NA) and morphological appearance of the restenotic tissue. METHODS AND RESULTS Utilizing Optical frequency domain imaging, two independent reviewers, retrospectively compared the prevalence of neoatherosclerosis (NA), and the morphological differences, and tissue characteristics of 50 G2-DESs in-stent restenosis (ISR) lesions (35 everolimus-eluting stent [22 cobalt-chromium (CoCr), 13 platinum-chromium (PtCr)], and 15 biolimus-eluting stent [BES]) implanted liberally in unrestricted coronary lesions. More than half of the stents were implanted in type C lesions, while 40% of the stents were implanted primarily in lesions with recanalized chronic total occlusion. NA, defined as a neointima formation with the presence of lipids or calcification, was observed in fewer than half (24/50) of all ISR lesions with no significant in-between group differences (41%, 69%, and 40% in CoCr, PtCr, and BES respectively, P = 0.22), nor were there any significant differences in the morphological appearance or tissue characteristics between all G2-DESs subtypes. CONCLUSIONS Acknowledging some limitations, our results may suggest that the prevalence of NA and the morphological appearance of restenotic lesions might not differ when G2-DESs are implanted in unrestricted, rather complex, coronary lesions.

Objectives This study evaluated the progression of very late in-stent restenosis (VL-ISR) by analyzing four serial coronary angiography (CAG) images and its correlation with neointimal tissue characterization of the VL-ISR lesions on optical coherence tomography (OCT). Background Recently, VL-ISR is occasionally observed beyond a few years after drug-eluting stents (DESs) implantation. Methods This study analyzed 50 VL-ISR lesions after DES in which 4 serial CAGs over a period of 2 years, including at baseline procedure, 9 months after baseline procedure, 12 months before VL-ISR, and at the time of VL-ISR, were performed. Neointimal tissue characteristics by OCT were categorized as homogeneous, heterogeneous with invisible strut (Type I), heterogeneous with visible strut (Type II), speckled (Type III), or heterogeneous with sharply delineated border (Type IV). Results From the development process, 23 VL-ISRs (46%) were categorized as rapid progression and 27 (54%) as gradual progression. The five categories of neointimal tissue composition significantly differed between lesions with rapid and gradual progression. Homogeneous neointima and Type IV heterogeneous neointima were observed only in lesions with gradual progression. Moreover, most Type I heterogeneous neointima was identified in lesions with gradual progression. Instead, main neointimal tissue components of lesions with rapid progression were Type II (43%) and Type III (43%) heterogeneous neointima. Conclusion The progression rate of in-stent atherosclerotic changes is gradual, whereas organized thrombus could be associated with an increased risk of rapid neointimal growth. The two types of stenosis progression provide a new insight into the mechanism of VL-ISR development after DES implantation.

Objectives The aim of this study was to evaluate the very long‐term clinical outcome after radioactive stent (RS) implantation and intracoronary β radiation brachytherapy (IRBT). Background Radioactive stents (RS) and intracoronary β radiation brachytherapy (IRBT) were introduced to prevent restenosis after percutaneous coronary intervention (PCI). Both techniques were associated with a higher incidence of major adverse cardiac events (MACE) in the short and intermediate‐term follow up as compared to conventional PCI. Methods One hundred and thirty‐three patients received radioactive stents (32P) and 301 patients were treated with IRBT adjunctive to PCI. These groups were propensity matched to respectively 266 and 602 control patients who were treated with routine PCI during the same inclusion period. Endpoints were all‐cause mortality and MACE, defined as all‐cause death, any myocardial infarction or any revascularization. Results Median follow‐up duration was 17 years. All‐cause mortality rates were similar in all groups. Adjusted hazard ratios for MACE and mortality in the RS cohort were 1.55 (95% CI 1.20–2.00) and 0.92 (95% CI 0.63–1.34), respectively. Adjusted hazard ratios for MACE and all‐cause mortality in the IRBT cohort were 1.41 (95% CI 1.18–1.67) and 0.95 (95% CI 0.74–1.21), respectively. The difference in MACE rates was predominantly driven by coronary revascularizations in both groups, with a higher MI rate in the IRBT group as well. Conclusions Coronary radiation therapy was associated with early increased MACE rates, but the difference in MACE rates decreased beyond 2 years, resulting in a comparable long‐term clinical outcome. Importantly, no excess in mortality was observed.

Objectives The aim of this study was to evaluate the long-term clinical safety and efficacy of drug-coated balloon (DCB) in the treatment of in-stent restenosis (ISR). Background There is a long-term safety issue in peripheral arterial disease patients treated with paclitaxel-coated balloon, this has also raised concerns on DCB in coronary intervention. Methods Nine randomized controlled trials (RCTs) and nine observational studies (OSs) were included with a total of 3,782 patients (1,827 in the DCB group, 1,955 in the drug-eluting stent [DES] group) being analyzed. The primary outcome measure-major adverse cardiovascular events (MACEs), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), cardiac death (CD), stent thrombosis (ST), all-cause death (AD), and coronary angiography outcomes included late lumen loss (LLL), minimum luminal diameter (MLD), diameter stenosis (DS) were analyzed. Results DCB treatment significantly reduced the LLL (MD: -0.13; [CI -0.23 to -0.03], p = .01). No difference was found for MLD (MD: -0.1; [CI -0.24 to 0.04], p = .17) and DS% (RR = 0.98 [CI 0.80-1.20], p = .86). There was no significant difference in TLR, TVR, MI, CD, ST, AD, and the overall incidence of MACEs between the two groups up to 3 years follow-up. Subgroup analysis for different type of ISR and DES showed no significant difference in the incidence of endpoints, and there is no difference when considering RCTs or OSs only. Conclusions The safety and efficacy of the DCB and DES in the treatment of ISR is comparable at up to 3 years follow-up.

Background Percutaneous coronary intervention (PCI) with bare-metal and first-generation drug-eluting stents (DES) for cardiac allograft vasculopathy (CAV) is associated with unexpectedly high restenosis rates and target lesion revascularization (TLR). Long-term outcomes of stenting for CAV using second-generation everolimus-eluting stents (EES) are not established. Objective To evaluate clinical and angiographic outcomes of CAV stenting with EES. Methods Patients who underwent PCI with EES for CAV were studied. Surveillance angiography was performed at 6–12 months post-PCI and as indicated. Patient survival, freedom from MACE, binary restenosis, TLR, target vessel revascularization (TVR), and non-TVR are reported. Results One-hundred and thirty two EES were placed in 113 discrete lesions in 48 patients. Pre-PCI stenosis was 82.1 ± 12.4%, and average stent length and diameter were 16.9 ± 5.7 and 3.0 ± 0.6 mm, respectively. Mean follow-up was 30.7 ± 18.8 months. Time from transplantation to PCI was 9.9 ± 5.1 years. Post-PCI survival at 1 (93.5 ± 3.6%), 2 (91.0 ± 4.3%), and 3 years (83.8 ± 6.3%), and freedom from MACE (87.2 ± 4.9%, 82.3 ± 5.7%, 75.8 ± 6.9%) were high. Binary restenosis at 1 (3.0 ± 1.7%), 2 (6.9 ± 3.2%), and 3 years (10.0 ± 4.3%) mirrored expected rates with EES use in native CAD. One-, two-, and three-year rates of TLR (5.1 ± 2.5%, 14.3 ± 4.6%, and 21.2 ± 6.3%), TVR (17.1 ± 4.5%, 39.0 ± 6.9%, and 46.2 ± 7.8%), and NTVR (26.3 ± 5.4%, 55.4 ± 7.0%, and 58.0 ± 7.0%) remain high. Diabetes was associated with an increased hazard ratio for binary restenosis 6.084 (95% CI 1.271–29.133, P = 0.024). Conclusions PCI strategy using EES in the treatment of CAV was associated with a low binary restenosis rate, a high survival rate, and a high rate of freedom from MACE. However, at 3 years, TLR and TVR rates appeared similar to rates observed with first-generation DES. © 2016 Wiley Periodicals, Inc.

In order to keep the interventional community up-to-date with the overwhelming amount of new data, we have selected where we believe to be the most important publications in percutaneous coronary intervention from January 1, 2015 to mid-November 2015. We hope that this will serve as an important overview of 2015, and ongoing reference for future years.

Summary Aims To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. Methods This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. Results After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority

Aim In primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI), stenting has proved to reduce the need for repeat revascularization compared with balloon angioplasty alone. The incidence of cardiac death or recurrent myocardial infarction, though, is not reduced by stenting. This is in part attributable to stent-related complications like stent thrombosis which may occur even years after implantation. A strategy of drug coated balloon (DCB) angioplasty without stenting would abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty. Our aim is to evaluate the efficacy and safety of a DCB only strategy versus drug-eluting stents (DES) in PPCI for STEMI. Study design The REVELATION trial is a prospective, single center, randomized study, in which 120 patients presenting with STEMI will be allocated to treatment with a DCB versus DES. Appertaining to the established prognostic value of fractional flow reserve (FFR) rather than angiographic lesion severity, the functional assessment of the infarct-related lesion by FFR at 9 months after initial treatment is the primary end point. Assuming an FFR value of 0.90 after stenting and an increased risk of adverse events if post-PCI FFR

Lipoprotein(a) (Lp(a)) is known to be associated with cardiovascular complications and atherothrombotic properties in general populations. However, it has not been examined whether Lp(a) levels are able to predict adverse cardiovascular outcomes in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). A total of 595 consecutive patients with angina pectoris who underwent elective PCI with DES were enrolled from 2004 to 2010. The patients were divided into two groups according to the levels of Lp(a): Lp(a)50 mg/dL (n = 485 patients), and Lp(a) ≥ 50 mg/dL (n = 111 patients). The 6-9-month angiographic outcomes and 3-year cumulative major clinical outcomes were compared between the two groups. Binary restenosis occurred in 26 of 133 lesions (19.8%) in the high Lp(a) group and 43 of 550 lesions (7.9%) in the low Lp(a) group (P = 0.001). In multivariate analysis, the reference vessel diameter, low density lipoprotein cholesterol, total lesion length, and Lp(a) ≥ 50 mg/dL were predictors of binary restenosis. In the Cox proportional hazards regression analysis, Lp(a)50 mg/dL was significantly associated with the 3-year adverse clinical outcomes including any myocardial infarction, revascularization (target lesion revascularization (TLR) and target vessel revascularization (TVR)), TLR-major adverse cardiac events (MACEs), TVR-MACE, and All-MACEs. In our study, high Lp(a) level ≥ 50 mg/dL in angina pectoris patients undergoing elective PCI with DES was significantly associated with binary restenosis and 3-year adverse clinical outcomes in an Asian population.

Background The TAXUS Element (ION) platinum chromium paclitaxel-eluting stent (PtCr-PES) incorporates a thin (81 μm) strut design with a similar polymer and drug dose density as prior PES. The pivotal PERSEUS trial program consisted of two studies: PERSEUS Workhorse (WH) and PERSEUS Small Vessel (SV). The PERSEUS WH trial demonstrated the PtCr-PES to be non-inferior to the predicate TAXUS Express PES (TE-PES) for target lesion failure (TLF) at 1 year and in-segment angiographic percent diameter stenosis at 9 months. The PERSEUS SV trial demonstrated the PtCr-PES to be superior to a historical bare metal stent (BMS) for angiographic late lumen loss at 9 months. Long-term (5-year) clinical outcomes following PtCr-PES have not been previously reported. Methods PERSEUS WH was a prospective, Bayesian, 3:1 randomized (PtCr-PES vs. TE-PES) trial in patients with lesion length ≤28 mm and vessel diameter ≥2.75 to ≤4.0 mm. PERSEUS SV was a prospective, single-arm trial in patients with lesion length ≤20 mm and vessel diameter ≥2.25 to

Summary The association of the miRNA-146a polymorphism rs2910164 with atherosclerosis and restenosis was investigated. We found no association with atherosclerosis; however, we found a negative association for the G/C (P = 0.007) and a positive association for the C/C genotype with the risk of restenosis, which is the main drawback for cardiac surgery.

Background In-stent restenosis (ISR) remains one of the main limitations for percutaneous coronary intervention of unprotected distal left main (UDLM). This study aims to demonstrate the impact of main-branch ISR (MB-ISR) on mortality and to clarify the optimal strategy. Methods Between 2002 and 2008, 482 consecutive UDLM patients treated with drug eluting stent (sirolimus and paclitaxel) were evaluated. Results During follow-up period (median 52.6 months), MB-ISR occurred in 29, SB-ISR in 65, and MB/SB-ISR in 24. Multivariable analysis demonstrated that the independent predictors of MB-ISR were calcification (HR 2.284, p = 0.016), true-bifurcation (HR 2.331, p = 0.024), insulin-dependent diabetes mellitus (insulin-DM) (HR 2.259, p = 0.048). Furthermore, final proximal postdilatation (FPPD) (HR 0.548, p = 0.077), full LM cover approach (FCA) (HR 0.605, p = 0.093) and greater MLD (HR 0.611, p = 0.062) had a tendency to reduce MB-ISR. Furthermore, the occurrence of MB-ISR within 1-year was associated with cardiac-death (HR 2.734, p = 0.017). Conclusions The patients with MB-ISR had more comorbidities and complex lesions, resulting in higher risk of cardiac mortality as compared to the patients without MB-ISR. Presence of calcification, true-bifurcation and insulin-DM were associated with MB-ISR following UDLM intervention, while FCA, FPPD, and greater MLD seemed to be associated with the low occurrence of MB-ISR. © 2013 Wiley Periodicals, Inc.

There are few histologic studies of intracoronary stents found at autopsy. We studied histologic findings of 87 intracoronary stents from 45 autopsy hearts. There were 40 patients with chronically implanted stents and five shorter than 30 days. Of five patients with recent stent placement, the cause of death was related to the stent (in-stent thrombosis) in one case. Of the 40 patients with chronic stents, there were 16 sudden coronary deaths and 24 noncoronary deaths (controls). There were no late stent thromboses in the coronary deaths. In the coronary deaths, 26% of stents showed restenosis versus 11% in controls (p = 0.1). The rate of healed infarcts and cardiomegaly was similar in the coronary and noncoronary groups, and acute thrombi in native arteries were seen only in three hearts in the coronary group. We conclude that the cause of death is rarely impacted by in-stent findings at autopsy, especially in chronically implanted stents.