Target Lesion Myocardial Infarction Research Articles

Value of Combined Optical Coherence Tomography and Optical Flow Ratio Measurements After Percutaneous Coronary Intervention

BackgroundOptical flow ratio (OFR) is a novel computational fractional flow reserve derived from optical coherence tomography (OCT). However, the impact of combining post-stenting morphology (OCT) and physiology (OFR) remains largely unknown. MethodsOCT and OFR were analysed at an independent core laboratory. Target lesion failure (TLF) was defined as the composite of cardiac death, target lesion myocardial infarction, and target lesion revascularisation. Suboptimal stent deployment was identified with at least 1 TLF-related OCT or OFR characteristic. ResultsA total of 448 patients with acute coronary syndrome (459 vessels) were assessed. Stent expansion < 80%, minimal stent area < 4.5 mm2, stent edge lipid-rich plaque and OFR < 0.90 were independent predictors of TLF (all P < 0.001). Patients with OCT-suboptimal (adjusted hazard ratio [aHR] 7.88, 95% CI 2.73-22.72,-P < 0.001) or OFR-suboptimal (aHR 5.78, 95% CI 2.54-13.14; P < 0.001) stent deployment showed significantly higher risk of TLF compared with those with optimal stent deployment, with a significant interaction (Pinteraction < 0.001). OCT and OFR both–suboptimal stent deployment was confirmed as an independent predictor of TLF (aHR 9.39, 95% CI 4.25-20.76; P < 0.001). ConclusionsCombined OCT and OFR conferred an optimal reclassification of stent deployment, which may aid in decision making regarding a tailored PCI strategy for optimal stent deployment.

Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial.

Diabetes mellitus is associated with higher risk of target lesion failure (TLF) after percutaneous coronary intervention. We studied the 5-year outcome in patients with diabetes mellitus treated with biodegradable polymer stents. The SORT OUT VII was a randomised trial comparing the ultrathin sirolimus-eluting Orsiro stent (O-SES) and the biolimus-eluting Nobori stent (N-BES) in an all-comer setting. Patients (n = 2525) were randomised to receive O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). Endpoints were TLF (a composite of cardiac death, target-lesion myocardial infarction (MI), target lesion revascularization (TLR)), definite stent thrombosis and a patient related outcome (all-cause mortality, MI and revascularization) within 5years. Patients with diabetes mellitus had higher TLF (20.6% vs 11.0%, (Rate ratio (RR) 1.85 95% confidence interval (CI): (1.42-2.40) and patient related outcome (42.0% vs 31.0%, RR 1.43 95% CI: (1.19-1.71)) compared to patients without diabetes. Among patients with diabetes mellitus, TLF after 5 years did not differ between O-SES and N-BES (21.2% vs 20.0%), RR 1.05 95% CI: (0.70-1.58), p = 0.81). Cardiac death, MI, TLR, and definite stent thrombosis did not differ between the groups. In patients with diabetes mellitus, 5-year outcomes were similar among patients treated with biodegradable polymer O-SES or N-BES. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01879358.

OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

BackgroundImaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.MethodsWe conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.ResultsWe assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P=0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.ConclusionsAmong patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.)

Clinical implication of ticagrelor monotherapy in patients with small vessel coronary artery disease: results from the TICO randomized trial.

The aim of this study was to evaluate the efficacy and safety of ticagrelor monotherapy in patients with small vessel disease compared with ticagrelor-based DAPT within the Ticagrelor Monotherapy after 3 Months in the Patients Treated with New Generation Sirolimus Eluting Stent for Acute Coronary Syndrome (TICO) trial population. Reference vessel diameter ≤2.5 mm was considered as small vessel disease. We conducted a comparison of the incidence of target lesion failure (TLF) and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. TLF was defined as a composite of cardiac death, target lesion myocardial infarction, stent thrombosis, and target lesion revascularization. 652 patients among 3,056 TICO population (21.3%) had small vessel disease. Patients with small vessel disease showed a higher rate of TLF compared to those without small vessel disease (2.9% vs. 1.0%, log-rank p < 0.001). The presence of small vessel disease emerged as an independent predictor for 1-year TLF (HR 2.84, 95% CI 1.54-5.25), while it did not show a significant association with bleeding complications. The 12-month TLF rate was 1.6% for ticagrelor monotherapy after 3-month DAPT, and 4.2% for ticagrelor-based 12-month DAPT (p = 0.059) in patients with small vessel disease (HR 0.38, 95% CI 0.14-1.04, p for interaction = 0.261). The incidence of BARC type 3 or 5 bleeding rate 2.5% for ticagrelor monotherapy after 3-month DAPT, and 5.6% for ticagrelor-based 12-month DAPT (p = 0.052) in patients with small vessel disease (HR 0.44, 95% CI 0.19-1.01, p for interaction = 0.322). In the 3-month landmark analysis, ticagrelor monotherapy significantly reduced BARC type 3 or 5 bleeding in patients with small vessel disease (HR 0.09, 95% CI 0.01-0.69, log-rank p = 0.005) while demonstrating a similar incidence of TLF compared to ticagrelor based 12-month DAPT during the 3-12 months period. There are no significant interactions between the antiplatelet strategy regarding the 12-month incidence of ischemic and bleeding complications. Ticagrelor monotherapy demonstrated a reduction in bleeding complications after a 3-month period of DAPT without increasing the rate of TLF, when compared to ticagrelor-based 12-month DAPT, specifically in patients with small vessel disease. Clinical Trial Registration: www.ClinicalTrials.gov, identifier, NCT02494895.

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions.

Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. URL: https://www. gov; Unique identifier: NCT02996318, NCT03242096.

P79 FIRST GENERATION BIORESORBABLE VASCULAR SCAFFOLD VS NEXT GENERATION BIORESORBABLE VASCULAR SCAFFOLD: SINGLE CENTER, LONG–TERM FOLLOW UP EXPERIENCE

Abstract Background Previous randomized controlled trials demonstrated a higher rate of stent thrombosis with first generation (Absorb; Abbott Vascular, USA) bioresorbable vascular scaffold (BVS) implantation as compared with second–generation drug–eluting stent. Currently, with limited indications, others next generation BVS (NGB) are available (Magmaris; Biotronik AG, Switzerland and DESolve; Elixir Medical Corporation, USA). Real world long–term outcomes of such devices are limited. Methods and Results In our center from 27/09/2012 to 28/08/2018 in a cohort of 277 patients, a total of 259 BVS and 191 NGB (120 Magmaris and 71 DESolve) devices were implanted. The primary efficacy endpoint was a combined end point of target–lesion revascularization (TLR) and target lesion myocardial infarction (TLMI) the primary safety endpoint was scaffold thrombosis (ScT). At a median follow–up, of 83 months (interquartile range–IQR, 61–91 months) for BVS, and 48 months (IQR, 41–53.5 months) and 64.5 months (IQR, 58.5–69 months) for Magmaris and DESolve respectively, TLR/TLMI occurred in 17 patients (10.5%) in the BVS group and 4 patients (3.5%) in the NGB group (p value= 0.03), ScT occurred in 5 patient (3.1%) and 1 patient (0.9%), p–value=0.23, respectively. Median time of ScT occurrence in the BVS group was 12.5 months (IQR 9.75–16.75), ScT in the NGB group occurred after patient’s suspension of dual antiplatelet therapy 3 months later from the implantation date. Conclusion In a single center real world setting, the use of NGB appear safer compared to BVS at long–term follow–up.

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

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

Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon

The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents. Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4μg/mm2) with a PCB (SeQuent Please, B. Braun Melsungen; 3μg/mm2). The primary endpoint was angiographic late lumen loss (LLL) at 6months. Secondary endpoints included major adverse cardiovascular events and individual clinical endpoints such as cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6months, in-segment LLL was 0.01 ± 0.33mm in the PCB group versus 0.10 ± 0.32mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95%CI:-0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P=0.019). Major adverse cardiovascular events up to 12months also did not differ between the groups. This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia [SCBDNMAL]; NCT04017364).

Post-PCI quantitative flow ratio predicts 3-year outcome after rotational atherectomy in patients with heavily calcified lesions.

BackgroundThe study sought to investigate the clinical predictive value of quantitative flow ratio (QFR) for the long‐term outcome in patients with heavily calcified lesions who underwent percutaneous coronary intervention (PCI) following rotational atherectomy (RA).MethodsIn this retrospective study, 393 consecutive patients from 2009 to 2017 were enrolled. The QFR of the entire target vessel (QFRv) and the QFR of the stent plus 5 mm proximally and distally (in‐segment) (QFRi) were measured. The primary endpoint was target lesion failure (TLF), including target lesion‐cardiac death (TL‐CD), target lesion‐myocardial infarction (TL‐MI), and clinically driven‐target lesion revascularization (CD‐TLR).ResultsA total of 224 patients with 224 calcified lesions completed the clinical follow‐up, and 52 patients had TLF. There was no significant difference in QFRv post‐PCI between non‐TLF and TLF groups (p > .05). However, QFRi post PCI was significantly higher in the non‐TLF group than in the TLF group. Multivariate Cox regression showed that QFRi post‐PCI was an excellent predictor of TLF after a 3‐year follow‐up (HR 1.7E−8 [5.3E−11–5.6E‐6]; p < .01). Furthermore, receiver‐operating characteristic curve analysis demonstrated that the optimal cutoff value of QFRi for predicting the long‐term TLF was 0.94 (area under the curve: 0.826, 95% confidence interval: 0.756–0.895; sensitivity: 89.5%, specificity: 69.2%; p < .01). The QFRi ≤ 0.94 post‐PCI was negatively associated with TLF, including TL‐CD, TL‐MI, and CD‐TLR (p < .01).ConclusionsQFRi post‐PCI showed a high predictive value for TLF for during a 3‐year follow‐up in patients who underwent PCI following RA; specifically, lower QFRi values post‐PCI were associated with worse TLF.

Rationale, Design, and Implications of Bifurcation Coronary Stenting: Insight from the Indian Bifurcation Stenting (IBIS) Registry.

BackgroundBifurcation coronary stenting (BCS) has unique therapeutic challenges. Several BCS strategies are prescribed for treatment, with conflicting data, and which is the best strategy for optimal short- and long-term outcomes remains a matter of debate. There is no systematic data from an Indian perspective in regard to patterns of BCS and its outcomes.Methods and analysisThe Indian Bifurcation Stenting (IBIS) registry is a prospective, nationwide, endpoint-driven, investigator-initiated, multi-center, observational registry to compare the different bifurcation stent strategies, the effect of adjuvant techniques, and bifurcation anatomical differences in predicting short- and long-term clinical outcomes of bifurcation coronary interventions in India. A total of 1,000 patients from 20 clinical sites across the country will be enrolled in this study from September 2020 to August 2023. The primary endpoint will be the composite endpoint of major adverse cardiac events including cardiac death, target lesion myocardial infarction (MI), and ischemia-driven target lesion revascularization at the end of two years. The secondary endpoints include all causes of death, MI, target vessel revascularization, in-stent restenosis, stroke, and predefined procedural parameters. The safety endpoint is the occurrence of definite or probable stent thrombosis.ConclusionThe aim of this prospective observational registry is to assess the practice patterns and clinical outcomes of patients undergoing coronary bifurcation lesion angioplasty in India. This will be extremely useful to provide an evidence-based insight as well as guidance to bifurcation angioplasty in India.

Clinical outcomes of calcified nodules detected by optical coherence tomography: a sub-analysis of the CLIMA study.

The goal of the present post hoc analysis of the CLIMA registry was to establish the relationship between calcified nodules (CNs) with (CND) or without (CNWD) disruption of the superficial intimal fibrous layer and one-year occurrence of target lesion myocardial infarction (MI) and/or cardiac death. CND and CNWD were identified based on the presence or absence of superficial irregularities indicative of disruption of the intimal fibrous layer, with possible overlying local thrombus. In total, 222 CNs were found in the 1,776 non-culprit LAD plaques. CND had larger maximum calcific arc and smaller lumen area. Cardiac death and MI occurred in 20% of patients in the CND group versus 2.7% in the CNWD group and 3.3% in the group without CN (p<0.001). This figure was mainly due to the 13.3% incidence of cardiac death in the CND group versus 2.0% in the CNWD group and versus 2.2% in the group without CN (p<0.001). The presence of CND was confirmed as an independent predictor of events (HR 6.58, 95% CI: 2.7-15.8, p<0.001). The presence of CND was associated with a high one-year incidence of cardiac death and/or target lesion MI.

Outcomes of intravascular brachytherapy for recurrent drug-eluting in-stent restenosis.

To examine the outcomes of vascular brachytherapy (VBT) for recurrent drug-eluting stents (DES) in-stent restenosis (ISR). Recurrent DES-ISR can be challenging to treat. VBT has been used with encouraging results. We report the long-term outcomes of patients with recurrent DES-ISR treated with VBT between January 2014 and September 2018 at a tertiary care institution. The main outcome was target lesion failure (TLF), defined as the composite of clinically driven target lesion revascularization (TLR), target lesion myocardial infarction (MI), and target lesion-related cardiac death. Cox proportional hazards analysis was performed to identify variables associated with recurrent TLF. During the study period, 116 patients (143 lesions) underwent VBT. Median follow-up was 24.7 (14.5-35.4) months. The incidence of TLR, target-lesion MI, and TLF was 18.9%, 5.6%,and 20.1% at 1 year, and 29.4%, 10.5%, and 32.9% at 2 years.Initial presentation with acute coronary syndrome (ACS) was independently associated with TLF (hazard ratio = 1.975, 95% CI [1.120, 3.485], p = .019). Lesions treated with intravascular ultrasound (IVUS) guidance had a lower incidence of TLR (14.3% vs. 39.6%, log-rank p = .038), and a trend toward lower incidence of TLF (19% vs. 42.6%, log-rank p = .086). VBT can improve the treatment of recurrent DES-ISR, but TLF occurs in approximately one in three patients at 2 years. Initial presentation with ACS was associated with higher TLF and the use of IVUS with a trend for lower incidence of TLF.

The Current Literature on Bioabsorbable Stents: a Review.

The purpose of this review is to explore the evolution of the coronary stent, from the advent of bare-metal stents, to the newest adopted technology of bioresorbable vascular scaffolds (BVS) used in bioresorbable stents. To date, there have been conflicting data regarding the safety and efficacy of BVS stents, especially when compared to current-generation drug-eluting stents (DES). This review will cover the data that exist regarding current BVS stents, as well as the active clinical trials for future iterations of BVS. The ABSORB BVS, the most widely circulated stent of its class, was promised to decrease rates of stent thrombosis and target vessel revascularization. Several randomized control trials, however, found the opposite to be true, with the ABSORB BVS demonstrating higher rates of thrombosis, target vessel revascularization, and even target lesion myocardial infarctions when compared to current-generation DES. These data caused the product to be pulled from all markets, leaving the field with uncertainty as to the role of BVS in coronary interventions. Coronary stents have evolved significantly from 1977, when they were first introduced. The original bare-metal stent was later fitted with a drug-eluting polymer, to prevent restenosis and thrombosis over time. Subsequent iterations of the stent attempted to further mitigate that risk by replacing the durable polymer to one that is bioresorbable. The final step in this progression was to create a stent that was fully bioresorbable, which Abbott did with the creation of their ABSORB BVS stent. The product, however, was found to perform poorly when compared to current-generation drug-eluting stents, with several trials showing high rates of stent thrombosis (ST), late stent thrombosis (LST), target-lesion myocardial infarction, and target vessel revascularization. Observational studies of BVS stents have proposed several mechanisms for their thrombogenicity, including higher stent-strut profiles leading to turbulent flow, low radial strength leading to strut disruption, and a higher propensity for neoatherosclerosis. Given the failure of the first-generation BVS stent, but the lingering desire for fully bioresorbable scaffolds, various manufacturers have proposed their solutions with new stents. Until data from their clinical trials emerge, it remains unclear whether fully bioresorbable stents will play any role in coronary interventions.

Everolimus-Eluting Versus Biolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus

Diabetes mellitus is associated with a higher risk of target lesion revascularization after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus, treated with everolimus-eluting stents (EES; Synergy; Boston Scientific, Marlborough, Massachusetts) or biolimus-eluting stents (BES; BioMatrix NeoFlex; Biosensors Interventional Technologies Pte Ltd., Singapore). In total, 2,764 patients were randomized to stent implantation with EES (n = 1,385, diabetes: n = 250) or the BES (n = 1,379, diabetes: n = 262), stratified by gender and diabetes. The primary end point, target lesion failure (TLF), was a composite of cardiac death, target-lesion myocardial infarction, or target lesion revascularization at 12 months. Secondary end points included individual components of TLF, all-cause death, and stent thrombosis. TLF was 2.1% lower in the EES versus the BES groups in patients with diabetes (3.6% vs 5.7%; rate ratios 0.61, 95% confidence interval [CI] 0.27 to 1.41) and similar in patients without diabetes (4.1% vs 4.0%; rate ratios 0.99, 95% CI 0.66 to 1.51). In patients with diabetes, the point estimates of the individual components of TLF also favored the EES but CIs were wide. No interaction between stent type and presence of diabetes was found. The current subgroup analysis found that a thin-strut EES as compared with a thicker strut BES had a numerically lower TLF rate in patients with diabetes, but the subgroup analysis was underpowered for definite conclusions.

Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon

ObjectivesThe aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). BackgroundTreatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR. MethodsFifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm2) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm2) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. ResultsQuantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups. ConclusionsThis first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318)

Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER)

Percutaneous coronary intervention in complex bifurcation lesions is prone to suboptimal implantation results and is associated with increased risk of subsequent clinical events. Angiographic ambiguity is high during bifurcation stenting, but it is unknown if procedural guidance by intravascular optical coherence tomography (OCT) improves clinical outcome. OCTOBER is a randomized, investigator-initiated, multicenter trial aimed to show superiority of OCT-guided stent implantation compared to standard angiographic-guided implantation in bifurcation lesions. The primary outcome measure is a 2-year composite end point of cardiac death, target lesion myocardial infarction, and ischemia-driven target lesion revascularization. The calculated sample size is 1,200 patients in total, and allocation is 1:1. Eligible patients have stable or unstable angina pectoris or stabilized non–ST elevation myocardial infarction, and a coronary bifurcation lesion with significant main vessel stenosis and more than 50 % stenosis in a side branch with a reference diameter ≥2.5mm. Treatment is performed by the provisional side branch stenting technique or 2-stent techniques, and the systematic OCT guiding protocol is aimed to evaluate (1) plaque preparation, (2) lesion length, (3) segmental reference sizes, (4) lesion coverage, (5) stent expansion, (6) malapposition, (7) wire positions, and (8) ostial results. A positive outcome of the OCTOBER trial may establish OCT as a routine tool for optimization of complex percutaneous coronary intervention, whereas a negative result would indicate that OCT remains a tool for ad hoc evaluation in selected cases.

Experiences with the Absorb everolimus-eluting bioresorbable vascular scaffold in all comers: The St. Antonius hospital single centre registry

BackgroundData on procedural and clinical outcomes of the everolimus-eluting bioresorbable vascular scaffold (BVS, Abbott) in percutaneous coronary intervention in a real-world setting is limited. Early and mid-term clinical outcomes of the BVS in a real-world population were investigated in this single centre study. MethodsPatients treated with the BVS in the St. Antonius Hospital from April 2012 to February 2015 were included in a prospective single centre registry. Procedural success defined as <20% residual restenosis and 30-day and 6-month clinical outcome were investigated. Cumulative event rates were expressed using Kaplan−Meier method. ResultsA total of 108 patients were included in the study, including patients with ST-segment elevation myocardial infarction (STEMI) 18.5%, non-STEMI 22.2% and unstable angina 9.3%. In total 125 lesions were treated with the BVS, of which 48.8% B2/C type lesions including 19.2% bare metal or drugs-eluting in-stent restenosis. Procedural angiographic success was achieved in 99.2% of all patients. Clinical follow-up rate was 100% at 30-day and 87% at 6-month. The rate of cardiac death, target vessel revascularization and definite stent thrombosis was 0%, 0.9% and 0.9% at 30-day and 0.9%, 5.6% and 1.9% at 6-month. The composite end point of target lesion failure (Cardiac death, target lesion myocardial infarction MI and target lesion revascularization) was 1.9% at 30-day and 5.6% at 6-month, respectively. ConclusionsThe use of the BVS in a real-world setting demonstrated excellent procedural success and acceptable mid-term clinical outcomes. The rate of definite scaffold thrombosis was not dissimilar to other BVS registries.

Prospective study to evaluate safety and efficacy of Zotarolimus Eluting Stent (PSEZES) in patients with long coronary artery lesions

BackgroundAlthough the safety and effectiveness of Drug-Eluting Stents (DES) has been established extensively, reports on long term clinical outcome with angiographic findings in patients with long coronary artery lesions are not many. MethodsIn this single-center prospective registry of 100 patients, a total of 110 denovo long lesions (>20 mm) were treated with Resolute Zotarolimus Eluting Stent (R-ZES). The patients were followed up clinically at 3, 6 and 12 months and follow up coronary angiography was performed at 9-months. The primary end point was one year rate of target lesion failure (TLF) which is a composite of cardiac death, target lesion myocardial infarction or ischemia driven target lesion revascularization (TLR). The secondary end points included definite or probable stent thrombosis, 9-month angiographic restenosis and late lumen loss. ResultsThe mean age of patients was 58.7 ± 9.50 years with prevalence of diabetes as high as 60%. The mean lesion length was 24.67 ± 4.87 mm with a mean reference vessel diameter of 2.85 ± 0.32 mm and 67.3% were Type C lesions (ACC/AHA classification). Two patients died during follow-up, of which one was non-cardiac death. One patient had target vessel myocardial infarction and five patients (4.5%) had ischemia driven TLR. The incidence of TLF was 6.36%. Binary restenosis was seen in 7 out of 93 lesions (7.5%). Median late lumen loss at 9 month was 0.22 mm. No stent thrombosis was noted in the study. ConclusionImplantation of R-ZES in real-world patients with long coronary artery lesions is safe with comparable efficacy to what is observed in the treatment of less complex lesions.