Native Coronary Artery Lesions Research Articles

Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent

Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI). The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients. The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.

Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions.

The use of multiple overlapping stents for long lesions in tapered coronary arteries has been associated with poor outcomes. This study was conducted to evaluate the 3-year safety and performance of the BioMime™ Morph sirolimus-eluting stent (SES) in very long (length 30 to ≤ 56 mm) coronary lesions in native coronary arteries with a reference vessel diameter of 2.25 to 3.50 mm. This was a prospective, single-center, observational, real-world, post-marketing surveillance study. Eligible patients were implanted with BioMime™ Morph SES. Patients were followed up at 6, 12, 24, and 36 months. A total of 88 patients were enrolled in the study. The mean age was 58.72 ± 10.10 years and 82.95% were male. Most patients had angina (81.82%) and ischemic heart disease (78.41%), and there was a high prevalence of comorbidities like diabetes mellitus (59.09%), and hypertension (54.55%). A total of 92 long coronary de novo lesions were treated with BioMime™ Morph SES with an average stent length of 45.54 ± 10.20 mm. Device and procedural success rates were 100%. One patient died at 30 days and one case of myocardial infarction was recorded. The cumulative rates of major adverse cardiovascular events (MACEs) at 6, 12, 24, and 36 months were 3.41%, 6.82%, 7.95%, and 7.95%, respectively. There were no cases of stent thrombosis (ST), ischemia-driven target vessel revascularization, or ischemia-driven target lesion revascularization until 36 months of follow-up. BioMime™ Morph SES showed favorable outcomes up to 3 years in treating very long coronary lesions in native coronary arteries, as demonstrated by an acceptable rate of MACEs and absence of ST, based on clinical outcomes up to 3 years.

COMPARING OUTCOMES OF PERCUTANEOUS CORONARY INTERVENTION OF NATIVE ARTERY VERSUS BYPASS GRAFT IN PATIENTS WITH PRIOR CORONARY ARTERY BYPASS GRAFTING : A SYSTEMATIC REVIEW

Background: Percutaneous coronary intervention (PCI) is common in patients with prior coronary artery bypass graft surgery (CABG), however the data on the association between the PCI target-vessel and clinical outcomes are not clear. We aimed to investigate long-term clinical outcomes of patients with prior CABG who underwent PCI of either bypass graft or native artery. We performed a systematic review of observational studies comparing PCI of either bypass graft or native artery in patients with prior CABG. Methods: By comparing itself to the standards set by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020, this study was able to show that it met all of the requirements. So, the experts were able to make sure that the study was as up-to-date as it was possible to be. For this search approach, publications that came out between 2013 and 2023 were taken into account. Several different online reference sources, like Pubmed and SagePub, were used to do this. It was decided not to take into account review pieces, works that had already been published, or works that were only half done. Result: In the PubMed database, the results of our search brought up 23 articles, whereas the results of our search on SagePub brought up 19 articles. The results of the search conducted for the last year of 2013 yielded a total 9 articles for PubMed and 5 articles for SagePub. In the end, we compiled a total of 5 papers, 4 of which came from PubMed and 1 of which came from SagePub. We included five research that met the criteria. Conclusion: Most PCIs performed in prior CABG patients are done in native coronary artery lesions. Compared with native coronary PCI, bypass graft PCI is independently associated with higher in-hospital mortality.

The imPAct of Trimetazidine on MicrOcirculation after Stenting for stable coronary artery disease (PATMOS study).

Myocardial ischemia is caused by epicardial coronary artery stenosis or atherosclerotic disease affecting microcirculation. Trimetazidine (TMZ), promotes glucose oxidation which optimizes cellular energy processes in ischemic conditions. Small studies demonstrated protective effects of TMZ in terms of reducing myocardial injury after percutaneous coronary intervention (PCI), its effect on microcirculation using contemporary investigative methods has not been studied. The aim of the study was to examine effects of trimetazidine, given before elective PCI, on microcirculation using invasively measured index of microcirculatory resistance (IMR). This was prospective, single blinded, randomized study performed in a single university hospital. It included consecutive patients with an indication for PCI of a single, de novo, native coronary artery lesion. Patients were randomly assigned to receive either TMZ plus standard therapy (TMZ group) or just standard therapy. Coronary physiology indices fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) were measured before and after PCI using coronary pressure wire. We randomized 71 patients with similar clinical characteristics and risk profile, previous medications and coronary angiograms. Patientshad similar values of Pd/Pa, FFR and CFR prior to PCI procedure. After PCI, FFR values were higher in TMZ group, while IMR values were lower in this group respectively (FFR TMZ + 0.89 ± 0.05 vs. TMZ - 0.85 ± 0.06, p = 0.007; CFR TMZ + 2.1 ± 0.8 vs. TMZ- 2.3 ± 1.3, p = 0.469; IMR TMZ + 18 ± 9 vs. TMZ- 24 ± 12, p = 0.028). In two-way repeated measures ANOVA PCI was associated with change in FFR values (TMZ p = 0.050; PCI p < 0.001; p for interaction 0.577) and TMZ with change in IMR values (TMZ p = 0.034, PCI p = 0.129, p for interaction 0.344). Adding trimetazidine on top of medical treatment prior to elective PCI reduces microvascular dysfunction by lowering postprocedural IMR values when compared to standard therapy alone.

Stent expansion evaluated by optical coherence tomography and subsequent outcomes

Regarding stent expansion indices, previous optical coherence tomography (OCT) studies have shown minimal stent area (MSA) to be most predictive of adverse events. We sought to evaluate the impact of various stent expansion and apposition indices by post-stent OCT on clinical outcomes and find OCT-defined optimal stent implantation criteria. A total of 1071 patients with 1123 native coronary artery lesions treated with new-generation drug-eluting stents with OCT guidance and final post-stent OCT analysis were included. Several stent expansion indices (MSA, MSA/average reference lumen area, MSA/distal reference lumen area, mean stent expansion, and stent expansion by linear model [stent volume/adaptive reference lumen volume]) were evaluated for their association with device-oriented clinical endpoints (DoCE) including cardiac death, target vessel-related myocardial infarction (MI) or stent thrombosis, and target lesion revascularization. MSA was negatively correlated with the risk of DoCE (hazard ratio [HR] 0.80 [0.68‒0.94]). However, stent expansion by linear model representing the overall volumetric stent expansion was associated with greater risk of DoCE (HR 1.02 [1.00‒1.04]). As categorical criteria, MSA < 5.0 mm2 (HR 3.90 [1.99‒7.65]), MSA/distal reference lumen area < 90% (HR 2.16 [1.12‒4.19]), and stent expansion by linear model ≥ 65.0% (HR 1.95 [1.03‒3.89]) were independently associated with DoCE. This OCT study highlights the importance of sufficient stent expansion to achieve adequate, absolute, and relative MSA criteria for improving clinical outcome. It also emphasises that overall volumetric excessive stent expansion may have detrimental effects.

Stent expansion evaluated by optical coherence tomography and subsequent outcomes

Abstract Background Regarding stent expansion indexes, previous optical coherence tomography (OCT) studies have shown minimal stent area (MSA) to be most predictive of adverse events. Purpose We sought to evaluate the impact of various stent expansion indexes by post-stent OCT on long-term clinical outcomes, and hence to find OCT-defined optimal stent expansion criteria. Methods Of the patients registered in the Yonsei OCT registry, a total of 1071 patients with 1123 native coronary artery lesions treated with new-generation drug-eluting stents under the OCT guidance and analyzable final post-stent OCT were included. Stent expansion indexes and different suboptimal stent expansion criteria were evaluated for their association with device-oriented clinical endpoints (DoCE) including cardiac death, target vessel-related myocardial infarction (TVMI) or stent thrombosis, and target lesion revascularization. Major safety events (MSE) included cardiac death, TVMI or stent thrombosis. Results The median follow-up period was 40.6 (interquartile range 22.0–50.0) months. As a continuous variable, MSA, adaptive volumetric stent expansion (stent volume/adaptive reference lumen volume) and overall volumetric stent expansion (stent volume/post-stent lumen volume) were significantly predictive of DoCE. As a categorical criteria, MSA &amp;lt;5.0 mm2 (hazard ratio [HR] 3.80; 95% confidence interval [CI] 1.53–9.45), MSA/distal reference lumen area &amp;lt;90% (HR 2.13; 95% CI 1.10–4.14), and overall volumetric stent expansion ≥96.6% (HR 2.38; 95% CI 1.09–5.22) were independently associated with DoCE after adjusting for confounders, and a total malapposition volume ≥7.0 mm3 (HR 3.38; 95% CI 1.05–10.93) was linked to MSE. Conclusions This OCT study highlights that sufficient stent expansion to achieve adequate absolute MSA and relative MSA by distal reference lumen area and alleviate significant malapposition is important to improve clinical outcome, but overall stent overexpansion may have deleterious effect. Funding Acknowledgement Type of funding sources: None.

TCT-134 Vascular Healing of Native Coronary Artery Lesions Following Treatment With Drug-Coated Balloons − Insights From an Optical Coherence Tomographic Study

TCT-134 Vascular Healing of Native Coronary Artery Lesions Following Treatment With Drug-Coated Balloons − Insights From an Optical Coherence Tomographic Study

Long-Term Clinical Outcomes After Percutaneous Coronary Intervention With Drug-Coated Balloon-Only Strategy in de novo Lesions of Large Coronary Arteries.

Background and ObjectivesUse of drug-coated balloon (DCB)-only strategy for revascularization of native large coronary artery lesions is on the rise. The long-term efficacy of this approach for bifurcation and non-bifurcation lesions remains unknown. We aim to assess the long-term clinical outcomes of DCB-only strategy for the treatment of de novo bifurcation and non-bifurcation lesions in large coronary arteries.MethodsThis multicenter, prospective, observational study enrolled 119 patients with de novo coronary lesions in vessels ≥2.75 mm. The primary end point was the rate of clinically driven target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR). Patients were followed up for a median of 2 years.ResultsOf 119 patients with 138 lesions, 66 patients (75 lesions) had bifurcation and 53 patients (63 lesions) had non-bifurcation lesions. Average reference vessel diameter was 3.1 ± 0.3 mm, and there was no difference in bifurcation and non-bifurcation group (3.0 ± 0.3 vs. 3.1 ± 0.3mm; p = 0.27). At 2-year follow-up, the TLF occurred in five (4.2%), TLR in four (3.4%), and target vessel revascularization (TVR) in five (4.2%) cases. The frequency of TLR and TVR was higher in the non-bifurcation group (p = 0.04 and 0.02, respectively), but there were no differences in TLF between the two groups (p = 0.17). The cumulative incidence of TLF (Kaplan–Meier estimates) was also not different in the two groups (log-rank p = 0.11).ConclusionDCB-only strategy for de novo lesions in large coronary arteries appears to be safe and effective for both bifurcation and non-bifurcation lesions. Further randomized clinical trials are warranted to confirm the value of DCB-only strategy in de novo bifurcation lesions of large vessels.

Percutaneous Coronary Intervention of Native Artery Versus Bypass Graft in Patients with Prior Coronary Artery Bypass Graft Surgery.

Percutaneous coronary intervention (PCI) is common in patients with prior coronary artery bypass graft surgery (CABG), however, there is limited data on the association between the PCI target-vessel and clinical outcomes. In this article, we provide a state-of-the-art overview of the contemporary management of patients with prior CABG and a clear indication for revascularization. We performed a structured literature search of PubMed and Cochrane Library databases from inception to March 2021. Relevant studies were extracted and synthesized for narrative review. Twenty-six observational studies focusing on PCI of bypass graft versus native coronary artery lesions in 366,060 patients with prior CABG were included. The data from observational studies suggest that bypass graft PCI is associated with higher short- and long-term major adverse cardiac events compared to native coronary artery PCI. Whenever feasible, native coronary artery PCI should be the prioritized treatment for saphenous vein graft failure. Prospective randomized trials are needed to elucidate the optimal revascularization strategy for patients with prior CABG.

Reasons for lesion uncrossability as assessed by intravascular ultrasound.

The purpose of the current study was to use intravascular ultrasound (IVUS) to clarify anatomical and morphological lesion characteristics of uncrossable lesions. Uncrossable lesions are not always severely calcified. The prevalence of uncrossable lesions that are nonseverely calcified as well as other mechanisms for uncrossability has not been well clarified. A total of 252 de novo uncrossable lesions in native coronary arteries that underwent either rotational or orbital atherectomy due to inability of any balloon to cross the lesion and 38 lesions with severe calcium in which IVUS crossed preatherectomy were included. Severe calcium is defined as maximum arc of calcium ≥270°. Severe calcification was absent in 16% of uncrossable lesions, 83% of which had a significant vessel bend. Compared with crossable lesions with severe calcium, uncrossable lesions with severe calcium more often had a bend in the vessel (71% vs. 21%, p < 0.001) and a longer length of continuous severe calcium (median length of calcium ≥270° 3.8 mm vs. 1.9 mm, p = 0.001). Other than severe calcium (especially long continuous calcium) or a bend in the vessel, anatomical factors associated with uncrossabilty were aorto-ostial lesion location and small vessels. Uncrossable lesions are not always severely calcified. The interaction of lesion morphology (continuous long and large arcs of calcium) and vessel geometry (bend in the vessel or ostial lesion location) affect lesion crossability.

Favorable Vasomotor Function after Drug-Coated Balloon-Only Angioplasty of De Novo Native Coronary Artery Lesions.

Balloon-injured coronary segments are known to harbor abnormal vasomotion. We evaluated whether de novo coronary lesions treated using drug-coated balloon (DCB) are prone to vasospasm and how they respond to ergonovine and nitrate. Among 132 DCB angioplasty recipients followed, 89 patients underwent ergonovine provocation test at 6–9 months follow-up. Within-subject ergonovine- and nitrate-induced diameter changes were compared among three different sites: DCB-treated vs. angiographically normal vs. segment showing prominent vasoreactivity (spastic). No patient experienced clinically refractory vasospastic angina or symptom-driven revascularization during follow-up. Ergonovine induced vasospasm in seven patients; all were multifocal spasm either involving (n = 2) or rather sparing DCB-treated segments (n = 5). None showed focal spasm that exclusively involved DCB-treated lesions. Among 27 patients with vasospastic features, DCB-treated segments showed less vasoconstriction than spastic counterparts (p < 0.001). A total of 110 DCB-treated lesions were analyzed to assess vasomotor function. Vasomotor function, defined as a combined constrictor and dilator response, was comparable between DCB-treated and angiographically normal segments (p = 0.173), while significant differences were observed against spastic counterparts (p < 0.001). In our study, DCB-treated lesions were not particularly vulnerable to vasospasm and were found to have vasomotor function similar to angiographically normal segments, supporting safety of DCB-only strategy in treating de novo native coronary lesions.

Comparison between a novel sirolimus-eluting bioresorbable scaffold with everolimus-eluting metallic stent in patients with coronary artery disease: three-year follow-up from the neovas rct study

Abstract Background Previous trials and meta-analyses have demonstrated that risk of adverse clinical events, especially thrombosis and target vessel myocardial infarction is increasing between 1 and 3 years after Bioresorbable Scaffolds (BRS) implantation. Purpose We sought to evaluate the long-term clinical outcomes of a novel NeoVas BRS in comparison with cobalt chromium everolimus-eluting stent (EES) following implantation in patients with coronary artery disease by 3-year follow-up results from the NeoVas RCT. Methods Overall, 560 patients with a single de novo native coronary artery lesion with reference vessel diameter 2.5–3.75 mm and lesion length ≤20 mm were randomized 1:1 to NeoVas BRS vs. cobalt-chromium everolimus-eluting stents (CoCr-EES). Optical coherence tomography (OCT) and fractional flow reserve (FFR) were both performed in a pre-specified subgroup at 3-year follow-up. Clinical outcomes from NeoVas RCT were analyzed by randomized device (intention to treat) cumulative to 3 years. Results Over 3 years, the overall target lesion failure (TLF) rate was 6.9% in the NeoVas group and 6.1% in the CoCr-EES group (HR 1.13, 95% CI 0.59 to 2.18; p=0.71). There was no statistically significant difference of the definite or probable stent thrombosis between the NeoVas group and the CoCr-EES group (1.1% vs. 0.7%, HR 1.51, 95% CI 0.26 to 8.73, p=0.64). In a landmark analysis of TLF, we found no difference in rate of late events from 2 to 3 years between two groups. FFR was not significantly different between the two group at 3 years (NeoVas vs. CoCr-EES, 0.89±0.07 vs. 0.90±0.05). NeoVas was largely absorbed (72.26% ± 13.21%) examined by OCT follow-up. Of 55 patients who finished 3-year absorption analysis, NeoVas was totally absorbed in 4 patients. Conclusions At the 3-year follow-up in the Neovas RCT trial, overall TLF rates were comparable between Neovas BRS and CoCr-EES, and adverse event rates relating to device safety were not increased with Neovas BRS compared with CoCr-EES up to 3 years after implantation. Funding Acknowledgement Type of funding sources: None.

Stent Expansion Indexes to Predict Clinical Outcomes: An IVUS Substudy From ADAPT-DES.

The aim of this study was to evaluate various stent expansion indexes to determine the best predictor of clinical outcomes. Numerous intravascular ultrasound (IVUS) studies have shown minimum stent area (MSA) to be the most powerful predictor of future events. ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. Native coronary artery lesions treated with IVUS-guided PCI with final analyzable IVUS were included. Ten stent expansion indexes (MSA, MSA/vessel area at MSA site, conventional stent expansion [MSA/average of proximal and distal reference luminal area], minimum stent expansion using Huo-Kassab or linear model accounting for vessel tapering, stent asymmetry [minimum/maximum stent diameter within the entire stent], stent eccentricity [smallest minimum/maximum stent diameter at a single slice within the stent], IVUS-XPL [Impact of intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions] criteria, and ILUMIEN IV criteria) were evaluated for their associations with lesion-specific 2-year clinically driven target lesion revascularization (TLR) or definite stent thrombosis. Overall, 2,140 lesions in 1,831 patients were included; final MSA measured 6.2 ± 2.4mm2. Among the 10 stent expansion indexes, only MSA/vessel area at the MSA site was independently associated with 2-year clinically driven TLR or definite stent thrombosis (hazard ratio: 0.77; 95% confidence interval: 0.59-0.99; P=0.04) after adjusting for morphologic and procedural parameters. In this IVUS-guided PCI cohort with excellent final MSA overall, stent/vessel area at the MSA site, an index of relative stent expansion, was superior to absolute MSA and other expansion indexes in predicting 2-year clinically driven TLR or definite stent thrombosis.

TCTAP A-036 A Non-randomized, Clinical Registry of the DynamX Novolimus Eluting Coronary Bioadaptor System in the Treatment of Patients with De Novo Native Coronary Artery Lesions - “DynamX Hong Kong Registry”

TCTAP A-036 A Non-randomized, Clinical Registry of the DynamX Novolimus Eluting Coronary Bioadaptor System in the Treatment of Patients with De Novo Native Coronary Artery Lesions - “DynamX Hong Kong Registry”

The safety and efficacy of Firesorb bioresorbable scaffold in first-in-man study for coronary artery disease: the four-year outcomes

Objective: To evaluate the 4-year clinical outcomes of patients following Firesorb bioresorbable scaffold (BRS) implantation. Methods: The study reported the 4-year follow-up results of the FUTURE I study. FUTURE I was a prospective, single-center, open-label, first-in-man study which evaluated the feasibility, preliminary safety, and efficacy of Firesorb stent in the treatment of coronary artery stenosis. A total of 45 patients with single de novo lesions in native coronary arteries ,who hospitalized in Fuwai Hospital from January to March 2016 were enrolled. After successfully stent implantation these patients were randomized in a 2∶1 ratio into cohort 1 (n=30) or cohort 2 (n=15). The patients in cohort 1 underwent angiographic, IVUS or OCT examination at 6 months and 2 years; and cohort 2 underwent angiographic, IVUS or OCT at 1 and 3 years. All patients underwent clinical follow-up at 1, 6 months and 1 year and annually thereafter up to 5 years. The primary endpoint was target lesion failure (TLF, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization). Secondary endpoints included patient-oriented composite endpoint (PoCE, defined as composite of all death, all miocardial infarction, or any revascularization). Results: A total of 45 patients were enrolled and implanted with Firesorb BRS, including 35 males (77.8%), and the age was (54.4±9.3) years. At 4 years, 10 patients in cohort 1 were reexamined by coronary angiography and OCT examination. Among them, 2 patients' stents were completely degraded and absorbed. Compared with the OCT images of the other 8 patients in cohort 2 at 3 years, the degree of stent degradation was increased, and no stent adherence was found. The 4-year clinical follow-up rate was 100%. In 4-year clinical following up, 2 patients suffered PoCE (4.4%): 1 patient underwent non-target vessel revascularization the day after index procedure and target vessel revascularization (Non-target lesion revascularization) at 2-year imaging follow-up; the other patient underwent target lesion revascularization during imaging follow-up at 4 years but not due to ischemic driven. There was no scaffold thrombosis or TLF events through 4 years. Conclusions: Four years after the implantation, complete degradation and absorption of the Firsorb stent are evidenced in some patients. Firesorb stent is feasible and effective in the treatment of patients with non-complex coronary lesions.

Nine-month angiographic and 2-year clinical outcomes of the RECOVERY trial: A randomized study of the biodegradable polymer sirolimus-eluting COMBO dual-therapy stent versus a polymer-free sirolimus-eluting stent in Chinese patients.

We evaluated the safety and efficacy of the novel dual-therapy sirolimus-eluting and endothelial progenitor cell (EPC) capture COMBO stent. (Very) late stent thrombosis (ST) and neo-atherosclerosis limit the performance of drug-eluting stents. The capture of EPCs accelerates stent re-endothelialization, thereby potentially decreasing the risk of restenosis and ST. In total, 440 patients with de novo lesions in native coronary arteries were randomized (1:1) to either receive the COMBO stent (n = 220) or Nano polymer-free sirolimus-eluting stent (n = 220). The primary endpoint was the 9-month angiographic in-segment late lumen loss (LLL). Secondary endpoints included target lesion failure (TLF), a patient-oriented composite endpoint (PoCE), and ST. At 9 months, the COMBO in-segment LLL (0.29 ± 0.46 mm) was non-inferior to that of the Nano comparator stent (0.31 ± 0.44 mm; pnon-inferiority < .0001). Clinical outcomes were also similar between the COMBO and Nano stents, with TLF rates of 9.3% and 7.9% (p = .61) at 12 months, and 9.4% and 8.0% (p = .62) at 24 months, respectively. The PoCE rate was 14.8% and 10.6% (p = .19) at 12 months, and 16.0% and 11.3% (p = .16) at 24 months, respectively. Ischemia-driven target lesion revascularization rates were 6.0% and 3.7% (p = .26) at 12 months, and 6.2% and 3.8% (p = .26) at 24 months, respectively. No case of ST occurred in either group. The RECOVERY trial has shown the COMBO stent was effective, meeting the primary non-inferiority angiographic endpoint, and safe, with an overall low rate of clinical events in both stent groups, including no ST for up to 2 years.

Final 5-Year Results in Randomized Japanese Patients Implanted With a Thin-Strut, Bioabsorbable, Polymer-Coated, Everolimus-Eluting SYNERGY Stent (From the EVOLVE II Study).

Background: SYNERGY is a thin-strut, platinum-chromium metal alloy stent with an ultrathin abluminal everolimus-eluting bioabsorbable polymer. EVOLVE II was a global randomized controlled trial that enrolled 1,684 patients treated with either a SYNERGY or durable polymer PROMUS Element Plus (PE+) everolimus-eluting stent, including 155 patients from Japanese sites. This substudy analyzed 5-year clinical outcomes in the Japanese and non-Japanese cohorts.Methods and Results: Patients aged ≥18 years with ≤3 native coronary artery lesions (reference vessel diameter ≥2.25–≤4.00 mm; length ≤34 mm) in ≤2 major vessels were randomized 1 : 1 to receive either SYNERGY (n=74 patients in Japan) or PE+ (n=81 patients in Japan). Five-year target lesion failure (TLF) was observed in 8.3% SYNERGY- and 11.2% PE+-treated patients (P=0.54). There were no cardiac deaths, and rates of target lesion revascularization and myocardial infarction were comparable between treatment arms. One patient in the SYNERGY arm experienced a very late definite stent thrombosis (ST); no ST occurred in the PE+ arm (P=0.30). Despite differences in baseline clinical and lesion characteristics, the 5-year TLF rates were not significantly different in SYNERGY-treated patients either in (8.3%) or outside (14.8%) Japan (P=0.14).Conclusions: In Japanese patients with coronary artery disease, SYNERGY showed comparable efficacy to PE+, with low rates of adverse events over 5 years. Similarly, 5-year clinical outcomes were favorable in Japanese vs. non-Japanese patients implanted with SYNERGY.

Optical coherence tomography findings in healed vulnerable plaques in patients with coronary artery disease

Abstract Background Histopathological analysis or intracoronary image assessment of healed plaques (HPs) has been reported both in acute coronary syndrome (ACS) and stable angina pectoris (SAP) patients. However, background characteristics or lesion morphologies of HPs could not be fully clarified and their differences according to the clinical status remain undetermined. Purpose We sought to investigate the clinical and morphological characteristics and compare their differences among ACS and SAP patients in order to clarify the clinical significance in HPs lesions. Methods We enrolled consecutive 201 patients with 213 native coronary artery lesions (139 lesions with SAP, 42 ST elevation-ACS (STE-ACS) and 32 non-ST elevation ACS (NSTE-ACS) undergoing pre-intervention optical coherence tomography (OCT). HPs was defined as layered phenotype on OCT. Clinical and angiography characteristics and lesion morphologies on OCT were assessed. Results HPs were observed in 110 lesions (51.6%) and their prevalence were not different according to the clinical status (SAP:55.1%, STE-ACS:38.1%, NSTE-ACS:56.3%, p=0.14). Lesions with HPs had higher frequencies of angiography-eccentric lesions (62.7% vs. 35.9%, p&amp;lt;0.001) and OCT-macrophages (65.5% vs. 43.1%, p&amp;lt;0.001), and greater OCT-lumen area stenosis (%-AS) (77.1±10.2% vs. 73.6±10.6%, p=0.01) than those without HPs. Of lesions with HPs, OCT-thin-cap fibroatheroma (SAP 14.4%, STE-AC43.8%, NSTE-ACS 16.7%, p=0.03), plaque rupture (5.3%; 37.5%; 11.1%, p&amp;lt;0.001) and thrombus (6.6%, 75.0%, 22.2%, p=0.007) were more frequently observed in STE-ACS than in SAP patients, whereas OCT-microvessels were more frequent in SAP than in ACS patients (19.7%, 0.0%, 0.0%, p=0.02). Other OCT findings such as macrophages, cholesterol crystal, multiple layered phenotype, and %-AS were not significantly different according to the clinical status. Multivariate logistic regression analysis identified the angiography-eccentric lesions (odds ratio (OR): 2.97, 95% confidence intervals (CI): 1.68–5.25, p&amp;lt;0.001) and OCT macrophages (OR 2.41, 95% CI 1.36–4.27, p=0.003) as independent related factors for the existence of HPs. Conclusions The present study showed that HPs lesions had eccentric and large plaque burden, and persistent plaque inflammations regardless of clinical status, which might lead to future coronary events. Funding Acknowledgement Type of funding source: None

Optical coherence tomography and coronary angioscopy assessment of healed vulnerable plaque components in patients with coronary artery lesions undergoing elective percutaneous coronary intervention

Abstract Background Many vulnerable plaques would progress without clinical events and might result in healed plaques (HPs). Histopathological or intracoronary image assessment of HPs has been reported. However, the morphological characteristics of HPs remain unclear yet. Purpose We sought to assess the healed vulnerable plaque components in patients with coronary artery lesions using optical coherence tomography (OCT) and coronary angioscopy (CAS). Methods We enrolled 47 patients with 50 native coronary artery lesions with angiographical severe stenosis (&amp;gt;90% diameter-stenosis) and without severe calcification (36 lesions with stable angina pectoris (SAP) and 14 acute coronary syndrome (ACS)) undergoing pre-intervention OCT and CAS. HPs was defined as layered phenotype on OCT. Lesion morphologies and plaque characteristics in lesions with HPs were assessed using OCT and CAS images. Results HPs were observed in 27 lesions (54.0%) and their prevalence were similar among each clinical status (SAP 52.8%, ACS 57.1%, p=1.00). Lesions with HPs had higher prevalence of OCT-macrophage (88.0% vs. 52.0%, p=0.01), CAS-red thrombus (88.8% vs. 52.2%, p=0.004) and CAS-low grade-yellow plaque (grade 1) (55.6% vs. 21.7%, p=0.02) than those without. SAP lesions with HPs had higher prevalence of CAS-yellow plaque (35.3% vs. 5.9%, p=0.09) and OCT-thin-cap fibroatheroma (42.1% vs. 5.9%, p=0.04) than SAP without HPs. ACS lesions with HPs had less CAS-red thrombus (0.0% vs. 50.0%, p=0.03) and OCT-plaque rupture (12.5% vs. 66.7%, p=0.04) than ACS without HPs. Multivariate logistic regression analysis revealed that OCT-macrophages (odds ratio (OR): 6.65, 95%-confidence intervals: 1.07–41.5, p=0.043), CAS-red thrombus (OR 8.77, 95% CI 1.33–57.8, p=0.02), and low grade-yellow plaque (OR 13.05, 95% CI 1.97–86.5, p=0.008) were independently related with the existence of HPs lesions. Combination of these 3 factors showed a high predictive value of OCT-HPs lesions (90.9%). Conclusions HPs lesions showed the lower lesion vulnerability than common ACS lesions but had more intraplaque inflammatory condition compared with common SAP lesions. Combined CAS and OCT examination might be useful to clarify the plaque components of HPs lesions in vivo, leading to help us understand the clinical significance of HPs. Funding Acknowledgement Type of funding source: None

Clinical profile of post coronary artery bypass graft patients undergoing percutaneous coronary intervention in native or graft vessels

Background: The PCI target vessel and corresponding outcomes in prior CABG patients are poorly studied. The study aims to determine the predictors and outcomes of native coronary artery and bypass graft percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass graft surgery (CABG).Methods: The factors associated with native and bypass graft PCI were analyzed in prior CABG patients undergoing PCI between July 2011 and December 2013, at Sri Jayadeva Institute Of Cardiovascular Sciences and Research, Bengaluru. Clinical/procedural characteristics and immediate procedural outcomes were recorded and analyzed.Results: During the study period, 76 patients underwent PCI who were before CABG patients. The PCI target was a native coronary artery in 73.6% and a bypass graft in 28.9%. The majority of patients presented more than five years after the CABG (64.4%). Post PCI angina was seen in 7(9.2%), and in 6(7.8%) patients, procedural complications seen. It was found that most PCI was done in patients who presented more than five years after CABG.Conclusions: Most PCIs performed in prior CABG patients are done in native coronary artery lesions.