New-generation Drug-eluting Stents Research Articles

Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group

Coronary artery disease (CAD) is currently the leading cause of death globally, and the prevalence of this disease is growing more rapidly in the Asia-Pacific region than in Western countries. Although the use of metal coronary stents has rapidly increased thanks to the advancement of safety and efficacy of newer generation drug eluting stent (DES), patients are still negatively affected by some the inherent limitations of this type of treatment, such as stent thrombosis or restenosis, including neoatherosclerosis, and the obligatory use of dual antiplatelet therapy (DAPT) with unknown optimal duration. Drug-coated balloon (DCB) treatment is based on a leave-nothing-behind concept and therefore it is not limited by stent thrombosis and long-term DAPT; it directly delivers an anti-proliferative drug which is coated on a balloon after improving coronary blood flow. At present, DCB treatment is recommended as the first-line treatment option in metal stent-related restenosis linked to DES and bare metal stent. For de novo coronary lesions, the application of DCB treatment is extended further, for conditions such as small vessel disease, bifurcation lesions, and chronic total occlusion lesions, and others. Recently, several reports have suggested that fractional flow reserve guided DCB application was safe for larger coronary artery lesions and showed good long-term outcomes. Therefore, the aim of these recommendations of the consensus group was to provide adequate guidelines for patients with CAD based on objective evidence, and to extend the application of DCB to a wider variety of coronary diseases and guide their most effective and correct use in actual clinical practice.

Coronary endothelial and microvascular function distal to polymer-free and endothelial cell-capturing drug-eluting stents. The randomized FUNCOMBO trial

Introduction and objectivesThe vasomotor function of new-generation drug-eluting stents designed to enhance stent healing and reendothelialization is unknown. This study aimed to compare the endothelial function of the infarct-related artery (IRA) treated with bioactive circulating endothelial progenitor cell-capturing sirolimus-eluting stents (COMBO) vs polymer-free biolimus-eluting stents (BioFreedom) in ST-segment elevation myocardial infarction patients at 6 months. Secondary objectives were to compare the microcirculatory function of the IRA and stent healing at 6 months. MethodsSixty patients were randomized to bioactive sirolimus-eluting stent vs polymer-free biolimus-eluting stents implantation. At 6 months, patients underwent coronary angiography with vasomotor, microcirculatory and optical coherence tomography examinations. Endothelial dysfunction of the distal coronary segment was defined as ≥ 4% vasoconstriction to intracoronary acetylcholine infusion. ResultsEndothelial dysfunction was similarly observed between groups (64.0% vs 62.5%, respectively; P=.913). Mean lumen diameter decreased by 16.0 ±20.2% vs 16.1 ±21.6% during acetylcholine infusion (P=.983). Microcirculatory function was similar in the 2 groups: coronary flow reserve was 3.23 ±1.77 vs 3.23±1.62 (P=.992) and the index of microcirculatory resistance was 24.8±16.8 vs 21.3±12.0 (P=.440). Optical coherence tomography findings were similar: uncovered struts (2.3% vs 3.2%; P=.466), malapposed struts (0.1% vs 0.3%; P=.519) and major evaginations (7.1% vs 5.6%; P=.708) were observed in few cases. ConclusionsEndothelial dysfunction of the IRA was frequent and was similarly observed with new-generation drug-eluting stents designed to enhance stent reendothelialization at 6 months. Endothelial dysfunction was observed despite almost preserved microcirculatory function and complete stent coverage. Larger and clinically powered studies are needed to assess the role of residual endothelial dysfunction in ST-segment elevation myocardial infarction patients.Registered in ClinicalTrials.gov: NCT04202172

Early Vascular Response to Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents for the Treatment of ST-Elevation Myocardial Infarction After Plaque Rupture.

Recent clinical studies suggest that newer-generation drug-eluting stents that combine ultrathin struts and nanocoating (biodegradable polymer sirolimus-eluting stents, BP-SES) could improve long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). However, the early vascular response to BP-SES in these patients has not been investigated so far.We examined this response in 20 patients with STEMI caused by plaque rupture using frequency-domain optical coherence tomography (OCT) to understand the underlying mechanisms. Plaque rupture was diagnosed by OCT before PCI with BP-SES implantation was performed. OCT was again performed before the final angiography (post-PCI) and after 2 weeks (2W-OCT).BP-SES placement caused protrusion of atherothrombotic material into the stent lumen and incomplete stent apposition in all patients. After 2 weeks, incomplete stent apposition was significantly reduced (% malapposed struts: post-PCI 4.7 ± 3.3%; 2W-OCT 0.9 ± 1.2%; P < 0.0001), and the percentage of uncovered struts also significantly decreased (% uncovered struts: post-PCI; 69.8 ± 18.3%: 2W-OCT; 29.6 ± 11.0%, P < 0.0001). The maximum protrusion area of the atherothrombotic burden was significantly reduced (post-PCI 1.36 ± 0.70 mm2; 2W-OCT 0.98 ± 0.55 mm2; P = 0.004).This study on the early vascular responses following BP-SES implantation showed rapid resolution of atherothrombotic material and progression of strut apposition and coverage. (UMIN000041324).

Stentless Interventional Procedure Using Rotational Atherectomy and Drug-Coated Balloon for Noncalcified De Novo Lesions

BackgroundSeveral recent reports have shown that a stentless interventional procedure using rotational atherectomy followed by drug-coated balloon (DCB) treatment (RA/DCB) is a potent revascularization therapy for calcified de novo lesions even in the new-generation drug-eluting stent era; however, the role of the RA/DCB procedure for noncalcified de novo lesions remains unclear. MethodsA total of 47 consecutive patients (53 lesions) who underwent RA/DCB for coronary de novo lesions were enrolled. According to the presence or absence of severe calcification at target lesions on fluoroscopy, the 47 patients were divided into the noncalcified cases (n = 12) and the calcified cases (n = 35), and the 53 lesions were divided into the noncalcified lesions (n = 14) and the calcified lesions (n = 39). ResultsThe noncalcified cases tended to have a higher frequency of bleeding risk and had a significantly lower prevalence of dual antiplatelet therapy compared with the calcified cases. The main lesion-specific factors for the RA/DCB procedure among the noncalcified lesions were presence of left circumflex coronary artery ostial lesion. The final burr size, DCB diameter used, and angiographic success rate did not significantly differ between the 2 groups. The noncalcified lesions had a larger reference diameter and a shorter lesion length than the calcified lesions, whereas acute gain and late lumen loss did not differ between the 2 groups. Nine-month clinical outcomes were comparable between the 2 groups. ConclusionsUnder drug-eluting stent-unsuitable clinical or lesion conditions, acute and midterm outcomes of RA/DCB for noncalcified de novo lesions might be comparable with those for calcified de novo lesions.

Association between angiographic and intravascular ultrasound optimizations after new-generation drug-eluting stent implantation and clinical outcomes.

Uncertainty remains regarding the associations of angiographic optimization and intravascular ultrasound (IVUS) optimization after new-generation drug-eluting stent (DES) implantation. From four randomized trials comparing outcomes between IVUS and angiography-guidance for long or chronic total occlusion (CTO) lesions, 1396 patients who underwent IVUS-guided new-generation DES implantation were enrolled. Of these, 1112 patients (80%) met angiographic optimization criteria (postprocedural diameter stenosis, ≤20%) and were further classified into the matched (same results for angiographic optimization and IVUS optimization) and the mismatched group (opposite results for angiographic optimization and IVUS optimization) according to the meeting of IVUS optimization criteria (minimal stent area, ≥5.5 mm2 or ≥80% of mean reference lumen area). The major adverse clinical events (MACE) were compared. Of 1112 patients with angiographic optimization, 675 patients met the IVUS optimization criteria (61%; matched), but 437 patients (39%; mismatched) failed to meet IVUS optimization criteria (false-positive rate = 76%). On multivariate analyses, age >60 years, reference vessel diameter ≤2.7 mm, left circumflex artery and lesion length ≥33 mm were significant predictors for the mismatched. When comparing the 12-month MACE rates, the mismatched group (6.8%) showed a significantly higher rate than the matched group (1.5%; hazard ratio = 2.62; 95% confidence interval = 1.20-5.72; P = 0.012), mainly driven by a higher target-vessel revascularization rate (6.4 vs 1.4%; P = 0.021). Despite meeting angiographic optimization criteria in long or CTO lesions, more than one-third of the patients with IVUS-guided new-generation DES implantation failed to meet the IVUS optimization criteria and had worse clinical outcomes. Therefore, IVUS optimization should be considered for patients who had predictors of mismatch.

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Graftinge Among Patients with Unprotected Left Main Coronary Artery Disease in the New-Generation Drug-Eluting Stents Era (From the CREDO-Kyoto PCI/CABG Registry Cohort-3)

Long-term safety of percutaneous coronary intervention (PCI) as compared with coronary artery bypass grafting (CABG) is still controversial in patients with unprotected left main coronary artery disease (ULMCAD), and there is a scarcity of real-world data on the comparative long-term clinical outcomes between PCI and CABG for ULMCAD in new-generation drug-eluting stents era. The CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients undergoing first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013, and we identified 855 patients with ULMCAD (PCI: N = 383 [45%], and CABG: N = 472 [55%]). The primary outcome measure was all-cause death. Median follow-up duration was 5.5 (interquartile range: 3.9 to 6.6) years. The cumulative 5-year incidence of all-cause death was not significantly different between the PCI and CABG groups (21.9% vs 17.6%, Log-rank p = 0.13). After adjusting confounders, the excess risk of PCI relative to CABG remained insignificant for all-cause death (HR, 1.00; 95% CI, 0.68 to 1.47; p = 0.99). There were significant excess risks of PCI relative to CABG for myocardial infarction and any coronary revascularization (HR, 2.07; 95% CI, 1.30 to 3.37; p = 0.002, and HR, 2.96; 95% CI, 1.96 to 4.46; p < 0.001), whereas there was no significant excess risk of PCI relative to CABG for stroke (HR, 0.85; 95% CI, 0.50 to 1.41; p = 0.52). In conclusion, there was no excess long-term mortality risk of PCI relative to CABG, while the excess risks of PCI relative to CABG were significant for myocardial infarction and any coronary revascularization in the present study population reflecting real-world clinical practice in Japan.

Comparison of Outcomes of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting Among Patients With Three-Vessel Coronary Artery Disease in the New-Generation Drug-Eluting Stents Era (From CREDO-Kyoto PCI/CABG Registry Cohort-3)

There is a scarcity of data comparing long-term clinical outcomes between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel coronary artery disease (3VD) in the new-generation drug-eluting stents era. CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients who had undergone first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013. We identified 2525 patients with 3VD (PCI: n = 1747 [69%], and CABG: n = 778 [31%]). The primary outcome measure was all-cause death. Median follow-up duration was 5.7 (interquartile range: 4.4 to 6.6) years. The cumulative 5-year incidence of all-cause death was significantly higher in the PCI group than in the CABG group (19.8% vs 13.2%, log-rank p = 0.001). After adjusting confounders, the excess risk of PCI relative to CABG for all-cause death remained significant (HR, 1.45; 95% CI, 1.14 to 1.86; p = 0.003), which was mainly driven by the excess risk for non-cardiovascular death (HR, 1.88; 95% CI, 1.30 to 2.79; p = 0.001), while there was no excess risk for cardiovascular death between PCI and CABG (HR, 1.19; 95% CI, 0.87 to 1.64; p = 0.29). There was significant excess risk of PCI relative to CABG for myocardial infarction (HR, 1.77; 95% CI, 1.19 to 2.69; p = 0.006), whereas there was no excess risk of PCI relative to CABG for stroke (HR, 1.24; 95% CI, 0.83 to 1.88; p = 0.30). In conclusion, in the present study population reflecting real-world clinical practice in Japan, PCI compared with CABG was associated with significantly higher risk for all-cause death, while there was no excess risk for cardiovascular death between PCI and CABG.

Update on coronary artery bioresorbable vascular scaffolds in percutaneous coronary revascularization.

Coronary angioplasty was first introduced in 1977. From plain old balloon angioplasty to the introduction of bare metal stents in 1986 and dual antiplatelet therapy in 1992 to much more later on. Due to the unacceptable rate of stent restenosis, drug eluting stents (DES) were introduced in 2000. The first generation showed an increase in late stent thrombosis which led to the introduction of the second generation DES with biocompatible or biodegradable polymers and thinner platforms. However very late stent thrombosis and late restenosis might still pose problems in the latter. Furthermore, there has been major debate regarding the impact of long-term vessel caging on normal vasomotricity and long-term positive remodeling. To resolve these issues, the bioresorbable vascular scaffolds (BVS) were launched into the real world in 2011, showing promising initial results. Multiple randomized trials, meta-analyses, and registries were performed, mainly with the Absorb Bioresorbable Vascular Scaffold System (Abbott Vascular, Chicago, IL, USA). This new technology is hindered by certain features, such as the BVS radial strength, its strut thickness, and the inflammatory process related to scaffold degradation. Moreover, there is known data indicating higher thrombosis rate with the Absorb BVS compared with the new generation of DES, despite similar cardiovascular death. In this review, we discuss the clinical procedural and technical evidence on BVS, with emphasis on their clinical impact. We finally tackle the future directions on device and procedural improvement while asking: is the bioresorbable technology still the way to the future?

Short and long-term follow-up after coronary artery bypass surgery or percutaneous coronary intervention among elderly patients with multivessel disease

Aim: Compared to young patients, elderly patients are more prone to multivessel coronary artery disease, have more calcific coronary vessels, and experience greater delays in receiving medical help. Notably, differences in in-hospital and post-discharge mortality and morbidity rates have been observed between patient who underwent percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). The present study primarily aimed to determine differences between CABG and PCI (with new-generation drug-eluting stents) among elderly patients with unstable angina pectoris (USAP) or non-ST segment elevation myocardial infarction (NSTEMI) and intermediate SYNTAX score.Materials and Methods: This study evaluated the 441 consecutive elderly patients with with USAP or NSTEMI divided into two groups as PCI or CABG were retrospectively evaluated and followed up for 30 days and 5 years. All clinical incidents, such as all-cause mortality, cardiac death, myocardial infarction (MI),stroke, revascularization and stent thrombosis were recorded.Results: Among the include patients, 200 received PCI (%45.4) and 241 (%54.6) received CABG. 1.3% and 4.8% of the patients in the PCI and CABG group developed a stroke, respectively (p=0.048). The PCI group (23%) exhibited a higher major adverse cardiovascular events percentage than the CABG group (18.7%), albeit not significantly (p=0.264). Repeat revascularization was required in 20 (10.1%) and 18 patients (10.8%) in the PCI and CABG group, respectively (p = 0.337). Among the included patients, 10.3% of those who underwent PCI developed MI, whereas only of 5.3% of those who underwent CABG developed the same (p=0.045). All-cause mortality rates at the 5-year follow-up were 12.7% (25 patients) and 9.1% (21 patients) in the PCI and CABG group, respectively (p=0.225). Accordingly, no difference in all-cause mortality between both groups was found during the first 30 days following revascularization (p=0.13). Moreover, Kaplan–Meier survival analysis showed a difference between PCI and CABG during the 5-year observation period.Conclusion: No difference in all-cause mortality and repeat revascularization over a 5-year follow-up period was observed between the PCI and CABG groups. However, the CABG group had higher stroke rates, whereas the PCI group had higher MI rates.

Percutaneous coronary intervention using rotational atherectomy and new-generation drug-eluting stents in mild versus moderate-to-severe chronic kidney disease patients with coronary artery disease

Background: The presence of calcified lesions in chronic kidney disease (CKD) patients adversely affects the outcomes of percutaneous coronary interventions (PCIs). Lesion modification using rotational atherectomy (RA) followed by drug-eluting stent (DES) implantation may, therefore, be a suitable strategy to treat heavily calcified coronary lesions in CKD patients. Aim: The aim of the study was to compare the effectiveness and safety of PCI using RA and new-generation DES for treating calcified coronary lesions in patients with mild versus moderate-to-severe CKD. Methods: This was a single-center, retrospective study. Data were collected from the medical records of all CKD patients with calcified coronary artery lesions who underwent RA + DES implantation from November 2014 to October 2019. The primary outcomes were the rates of in-stent restenosis (ISR), repeat revascularization (RR), and major adverse cardiovascular and cerebrovascular events. Secondary outcomes included procedural success, death after intervention, and procedural/in-hospital complications. Results: A total of 77 and 126 patients with mild and moderate-to-severe CKD were treated with RA + DES. Patients with moderate-to-severe CKD were significantly older when compared to patients with mild CKD (mean age: 66.6 ± 8.2 vs. 59.5 ± 7.7 years, respectively, P

Outcomes of a New-Generation Polymer-Free Amphilimus-Eluting Stent in Complex Coronary Lesions

The new-generation Cre8 EVO amphilimus drug-eluting stent (DES) has an improved architecture and design, which is favourable for complex percutaneous coronary intervention (PCI).

Impact of Neointimal Condition and Platelet Reactivity on Intrastent Thrombus at Long-Term Follow-up After 2nd- and 3rd-Generation Drug-Eluting Stent Implantation - Insights From a Coronary Angioscopy and Pharmacodynamic Study.

Although the incidence of very late stent failure (VLSF) is reduced with newer generation drug-eluting stent (DES), the mechanism of VLSF has not been fully explored.Methods and Results:This study evaluated both local vascular healing using coronary angioscopy and systemic factors determined by platelet reactivity at long-term follow-up after 2nd- and 3rd-generation DES implantation in patients with acute coronary syndrome. Coronary angioscopy was performed to assess neointimal coverage (NIC), yellow color (YC) grade and presence of thrombus. The obtained findings were compared with 2nd- and 3rd-DES. Platelet aggregation was assessed by light transmittance aggregometry. 100 consecutive patients were prospectively enrolled: 2nd- (n=50) and 3rd-DES (n=50). 3rd-DES patients had significantly higher NIC grade and lower YC grade compared with 2nd-DES. The presence of thrombus was tended to be lower with 3rd-DES than with 2nd-DES (8% vs. 18%, P=0.11). Patients with thrombus had significantly higher maximum platelet aggregation and higher prevalence of high on-treatment platelet reactivity (HPR) than those without thrombus. Multivariable analysis showed stent strut exposure and HPR as independent predictors of thrombus. Newer generation DES contribute to better vascular healing depending on the degree of neointimal coverage. In addition to local factors at the stented lesion, systemic factors such as degree of platelet reactivity might also contribute to VLSF.

Mechanisms of drug-eluting stent restenosis.

Drug-eluting stents (DES) were developed to overcome in-stent restenosis (ISR), which has long been considered the main complication limiting the long-term efficacy of coronary stenting. New-generation DES which composed of advanced stent design with and without specific biocompatible polymer contributes a reduction of the incidence of ISR to rate ranging from 5 to 10%. The precise reasons of DES restenosis are still controversial and not fully understood. Angiographic and coronary images at the index procedure, systemic status of patients, medications, and intracoronary imaging at ISR site are all considered to find the possible mechanisms of DES restenosis. Multiple biological, genetic, mechanical, and technical factors might intricately contribute to DES restenosis. Biological and genetic factors of ISR are not able to be sufficiently modified by the current medical approaches. Tailored treatments avoiding mechanical and technical factors of ISR are required to reduce DES restenosis. Elucidation of DES restenosis leads to further improvement in the current DES system and finds the optimal approach to treat DES restenosis. The possible mechanisms of DES restenosis are discussed in this review.

Abstract 15409: The Need for Lesion-specific Stent Optimization Criteria in Intravascular Ultrasound-guided Intervention for Diffuse Long Coronary Lesions: An Individual Patient-level Pooled Analysis of Four Randomized Controlled Trials

Introduction: Achieving stent optimization on intravascular ultrasound (IVUS) is associated with favorable clinical outcomes in new-generation drug-eluting stents (DESs) implantation. Little is known about the stent optimization criteria in lesion subsets assorted according to vessel size and lesion length. Hypothesis: We hypothesized lesion-specific IVUS criteria could provide a better prediction for the outcomes after DES implantation for diffuse coronary lesions. Methods: From four randomized trials comparing IVUS and angiography guidance in long coronary lesions, a total of 1,194 patients who underwent IVUS-guided intervention with DESs ≥26 mm in length were included. Primary endpoint was a major adverse cardiac event (MACE), defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, or stent thrombosis at 1 year following intervention. Results: MACE occurred in 41 (3.4%) patients. Among possible combinations of absolute and relative expansion criteria, the combination best predicting MACE was minimal stent area (MSA) ≥5.4 mm 2 or 80% of mean lumen area (MLA) (Youden index=0.250) in overall patients. In 2x2 factorial subgroup analyses, the MSA cutoff was 4.9 mm 2 or 85% of MLA for shorter (&lt;30 mm) lesions with a smaller vessel diameter (reference vessel diameter [RVD] &lt;3.0 mm) (Index=0.616) and 5.6 mm 2 or 85% for shorter lesions with a larger vessel diameter (RVD ≥3.0 mm) (Index=0.211). In longer lesions (≥30 mm), the MSA cutoff was 5.5 mm 2 or 70% of MLA for smaller vessels (RVD &lt;3.0 mm) (Index=0.469), and 6.2 mm 2 or 70% for larger vessels (RVD ≥3.0 mm) (Index=0.578). Conclusions: When IVUS is used to optimize DES implantations for long coronary stenoses, applying different criteria according to angiographic parameters might improve the outcomes. In relatively longer lesions with a larger vessel diameter, pursuing to achieve a higher absolute MSA value rather than relative expansion might be more important.

Cancer treatment resumption in patients with new-generation drug-eluting stents.

Percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DESs) may provide survival benefits to the cancer population undergoing PCI by expediting cancer treatment due to improved safety profile. We aimed to assess the safety of starting or resuming cancer treatment within 6 months of DES placement. We also compared the impact of different DES types on the overall survival (OS) in cancer patients and to identify a safe threshold for dual antiplatelet therapy (DAPT) discontinuation. Cancer patients at our institution undergoing PCI with DES from December 2014 to June 2017 were included. Baseline demographics, DAPT duration, malignancy type, stage, and treatment were retrospectively analyzed. Univariate Cox regression was used to pinpoint baseline characteristics that correlated with OS. Survivorship was determined by Kaplan-Meier analysis, and the log-rank test was used to compare OS among DES types. Seventy-five patients were included. Of these, 45 had biodegradable polymer DES (Synergy) and 30 patients had durable polymer DES (Resolute Integrity, Xience, Ion, or Promus). Mean duration of follow-up was 1367 ± 334 days. There were two minor bleeding complications. No statistically significant differences in OS were found among different stent brands. Discontinuation of aspirin, early P2Y12 inhibitor discontinuation, and advanced cancer were significantly associated with OS. DAPT discontinuation <6 months after PCI was not associated with stent thrombosis or in-stent restenosis. There were two major adverse cardiac events: one in-stent restenosis while on DAPT for >12 months (attributed to radiation-induced heart disease) and one myocardial infarction and death. Of patients who resumed or started cancer treatment (chemotherapy, radiation therapy, or surgery) after PCI, all but one did so within 6 months of PCI, and most of them as early as 2 weeks. Patients may resume cancer treatment <6 months after PCI. We suggest that DAPT may be safely interrupted as early as 6 months, but additional longitudinal studies are needed.

Cardiac outcomes in patients with acute coronary syndrome attributable to calcified nodule

Background and aimsCalcified nodule (CN) is an eruptive calcified mass causing acute coronary syndrome (ACS). Since coronary calcification is associated with an elevated cardiac event's risk, ACS attributable to CN may exhibit worse clinical outcome following percutaneous coronary intervention (PCI). MethodsWe retrospectively analyzed 657 ACS patients receiving PCI with newer-generation drug-eluting stent (DES) implantation under intravascular ultrasound (IVUS) guidance. CN was defined as (1) protruding calcification with its irregular surface and (2) the presence of calcification at adjacent proximal and distal segments. The primary endpoint was a composite of major adverse cardiac event [MACE = cardiac death + ACS recurrence + target lesion revascularization (TLR)]. ResultsCN was identified in 5.3% (=35/657) of the study subjects. CN patients were more likely to have coronary risk factors including hypertension (p = 0.005), chronic kidney disease (p < 0.001), maintenance hemodialysis (p < 0.001) and a history of PCI (p < 0.001). During the observational period (median = 1304 days), CN was associated with an increased risk of MACE (HR = 7.68, 95%CI = 4.61–12.80, p < 0.001), ACS recurrence (HR = 12.32, 95%CI = 6.05–25.11, p < 0.001) and TLR (HR = 10.48, 95%CI = 5.80–18.94, p < 0.001). These cardiac risks related to CN were consistently observed by Cox proportional hazards model (MACE: p < 0.001, ACS recurrence: p < 0.001, TLR: p < 0.001) and a propensity score–matched cohort analysis (MACE: p = 0.002, ACS recurrence: p = 0.01, TLR: p = 0.005). Of note, over 80% of TLR at the CN lesion was driven by its re-appearance within the implanted DES. ConclusionsACS patients attributable to CN have an increased risk of ACS recurrence and TLR, mainly driven by the continuous growth and protrusion of the calcified mass.

Hybrid minimally invasive multivessel coronary artery bypass grafting to achieve complete myocardial revascularisation: the first clinical case

Aim. To report the first clinical case of the hybrid procedure combining off-pump minimally invasive multivessel coronary artery bypass grafting (MICS-CABG) and percutaneous coronary intervention (PCI) of the obtuse marginal (OM) artery to achieve complete myocardial revascularisation.Clinical case. Bilateral in situ skeletonised left internal mammary artery (IMA) grafting to the left anterior descending artery was performed, and a Y-shape anastomosis was created from the left IMA-right IMA to the circumflex branch. At 2 hours postoperatively, graft failure caused by subtotal stenosis at the graft was diagnosed. Reconstruction of the anastomosis improved the transit time flow measurement by 3.5 hours postoperatively. Acute myocardial infarction did not develop. On postoperative day 1, graft patency was assessed, and then the OM stent was placed. On postoperative day 8, the patient was discharged and referred to the outpatient centre for further treatment and rehabilitation. Hybrid revascularisation offers the advantages of both CABG and PCI; however, the technical complexity is a major limitation for its widespread use. This case reports the development of adverse events during the surgeon's training to perform this nonstandard technology. Timely diagnosis of the initial graft failure and surgical revision led to a successful and complication-free outcome and avoided prolonged patient rehabilitation.Conclusion. Hybrid revascularisation combining MICS-CABG and PCI with new-generation drug-eluting stents can be a worthwhile alternative to conventional multivessel CABG with minimal invasiveness and complete revascularisation. Received 5 June 2020. Revised 10 September 2020. Accepted 15 September 2020. Funding: The study did not have sponsorship. Conflict of interest: Authors declare no conflict of interest.

Utilization and outcomes of rotational atherectomy in Sweden

Abstract Aim To evaluate utilization and outcomes of rotational atherectomy (RA) using data from the Swedish Coronary and Angioplasty Registry (SCAAR) Methods We included 1476 patients with 2218 lesions who underwent RA from 2005 to 2016. To study temporal changes, the study period was divided into three equal time-periods, period A, B and C. Results Although the number of RA procedures increased 3-fold from 2005 to 2016, the rate of RA (of all PCI procedures) remained low (0.5% vs 1.2% in 2005 vs 2016). RA patients consisted a high-risk group, with advanced age and clustering of comorbidities. Over time, included patients were older and had a higher risk profile. Trans-radial access, drug eluting stent (DES) use and use of intravascular imaging significantly increased from period A to C whereas positioning of a temporary pacemaker or intra-aortic balloon pump declined. Unfractionated heparin became the main anticoagulant (52 vs 87%) and use of glycoprotein IIb/IIIa inhibitors declined (31 vs 12%, in period A vs C). Following RA, 11% of lesions were treated without stent (15 vs 15 vs 8%, in period A, B and C) (Rota-only). In lesions treated with a stent, a bare metal stent (BMS) was implanted in 39% vs 12% vs 2% and a new generation DES (N-DES) in 5 vs 75 vs 97% (period A vs B vs C) of lesions. The 3-year cumulative rate of restenosis was 6.7% (122 events), (11.1 vs 7.1 vs 4.1% in period A vs B vs C). As compared to DES, rota-only (adjusted HR 2.71; 95% CI 1.69- 4.36) and BMS (adjusted HR 3.63; 95% CI 2.27- 5.81) were associated with significantly higher risk for restenosis. First generation DES were associated with numerically higher but not significantly different risk for restenosis as compared to N-DES (adjusted HR 1.31; 95% CI 0.74- 2.31). The 3 year cumulative rate of major adverse cardiac events (MACE), including death, myocardial infarction (MI) or any restenosis was 30.6% (34.2 vs 31.4 vs 28.2%, in period A vs B vs C) and the corresponding numbers for all-cause mortality were 18.1% (18.9 vs 18.4 vs 17.0%). After adjustment for baseline characteristics and angiographic findings, RA in period A was associated with higher risk for MACE as compared to period C (adjusted HR 1.40; 95% CI 1.09- 1.79), due to higher risk for MI and restenosis. The difference disappeared when procedural characteristics, including DES use, were added to the model. The rate of major in-hospital complications was 7.0%, including in-hospital death 1.3%, periprocedural MI 2.8%, perforation 1.1%, cardiac tamponade 0.7%, stroke 0.2% and major bleedings 2.1%. We found no significant differences over time. Conclusion During the studied period, RA remained a rare procedure, utilised in a highly selected population. Over time a declining rate of restenosis and MI after RA was observed, a finding that appeared to be mainly driven by an increased use of DES. The rate of major in-hospital complication remained low. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boston Scientific International

Comprehensive Outcomes Evaluation After Percutaneous Coronary Intervention in Stable Ischemic Heart Disease and Acute Coronary Syndrome for Short- Versus Standard-Term Dual Antiplatelet Therapy: A Systematic Review and Meta-analysis of Randomized Control Trials.

Newer generation drug eluting stents (DES) and pharmacotherapy have decreased thrombotic events post-percutaneous coronary intervention (PCI). There is lack of wide-ranging safety and efficacy evaluation in both stable ischemic heart disease and acute coronary syndrome in short-term (3-6 months) versus Standard-term (12 months) dual antiplatelet therapy (DAPT). We searched electronic databases using specific terms to identify randomized control trials comparing different durations of DAPT after PCI with DES. The outcomes of interest included all-cause mortality, myocardial infarction, stent thrombosis, major bleeding, target lesion and vessel revascularization, and stroke at follow-up duration ≥12 months post index PCI. Studies that compared DAPT <3 months or DAPT ≥12 months were excluded. Thirteen randomized control trials (n = 31,831) were included; 8401 patients received DAPT for 3 months and 7482 patients received DAPT in the 6 months group. Major bleeding rate was lower in the short-term (3-6 months) versus Standard-term (12 months) group (risk ratio 0.66; 95% confidence interval, 0.52-0.84, P < 0.05). Repeat revascularization rate was higher in the short-term (3-6 months) versus Standard-term (12 months) (risk ratio 1.17; 95% confidence interval, 1.01-1.36, P < 0.05) of DAPT duration after PCI with DES. No difference in other outcomes were observed when comparing short versus standard duration of DAPT in both stable ischemic heart disease and acute coronary syndrome.

A prospective, randomized, comparison of the coronary vasomotion associated with drug-coated balloon versus drug-eluting stent

Abstract Background It is widely known that even new-generation drug-eluting stent (DES) induce coronary vasomotion abnormality. On the other hand, recent studies reported that drug-coated balloon (DCB) for native coronary artery was non-inferior to DES in medium term outcomes. However, there is no available information about vasomotion after treatment with DCB. Purpose The aim of this study was to prospectively compare coronary vasomotion in patients treated with DCB versus new-generation DES. Methods Twenty-seven patients were randomly treated with angioplasty with DCB (n=12) versus implantation of bioabsorbable polymer everolimus-eluting stent (BP-EES, n=15) after successful predilation. At 8 months after treatment, endothelium-dependent and -independent vasomotion were evaluated by intracoronary infusion of incremental doses of acetylcholine (for right coronary artery: low-dose 5μg, high-dose 50μg and for left coronary artery: low-dose 10μg, high-dose 100μg) and nitroglycerine (200μg). Mean luminal diameter of the distal segments, beginning 5 mm and ending 15 mm distal to the edge of the treated segment was quantitatively measured by angiography. Results Clinical and procedural characteristics were not different between two groups. Vasoconstriction after acetylcholine infusion was less pronounced in the DCB group than the BP-EES group (low-dose: 4±13% vs −4±14%, p=0.158, high-dose: −2±14% vs −28±30%, p=0.013). The response to nitroglycerin was not different between two groups (17±13% vs 18±24%, p=0.838). Conclusion Vasoconstriction after acetylcholine infusion in the peri-treated region was more pronounced in the BP-EES group than in the DCB group, which suggests that endothelial function of coronary vessel treated by DCB can be more preserved than new-generation DES. Figure 1 Funding Acknowledgement Type of funding source: None