Conventional Percutaneous Coronary Intervention Research Articles

Clinical Impact of Perfusion Balloon for ST-Segment Elevated Myocardial Infarction: RYUSEI Study

Drug-eluting stents have significantly contributed to reducing mortality in patients with ST-segment elevation myocardial infarctions (STEMIs), but slow flow/no-reflow phenomenon (SFNR) and in-stent restenosis are still clinical problems. On the other hand, perfusion balloons (PBs) can compress thrombi and ruptured plaque for long inflation without ischemia and can be used as a delivery device for infusion of nitroprusside to distal risk area during ballooning. We conducted RYUSEI (Reduction of risk bY perfUsion balloon for ST-segment Elevated myocardial Infarction) study to evaluate whether PBs before stenting are more effective than conventional stenting for STEMIs. We divided consecutive patients with STEMIs who underwent optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) into PB group who were treated with PBs (Ryusei®; Kaneka Medix Corporation, Osaka, Japan) before stenting and the conventional PCI (CP) group. We compared clinical results including SFNR, OCT findings, and clinical events between the two groups. We finally analyzed 34 patients in PB group and 90 in CP group. After propensity score matching, PB and CP groups consisted of 23 patients, respectively. In the propensity score-matched cohort, SFNR and maximum protrusion area detected by OCT were significantly lower (P=0.047 and P=0.019) and TIMI flow grade 3 higher (P=0.022) in the PB group than CP group. Kaplan-Meier analysis revealed a significantly better clinical outcome in PB group than CP group (p=0.038). In conclusion, the RYUSEI study revealed a pre-stent lesion modification in addition to nitroprusside infusion using PB is useful to achieve better clinical course in STEMI patients.

Effect of modified Buyang huanwu decoction on hemorheology, myocardial remodeling, serum soluble CD40 ligand and serum soluble P-selectin in patients with acute myocardial infarctionafter percutaneous coronary intervention

Purpose: To investigate the effect of modified Buyang Huanwu decoction on hemorheology and myocardial remodeling in patients with acute myocardial infarction (AMI) after conventional percutaneous coronary intervention (PCI), and its relationship with serum levels of soluble CD40 ligand (sCD40L) and soluble P-selectin (sP-sel). 
 Methods: After PCI, 80 patients seen from February 2021 to February 2022 in Shijiazhuang Fourth Hospital, China with AMI were enrolled in the study. Subjects were assigned to study and control groups. Control group received standard conventional medical treatments, while study group received modified Buyang Huanwu decoction, in addition to the same standard treatment, orally twice a day (morning and night) for 3 months). The effect of modified Buyang Huanwu decoction was determined by comparing the post-treatment clinical outcomes and levels of hemorheology indices and myocardial remodeling-associated indices (myocardial injury markers) in both groups of patients. 
 Results: The clinical outcome in study group was significantly better, and the hemorheology indices were significantly improved when compared to control subjects (p < 0.05). Serum levels of myocardial injury markers (cardiac troponin (cTnI), cardiac markers (CRP), and brain natriuretic peptide (BNP)), and inflammatory markers (sCD40L and sP-sel) in study group were significantly decreased to varying degrees, relative to control group (p < 0.05). 
 Conclusion: Modified Buyang Huanwu decoction reduces inflammatory marker levels, cardiac inflammatory response and myocardial remodeling, and improves the prognosis of AMI in patients after PCI. Therefore, it may be beneficial to develop other methods for treating acute myocardial infarction after percutaneous coronary intervention.

Drug coated balloons-based approach versus conventional percutaneous coronary intervention with drug eluting stents for left anterior descending revascularization

Abstract Introduction While representing the gold standard for percutaneous coronary interventions (PCI), drug eluting stents (DES) are associated with a progressively increasing risk of stent-related adverse events over time. (1) Left anterior descending (LAD) disease is a critical area for coronary stenting, due to the wide distribution with several side branches at risk of occlusion after stent implantation. Thus, the development of novel approaches for LAD PCI is warranted. Drug-coated balloons (DCB) used alone or in combination with DES as part of a hybrid procedure could allow to minimize stent burden and reduce the occurrence of stent-related events, but the evidence on their use for de novo lesions in large vessels is limited. (2-4) Methods Consecutive patients undergoing DCB implantation on the LAD in two Italian centers from 2018 to 2021 were retrospectively enrolled and compared to a historical cohort of LAD PCI with DES. Patients with in-stent restenosis were excluded. The primary endpoint was target lesion revascularization (TLR), while secondary endpoints included target vessel revascularization (TVR) and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, TLR and TVR. Results 175 patients undergoing a DCB-based treatment on the LAD were included and compared to 1503 patients who received conventional PCI with DES. 83.9% of patients were male and 28.3% were diabetics, with no differences between the two groups. Total treated length was higher in the DCB group (54.9±20 for DES vs.66.2±35.2 mm for DCB, p<0.001); conversely, a greater mean DES length (54.9±20 vs.42.5±27.1 mm, p<0.001) was observed in the DES cohort. In the DCB group, mean DCB length was 36.8±20.2 mm; 32% of patients underwent DCB-only PCI and, in those who had hybrid PCI, DCB length was higher than stent length in 61.1% of cases. Large vessels (device diameter ≥3 mm) were treated in 81.6% and 77.1% of patients in the DES and DCB groups respectively, with no significant differences, while DCB with diameter ≥3 mm were used in 41.7% of patients in the DCB cohort. Mean follow-up duration was 2024 and 495 days in the DES and DCB groups respectively. At two years, the cumulative incidence of TLR was 9.1% (95% CI:7.6-10.9%) in the DES group vs. 4.8% (95% CI: 1.8-12.3%) in the DCB group (Log-rank p =0.225). After covariate adjustment through stepwise multivariable Cox regression analysis, DCB use was independently associated with lower TLR occurrence (HR 0.23, 95% CI: 0.06-0.98), alongside with large vessels involvement, while diabetes, dyslipidemia, and prior CABG correlated with greater TLR risk. No differences between DES and DCB were detected for secondary endpoints. Conclusions A DCB-based treatment approach allowed a significantly reduced stent burden for LAD PCI and led to a lower risk of target lesion failure at two years. Future randomized studies are warranted to demonstrate the effect of DCB-based LAD PCI on long term outcomes.Major adverse cardiovascular eventsTLR predictors at Cox regression

Drug-Coated Balloon Angioplasty for De Novo Lesions on the Left Anterior Descending Artery.

Drug-coated balloons (DCB) are an emerging tool for modern percutaneous coronary intervention (PCI), but evidence on their use for de novo lesions on large vessels is limited. Consecutive patients undergoing DCB-based PCI on the left anterior descending artery in 2 Italian centers from 2018 to 2022 were retrospectively enrolled and compared with patients who received left anterior descending PCI with contemporary drug-eluting stents (DES). In-stent restenosis was excluded. The DCB group included both patients undergoing DCB-only PCI and those receiving hybrid PCI with DCB and DES combined. The primary end point was target lesion failure at 2 years, defined as the composite of target lesion revascularization, cardiac death, and target vessel myocardial infarction. We included 147 consecutive patients undergoing DCB-based treatment on the left anterior descending artery and compared them to 701 patients who received conventional PCI with DES. In the DCB group, 43 patients (29.2%) were treated with DCB only and 104 (70.8%) with a hybrid approach; DCB length was greater than stent length in 55.1% of cases. Total treated length was higher in the DCB group (65 [40-82] versus 56 [46-66] mm; P=0.002), while longer DESs were implanted (38 [24-62] versus 56 [46-66] mm; P<0.001) and a higher rate of large vessels were treated (76.2% versus 83.5%; P=0.036) in the DES cohort. The cumulative 2-year target lesion failure incidence was not significantly different between the 2 groups (DCB, 4.1% versus DES, 9.8%; hazard ratio, 0.51 [95% CI, 0.20-1.27]; P=0.15). After a 1:1 propensity score matching resulting in 139 matched pairs, the DCB-based treatment was associated with a lower risk for target lesion failure at 2 years compared with DES-only PCI (hazard ratio, 0.2 [95% CI, 0.07-0.58]; P=0.003), mainly driven by less target lesion revascularization. A DCB-based treatment approach for left anterior descending revascularization allows a significantly reduced stent burden, thereby potentially limiting target lesion failure risk at midterm follow-up.

Coronary Physiology Guidance vs Conventional Angiography for Optimization of Percutaneous Coronary Intervention: The AQVA-II Trial

BackgroundThe debate surrounding the efficacy of coronary physiological guidance compared with conventional angiography in achieving optimal post–percutaneous coronary intervention (PCI) fractional flow reserve (FFR) values persists. ObjectivesThe primary aim of this study was to demonstrate the superiority of physiology-guided PCI, using either angiography or microcatheter-derived FFR, over conventional angiography-based PCI in complex high-risk indicated procedures (CHIPs). The secondary aim was to establish the noninferiority of angiography-derived FFR guidance compared with microcatheter-derived FFR guidance. MethodsPatients with obstructive coronary lesions and meeting CHIP criteria were randomized 2:1 to receive undergo physiology- or angiography-based PCI. Those assigned to the former were randomly allocated to angiography- or microcatheter-derived FFR guidance. CHIP criteria were long lesion (>28 mm), tandem lesions, severe calcifications, severe tortuosity, true bifurcation, in-stent restenosis, and left main stem disease. The primary outcome was invasive post-PCI FFR value. The optimal post-PCI FFR value was defined as >0.86. ResultsA total of 305 patients (331 study vessels) were enrolled in the study (101 undergoing conventional angiography-based PCI and 204 physiology-based PCI). Optimal post-PCI FFR values were more frequent in the physiology-based PCI group compared with the conventional angiography-based PCI group (77% vs 54%; absolute difference 23%, relative difference 30%; P < 0.0001). The occurrence of the primary outcome did not differ between the 2 physiology-based PCI subgroups, demonstrating the noninferiority of angiography- vs microcatheter-derived FFR (P < 0.01). ConclusionsIn CHIP patients, procedural planning and guidance on the basis of physiology (through either angiography- or microcatheter-derived FFR) are superior to conventional angiography for achieving optimal post-PCI FFR values. (Physiology Optimized Versus Angio-Guided PCI [AQVA-II]; NCT05658952)

Comparison of Intravascular Imaging, Functional, or Angiographically Guided Coronary Intervention

BackgroundIn patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether intravascular imaging guidance or functional guidance is the best strategy to optimize outcomes and if the results are different in patients with vs without acute coronary syndromes (ACS). ObjectivesThe purpose of this study was to evaluate clinical outcomes with imaging-guided PCI or functionally guided PCI when compared with conventional angiography-guided PCI. MethodsWe searched PUBMED and EMBASE for randomized controlled trials investigating outcomes with intravascular imaging-guided, functionally guided, or angiography-guided PCI. The primary outcome from this network meta-analysis was trial-defined major adverse cardiovascular event (MACE)—a composite of cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR). PCI strategies were ranked (best to worst) using P scores. ResultsOur search identified 32 eligible randomized controlled trials and included a total of 22,684 patients. Compared with angiography-guided PCI, intravascular imaging-guided PCI was associated with reduced risk of MACE (relative risk [RR]: 0.72; 95% CI: 0.62-0.82), cardiovascular death (RR: 0.56; 95% CI: 0.42-0.75), MI (RR: 0.81; 95% CI: 0.66-0.99), stent thrombosis (RR: 0.48; 95% CI: 0.31-0.73), and TLR (RR: 0.75; 95% CI: 0.57-0.99). Similarly, when compared with angiography-guided PCI, functionally guided PCI was associated with reduced risk of MACE and MI. Intravascular imaging-guided PCI ranked first for the outcomes of MACE, cardiovascular death, stent thrombosis, and TLR. The results were consistent in the ACS and non-ACS cohorts. ConclusionsAngiography-guided PCI had consistently worse outcomes compared with intravascular imaging-guided and functionally guided PCI. Intravascular imaging-guided PCI was the best strategy to reduce the risk of cardiovascular events.

Impact of myocardial deformation on risk prediction in patients following acute myocardial infarction.

Strain analyses derived from cardiovascular magnetic resonance-feature tracking (CMR-FT) provide incremental prognostic benefit in patients sufferring from acute myocardial infarction (AMI). This study aims to evaluate and revalidate previously reported prognostic implications of comprehensive strain analyses in a large independent cohort of patients with ST-elevation myocardial infarction (STEMI). Overall, 566 STEMI patients enrolled in the CONDITIONING-LIPSIA trial including pre- and/or postconditioning treatment in addition to conventional percutaneous coronary intervention underwent CMR imaging in median 3 days after primary percutaneous coronary intervention. CMR-based left atrial (LA) reservoir (Es), conduit (Ee), and boosterpump (Ea) strain analyses, as well as left ventricular (LV) global longitudinal strain (GLS), circumferential strain (GCS), and radial strain (GRS) analyses were carried out. Previously identified cutoff values were revalidated for risk stratification. Major adverse cardiac events (MACE) comprising death, reinfarction, and new congestive heart failure were assessed within 12 months after the occurrence of the index event. Both atrial and ventricular strain values were significantly reduced in patients with MACE (p < 0.01 for all). Predetermined LA and LV strain cutoffs enabled accurate risk assessment. All LA and LV strain values were associated with MACE on univariable regression modeling (p < 0.001 for all), with LA Es emerging as an independent predictor of MACE on multivariable regression modeling (HR 0.92, p = 0.033). Furthermore, LA Es provided an incremental prognostic value above LVEF (a c-index increase from 0.7 to 0.74, p = 0.03). External validation of CMR-FT-derived LA and LV strain evaluations confirmed the prognostic value of cardiac deformation assessment in STEMI patients. In the present study, LA strain parameters especially enabled further risk stratification and prognostic assessment over and above clinically established risk parameters. ClinicalTrials.gov, identifier NCT02158468.

QFR-Based Virtual PCI or Conventional Angiography to Guide PCI: The AQVA Trial

BackgroundPost–percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) values ≥0.90 are associated with a low incidence of adverse events. ObjectivesThe AQVA (Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR) trial aims to test whether a QFR-based virtual percutaneous coronary intervention (PCI) is superior to a conventional angiography-based PCI at obtaining optimal post-PCI QFR results. MethodsThe AQVA trial is an investigator-initiated, randomized, controlled, parallel-group clinical trial. A total of 300 patients (356 study vessels) undergoing PCI were randomized 1:1 to receive either QFR-based virtual PCI or angiography-based PCI (standard of care). The primary outcome was the rate of study vessels with a suboptimal post-PCI QFR value, which was defined as <0.90. Secondary outcomes were procedure duration, stent length/lesion, and stent number/patient. ResultsOverall, 38 (10.7%) study vessels missed the prespecified optimal post-PCI QFR target. The primary outcome occurred significantly more frequently in the angiography-based group (n = 26, 15.1%) compared with the QFR-based virtual PCI group (n = 12 [6.6%]; absolute difference = 8.5%; relative difference = 57%; P = 0.009). The main cause of a suboptimal result in the angiography-based group is the underestimation of a diseased segment outside the stented one. There were no significant differences among secondary endpoints, although stent length/lesion and stent number/patient were numerically lower in the virtual PCI group (P = 0.06 and P = 0.08, respectively), whereas procedure length was higher in the virtual PCI group (P = 0.06). ConclusionsThe AQVA trial demonstrated the superiority of QFR-based virtual PCI over angiography-based PCI with regard to post-PCI optimal physiological results. Future larger randomized clinical trials that demonstrate the superiority of this approach in terms of clinical outcomes are warranted. (Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR [AQVA]; NCT04664140)

Intravascular Imaging for Guiding In-Stent Restenosis and Stent Thrombosis Therapy.

Advances in stent technology and the design of endovascular devices with thinner struts, anti-inflammatory and antithrombotic polymers, and better drug kinetics have enhanced the safety and efficacy of the second-generation drug-eluting stents and broadened their use in the therapy of high-risk patients and complex anatomies. However, despite these developments, in-stent restenosis and stent thrombosis remain the Achilles' heel of percutaneous coronary intervention, with their cumulative incidence reaching up to 10% at 5 years following percutaneous coronary intervention. The treatment of stent failure poses challenges and is associated with a worse prognosis than conventional percutaneous coronary intervention. Several studies have recently highlighted the value of intravascular imaging in identifying causes of stent failure, underscored its role in treatment planning, and registries have shown that its use may be associated with better clinical outcomes. The present review aims to summarize the evidence in the field; it discusses the value of intravascular imaging in identifying the mechanisms of in-stent restenosis and stent thrombosis in assessing the morphological characteristics of neointima tissue that appears to determine long-term outcomes in evaluating procedural results, and presents the findings of studies supporting its value in guiding therapy in stent failure.

Techniques and Evidence for Percutaneous Coronary Intervention for Coronary Bifurcation Lesions: An Ongoing Journey

Techniques and Evidence for Percutaneous Coronary Intervention for Coronary Bifurcation Lesions: An Ongoing Journey

Clinical outcomes of no stenting in patients with ST-segment elevation myocardial infarction undergoing deferred primary percutaneous coronary intervention.

ST-segment elevation myocardial infarction (STEMI) is treated with stenting, but the underlying stenosis is often not severe, and stenting may potentially be omitted. The aim of the study was to investigate outcomes of patients with STEMI treated with percutaneous coronary intervention (PCI) without stenting. Patients were identified through the DANAMI-3-DEFER study. Stenting was omitted in the patients with stable flow after initial PCI and no significant residual stenosis on the deferral procedure, who were randomised to deferred stenting. These patients were compared to patients randomised to conventional PCI treated with immediate stenting. The primary endpoint was a composite of all-cause mortality, recurrent myocardial infarction (MI), and target vessel revascularisation (TVR). Of 603 patients randomised to deferred stenting, 84 were treated without stenting, and in patients randomised to conventional PCI (n=612), 590 were treated with immediate stenting. Patients treated with no stenting had a median stenosis of 40%, median vessel diameter of 2.9 mm, and median lesion length of 11.4 mm. During a median follow-up of 3.4 years, the composite endpoint occurred in 14% and 16% in the no and immediate stenting groups, respectively (unadjusted hazard ratio [HR] 0.87, 95% confidence interval [CI]: 0.48-1.60; p=0.66). The association remained non-significant after adjusting for confounders (adjusted HR 0.53, 95% CI: 0.22-1.24; p=0.14). The rates of TVR and recurrent MI were 2% vs 4% (p=0.70) and 4% vs 6% (p=0.43), respectively. Patients with STEMI, with no significant residual stenosis and stable flow after initial PCI, treated without stenting, had comparable event rates to patients treated with immediate stenting.

Ultra-low contrast PCI vs conventional PCI in patients of ACS with an increased pre-procedural risk of CI-AKI (CONSaVE-AKI study)

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Patients with acute coronary syndrome (ACS) and at an increased risk of developing CI-AKI can be identified prior to percutaneous coronary intervention (PCI) based on their pre-procedural risk scores. Ultra-low contrast PCI (ULC-PCI) is a novel contrast conservation strategy in such high risk patients for prevention of CI-AKI, however evidence of its feasibility and clinical utility is limited with no prospective randomized control trial available. Purpose This single center, prospective, randomized study assessed short-term outcomes and safety of ULC-PCI vs conventional PCI. It tested the hypothesis that in ACS patients undergoing PCI who are at an increased pre-procedural risk of developing CI-AKI, use of ULC-PCI strategy will cause less incidence of CI-AKI than in conventional PCI. Methods 82 patients [age 60.12 (±8.98) years] undergoing PCI for ACS were enrolled between December 2019 and August 2021 in a tertiary care center in India having creatinine clearance &amp;lt;60 ml/min/1.73 m2 by the MDRD equation and having a moderate to very high pre-procedural risk of developing CI-AKI as calculated by Maioli et al risk score(1). They were randomized into two groups of 41 patients each. In the ULC-PCI group, the total volume of contrast used was ≤ 1 x patient’s GFR and in the conventional PCI group, contrast volume was kept ≤ 3 x patient’s GFR. ULC-PCI protocol used aggressive intra-procedural contrast sparing strategies along with the use of IVUS guidance or staging of the multi-vessel PCI whenever feasible. Patients were followed up for primary end point of development of CI-AKI and secondary end point of any need for dialysis, re-hospitalization, death, repeat myocardial infarction or unplanned coronary re-interventions in a follow-up of 30 days. Primary PCI, chronic total occlusions and patients on maintenance hemodialysis were excluded from the study. Results Baseline clinical and angiographic characteristics were similar between groups. The primary outcome of CI-AKI occurred more in patients of the conventional PCI group [7 (17.1%)] than in the ULC PCI group [(0 patients), p = 0.012]. Contrast volume (41.02 (±9.8) mL vs 112.54 (±25.18) mL; P&amp;lt;.0001) was markedly lower in the ULC-PCI group. 6 patients had stage 1 AKI with recovery and 1 patient had stage 3 AKI requiring dialysis. ULC PCI was reasonably safe and effective with no significant difference in secondary safety outcomes between the two study arms. It was also applicable without lesion restriction. IVUS was used in 17% patients in the ULC PCI group. Conclusion An ULC-PCI in patients with increased risk of developing CI-AKI is feasible, appears to be safe, and has the potential to decrease the incidence of CI-AKI, compared with conventional PCI specially in resource limited setting such as ours where coronary imaging by IVUS is not possible in every patient. Also, in ACS patients with baseline renal dysfunction, revascularization is associated with improved GFR post PCI.

Feasibility, Safety, and Long-Term Outcomes of Zero-Contrast Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease.

The long-term safety and utility of intravascular ultrasound (IVUS)-guided zero-contrast percutaneous coronary intervention (PCI) in patients with chronic kidney disease (CKD) are unknown.Methods and Results: A total of 698 consecutive patients treated with PCI (1,061 procedures) in our center were studied. Patients with acute coronary syndrome, who are on maintenance hemodialysis, and who had a planned rotational atherectomy were excluded. Finally, they were divided into 2 groups: zero-contrast PCI (n=55, 78 procedures) and conventional PCI (n=462, 670 procedures). After propensity score matching, 50 patients were matched for each group to evaluate long-term outcomes. Primary endpoints were major adverse cardiovascular events (MACE), including all-cause death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization. All patients in the zero-contrast PCI group had stage 3-5 CKD with an estimated glomerular filtration rate of 38.3±14.8 mL/min/1.73 m2. Zero-contrast PCI was successful in all 78 procedures without renal events such as acute kidney injury or emergent hemodialysis and procedural complications such as coronary perforation or periprocedural MI. During a follow-up period of 32 months, 7 patients died (1 cardiac, 6 non-cardiovascular), and 4 patients were introduced to renal replacement therapy. The incidence of MACE was similar between the zero-contrast and conventional PCI groups (log-rank, P=0.95). IVUS-guided zero-contrast PCI might be safe and feasible in patients with CKD with satisfactory acute and long-term renal and cardiovascular outcomes.

Synthetic recovery of impulse propagation in myocardial infarction via silicon carbide semiconductive nanowires

Myocardial infarction causes 7.3 million deaths worldwide, mostly for fibrillation that electrically originates from the damaged areas of the left ventricle. Conventional cardiac bypass graft and percutaneous coronary interventions allow reperfusion of the downstream tissue but do not counteract the bioelectrical alteration originated from the infarct area. Genetic, cellular, and tissue engineering therapies are promising avenues but require days/months for permitting proper functional tissue regeneration. Here we engineered biocompatible silicon carbide semiconductive nanowires that synthetically couple, via membrane nanobridge formations, isolated beating cardiomyocytes over distance, restoring physiological cell-cell conductance, thereby permitting the synchronization of bioelectrical activity in otherwise uncoupled cells. Local in-situ multiple injections of nanowires in the left ventricular infarcted regions allow rapid reinstatement of impulse propagation across damaged areas and recover electrogram parameters and conduction velocity. Here we propose this nanomedical intervention as a strategy for reducing ventricular arrhythmia after acute myocardial infarction.

A Novel Robotic Control System Mimics Doctor’s Operation to Assist Percutaneous Coronary Intervention

Objectives: The use of current robotic systems to assist in percutaneous coronary intervention (PCI) fundamentally differs from performing conventional PCI. To overcome this problem, we developed a novel master-slave robotic control system to assist in PCI, and evaluated its safety and feasibility in the delivery and manipulation of coronary guidewires in vitro and in vivo. Methods: The novel robotic assist PCI system is composed of three parts: 1) a master actuator, which imitates the traditional torque used by surgeons in conventional PCI, 2) a slave actuator, including a guidewire delivery system and force monitoring equipment, and 3) a local area network based communication system. Results: The experiment was performed in six pigs. Both robotic and manual control completed the operation with no device- or procedure-associated complications. An experienced interventional cardiologist who was a first-time user of the novel robotic PCI system was able to advance the guidewire into a distal branch of a coronary artery within a similar time to that required with the manual procedure. Conclusion: This early in vivo experiment with the novel robotic assisted PCI control system demonstrated that its feasibility, safety, and procedural effectiveness are comparable to those of manual operation. The novel robotic-assisted PCI control system required significantly less time to learn than other currently available systems.

745 Meta-analysis comparing the safety and efficacy of ticagrelor monotherapy after a short course of ticagrelor-based dual antiplatelet therapy versus standard therapy in complex percutaneous coronary interventions

Abstract Aims Current guidelines recommend dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor for 6–12 months after percutaneous coronary intervention (PCI). A shorter duration ticagrelor-based DAPT followed by ticagrelor monotherapy can significantly reduce bleeding events while preserving anti-ischaemic effects in patients undergoing conventional PCI. Whether this strategy can be safely and effectively applied to those patient that undergo ‘complex’ PCI is uncertain. Methods We performed a systematic search of randomized controlled trials comparing a short course of ticagrelor-based DAPT vs. standard DAPT in patients undergoing complex PCI. A mixed-effects Poisson regression model with random intervention effects was used to estimate the pooled incidence rate ratios (IRR) with 95% confidence intervals (CI). Results Out of 10 689 studies screened, three were identified for a total of 4176 participants on ticagrelor monotherapy after a short course of ticagrelor based DAPT, and 4209 on standard DAPT. Overall, the pooled analysis showed a strong evidence that compared to standard treatment, ticagrelor monotherapy after a short course of ticagrelor-based DAPT (1–3 months) reduced the risk of cardiovascular death [IRR 0.52; CI (0.28–0.96); P = 0.04; I2 = 0%], all-cause death [IRR 0.65; CI (0.49–0.86); P = 0.003; I2 = 0%], and any bleeding events [IRR 0.62; CI (0.47–0.81); P &amp;lt; 0.001; I2 = 44%]. Weak evidence was found of an association between the experimental strategy and a lower risk of myocardial infarction [IRR 0.79; CI (0.61–1.01); P = 0.06; I2 = 0%]. Instead, no significant difference in the risk of major bleeding [IRR 0.72; CI (0.48–1.08); P = 0.11; I2 = 61%], definite or probable stent thrombosis [IRR 0.77; CI (0.34–1.75); P = 0.53; I2 = 0%] and ischaemic stroke [IRR 0.83; CI (0.25–2.73); P = 0.76; I2 = 0%] was observed. We speculate that the observed mortality benefits might be related to the reduction of any bleeding events, mainly dictated by minor bleeding reduction, since major bleeding did not seem to be decreased in the shorter regimen group. Conclusion Among patients undergoing complex PCI, ticagrelor monotherapy after a short course of ticagrelor-based DAPT significantly reduced bleeding risk without increasing ischaemic risk. As complex PCI procedures are being increasingly performed nowadays, and more comorbid patients are being treated, more studies are required to confirm and explain these findings. This could lead to optimization of antiplatelet therapy across a broad spectrum of patients.

Walking the Line with Ticagrelor: Meta-Analysis Comparing the Safety and Efficacy of Ticagrelor Monotherapy after a Short Course of Ticagrelor-Based Dual Antiplatelet Therapy versus Standard Therapy in Complex Percutaneous Coronary Intervention.

(1) Shorter-duration dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy has been shown to significantly reduce bleeding events while preserving anti-ischemic effects in patients undergoing conventional percutaneous coronary interventions (PCI). Whether this strategy is also safe and effective in complex PCI remains elusive; (2) A systematic search of randomized controlled trials comparing a short course of ticagrelor-based DAPT versus standard DAPT in patients undergoing complex PCI was performed; (3) Of 10,689 studies screened, 3 were identified for a total of 4176 participants on ticagrelor monotherapy after a short course of ticagrelor-based DAPT, and 4209 on standard DAPT. The pooled analysis revealed no difference in the outcomes of major bleeding, myocardial infarction, definite or probable stent thrombosis and ischemic stroke. A significant reduction in the risk of cardiovascular death (incidence rate ratio (IRR) 0.52; 95% CI 0.28–0.96; p = 0.04), all-cause death (IRR 0.65; 95% CI 0.49–0.86; p = 0.003), and any bleeding events (IRR 0.62; 95% CI 0.47–0.81; p < 0.001) was seen in the shorter DAPT group; (4) Among patients undergoing complex PCI, ticagrelor monotherapy after a short course of ticagrelor-based DAPT significantly reduced bleeding risk without increasing ischemic risk. More data are needed to definitively explain mortality benefits.

Saphenous Vein Graft Disease Interventions

AbstractIn the current era, coronary artery bypass grafting (CABG) is being increasingly performed using total arterial revascularization or a hybrid procedure of stenting of non-LAD disease and minimal access left internal mammary artery (LIMA) to LAD grafts, in order to minimize the need for vein grafts. Still, we encounter saphenous vein graft (SVG) disease, and it might require PCI, which often presents with unique challenges. The current favored strategy is to attempt PCI of the native coronary, if feasible, especially in long degenerated SVG disease, as it has shown better short- and long-term outcome. PCI is preferred over repeat CABG for early recurrent symptoms after CABG in patent LIMA graft and amenable anatomy patients. Balloon predilatation is not recommended unless delivery of an EPD or stent is not possible. Distal protection should be considered the standard of care for percutaneous coronary intervention (PCI) in most patients with older vein grafts, as periprocedural myocardial infarction and no reflow are the Achilles heel of SVG PCI. Intragraft vasodilators should be used liberally, even before balloon angioplasty/stenting. Avoid postdilatation, and usage of undersized but a longer stent length to reduce plaque extrusion through stent struts is preferred. Consider thrombectomy in lesions with a heavy thrombus burden. Keep activated clotting time on the higher side than in conventional PCI. Prolonged dual antiplatelet therapy (DAPT) based on the DAPT score is recommended. With all the precautions and care, we still need a fair wind in our favor to sail through the vein grafts disease.

Safety and Efficacy of Minimum- or Zero-Contrast IVUS-Guided Percutaneous Coronary Interventions in Chronic Kidney Disease Patients: A Systematic Review.

Conventional percutaneous coronary interventions (PCIs) frequently cause severe complications in chronic kidney disease (CKD) patients. Low-to-zero contrast intravascular ultrasound (IVUS) guided PCIs are promising alternatives in the CKD setting. We aim to systematically review up-to-date literature that have reported data and outcomes of low-to-zero contrast PCIs performed in CKD patients. We searched Embase, PubMed, and Cochrane databases for full-text articles that reported original data regarding efficacy and/or safety outcomes of IVUS-guided PCIs in patients with CKD. The quality of non-randomized trials included was assessed using the Newcastle–Ottawa scale. Six papers were included in the present systematic review: One non-randomized trial, two case series, and three case reports. Given the literature reported so far, contrast-free and IVUS-guided PCI procedures in patients with CKD appear to be safe (both in cardiac and renal outcomes) with a comparable efficacy to the conventional procedure, even in complex atherosclerotic lesions. No patient included in the mentioned studies showed renal function deterioration and did not need renal replacement therapy after the zero-contrast IVUS-guided percutaneous procedures. From a cardiovascular point of view, this technique proved to be safe in terms of cardiovascular outcomes. The undesirable consequences of conventional PCI in the CKD population might soon be effectively hampered by safer low-to-zero contrast IVUS-guided PCI procedures after a mandatory and rigorous evidence-based validation in long-awaited randomized controlled trials.

Aspiration thrombectomy in ST-Elevation myocardial infarction: Further insights from a network meta-analysis of randomized trials.

BackgroundThe initial enthusiasm for thrombectomy during percutaneous coronary intervention (PCI) of ST-elevation myocardial infarction (STEMI) patients has given way to restraint. There has been some limited interest whether it is beneficial in a few selected subgroups. Hence, we performed a network meta-analysis to compare conventional PCI (cPCI), Aspiration or manual thrombectomy (AT) and Mechanical thrombectomy (McT) for clarification.MethodsElectronic databases were searched for randomized studies that compared AT, McT, or cPCI. A network meta-analysis was performed and odd’s ratio (OR) with 95% confidence intervals was generated for major adverse cardiac events (MACE), mortality, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST), stroke, left ventricular ejection fraction (LVEF), myocardial blush grade (MBG) and ST segment resolution (STR).ResultsA total of 43 randomized trials (n = 26,682) were included. The risk of MACE (OR 0.86 95% CI 0.73–1.00), Mortality (OR 0.85 95% CI 0.73–0.99), MI (OR 0.65, 95% CI: 0.44–0.95) and TVR (OR 0.86, 95% CI: 0.74–1.00) were lower with AT compared to cPCI. The risk of ST and stroke was no different with the use of adjunctive AT. MBG, STR, and LVEF improved with the use of AT while the infarct size was no different in the two groups.ConclusionsOur comprehensive network meta-analysis suggests conflicting outcomes with AT. While Mortality, MACE, MI seem better, there is a suggestion that, Stroke and ST might be worse. Whether AT can still be pursued in any select cases should be further scrutinized.