Circulation: Cardiovascular Interventions最新文献

Background: Stent underexpansion is a significant challenge in percutaneous coronary intervention, critically impacting patient outcomes. While excimer laser coronary angioplasty (ELCA) and intravascular lithotripsy (IVL) are increasingly used to address this issue, their full impact on the integrity of drug-eluting stents remains unclear, raising concerns about their safety and efficacy.

Methods: This in vitro study assessed the effects of ELCA and IVL on the structural integrity of drug-eluting stents using scanning electron microscopy. Nine stents, 5 Onyx Frontier (with durable circumferential polymer coating) and 4 Cre8 (polymer-free), were implanted in a 3-dimensional coronary artery simulator following standardized protocols. After implantation, treatments with saline-ELCA, contrast-ELCA, IVL, and high-pressure balloon dilatation were applied. A comprehensive evaluation of the stent surface was performed at 60-fold magnification.

Results: Scanning electron microscopy analysis revealed significant differences in polymer damage between the techniques. High-pressure balloon dilatation and contrast-ELCA exhibited substantial polymer fragmentation and detachment compared with IVL, saline-ELCA, and conventional dilatation. High-pressure balloon dilatation demonstrated the highest incidence of polymer shaving and overcoating. No significant alterations were observed in polymer-free stents, regardless of the technique used.

Conclusions: IVL and saline-ELCA applied immediately after stent implantation produce minimal polymer damage, whereas high-pressure balloon dilatation and contrast-ELCA cause significant damage to the polymer coating. The integrity of polymer-free drug-eluting stent appears stable regardless of the technique used. Further research is needed to validate these findings and explore their clinical implications.

Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery.

Methods: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years.

Results: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation.

Conclusions: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR.

Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.

Background: In the AUGUSTUS trial (An Open-Label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention), the combination of dual antiplatelet therapy plus oral anticoagulation increased the risk of bleeding without reducing ischemic events compared with a P2Y12 inhibitor plus oral anticoagulation among patients with atrial fibrillation and acute coronary syndrome or elective percutaneous coronary intervention. However, AUGUSTUS enrolled patients up to 14 days after acute coronary syndrome or percutaneous coronary intervention, and there may be a benefit to dual antiplatelet therapy plus oral anticoagulation early after an ischemic event.

Methods: In this secondary analysis of AUGUSTUS, we divided patients into groups based on whether they were enrolled <6 days (early) or ≥6 days (later) after their index acute coronary syndrome or percutaneous coronary intervention, and tested the interaction between time from the index event to enrollment and randomized treatment (apixaban versus vitamin K antagonist and aspirin versus placebo) on 30-day and 6-month clinical outcomes using Cox proportional hazards models.

Results: Among 4605 patients enrolled in AUGUSTUS with data available on time from the index event to enrollment, the median time from the index event to enrollment was 6 (range, 0-14) days. There were no significant interactions between time from the index event and aspirin versus placebo on clinical outcomes at 30 days or 6 months, though patients with time from the index event <6 days had a nominally significant reduction in death or ischemic events at 30 days with aspirin (hazard ratio, 0.55 [95% CI, 0.30-0.99]), whereas patients with time from the index event ≥6 days did not (hazard ratio, 0.88 [95% CI, 0.54-1.43]; interaction P=0.23). There were no significant interactions between time from the index event and apixaban versus vitamin K antagonist on clinical outcomes.

Conclusions: Among patients with atrial fibrillation with acute coronary syndrome or undergoing percutaneous coronary intervention, there was no difference in the relative benefit of apixaban versus vitamin K antagonist or aspirin versus placebo when patients were enrolled early versus later after their index event.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02415400.

The left main coronary artery (LMCA) supplies over 70% of the myocardium, and significant LMCA disease is associated with high morbidity and mortality. With remarkable advances in percutaneous coronary intervention (PCI), including stent technology, antithrombotic agents, and evolving procedural techniques, PCI has become an important treatment option in clinical practice guidelines for the revascularization of LMCA disease. In contemporary clinical practice, a heart-team approach to shared decision-making, considering clinical/anatomic factors along with patient preferences, is emphasized for patients with significant LMCA disease requiring myocardial revascularization. Furthermore, recent progress in PCI procedures combined with intravascular imaging or functional guidance has resulted in significant improvements in PCI outcomes, especially for complex lesions, including LMCA disease. Nevertheless, owing to inherent anatomic complexities and frequent multivessel involvement, several unmet issues remain regarding the determination of the appropriate treatment approach for significant LMCA disease, for which further clinical research is required. This contemporary review article provides a comprehensive overview of left main PCI based on current guidelines and underlying trial data, addresses important unresolved diagnostic and therapeutic issues, and identifies future perspectives likely to advance progress in this field.

Background: The clinical impact of a chronic total occlusion (CTO) in patients with 3-vessel coronary artery disease undergoing fractional flow reserve-guided percutaneous coronary intervention (PCI) with current-generation drug-eluting stents or coronary artery bypass grafting (CABG) is unclear.

Methods: The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3) compared fractional flow reserve-guided PCI with CABG in patients with 3-vessel coronary artery disease. The primary end point was major adverse cardiac and cerebrovascular events, a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. In this substudy, the 3-year outcomes were analyzed in patients with or without a CTO.

Results: Of the patients randomized to PCI or CABG in the FAME 3 trial, 305 (21%) had a CTO. In the PCI arm, revascularization of the CTO was attempted in 61% with a procedural success rate of 88%. The incidence of major adverse cardiac and cerebrovascular events at 3 years was not significantly different between those with or without a CTO in both the PCI (15.2% versus 20.1%; adjusted hazard ratio, 0.62 [95% CI, 0.38-1.03]; P=0.07) and the CABG (13.0% versus 12.9%; adjusted hazard ratio, 0.96 [95% CI, 0.55-1.66]; P=0.88) arms. In those without a CTO, PCI was associated with a significantly higher risk of major adverse cardiac and cerebrovascular events compared with CABG (adjusted hazard ratio, 1.61 [95% CI, 1.20-2.17]; P<0.01) but not in those with a CTO (adjusted hazard ratio, 1.21 [95% CI, 0.64-2.28]; P=0.56; P_interaction=0.31).

Conclusions: The presence of a CTO did not significantly impact the treatment effect of PCI versus CABG at 3 years in patients with 3-vessel coronary artery disease.

Clinical trial registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.

Background: Mitral annular calcification with valve dysfunction remains a challenging syndrome. Operative risk is high, and available transcatheter therapies are limited.

Methods: This study describes our initial experience with a novel procedure to address large mitral annuli when no surgical or trial-based transcatheter mitral valve replacement device is available. The rationale was to shorten the intercommissural distance using commissural mitral transcatheter edge-to-edge repair (TEER) followed by valve-in-mitral annular calcification transcatheter mitral valve replacement with a balloon-expandable aortic valve platform. Patients with long intercommissural distances and large mitral annulus areas were selected based on a high perceived risk of transcatheter valve embolization. Patients underwent mitral TEER with MitraClip in a commissural position, followed immediately by transseptal transcatheter mitral valve replacement with a 29 mm SAPIEN 3 valve.

Results: Thirteen patients were included. Median intercommissural distance and annular area were 39.1 mm and 930 mm², respectively. Commissural mitral TEER was successful in all patients with no instances of single leaflet detachment. In 10 of 13 instances, an NTW device size was used. In 12 of 13 patients, valve implantation was successful, including 1 case that required a second valve for atrial positioning of the first valve. In 1 case, frank valve embolization into the left atrium occurred. Among the 12 successful cases, paravalvular leak was 1+ or less, and there were no instances of paravalvular leak adjacent to the TEER device.

Conclusions: In patients with large annuli and sufficient annular calcium, a hybrid mitral TEER and valve replacement with the SAPIEN platform can be successfully used to facilitate transcatheter mitral valve replacement.

Background: While clinical practice guidelines advocate for multidisciplinary heart team (MDHT) discussions in coronary revascularization, variability in implementation across health care settings remains a challenge. This variability could potentially be addressed by language learning models like ChatGPT, offering decision-making support in diverse health care environments. Our study aims to critically evaluate the concordance between recommendations made by MDHT and those generated by language learning models in coronary revascularization decision-making.

Methods: From March 2023 to July 2023, consecutive coronary angiography cases (n=86) that were referred for revascularization (either percutaneous or surgical) were analyzed using both ChatGPT-3.5 and ChatGPT-4. Case presentation formats included demographics, medical background, detailed description of angiographic findings, and SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery; I and II), which were presented in 3 different formats. The recommendations of the models were compared with those of an MDHT.

Results: ChatGPT-4 showed high concordance with decisions made by the MDHT (accuracy 0.82, sensitivity 0.8, specificity 0.83, and kappa 0.59), while ChatGPT-3.5 (0.67, 0.27, 0.84, and 0.12, respectively) showed lower concordance. Entropy and Fleiss kappa of ChatGPT-4 were 0.09 and 0.9, respectively, indicating high reliability and repeatability. The best correlation between ChatGPT-4 and MDHT was achieved when clinical cases were presented in a detailed context. Specific subgroups of patients yielded high accuracy (>0.9) of ChatGPT-4, including those with left main disease, 3 vessel disease, and diabetic patients.

Conclusions: The present study demonstrates that advanced language learning models like ChatGPT-4 may be able to predict clinical recommendations for coronary artery disease revascularization with reasonable accuracy, especially in specific patient groups, underscoring their potential role as a supportive tool in clinical decision-making.

Background: No randomized data exist on ultrathin-strut stents in patients at high bleeding risk (HBR) undergoing an abbreviated dual antiplatelet therapy after coronary stenting. The aim of this study was to compare the safety and effectiveness of the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent with the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent in patients at HBR with abbreviated dual antiplatelet therapy after stenting.

Methods: In the investigator-initiated, randomized, open-label COMPARE 60/80 HBR trial (Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in HBR Percutaneous Coronary Intervention Population), 741 patients at HBR according to the Academic Research Consortium HBR criteria were randomized to receive either the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent or thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. Dual antiplatelet therapy was recommended according to the applicable guidelines and trial data for patients at HBR. The primary outcome was net adverse clinical events, the composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke, and major bleeding, and was powered for noninferiority with an absolute margin of 4.0% at 1-sided 2.5% alpha.

Results: Between September 2020 and August 2022, 371 patients were randomized to the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent and 370 patients to the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent at 11 sites in the Netherlands. At 1 year, the primary outcome was observed in 56 (15.4%) patients in the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent group and 61 (17.1%) in the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent group (risk difference, -1.65%; upper boundary of the 1-sided 95% CI, 3.74; P=0.02 for noninferiority at a 0.025 significance level and P=0.55 for 2-sided superiority at a 0.05 significance level).

Conclusions: Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500912.