Tetsuya Ishikawa

Direction of guidelines about drug-coated balloon angioplasty for in-stent restenosis of drug-eluting stents

Drug-coated balloon (DCB) Academic Research Consortium (ARC) defined post-procedural percent diameter stenoses (final %DSs) of 40 and 20 as the thresholds of successful DCB angioplasty and drug-eluting stent (DES) placement, respectively. The present single-center, retrospective, lesion-based study clarified the clinically relevant final %DS threshold by including consecutive 297 de novo lesions in 250 patients after successful DCB angioplasty between January 2016 and March 2022, irrespective of vessel size. The whole lesions were stratified into 2 groups of final %DS below 20 (n = 168) and final %DS between 20 and 40 (n = 129). Cumulative 2-year target vessel failure (TVF), comprising of cardiac mortality, non-fatal myocardial infarction, and target vessel revascularization, in final %DS between 20 and 40 group (14.0% with mean observational interval of 629 ± 199 days) was significantly higher than that in final %DS below 20 group (6.5%, 649 ± 168 days, p = 0.033). Final %DS between 20 and 40 was one of the predictors of cumulative 2-year TVF by multiple Cox proportional hazard model (hazard ratio: 2.29, 95% confidence interval: 1.04-5.00, p = 0.039), besides with congestive heart failure and bending lesion. Lesions of calcification, smaller and longer DCB used were the predictors of final %DS between 20 and 40 by multiple logistic regression analysis. Thus, we postulated final %DS of 20 as a candidate of clinically relevant cutoff value of angiographic endpoint associated with favorable outcomes after elective DCB angioplasty for de novo lesions, in response to latest international DCB ARC statement.

BACKGROUND: There were no previous studies comparing aspirin with clopidogrel on top of oral anticoagulation (OAC) within 1 year after percutaneous coronary intervention when dual therapy with OAC and clopidogrel was recommended. METHODS: We conducted a subgroup analysis stratified by OAC in the 1-year follow-up of the STOPDAPT-3 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-3), which randomly compared 1-month dual antiplatelet therapy followed by aspirin monotherapy (aspirin group) with 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). This subgroup analysis compared aspirin with clopidogrel in patients with or without OAC by the 30-day landmark analysis. The coprimary end points were the cardiovascular (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke), and bleeding end points (Bleeding Academic Research Consortium 3 or 5). RESULTS: In the 30-day landmark analysis (N=5809), there were 788 patients (13.6%) with OAC at discharge. Regardless of OAC, the incidence rates beyond 30 days up to 1 year were similar between the aspirin and clopidogrel groups for cardiovascular end point (OAC: 3.7% versus 3.9%, hazard ratio, 0.92 [95% CI, 0.44–1.93]; no OAC: 3.7% versus 3.6%; hazard ratio, 1.03 [95% CI, 0.77–1.38]; P interaction=0.78) and for bleeding end point (OAC: 3.5% versus 4.2%, hazard ratio, 0.82 [95% CI, 0.39–1.73]; no OAC 1.5% versus 1.4%, hazard ratio, 1.07 [95% CI, 0.66–1.72]; P interaction=0.57). CONCLUSIONS: Aspirin compared with clopidogrel was associated with similar cardiovascular and bleeding outcomes beyond 30 days and up to 1 year after percutaneous coronary intervention regardless of OAC at discharge. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04609111.

BACKGROUND: The effects of the aspirin-free strategy on bleeding and cardiovascular events were unknown in patients with high bleeding risk (HBR), with or without acute coronary syndrome (ACS), undergoing percutaneous coronary intervention. METHODS: We conducted a subgroup analysis stratified by ACS among patients with HBR in the STOPDAPT-3 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-3), which randomly compared no-aspirin (prasugrel monotherapy) with dual antiplatelet therapy (DAPT) in patients with ACS and HBR. RESULTS: There were 3258 patients with HBR, including 1803 ACS and 1455 non-ACS patients. The effects of no-aspirin compared with DAPT at 1 month after percutaneous coronary intervention were not significant for major bleeding regardless of ACS or non-ACS (7.3% versus 7.9%; hazard ratio [HR], 0.91 [95% CI, 0.65–1.28], and 3.1% versus 2.9%; HR, 1.06 [95% CI, 0.58–1.93]; P interaction=0.66). There was a numerically higher risk in the no-aspirin group relative to the DAPT group for a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke in patients with ACS, but not in patients with non-ACS (7.9% versus 5.8%; HR, 1.39 [95% CI, 0.97–1.99], and 2.4% versus 3.0%; HR, 0.78 [95% CI, 0.41–1.47]; P interaction=0.12). There was a significant treatment-by-subgroup interaction for myocardial infarction (1.6% versus 0.3%; HR, 4.57 [95% CI, 1.31–15.89], and 1.4% versus 1.8%; HR, 0.78 [95% CI, 0.34–1.77]; P interaction=0.02). CONCLUSIONS: The aspirin-free strategy compared with the DAPT strategy failed to reduce major bleeding in patients with HBR irrespective of ACS. There was a signal of the excess risk of the aspirin-free strategy relative to the DAPT strategy for cardiovascular events, myocardial infarction in particular, in patients with ACS, but not in patients with non-ACS. The aspirin-free strategy may be considered as a potential treatment option after percutaneous coronary intervention in patients with non-ACS. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04609111.

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Aim: We aimed to determine whether baseline high-density lipoprotein (HDL) cholesterol efflux capacity (CEC) at the time of coronary angiography (CAG) could serve as a prognostic marker for future major adverse cardiovascular events (MACE) in patients with coronary artery disease (CAD) through a systematic review and meta-analysis.Methods: The MEDLINE, Cochrane, and Embase databases were used for data collection. As of April 2024, 2,871 studies have been identified. Clinical studies comparing MACEs over an observational interval exceeding 12 months in patients with angiographically defined CAD with estimated hazard ratios (HRs) of MACEs in the higher or top-quartile HDL-CEC (H-HDL-CEC) group compared with the lower or bottom-quartile HDL-CEC (L-HDL-CEC) group, after adjusting for six confounding variables, including HDL-C, were included. HRs of 1) overall cardiovascular outcomes, composite of cardiovascular mortality, myocardial infarction, any coronary revascularization, and all-cause mortality (Model-1), and 2) cardiovascular outcomes excluding all-cause mortality from Model-1 (Model-2), compared between the L-HDL-CEC and H-HDL-CEC groups, were estimated using a random-effects model, respectively.Results: In five studies, 5,725 patients with CAD with a mean observational interval of 4.9 years were included. The H-HDL-CEC group had significantly lower risks for both estimates (Model-1: HR: 0.34, 95% confidence interval [CI]: 0.18–0.63 [p=0.0005], and I2=59.8% [p=0.04]; Model-2: HR: 0.28, 95% CI: 0.13–0.60 [p=0.0013], and I2=64% [p=0.04]).Conclusion: This is the first systematic review and meta-analysis to demonstrate a significant inverse relationship between the baseline HDL-CECs on CAG and long-term MACEs in CAD patients.

Superiority of coronary paclitaxel DCBs to limus DCBs in the late angiographic outcomes: the first meta-analysis showing the differences of coronary DCBs

Background: The effects of aspirin‐free strategy on bleeding and cardiovascular events in patients undergoing percutaneous coronary intervention with oral anticoagulation (OAC) have not been fully elucidated. Methods and Results: We conducted the prespecified subgroup analysis based on the use of OAC, including vitamin K antagonist and direct oral anticoagulants, within 7 days before percutaneous coronary intervention in the STOPDAPT‐3 (Short and Optimal Duration of Dual Antiplatelet Therapy‐3) trial, which randomly compared prasugrel monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The coprimary end points were major bleeding events (Bleeding Academic Research Consortium types 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. Among 5966 study patients, there were 530 patients (8.9%) with OAC (no aspirin: N=248, and DAPT: N=282) and 5436 patients (91.1%) without OAC (no aspirin: N=2736, and DAPT: N=2700). Regardless of the use of OAC, the effects of no aspirin compared with DAPT were not significant for the bleeding end point (OAC: 4.45% and 4.27%, hazard ratio [HR], 1.04 [95% CI, 0.46–2.35]; no‐OAC: 4.47% and 4.75%, HR, 0.94 [95% CI, 0.73–1.20]; P for interaction=0.82), and for the cardiovascular end point (OAC: 4.84% and 3.20%, HR, 1.53 [95% CI, 0.64–3.62]; no‐OAC: 4.06% and 3.74%, HR, 1.09 [95% CI 0.83–1.42]; P for interaction =0.46). Conclusions: The no‐aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of the use of OAC. There was a numerical excess risk of the no‐aspirin strategy relative to the DAPT strategy for cardiovascular events in patients with OAC.

Background: We conducted a systematic review and meta-analysis to examine the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo lesions in patients with acute coronary syndrome (ACS) by comparing with drug-eluting stent (DES) placement. Methods: By a systematic literature search, nine (five randomized controlled, two retrospective propensity-score matched, and two retrospective baseline-balanced) studies comparing the midterm clinical and angiographic outcomes after PCB angioplasty and DES placement were included, yielding 974 and 1130 ACS cases in PCB and DES groups, respectively. Major adverse cardiac event (MACE) was defined as a composite of cardiac mortality (CM), all-cause mortality (ACM), myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). Late luminal loss (LLL) and bleeding events (BLD) were also estimated. Results: The frequencies of MACE in PCB and DES groups were 8.42% and 10.62%, respectively. PCB angioplasty had no significant impacts on all of MACE (risk ratio: 0.90, 95%CI: 0.68–1.18, p = 0.44), CM, ACM, MI, TVR, TLR, BLD, and LLL, compared to DES placement in random-effects model. Conclusions: The present systematic review and meta-analysis showed the feasibility of PCB angioplasty for the de novo lesions in patients with ACS in comparison with DES placement by the emergent procedures.