An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial.

BACKGROUND: Bleeding rates on dual antiplatelet therapy (DAPT) within 1 month after percutaneous coronary intervention (PCI) remain high in clinical practice, particularly in patients with acute coronary syndrome or high bleeding risk. Aspirin-free strategy might result in lower bleeding early after PCI without increasing cardiovascular events, but its efficacy and safety have not yet been proven in randomized trials. METHODS: We randomly assigned 6002 patients with acute coronary syndrome or high bleeding risk just before PCI either to prasugrel (3.75 mg/day) monotherapy or to DAPT with aspirin (81-100 mg/day) and prasugrel (3.75 mg/day) after loading of 20 mg of prasugrel in both groups. The coprimary end points were major bleeding (Bleeding Academic Research Consortium 3 or 5) for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) for noninferiority with a relative 50% margin. RESULTS: The full analysis set population consisted of 5966 patients (no-aspirin group, 2984 patients; DAPT group, 2982 patients; age, 71.6±11.7 years; men, 76.6%; acute coronary syndrome, 75.0%). Within 7 days before randomization, aspirin alone, aspirin with P2Y12 inhibitor, oral anticoagulants, and intravenous heparin infusion were given in 21.3%, 6.4%, 8.9%, and 24.5%, respectively. Adherence to the protocol-specified antiplatelet therapy was 88% in both groups at 1 month. At 1 month, the no-aspirin group was not superior to the DAPT group for the coprimary bleeding end point (4.47% and 4.71%; hazard ratio, 0.95 [95% CI, 0.75-1.20]; Psuperiority=0.66). The no-aspirin group was noninferior to the DAPT group for the coprimary cardiovascular end point (4.12% and 3.69%; hazard ratio, 1.12 [95% CI, 0.87-1.45]; Pnoninferiority=0.01). There was no difference in net adverse clinical outcomes and each component of coprimary cardiovascular end point. There was an excess of any unplanned coronary revascularization (1.05% and 0.57%; hazard ratio, 1.83 [95%CI, 1.01-3.30]) and subacute definite or probable stent thrombosis (0.58% and 0.17%; hazard ratio, 3.40 [95% CI, 1.26-9.23]) in the no-aspirin group compared with the DAPT group. CONCLUSIONS: The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.

Aspirin versus Clopidogrel Monotherapy After Percutaneous Coronary Intervention: 1-Year Follow-up of the STOPDAPT-3 Trial.

BACKGROUND AND AIMS: There was no previous trial comparing aspirin monotherapy with a P2Y12 inhibitor monotherapy following short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS: In the STOPDAPT-3, patients with acute coronary syndrome (ACS) or high bleeding risk (HBR) were randomly assigned to either 1-month DAPT with aspirin and prasugrel followed by aspirin monotherapy (aspirin group) or 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). This secondary analysis compared aspirin monotherapy with clopidogrel monotherapy by the 30-day landmark analysis. The co-primary endpoints were the cardiovascular endpoint defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischaemic stroke, and the bleeding endpoint defined as Bleeding Academic Research Consortium 3 or 5. RESULTS: Of 6002 assigned patients, 5833 patients (aspirin group: N = 2920 and clopidogrel group: N = 2913) were included in the 30-day landmark analysis. Median age was 73 (interquartile range 64-80) years, women 23.4%, ACS 74.6%, and HBR 54.1%. The assigned monotherapy was continued at 1 year in 87.5% and 87.2% in the aspirin and clopidogrel groups, respectively. The incidence rates beyond 30 days and up to 1 year were similar between the aspirin and clopidogrel groups for both cardiovascular endpoint (4.5 and 4.5 per 100 person-year, hazard ratio [HR] 1.00 [95% confidence interval (CI) 0.77-1.30], P = .97), and bleeding endpoint (2.0 and 1.9, HR 1.02 [95% CI 0.69-1.52], P = .92). CONCLUSIONS: Aspirin monotherapy compared to clopidogrel monotherapy was associated with similar cardiovascular and bleeding outcomes beyond 1 month and up to 1 year after PCI with DES.

Regional Disparities in Transvenous Lead Extraction for Cardiac Implantable Electronic Device Infection in Japan　- A Descriptive Study Using the National Database Open Data.

BACKGROUND: Because the penetration of transvenous lead extraction (TLE) for cardiac implantable electronic device (CIED) infection has not been investigated in Japan, we conducted a population-based, retrospective, descriptive study to evaluate regional disparities in the use of TLE for CIED infection and the potential undertreatment of CIED infection using a nationwide insurance claims database.Methods and Results: Patients who underwent CIED implantation or generator exchange and TLE between April 2018 and March 2020 were identified. Moreover, the penetration ratio of TLE for CIED infection in each prefecture was estimated. CIED implantation and TLE were most prevalent in the age categories of 80-89 years (40.3%) and 80-89 years (36.9%), respectively. There was no correlation between the number of CIED implantations and that of TLE (rho=-0.087, 95% confidence interval -0.374 to 0.211, P=0.56). The median penetration ratio was 0.00 (interquartile range 0.00-1.29). Of the 47 prefectures, 6, comprising Okinawa, Miyagi, Okayama, Fukuoka, Tokyo, and Osaka, showed a penetration ratio ≥2.00. CONCLUSIONS: Our study data indicated great regional disparities in the penetration of TLE and potential undertreatment of CIED infection in Japan. Additional measures are needed to address these issues.

Drug-Coated Balloon for the Treatment of Small Vessel Coronary Artery Disease　- A Randomized Non-Inferiority Trial.

BACKGROUND: Drug-coated balloons (DCB) have shown promising results for the treatment of in-stent restenosis (ISR) and small vessel disease (SVD). However, data comparing the treatment efficacy of different DCBs are limited.Methods and Results: AGENT Japan is a prospective randomized controlled trial that compares the Agent balloon coated with a low-dose formulation of paclitaxel (2 µg/mm2) to the SeQuent Please paclitaxel-coated balloon (3 µg/mm2) for the treatment of SVD. Patients with target lesion length ≤28 mm and reference diameter between ≥2.00 and <3.00 mm were randomized 2 : 1 for treatment with Agent (n=101) or SeQuent Please (n=49). This trial also includes a separate single-arm substudy evaluating the clinical safety and effectiveness of Agent in patients with ISR. The primary endpoint of 6-month target lesion failure (TLF) was observed in 3.0% of Agent and 0.0% of SeQuent Please patients (difference=3.0%; 97.5% upper confidence bound [UCB]=9.57%, which is less than the prespecified margin of 13.2%; Pnon-inferiority=0.0012). There were no deaths or thrombosis, and angiographic and quality-of-life outcomes were comparable between groups. The AGENT Japan ISR substudy (n=30) primary endpoint was met because the one-sided 97.5% UCB for 6-month TLF (3.3%) was significantly less than the study success criterion of 15.1% (97.5% UCB=9.8%; P<0.0001). CONCLUSIONS: Data from this study demonstrate good clinical outcomes with the Agent DCB when used to treat patients with SVD or ISR.

Prevalence and Effects of High-Intensity Statins for Japanese Patients Presenting With Acute Coronary Syndrome　- A Post Hoc Secondary Analysis of STOPDAPT-2 ACS.

BACKGROUND: The REAL-CAD trial, reported in 2017, demonstrated a significant reduction in cardiovascular events with high-intensity statins in patients with chronic coronary syndrome. However, data are scarce on the use of high-intensity statins in Japanese patients with acute coronary syndrome (ACS).Methods and Results: In STOPDAPT-2 ACS, which exclusively enrolled ACS patients between March 2018 and June 2020, 1,321 (44.2%) patients received high-intensity statins at discharge, whereas of the remaining 1,667 patients, 96.0% were treated with low-dose statins. High-intensity statins were defined as the maximum approved doses of strong statins in Japan. The incidence of the cardiovascular composite endpoint (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke) was significantly lower in patients with than without high-intensity statins (1.44% vs. 2.69% [log-rank P=0.025]; adjusted hazard ratio [aHR] 0.48, 95% confidence interval [CI] 0.24-0.94, P=0.03) and the effect was evident beyond 60 days after the index percutaneous coronary intervention (log-rank P=0.01; aHR 0.38, 95% CI 0.17-0.86, P=0.02). As for the bleeding endpoint, there was no significant difference between the 2 groups (0.99% vs. 0.73% [log-rank P=0.43]; aHR 0.96, 95% CI 0.35-2.60, P=0.93). CONCLUSIONS: The prevalence of high-intensity statins has increased substantially in Japan. The use of the higher doses of statins in ACS patients recommended in the guidelines was associated with a significantly lower risk of the primary cardiovascular composite endpoint compared with lower-dose statins.

Incidence, Clinical Characteristics, and Predictors of Cardiovascular Immune-Related Adverse Events Associated with Immune Checkpoint Inhibitors.

BACKGROUND: Cardiovascular immune-related adverse events (CV-irAEs) associated with immune checkpoint inhibitors (ICIs) may have been underreported given that most previous reports were retrospective. We aimed to evaluate the incidence, clinical characteristics, and predictors of CV-irAEs and determine the feasibility of serial cardiac monitoring using a combination of B-type natriuretic peptide, cardiac troponin T, and electrocardiogram for the prediction of future symptomatic (grade ≥2) CV-irAEs. MATERIALS AND METHODS: This was a prospective observational study that included 129 consecutive patients with non-small-cell lung cancer who received ICI monotherapy at a single center. Serial cardiac monitoring was performed during ICI monotherapy. RESULTS: A total of 35 (27%) patients developed any grade ≥1 CV-irAEs with a median time of onset of 72 (interquartile range 44-216) days after ICI treatment initiation. Multivariate Fine-Gray regression analysis showed that prior acute coronary syndrome (adjusted hazard ratio [HR] 3.15 (95% [CI], 2.03-4.91), prior heart failure hospitalization (adjusted HR 1.65 [95% CI, 1.17-2.33]), and achievement of disease control (adjusted HR 1.91, [95% CI, 1.16-3.14]) were significantly associated with grade ≥1 CV-irAEs. Serial cardiac monitoring revealed that patients with preceding grade 1 CV-irAEs were associated with a significantly higher risk of onset of grade ≥2 CV-irAEs compared with those without preceding grade 1 CV-irAEs (HR: 6.17 [95% CI, 2.97-12.83]). CONCLUSION: CV-irAEs were more common than previously recognized and have several predictors. Moreover, serial cardiac monitoring may be feasible for the prediction of future grade ≥2 CV-irAEs.

Erratum to "Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices".

[This corrects the article DOI: 10.1155/2020/8216831.].

Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices.

A Glidesheath slender (Terumo, Tokyo, Japan) and a sheathless Eaucath guiding catheter (Asahi Intecc, Nagoya, Japan) are two major slender devices utilized in percutaneous coronary intervention (PCI). This study aimed to investigate the differences in access-site complications between these devices in PCI for acute coronary syndrome (ACS). A total of 1108 consecutive patients who underwent transradial PCI for ACS were enrolled. Transradial PCI was performed using either a 7-Fr Glidesheath slender/7-Fr guiding catheter combination (Glidesheath group) or a 7.5-Fr sheathless guiding catheter (Sheathless group); 1 : 1 propensity score matching was performed, and 728 patients (364 in each group) were included in the propensity-matched population. In the matched patients, univariate analysis revealed that the Glidesheath group had less radial artery occlusion (RAO) at 30 days (Glidesheath: 1.4% vs. Sheathless: 4.1%, odds ratio (OR) = 0.33, 95% confidence interval (CI) = 0.12-0.91, p=0.039), whereas no significant between-group differences were observed in severe radial spasm (Glidesheath: 1.4% vs. Sheathless: 1.9%, OR = 0.71, 95% CI = 0.23-2.22, p=0.58) or access-site major bleeding (Glidesheath: 1.4% vs. Sheathless: 1.6%, OR = 0.83, 95% CI = 0.26-2.71, p=1.00). Multivariate analysis revealed that the choice for Glidesheath was significantly associated with less RAO (OR = 0.32, 95% CI = 0.11-0.93, p=0.036). In conclusion, 7-Fr Glidesheath slender/7-Fr guiding catheter combination is obviously more advantageous than 7.5-Fr sheathless guiding catheters for decreased risk of RAO. The potential low risk of RAO in our findings supports the adoption of the 7-Fr Glidesheath slender sheath/7-Fr guiding catheter combination in transradial PCI for ACS.

Apixaban for the treatment of saphenous vein graft thrombosis presenting as unstable angina: a case report.

BACKGROUND: Saphenous vein graft thrombosis can present as unstable angina. However, percutaneous coronary intervention for saphenous vein graft lesions poses a high risk of slow flow related to the procedure. Here we present the utilization of the novel oral anticoagulant, apixaban, in the treatment of unstable angina with extensive saphenous vein graft thrombus, leading to considerable thrombus resolution and eliminating the need of percutaneous coronary intervention. CASE PRESENTATION: A 72-year-old man with 3-vessel coronary artery bypass graft surgery using a saphenous vein graft and a left internal mammary artery, performed 25 years earlier, presented at our hospital with recurrent chest tightness. The echocardiography showed regional hypokinesis of the post-lateral wall with moderate left ventricular dysfunction, which had not been previously confirmed. Coronary angiography showed obstruction of the saphenous vein graft with a large thrombus burden. The left internal mammary artery was patent and other natives were the same as they had been 3 years ago. He was diagnosed with unstable angina due to acute saphenous vein graft thrombosis. Instead of percutaneous coronary intervention, he was treated with apixaban 5 mg twice a day. The angiography 3 weeks after starting apixaban showed considerable resolution of the thrombus and opening of the saphenous vein graft. CONCLUSIONS: Apixaban could become a viable treatment option for acute saphenous vein graft thrombosis.

Symbiosis island shuffling with abundant insertion sequences in the genomes of extra-slow-growing strains of soybean bradyrhizobia.

Extra-slow-growing bradyrhizobia from root nodules of field-grown soybeans harbor abundant insertion sequences (ISs) and are termed highly reiterated sequence-possessing (HRS) strains. We analyzed the genome organization of HRS strains with the focus on IS distribution and symbiosis island structure. Using pulsed-field gel electrophoresis, we consistently detected several plasmids (0.07 to 0.4 Mb) in the HRS strains (NK5, NK6, USDA135, 2281, USDA123, and T2), whereas no plasmids were detected in the non-HRS strain USDA110. The chromosomes of the six HRS strains (9.7 to 10.7 Mb) were larger than that of USDA110 (9.1 Mb). Using MiSeq sequences of 6 HRS and 17 non-HRS strains mapped to the USDA110 genome, we found that the copy numbers of ISRj1, ISRj2, ISFK1, IS1632, ISB27, ISBj8, and IS1631 were markedly higher in HRS strains. Whole-genome sequencing showed that the HRS strain NK6 had four small plasmids (136 to 212 kb) and a large chromosome (9,780 kb). Strong colinearity was found between 7.4-Mb core regions of the NK6 and USDA110 chromosomes. USDA110 symbiosis islands corresponded mainly to five small regions (S1 to S5) within two variable regions, V1 (0.8 Mb) and V2 (1.6 Mb), of the NK6 chromosome. The USDA110 nif gene cluster (nifDKENXSBZHQW-fixBCX) was split into two regions, S2 and S3, where ISRj1-mediated rearrangement occurred between nifS and nifB. ISs were also scattered in NK6 core regions, and ISRj1 insertion often disrupted some genes important for survival and environmental responses. These results suggest that HRS strains of soybean bradyrhizobia were subjected to IS-mediated symbiosis island shuffling and core genome degradation.

One-year safety and effectiveness of the Agent paclitaxel-coated balloon for the treatment of small vessel disease and in-stent restenosis.

The Agent device consists of a semi-compliant balloon catheter, which is coated with a therapeutic low-dose formulation of paclitaxel (2 µg/mm2) blended with an inactive excipient acetyl-tri-n-butyl citrate (ATBC). AGENT Japan SV is a randomized controlled study that enrolled 150 patients from 14 Japanese sites treated with Agent or SeQuent Please paclitaxel-coated balloon. This study also includes a single-arm substudy evaluating the safety and effectiveness of Agent in patients with in-stent restenosis (ISR). Patients with a single de novo native lesion (lesion length ≤ 28 mm and reference diameter ≥ 2.00 to < 3.00 mm) were randomized 2:1 to receive either Agent (n = 101) or SeQuent Please (n = 49). The ISR substudy enrolled 30 patients with lesion length ≤ 28 mm and reference diameter ≥ 2.00 to ≤ 4.00 mm. In the SV RCT, target lesion failure (TLF) at 1 year occurred in four patients treated with Agent (4.0%) versus one patient with SeQuent Please (2.0%; P = 1.00). None of the patients in either treatment arm died. There were no significant differences in the rates of myocardial infarction, target lesion revascularization and target lesion thrombosis through 1 year. In the ISR substudy, the 1-year rates of TLF and target lesion thrombosis were 6.7% and 0.0%, respectively. These data support the safety and effectiveness of the Agent paclitaxel-coated balloon in patients with small vessels and ISR.

Optimal Intravascular Ultrasound-Guided Percutaneous Coronary Intervention in Patients With Multivessel Disease and Diabetes.

There is a scarcity of data on clinical outcomes after intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in patients with multivessel disease and diabetes. The Optimal Intravascular Ultrasound Guided Complex Percutaneous Coronary Intervention study multivessel cohort was a prospective, multicenter, single-arm trial enrolling 1,021 patients who underwent multivessel PCI, including left anterior descending coronary artery using IVUS, aiming to meet the prespecified OPTIVUS criteria for optimal stent expansion. We compared the clinical outcomes between those patients with and without diabetes. The primary end point was a composite of death, myocardial infarction, stroke, or any coronary revascularization. There were 560 patients (54.8%) with diabetes and 461 patients (45.2%) without diabetes. The mean age was not different between the 2 groups (70.9 ± 9.7 vs 71.7 ± 10.4 years, p = 0.17). Patients with diabetes more often had chronic kidney disease and complex coronary artery disease, as indicated by the greater total number of stents and longer total stent length. The rate of meeting the OPTIVUS criteria was not different between the 2 groups (61.2% vs 60.7%, p = 0.83). The cumulative 1-year incidence of the primary end point was not different between the 2 groups (10.8% vs 9.8%, log-rank p = 0.65). After adjusting for confounders, the risk of diabetes relative to nondiabetes remained insignificant for the primary end point (hazard ratio 0.97, 95% confidence interval 0.65 to 1.44, p = 0.88). In conclusion, in patients who underwent multivessel IVUS-guided PCI and were managed with contemporary clinical practice, patients with diabetes had similar 1-year outcomes to patients without diabetes.

Aspirin-free strategy for percutaneous coronary intervention in acute coronary syndrome based on the subtypes of acute coronary syndrome and high bleeding risk: the STOPDAPT-3 trial.

BACKGROUND AND AIMS: High bleeding risk (HBR) and acute coronary syndrome (ACS) subtypes are critical in determining bleeding and cardiovascular event risk after percutaneous coronary intervention (PCI). METHODS AND RESULTS: In 4476 ACS patients enrolled in the STOPDAPT-3, where the no-aspirin and dual antiplatelet therapy (DAPT) strategies after PCI were randomly compared, the pre-specified subgroup analyses were conducted based on HBR/non-HBR and ST-segment elevation myocardial infarction (STEMI)/non-ST-segment elevation ACS (NSTE-ACS). The co-primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5, and the co-primary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischaemic stroke at 1 month. Irrespective of the subgroups, the effect of no-aspirin compared with DAPT was not significant for the bleeding endpoint (HBR [N = 1803]: 7.27 and 7.91%, hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.65-1.28; non-HBR [N = 2673]: 3.40 and 3.65%, HR 0.93, 95% CI 0.62-1.39; Pinteraction = 0.94; STEMI [N = 2553]: 6.58 and 6.56%, HR 1.00, 95% CI 0.74-1.35; NSTE-ACS [N = 1923]: 2.94 and 3.64%, HR 0.80, 95% CI 0.49-1.32; Pinteraction = 0.45), and for the cardiovascular endpoint (HBR: 7.87 and 5.75%, HR 1.39, 95% CI 0.97-1.99; non-HBR: 2.56 and 2.67%, HR 0.96, 95% CI 0.60-1.53; Pinteraction = 0.22; STEMI: 6.07 and 5.46%, HR 1.11, 95% CI 0.81-1.54; NSTE-ACS: 3.03 and 1.71%, HR 1.78, 95% CI 0.97-3.27; Pinteraction = 0.18). CONCLUSION: In patients with ACS undergoing PCI, the no-aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of HBR and ACS subtypes. The numerical excess risk of the no-aspirin strategy relative to the DAPT strategy for cardiovascular events was observed in patients with HBR and in patients with NSTE-ACS.

Aspirin-Free Strategy for Percutaneous Coronary Intervention in Patients With Oral Anticoagulation: Prespecified Subgroup Analysis From the STOPDAPT-3 Trial.

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.

An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention.

BACKGROUND: There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI). OBJECTIVES: The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI. METHODS: We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. RESULTS: Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions. CONCLUSIONS: The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).

Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial.

The current guidelines for acute coronary syndrome (ACS) discourage the use of anticoagulation after percutaneous coronary intervention (PCI) without specific indications, although the recommendation is not well supported by evidence. In this post hoc analysis of the ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 (STOPDAPT-3) trial, 30-day outcomes were compared between the 2 groups with and without post-PCI heparin administration among patients with ACS who did not receive mechanical support devices. The co-primary end points were the bleeding end point, defined as the Bleeding Academic Research Consortium type 3 or 5 bleeding, and the cardiovascular end point, defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. Among 4,088 patients with ACS, 2,339 patients (57.2%) received post-PCI heparin. The proportion of patients receiving post-PCI heparin was higher among those with ST-elevation myocardial infarction compared with others (72.3% and 38.8%, p <0.001), and among patients with intraprocedural adverse angiographic findings compared with those without (67.6% and 47.5%, p <0.001). Post-PCI heparin compared with no post-PCI heparin was associated with a significantly increased risk of the bleeding end point (4.75% and 2.52%, adjusted hazard ratio 1.69, 95% confidence interval 1.15 to 2.46, p = 0.007) and a numerically increased risk of the cardiovascular end point (3.16% and 1.72%, adjusted hazard ratio 1.56, 95% confidence interval 0.98 to 2.46, p = 0.06). Higher hourly dose or total doses of heparin were also associated with higher incidence of both bleeding and cardiovascular events within 30 days. In conclusion, post-PCI anticoagulation with unfractionated heparin was frequently implemented in patients with ACS. Post-PCI heparin use was associated with harm in terms of increased bleeding without the benefit of reducing cardiovascular events. Trial identifier: STOPDAPT-3 ClinicalTrials.gov number, NCT04609111.

Prognostic impact of Achilles tendon thickness in elderly patients after percutaneous coronary intervention: A 5-year follow-up.

BACKGROUND: Evaluating the Achilles tendon thickness (ATT) may be beneficial for risk stratification of long-term secondary cardiovascular events among patients who underwent percutaneous coronary intervention (PCI). METHODS: This observational study evaluated major adverse cardiac and cerebrovascular events (MACCEs), including cardiovascular death/death from unknown causes, at 5 years after PCI according to the baseline ATT (≥9 mm vs. <9 mm). RESULTS: Overall, 355 patients aged ≥75 years were enrolled; 47 (13.2 %) and 308 patients (86.8 %) had an ATT ≥9 mm and <9 mm, respectively. The incidence of MACCEs at 5 years was numerically higher but not significantly different for the ATT ≥9 mm group compared with the ATT <9 mm group (Gray's p-value = 0.10). However, the incidence of cardiovascular death/death from unknown causes at 5 years was significantly higher in the ATT ≥9 mm group than in the ATT <9 mm group (Gray's p-value = 0.034). Multivariable Fine and Gray competing risk analysis showed that an ATT ≥9 mm was associated with both MACCEs [hazard ratio (HR), 1.95; 95 % confidence interval (CI), 1.12-3.41; p-value = 0.019] and cardiovascular death/death from unknown causes (HR, 2.81; 95 % CI, 1.31-6.03; p-value = 0.008) at 5 years in patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2. CONCLUSIONS: A significantly thick Achilles tendon could be a marker for MACCEs, including cardiovascular death/death from unknown causes, at 5 years among elderly patients with an eGFR ≥30 mL/min/1.73 m2 after PCI.

Associated factors and outcomes of crossover from a laser sheath to a bidirectional rotational mechanical sheath during transvenous lead extraction.

Background: During transvenous lead extraction (TLE), a GlideLight laser sheath (Philips) cannot always be advanced over the lead, and crossover to the Evolution system (i.e., an Evolution RL sheath or Evolution Shortie RL sheath [Cook Medical]) is required. We aimed to determine the associated factors and outcomes of such device crossover. Methods: This observational study included 112 patients who underwent TLE. The patients were divided into crossover and non-crossover groups. Outcomes and associated factors of crossover were evaluated. Results: Overall, 57 (50.9%) patients required crossover to the Evolution system (crossover group), whereas 55 (49.1%) patients did not require crossover (non-crossover group). Clinical success rate was similar between the two groups (98.3% vs. 100%; p = 1.00). No major intraprocedural complications related to powered sheaths occurred. Multivariate logistic regression analysis results showed that dwell time of the oldest extracted lead (per year) (odds ratio [OR]: 1.18, 95% confidence interval [CI]: 1.02-1.36; p = .026), number of leads extracted per procedure (OR: 7.23, 95% CI: 1.74-29.99; p = .007), and use of a femoral approach (OR: 21.09, 95% CI: 2.33-190.67; p = .007) were associated factors of crossover. The cutoff for crossover was 7.7 years from the implant (sensitivity 90.5%, specificity 64.9%, area under the curve 0.80). Conclusions: Both groups showed a high rate of clinical success. Switching to the Evolution system may facilitate a safe and effective TLE when a laser sheath does not advance despite laser activation.

Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Diabetes was reported to be associated with an impaired response to clopidogrel. OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) in patients with diabetes undergoing percutaneous coronary intervention (PCI). METHODS: A subgroup analysis was conducted on the basis of diabetes in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) Total Cohort (N = 5,997) (STOPDAPT-2, n = 3,009; STOPDAPT-2 ACS [Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 for the Patients With ACS], n = 2,988), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The primary endpoint was a composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (TIMI [Thrombolysis In Myocardial Infarction] major or minor) endpoints at 1 year. RESULTS: There were 2,030 patients with diabetes (33.8%) and 3967 patients without diabetes (66.2%). Regardless of diabetes, the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (diabetes, 3.58% vs 4.12% [HR: 0.87; 95% CI: 0.56-1.37; P = 0.55]; nondiabetes, 2.46% vs 2.49% [HR: 0.99; 95% CI: 0.67-1.48; P = 0.97]; Pinteraction = 0.67) and for the cardiovascular endpoint (diabetes, 3.28% vs 3.05% [HR: 1.10; 95% CI: 0.67-1.81; P = 0.70]; nondiabetes, 1.95% vs 1.43% [HR: 1.38; 95% CI: 0.85-2.25; P = 0.20]; Pinteraction = 0.52), while it was lower for the bleeding endpoint (diabetes, 0.30% vs 1.50% [HR: 0.20; 95% CI: 0.06-0.68; P = 0.01]; nondiabetes, 0.61% vs 1.21% [HR: 0.51; 95% CI: 0.25-1.01; P = 0.054]; Pinteraction = 0.19). CONCLUSIONS: Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498).