Ogo T, Shinke T, Inami T
… +12 more, Ikeda N, Abe K, Sugiura T, Anzai A, Ito H, Taniguchi Y, Tsujino I, Tamura Y, Ishida K, Shimahara Y, Matsubara H, J-BPA Investigators
BACKGROUND: Over the past decade, balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension has shown improved outcomes with procedural refinement in expert hospitals with high procedural volu...BACKGROUND: Over the past decade, balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension has shown improved outcomes with procedural refinement in expert hospitals with high procedural volume. Whether the outcomes of BPA are reproducible in hospitals with limited procedural volumes remains unknown. The Japan BPA registry was designed to assess the outcomes of contemporary BPA from a nationwide perspective, including hospitals with low treatment volume. METHODS: This prospective multicenter registry enrolled 1202 consecutive patients with chronic thromboembolic pulmonary hypertension who underwent BPA at 44 hospitals between April 2018 and March 2023. We assessed the efficacy and safety of BPA and survival rates, comparing high- and low-volume hospitals based on the BPA center definition (≥50 procedures per year) from the seventh World Symposium on Pulmonary Hypertension. RESULTS: A total of 5207 procedures were performed. Thirty-five low-volume hospitals (79.5%) performed 40.8% of all BPA procedures. BPA significantly improved symptoms, clinical parameters, and hemodynamics (55.6% reduction in pulmonary vascular resistance), with 0.2% periprocedural BPA-related mortality. Severe lung injury (0.3%), balloon overdilatation (0.67%), and mechanical ventilation (0.3%) were less common in high-volume hospitals than in low-volume hospitals (1.3%, 1.7%, and 1.5%, respectively; <0.001). In the Kaplan-Meier analysis, the survival rate of all patients at 3 years was 94.7% (95% CI, 92.5%-96.3%). Multivariable Cox regression analysis showed an increased mortality risk with higher right atrial pressure, and high-volume hospitals were associated with a reduced mortality risk. CONCLUSIONS: This nationwide registry demonstrated the outcomes of contemporary BPA in patients with chronic thromboembolic pulmonary hypertension. No significant differences were observed in efficacy and periprocedural mortality between low- and high-volume hospitals. However, the significantly lower rate of severe complications in high-volume hospitals indicates that BPA may be safer in high-volume hospitals.
Armstrong DG, Conte MS, Mills JL
… +10 more, Menard MT, Orgill DP, Galiano RD, Kirsner RS, Farber A, Lantis JC, Zelen CM, Carter MJ, Hicks CW, Powell RJ
Circ Cardiovasc Interv
· 2026 Jan · PMID 41186002
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BACKGROUND: People with chronic limb-threatening ischemia lack Food and Drug Administration-approved therapies for wound healing, creating an unmet need for novel approaches. Prior studies of biologics in chronic limb-th...BACKGROUND: People with chronic limb-threatening ischemia lack Food and Drug Administration-approved therapies for wound healing, creating an unmet need for novel approaches. Prior studies of biologics in chronic limb-threatening ischemia have largely targeted end-stage patients with amputation-free survival as the primary outcome. This trial evaluated the efficacy of intramuscular administration of AMG0001, a plasmid encoding human HGF (hepatocyte growth factor), to promote ulcer healing in patients with chronic limb-threatening ischemia and neuroischemic ulcers. METHODS: LEGenD-1 was a double-blind, randomized, placebo-controlled phase II trial conducted at 22 US sites. Seventy-five participants with neuroischemic ulcers and toe pressure or transcutaneous oxygen pressure between 30 and 59 mm Hg were randomized to receive AMG0001 at 4 mg, 8 mg, or placebo. Injections were administered intramuscularly along an angiographically guided target artery path on days 0, 28, 56, and 84. The 2 coprimary end points were time to complete healing and the proportion of subjects with ulcers healed by 6 months in a pooled AMG0001 analysis. Secondary end points included healing by 12 months, ulcer recurrence, and hemodynamic changes. RESULTS: Baseline characteristics were comparable across groups (mean age 62.6 years; 80.0% male; 70.7% with diabetes). Mean toe pressure was 46.1 mm Hg, and transcutaneous oxygen pressure was 49.8 mm Hg. Median time to healing was significantly shorter with AMG0001 versus placebo (84 versus 280 days; =0.007); 4 mg: 98 days (=0.017); 8 mg: 84 days (=0.022). By 6 months, 63.3% of AMG0001-treated participants healed versus 38.5% of placebo (=0.053). By 12 months, healing rates were 77.6% versus 46.2% (=0.010). Adverse events were similar across groups. CONCLUSIONS: Anatomically targeted intramuscular delivery of AMG0001 significantly accelerated healing in patients with moderate chronic limb-threatening ischemia and neuroischemic ulcers and may represent a promising nonsurgical therapeutic strategy. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04267640.
BACKGROUND: While balloon postdilation (BPD) during transcatheter aortic valve replacement may enhance hemodynamic performance by optimizing valve expansion, it was also linked with leaflet mechanical stress, potentially...BACKGROUND: While balloon postdilation (BPD) during transcatheter aortic valve replacement may enhance hemodynamic performance by optimizing valve expansion, it was also linked with leaflet mechanical stress, potentially reducing valve durability. The aim of this study was to investigate the impact of BPD on long-term bioprosthetic valve durability. METHODS: We analyzed the data of a prospective single-center registry including consecutive patients undergoing transcatheter aortic valve replacement between May 2007 and March 2024 alive at 1-year and without a valve-in-valve procedure. To reduce imbalance in baseline and procedural characteristics, the effect of BPD on events was assessed using a propensity score-matched population (215 patients with BPD versus 761 patients without BPD, out of a total of 1911 patients). The primary end point was the occurrence of stage 2 or 3 hemodynamic valve deterioration according to Valve Academic Research Consortium-3. RESULTS: In the propensity-score matched population, BPD was associated with a lower risk of stage 2 or 3 hemodynamic valve deterioration occurrence compared with no-BPD (2.8% versus 5.8%; subdistribution hazard ratio, 0.37 [95% CI, 0.15-0.95]; =0.039), and a lower rate of bioprosthetic valve failure (2.8% versus 5.1%; subdistribution hazard ratio, 0.39 [95% CI, 0.15-0.98]; =0.046). Long-term echocardiographic follow-up up to 10 years showed better hemodynamic parameters over time in patients with BPD. A trend toward a higher prevalence of heart failure hospitalization was observed in patients with BPD. CONCLUSIONS: BPD was associated with a lower incidence of stage 2 and 3 hemodynamic valve deterioration and bioprosthetic valve failure, along with improved bioprosthetic valve hemodynamic parameters over time. Further studies are warranted.
BACKGROUND: Residual mitral regurgitation (rMR) ≤1+ has been associated with improved 1-year outcomes after mitral valve transcatheter edge-to-edge repair, regardless of the mean mitral pressure gradient (MPG). Prior evi...BACKGROUND: Residual mitral regurgitation (rMR) ≤1+ has been associated with improved 1-year outcomes after mitral valve transcatheter edge-to-edge repair, regardless of the mean mitral pressure gradient (MPG). Prior evidence is limited to 30-day echocardiographic follow-up and patients treated with the MitraClip (Abbott Structural Heart). Whether rMR and MPG assessed at discharge are associated with outcomes after PASCAL mitral valve transcatheter edge-to-edge repair (Edwards Lifesciences) remains unknown. METHODS: REPAIR (Registry of Pascal for Mitral Regurgitation) is an investigator-initiated, multicenter registry including all consecutive patients treated with PASCAL mitral valve transcatheter edge-to-edge repair. Based on discharge echocardiography, patients were stratified into 4 groups: optimal (rMR ≤1+, MPG <5 mm Hg), MPG-suboptimal (rMR ≤1+, MPG ≥5 mm Hg), rMR-suboptimal (rMR ≥2+, MPG <5 mm Hg), and dual-suboptimal (rMR ≥2+, MPG ≥5 mm Hg). The primary end point was 1-year mortality. RESULTS: Among 2172 patients (median follow-up, 463 days [Q1-Q3, 357-815]), 59.4% were classified as optimal, 12.2% MPG-suboptimal, 21.3% rMR-suboptimal, and 7.0% dual-suboptimal. One-year mortality differed significantly across groups (<0.001), with the lowest rate in the optimal (8.7% [95% CI, 6.8%-10.5%]) and highest in the dual-suboptimal group (20.1% [95% CI, 12.0%-27.4%]; <0.001). rMR ≤1+ was associated with lower 1-year mortality (hazard ratio, 0.54 [95% CI, 0.37-0.74]; <0.001) and remained significant, independent of dichotomized (MPG, <5 versus ≥5 mm Hg) or continuous MPG. Dichotomized MPG was not significantly associated with 1-year mortality (hazard ratio, 0.73 [95% CI, 0.51-1.04]; =0.078), whereas continuous MPG was (hazard ratio per mm Hg increase, 1.10 [95% CI, 1.00-1.21]; =0.048) with a trend after adjusting for rMR ≤1+ (adjusted hazard ratio per mm Hg increase, 1.07 [95% CI, 0.98-1.18]; =0.145). No interaction was observed between rMR ≤1+ and dichotomized/continuous MPG (both >0.450). CONCLUSIONS: Discharge rMR ≤1+ is independently associated with lower 1-year mortality after PASCAL mitral valve transcatheter edge-to-edge repair. Although MPG was not independently associated, modestly elevated gradients may be acceptable when rMR ≤1+ is achieved, but should still warrant clinical attention. REGISTRATION:URL: https://www.drks.de; Unique identifier: DRKS00033959.
BACKGROUND: It remains unclear whether drug-coated balloons (DCBs) and drug-eluting stents are comparable in the treatment of coronary artery disease (CAD) and whether limus versus paclitaxel DCBs yield similar clinical...BACKGROUND: It remains unclear whether drug-coated balloons (DCBs) and drug-eluting stents are comparable in the treatment of coronary artery disease (CAD) and whether limus versus paclitaxel DCBs yield similar clinical outcomes. We aimed to assess the clinical efficacy of limus and paclitaxel DCBs in patients with CAD through a network meta-analysis. METHODS: We comprehensively searched multiple databases for randomized controlled trials comparing the following 4 strategies: limus DCB, paclitaxel DCB, second-generation or newer drug-eluting stent, and plain old balloon angioplasty. The primary outcome was trial-defined major adverse cardiovascular events (MACEs), typically a composite of death, myocardial infarction, or target lesion revascularization. Secondary outcomes included individual components of MACE. We performed subgroup analyses for in-stent restenosis, small-vessel (<3 mm) CAD, and other de novo CAD, such as large vessel and ST-segment-elevation myocardial infarction. RESULTS: We identified 39 randomized controlled trials including 10 219 patients. There was no significant difference in MACE between limus and paclitaxel DCBs (relative risk, 1.22 [95% CI, 0.86-1.73]). There were no significant differences in MACE between limus or paclitaxel DCB and second-generation or newer drug-eluting stents. Plain old balloon angioplasty had an increased risk of MACE compared with others. These results were consistent across subgroup analyses for in-stent restenosis, small-vessel CAD, and other de novo CAD. CONCLUSIONS: No significant differences were observed in MACE or its components between limus and paclitaxel DCBs, albeit with limited statistical power. Furthermore, DCB and second-generation or newer drug-eluting stents yielded similar outcomes though power was limited, especially for other de novo CAD. REGISTRATION:URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD420250654276.
Egbe AC, Cabalka AK, Taggart NW
… +4 more, Hagler DJ, Eleid MF, Rihal CS, Anderson JH
Circ Cardiovasc Interv
· 2025 Dec · PMID 41140155
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BACKGROUND: The current study aims to describe outcomes after transcatheter valve replacement in adults with congenital heart disease. METHODS: Retrospective study of adults with congenital heart disease who underwent tr...BACKGROUND: The current study aims to describe outcomes after transcatheter valve replacement in adults with congenital heart disease. METHODS: Retrospective study of adults with congenital heart disease who underwent transcatheter valve replacement and had a 1-year follow-up postintervention at Mayo Clinic (2010-2024). The study period was divided into early (2010-2014), mid (2015-2019), and late (2020-2024) eras. The primary outcome was valve reintervention. The secondary outcomes were all-cause mortality and temporal change in prosthetic valve gradient and clinical indices of disease severity. RESULTS: Overall, 341 patients (age 38±17 years; 175 [51%] men) received 346 prostheses (pulmonary [N=236, 68%], tricuspid [N=75, 22%], aortic [N=22, 8%], and mitral [N=7, 2%]). The prostheses were Sapien (N=181, 52%), Melody (N=142, 41%), and Harmony prostheses (N=23, 7%). The number of transcatheter valve implantations increased from the early era (N=75), mid era (N=109), to the late era (N=162). The 10-year incidence of valve reintervention was 35%, and was similar between Sapien versus Melody prosthesis (41% versus 33%; =0.11). The 10-year incidence of all-cause mortality was 13%. There was a temporal increase in prosthetic valve Doppler mean gradient (baseline versus 10 years) for pulmonary (12±5 versus 28±11 mmHg; <0.001), tricuspid (3±1 versus 8±3 mmHg; <0.001), and aortic prosthesis (13±5 versus 26±12 mmHg; <0.001). There was a temporal increase in predicted peak oxygen consumption (absolute ∆, 9% [95% CI, 4-13]; =0.006) and a decrease in NT-proBNP (N-terminal pro-B-type natriuretic peptide) level (absolute ∆, -138 pg/mL [95% CI, -209 to -64]; <0.001) at 1-year postintervention. CONCLUSIONS: There has been a temporal increase in the number of transcatheter valve implantations over time. Transcatheter valve replacement was associated with clinical improvement across multiple domains. However, there was a significant increase in prosthetic valve gradient within 10 years of follow-up, suggesting limited prosthesis longevity. There is a need for strategies to improve prosthetic valve longevity, which in turn may improve outcomes in this population.
Ikeda K, Mizukami T, Sakai K
… +41 more, Bouisset F, Sonck J, Wilgenhof A, Matsuo H, Shinke T, Ando H, Hada M, Ko B, Biscaglia S, Rivero F, Engstrøm T, Leone AM, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Keulards D, Zimmermann FM, Storozhenko T, da Costa BR, Campo G, Berry C, Collison D, Johnson TW, Munhoz D, Amano T, Perera D, Jeremias A, Ali ZA, Kubo T, Satomi K, Tanaka N, De Bruyne B, Johnson NP, Collet C
BACKGROUND: Impaired flow following percutaneous coronary intervention (PCI) is a known predictor of adverse outcomes. The pullback pressure gradient (PPG) is a novel physiological metric that differentiates focal from d...BACKGROUND: Impaired flow following percutaneous coronary intervention (PCI) is a known predictor of adverse outcomes. The pullback pressure gradient (PPG) is a novel physiological metric that differentiates focal from diffuse disease and enables prediction of post-PCI fractional flow reserve (FFR). This post hoc analysis of the PPG Global (NCT04789317) study aimed to evaluate the prognostic performance of a PPG model for predicting post-PCI FFR and to determine whether the predicted physiological outcome is associated with adverse events following PCI. METHODS: Prospective and multicenter study including patients with hemodynamically significant coronary artery disease undergoing PCI. A prediction model based on FFR and PPG was used to estimate post-PCI FFR. Based on the predicted values, vessels were classified as having either optimal or suboptimal post-PCI physiology. The primary end point was target vessel failure at 1 year. Target vessel failure was defined as a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target vessel revascularization. RESULTS: A total of 855 patients (890 vessels) were analyzed. The mean difference between predicted and measured post-PCI FFR was 0.001 (limits of agreement, -0.10 to 0.10). There was a strong correlation between predicted and measured delta FFR (=0.92 [95% CI, 0.91-0.93]; <0.001). Vessels with predicted suboptimal post-PCI physiology had a significantly higher incidence of target vessel failure (adjusted hazard ratio, 1.97 [95% CI, 1.24-3.15]; =0.004). Predicted suboptimal physiology was independently associated with adverse clinical outcomes. CONCLUSIONS: PPG-predicted post-PCI physiology was associated with target vessel failure at 1 year. These findings extend the role of coronary physiology beyond diagnostic assessment to include risk stratification and outcome prediction following PCI.
BACKGROUND: There is a paucity of data regarding the longer-term durability of transcatheter heart valves. This analysis aimed to describe the 5-year clinical outcomes and valve durability for patients treated with the P...BACKGROUND: There is a paucity of data regarding the longer-term durability of transcatheter heart valves. This analysis aimed to describe the 5-year clinical outcomes and valve durability for patients treated with the Portico transcatheter heart valves across 3 studies harmonized in their prospective enrollment, inclusion/exclusion criteria, centralized independent core laboratory echocardiographic analysis, and independent clinical events committee adjudication. METHODS: Patient-level data from the PORTICO IDE randomized controlled trial, the PORTICO I postmarket study, and the PORTICO continued access protocol were pooled using a random-effects meta-analysis model. All 3 studies collected follow-up data at discharge, 30 days, and annually through 5 years. Adverse events and pooled echocardiographic data were assessed using Valve Academic Research Consortium-2 definitions. Durability definitions were adapted from Valve Academic Research Consortium-3 and European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery consensus guidelines. RESULTS: A total of 1464 patients with severe symptomatic aortic stenosis and high or extreme surgical risk were included. Median age was 83 years, 61.7% were women, and the median Society of Thoracic Surgeons score was 4.9%. At 5 years, all-cause mortality and stroke rates were 49.4% and 12.3%, respectively. Transvalvular gradient and effective orifice area at 5 years were 6.2 mm Hg and 1.83 cm, respectively, with paravalvular leak ≥moderate severity occurring in 1.9%. The 5-year bioprosthetic valve failure rate was 2.7%, including a 0.7% valve-related death rate and a 2.0% valve reintervention rate, but no patients with severe hemodynamic structural valve deterioration. Moderate hemodynamic structural valve deterioration occurred in 0.9% of the patients at 5 years. Hemodynamic performance and transcatheter heart valve durability remained stable irrespective of annular size. CONCLUSIONS: The use of the Portico transcatheter heart valve system in patients at high or extreme surgical risk demonstrated favorable clinical outcomes and hemodynamic performance with low transvalvular gradients and greater than mild paravalvular leak. Furthermore, bioprosthetic valve failure rates were low with no incidence of severe hemodynamic structural valve deterioration at 5 years, irrespective of annular size. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02000115 and NCT01802788.
Lerner JB, Crane BP, Colasurdo D
… +11 more, Gioiella L, Razzouk L, Tuozzo KA, Inoyatova I, Accardo M, Querijero M, Bar J, Murtha M, Kirchen K, Attubato M, Rao SV
BACKGROUND: The Minima Stent System is the first stent designed, tested, and Food and Drug Administration-approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Mini...BACKGROUND: The Minima Stent System is the first stent designed, tested, and Food and Drug Administration-approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Minima implantation for pulmonary artery stenosis (PAS) and coarctation of the aorta (CoA). METHODS: Multicenter, single-arm, prospective, nonrandomized trial. Primary end points included stenosis relief, freedom from device-related serious adverse events or surgical intervention through 6 months, and maintenance of vessel lumen diameter on computed tomography or catheter angiography at 6 months. RESULTS: Forty-two patients (21 PAS, 15 recurrent CoA, and 6 native CoA) underwent Minima implantation at a median age and weight of 9 (range, 0.4-112) months and 7.8 (3.4-28.3) kg. Implantation was successful in 41 (97.6%) and resulted in a median increase in minimal vessel diameter of 131% (46%-483%) and reduction in median pressure gradients from 25 (0-63) to 0 (0-6; <0.001) mm Hg in patients with CoA. Two acute PAS stent embolizations occurred; both stents were secured in the contralateral PA, and one was treated with an additional Minima stent. Seven patients with CoA, all under 6 kg, experienced transient femoral artery thrombosis. At 6 months, there were no explants or device-related serious adverse events. Luminal diameter was maintained at 89% (59%-137%) of the implant diameter. During a median follow-up of 596 (412-979) days, 13 (31%; 7 CoA and 6 PAS) patients underwent planned stent expansion without complications. CONCLUSIONS: The Minima system is safe and effective for treating PAS and CoA in infants and small pediatric patients. Luminal patency was preserved, and planned reinterventions for somatic growth seem well-tolerated in early follow-up. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT05086016.
Sarti A, Erriquez A, Dal Passo B
… +17 more, Casella G, Guiducci V, Moreno R, Escaned J, Marchini F, Cocco M, Verardi FM, Clò S, Caglioni S, Farina J, Barbato E, Vadalà G, Cavazza C, Capecchi A, Gallo F, Campo G, Biscaglia S
BACKGROUND: The FIRE trial (Functional Assessment in Elderly Myocardial Infarction Patients With Multivessel Disease) showed the superiority of complete revascularization in older patients with myocardial infarction (MI)...BACKGROUND: The FIRE trial (Functional Assessment in Elderly Myocardial Infarction Patients With Multivessel Disease) showed the superiority of complete revascularization in older patients with myocardial infarction (MI) and multivessel disease. Whether this result applies equally to patients at higher risk of ischemic events due to nonculprit lesion complexity is unclear. METHODS: Overall, 1445 patients were randomized to culprit-only or complete revascularization. In this prespecified analysis, patients were divided into those with or without at least 1 complex nonculprit lesion. A nonculprit lesion was defined as complex if it met any of the following criteria: angiographic heavy calcification, ostial lesion, true bifurcation lesion involving side-branches >2.5 mm, in-stent restenosis, or long-lesions (estimated stent length >28 mm). The primary outcome comprised a composite of death, MI, stroke, or revascularization at 3 years. The key secondary outcome was a composite of cardiovascular death or MI. The safety outcome included a composite of contrast-associated acute kidney injury, stroke, and Bleeding Academic Research Consortium 3 to 5. RESULTS: Overall, 641 patients (44%, complex subgroup) had at least 1 complex nonculprit lesion, whereas 804 patients (56%, noncomplex subgroup) did not. After adjustment for potential confounders, patients in the complex subgroup were at higher risk of 3-year cardiovascular death or MI (hazard risk [HR], 1.32 [95% CI, 1.01-1.74]), MI (HR, 2.33 [95% CI, 1.44-3.78]) and ischemia-driven coronary revascularization (HR, 2.28 [95% CI, 1.46-3.56]). Complete revascularization reduced the primary outcome in both the complex (HR, 0.75 [95% CI, 0.56-0.99]) and noncomplex (HR, 0.71 [95% CI, 0.53-0.95]) subgroups, with no significant interaction ( for interaction=0.625). Similarly, no evidence of heterogeneity related to nonculprit lesion complexity was observed for either key secondary or safety end points. CONCLUSIONS: In older patients with MI and multivessel disease, physiology-guided complete revascularization reduced ischemic events, regardless of the complexity of nonculprit lesions. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03772743.
Natsuaki M, Watanabe H, Morimoto T
… +20 more, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tamura T, Kawahatsu K, Hayashi F, Akao M, Serikawa T, Mori H, Kawamura T, Hagikura A, Shibata N, Ono K, Kimura T
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 rec...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]; 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]; 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.
Kang J, Park S, Park KW
… +20 more, Joo HJ, Chang K, Park Y, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Jeong YH, Kim BK, Kim MH, Shin ES, Lim DS, Hwang D, Han JK, Yang HM, Koo BK, Kim HS, PTRG Investigators
BACKGROUND: Platelet reactivity (PR) and clinical risk factors are known to have impact on outcomes in patients receiving percutaneous coronary intervention (PCI). We aimed to assess the interaction of PR and clinical ri...BACKGROUND: Platelet reactivity (PR) and clinical risk factors are known to have impact on outcomes in patients receiving percutaneous coronary intervention (PCI). We aimed to assess the interaction of PR and clinical risk assessment using the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2P) on adverse clinical outcomes following PCI. METHODS: From the PTRG-DES (Platelet function and Genotype-Related Long-Term Prognosis in Drug-Eluting Stent-Treated Patients With Coronary Artery Disease) registry, 11 714 patients who underwent PCI and had a mean platelet reactivity unit (PRU) value were studied. Clinical risk was stratified using the TRS2P as low clinical risk (score 0-1) or high clinical risk (≥2), and PR was stratified as high PR (HPR, PRU ≥252) and non-HPR (PRU <252). The primary outcome was a composite of cardiac death, myocardial infarction, and stent thrombosis. Landmark analysis was performed at 1- and 12 months after PCI. RESULTS: Among total population, mean PRU was 217.8±78.7, and mean TRS2P was 1.56±1.12. Over the long-term follow-up period, the primary outcome occurred in 335 (5.3%) patients. Patients with both high clinical risk and HPR had the highest incidence of the primary outcome (9.4%), followed by high clinical risk/non-HPR (5.9%), low clinical risk/HPR (4.8%), and low clinical risk/non-HPR (3.9%) (<0.001). Compared with low clinical risk/non-HPR patients, those with both high clinical risk and HPR had a 3.25-fold higher risk of the primary outcome (hazard ratio, 3.25 [95% CI, 2.38-4.42]; <0.001). Both PRU and TRS2P were independent predictors of the primary outcome. In landmark analyses, the risk of primary outcome within 1 month after PCI were mainly determined by PRU, while outcome beyond 1 month after PCI was mainly determined by TRS2P. CONCLUSIONS: In the secondary prevention after percutaneous coronary intervention, platelet reactivity and clinical risk had additive value in predicting outcomes. Platelet reactivity had greater relative impact within 1 month while clinical risk had greater relative impact beyond 1 month. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04734028.