Stent Expansion Indexes to Predict Clinical Outcomes: An IVUS Substudy From ADAPT-DES

ObjectivesThe aim of this study was to evaluate various stent expansion indexes to determine the best predictor of clinical outcomes.BackgroundNumerous intravascular ultrasound (IVUS) studies have shown minimum stent area (MSA) to be the most powerful predictor of future events.MethodsADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. Native coronary artery lesions treated with IVUS-guided PCI with final analyzable IVUS were included. Ten stent expansion indexes (MSA, MSA/vessel area at MSA site, conventional stent expansion [MSA/average of proximal and distal reference luminal area], minimum stent expansion using Huo-Kassab or linear model accounting for vessel tapering, stent asymmetry [minimum/maximum stent diameter within the entire stent], stent eccentricity [smallest minimum/maximum stent diameter at a single slice within the stent], IVUS-XPL [Impact of intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions] criteria, and ILUMIEN IV criteria) were evaluated for their associations with lesion-specific 2-year clinically driven target lesion revascularization (TLR) or definite stent thrombosis.ResultsOverall, 2,140 lesions in 1,831 patients were included; final MSA measured 6.2 ± 2.4 mm². Among the 10 stent expansion indexes, only MSA/vessel area at the MSA site was independently associated with 2-year clinically driven TLR or definite stent thrombosis (hazard ratio: 0.77; 95% confidence interval: 0.59-0.99; P = 0.04) after adjusting for morphologic and procedural parameters.ConclusionsIn this IVUS-guided PCI cohort with excellent final MSA overall, stent/vessel area at the MSA site, an index of relative stent expansion, was superior to absolute MSA and other expansion indexes in predicting 2-year clinically driven TLR or definite stent thrombosis.     

Dual Antiplatelet Therapy Discontinuation,Platelet Reactivity,and Adverse Outcomes After Successful Percutaneous Coronary Intervention

ObjectivesThe purpose of this study was to assess the extent to which the association between premature dual antiplatelet therapy (DAPT) discontinuation and excess risk of thrombotic events varies according to the reason and timing of DAPT discontinuation and whether high on-treatment platelet reactivity (HPR) influences the risk of thrombotic events after premature DAPT discontinuation.BackgroundDAPT after percutaneous coronary intervention (PCI) suppresses platelet reactivity, and HPR on clopidogrel after PCI is associated with an increased risk of thrombotic events.MethodsADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients successfully treated with coronary drug-eluting stents that assessed HPR on clopidogrel. For patients who discontinued aspirin or clopidogrel at any time during the study, the reasons for discontinuation were systematically categorized.ResultsPlanned DAPT discontinuation occurred within 2 years in 3,203 (37.3%) patients. One thousand four hundred eighteen (16.5%) patients discontinued DAPT for unplanned reasons, including surgery or trauma (n = 768 [8.9%]), patient nonadherence (n = 321 [3.7%]), bleeding complications (n = 264 [3.1%]), and drug allergy or hypersensitivity (n = 113 [1.3%]). Unplanned but not planned DAPT discontinuation was associated with an increased risk of a major adverse cardiac event (MACE, defined as the composite of cardiac death, myocardial infarction, or stent thrombosis); with highest risk within 3 months after PCI (adjusted HR: 7.65, 95% CI: 2.77-21.10 vs adjusted HR: 2.47, 95% CI: 1.70-3.58 for unplanned DAPT discontinuation ≥3 months after PCI). MACE risk after DAPT discontinuation was not moderated by HPR (P_interaction = 0.91).ConclusionsIn this large-scale all-comers registry, premature DAPT discontinuation for unplanned reasons occurred in approximately 1 of 6 patients after DES implantation and was associated with a markedly increased risk of MACEs. (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents [ADAPT-DES]; NCT00638794)     

3-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation

ObjectivesThe aim of this study was to explore the difference in target vessel failure (TVF) 3 years after intravascular ultrasound (IVUS) guidance versus angiographic guidance among all comers undergoing second-generation drug-eluting stent (DES) implantation.BackgroundThe multicenter randomized ULTIMATE (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions) trial showed a lower incidence of 1-year TVF after IVUS-guided DES implantation among all comers compared with angiographic guidance. However, the 3-year clinical outcomes of the ULTIMATE trial remain unknown.MethodsA total of 1,448 all comers undergoing DES implantation who were randomly assigned to either IVUS guidance or angiographic guidance in the ULTIMATE trial were followed for 3 years. The primary endpoint was the risk for TVF at 3 years. The safety endpoint was definite or probable stent thrombosis (ST).ResultsAt 3 years, TVF occurred in 47 patients (6.6%) in the IVUS-guided group and in 76 patients (10.7%) in the angiography-guided group (p = 0.01), driven mainly by the decrease in clinically driven target vessel revascularization (4.5% vs. 6.9%; p = 0.05). The rate of definite or probable ST was 0.1% in the IVUS-guided group and 1.1% in the angiography-guided group (p = 0.02). Notably, the IVUS-defined optimal procedure was associated with a significant reduction in 3-year TVF relative to that with the suboptimal procedure.ConclusionsIVUS-guided DES implantation was associated with significantly lower rates of TVF and ST during 3-year follow-up among all comers, particularly those who underwent the IVUS-defined optimal procedure compared with those with angiographic guidance. (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions; NCT02215915)     

Improved 3-Year Cardiac Survival After IVUS–Guided Long DES Implantation: A Patient-Level Analysis From 2 Randomized Trials

ObjectivesThe present study aimed to evaluate long-term cardiac survival benefit for intravascular ultrasound (IVUS)- versus angiography-guided long drug-eluting stent (DES) implantation.BackgroundAlthough the long-term benefit of IVUS guidance for DES implantation has been reported from recent randomized trials, this benefit was primarily driven by the reduction in repeat revascularization. Thus, it remains uncertain whether IVUS guidance improved survival during long-term follow-up.MethodsWe pooled the data of 2 randomized trials (IVUS-XPL [Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions] and ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in All-Comers Coronary Lesions]) and compared IVUS guidance versus angiography guidance in 2,577 patients with long lesions treated with an implanted stent length ≥28 mm. The primary end point was cardiac death at 3 years.ResultsA 3-year clinical follow-up was completed in 96%. The primary end point of cardiac death occurred in 12 patients (1.0%) in the IVUS-guided group vs 28 patients (2.2%) in the angiography-guided group (HR: 0.43; 95% CI: 0.22-0.84; P = 0.011). In addition, target lesion–related myocardial infarction occurred in 3 patients (0.2%) in the IVUS-guided group and in 9 patients (0.7%) in the angiography-guided group (HR: 0.33; 95% CI: 0.09-1.22; P = 0.081), stent thrombosis developed in 3 patients (0.2%) in the IVUS-guided group and 9 patients (0.7%) in the angiography-guided group (HR: 0.33; 95% CI: 0.09-1.23; P = 0.082), and ischemia-driven target lesion revascularization was observed in 47 patients (3.8%) in the IVUS-guided group and 80 patients (6.5%) in the angiography-guided group (HR: 0.57; 95% CI: 0.40-0.82; P = 0.002).ConclusionsIn this post hoc pooled patient-level analysis, the use of IVUS-guided long DES implantation compared with angiography-guided stent implantation improved long-term patient cardiac survival.     

Impact of Coronary Artery Tortuosity on Outcomes Following Stenting: A Pooled Analysis From 6 Trials

ObjectivesThe authors sought to determine whether coronary artery tortuosity negatively affects clinical outcomes after stent implantation.BackgroundCoronary artery tortuosity is a common angiographic finding and has been associated with increased rates of early and late major adverse events after balloon angioplasty.MethodsIndividual patient data from 6 prospective, randomized stent trials were pooled. Outcomes at 30 days and 5 years following percutaneous coronary intervention of a single coronary lesion were analyzed according to the presence or absence of moderate/severe vessel tortuosity, as determined by an angiographic core laboratory. The primary endpoint was target vessel failure (TVF) (composite of cardiac death, target vessel–related myocardial infarction [TV-MI], or ischemia-driven target vessel revascularization [ID-TVR]).ResultsA total of 6,951 patients were included, 729 of whom (10.5%) underwent percutaneous coronary intervention in vessels with moderate/severe tortuosity. At 30 days, TVF was more frequent in patients with versus without moderate/severe tortuosity (3.8% vs. 2.4%; hazard ratio [HR]: 1.64; 95% confidence interval [CI]: 1.09 to 2.46; p = 0.02), a difference driven by a higher rate of TV-MI. At 5 years, TVF remained increased in patients with moderate/severe tortuosity (p = 0.003), driven by higher rates of TV-MI (p = 0.003) and ID-TVR (p = 0.01). Definite stent thrombosis was also greater in patients with versus without moderate/severe tortuosity (1.9% vs. 1.0%; HR: 1.86; 95% CI: 1.02 to 3.39; p = 0.04). After adjustment for baseline covariates, moderate/severe vessel tortuosity was independently associated with TV-MI and ID-TVR at 5 years (p = 0.04 for both).ConclusionsStent implantation in vessels with moderate/severe coronary artery tortuosity is associated with increased rates of TVF due to greater rates of TV-MI and ID-TVR.     

Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation

ObjectivesThe aim of this study was to develop a risk model incorporating clinical, angiographic, and physiological parameters to predict future clinical events after drug-eluting stent implantation.BackgroundPrognostic factors after coronary stenting have not been comprehensively investigated.MethodsA risk model to predict target vessel failure (TVF) at 2 years was developed from 2,200 patients who underwent second-generation drug-eluting stent implantation and post-stent fractional flow reserve (FFR) measurement. TVF was defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization. A random survival forest model with automatic feature selection by minimal depth analysis was used for risk model development.ResultsDuring 2 years of follow-up, the cumulative incidence of TVF was 5.9%. From clinical, angiographic, and physiological parameters, 6 variables were selected for the risk model in order of importance within the model as follows: total stent length, post-stent FFR, age, post-stent percentage diameter stenosis, reference vessel diameter, and diabetes mellitus. Harrell’s C index of the random survival forest model was 0.72 (95% confidence interval [CI]: 0.62 to 0.82). This risk model showed better prediction ability than models with clinical risk factors alone (Harrell’s C index = 0.55; 95% CI: 0.41 to 0.59; p for comparison = 0.005) and with clinical risk factors and angiographic parameters (Harrell’s C index = 0.65; 95% CI: 0.52 to 0.77; p for comparison = 0.045). When the patients were divided into 2 groups according to the median of total stent length (30 mm), post-stent FFR and total stent length showed the highest variable importance in the short- and long-stent groups, respectively.ConclusionsA risk model incorporating clinical, angiographic, and physiological predictors can help predict the risk for TVF at 2 years after coronary stenting. Total stent length and post-stent FFR were the most important predictors. (International Post PCI FFR Registry; NCT04012281)     

1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial

ObjectivesThe aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation.BackgroundIt is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI).MethodsIn this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%).ResultsThe primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference −0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842).ConclusionsAmong patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy. (A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-Eluting Stent Implantation; NCT02513810)     

1-Year Clinical Outcomes of All Comers Treated With 2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents: Propensity Score–Matched Comparison of the COMBO and Ultrathin-Strut Orsiro Stents

ObjectivesThe aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents.BackgroundThe COMBO stainless-steel stent has an anti-CD34⁺ antibody coating to capture endothelial progenitor cells, thereby promoting faster endothelialization. The Orsiro is an ultrathin-strut cobalt-chromium stent, covered by an extremely thin layer of amorphous silicon carbide to minimize ion leakage. Both devices elute sirolimus from biodegradable polymers.MethodsFor this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score–matched analysis.ResultsAt baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score–matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99).ConclusionsA propensity score–matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT–Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002)     

Effect of Intravascular Ultrasound–Guided Drug-Eluting Stent Implantation: 5-Year Follow-Up of the IVUS-XPL Randomized Trial

ObjectivesThe goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up.BackgroundThe use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up.MethodsThe IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion–related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat.ResultsFive-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031).ConclusionsCompared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486)     

Pathology and Multimodality Imaging of Acute and Chronic Femoral Stenting in Humans

ObjectivesThe objective of this study was to comprehensively evaluate the pathology of acute and chronic femoral stenting in symptomatic atherosclerotic patients and to understand the causes of stent failure (SF) using multimodality imaging including micro–computed tomography.BackgroundAlthough the pathology of coronary stenting has been well studied, the pathology of lower extremity femoral stenting remains poorly understood.MethodsTwelve stented femoral lesions removed at surgery (n = 10) and at autopsy (n = 2) were obtained from 10 patients (median age 74 years; interquartile range [IQR]: 66 to 82 years) with histories of peripheral artery disease (critical limb ischemia in 7) (7 men and 3 women). All specimens underwent radiography, micro–computed tomography, and histological assessment.ResultsThe median duration of implantation was 150 days (IQR: 30 to 365 days), the median stent diameter was 5.90 mm (IQR: 5.44 to 7.16 mm), and the median stent length was 39.5 mm (IQR: 27 to 107.5 mm). Of the 12 stented lesions, 2 had drug-eluting stents, and 10 had bare-metal stents. SF was observed in 8 of 12 lesions. The major cause of SF was acute thrombosis (6 of 8), but causes varied (delayed healing, stent underexpansion, false lumen stenting, and fracture), and 2 had restenosis. Stent fractures were observed in 3 cases by micro–computed tomography. Both drug-eluting stents, implanted for >1 year, showed delayed healing with circumferential peristrut fibrin deposition and SF.ConclusionsThis histological study is the first to examine the pathological cause of SF. Stent thrombosis was the major cause of SF. Delayed healing was a common feature of bare-metal stents implanted for <90 days, while all drug-eluting stents, despite implantation duration >1 year, showed delayed healing.     

1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration

ObjectivesThis study aimed to investigate the 1-year risk of restenosis and aneurysmal degeneration and explore the associated factors after femoropopliteal implantation of fluoropolymer-based drug-eluting stents (FP-DESs) for symptomatic atherosclerotic peripheral artery disease in real-world practice.BackgroundAlthough clinical trials have demonstrated that FP-DES implantation has favorable 1-year outcomes, its performance in real-world practice has not been well elucidated.MethodsThis multicenter, prospective, observational study evaluated 1,204 limbs (chronic limb-threatening ischemia: 34.8%, mean lesion length: 18.6 ± 9.9 cm, chronic total occlusion: 53.2%, bilateral wall calcification: 41.9%) of 1,097 patients with peripheral artery disease (age: 75 ± 9 years, men: 69.4%, diabetes mellitus: 60.8%, chronic kidney disease: 66.2%) undergoing Eluvia (Boston Scientific) drug-eluting stent implantation for femoropopliteal lesions. The primary outcome measure was 1-year restenosis, whereas the secondary outcome measures were 1-year occlusive restenosis, stent thrombosis, target lesion revascularization, and aneurysmal degeneration.ResultsThe 1-year occurrence rates of restenosis (12.9%), occlusive restenosis (9.2%), stent thrombosis (3.3%), target lesion revascularization (6.2%), and aneurysmal degeneration (16.8%) were found. Multivariate analysis demonstrated that dialysis, chronic limb-threatening ischemia, history of revascularization, a smaller reference vessel diameter, chronic total occlusion, and spot stenting were significantly associated with an increased risk of 1-year restenosis, whereas intravascular ultrasound use and subintimal wire passage were significantly associated with an increased risk of 1-year aneurysmal degeneration.ConclusionsThis study documented the 1-year clinical outcomes after femoropopliteal endovascular therapy with FP-DES implantation in real-world practice. The 1-year restenosis rate would be clinically acceptable, whereas the occurrence of occlusive restenosis and aneurysmal degeneration should be noted.     

Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions

BackgroundThe comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied.ObjectivesThis study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT).MethodsPatient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization.ResultsAmong 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups.ConclusionsIn patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.     

Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study

ObjectivesThe aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD).BackgroundRecent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far.MethodsThe study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months.ResultsFrom February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred.ConclusionsAspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856)     

Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry

ObjectivesThe aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR).BackgroundCoronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality.MethodsData were collected retrospectively from a multicenter international registry between April 2011 and February 2019.ResultsAmong 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in “valve-in-valve” procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19).ConclusionsIn patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.     

Proximal LAD Treated With Thin-Strut New-Generation Drug-Eluting Stents: A Patient-Level Pooled Analysis of TWENTE I-III

ObjectivesThis study sought to assess 2-year clinical outcome following percutaneous coronary intervention (PCI) with thin-strut new-generation drug-eluting stents (DES) in patients treated in proximal left anterior descending artery (P-LAD) versus non–P-LAD lesions.BackgroundIn current revascularization guidelines, P-LAD coronary artery stenosis is discussed separately, mainly because of a higher adverse event risk and benefits of bypass surgery.MethodsThe study included 6,037 patients without previous bypass surgery or left main stem involvement from the TWENTE I, II, and III randomized trials. A total of 1,607 (26.6%) patients had at least 1 DES implanted in P-LAD and were compared with 4,430 (73.4%) patients who were exclusively treated in other (non–P-LAD) segments.ResultsTwo-year follow-up was available in 5,995 (99.3%) patients. At baseline, P-LAD patients had more multivessel treatment and longer total stent length. The rate of the patient-oriented composite clinical endpoint (any death, any myocardial infarction, or any revascularization) was similar in P-LAD versus non–P-LAD patients (11.4% vs. 11.6%; p = 0.87). In P-LAD patients, the rate of the device-oriented composite clinical endpoint (cardiac death, target vessel myocardial infarction, or target lesion revascularization) was higher (7.6% vs. 6.0%; p = 0.020), driven by a higher rate of target vessel myocardial infarction (4.1% vs. 2.6%; p = 0.002). However, multivariate analysis showed no independent association between stenting P-LAD lesions and clinical endpoints.ConclusionsIn this patient-level pooled analysis of 3 large-scale contemporary DES trials, treatment of P-LAD lesions was not independently associated with higher 2-year adverse clinical event rates. These results imply that separate consideration in future revascularization guidelines may not be mandatory any longer.     

Thin Composite-Wire-Strut Zotarolimus-Eluting Stents Versus Ultrathin-Strut Sirolimus-Eluting Stents in BIONYX at 2 Years

ObjectivesThe aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis.BackgroundThe Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates.MethodsA total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel–related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods.ResultsTwo-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]).ConclusionsAt 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.     

2-Year Outcomes After Stenting of Lipid-Rich and Nonrich Coronary Plaques

BackgroundAutopsy studies suggest that implanting stents in lipid-rich plaque (LRP) may be associated with adverse outcomes.ObjectivesThe purpose of this study was to evaluate the association between LRP detected by near-infrared spectroscopy (NIRS) and clinical outcomes in patients with coronary artery disease treated with contemporary drug-eluting stents.MethodsIn this prospective, multicenter registry, NIRS was performed in patients undergoing coronary angiography and possible percutaneous coronary intervention (PCI). Lipid core burden index (LCBI) was calculated as the fraction of pixels with the probability of LRP >0.6 within a region of interest. MaxLCBI_4mm was defined as the maximum LCBI within any 4-mm-long segment. Major adverse cardiac events (MACE) included cardiac death, myocardial infarction, definite or probable stent thrombosis, or unplanned revascularization or rehospitalization for progressive angina or unstable angina. Events were subcategorized as culprit (treated) lesion–related, nonculprit (untreated) lesion–related, or indeterminate.ResultsAmong 1,999 patients who were enrolled in the COLOR (Chemometric Observations of Lipid Core Plaques of Interest in Native Coronary Arteries Registry), PCI was performed in 1,621 patients and MACE occurred in 18.0% of patients, of which 8.3% were culprit lesion–related, 10.7% were nonculprit lesion–related, and 3.1% were indeterminate during 2-year follow-up. Complications from NIRS imaging occurred in 9 patients (0.45%), which resulted in 1 peri-procedural myocardial infarction and 1 emergent coronary bypass. Pre-PCI NIRS imaging was obtained in 1,189 patients, and the 2-year rate of culprit lesion–related MACE was not significantly associated with maxLCBI_4mm (hazard ratio of maxLCBI_4mm per 100: 1.06; 95% confidence interval: 0.96 to 1.17; p = 0.28) after adjusting clinical and procedural factors.ConclusionsFollowing PCI with contemporary drug-eluting stents, stent implantation in NIRS-defined LRPs was not associated with increased periprocedural or late adverse outcomes compared with those without significant lipid.     

EROSION III: A Multicenter RCT of OCT-Guided Reperfusion in STEMI With Early Infarct Artery Patency

ObjectivesThe aim of this study was to test whether optical coherence tomographic (OCT) guidance would provide additional useful information beyond that obtained by angiography and lead to a shift in reperfusion strategy and improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) with early infarct artery patency.BackgroundAngiography is limited in assessing the underlying pathophysiological mechanisms of the culprit lesion.MethodsEROSION III (Optical Coherence Tomography–Guided Reperfusion in ST-Segment Elevation Myocardial Infarction With Early Infarct Artery Patency) is an open-label, prospective, multicenter, randomized, controlled study approved by the ethics committees of participating centers. Patients with STEMI who had angiographic diameter stenosis ≤ 70% and TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 at presentation or after antegrade blood flow restoration were recruited and randomized to either OCT guidance or angiographic guidance. The primary efficacy endpoint was the rate of stent implantation.ResultsAmong 246 randomized patients, 226 (91.9%) constituted the per protocol set (112 with OCT guidance and 114 with angiographic guidance). The median diameter stenosis was 54.0% (IQR: 48.0%-61.0%) in the OCT guidance group and 53.5% (IQR: 43.8%-64.0%) in the angiographic guidance group (P = 0.57) before randomization. Stent implantation was performed in 49 of 112 patients (43.8%) in the OCT group and 67 of 114 patients (58.8%) in the angiographic group (P = 0.024), demonstrating a 15% reduction in stent implantation with OCT guidance. In patients treated with stent implantation, OCT guidance was associated with a favorable result with lower residual angiographic diameter stenosis (8.7% ± 3.7% vs 11.8% ± 4.6% in the angiographic guidance group; P < 0.001). Two patients (1 cardiac death, 1 stable angina) met the primary safety endpoint in the OCT guidance group, as did 3 patients (3 cardiac deaths) in the angiographic guidance group (1.8% vs 2.6%; P = 0.67). Reinfarction was not observed in either group. At 1 year, the rates of predefined cardiocerebrovascular events were comparable between the groups (11.6% after OCT guidance vs 9.6% after angiographic guidance; P = 0.66).ConclusionsIn patients with STEMI with early infarct artery patency, OCT guidance compared with angiographic guidance of reperfusion was associated with less stent implantation during primary percutaneous coronary intervention. These favorable results indicate the value of OCT imaging in optimizing the reperfusion strategy of patients with STEMI. (EROSION III: OCT- vs Angio-Based Reperfusion Strategy for STEMI; NCT03571269)     

Long-Term Prognostic Impact of Restenosis of the Unprotected Left Main Coronary Artery Requiring Repeat Revascularization

ObjectivesThe aim of this study was to evaluate the prognostic impact of target lesion revascularization (TLR) of the unprotected left main coronary artery (ULMCA) after stent failure.BackgroundAlthough drug-eluting stents are safe and effective for treatment of the ULMCA, increased rates of repeat revascularization have been observed.MethodsThis is a patient-level pooled analysis of the randomized ISAR-LEFT-MAIN (Drug-Eluting-Stents for Unprotected Left Main Stem Disease) and ISAR-LEFT-MAIN-2 (Drug-Eluting Stents to Treat Unprotected Coronary Left Main Disease) trials, in which patients underwent stenting of the ULMCA. The present analysis includes patients who underwent angiography during follow-up. Patients with TLR were compared with those without. Additional long-term clinical follow-up after TLR was conducted, and its influence on mortality was evaluated. Mortality was calculated using the Kaplan-Meier method. Predictors of mortality were assessed in a multivariate analysis.ResultsA total of 1,001 patients were eligible, of whom 166 experienced TLR. The 5-year mortality rate was 30.2% in patients with TLR compared with 17.3% in those without TLR (p < 0.001). In the multivariate analysis, glomerular filtration rate (−30 ml/min; hazard ratio [HR]: 2.25; 95% confidence interval [CI]: 1.54 to 3.27; p < 0.001), chronic obstructive pulmonary disease (HR: 4.95; 95% CI: 1.33 to 18.42; p = 0.02), and body mass index (+5 kg/m²; HR: 1.61; 95% CI: 1.12 to 2.32; p = 0.01) were independent predictors of mortality after TLR due to left main stent failure. The type of repeat revascularization and the underlying stent did not influence the mortality after TLR of the ULMCA.ConclusionsMortality after TLR for left main stent failure is high. Patient-related factors seem to have a greater impact on mortality after TLR than other variables.     

Impact of SYNTAX Score on 10-Year Outcomes After Revascularization for Left Main Coronary Artery Disease

ObjectivesThe aim of this study was to investigate the long-term impact of SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS) on differential outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease.BackgroundThe very long term prognostic effect of SS on mortality and major cardiovascular events after LMCA revascularization is still undetermined.MethodsIn the MAIN-COMPARE (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease) registry, patients with baseline SS measurements were analyzed. The 10-year rates of all-cause mortality, the composite of death, Q-wave myocardial infarction, or stroke, and target vessel revascularization after PCI or CABG were compared according to baseline SS.ResultsAmong 1,580 patients with baseline SS, 547 patients (34.6%) had low SS (≤22), 350 (22.2%) had intermediate SS (23 to 32), and 683 (43.2%) had high SS (≥33). In patients with low to intermediate SS, the adjusted 10-year risks for death and serious composite outcome were similar between the PCI group and the CABG group. However, in patients with high SS, PCI with stenting, compared with CABG, was associated with a higher risk for death (hazard ratio: 1.39; 95% confidence interval: 1.00 to 1.92; p = 0.048) and serious composite outcome (hazard ratio: 1.27; 95% confidence interval: 0.94 to 1.74; p = 0.123). In each revascularization group, conventional tertiles of SS had a differential prognostic impact on 10-year clinical outcomes in the PCI arm but not in the CABG arm.ConclusionsIn this 10-year extended follow-up of patients undergoing LMCA revascularization, CABG showed a clear prognostic benefit over PCI in patients with high anatomic complexity measured by SS at baseline. The discriminative capacity of SS on long-term outcomes was relevant in the PCI group but not in the CABG group. (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease [MAIN-COMPARE]; NCT02791412)