Target Vessel-related Myocardial Infarction Research Articles

Outcome of Coronary Edge In-stent Restenosis Management by Restenting Versus Drug-Eluting Balloon

Abstract Background: The optimal therapeutic strategy for coronary intervention in edge in-stent restenosis (edge ISR) remains less well-defined. Aim: The aim of this study was to assess 12-month outcomes of re-stenting using drug-eluting stents (DESs) versus using drug-eluting balloon (DEB) for managing coronary edge ISR. Patients and Methods: One hundred and four patients with edge ISR were randomly assigned to either DES or DEB. The primary endpoint was stent failure at 12-month follow-up. Results: Significantly lower target vessel revascularization among the DEB group compared to restenting group, (7.7% vs. 23.1%, P = 0.04). Likewise, target vessel-related myocardial infarction rate was significantly lower among the DEB group than restenting (5.7% vs. 23.1%, P = 0.04). On the other hand, there were no significant differences in the rates of deaths or restenosis between the two groups. Conclusion: The DEB is superior to the DES with better both safety and efficacy.

Prognostic impact of intravascular imaging in percutaneous coronary intervention according to atherothrombotic risk

Abstract Background Recent randomized controlled trials support intravascular imaging-guided PCI to improve patient prognosis, however, future risk of clinical events in patient with coronary artery disease is not solely determined by lesion characteristics or how these lesions are treated. Objectives Current study investigated whether the effects of intravascular imaging in complex percutaneous coronary invention (PCI) would differ according to atherothrombotic risks. Methods This study was post-hoc analysis of the RENOVATE-COMPLEX-PCI trial that compared intravascular imaging-guided PCI with angiography-guided PCI in patients with complex coronary artery lesions. Study population was stratified according to atherothrombotic risk assessed by Thrombolysis In Myocardial Infarction Risk Score for Secondary Prevention (TRS-2P) (a sum of age≥75 years, diabetes mellitus, hypertension, smoking, peripheral arterial disease, stroke, coronary artery bypass grafting, heart failure, and renal dysfunction) into low-risk (TRS-2P<3) or high-risk (TRS-2P≥3) groups. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization. Results Among the total patients, 1,247 were low-risk and 392 were high-risk. The risk of TVF was significantly higher in the high-risk group than the low-risk group (15.5% vs. 7.2%; hazard ratio [HR], 2.13; 95% confidence interval [CI], 1.51–3.00; P<0.001). The benefits of intravascular imaging-guided PCI over angiography-guided PCI did not differ between the low-risk group (5.6% vs. 10.4%; HR, 0.56; 95% CI, 0.36–0.86) and the high-risk group (14.1% vs. 18.5%; HR, 0.71; 95% CI, 0.41–1.24) without significant interaction (interaction P=0.496). Conclusions Although patients with high atherothrombotic risk had significantly worse clinical outcome than those with low atherothrombotic risk, the prognostic impact of intravascular imaging-guided PCI compared with angiography-guided PCI was similarly observed in both low and high future atherothrombotic risk groups.Structured Graphical Abstract

Association between stent implantation results and target vessel failure after IVUS-Guided PCI: A FLAVOUR substudy

Abstract Background Despite substantial advancements in coronary stent systems and implantation techniques, target vessel failure (TVF) remains a clinical issue to be addressed. Purpose We used deep learning algorithms for automatic stent analysis of intravascular ultrasound (IVUS) data to identify stent implantation characteristics associated with TVF. Methods In patients from the IVUS-guided group of the FLAVOUR trial who had undergone successful stenting, validated deep learning algorithms were applied to IVUS images to delineate plaque and stent strut for the quantification of stent expansion, apposition, and residual plaque burden. Stent overexpansion was defined as stent area exceeding 120% of the hypothetical healthy lumen area. Murray law-based quantitative flow ratio (μQFR) was also assessed from angiographic images. The primary endpoint was TVF at 2 years, defined as a composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. Results A total of 459 vessels in 441 patients were included, with TVF events occurred in 15 vessels (3.3%) during the 2-year follow-up. Stent analysis was performed in 687,379 stent struts from 70,369 IVUS image frames of the interrogated vessels with the assistance of specific deep learning algorithms. On vessel-level multivariate analysis adjusting for procedural covariates, stent overexpansion length >5 mm (hazard ratio, 4.57; 95% confidence interval [CI], 1.31 to 15.92; P=0.017), residual plaque burden at proximal stent edge >50% (hazard ratio, 3.34; 95% CI, 1.19 to 9.33; P=0.022), and post-PCI μQFR <0.90 (hazard ratio, 5.09; 95% CI, 1.62 to 15.97; P=0.005) were more likely to be present in vessels with TVF events than in those without. Conclusions Besides the established indexes of post-procedural residual plaque burden and low μQFR, deep learning-powered IVUS stent overexpansion was significantly associated with increased risk of TVF.Suboptimal stenting results and TVF

Comparative clinical outcomes of amphilimus-eluting stents in diabetic versus non-diabetic patients

Abstract Background Patients with diabetes mellitus (DM) are at an increased risk of experiencing adverse events following percutaneous coronary intervention (PCI). The Cre8 EVO stent, which releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, has demonstrated clinical benefits specifically in diabetic populations. We aimed to explore the impact of DM on clinical outcomes in a large, real-world registry of all-comer patients treated with Cre8 and Cre8 EVO stents. Methods We did an investigator-initiated, prospective, single-arm observational trial at 28 sites in South Korea. The primary endpoint was a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically-driven repeat revascularization at 12 months. All-cause mortality was a key secondary endpoint. Results A total of 2,045 patients (66.0 ± 11.5 years of age; 76.2% male) were analyzed. Diabetic patients (n = 774; 37.8%) were more likely to be older, female, and have hypertension, dyslipidemia, or chronic kidney disease. There were 39 cases of primary events, 17 (2.5%) in the DM group and 22 (1.9%) in the non-DM group (hazard ratio, 1.34; 95% confidence interval, 0.74–2.41; log-rank p = 0.33). Overall, the primary endpoint occurred in 2.1% of patients, with a cardiac death rate of 0.4%, a target vessel-related MI rate of 0.3%, and a clinically driven TLR rate of 1.8%. Among the secondary endpoints, the DM group exhibited a significantly higher all-cause mortality rate compared to the non-DM group (2.0% vs. 0.9%; hazard ratio, 2.20; 95% confidence interval, 1.04–4.65). Conclusion In this real-world registry, diabetic patients treated with amphilimus-eluting stents demonstrated excellent safety and effectiveness at 12 months, with a similar occurrence of MACE compared to non-diabetics. These results underscore the potential for amphilimus-eluting stents to become a preferred option for PCI in diabetic patients, prompting further investigation into their long-term benefits and mechanisms of action.

Prognostic impact of intravascular imaging in percutaneous coronary intervention according to procedural complexity

Abstract Background/Introduction Few randomized controlled trials have shown reduction of adverse cardiac events with intravascular imaging (IVI)-guided percutaneous coronary intervention (PCI) compared with conventional angiography. However, data for IVI in complex PCI remains scarce. Purpose Current study investigated whether optimization of stent implantation in the IVI-guided PCI could improve the efficacy of PCI across various degrees of PCI procedural complexity. Methods This study was post-hoc analysis of the RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) trial. Study population was stratified according to PCI procedural complexity assessed by the ESC criteria into low-, moderate-, or high-procedural complexity group. The high-procedural complexity group consisted of patients meeting at least one of the clinical risk criteria [diabetes mellitus, chronic kidney disease, defined as glomerular filtration rate between 15 and 60 mL/min, prior myocardial infarction (MI), peripheral artery disease, age < 45 years, multivessel coronary artery disease] and at least one of the procedural risk criteria (≥3 stents implanted, ≥3 lesions treated, total stent length >60 mm, left main PCI, chronic total occlusion, bifurcation lesion treated with 2 stents). The primary endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel-related MI, or clinically driven target vessel revascularization. Results At a median follow-up of 2.1 years (interquartile range 1.4 to 3.0 years), the risk of TVF significantly increased in a stepwise fashion from the low- (reference group) to the moderate- (adjusted hazard ratio [HR]: 3.530; 95% confidence interval [CI]: 1.226-10.163, p=0.019) and high-procedural complexity group (adjusted HR: 3.951; 95% CI: 1.576-9.908; p=0.003). The effect of IVI-guided PCI was heterogeneous per PCI procedural complexity, with a significant benefit in patients who underwent high-procedural complexity PCI (adjusted HR: 0.598; 95% CI: 0.370-0.966) compared with those who had low-procedural complexity PCI (adjusted HR: 1.969; 95% CI: 0.217-17.881). Importantly, the magnitude of the benefit with IVI-guided PCI was progressively greater per increase in procedural complexity (p for interaction=0.026). Conclusions In patients who underwent complex PCI, compared with a conventional angiography, IVI-guided PCI significantly reduced the risk of adverse cardiac events with a magnitude that was greater for higher procedural complexity.

Randomized Comparison of NovelLow-Dose Sirolimus-Eluting Biodegradable Polymer Stent vsSecond-Generation DES: TARGET-IV NA Trial.

Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs. We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs. The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12months (composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss). A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). Atotal of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5%CI: 2.03, Pnoninferiority< 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263mm for BP-SES and 0.327 ± 0.463mm for control (least squares mean difference:-0.178; 90%CI:-0.2943 to-0.0632; Pnoninferiority< 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13months (Pnoninferiority=0.01). The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (Firehawk® Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532).

Impact of Antiplatelet Therapy on 5-Year Outcomes After Fractional Flow Reserve-Guided Deferral of Revascularization in Nonsignificant Obstructive Coronary Artery Disease.

Because the clinical benefit of antiplatelet therapy (APT) for patients with nonsignificant coronary artery disease (CAD) remains poorly understood, we evaluated it in patients after fractional flow reserve (FFR)-guided deferral of revascularization. From the J-CONFIRM (Long-Term Outcomes of Japanese Patients with Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), we investigated 265 patients with deferred lesions who did not require APT for secondary prevention of cardiovascular disease. A 2-year landmark analysis assessed the relationship between APT at 2 years and 5-year major cardiac adverse events (MACE: composite of all-cause death, target vessel-related myocardial infarction, clinically driven target vessel revascularization). Of the 265 patients, 163 (61.5%) received APT. The 5-year MACE did not significantly differ between the APT and non-APT groups after adjustment for baseline clinical characteristics (9.2% vs. 6.9%, inverse probability weighted hazard ratio, 1.40 [95% confidence interval, 0.53-3.69]; P=0.49). There was a marginal interaction between the effect of APT on MACE and FFR values (< or ≥0.84) (P for interaction=0.066). The 5-year outcomes after FFR-guided deferral of revascularization did not significantly differ between the APT and non-APT groups, suggesting that APT might not be a critical requirement for nonsignificant obstructive CAD patients not requiring APT for secondary prevention of cardiovascular disease.

Impact of morphofunctional assessment with quantitative flow ratio and optical coherence tomography in patients with acute coronary syndromes.

Combining morphological and physiological evaluations might improve the risk stratification of patients who undergo percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) culprit lesions. We aimed to investigate the clinical utility of morphofunctional evaluation after PCI for identifying ACS patients with increased risk of subsequent clinical events. We retrospectively studied 298 consecutive ACS patients who had undergone optical coherence tomography (OCT)-guided PCI. We performed OCT-based morphological analysis and quantitative flow ratio (QFR)-based physiological assessment immediately after PCI. The non-culprit segment (NCS) was defined as the most stenotic untreated segment in the culprit vessel. The primary outcome was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, and ischaemia-driven target vessel revascularisation. During a median follow-up period of 990 days, 42 patients experienced TVF. Cox regression analysis revealed that the presence of thin-cap fibroatheroma (TCFA) in the NCS and a low post-PCI QFR, or the presence of TCFA in the NCS and a high ΔQFR in the NCS (QFRNCS), were independently associated with TVF. The subgroup with TCFA in the NCS and a low post-PCI QFR had a significantly higher incidence of TVF (75%) than the other subgroups, and those with TCFA in the NCS and a high ΔQFRNCS had a significantly higher incidence of TVF (86%) than the other subgroups. The integration of TCFA in NCS, post-PCI QFR, and ΔQFRNCS with traditional risk factors significantly enhanced the identification of subsequent TVF cases. Combining post-PCI OCT and QFR evaluation may enhance risk stratification for ACS patients after successful PCI, particularly in predicting subsequent TVF.

Complete versus incomplete revascularization in patients with a non-ST-elevation myocardial infarction: Analysis from the e-ULTIMASTER registry

BackgroundIncomplete revascularization (ICR) has been associated with a worse prognosis after a percutaneous coronary intervention (PCI). In NSTEMI patients with multivessel disease (MVD) however, the benefit of a complete revascularization (CR) remains unclear. MethodsPatients presenting with an NSTEMI and MVD were selected from the global e-ULTIMASTER registry and grouped according to completeness of revascularization at index hospitalization discharge. The primary endpoint was the patient oriented composite endpoint (POCE) defined as all death, any myocardial infarction, and any revascularization at 1 year. Target lesion failure (TLF) was defined as the composite of cardiac death, target vessel related myocardial infarction and clinically driven target lesion revascularization. Inverse propensity score weighting (IPSW) was performed to harmonize the patient's baseline characteristics between the groups. ResultsCR was achieved in 1800 patients (47.0 %) and ICR in 2032 patients (53.0 %). The incidence of POCE at 1 year was lower in the CR group compared to the ICR group: 7.0 % vs. 12.9 %, p < 0.0001. Similarly for TLF at 1 year: 3.6 % vs. 5.5 %, p < 0.01. After IPSW, the incidence of POCE was 7.7 % vs. 12.0 %, p < 0.0001, due to a lower all-cause mortality: 2.7 % vs. 4.2 %, p = 0.02 and less revascularizations: 4.9 % vs. 7.9 %, p < 0.001. The incidence of TLF was no longer statistically significant: CR 3.9 % vs. IR 5.0 %, p = 0.10. ConclusionsPatients with a NSTEMI and multi vessel disease undergoing a percutaneous coronary revascularization with a complete revascularization during index hospitalization have better 1-year clinical outcomes. Randomized studies are warranted to confirm these results.

Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes

Data are limited regarding the effects of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) in patients with diabetes. To compare the clinical outcomes of intravascular imaging-guided vs angiography-guided complex PCI in patients with or without diabetes. This prespecified secondary analysis of a subgroup of patients in RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention), an investigator-initiated, open-label multicenter trial, analyzed enrolled patients who underwent complex PCI at 20 sites in Korea from May 2018 through May 2021. Eligible patients were randomly assigned in a 2:1 ratio to undergo either the intravascular imaging-guided PCI or angiography-guided PCI. Data analyses were performed from June 2023 to April 2024. Percutaneous coronary intervention was performed either under the guidance of intravascular imaging or angiography alone. The primary end point was target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Among the 1639 patients included in the analysis (mean [SD] age, 65.6 [10.2] years; 1300 males [79.3%]), 617 (37.6%) had diabetes. The incidence of TVF was significantly higher in patients with diabetes than patients without diabetes (hazard ratio [HR], 1.86; 95% CI, 1.33-2.60; P < .001). Among patients without diabetes, the intravascular imaging-guided PCI group had a significantly lower incidence of TVF compared with the angiography-guided PCI group (4.7% vs 12.2%; HR, 0.41 [95% CI, 0.25-0.67]; P < .001). Conversely, in patients with diabetes, the risk of TVF was not significantly different between the 2 groups (12.9% vs 12.3%; HR, 0.97 [95% CI, 0.60-1.57]; P = .90). There was a significant interaction between the use of intravascular imaging and diabetes for the risk of TVF (P for interaction = .02). Among patients with diabetes, only those with good glycemic control (hemoglobin A1c level ≤7.5%) and who achieved stent optimization by intravascular imaging showed a lower risk of future ischemic events (HR, 0.31; 95% CI, 0.12-0.82; P = .02). In this secondary analysis of a subgroup of patients in the RENOVATE-COMPLEX-PCI trial, intravascular imaging guidance reduced the risk of TVF compared with angiography guidance in patients without diabetes (but not in patients with diabetes) during complex PCI. In patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging and glycemic control to improve outcomes. ClinicalTrials.gov Identifier: NCT03381872.

Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention

BackgroundThere are limited clinical data on drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) compared with drug-eluting stent (DES)-only PCI in patients with complex coronary artery lesions. ObjectivesThe goal of the current study was to investigate the efficacy of DCB in patients undergoing PCI for complex coronary artery lesions. MethodsFrom an institutional registry of patients with de novo complex coronary artery lesions, 126 patients treated with DCB-based PCI were compared with 234 propensity score–matched patients treated with DES-only PCI. Complex coronary artery lesions were defined as the presence of at least 1 of the following: bifurcation, chronic total occlusion, unprotected left main disease, long lesion ≥38 mm, multivessel disease, lesion requiring ≥3 devices, or severe calcification. The primary endpoint was target vessel failure (TVF) at 2 years, a composite of cardiac death, target vessel–related myocardial infarction, and target vessel revascularization. ResultsBaseline characteristics were comparable between the 2 groups. DCB-based PCI showed a comparable risk of TVF vs DES-based PCI (7.6% vs 8.1%; HR: 0.81; 95% CI: 0.33-1.99; P = 0.638). The risks of cardiac death (5.0% vs 5.7%; HR: 0.78; 95% CI: 0.24-2.49), target vessel–related myocardial infarction (0.9% vs 1.3%; HR: 2.65; 95% CI: 0.26-27.06), and target vessel revascularization (3.5% vs 2.0%; HR: 1.30; 95% CI: 0.30-5.67) were also comparable between the 2 groups. ConclusionsDCB-based PCI showed comparable risks of TVF vs those of DES-only PCI in patients with complex coronary artery lesions. DCB might be considered as a suitable alternative device to DES in patients undergoing complex PCI. (Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI; NCT03870815)

Intravascular Imaging–Guided Optimization of Complex Percutaneous Coronary Intervention by Sex

There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions. To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men. This prespecified substudy evaluates the interaction of sex in the investigator-initiated, open-label, multicenter RENOVATE-COMPLEX-PCI randomized clinical trial, which demonstrated the superiority of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. The trial was conducted at 20 sites in Korea. Patients with complex coronary artery lesions undergoing PCI were enrolled between May 2018 and May 2021, and the median (IQR) follow-up period was 2.1 (1.4-3.0) years. Data were analyzed from December 2022 to December 2023. After diagnostic coronary angiography, eligible patients were randomly assigned in a 2:1 ratio to receive intravascular imaging-guided PCI or angiography-guided PCI. The choice and timing of the intravascular imaging device were left to the operators' discretion. The primary end point was target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Secondary end points included individual components of the primary end point. Of 1639 included patients, 339 (20.7%) were women, and the mean (SD) age was 65.6 (10.2) years. There was no difference in the risk of the primary end point between women and men (9.4% vs 8.3%; adjusted hazard ratio [HR], 1.39; 95% CI, 0.89-2.18; P = .15). Intravascular imaging-guided PCI tended to have lower incidence of the primary end point than angiography-guided PCI in both women (5.2% vs 14.5%; adjusted HR, 0.34; 95% CI, 0.15-0.78; P = .01) and men (8.3% vs 11.7%; adjusted HR, 0.72; 95% CI, 0.49-1.05; P = .09) without significant interaction (P for interaction = .86). In patients undergoing complex PCI, compared with angiographic guidance, intravascular imaging guidance was associated with similar reduction in the risk of target vessel failure among women and men. The treatment benefit of intravascular imaging-guided PCI showed no significant interaction between treatment strategy and sex. ClinicalTrials.gov Identifier: NCT03381872.

Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis

Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority. Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively. Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. ClinicalTrials.gov Identifier: NCT04647253.

Impact of the number of modifiable risk factors on clinical outcomes after percutaneous coronary intervention: An analysis from the e-Ultimaster registry

AimsA substantial proportion of the patients undergoing percutaneous coronary intervention (PCI) have none of the of standard modifiable cardiovascular risk factors (SMuRFs): hypertension, diabetes, hypercholesterolaemia and smoking. The aim of this analysis was to compare clinical outcomes after PCI according to the number of SMuRFs. MethodsPatients with an indication for a PCI were stratified based upon the number of SMuRFs: 0, 1, 2 or 3–4. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction or clinically driven target lesion revascularization at 1-year. Inverse weighted propensity score (IWPS) adjustment was performed to adjust for differences in baseline characteristics. ResultsThe prevalence of SMuRFs was: 0 SMuRF 16.4 %; 1 SMuRF 27.8 %; 2 SMuRFs 34.7 % and 3–4 SMuRFs 21.1 %. Patients without SMuRFs were younger, more likely to be male and had less complex coronary artery disease. The incidence of TLF increased with the number of SMuRFs: 2.65 %, 2.75 %, 3.23 %, and 4.24 %, Ptrend < 0.001. The relative risk (RR) for a TLF was 60 % higher (95 % confidence interval 1.32–1.93, p < 0.01) for patients with 3–4 SMuRFs compared to patients without SMuRFs. The trend remained (Ptrend < 0.01) after IWPS with TLF rates of 2.88 %, 2.64 %, 2.88 % and 3.65 %. The RR for a TLF was 27 % higher (95 % CI 1.05–1.53, p < 0.01). ConclusionThe incidence of clinical events at 1-year increased with the number of SMuRFs. While patients without SMuRFs have a relatively favourable risk profile, more research is needed to optimize therapeutic management in the majority of patients.

Invasiveness of previous treatment for peripheral arterial disease and risk of adverse cardiac events after coronary stenting

Patients with peripheral arterial disease (PADs), undergoing percutaneous coronary intervention (PCI), have higher adverse event risks. The effect of invasiveness of PADs treatment on PCI outcome is unknown. This study assessed the impact of the invasiveness of previous PADs treatment (invasive or non-invasive) on event risks after PCI with contemporary drug-eluting stents. This post-hoc analysis pooled 3-year patient-level data of PCI all-comer patients living in the eastern Netherlands, previously treated for PADs. PADs included symptomatic atherosclerotic lesion in the lower or upper extremities; carotid or vertebral arteries; mesenteric arteries or aorta. Invasive PADs treatment comprised endarterectomy, bypass surgery, percutaneous transluminal angioplasty, stenting or amputation; non-invasive treatment consisted of medication and participation in exercise programs. Primary endpoint was (coronary) target vessel failure: composite of cardiac mortality, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. Of 461 PCI patients with PADs, information on PADs treatment was available in 357 (77.4%) patients; 249 (69.7%) were treated invasively and 108 (30.3%) non-invasively. Baseline and PCI procedural characteristics showed no between-group difference. Invasiveness of PADs treatment was not associated with adverse event risks, including target vessel failure (20.5% vs. 16.0%; HR: 1.30, 95%-CI 0.75–2.26, p = 0.35), major adverse cardiac events (23.3% vs. 20.4%; HR: 1.16, 95%-CI 0.71–1.90, p = 0.55), and all-cause mortality (12.1% vs. 8.3%; HR: 1.48, 95%-CI 0.70–3.13, p = 0.30). In PADs patients participating in PCI trials, we found no significant relation between the invasiveness of previous PADs treatment and 3-year outcome after PCI. Consequently, high-risk PCI patients can be identified by consulting medical records, searching for PADs, irrespective of the invasiveness of PADs treatment.Graphical abstractComparison of patients with non-invasive and invasive PADs treatment. PADs peripheral arterial disease, PCI percutaneous coronary intervention.

Intravascular Imaging in Patients With Complex Coronary Lesions and Chronic Kidney Disease

As patients with chronic kidney disease (CKD) are more likely to have complex coronary lesions, intravascular imaging guidance in percutaneous coronary intervention (PCI) for this population could be potentially beneficial. To investigate whether the outcomes of intravascular imaging-guided procedural optimization would be different according to the presence of CKD. This was a prespecified substudy of RENOVATE-COMPLEX-PCI, a recently published multicenter randomized clinical trial in Korea studying the benefits of intravascular imaging for complex coronary lesions. Patients with complex coronary lesions, with or without CKD, were enrolled between May 2018 and May 2021. Data were analyzed from January to June 2023. PCI in each group was done either under the guidance of intravascular imaging or angiography alone. The primary end point was target vessel failure (TVF) at the 3-year point, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. A total of 1639 patients (1300 male [79.3%]) treated with PCI for complex coronary lesions were stratified into CKD (296 participants) and non-CKD (1343 participants) groups. The mean (SD) age of each group was 70.3 (9.4) and 64.5 (10.1) years, and mean (SD) estimated serum creatinine was 2.9 (5.3) and 0.8 (0.2) mg/dL for CKD and non-CKD groups, respectively. Intravascular imaging-guided revascularization was associated with significantly lower incidence of the primary end point compared with angiography-guided revascularization in both CKD (13.3% vs 23.3%; hazard ratio [HR], 0.51; 95% CI, 0.27-0.93; P = .03) and non-CKD (6.4% vs 9.9%; HR, 0.66; 95% CI, 0.44-0.99; P = .05) groups. The significantly lower incidence of the primary end point was mainly associated with the lower risk of cardiac death or target vessel-related myocardial infarction (9.4% vs 22.2%; HR, 0.39; 95% CI, 0.20-0.76; P = .006) in the CKD group and by target vessel revascularization (3.0% vs 5.5%; HR, 0.55; 95% CI, 0.30-0.99; P = .05) in the non-CKD group. Those with a glomerular filtration rate of at least 30 mL/min/1.73m2 and less than 60 ml/kg/1.73m2 showed the greatest benefit from imaging-guided complex PCI (8.8% vs 21.2%; HR, 0.28; 95% CI, 0.11-0.68; P = .02). In this prespecified cohort substudy of the Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention trial, intravascular imaging guidance showed clinical benefit over angiography guidance in reducing the risk of TVF, regardless of the presence of CKD. The greatest benefits of imaging-guided complex PCI were observed in stage 3 CKD. ClinicalTrials.gov Identifier: NCT03381872.

Long-Term Evaluation of Revascularization Strategies for Medina 0.1.0 Left Main Bifurcation Lesions: The LM-CROSSOVER Registry.

The present study aimed to compare long-term outcomes of patients with Medina 0.1.0 left main (LM) bifurcation lesions treated by crossover stenting (COS) versus accurate ostial stenting (AOS). A total of 229 consecutive eligible patients with Medina 0.1.0 LM bifurcation lesions were enrolled and were stratified according to the stenting techniques. The primary end-point was major cardiovascular and cerebral events (MACCE), defined as the combination of all-cause death, target vessel related-myocardial infarction (MI), clinically driven target lesion revascularization (TLR), stroke, or stent thrombosis. COS and AOS were applied to 78 (34%) and 151 (66%) patients, respectively. During a mean of 40.6 ± 21.1months of follow-up, the rate of MACCE (27.8 vs 12.8%; P=.007) was higher in patients treated with AOS than those treated with the COS technique, mainly driven by more frequent all-cause death (13.9 vs 3.8%, P = .013) and TLR (6.4 vs 15.9%; P = .029). In multivariable Cox regression analysis, AOS strategy was one of the independent predictors of MACCE (odds ratio: 2.166; 95% confidence interval, 1.080-4.340; P = .029). The current study suggests that COS was associated with a better long-term MACCE rate and lower all-cause mortality rate than AOS in patients with Medina 0.1.0 LM bifurcation disease.

Guiding Intervention for Complex Coronary Lesions by Optical Coherence Tomography or Intravascular Ultrasound

BackgroundOptical coherence tomography (OCT) and intravascular ultrasound (IVUS) have shown comparable outcomes in guiding percutaneous coronary intervention (PCI). However, their comparative effectiveness in complex coronary artery lesions remains unclear. ObjectivesThis study compared the effectiveness and safety of OCT-guided vs IVUS-guided PCI for complex coronary artery lesions. MethodsThis was a prespecified, main subgroup analysis of complex coronary artery lesions in the OCTIVUS (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention) trial, which included unprotected left main disease, bifurcation disease, an aorto-ostial lesion, a chronic total occlusion, a severely calcified lesion, an in-stent restenotic lesion, a diffuse long lesion, or multivessel PCI. The primary endpoint was a composite of death from cardiac causes, target vessel–related myocardial infarction, or ischemia-driven target vessel revascularization. ResultsIn 2,008 randomized patients, 1,475 (73.5%) underwent imaging-guided PCI for complex coronary artery lesions; 719 (48.7%) received OCT-guided and 756 (51.3%) IVUS-guided PCI. At a median follow-up of 2.0 years, primary endpoint event had occurred in 47 patients (6.5%) in the OCT-guided group and in 56 patients (7.4%) in the IVUS-guided group (HR: 0.87; 95% CI: 0.59-1.29; P = 0.50). These findings were consistent in adjusted analyses. The incidence of contrast-induced nephropathy was similar between the 2 groups (1.9% vs 1.5%; P = 0.46). The incidence of major procedural complications was lower in the OCT-guided group than in the IVUS-guided group (1.7% vs 3.4%; P = 0.03). ConclusionsAmong patients with complex coronary artery lesions, OCT-guided PCI showed a similar risk of primary composite event of death from cardiac causes, target vessel–related myocardial infarction, or target vessel revascularization as compared with IVUS-guided PCI. (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention [OCTIVUS]; NCT03394079)

Cardiovascular Outcomes After Mini-Crush or Double Kissing Crush Stenting Techniques for Complex Bifurcation Lesions: The EVOLUTE-CRUSH Registry

Comparison of clinical outcomes of double kissing crush (DKC) and mini-crush (MC) techniques in patients with complex coronary bifurcation lesions is lacking. This study sought to determine the clinical results of DKC and MC stenting techniques in mid-term follow-up. This retrospective study included a total of 269 consecutive patients with complex bifurcation lesions who underwent percutaneous coronary intervention; 132 (49%) of them were treated with MC technique, whereas 137 (51%) treated with DKC technique. The primary end point was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. This is the first study to compare the cardiovascular outcomes of DKC and MC stenting techniques in patients with complex bifurcation lesions. The SYNTAX scores were similar in both groups (23 [20 to 30] vs 23 [19 to 28], p=0.631)]. The number of balloons (6.31 ± 1.80 vs 4.42 ± 0.87, p <0.001) and guidewires (3.55 ± 0.83 vs 2.86 ± 0.74, p <0.001) used, fluoroscopy time (21.55 ± 7.05 vs 16.66 ± 4.19minutes, p <0.001), and procedure time (80.42 ± 27.95 vs 69.61 ± 18.97minutes, p <0.001) were significantly higher in the DKC group. The rate of composite TLF was similar in complex bifurcation patients treated with MC than those treated with the DKC technique (14% vs 12%, p=0.453). Moreover, both groups had similar rates in terms of cardiac death or all-cause death, target vessel-related myocardial infarction, clinically driven target lesion revascularization, and stent thrombosis. In conclusion, the present study showed that both techniques of bifurcation treatment met high angiographic success with low complication and similar TLF rates.

Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial.

Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared with angiography-guided PCI. However, the comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown. In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group compared with the IVUS group. Safety outcomes were also assessed. At 1 year, primary end point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% CI, 0.97 percentage points; P<0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group versus 15 patients [1.5%] in the IVUS group; P=0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] versus 37 [3.7%]; P=0.047), although imaging procedure-related complications were not observed. In patients with significant coronary artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower-than-expected event rates should be considered in interpreting the trial. URL: https://www. gov; Unique number: NCT03394079.