Risk Of Target Lesion Revascularization Research Articles

Evaluation of acute and midterm outcomes after complex combined antegrade/retrograde recanalization for occlusions of the femoropopliteal and infrapopliteal arteries

IntroductionWhen antegrade recanalization of femoro- and/or infrapopliteal occlusions fails, retrograde access has become an established option. To evaluate the results of combined antegrade and retrograde recanalization of femoropopliteal and infrapopliteal occlusions, patients undergoing secondary retrograde recanalization attempts were analyzed retrospectively. MethodsPrimary endpoint was the success of the procedure (successful occlusion crossing using the ante-/retrograde technique). Secondary endpoints include complication rate, primary patency and target lesion revascularization (TLR) rate, amputation rate, changes in ankle-brachial index (ABI), and Rutherford-Becker class (RBC). Predictors for procedure failure and TLR were analyzed. ResultsWe included 888 patients: 362 with femoropopliteal (group 1), 353 with infrapopliteal (group 2), and 173 with multi-level (group 3) recanalization. Critical limb threatening ischemia (CLTI) was present in group 1, 2, and 3 in 36%, 62%, and 76%, respectively. The intervention was successful in 92.5%, 93.8%, 90.8% of respective cases (p=0.455). The overall peri-interventional complication rate was 7.2%.At 6, 12 and 24 months, primary patency was highest in group 1 (63.9%, 45.8%, 33.3%), followed by group 3 (59.8%, 46.1%, 33.3%), and group 2 (58.5%, 43.1%, 30.4%), p=0.537).The risk of undergoing repeated TLR within 24 months was 31.4% for group 1, 39.1% for group 2, and 45.7% for group 3.At 24 months, the survival rate in groups 1, 2, 3 was 93.8%, 79.4% and 87.5%, respectively. During 24 months, 75 patients (8.4%) had to undergo amputation. Significant improvements in both ABI and RBC were present at discharge as well as at 6, 12 and 24 months (p<0.001).Dialysis dependency was a predictor of unsuccessful ante/retrograde recanalization (p=0.048).Lesion length (p=0.0043), dialysis (p=0.033) and recanalization level (p=0.013) increase the risk of TLR. ConclusionUsing a combined antegrade/retrograde access, recanalization of occluded femoropopliteal and/or infrapopliteal arteries can be achieved in a large number of cases. Due to the high rate of repeated TLR across all lesion localizations, the indication for ante- and retrograde recanalization may be limited to patients with CLTI.

Application of optical coherence tomography in cardiovascular diseases: bibliometric and meta-analysis.

Since the advent of Optical Coherence Tomography (OCT) two decades ago, there has been substantial advancement in our understanding of intravascular biology. Identifying culprit lesion pathology through OCT could precipitate a paradigm shift in the treatment of patients with Acute Coronary Syndrome. Given the technical prowess of OCT in the realm of cardiology, bibliometric analysis can reveal trends and research focal points in the application of OCT for cardiovascular diseases. Concurrently, meta-analyses provide a more comprehensive evidentiary base, supporting the clinical efficacy of OCT-guided Percutaneous Coronary Intervention (PCI). This study employs a dual approach of Bibliometric and Meta-analysis. Relevant literature from 2003 to 2023 was extracted from the Web of Science Core Collection (WoSCC) and analyzed using VOSviewer, CiteSpace, and R for publication patterns, countries, institutions, authors, and research hotspots. The study compares OCT-guided and coronary angiography-guided PCI in treating adult coronary artery disease through randomized controlled trials (RCTs) and observational studies. The study has been reported in the line with PRISMA and AMSTAR Guidelines. Adhering to inclusion and exclusion criteria, 310 publications were incorporated, demonstrating a continual rise in annual output. Chinese researchers contributed the most studies, while American research wielded greater influence. Analysis of trends indicated that research on OCT and angiography-guided PCI has become a focal topic in recent cohort studies and RCTs. In 11 RCTs (n = 5,277), OCT-guided PCI was not significantly associated with a reduction in the risk of Major Adverse Cardiac Events (MACE) (Odds ratio 0.84, 95% CI 0.65-1.10), cardiac death (0.61, 0.36-1.02), all-cause death (0.7, 0.49-1.02), myocardial infarction (MI) (0.88, 0.69-1.13), target lesion revascularization (TLR) (0.94, 0.7-1.27), target vessel revascularization (TVR) (1.04, 0.76-1.43), or stent thrombosis (0.72, 0.38-1.38). However, in 7 observational studies (n = 4,514), OCT-guided PCI was associated with a reduced risk of MACE (0.66, 0.48-0.91) and TLR (0.39, 0.22-0.68). Our comprehensive review of OCT in cardiovascular disease literature from 2004 to 2023, encompassing country and institutional origins, authors, and publishing journals, suggests that OCT-guided PCI does not demonstrate significant clinical benefits in RCTs. Nevertheless, pooled results from observational studies indicate a reduction in MACE and TLR.

Comparison Among Ultra-Thin Coronary Stents: A Network Meta-Analysis

Ultrathin-strut drug-eluting stents (DES) have been related to potential improvement in stent-related outcomes compared with thicker-struts DES. However, comparisons among different ultrathin devices are lacking. All randomized controlled trials comparing ultrathin (struts thickness <70 µm) and thicker-struts DESs in an all-comers population were included. Target lesion failure (TLF), as defined by included trials, at 1-year follow-up was the primary end point. Overall mortality, myocardial infarction, target lesion revascularization (TLR), and stent thrombosis were the secondary end points. Arms of included trials were compared using network meta-analysis. Nine studies encompassing 20,081 patients were included, of which 9,509 patients had an ultrathin DES: Orsiro (evaluated in 7 arms with 8,086 patients), MiStent (1 arm with 703 patients), or Supraflex (1 arm with 720 patients). At 1-year follow-up, no significant differences were noted for TLF among these ultrathin DES. In particular, Orsiro was associated with a similar risk of TLF compared with Supraflex (risk rate 1.07, 95% confidence interval 0.59 to 1.78) and showed the highest probability of performing best in terms of TLF, myocardial infarction, and TLR. Ultrathin DES are all associated with a comparable risk of TLF compared with thicker-strut DES. In terms of TLR and TLF risk, Orsiro was the one with the highest probability of best performances, either compared with other ultrathin DES or to devices with thicker struts.

Optical coherence tomography-guided vs. intravascular ultrasound-guided percutaneous coronary intervention: a systematic review and meta-analysis of randomized controlled trials.

Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) are superior to coronary angiography for guiding percutaneous coronary intervention (PCI). However, whether one technique is superior to the other is inconclusive. We searched PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov from inception to November 2023 for randomized controlled trials (RCTs) comparing OCT and IVUS in patients undergoing PCI. RevMan 5.4 was used to pool outcomes with risk ratio (RR) as the effect measure. Six RCTs (4,402 patients) were included in this meta-analysis. There was no significant difference between the OCT- and IVUS-guided PCI groups in the risk of major adverse cardiovascular events (RR 0.87, 95% CI: 0.65, 1.16; I2 = 0%) and cardiac mortality (RR 0.73, 95% CI: 0.24, 2.21; I2 = 0%). The results were consistent across the subgroups of the presence or absence of left main disease (P interaction >0.1). There were no significant differences between OCT and IVUS in the risk of target lesion revascularization (RR 0.78, 95% CI: 0.47, 1.30; I2 = 0%), target vessel revascularization (RR 1.06, 95% CI: 0.69, 1.62; I2 = 0%), target-vessel myocardial infarction (RR 0.79, 95% CI: 0.40, 1.53; I2 = 0%), stent thrombosis (RR 0.59, 95% CI: 0.12, 2.97; I2 = 0%), and all-cause mortality (RR 1.01, 95% CI: 0.53, 1.90; I2 = 0%). Our meta-analysis demonstrated similar clinical outcomes in OCT- and IVUS-guided PCI. New large-scale multicenter RCTs with long-term follow-up are required to confirm or refute our findings and provide more reliable results. PROSPERO, identifier, CRD42023486933.

Two-year real world clinical outcomes after intravascular imaging device guided percutaneous coronary intervention with ultrathin-strut biodegradable-polymer sirolimus-eluting stent

BackgroundThere are little clinical data on imaging-guided percutaneous coronary intervention (PCI) 1 year after the biodegradable-polymer sirolimus-eluting stents (BP-SES) implantation, when the polymer disappears. MethodsWe retrospectively analyzed 2455 patients who underwent successful PCI with BP-SES or durable-polymer everolimus-eluting stents (DP-EES) between September 2011 and March 2021, and compared 2-year clinical outcomes of BP-SES (n = 459) with DP-EES (n = 1996). The outcome measures were target lesion revascularization (TLR) and major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. Multivariate analysis using the Cox proportional hazard model and inverse probability weighting (IPW) analysis based on the propensity score were used to evaluate the clinical outcomes. ResultsThe 2-year cumulative incidences of TLR (BP-SES: 4.9% vs. DP-SES: 6.1%, p = 0.304) and MACE (10.3% vs. 12.5%, p = 0.159) were similar between the two groups. Multivariable and IPW analysis revealed the risks of TLR (p = 0.388 and p = 0.500) and MACE (p = 0.139 and p = 0.083) also had no significant difference. There was a significant interaction between none/mild and moderate/severe calcification with respect to MACE and TLR (adjusted p for interaction = 0.036 and 0.047, respectively). The risk of MACE was significantly lower in BP-SES than in DP-EES in lesions with none/mild calcification (adjusted hazard ratio [aHR]: 0.53; 95% confidence interval [CI]: 0.30–0.91), while it was similar in those with moderate/severe calcification (aHR: 0.95; 95% CI: 0.58–1.55). ConclusionsCompared with DP-EES, BP-SES demonstrated durable 2-year clinical outcomes. However, BP-SES showed better clinical performance than DP-EES for lesions with none/mild calcification.

Repeat coronary revascularization in high-risk patients treated with ticagrelor monotherapy after PCI: Insights from the randomized TWILIGHT trial

Abstract Background Repeat revascularization after percutaneous coronary intervention (PCI) remains a major concern, even though its impact on mortality is limited. The effect of ticagrelor monotherapy vs. standard dual antiplatelet therapy (DAPT) on this outcome is unclear. Aim To assess the impact of ticagrelor monotherapy vs. DAPT on repeat revascularization after PCI. Methods In the TWILIGHT trial, high-risk patients who were event-free and adherent to a ticagrelor-based DAPT for 3 months after PCI were randomized to ticagrelor plus aspirin or ticagrelor plus placebo for 12 additional months. In this post-hoc analysis, the primary endpoint was repeat revascularization due to recurrent or persistent symptomatic myocardial ischemia. Secondary endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR) and major adverse cardiac and cerebrovascular events (MACCE) and net adverse clinical events (NACE) (Figure). All endpoints were adjudicated and assessed at 12 months after randomization in the per-protocol population. Results Among 6,759 patients, ticagrelor monotherapy and ticagrelor plus aspirin were associated with a similar risk of repeat revascularization (7.1% vs 6.7%, HR 1.07, 95% CI 0.89-1.29), TLR, TVR and MACCE (Figure), while NACE was lower with ticagrelor monotherapy. Conclusion In high-risk patients undergoing PCI, ticagrelor monotherapy after 3 months of ticagrelor plus aspirin was associated with similar rates of recurrent coronary revascularization and MACCE and a lower risk of NACE compared with continued DAPT.

Drug coated balloons-based approach versus conventional percutaneous coronary intervention with drug eluting stents for left anterior descending revascularization

Abstract Introduction While representing the gold standard for percutaneous coronary interventions (PCI), drug eluting stents (DES) are associated with a progressively increasing risk of stent-related adverse events over time. (1) Left anterior descending (LAD) disease is a critical area for coronary stenting, due to the wide distribution with several side branches at risk of occlusion after stent implantation. Thus, the development of novel approaches for LAD PCI is warranted. Drug-coated balloons (DCB) used alone or in combination with DES as part of a hybrid procedure could allow to minimize stent burden and reduce the occurrence of stent-related events, but the evidence on their use for de novo lesions in large vessels is limited. (2-4) Methods Consecutive patients undergoing DCB implantation on the LAD in two Italian centers from 2018 to 2021 were retrospectively enrolled and compared to a historical cohort of LAD PCI with DES. Patients with in-stent restenosis were excluded. The primary endpoint was target lesion revascularization (TLR), while secondary endpoints included target vessel revascularization (TVR) and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, TLR and TVR. Results 175 patients undergoing a DCB-based treatment on the LAD were included and compared to 1503 patients who received conventional PCI with DES. 83.9% of patients were male and 28.3% were diabetics, with no differences between the two groups. Total treated length was higher in the DCB group (54.9±20 for DES vs.66.2±35.2 mm for DCB, p&amp;lt;0.001); conversely, a greater mean DES length (54.9±20 vs.42.5±27.1 mm, p&amp;lt;0.001) was observed in the DES cohort. In the DCB group, mean DCB length was 36.8±20.2 mm; 32% of patients underwent DCB-only PCI and, in those who had hybrid PCI, DCB length was higher than stent length in 61.1% of cases. Large vessels (device diameter ≥3 mm) were treated in 81.6% and 77.1% of patients in the DES and DCB groups respectively, with no significant differences, while DCB with diameter ≥3 mm were used in 41.7% of patients in the DCB cohort. Mean follow-up duration was 2024 and 495 days in the DES and DCB groups respectively. At two years, the cumulative incidence of TLR was 9.1% (95% CI:7.6-10.9%) in the DES group vs. 4.8% (95% CI: 1.8-12.3%) in the DCB group (Log-rank p =0.225). After covariate adjustment through stepwise multivariable Cox regression analysis, DCB use was independently associated with lower TLR occurrence (HR 0.23, 95% CI: 0.06-0.98), alongside with large vessels involvement, while diabetes, dyslipidemia, and prior CABG correlated with greater TLR risk. No differences between DES and DCB were detected for secondary endpoints. Conclusions A DCB-based treatment approach allowed a significantly reduced stent burden for LAD PCI and led to a lower risk of target lesion failure at two years. Future randomized studies are warranted to demonstrate the effect of DCB-based LAD PCI on long term outcomes.Major adverse cardiovascular eventsTLR predictors at Cox regression

Abstract 17558: Using Patient Reported Outcomes to Predict Patency and Revascularization in Peripheral Artery Disease: A Zilver PTX Sub-Analysis

Introduction: Health status measured by patient reported outcomes (PROs) can predict future major cardiovascular events in patients with peripheral artery disease (PAD). It is unclear, however, whether health status outcomes can also predict revascularization success. Methods: We preformed sub-analysis of the Zilver PTX trial (multinational randomized trial and US single arm) including patients with above-the-knee symptomatic femoropopliteal disease and receiving paclitaxel-eluting stents (Zilver PTX) between 2005-August 2008. We examined the association of patients’ pre-procedural health status measured by EQ-5D-3L Index (EQ-5D), a validated PROs instrument (Value &lt; 0 means health status worse than death, 0: death and 1: full health) and the 12-month treatment durability outcomes measured as primary patency and target lesion revascularization (TLR). Point-biserial correlations were calculated between EQ-5D and outcomes. The 12-month cumulative incidence of patency and TLR was constructed using Kaplan-Meier curves and compared by EQ-5D quartile using Log-rank test. Results: The Zilver PTX arm included 704 patients with a mean age of 68±10 years, 26% women, and 3% Black/African American. The mean EQ-5D pre-procedural Index was 0.79±0.12 and 0.87±0.15 at 12 months. Correlations between the pre-procedural EQ-5D and patency and TLR were, respectively, -0.006 (P=0.82) and 0.034 (P=0.31). In the overall cohort, the cumulative incidence of patency loss was 17% 95%CI 15-21 and of TLR was 9% 95%CI 7-11. There was no significant difference in the 12-month risk of either patency loss or TLR across EQ-5D quartiles (P=0.93 and P=0.85) (Figure). Conclusions: Pre-procedural generic health status are not predictive of post procedural endpoints of revascularization success such as patency and TLR in patients receiving Zilver PTX, underscoring the need of adding these complementary measures to evaluate the full scope of success following revascularization in PAD.

Abstract 14388: Meta-Analysis of Randomized Controlled Trials Comparing Immediate vs Staged Complete Revascularization in Patients With Acute Coronary Syndrome

Introduction: Complete revascularization with percutaneous coronary intervention (PCI) has been shown to improve clinical outcomes in patients with acute coronary syndromes (ACS) and multivessel disease (MVD). In order to address the conflicting results reported with respect to the timing, we aimed to perform a meta-analysis of the available randomized controlled trials (RCTs). Methods: Online databases were searched for RCTs comparing immediate to staged complete PCI in patients presenting with ACS. The primary outcomes of interest were major adverse cardiovascular events (MACE), all cause death, myocardial infarction (MI), cardiovascular death, stent thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), cerebrovascular events and bleeding at the longest available follow up. Pooled risk ratios (RR) and 95% confidence intervals (CI) were calculated using a random-effects model. Results: Three RCTs with a total of 2,261 patients, with 1,131 in the immediate PCI group and 1,130 in the staged PCI group were included. The mean age was 67 years, 79% of patients were men and the mean duration of follow up was 1 year. The immediate PCI group compared to staged complete PCI was associated with a significant reduction in MI (RR 0.50, 95% CI 0.31-0.83, p = 0.007) (Figure 1) and TVR (RR 0.58, 95% CI 0.41-0.80, p = 0.001). There were similar risks of cardiovascular death (RR 1.15, 95% CI 0.55-2.42, p = 0.71), TLR (RR 0.88, 95% CI 0.17-4.65, p = 0.88), cerebrovascular events (RR 0.87, 95% CI 0.41-1.82, p = 0.71), all-cause death (RR 1.30, 95% CI 0.48-3.50, p = 0.61), MACE (RR 0.70, 95% CI 0.48-1.02, p = 0.06), stent thrombosis (RR 0.89, 95% CI 0.36-2.22, p = 0.81) and bleeding (RR 0.65, 95% CI 0.18-2.41, p = 0.52) between the two groups. Conclusions: Complete PCI of the culprit and non-culprit vessels during the index procedure (immediate) significantly reduces the risk of MI and TVR when compared with staged PCI.

Comparison of Intravascular Imaging, Functional, or Angiographically Guided Coronary Intervention

BackgroundIn patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether intravascular imaging guidance or functional guidance is the best strategy to optimize outcomes and if the results are different in patients with vs without acute coronary syndromes (ACS). ObjectivesThe purpose of this study was to evaluate clinical outcomes with imaging-guided PCI or functionally guided PCI when compared with conventional angiography-guided PCI. MethodsWe searched PUBMED and EMBASE for randomized controlled trials investigating outcomes with intravascular imaging-guided, functionally guided, or angiography-guided PCI. The primary outcome from this network meta-analysis was trial-defined major adverse cardiovascular event (MACE)—a composite of cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR). PCI strategies were ranked (best to worst) using P scores. ResultsOur search identified 32 eligible randomized controlled trials and included a total of 22,684 patients. Compared with angiography-guided PCI, intravascular imaging-guided PCI was associated with reduced risk of MACE (relative risk [RR]: 0.72; 95% CI: 0.62-0.82), cardiovascular death (RR: 0.56; 95% CI: 0.42-0.75), MI (RR: 0.81; 95% CI: 0.66-0.99), stent thrombosis (RR: 0.48; 95% CI: 0.31-0.73), and TLR (RR: 0.75; 95% CI: 0.57-0.99). Similarly, when compared with angiography-guided PCI, functionally guided PCI was associated with reduced risk of MACE and MI. Intravascular imaging-guided PCI ranked first for the outcomes of MACE, cardiovascular death, stent thrombosis, and TLR. The results were consistent in the ACS and non-ACS cohorts. ConclusionsAngiography-guided PCI had consistently worse outcomes compared with intravascular imaging-guided and functionally guided PCI. Intravascular imaging-guided PCI was the best strategy to reduce the risk of cardiovascular events.

DRUG-COATED BALLOONS FOR THE TREATMENT OF STENT EDGE RESTENOSIS

This study aimed to compare the effectiveness of Drug-Coated Balloon (DCB) treatment with New-Generation Drug-Eluting Stent (DES) implantation for Stent Edge Restenosis (SER). The study was conducted at LRH Peshawar from 11-02-2022 to 11-02-2023 and included 130 patients with stent edge restenosis. Ethical approval was obtained from the hospital's ethical committee, and informed consent was taken from all patients. Patients were divided into two groups, Group A (DES) and Group B (DCB), and their clinical outcomes were analyzed using propensity score matching (PSM). The study showed that DCB therapy reduced the risk of target lesion revascularization (TLR) compared to DES during a median follow-up period of 1080 days. After conducting PSM, there was no significant difference in the risk of TLR between the two groups. Moreover, there were no significant differences in the risk of all-cause death, major adverse cardiovascular events (MACE), or TLR between Group A and Group B. In conclusion, DCB treatment for SER was found to be equally as effective as new-generation DES following PSM. Therefore, DCB can be considered a viable alternative to the new-generation DES for treating SER.

Complex Percutaneous Coronary Intervention Outcomes in Older Adults.

Background Complex percutaneous coronary intervention (PCI) is increasingly performed in older adults (age ≥75 years) with stable ischemic heart disease. However, little is known about clinical outcomes. Methods and Results We derived a cohort of older adults undergoing elective PCI for stable ischemic heart disease across a large health system. We compared 12-month event-free survival (freedom from all-cause death, nonfatal myocardial infarction, stroke, and major bleeding), all-cause death, target lesion revascularization, and bleeding events for patients receiving complex versus noncomplex PCI and derived risk estimates with Cox regression models. We included 513 patients (mean age, 81±5 years). Patients receiving complex PCI versus noncomplex PCI did not significantly differ across a host of clinical characteristics including cardiovascular disease features, noncardiac comorbidities, guideline-directed medical therapy use, and frailty. Patients receiving complex PCI versus noncomplex PCI experienced worse event-free survival (80.4% versus 86.8%), which was not significant in adjusted analyses (hazard ratio [HR], 1.38 [95% CI, 0.88-2.16]). All-cause death at 1 year for patients undergoing complex PCI was nearly double that seen for patients receiving noncomplex PCI (10.2% versus 5.9%), and the risk was significant in models adjusted for clinical characteristics (HR, 1.97 [95% CI, 1.02-3.79]). Target lesion revascularization risk was lower for patients receiving complex PCI (2.2% versus 3.5%, adjusted HR), but bleeding events were not statistically different between groups (25.3% versus 20.5%; P=0.19). Conclusions Complex PCI in older adults with stable ischemic heart disease was associated with lower risk of target lesion revascularization but higher all-cause death compared with noncomplex PCI.

The mid-term effect of intravascular ultrasound on endovascular interventions for lower extremity peripheral arterial disease: A systematic review and meta-analysis

ObjectiveIntravascular ultrasound (IVUS) is an important adjunctive tool for patients with lower extremity peripheral arterial disease (PAD) undergoing endovascular therapy (EVT). The evidence regarding the advantages of IVUS use is evolving, and recent studies have reported conflicting results. We aimed to perform a meta-analysis to evaluate the efficacy of IVUS during angiography-guided EVT for patients with PAD. MethodsMEDLINE and EMBASE were searched through April 2023 to identify studies that investigated the outcomes of IVUS with angiography-guided EVT vs angiography-alone-guided EVT. The primary outcome was restenosis/occlusion rate; secondary outcomes were target lesion revascularization, major amputation, and mortality. ResultsOne randomized controlled trial and 14 observational studies, largely of moderate quality, were included, yielding a total of 708,808 patients with 709,189 lesions that were treated with IVUS-guided EVT (n = 101,405) vs angiography-alone (n = 607,784). Compared with angiography alone, IVUS-guided EVT was associated with a non-significant trend towards decreased restenosis/occlusion (relative risk [RR], 0.74; 95% confidence interval [CI], 0.54-1.00; I2 = 60%). Although the risk of target lesion revascularization and mortality were comparable (RR, 0.85; 95% CI, 0.65-1.10; I2 = 70%; RR, 1.01; 95% CI, 0.79-1.28; I2 = 43%, respectively), the use of IVUS was also associated with significantly lower risk of major amputation (RR, 0.74; 95% CI, 0.67-0.82; I2 = 47%). Subgroup analysis focusing on femoropopliteal disease demonstrated significantly higher patency (RR, 0.72; 95% CI, 0.52-0.98; I2 = 73%). However, superiority with major amputation was not observed. ConclusionsIVUS-guided EVT for PAD may possibly be associated with a lower major amputation rate compared with angiography alone-guided EVT, although the difference in patency remained an insignificant trend in favor of IVUS-guided EVT. Adjunctive use of IVUS during EVT may be beneficial, and further prospective studies are warranted to delineate this relationship and the applicability of this technology in routine practice.

Device Effectiveness for Femoropopliteal Artery Disease Treatment: An Analysis of K-VIS ELLA Registry

BackgroundAlthough drug-coated balloons (DCBs) and drug-eluting stents (DES) are frequently used for the treatment of femoropopliteal artery (FPA) disease, their mid- or long-term clinical efficacy in real-world practice is still limited. ObjectivesFrom the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) multicenter registry cohort, clinical outcomes of drug-eluting devices for FPA lesions in comparison with bare-metal stents (BMS) were evaluated. MethodsLimbs that underwent percutaneous transluminal angioplasty for FPA lesions with plain old balloon angioplasty (POBA, n = 826), BMS (n = 943), DCBs (n = 778), or DES (n = 227) between 2012 and 2020 were included. The primary outcome was target lesion revascularization (TLR) at 2 years. Inverse probability of treatment weighting was used to account for confounding. ResultsAfter inverse probability of treatment weighting, baseline characteristics were well-balanced among groups. Compared with the 2-year cumulative incidence of TLR with BMS (26.5%), the incidence of TLR was significantly lower in limbs treated with DCBs (15.9%; HR: 0.44; 95% CI: 0.30-0.64; P < 0.001) or DES (15.9%; HR: 0.51; 95% CI: 0.29-0.87; P = 0.014). No significant differences were observed in the risk of TLR between DCBs vs DES (HR: 0.87; 95% CI: 0.51-1.49; P = 0.613) and POBA vs BMS (HR: 0.94; 95% CI: 0.73-1.21; P = 0.626). All-cause mortality was comparable in the 4 groups. Treatment with DCBs showed a more pronounced favorable outcome in limbs with Trans-Atlantic Inter-Society Consensus II type C/D lesions or long lesions (≥150 mm) compared with POBA, BMS, or DES (Pinteraction< 0.05). ConclusionsIn real-world practice, DCBs and DES demonstrated comparably superior midterm outcomes over POBA or BMS in the treatment of FPA lesions.

Impact of post-implantation time on bioresorbable vascular scaffold outcomes for type C versus non-type C coronary lesions: A longer-term study

We have demonstrated that bioresorbable vascular scaffold (BVS) for ACC/AHA type C lesions was associated with higher risks of long-term target lesion revascularization (TLR) and target lesion failure (TLF). We determined the specific time after which higher risks of BVS for type C lesions are reduced in a longer-term follow-up. We analyzed data of 457 patients (59±12 years, 87% male) with 714 BVS implanted for 529 lesions and a median follow-up of 56.4 (48.6-62.6) months. Patients with BVS for at least one type C lesion (N=177) at index intervention and all non-type C lesions (N=280) were compared for TLF (cardiac death, target vessel myocardial infarction, TLR). We specified the interactions between the non-type C versus type C group and the event-free survival times dichotomized at 24, 30, 32, 33, 36, and 39 months respectively. The type C group had more multivessel disease (86% versus 65%, p<0.001), left anterior descending artery treated (68% versus 53%, p=0.002), intravascular imaging used (48% vs. 25%, p<0.001), and BVS (2.3±0.9 vs. 1.1±0.3, p<0.001) implanted with a longer total length (57±21 vs. 29±8mm, p<0.001). The TLR or TLF was higher (both log-rank p<0.05) in the type C than in the non-type C group. However, the risks of TLR (hazard ratio: 3.6, 95% CI=1.1-11.6) and TLF (hazard ratio: 3.8, 95% CI=1.2-12.1) for type C lesions only remained higher until 24 months post-BVS implantation. BVS provides a longer-term advantage, particularly for type C lesions with the majority requiring long stenting.

Drug-coated balloons for the treatment of stent edge restenosis.

Drug-coated balloon (DCB) is a device for treating patients with in-stent restenosis; however, there are scant data on its efficacy for stent edge restenosis (SER). This study aimed to investigate the clinical outcomes of DCB use for treating SER compared with new-generation drug-eluting stent (DES) implantation. From December 2013 to January 2019, patients who underwent DES implantation or DCB for SER were enrolled. Clinical outcomes were analyzed, and propensity score with matching was conducted. The primary outcome was target-vessel revascularization (TVR). The secondary outcomes were the incidence of all-cause mortality, major adverse cardiovascular events (MACE), and target lesion revascularization (TLR). A total of 291 patients with SER were included: 160 were treated with DCB, and 131 with new-generation DES. DCB treatment for SER treatment was associated with a lower risk of TVR than DES [hazard ratio, 0.549; 95% confidence interval (CI), 0.339-0.891] at a median follow-up of 1080 days (interquartile range; 729-1080 days). Propensity score matching (PSM) was performed to adjust for baseline clinical and lesion characteristics. After PSM, no significant difference in the risk of TVR was observed (hazard ratio, 0.965; 95% CI, 0.523-1.781). Similarly, the risk for all-cause death (hazard ratio, 0.507; 95% CI, 0.093-2.770), MACE (hazard ratio: 0.812; 95% CI, 0.451-1.462), and TLR (hazard ratio: 0.962; 95% CI, 0.505-1.833) were comparable between the two groups. DCB treatment efficacy for SER was similar to that of new-generation DES after PSM. DCB is a significant alternative to obtain comparable results with new-generation DES for the treatment of SER.

Efficacy of intravascular ultrasound versus coronary angiographic guided drug-eluting stent implantation in the treatment of left main coronary artery disease: a meta-analysis

Objective: To compare the efficacy of intravascular ultrasound (IVUS) and coronary angiography guided drug eluting stent (DES) implantation for the treatment of left main coronary artery (LMCA) lesions. Methods: Randomized controlled trials (RCT) and observational studies, which compared IVUS with coronary angiography guided DES implantation for the treatment of LMCA lesions published before August 2021 were searched in PubMed, Embase and Cochrane Library databases. Baseline data, interventional procedures and endpoint events of each study were collected. The primary endpoint was major cardiovascular adverse events (MACE), and the secondary endpoints were all-cause death, cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR). The Newcastle-Ottawa Scale (NOS) and the Cochrane Collaboration Risk of Bias tool were used to evaluate the quality of the included studies. Results: Nine studies were included, including 3 RCT and 6 observational studies, with a total of 5 527 cases of LMCA. All the 6 observational studies had NOS scores≥6, and the 3 RCT had a low risk of overall bias. The results of meta-analysis showed that compared with coronary angiography guided group, MACE rate (OR=0.55, 95%CI 0.47-0.66, P<0.001), all-cause death (OR=0.56, 95%CI 0.43-0.74, P<0.001), cardiac death (OR=0.43, 95%CI 0.30-0.61, P<0.001), MI (OR=0.64, 95%CI 0.52-0.79, P<0.001), TLR (OR=0.49, 95%CI 0.28-0.86, P=0.013) and TVR (OR=0.77, 95%CI 0.60-0.98, P=0.037) were all significantly lower in the IVUS guided group. Conclusions: Compared with angiography guided, IVUS guided PCI with DES implantation in LMCA lesions could significantly reduce the risk of MACE, death, MI, TLR and TVR. IVUS is thus superior to coronary angiography for guiding PCI treatment among patients with LMCA.

Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis.

Provisional stenting using drug-eluting stents (DES) has become the preferred treatment for coronary bifurcation lesions (CBLs). We performed a meta-analysis to compare the effects of side branch (SB) protection using a drug-coated balloon (DCB) versus an uncoated balloon (UCB) during the procedure. Relevant randomized and nonrandomized studies were identified by searching the Medline, Embase, Web of Science, Wanfang, and CNKI databases. We used a random-effect model to pool the data by incorporating the heterogeneity between the included studies. Overall, 803 patients with CBLs treated with provisional stenting using DES were included from seven studies. With a follow-up duration of 6 to 12 months, SB protection with DCB was associated with a lower degree of postoperative diameter stenosis (mean difference (MD): -11.35%, 95% confidence interval (CI): -14.17 to-8.53, p < 0.001; I2 = 0%) and less late lumen loss (MD: -0.19 mm, 95% CI:-0.28 to-0.10, p < 0.001; I2 = 69%) of SB compared to those with UCB. Moreover, SB protection with DCB was associated with reduced risks of target lesion revascularization (risk ratio [RR]: 0.49, 95% CI: 0.27 to 0.88, p = 0.02; I2 = 0%) and major adverse cardiovascular events (RR: 0.42, 95% CI: 0.27 to 0.66, p < 0.01; I2 = 0%). Subgroup analysis according to the study design showed similar results. For patients with CBL treated with provisional stenting using DES, SB protection with DCB was associated with better angiographic and clinical outcomes than those with UCB.

784 IMPACT OF ELECTIVE, UNCOMPLICATED TARGET LESION REVASCULARIZATION ON CARDIAC MORTALITY AFTER ELECTIVE PERCUTANEOUS CORONARY INTERVENTION OF UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE

Abstract Background Percutaneous coronary intervention (PCI) appears a reasonable alternative to coronary artery bypass graft in selected groups of patients with unprotected left main coronary artery (ULMCA) disease. Despite technological progression, improved operator skills and introduction of drug-eluting stents (DES), in-stent restenosis still remains a major limitation after PCI of ULMCA disease. The prognostic relevance of target lesion revascularization (TLR) after PCI of ULMCA disease is unknown. Objectives This study sought to evaluate the impact of elective, uncomplicated target lesion revascularization on long-term cardiac mortality after PCI of ULMCA disease. Methods Consecutive patients undergoing PCI for ULMCA disease between January 2003 and December 2015 in one interventional center in Italy were included. Patients presenting with cardiogenic shock, ST-segment elevation myocardial infarction (MI), as well as those undergoing urgent or complicated TLR were excluded. The primary endpoint of the study was cardiac mortality. The secondary endpoints of the study were all-cause death, MI, stroke as individual endpoints, or the composite of cardiac death, MI or stroke defined as major adverse cardiac events (MACE). Results Among the 418 patients fulfilling the study criteria, 79 (18.46%) underwent elective, uncomplicated TLR. After a median follow-up of 5.5 years, there were 23 cardiac deaths among patients undergoing elective, uncomplicated TLR versus 50 in patients not undergoing TLR. After adjusting for possible confounders, TLR was an independent predictor of cardiac mortality (Hazard ratio [HR] = 1.92, 95% confidence interval [CI]: 1.05 to 3.49; p = 0.03). Patients undergoing TLR had also significantly higher rates of the composite of cardiac death, MI and stroke compared with the no TLR group (adjusted HR = 1.76, 95% CI 1.14 to 2.72). Conclusion Elective, uncomplicated TLR after PCI of ULMCA disease is associated with increased risk of long-term cardiac mortality. Reducing the risk of TLR after PCI of ULMCA disease may potentially improve the survival of these patients.

Effect of Stenting Strategy on the Outcome in Patients with Non-Left Main Bifurcation Lesions.

Previous studies have not compared outcomes between different percutaneous coronary intervention (PCI) strategies and lesion locations in non-left main (LM) bifurcation lesions. We enrolled 2044 patients from a multicenter registry with an LAD bifurcation lesion (n = 1551) or non-LAD bifurcation lesion (n = 493). The primary outcome was target lesion failure (TLF), a composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). During a median follow-up period of 38 months, non-LAD bifurcation lesions treated with the two-stent strategy, compared with the one-stent strategy, were associated with more frequent TLF (20.7% vs. 6.3%, p < 0.01), TLR (16.7% vs. 4.7%, p < 0.01), and target vessel revascularization (TVR; 18.2% vs. 6.3%, p < 0.01). There was no significant difference in outcome among LAD bifurcation lesions treated with different PCI strategies. The two-stent strategy was associated with a higher risk of TLF (adjusted HR 4.34, CI 1.93–9.76, p < 0.01), TLR (adjusted HR 4.30, CI 1.64–11.27, p < 0.01), and TVR (adjusted HR 5.07, CI 1.69–9.74, p < 0.01) in the non-LAD bifurcation lesions. The planned one-stent strategy is preferable to the two-stent strategy for the treatment of non-LAD bifurcation lesions.