Risk Of Target Lesion Revascularization Research Articles

Provisional stenting : drug-coated versus uncoated balloon for side branch in coronary bifurcation lesions: randomized study

Abstract Introduction The rePOT technique is a novel and easily applied approach for coronary bifurcations. Drug-Coated Balloon (DCB) angioplasty is increasingly being utilized in management of small vessels and coronary bifurcation lesions. Herein, we propose a new approach for treating coronary bifurcation lesions with the application of DCB to treat the side-branch in addition to the rePOT technique: the POT-sideDCB-POT technique. Materiel and Method: We described for the first time the POT-sideDCB-POT method for true bifurcation lesions (including the side-branch ostium), which is in line with the recommended management algorithm of the European Bifurcation Club8 consisting of a sequential approach to bifurcation stenting using the provisional strategy. The POT-sideDCB-POT is easy to perform and respects the geometry of all the three bifurcation segments. Results Overall, 100 patients with CBLs treated with provisional stenting using DES were included from our studie,50 with DCB side branche and 50 with UCB With a follow-up duration of 12 months, SB protection with DCB was associated with a lower degree of postoperative diameter stenosis (mean difference (MD): −10.35%, 95% confidence interval (CI): −13.17 to−8.53, p < 0.001; I2 = 0%) and less late lumen loss (MD: −0.18 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]: 0.45, 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. Conclusions 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.

Comparison of Outcome After Percutaneous Coronary Intervention for De Novo and In-Stent Restenosis Indications

In-stent restenosis (ISR) still occur after percutaneous coronary intervention (PCI). Few studies have compared outcomes after PCI for de novo stenosis and ISR and the results are conflicting. The aim of the present study is to compare outcomes after PCI for ISR and de novo coronary stenosis. Using patient level data from the randomized all-comer SORT OUT studies III-X, we included all patients with previous PCI and either an ISR or a de novo lesion as the study target lesion. Outcomes of interest were major adverse cardiac events (MACE) and target lesion revascularization (TLR) after 5 years. Of the 2928 patients with a previous PCI included in the SORT OUT studies, 491 (17%) were treated for ISR and 2437 (83%) for a de novo stenosis. Baseline characteristics did not differ significantly. At 5 years, MACE occurred in 148 patients (32%) in the ISR group and in 654 patients (28%) in the de novo stenosis group (Crude and adjusted HR 1.16 (0.97-1.38) and 1.16 (0.97-1.38)). The risk of TLR was higher in the ISR group when compared to the de novo stenosis group (Crude and adjusted HR 1.64 (95% CI, 1.24-2.17) and 1.71 (95% CI, 1.27-2.30)). In conclusion, the risk of MACE was similar after PCI of ISR and de novo lesions after 5 years. However, the risk of TLR was higher in the ISR group compared to the de novo stenosis group.

Comparative long-term efficacy and safety of two paclitaxel-coated balloons with different coating strategies for the treatment of drug-eluting coronary stent restenosis.

We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined. 262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years. At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices. In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495).

Comparison of efficacy and safety of sarpogrelate-based anti-platelet therapy with clopidogrel-based anti-platelet therapy following arterial endovascular therapy: A systematic review

Objective: Sarpogrelate is a selective serotonin/5-hydroxytryptamine 2A receptor antagonist used in the management of peripheral artery disease (PAD). The drug has emerged as a promising choice for medical management post-endovascular therapy (EVT) due to its anti-platelet aggregation, vasoconstriction, and anti-vascular smooth muscle proliferation properties. The aim of the meta-analysis is to evaluate the efficacy and safety of sarpogrelate-based APT following arterial EVTs in PAD. Material and Methods: PubMed, Google Scholar, Scopus, and the Cochrane were systematically searched from inception to December 2023. Any randomized controlled trial studies in English that evaluated the efficacy and safety of sarpogrelate-based APT after EVT in patients with PAD was included. Data on the restenosis rate, target lesion revascularization (TLR), and safety parameters were extracted and studied. The pooled differences in efficacy and safety parameters between sarpogrelate-based APT and non-sarpogrelate-based APT was calculated using the relative risk (RR) with a 95% CI. Results: A total of three randomized controlled trials were included out of 354 articles obtained through a literature search. No significant differences were observed in the risk of restenosis (RR=0.74, 95% C.I.= 0.55- 1.00, P=0.954) and TLR (RR=0.76, 95% C.I.= 0.47- 1.23 , P=0.476) among patients being treated with sarpogrelate and non-sarpogrelate based APT. Likewise, sarpogrelate-based APT had similar safety profile as non-sarpogrelate-based APT. Conclusion: Sarpogrelate-based APT can be considered an effective alternative to clopidogrel-based conventional APT after EVTs. However, there is a huge need for a larger multicenter, multinational, and multiethnic global trial with sufficient participants in order to produce generalizable findings.

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

BackgroundWhen antegrade recanalization of femoropopliteal 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. MethodsThe primary end point was the success of the procedure (successful occlusion crossing using the antegrade/retrograde technique). Secondary end points include complication rate, primary patency and target lesion revascularization (TLR) rate, amputation rate, changes in ankle-brachial index, and Rutherford-Becker class. 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 multilevel (group 3) recanalization. Critical limb-threatening ischemia was present in group 1, 2, and 3 in 36%, 62%, and 76% of patients, respectively. The intervention was successful in 92.5%, 93.8%, and 90.8% of the respective cases (P = .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%, and 33.3%), followed by group 3 (59.8%, 46.1%, and 33.3%), and group 2 (58.5%, 43.1%, and 30.4%; P = .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 rates in groups 1, 2, and 3 were 93.8%, 79.4%, and 87.5%, respectively. Over 24 months, 75 patients (8.4%) had to undergo amputation. Significant improvements in both ankle-brachial index and Rutherford-Becker class were present at discharge as well as at 6, 12, and 24 months (P < .001). Dialysis dependency was a predictor of unsuccessful antegrade/retrograde recanalization (P = .048). Lesion length (P = .0043), dialysis (P = .033), and recanalization level (P = .013) increase the risk of TLR. ConclusionsUsing a combined antegrade/retrograde access, recanalization of occluded femoropopliteal and/or infrapopliteal arteries can be achieved in a large number of cases. Owing to the high rate of repeated TLR across all lesion localizations, the indication for antegrade and retrograde recanalization may be limited to patients with critical limb-threatening ischemia.

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.

Drug-eluting stent vs. Balloon angioplasty in patients with in-stent restenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

IntroductionIn-stent restenosis (ISR) is seen in up to 20% of cases and is the primary cause of percutaneous coronary intervention (PCI) failure. With the use of re-stenting with a drug-eluting stent (DES), plain old balloon angioplasty (BA) use is decreasing. We aim to compare the efficacy and safety profile of DES over BA in the management of ISR. MethodsElectronic databases were searched to identify all randomized controlled trials (RCTs) comparing DES to BA for coronary ISR. The mantel-Haenszel method with a random effects model was used to calculate pooled risk ratios (RR). ResultsFour trials comprising 912 patients (543 in DES and 369 in the BA group) were included in the final study. The mean follow-up was 45 months. DES was found to be superior with a lower requirement of target vessel revascularization (TVR) (RR: 0.45, 95% CI: 0.31–0.64, p-value <0.0001), and target lesion revascularization (TLR) (RR: 0.59, 95%CI: 0.44–0.78, p-value 0.0002) compared to BA. However, all-cause mortality, cardiovascular mortality, incidence of myocardial infarction (MI), and target lesion thrombosis were not different between the two intervention arms. ConclusionDES was found to be superior to BA for the management of coronary ISR with a reduction in the risk of TLR and TVR. No difference in mortality, risk of MI, or target lesion thrombosis was observed between the two interventions.

Efficacy of Drug-Coated Balloon Angioplasty in Pulmonary Vein Stenosis or Total Occlusion.

Current therapies for pulmonary vein stenosis (PVS) or pulmonary vein total occlusion (PVTO) involving angioplasty and stenting are hindered by high rates of restenosis. This study compares a novel approach of drug-coated balloon (DCB) angioplasty and stenting with the current standard of care in PVS or PVTO due to pulmonary vein isolation (PVI). A retrospective single-center study analyzed patients with PVS or PVTO due to PVI who underwent either angioplasty and stenting (NoDCB group; December 2012-December 2016) or DCB angioplasty and stenting (DCB group; January 2018-January 2021). Multivariable Andersen-Gill regression analysis assessed the risk of restenosis and target lesion revascularization (TLR). The NoDCB group comprised 58 patients and 89 veins, with a longer median follow-up of 35months, whereas the DCB group included 26 patients and 33 veins, with a median follow-up of 11months. The DCB group exhibited more PVTO (NoDCB: 12.3%; DCB: 42.4%; P=0.0001), with a smaller reference vessel size (NoDCB: 10.2mm; DCB: 8.4mm; P=0.0004). Follow-up computed tomography was performed in 82% of NoDCB and 85% of DCB, revealing lower unadjusted rates of restenosis (NoDCB: 26%; DCB: 14.3%) and TLR (NoDCB: 34.2%; DCB: 10.7%) in the DCB group. DCB use was associated with a significantly lower risk of restenosis and TLR (HR: 0.003: CI: 0.00009-0.118; P=0.002). The novel approach of DCB angioplasty followed by stenting is effective and safe and significantly reduces the risk of restenosis and reintervention compared with the standard of care in PVS or PVTO due to PVI.

Long-term clinical outcomes of intravascular imaging-guided percutaneous coronary intervention versus angiography-guided percutaneous coronary intervention in complex coronary lesions: a systematic review and meta-analysis.

Background: In this study, we aim to discuss the long-term clinical outcomes of intravascular ultrasound imaging-guided percutaneous intervention (IVUS-PCI) versus angiography-guided percutaneous coronary intervention (PCI) in complex coronary lesions over a mean period of 2years. Methods: A systematic search and meta-analysis were conducted to assess the efficacy of using intravascular ultrasound or optical coherence tomography guidance in coronary artery stenting compared to angiography. Results: A total of 11randomized controlled trialswith 6740 patients were included. For the primary outcome, a pooled analysis (3.2vs 5.6%). For secondary outcomes, the risk was significantly low in image-guided percutaneous intervention compared withangiography. Conclusion: Intravascular imaging-guided PCI is significantly more effective than angiography-guided PCI in reducing the risk of target lesion revascularization, target vessel revascularization, cardiac death, major adverse cardiovascular eventsandstent thrombosis.

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.