Risk Of Stent Thrombosis Research Articles

Is It Really Safe to Discontinue Antiplatelet Therapy 12 Months After Percutaneous Coronary Intervention in Patients with Atrial Fibrillation?

The prevalence of AF in patients with coronary artery disease is high. The guidelines from many professional groups, including the European Society of Cardiology, American College of Cardiology/American Heart Association and Heart Rhythm Society, recommend a maximum duration of 12 months of combination single antiplatelet and anticoagulation therapy in patients who undergo percutaneous coronary intervention and who have concurrent AF, followed by anticoagulation alone beyond 1 year. However, the evidence that anticoagulation alone without antiplatelet therapy adequately reduces the well-documented attritional risk of stent thrombosis after coronary stent implantation is relatively sparse, particularly given that very late stent thrombosis (>1 year from stent implantation) is the commonest type. By contrast, the elevated risk of bleeding from combined anticoagulation and antiplatelet therapy is clinically important. The aim of this review is to assess the evidence for long-term anticoagulation alone without antiplatelet therapy 1 year post-percutaneous coronary intervention in patients with AF.

Drug-coated balloon therapy is more effective in treating late drug-eluting stent in-stent restenosis than the early occurring one-a systematic review and meta-analysis.

Drug-eluting stent in-stent restenosis (DES-ISR) remains one of the important assignments to be resolved in interventional cardiology, as it is present in 5%-10% of total percutaneous coronary intervention cases. Drug-coated balloon (DCB) utilization is promising, as it comes with long-term protection from recurrent restenosis in optimal conditions without the hazard of higher risk for stent thrombosis and in-stent restenosis. We aim to reduce the need for recurrent revascularization in DES-ISR, specifying the population in which the DCB therapy should be used. In this meta-analysis, the results of studies containing data on the time frame between drug-eluting stent implantation and the clinical presentation of in-stent restenosis and concomitant drug-coated balloon treatment were summarized. A systematic search was performed in Medline, Central, Web of Science, Scopus and Embase databases on November 11th, 2021. The QUIPS tool was used to assess the risk of bias in the included studies. The occurrence of a major cardiac adverse events (MACE) composite endpoint, containing target lesion revascularization (TLR), myocardial infarction, and cardiac death, and each of these separately, was assessed at 12 months after the balloon treatment. Random effects meta-analysis models were used for statistical analysis. Data of 882 patients from four studies were analyzed. Across the included studies, a 1.68 OR (CI 1.57-1.80, p < 0.01) for MACE and a 1.69 OR (CI 1.18-2.42 p < 0.01) for TLR were observed, both in favor of late DES-ISR. The main limitation of the study is the relatively low patient number. Nevertheless, this analysis shows the first statistically significant results for the effect of DCB treatment in the early or late presentation of DES-ISR. As to date, intravascular imaging (IVI) remains limitedly accessible, other landmarks as the time frame of in-stent restenosis development are to be pursued to advance therapeutic outcomes. In consideration of other biological, technical and mechanical factors, time frame of occurrence as a prognostic factor could reduce the burden of recurrent revascularization in patients at an already high risk. Systematic Review Registration: identifier [CRD42021286262].

Management of Bifurcation Culprit Lesion in the Setting of Anterior ST Elevation Myocardial Infarction

Introduction: Coronary bifurcation lesions are considered one of the challenging entities in the field of coronary intervention due to the risk of side branch loss and higher risk of stent thrombosis. However, there is limited data about the proper management of such lesions in the setting of myocardial infarction as most bifurcation lesion studies excluded patients with acute coronary syndromes (ACS). The aim of this study was to compare in-hospital and mid-term outcomes of single-stent and two-stents strategy in the management of bifurcation culprit lesions in patients presenting with anterior STEMI.&#x0D; Methods: This retrospective multi-center study included all patients presented with anterior STEMI who underwent primary PCI between January 2017 and December 2019, coronary angiography showed true bifurcation lesion with sizable side branch that can be managed by stenting. Patients with left main bifurcation, those indicated for urgent CABG, and patients in cardiogenic shock were excluded. Included patients were divided into two groups according to the stenting strategy either single or two stents. Six months follow up data were collected by telephone calls and by examination of medical records.&#x0D; Results: Out of 1355 anterior STEMI patients presented between January 2017 and December 2019, 158 patients (11.6%) were identified to have bifurcation culprit lesions with a sizable diagonal branch. 93 patients (59%) were treated by single stent while 65 patients (41%) were managed by two-stents strategy. The baseline characteristics and angiographic findings were similar in both groups except for higher side branch involvement in the two stents group (83.31%±11.20 vs 71.88%±15.05, t= -5.39, p &lt;0.001). Mean fluoroscopy time (23.96±8.90 vs 17.81±5.72 mins) and contrast volume (259.23± 59.45 vs 232.58± 96.18 ml) were significantly higher in two stents group than single stent group (p=0.049). However, the angiographic success rates (residual stenosis ≤30% and restoration of TIMI flow grade II or III) were comparable (96.8% vs 99%, MCp=0.151). There is no significant difference in the overall incidence rate of MACE in both groups 6 months following the index procedure (13.9 % vs 16.9%, FEp=0.698), with no difference between different bifurcation stenting techniques in patients managed with two stents.&#x0D; Conclusion: Although two stents strategy in the setting of STEMI is much complex with more fluoroscopy time and contrast volume, the procedural success rate and the incidence of MACE were comparable to one stent strategy, on medium-term follow up.

P227 THE UNEXPECTED CONSEQUENCES OF A 30 METERS FALL

Abstract Introduction Acute myocardial infarction (AMI) is a rare but often lethal consequence of a blunt cardiac trauma. Falls leading to coronary artery dissections are rare, thus underlining the lack of experience in their management. Case report description: a 55–year–old male patient with type 2 diabetes and no relevant past medical history was admitted to our hospital facility after a 30–meter fall during rock–climbing. On arrival, he was hemodynamically and neurologically stable. He underwent a full trauma evaluation: multiple facial bones fractures were diagnosed. An electrocardiogram revealed a QS morphology of the QRS and ST elevation in the precordial lead from V1 to V3 with reciprocal ST depression in the inferior leads. High sensitivity (hs) Troponin T was slightly elevated (49 ng/L, normal values &amp;lt;14 ng/L). A cardiac ultrasound documented a left ventricular dysfunction (LVEF 40%) with akinesia of mid–apical antero–septal and anterior walls. Biomarkers further increased with Troponin reaching 199 ng/L and creatinine phosphokinase–MB 24,7 ug/L (normal value &amp;lt;5 ug/L). Coronary angiography demonstrated proximal occlusion of the left anterior descending (LAD) coronary artery with an image consistent with traumatic coronary artery dissection, confirmed by a cardiac CT scan showing the proximal occlusion of the LAD with retrograde perfusion of its downstream portion. Considering the left ventricular dysfunction, the elevation of cardiac biomarkers (peak CK–MB 187 ug/L, peak hs troponin T 5400 ng/L) and the acceptable hemorrhagic risk in spite of the need for facial surgery, a coronary angioplasty was performed. A dual antiplatlet therapy with acetilsalicidic acid and clopidogrel began. Nine days later the patient underwent the maxillo–facial surgery: clopidogrel was stopped provisionally and a bridge strategy using tirofiban was chosen. Post–operatory was uneventful. A full recovery of cardiac function was assessed after one year (LVEF of 55%). Discussion Few cases of blunt cardiac trauma with coronary artery dissections have been reported and treated successfully, with the LAD being the most frequently involved vessel (76%). If urgent non–cardiac surgery can be postponed, a percutaneus revascularization eventually followed by tirofiban as bridge therapy can be suggested, carefully considering the risk of stent thrombosis and the hemorrhagic risk conveyed by the trauma itself.

P201 DRUG–COATED BALLOON AND DIABETES MELLITUS: A MATTER OF SURVIVAL

Abstract Background Patients with diabetes mellitus (DM) are at higher risk of restenosis and stent thrombosis after percutaneous coronary intervention and drug eluting stent (DES) positioning. Limited although interesting data are available on prognosis after revascularization with drug–coated balloon (DCB) in this group of patients. The aim of this study is to evaluate the prognostic impact of DCB use in patients affected by DM. Methods Patients with DM enrolled in a retrospective multicenter registry were identified and matched to a control population of diabetic patients treated with DES enrolled in another retrospective registry, according to a propensity score calculated on the independent predictors of main adverse cardiac events (MACE). The primary study endpoint was the occurrence of MACE, a composite of death, myocardial infarction, and target vessel revascularization. Secondary endpoints were the independent components of the primary endpoint, or target lesion failure (TLF). Results 150 patients were identified in the DCB group and matched with 150 DES–treated patients. However, patients treated with DCB displayed more often a previous cardiovascular history and received a more complete pharmacological therapy. Target vessel diameter and the percentage of stenosis were lower in DCB patients, whereas binary in–stent restenosis was more common. At a median follow–up of 545.5 days, MACE occurred in 54 (19.4%) of the patients, with no difference according to the PCI strategy. Although a trend toward higher TLF was found (p=0.06), overall death was significantly reduced in diabetic patients (3.6% vs 10.9%; adjusted HR[95%CI]= 0.27[0.08–0.91], p=0.03). Conclusion Although limited by some differences among the groups, the present propensity–matched study shows that, among patients with DM undergoing PCI for in–stent restenosis or de novo lesions, the use of DCB is associated to a similar rate of MACE and a possible increase in TLF, but a significantly improved survival as compared to use of DES.

Treatment of Ostial Right Coronary Artery Narrowings: Outcomes From the Multicenter Prospective e-ULTIMASTER Registry.

Treatment of right coronary artery (RCA) aorto-ostial (AO) lesions with bare-metal stents and first-generation drug-eluting stents (DES) was associated with worse outcomes. This study aimed to assess the effect of RCA-AO stenting with current-generation DES on the clinical outcome. The large all-comer, multicontinental e-ULTIMASTER registry included 37,198 patients of whom 4775 underwent ostial and proximal RCA percutaneous coronary intervention (PCI) using the Ultimaster stent (Terumo). The primary clinical end point was 1-year target lesion failure (TLF), a composite of cardiac death; target vessel-related myocardial infarction; or clinically indicated target lesion revascularization. We compared 591 (12.4%) patients who underwent RCA-AO PCI with 4184 (87.6%) patients who underwent proximal RCA PCI. The RCA-AO group included more men and recorded significantly more comorbidities and more complex coronary anatomy. After propensity matching, the primary end point TLF occurred in 4.49% of the RCA-AO group compared with 3.00% of the proximal RCA group (P = .06). Target vessel revascularization (3.29% vs 1.90%; P = .03) and stent thrombosis (1.23% vs 0.42%, P = .01) were significantly higher among patients with RCA-AO lesions than those among patients with proximal RCA lesions. All-cause mortality was similar between the groups (2.97% vs 2.26%; P = .30). The treatment of RCA-AO with DES is feasible, with similar rates of TLF but with an increased risk of target vessel revascularization and stent thrombosis.

Is There an Advantage of Ultrathin-Strut Drug-Eluting Stents over Second- and Third-Generation Drug-Eluting Stents?

In patients undergoing percutaneous coronary intervention, the second-generation drug-eluting stents (DES) are considered the gold standard of care for revascularization. By reducing neointimal hyperplasia, drug-eluting coronary stents decrease the need for repeat revascularizations compared with conventional coronary stents without an antiproliferative drug coating. It is important to note that early-generation DESs were associated with an increased risk of very late stent thrombosis, most likely due to delayed endothelialization or a delayed hypersensitivity reaction to the polymer. Studies have shown a lower risk of very late stent thrombosis with developing second-generation DESs with biocompatible and biodegradable polymers or without polymers altogether. In addition, research has indicated that thinner struts are associated with a reduced risk of intrastent restenosis and angiographic and clinical results. A DES with ultrathin struts (strut thickness of 70 µm) is more flexible, facilitates better tracking, and is more crossable than a conventional second-generation DES. The question is whether ultrathin eluting drug stents suit all kinds of lesions. Several authors have reported that improved coverage with less thrombus protrusion reduced the risk of distal embolization in patients with ST-elevation myocardial infarction (STEMI). Others have described that an ultrathin stent might recoil due to low radial strength. This could lead to residual stenosis and repeated revascularization of the artery. In CTO patients, the ultrathin stent failed to prove non-inferiority regarding in-segment late lumen loss and showed statistically higher rates of restenosis. Ultrathin-strut DESs with biodegradable polymers have limitations when treating calcified (or ostial) lesions and CTOs. However, they also possess certain advantages regarding deliverability (tight stenosis, tortuous lesions, high angulation, etc.), ease of use in bifurcation lesions, better endothelialization and vascular healing, and reducing stent thrombosis risk. In light of this, ultrathin-strut stents present a promising alternative to existing DESs of the second and third generation. The aims of the study are to compare ultrathin eluting stents with second- and third-generation conventional stents regarding procedural performance and outcomes based on different lesion types and specific populations.

"Burying" covered coronary stents under drug-eluting stents: A novel approach to ensure long-term stent patency.

Covered coronary stent (CS) implantation is associated with a high risk for in-stent restenosis (ISR) and stent thrombosis (ST). We describe the outcomes after overstenting ("burying") CS using contemporary drug-eluting stents (DES). We analyzed short- and long-term outcomes of consecutive patients who had had a CS implanted, which was consecutively covered ("buried") with a third-generation DES. CSs were primarily post-dilated and then covered with a longer DES overlapping the proximal and distal edges of the CS. To ensure optimal stent expansion and appositions, all lesions were post-dilated using adequately sized non-compliant balloons. Between 2015 and 2020, 23 patients (mean age 67 ± 14 years, 74% males) were treated using this novel approach. Reasons for implanting CS included treatment of coronary aneurysms (n = 7; 30%), coronary perforations (n = 13; 57%), and aorto-ostial dissections (n = 3; 13%). All CSs were successfully deployed, and no peri-procedural complications occurred. The median time of follow-up was 24.5 (interquartile range [IQR] 11.7-37.9) months. All patients had a 1-month follow-up (FU) and 19/23 (83%) patients had 12-month FU (FU range 1-60 months). No probable or definite STs occurred, and no cardiovascular deaths were observed. Among patients undergoing angiographic FU (11/23 [48%]), 1/23 showed angiographically significant ISR 6 months post CS implantation. Burying a coronary CS under a DES appears to be a safe and promising strategy to overcome the limitations of the currently available CS devices, including a relatively high risk for target lesion failure due to ISR and ST.

Guided vs. conventional anti-platelet therapy for patients with acute coronary syndrome: A meta-analysis of randomized controlled trials.

Whether guided antiplatelet therapy in patients with acute coronary syndrome (ACS) is effective in improving net clinical benefits compared with conventional antiplatelet therapy remains controversial. Therefore, we assessed the safety and efficacy of guided antiplatelet therapy in patients with ACS and undergoing percutaneous coronary intervention. We searched PubMed, EMBASE, and Cochrane Library databases to select the relevant randomized controlled trials comparing the guided and conventional antiplatelet therapy in patients with ACS. The primary and safety outcomes are major adverse cardiovascular events (MACE) and major bleeding, respectively. The efficacy outcomes included myocardial infarction, stent thrombosis, all-cause death, and cardiovascular death. We selected the relative risk (RR) and 95% confidence intervals (CIs) as effect size and calculated it using the Review Manager software. In addition, we evaluated the final results by trial sequential analysis (registered by PROSPERO, CRD 42020210912). We selected seven randomized controlled trials and included 8,451 patients in this meta-analysis. Guided antiplatelet therapy can significantly reduce the risk of MACE (RR 0.64, 95% CI 0.54-0.76, P < 0.00001), myocardial infarction (RR 0.62, 95% CI 0.49-0.79, P = 0.0001), all-cause death (RR 0.61, 95% CI 0.44-0.85, P = 0.003), and cardiovascular death (RR 0.66, 0.49-0.90, P = 0.009). In addition, there is no significant difference between the two groups in stent thrombosis (RR 0.67, 95% CI 0.44-1.03, P = 0.07) and major bleeding (RR 0.86, 95% CI 0.65-1.13, P = 0.27). The subgroup analysis showed that the guided group based on genotype tests could bring benefits in MACE and myocardial infarction. The guided antiplatelet therapy is not only associated with a comparable risk of bleeding but also with a lower risk of MACE, myocardial infarction, all-cause death, cardiovascular death, and stent thrombosis than the conventional strategy in patients with ACS.

Sex Differences in 10-Year Outcomes After Percutaneous Coronary Intervention With Drug-Eluting Stents: Insights From the DECADE Cooperation.

Although some studies have investigated sex-related outcomes up to 5 years after percutaneous coronary intervention (PCI), analyses at longer follow-up (ie, to 10 years) in large cohorts treated exclusively with drug-eluting stent (DES) platforms are lacking. Therefore, this study aimed to define whether sex-related differences in long-term outcomes after PCI persist both in the DES era and at longer-term follow-up. Individual data of patients treated with DES in 5 randomized controlled trials with 10-year follow-up were pooled. Patients were divided into 2 groups by sex. The analysis of individual participant data was performed using a 1-stage approach by entering a clustering effect by parent study in all univariable and multivariable models focusing on sex. The main outcomes of interest for this analysis included cardiovascular death, myocardial infarction, repeat revascularization, and definite stent thrombosis to 10 years after PCI. Survival was analyzed by the Kaplan-Meier method to estimate the time to first event, and differences between the 2 groups were tested with the log-rank test. Hazard ratios (HRs) and 95% CIs were calculated with a Cox proportional hazards model. Conventional multivariable analyses with adjustment for relevant variables were performed. Among 9700 patients undergoing PCI with DES implantation included in the present analysis, 2296 were women and 7404 were men. Through to 10 years, cardiovascular death occurred in 407 of the 2296 female patients and 1012 of the 7404 male patients (adjusted HR [HRadj], 0.94 [95% CI, 0.80-1.11]). Female sex was associated with a lower risk of repeat revascularization of the target lesion (HRadj, 0.80 [95% CI, 0.74-0.87]), target vessel (HRadj, 0.81 [95% CI, 0.76-0.87]), and nontarget vessels (HRadj, 0.69 [95% CI, 0.62-0.77]). Compared with male patients, female patients displayed an increased risk of myocardial infarction in the first 30 days after PCI with DES (HRadj, 1.65 [95% CI, 1.24-2.19]) but a comparable risk of myocardial infarction thereafter. The risk of definite stent thrombosis was not significantly different between female and male patients (HRadj, 1.14 [95% CI, 0.89-1.47]). Through to 10-year follow-up after PCI with DES, female patients are at increased risk of early myocardial infarction, receive fewer repeat revascularizations, and have no difference in cardiovascular mortality compared with male patients.

Pro-Con Debate: Are Patients With Coronary Stents Suitable for Free-Standing Ambulatory Surgery Centers?

With increasing implantation of coronary artery stents over the past 2 decades, it is inevitable that anesthesiologists practicing in the outpatient setting will need to determine whether these patients are suitable for procedures at a free-standing ambulatory surgery center (ASC). Appropriate selection of patients with coronary artery stents for a procedure in an ASC requires consideration of factors that affect the balance between the risk of stent thrombosis due to interruption of antiplatelet therapy and the thrombogenic effects of surgery, and the risk of perioperative bleeding complications that may occur if antiplatelet therapy is continued. Thus, periprocedure care of these patients presents unique challenges, particularly for extensive surgical procedures that are increasingly scheduled for free-standing ASCs, where consultation and ancillary services, as well as access to percutaneous cardiac interventions, may not be readily available. Therefore, the suitability of the ambulatory setting for this patient population remains highly controversial. In this Pro-Con commentary, we discuss the arguments for and against scheduling patients with coronary artery stents in free-standing ASCs.

Early Stent Patency After Endovascular Therapy for Tandem or Isolated Carotid Steno-Occlusive Disease

Early Stent Patency After Endovascular Therapy for Tandem or Isolated Carotid Steno-Occlusive Disease

Extended dual antiplatelet therapy following percutaneous coronary intervention in clinically important patient subgroups: a systematic review and meta-analysis.

Dual antiplatelet therapy (DAPT) is routinely given to patients after percutaneous coronary intervention (PCI) with stenting; however, optimal duration remains uncertain in some situations. We assessed the benefits and harms of extending DAPT beyond 1 year after PCI in clinically important patient subgroups. We conducted a systematic review and meta-analysis. We searched electronic databases (Embase, MEDLINE, PubMed, Cochrane Library) and grey literature (from inception to Nov. 5, 2021) and included randomized controlled trials (RCTs) of extended DAPT (> 12 mo) compared with DAPT for 6-12 months following PCI with stenting. The primary outcome was death (all cause, cardiovascular, noncardiovascular); secondary outcomes included major adverse cardiovascular and cerebrovascular events, myocardial infarction (MI), stroke, stent thrombosis and bleeding. Subgroups were based on prespecified patient characteristics (prior MI, acute coronary syndrome [ACS], diabetes mellitus, age, smoking status). Data were analyzed by random-effects pairwise meta-analysis. We identified 9 RCTs that provided subgroup data. We found that extended DAPT reduced the risk of MI and stent thrombosis but increased the risk of bleeding, compared with standard DAPT, with no difference in the risk of all-cause death (relative risk [RR] 1.07, 95% confidence interval [CI] 0.80-1.42) or cardiovascular death (RR 0.98, 95% CI 0.74-1.30). We found that patients with a prior MI, with ACS at presentation, without diabetes or aged younger than 75 years may derive the most benefit from extended DAPT. Among patients who received extended DAPT, the risk of all-cause death was significantly increased among those with no prior MI (RR 1.64, 95% CI 1.08-2.24), whereas there was no significant difference in the risk of all-cause death between standard and extended DAPT for patients with ACS (RR 1.20, 95% CI 0.51-2.83), with diabetes (RR 1.27, 95% CI 0.86-1.89), aged older than 75 years (RR 1.32, 95% CI 0.39-4.54) or who smoked (RR 0.90, 95% CI 0.42-1.92). Similar results were found for cardiovascular death, where data were available. Patients with a previous MI with ACS at presentation, without diabetes, or aged younger than 75 years may derive the most benefit from extended DAPT. These findings support the need for careful selection of patients who may benefit most from extended DAPT. PROSPERO no. CRD42018082587.

Descriptive and prognostic study at 5 years of percutaneous coronary intervention by long active stents ≥ 40 mm

The treatment of long coronary lesions often requires long stents, which carries a higher risk of stent thrombosis, restenosis and major adverse cardiac events. Our objective is to evaluate the clinical and angiographic results, immediate, in the medium and in the long-term of the coronary angioplasties with very long active stents ≥ 40 mm. We carried out a retrospective, multicenter, descriptive and prognostic study, during a period of 5 years between January 2015 and January 2020 in four Tunisian centers, including all patients who underwent coronary angioplasty with an active stent ≥ 40 mm in length. Four hundred and eighty patients were included. Our population was at high cardiovascular risk: the mean age was 62.45 years with a sex ratio of 3.40. The most frequent cardiovascular risk factors were as follows: arterial hypertension: 61.1%, diabetes: 56.6% and tobacco: 60.5%. The most common clinical presentation was acute coronary syndromes in 69.70%. The artery most frequently stented with a very long stent was the anterior interventricular artery in 49.4%. The treated lesions were complex: 23.5% were calcified, 8.7% were total chronic occlusions and 25% had bifurcations. The average length of the implanted stents was 47.72 mm. The long coronary lesion required an overlap by a 2nd stent in 16.45% of the interventions. Angiographic and clinical success was observed in 96% and 95% of cases respectively. Seventeen cases of per-procedural complications were recorded during the procedure (3.55%). Angiographic control was only performed during the follow-up in 21.7% of patients. The stent thrombosis rate was 0.83%. The incidence of MACE, TVR and TLR and was 16.3%, 9.2% and 7.9%, respectively. Diabetes appeared to be predictive factors of TLR (survival without TLR at 12 months = 99% vs. 93.7%; P = 0.01). The study of the characteristics lesion showed that ostial lesions and bifurcation lesions are predictive factors for increased TLR (ostial lesion: survival without TLR at 5 years = 78.2% vs. 87.4%; P = 0.001/bifurcation lesion: survival without TLR at 5 years = 84% vs. 92.7%; P = 0.03). Coronary stenoses requiring treatment with long stents are generally associated with high cardiovascular risk and complex atheromatous disease. They can be revascularized with a long active stent (≥ 40 mm) with an acceptable MACE, TLR, TVR and thrombosis rate.

Comparative study between Nano-surface Polyzene F and drug eluting stents in acute coronary syndrome patients with one-month dual antiplatelet therapy: Immediate and one-year clinical outcome.

The current clinical practice advocates dual antiplatelet therapy (DAPT) for a year after ST segment elevation myocardial infarction (STEMI), primarily owing to persistent thrombotic risk. The novel COBRA PzF coronary stent was developed to reduce stent thrombosis risk. The primary goal of the current research was to compare the efficacy and safety of the novel nanocoated PzF stenting with one-month DAPT (dual anti-platelet therapy) against 12-month DAPT after the current drug- eluting stent (DES) in STEMI patients and single-vessel coronary artery disease (CAD).

47 UNDER THE BRIDGE: OFF-LABEL CANGRELOR FOR PCI PATIENTS UNDERGOING NON CARDIAC SURGERY

Abstract Background Dual antiplatelet therapy (DAPT) reduces the risk of stent thrombosis after percutaneous intervention (PCI), but it is estimated that approximately 5 to 10% of PCI patients undergo major noncardiac surgeries within 12 months from the procedure, which requires DAPT interruption. The interruption of DAPT reduces the risk of perioperative bleeding, but increases the risk of stent thrombosis. Peri-operative “bridge” therapy with cangrelor, a reversible and competitive intravenous P2Y12 receptor inhibitor with rapid on/offset of action, may offer a solution for high-risk patients undergoing major noncardiac surgery who require DAPT interruption. However, the use of cangrelor for this indication is currently off-label. Clinical Scenario A 58-year-old man was admitted to ER with increasing dyspnea and oppressive chest pain on exertion. A diagnosis of non-ST-segment elevation acute coronary syndrome (NSTE-ACS) was made and PCI of the left main-left anterior descendent artery segment and the right coronary artery was performed with implantation of four drug-eluting stents. DAPT was prescribed for 12 months with acetylsalicylic acid 100 mg daily and ticagrelor 90 mg twice daily. The day after the procedure, due to gross hematuria with clots formation; the hemoglobin level fell to 8 g/dL and a transfusion was required. Subsequent abdominal echocardiography revealed two bladder neoformations that required further endoscopic evaluation and transurethral resection of bladder tumor (TURBT). In preparation for such invasive procedure, DAPT required interruption despite the high risk of catastrophic consequences. Methods After ticagrelor interruption, cangrelor was started intravenously at a rate of 0.6 mcg/Kg/min for 5 days and stopped 2 hours before the TURBT procedure, which was performed with minimal blood loss and no ischemic complications. Cangrelor infusion was re-started 2 hours after surgery at the same initial rate and planned for 12 hours if no sudden bleeding occurred. The day after the TURBT procedure cangrelor was stopped and DAPT was re-initiated with aspirin 100 mg daily and clopidogrel 75 mg daily (after a 600 mg loading dose). The patient was discharged 2 days later without any new bleeding or ischemic event. Conclusions Premature discontinuation of DAPT is a strong predictor of stent thrombosis in patients undergoing PCI who require major noncardiac surgery. Cangrelor represents a viable option for managing high-risk individuals who require prolonged P2Y12 receptor blockade with rapid onset and offset of action despite discontinuation of oral therapy. This use is currently off-label due to lack of well powered randomized clinical trials of bridge therapy.

532 SEX-RELATED DIFFERENCES IN THROMBUS BURDEN IN ST-ELEVATION MYOCARDIAL INFARCTION PATIENTS UNDERGOING PRIMARY PERCUTANEOUS CORONARY INTERVENTION

Abstract Background Women have a worse prognosis after ST-segment elevation myocardial infarction (STEMI) than men. The prognostic role of thrombus burden (TB) in influencing the sex-related differences in clinical outcomes after STEMI has not been clearly investigated. Objectives The aim of this study was to assess the sex-related differences in TB and its clinical implication in patients with STEMI. Methods We analyzed individual patient data from the 3 major randomized clinical trials of manual thrombus aspiration, encompassing a total of 19,047 patients with STEMI, of whom 13,885 (76.1%) were men and 4,371 (23.9%) were women. The primary outcome of interest was 1-year cardiovascular (CV) death. The secondary outcomes of interest were recurrent myocardial infarction, heart failure, all-cause mortality, stroke, stent thrombosis (ST), and target vessel revascularization at 1 year. Results Patients with high TB (HTB) had worse 1-year outcomes compared with those presenting with low TB (adjusted HR for CV death; 1.52; 95% CI: 1.10-2.12; P=0.01). In unadjusted analyses, female sex was associated with an increased risk for 1-year CV death regardless of TB. After adjustment, this risk for 1-year CV death was higher only in women with HTB (HR 1.23, 95% CI: 1.18-1.28; P&amp;lt;0.001) who also had an increased risk for all-cause death and ST than men. Conclusion In patients with STEMI, angiographic evidence of HTB negatively affected prognosis. Among patients with HTB, women had an excess risk for stent thrombosis, CV and all-cause mortality than men. Further investigations are warranted to better understand the pathophysiological mechanisms leading to excess mortality in women with STEMI and HTB.

730 P2Y12 INHIBITORS MONOTHERAPY IN PATIENTS UNDERGOING COMPLEX VS NON-COMPLEX PERCUTANEOUS CORONARY INTERVENTION: A SYSTEMATIC REVIEW AND META-ANALYSIS

Abstract Background Monotherapy with P2Y12 inhibitors (P2Y12i) is emerging as alternative strategy to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). However, early withdrawal of aspirin as part of P2Y12i monotherapy regimens may pose concerns in high-risk patients, such as those undergoing complex PCI. Thus, we aimed to evaluate the efficacy and safety of P2Y12i monotherapy compared with standard DAPT according to PCI complexity. Methods We performed a meta-analysis of randomized trials using random effects models to combine hazard ratios (HRs) with 95% confidence intervals (CIs). No restrictions were applied to the type of P2Y12 receptor inhibitor or to the definition of complex PCI. Within-trial interactions were pooled to estimate heterogeneity between complex and noncomplex PCI strata. The study protocol was registered in the PROSPERO (CRD42021291027). Results After screening of 7,502 unique citations, we included in the analysis 5 randomized clinical trial enrolling 31,627 patients, of whom 8,328 (26.3%) underwent complex PCI (Table 1) Risk estimates for efficacy and safety outcomes associated with P2Y12i monotherapy and standard DAPT across studies included in the analysis, stratified by complex and noncomplex PCI, are reported in Figure 1. P2Y12i monotherapy compared with standard DAPT was associated with a similar risk of all-cause death, stent thrombosis, and stroke, with no evidence for interaction between complex and noncomplex PCI. We found heterogeneity in the treatment effect of P2Y12i monotherapy vs. standard DAPT with respect to myocardial infarction (P-interaction=0.027). Compared with standard DAPT, P2Y12i monotherapy decreased the risk of myocardial infarction in complex PCI (HR 0.77, 95%CI 0.60-0.99, P=0.042), but not in noncomplex PCI patients (HR 1.09, 95%CI 0.90-1.30, P=0.382). The risk of major bleeding was significantly reduced by P2Y12i monotherapy with a consistent treatment effect (P-interaction=0.699) in both complex and noncomplex PCI strata. Conclusions Patients undergoing complex PCI may derive more benefit and less harm from P2Y12i monotherapy after early aspirin withdrawal compared with standard DAPT, resulting in decreased risks of myocardial infarction and bleeding.

485 PROGNOSTIC IMPACT OF TREATMENTS EVOLUTION IN STEMI: INSIGHTS FROM A PRIMARY PCI REGISTRY

Abstract Objective We aimed to evaluate in a real world primary percutaneous coronary intervention (pPCI) registry the impact of the evolution of evidence-based treatments on prognosis, comparing different decades of treatment. Methods Consecutive STEMI patients undergoing pPCI at University Hospital of Trieste, Italy, were enrolled in a pPCI registry. Outcomes were evaluated during two successive periods: the first cohort (old treatments cohort) included STEMI patients treated between January 2007 and December 2012, and the second cohort (new treatments cohort), included STEMI patients treated between January 2013 and December 2020. Cox regression models were performed to predict the risk of the study primary endpoint (PE) a composite of all cause death, reinfarction and re-PCI at 5 years. The secondary endpoint was all cause of mortality at 5 years. Moreover, we evaluated the incidence of stent thrombosis at 12 months. Results A total of 2425 STEMI patients, 947 in the old treatments cohort and 1478 in the new treatments cohort were analysed. The mean age of the population was 66 ± 12.5 years, most were males (74.3%), 20.2% were diabetics, and 12% presented in Killip class III-IV. At 5-years of follow-up the new treatments cohort compared to the old treatments cohort presented a lower rate of primary outcome (18.5% vs 23.1%, p=0.006) and mortality (15.5% vs 19.9%, p=0.006). At Cox regression model adjusted for baseline differences between the two cohorts, patients in the new treatments cohort had lower risk of PE (HR 0.717, 95% CI 0.567–0.907, p=0.006) and mortality (HR 0.662, 95% CI 0.509–0.860, p=0.002). When considering both clinical and procedural variables, complete revascularization (HR 0.459, 95% CI 0.265–0.796, p=0.006) and the administration of prasugrel or ticagrelor (HR 0.721, 95% CI 0.524–0.992, p=0.013) were independent predictors of PE as well as of 5 years mortality. The new treatments cohort compared to the old treatments cohort had more frequent use of radial approach (83.1% vs 24.4%, p&amp;lt;0.001) and had lower ischaemia time (3.05 vs 3.45 hours, p&amp;gt;0.001), however they were not associated with PE. Patients receiving prasugrel or ticagrelor or drug eluting stent (DES) were at lower risk of stent thrombosis at 12 months (HR 0.502, 95% CI 0.280–0.900, p=0.021). Conclusions In a real-word STEMI population the prognosis of patients is improved in the last decades, and this was associated to the use of new antithrombotic treatments and to the implementation of complete revascularization. The application of new evidence-based therapies in clinical practise is fundamental to improve patient prognosis because the benefits demonstrated by clinical trials have translated into a benefit in the real-world population.

Lower Extremity Staged Revascularization (LESR) as a new innovative concept for lower extremity salvage in acute popliteal artery injuries: a hypothesis

Popliteal artery injury following knee dislocation is associated with significant morbidity and high amputation rates. The complex and multi-disciplinary input required to manage this injury effectively can take time to arrange, prolonging the time to revascularization. Furthermore, open surgical bypass or interposition graft can be technically challenging in the acute setting, further prolonging ischemic time.Temporary intravascular shunts can be used to temporarily restore flow but require surgical exposure which takes time. Endovascular techniques can decrease the time to revascularization; however, endovascular popliteal stent-grafting is controversial because the biomechanical forces relating to flexion and extension of the knee may increase the risk of stent thrombosis. An ideal operation would result in rapid revascularization, eventually leading to a definitive and durable surgical solution.We hypothesize that a staged approach combing extracorporeal shunting, temporary endovascular covered stent placement, external fixation of bony injury, and definitive open repair provides for a superior approach to popliteal artery injury than current standard of care. We term this approach lower extremity staged revascularization (LESR) and the aim is to minimize the known factors contributing to poor outcomes after traumatic popliteal artery injury.