Safety Of Percutaneous Coronary Intervention Research Articles

C-15 | Effectiveness and Safety of Percutaneous Coronary Intervention with Intravascular Imaging Compared to Angiography Alone

C-15 | Effectiveness and Safety of Percutaneous Coronary Intervention with Intravascular Imaging Compared to Angiography Alone

Percutaneous Coronary Intervention versus Coronary Artery Bypass Grafting for Chronic Total Occlusion of Coronary Arteries

Background: Chronic Total Occlusion (CTO) of coronary arteries presents a significant challenge in the management of coronary artery disease (CAD), influencing treatment outcomes and patient prognosis. Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Grafting (CABG) are two predominant revascularization strategies employed, each offering distinct benefits and limitations. Objective: This study aims to compare the efficacy and safety of PCI and CABG in managing patients with CTO, to inform clinical decision-making and optimize treatment approaches. Methods: A retrospective analysis was conducted at Lady Reading Hospital, Peshawar, from January 1, 2021, to December 31, 2023. We included 145 patients diagnosed with CTO who underwent PCI (n=65) or CABG (n=80). Data were collected on patient demographics, clinical features, lesion characteristics, procedural details, and follow-up outcomes. Major Adverse Cardiac Events (MACE) and quality of life measures were the primary endpoints. Statistical analysis was performed using SPSS version 25, employing Mann-Whitney U and Chi-square tests for continuous and categorical variables, respectively. Results: The procedural success rate was 84.6% for PCI and 90% for CABG. MACE occurred in 23.1% of the PCI group and 15% of the CABG group. The average hospitalization duration was 5.8 days for PCI and 8.5 days for CABG. Quality of life assessments showed comparable scores between groups, with PCI scoring 80.6 on the Seattle Angina Questionnaire and CABG scoring 79.8. Conclusion: PCI and CABG demonstrated similar efficacy and safety profiles in the management of CTO, underscoring the need for individualized treatment strategies based on patient-specific factors. Both methods proved viable, with slightly higher procedural success in CABG and comparable quality of life outcomes.

Management Considerations for Acute Coronary Syndromes in Chronic Kidney Disease.

Propensity of patients with chronic kidney disease (CKD) to adverse outcomes of acute coronary syndromes (ACS) derives, in part, from imperfection in management. Dearth of data resulting from underrepresentation of patients with CKD in ACS trials and underuse of evidence-based testing and therapy compound biological risks inherent to CKD. We sought in this narrative review to critically appraise contemporary evidence and offer suggested approaches to practicing clinicians for the optimization of ACS management in patients with CKD. Updated multisociety chest pain guidelines emphasize the diversity of clinical presentations of ACS, pertinent to recognition of ACS in patients with CKD. Evolving tools to predict and prevent acute kidney injury complicating invasive management of ACS serve to support improved access to and safety of percutaneous coronary intervention (PCI) in CKD patients, who remain at elevated risk. Growth in use of radial access, advances in PCI quality, incorporation of intravascular imaging, and new options and insights in pharmacotherapy contribute to an evolving calculus of ischemic and bleeding risk in ACS with bearing on management in CKD patients. Key opportunities to improve outcomes of ACS for patients with CKD center on avoiding underuse of beneficial medical and invasive therapies; enhancing safety of therapies by leveraging evidence-based strategies to prevent acute kidney injury; and devoting specific effort to investigation of ACS management in the context of CKD.

Impact of preprocedural left ventricular systolic function on the safety and durability of percutaneous coronary intervention.

Percutaneous coronary intervention (PCI) is considered less safe in patients with reduced ejection fraction (EF), an impression based on older data. Whether the safety and durability of contemporary PCI are different in patients with reduced EF compared with normal EF patients is unknown. Patients from the BIOFLOW II, IV and V clinical trials were grouped as normal EF (≥50%) and reduced EF (30%-50%). Using multivariable logistic regression and cox proportional hazards regression, we determined relations of EF category with procedural safety (a composite of cardiac death, myocardial infarction, stroke and urgent coronary artery bypass grafting within 30 days of PCI) and target lesion failure (TLF; comprising cardiac death, target vessel myocardial infarction, target vessel revascularization within 1 year of PCI) respectively. In sensitivity analyses, we regrouped patients into EF < 45% and ≥55% and repeated the aforementioned analyses. In 1685 patients with normal EF (mean age 65 years; 27% women; mean EF 61%) and 259 with low EF (mean age 64 years; 17% women; mean EF 41%), 101 safety and 148 TLF events occurred. Compared with patients in the normal EF group, those with reduced EF had neither a statistically significant higher proportion of safety events, nor a higher multivariable-adjusted risk for such events. Similarly, patients with reduced EF and normal EF did not differ in terms of TLF event proportions or multivariable-adjusted risk for TLF. The results were similar in sensitivity analyses with EF groups redefined to create a 10% between-group EF separation. PCI safety and durability outcomes are similar in patients with mild-moderately reduced EF and normal EF.

One-month dual antiplatelet therapy following stent implantation in patients with acute coronary syndromes and high bleeding risk

Abstract Background/introduction There is a paucity of data regarding the safety of a one-month dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) presenting with acute coronary syndromes (ACS). Purpose We aimed to compare the clinical outcomes of patients at HBR with ACS or chronic coronary syndromes (CCS) treated with PCI using bioresorbable-polymer everolimus-eluting stent followed by one-month DAPT. Methods This is a pre-specified sub-analysis of the POEM trial, an interventional, prospective, multicenter, single-arm trial, that evaluated the safety of PCI with bioresorbable-polymer everolimus-eluting stent followed by one-month DAPT in patients with HBR against an objective performance criterion (OPC). The OPC was derived from the reported 1-year primary endpoint rate of 9.4% observed in the LEADERS FREE trial. According to the POEM protocol, patients were treated with one-month DAPT. In case of need for anticoagulation, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for one month, followed by oral anticoagulation only after that. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. Results 263 (59.4%) patients with CCS and 180 (40.6%) patients with ACS were included. Most of the HBR inclusion criteria were comparable between the two groups, Figure 1. At one year, the rates of the primary outcome were 4.3% (95% CI, 2.4-7.6%) and 5.7% (95% CI, 3.1-10.3%) among patients with CCS and ACS, respectively. Both 1-sided 97.5% upper confidence limits of the risk difference between the primary outcome and the prespecified OPC of 9.4% were below the non-inferiority margin of 3.85 % (CCS: -1.8 %; ACS: 0.9 %), Figure 2. No significant difference was evident between CCS and ACS patients for each isolated component of the primary endpoint (cardiac death: 1.7% vs. 2.0%, p= 0.857; myocardial infarction: 3.9% vs. 3.1%, p= 0.934; definite/probable stent thrombosis: 1.2% vs. 0.8%, p= 0.689). The risk for Bleeding Academic Research Consortium (BARC) type 1-5 or type 3-5 bleedings was also similar between CCS and ACS patients (4.3% vs. 5.2%, p=0.677, and 1.6% vs. 2.9%, p=0.351, respectively). Conclusions Among HBR patients with ACS who underwent PCI with BP-EES, a one-month DAPT strategy is associated with a similar risk of ischemic and bleeding events compared to those with CCS. These findings support the hypothesis that DAPT should be tailored to patients’ bleeding risk profiles and that a one-month strategy might be safely applied also in a particular setting of ACS.Figure 1.HBR inclusion criteria.Figure 2.Primary endpoint analysis.

Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO)

Percutaneous coronary intervention (PCI) for chronic total coronary occlusions (CTO) improves clinical symptoms and quality of life. The longer-term safety of PCI compared to optimal medical therapy (OMT) remains uncertain. We sought to evaluate the long-term safety of PCI for CTO in a randomised trial as compared to OMT. A total of 396 patients with a symptomatic CTO were enrolled into a randomised, multicentre clinical trial comparing PCI and OMT. Half of the patients had a single CTO; the others had multivessel disease. Non-CTO lesions were treated prior to randomisation (2:1 ratio). During follow-up, crossover from OMT to PCI occurred in 7.3% (1 year) and 17.5% (3 years) of patients. At 3 years, the incidence of cardiovascular death or nonfatal myocardial infarction was not significantly different between the groups (OMT 3.7% vs PCI 6.2%; p=0.29). By per-protocol analysis, the difference remained non-significant (OMT 5.7% vs PCI 4.7%; p=0.67). Overall, major adverse cardiovascular events (MACE) were more frequent with OMT (OMT 21.2% vs PCI 11.2%), largely because of ischaemia-driven revascularisation. The rates of stroke or hospitalisation for bleeding were not different between the groups. At 3 years there was no difference in the rate of cardiovascular death or myocardial infarction between PCI or OMT among patients with a remaining single coronary CTO. The MACE rate was higher in the OMT group due largely to ischaemia-driven revascularisation. CTO PCI appears to be a safe option for patients with a single remaining significant coronary CTO. CinicalTrials.gov: NCT01760083.

Clinical Outcomes and Prognostic Factors in Complex, High-Risk Indicated Procedure (CHIP) and High-Bleeding-Risk (HBR) Patients Undergoing Percutaneous Coronary Intervention with Sirolimus-Eluting Stent Implantation: 4-Year Results.

We aimed to characterize the performance and safety of percutaneous coronary intervention (PCI) in complex, high-risk indicated procedure (CHIP) and high-bleeding-risk (HBR) patients at a 4-year follow up. We included all consecutive patients who underwent PCI with the sirolimus-eluting coronary stent Alex Plus (Balton, Poland) between July 2015 and March 2016. We analyzed various baseline demographic and clinical characteristics, laboratory data, and clinical outcomes. We enrolled 232 patients in whom 282 stents were implanted, including 81 patients meeting the CHIP criteria and 76 patients meeting the HBR criteria. In the whole population, the mean age was 68 ± 11 years, and 23.7% were females. Most procedures were performed from radial access (83.2%) using a 6F guiding catheter (95.7%). The lesions were mostly predilated (61.6%), and postdilatation was performed in 37.9%. The device success was 99.6% (in one case, a second stent was required due to heavy calcifications). Additional stents were deployed in 39% of cases due to edge dissection (6.9%), side branch stenting (5.2%), or diffuse disease (26.9%). Myocardial infarction (MI) type 4a was revealed in 2.2% of cases. At 4 years, the MACE rates for the whole population and for CHIP and HBR patients were 23.3%, 29.6%, and 27.6%, respectively. CHIP patients had a higher risk of MACEs (29.6% vs. 19.9%, HR 1.69, p = 0.032) and cardiac death (11.1% vs. 4.6%, HR 2.50, p = 0.048). There were no differences for MI (7.4% vs. 6.6%, p = 0.826) and TLR (18.5% vs. 12.6%, p = 0.150). HBR patients were also characterized by a higher risk of MACEs (27.6% vs. 21.2%, HR 1.84, p = 0.049) and cardiac death (17.1% vs. 1.9%, HR 9.61, p < 0.001). There were no differences for MI (7.9% vs. 6.4%, p = 0.669) and TLR (11.8% vs. 16.0%, p = 0.991). PCI in CHIP and HBR patients is feasible with a low rate of periprocedural complications. Nevertheless, CHIP and HBR patients are at a high risk of future adverse events and require strict surveillance to improve outcomes.

B-28 | Management of Clinical Stent-In-Stent Restenosis (SISR) in High Risk Coronary Artery Disease Patients With Percutaneous Coronary Intervention (PCI) Followed by Coronary Intravascular Brachytherapy (IVBT)

In-stent-restenosis (ISR) is seen in 10% of patients with DES and is often treated with a repeat DES placement. Recurrent ISR or SISR has a high repeat failure rates, requiring target vessel revascularization (TVR). A combination of the presence of multiple layers of stents, previous restenosis, and other additional comorbidities make this patient population complex and higher risk. Angioplasty followed by IVBT is one possible treatment option in the high-risk patients. This study reviewed the efficacy and safety of PCI followed by IVBT for coronary artery disease in high-risk patients experiencing SISR. A retrospective study was performed which reviewed 78 patients treated between 2016-2021 with SISR involving a total of 91 vessels. All patients underwent PCI with balloon angioplasty followed by IVBT. These patients received localized IVBT radiation using the Novoste Beta-Cath System using a strontium-90 isotope. Radiation dose was delivered based on the vessel diameter, with vessels ≥ 3.5mm in diameter receiving 23 Gy, while vessels of <3.5mm in diameter received 18.4 Gy. Major adverse cardiac events (MACE) were defined as all-cause death, myocardial infarction (MI), and stroke. All patients in the cohort had 2 previously placed DESs in the target lesion. Of total 91 treatments, 67% and 33% treatments were delivered to the LAD or the RCA and circumflex vessel or the marginal arteries, respectively. One patient had intraprocedural cardiac arrest due to suspected intracoronary thrombosis. All patients were symptomatic pre-IVBT and 44% experienced symptomatic reduction after treatment. MACE after IVBT includes MI in 18%, stroke in 5%, and all-cause death occurred in 16% of patients at a median time of 9.3 months post treatment with median follow-up being 22.8 months. Of total, 77% retained patency of the irradiated lesion, while 23% percent experienced restenosis requiring TVR. Coronary restenosis post-deployment of multiple layers of DES remains an ongoing challenge in current times. PCI followed by balloon angioplasty with IVBT is a safe and efficacious treatment option for high-risk coronary artery disease patients with SISR, who have very few treatment options otherwise.

High Non-Cardiac Death Incidence Should Be a Limitation of Drug-Eluting Stents Implantation? Insights from Recent Randomized Data.

Despite the introduction of drug-eluting stents (DES) significantly improved the efficacy and safety of percutaneous coronary interventions (PCI), particularly in a high-risk group of patients, the gap between PCI with his competitor's coronary artery bypass surgery (CABG) and/or optimal medical treatment alone was not reduced. In this revision, we highlighted the fact that in recent years landmark randomized studies reported at mid and long-term follow-ups a high incidence of non-cardiac death, cancer incidence, or both in the DES group of patients. The overall incidence of non-cardiac death was significantly higher in the DES vs. the comparator arm: 5.5% and 3.8%, respectively, p = 0.000018, and non-cardiac death appears to be more divergent between DES vs. the comparator at the extended follow-up to expenses of the last one. One of these trials reported five times greater cancer incidence in the DES arm at late follow-up, 5% vs. 0.7% p < 0.0018. We review the potential reason for these unexpected findings, although we can discard that DES biology could be involved in it. Until all these issues are resolved, we propose that DES implantation should be tailored accorded patient age, life expectancy, and lesion complexity.

Procedural Characteristics and Clinical Outcomes Associated with Chronic Total Occlusion Percutaneous Coronary Intervention in Patients with a History of Prior Coronary Artery Bypass Graft: A Meta-Analysis

Background: Owing to advances in procedural techniques and the training of interventional staff in catheterization labs, recent work has demonstrated the safety of percutaneous coronary intervention (PCI) as a treatment for patients suffering from chronic total occlusion (CTO). However, there has been little research focused on systematic comparisons of PCI outcomes in CTO patients that did or did not exhibit a history of previous coronary artery bypass grafting (CABG). Methods: Electronic databases were systematically searched for all studies comparing CTO-PCI outcomes for patients with and without a history of CABG, with event rates subsequently being compared via random-effects models with forest plots and odds ratios with 95% confidence intervals (CI), owing to the assumption of between-studies heterogeneity. Results: In total, 8 observational studies enrolling 13,509 CTO patients were identified, including 3389 and 10,120 patients with and without a history of prior CABG, respectively. Patients were enrolled in these studies from 1999–2018. Pooled analyses indicated that CABG history was not linked to a lower proportion of radial access 24 (95% CI 0.52–1.03, p = 0.08), and a prior CABG history was linked to a greater contrast volume (95% CI 0.12–0.44, p &lt; 0.001), higher radiation dose (95% CI 0.27–0.40, p &lt; 0.001), longer fluoroscopy time (95% CI 0.42–0.61, p &lt; 0.001), longer procedural time (95% CI 0.38–0.64, p &lt; 0.001), a higher number of implanted stents (95% CI 0.41–0.60, p &lt; 0.001), longer total stent length (95% CI 0.21–0.60, p &lt; 0.001), higher technical failure rates (95% CI 1.46–1.85, p &lt; 0.001), and higher rates of procedural failure (95% CI 1.42–1.79, p &lt; 0.001). The in-hospital mortality (95% CI 1.50–4.03, p &lt; 0.001) and periprocedural mortality (95% CI 1.63–3.73, p &lt; 0.001) of patients with a history of CABG were also higher. While stroke incidence was comparable in both groups (95% CI 0.80–4.47, p = 0.15), periprocedural major adverse cardiovascular and cerebrovascular events (MACCE) rates were significantly higher among patients exhibiting a history of CABG (95% CI 1.66–2.94, p &lt; 0.001). Conclusions: These results suggest that CTO-PCI procedures may be more challenging and associated with lower rates of success in CABG patients relative to procedures performed in patients without any history of CABG. Moreover, in-hospital outcomes including MACCE and mortality were worse for patients that had undergone prior CABG.

Renal Complications after Percutaneous Coronary Interventions on Concurrent Metformin Therapy: A Systematic Review with Meta-Analysis.

Objective: Metformin, commonly prescribed in diabetic patients, can cause lactic acidosis. Although generally rare, this side effect remains a source of concern in procedures requiring contrast media, due to the risk of contrast-induced nephropathy. Temporarily withdrawing metformin during the peri-procedural period is often practiced, but clinical decisions are difficult in emergency situations, such as acute coronary syndromes. In this systematic review with meta-analysis, we aimed to further investigate the safety of percutaneous coronary interventions in patients on concurrent metformin therapy.Design, Setting and Participants: We analyzed studies in patients undergoing (elective or emergency) percutaneous coronary interventions with or without concurrent metformin administration, reporting on the incidence of metformin-associated lactic acidosis and peri-procedural renal function.Methods: PubMed, ClinicalTrials.gov, Cochrane Library, and Scopus were systematically searched without language restrictions throughout August 2022. Randomized clinical trials and observational studies were assessed with the Revised Cochrane Collaboration Risk of Bias tool and the Newcastle-Ottawa quality scale, respectively. Data synthesis addressed the mean drop in estimated glomerular filtration rate (eGFR) and the incidence of contrast-induced nephropathy, in addition to lactic acidosis.Results: Nine studies were included, totaling 2235 patients (1076 continuing metformin during the peri-procedural period), mostly with eGFR above 30 mL/min/1.73m2 No cases of lactic acidosis were reported. The mean post-procedural drop in eGFR was 6.81mL/min/1.73m2 (95% confidence interval [CI]: 3.41 to 10.21) in the presence of metformin and 5.34 mL/min/1.73m2 (95% CI: 2.98 to 7.70) in its absence. The incidence of contrast-induced nephropathy was not affected by concurrent metformin, as shown by a (between-groups) standardized mean difference of 0.0007 (95% CI: -0.1007 to 0.1022).Conclusion: Concurrent metformin during percutaneous coronary interventions in patients with relatively preserved renal function is safe, without added risk of lactic acidosis or contrast-induced nephropathy. Thus, emergency revascularization in the context of acute coronary syndromes should not be deferred. More data from clinical trials in patients with severe renal disease are needed.

Prospective registry of percutaneous coronary interventions: Tyumen Cardiology Center’s experience

Objective. The aim of the study was to evaluate the efficacy and safety of percutaneous coronary interventions (PCI) and to identify the factors impacting long-term prognosis.Methods. The register included 1018 patients who underwent PCI at Tyumen Cardiology Center from October 2012 to November 2013.Results. Hospital cardiovascular mortality rate was 0.8%, while that at 1-year follow-up amounted to 2%. Mortality was associated with age (OR = 1.005; 95% CI 1.003-1.103; p = 0.037), left ventricular ejection fraction (OR = 0.91; 95% CI 0.86-0.96; p = 0.001), left anterior descending artery lesions (OR = 4.73; 95% CI 1.06-21.04; p = 0.042), success of PCI (OR = 0.07; 95% CI 0.02-0.35; p = 0.001), hypodynamia (OR = 5.99; 95% CI 1.78-20.2; p = 0.004) and a low level of social support (OR = 0.41; 95% CI 0.20-0 82; p = 0.012). Main adverse cardio-cerebral events (MACCE) were associated with the history of coronary artery bypass grafting (OR = 0.08; 95% CI 0.01-0.62; p = 0.016), PCI (OR = 1.66; 95 % CI 1.06-2.62; p = 0.028), SYNTAX score (OR = 1.07; 95% CI 1.04-1.09; p &lt;0.001), success of PCI (OR = 0.33; 95% CI 0.13-0.82; p = 0.017).Conclusion. PCI is a safe and effective procedure for treatment of coronary heart disease, which results in low MACCE and mortality rates.

Percutaneous coronary intervention with drug-coated balloon-only strategy combined with single antiplatelet treatment in patients at high bleeding risk:Single center experience of a novel concept.

At least 1 month of dual antiplatelet therapy is required after coronary stenting. The aim of this all-comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) with single antiplatelet treatment (SAPT). Between 2011 and 2020, 232 PCIs were performed in 172 patients using the DCB-only strategy and discharged with SAPT. The mean age of the patients was 75 ± 11 years and 59% were male. The clinical presentation was stable coronary artery disease (CAD) in 42% of the patients and acute coronary syndrome (ACS) in 58%. The lesions were mainly de novo (96%). The majority (58%) of treated lesions were in large coronary arteries (≥3.0 mm). Most (87%) of the patients were at high bleeding risk (HBR) with at least one major or two minor Academic Research Consortium (ARC) risk factors for bleeding. Periprocedural DAPT was used in 49% of the patients. The 12-month major adverse cardiac events (MACE, the composition of cardiovascular death, nonfatal myocardial infarction, and target-lesion revascularization) rate was 1.4% in stable CAD and 7.1% in ACS. The 12-month all-cause mortality after DBC only + SAPT strategy was 4.1% in stable CAD and 12.1% in ACS. The rate of ischemia-driven target lesion revascularisation (TLR) was 0% in stable CAD and 3.0% in ACS at 12 months. The 12-month rate of significant bleeding (BARC type 2-5) was 10.5%. There were no acute or subacute vessel closures. Despite the aged patient population with comorbidities, the TLR, MACE, and bleeding rates were low with DCB-only PCI combined with SAPT. This novel approach could reduce the post-PCI bleeding risk in patients with CAD and HBR compared to stenting.

Percutaneous Coronary Intervention (PCI) Followed by Intravascular Brachytherapy (IVBT) for Management of Stent-in-Stent Restenosis (SISR) in Patients with High-Risk Coronary Artery Disease

<h3>Purpose/Objective(s)</h3> Coronary artery disease (CAD) is the leading cause of death for both men and women in the United States. Percutaneous coronary intervention (PCI) with drug eluting stents (DES) has been a major advance in treatment with over 600,000 stents deployed annually. In-stent restenosis occurs in up to 10% of patients and is often managed with repeat DES placement. However, when stent-in-stent restenosis (SISR) occurs, options remain limited, and one technique includes angioplasty followed by intravascular brachytherapy (IVBT). We undertook this study to review efficacy and safety of PCI followed by IVBT for patients experiencing SISR. <h3>Materials/Methods</h3> We retrospectively reviewed 78 patients from 2016-2021 with SISR involving 91 vessels who received PCI with balloon angioplasty followed by IVBT. IVBT with a strontium-90 source was delivered via The Beta Cath® system (Novoste; Bes Vascular, Norcross, Ga, USA). The radiation dose delivered was 23Gy to vessels of ≥ 3.5mm in diameter, while 18.4 Gy was delivered to vessels of < 3.5 mm diameter. Radiation was prescribed to an area encompassing the angioplasty injury length with a 10mm longitudinal margin on each side. Major adverse cardiac events (MACE) include myocardial infarction (MI), stroke and all-cause death. Target vessel revascularization (TVR) was defined as percutaneous or surgical revascularization of the previously treated vessel. <h3>Results</h3> Median age was 67 years. All patients had at least 2 drug-eluting stents previously placed in the affected vessel. Sixty-one treatments were delivered to the left anterior descending artery or the right coronary artery with the remaining 30 delivered to either to a circumflex vessel or marginal artery. Sixty-three percent received 23Gy while 37% received 18.4Gy. One patient experienced cardiac arrest while receiving intervention, but no other procedure-related toxicities were reported. Median follow up was 22.8 months (range 0.9-60.6). All patients were symptomatic prior to IVBT and 44% experienced symptomatic reduction after treatment. The most common persistent symptom was angina in 71% of those patients. MACE after IVBT include MI in 18%, stroke in 5% and all-cause death occurring in 16% at a median time of 9.3 months after treatment (range 0.9-29.6). Seventy-seven percent had patency of the irradiated lesion, while 23% percent experienced restenosis requiring TVR. <h3>Conclusion</h3> PCI followed by IVBT is a safe and effective paradigm for patients with high-risk coronary artery disease experiencing SISR, who have few other treatment options.

Long-term outcomes of percutaneous versussurgical revascularization in patients with diabetes and left main coronary artery disease: A meta-analysis of randomized controlled trials.

The efficacy and safety of percutaneous coronary interventions (PCI) relative to coronary artery bypass grafting (CABG) in patients with diabetes and unprotected left main coronary artery disease (LMCAD) are not well established. To perform a meta-analysis evaluating the long-term outcomes after PCI with drug-eluting stents (DES), as compared with CABG, in patients with diabetes and unprotected LMCAD. MEDLINE, Cochrane, and Embase were searched for randomized controlled trials (RCTs) that reported outcomes after PCI with DES versusCABG in unprotected LMCAD among patients with diabetes. To evaluate the long-term effects of these interventions, we restricted this analysis to studies with a minimum follow-up period of 3 years. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled with a random-effects model. Quality assessment and risk of bias were performed according to Cochrane recommendations. Four RCTs with a total of 1080 patients were included, 553 (51.2%) of whom underwent PCI. There was no difference for individual outcomes of all-cause mortality (RR: 1.21; 95% CI: 0.86-1.71; p = .27; I2 = 28%), cardiovascular death (RR 1.29; 95% CI: 0.76-2.18; p = .34; I2 = 0%), or myocardial infarction (MI)(RR: 0.94; 95% CI: 0.61-1.45; p = .79; I2 = 0%). However, the risk of stroke was reduced with PCI relative to CABG (RR: 0.41; 95% CI: 0.18-0.94; p = .04; I2 = 0%), whereas the risk of any repeat revascularization was higher in the PCI group (RR: 1.99; 95% CI: 1.44-2.75; p < .001; I2 = 0%). The risk of the composite outcome of all-cause mortality, MI, stroke, or repeat revascularization was higher after PCI compared with CABG (RR: 1.30; 95% CI: 1.09-1.56; p = .004; I2 = 0%). In this meta-analysis with more than 1000 patients with diabetes and unprotected LMCAD followed for a minimum of 3 years, the incidence of repeat revascularization was higher among those treated with PCI, whereas the risk of stroke was higher in patients treated with CABG.

Is It Safe to Do Percutaneous Coronary Intervention in Moderate to Severe Chronic Kidney Disease Patients? A Prospective Cohort Study.

Contrast-induced acute kidney injury (CI-AKI) is a common and potentially serious complication of percutaneous coronary intervention (PCI) procedures, as it induces acute kidney injury (AKI), especially in previously diagnosed chronic kidney disease (CKD) patients, particularly in those who also have diabetes. Adequate hydration and using a minimal volume of contrast media are the recommended measures to decrease CI-AKI in CKD patients. A combination of sodium bicarbonate and N-acetylcysteine (NAC) may be a superior strategy for preventing CI-AKI. This study is aimed to evaluate the safety of PCI in moderate to severe CKD patients. This was a prospective, single-center study, from 2019 to 2021. We included all chronic kidney disease who undergo PCI procedures. The kidney level was measured on admission and 24 hours after the PCI procedure. The patients received 75 meq/500 mL of sodium bicarbonate one to six hours before procedures, oral acetylcysteine 600 mg bid for three days, and rehydration with 1000 ml of normal saline infusion for eight hours in patients without congestive heart failure. SPSS Version 23.0 (IBM SPSS Statistics for Windows, Version 23.0., IBM Corp., Armonk, NY) was used to input and process the data. This study included 118 subjects, with baseline characteristics of age 58.77 ± 9.08 years, 80.5% male, 47.5% diabetic, 50% hypertension, and 59.5% congestive heart failure. From the coronary angiogram, we found most of our subjects (57.6%) had three-vessel disease, 28.8% had two-vessel disease, and 15.6% had one-vessel disease. About 67.8% of subjects used <50 ml of low molecular contrast. The baseline creatinine level was 2.46 ± 1.04 mg/dL and the estimated glomerular filtration rate (eGFR) was 30 ± 12.65 mL/min. There were 19 (16.1%) patients with stage 3A CKD, 45 (38.1%) stage 3B, 41 (34.7%) stage 4, and 41 (34.7%) stage 5. The kidney function test after 24 hours of contrast admission showed a creatinine level of 2.37 ± 1.20 mg/dL (P<0.05) and the eGFR of 34.74 ± 16.10 mL/min. There was no significant difference in creatinine levels between stage 3A and stage 5 CKD. There was a significant reduction in creatinine in stage 3B CKD, from 1.917 ± 0.22 to 1.71 ± 0.37 mg/dL (P = 0.001); and stage 4 CKD, from 2.77 ± 0.55 to 2.72 ± 0.94 mg/dL (P = 0.013). CKD is a risk factor for developing CI-AKI after PCI, which is a marker of poor long-term outcomes. The development of CI-AKI is a strong predictor of post-PCI bleeding, which aggravates hemodynamic instability. The combination of NAC and NaHCO3 exerts a better antioxidative effect, which reduces the harmful short-term and long-term consequences of contrast media. Previous studies revealed the use of low-to-zero contrast media was safer in CKD patients who had undergone PCI. By applying these measures, our study showed a good outcome of PCI with no worsening renal function in CKD patients. With good prophylaxis measures, such as using minimal volume contrast media, adequate rehydration, and the combination of sodium bicarbonate and acetylcysteine, it is safe to do PCI in moderate to severe CKD patients.

Clinical outcomes of left main percutaneous coronary intervention in elderly patients at a long-term follow-up

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The progressive aging of the population leads to higher prevalence of ischemic heart disease with an increased left main coronary artery (LMCA) disease. Elderly patients (&amp;gt;75 years) represent an unfavorable subgroup because of their fragility, the frequent presence of multiple comorbidities associated and their especially high rate of surgical risk. Purpose The main objective of this study was to evaluate the efficacy and safety of percutaneous coronary interventions (PCI) in LMCA disease at 14 years follow-up in the elderly. Methods We prospectively included 217 consecutive patients (80.3 ± 2.4 years, 68.7% male) with LMCA disease treated with PCI between June 2006 and June 2020. We evaluated the occurrence of major adverse cardiovascular events (MACE) defined as cardiac death, non-fatal myocardial infarction, target lesion revascularization (TLR) and stent thrombosis after 14 years clinical follow-up (median 56 months). Results 48.4% of patients had stable coronary disease and 51.6% acute coronary syndrome (42.4% Non-STEMI and 9.2% STEMI). 43.3% were diabetic patients and 45.9% presented moderate-severe left ventricular systolic dysfunction. Mean logistic EuroSCORE was 10.4% and 47.5% of lesions with Syntax score ≥ 32. LMCA bifurcation was affected in 78.8% of cases and the most frequently bifurcation technique employed was "provisional stenting" in 64.1% of cases. Second-generation drug eluting stent was used in 97.6% of cases. The intraprocedural complication rate was 4.5% with one death. During follow-up, MACE rate at 14 years was 19.9% (14.7% cardiac death, 3.2% non-fatal myocardial infarction, 4.1% TLR and thrombosis rate 0.5%). There were significant differences in the occurrence of MACE in patients with moderate-severe ventricular systolic dysfunction (p=0.01 OR 3.92; IC 95% de 1.26-8.57). Conclusions Left main PCI in elderly patients with high surgical risk provide very favourable results with a low rate of immediate complications in the procedure and a low rate of cardiac adverse events at a very long-term follow-up. However, patients with ventricular dysfunction have poor prognosis.

Real-world clinical outcomes of left main percutaneous coronary intervention in diabetic patients at a long-term follow-up

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Coronary artery disease in diabetic patients has more aggressivity and tends to be a more complex disease characterized by small, diffuse, calcified, multivessel involvement that it presents higher in-stent restenosis rates after percutaneous coronary intervention (PCI). Besides, left main coronary artery (LMCA) disease has poor prognosis and it usually associates more severe lesions in other coronary arteries. Currently, the PCI in LMCA disease in these patients is controversial. Purpose The main objective of this study was to evaluate the efficacy and safety of PCI in LMCA disease in diabetic patients at a 14-year follow-up. Methods We prospectively included 228 consecutive patients (71 ± 11 years, 70.2% male) with LMCA disease treated with PCI between June 2006 and June 2020. We evaluated the occurrence of major adverse cardiovascular events (MACE) defined as cardiac death, nonfatal myocardial infarction, target lesion revascularization (TLR) and stent thrombosis after a 14-year clinical follow-up (median 66 months). Results 53.1% of patients had stable coronary disease and 46.9% acute coronary syndrome (42.1% Non-STEMI and 4.8% STEMI). 40.3% of patients presented moderate-severe left ventricular systolic dysfunction. 63.6% had LMCA and ≥ 2 vessels disease and 43% had a SYNTAX score ≥ 33. Mean Logistic Euroscore was 7.2%. The most frequent bifurcation technique employed in LMCA was "provisional stenting" in 65.4% and zotarolimus-eluting stent was used in 75.8% of cases. Angiographic success rate was 99.6% and complication rate intra-procedure was 3.1% without intraoperative death. During follow-up, MACE rate at 14 years was 19.8% (14.4% of cardiac death, 6.6% of nonfatal myocardial infarction, 5.7% of TLR and thrombosis rate 0.4%). Higher MACE rate was significantly associated to left ventricular systolic dysfunction (p=0.04) and chronic kidney insufficiency (p=0.02). 22.2% of patients had angiographic follow-up. Conclusions PCI on LMCA in diabetic patients is safe and effective, with low complication rate and a low rate of long-term follow-up events. Left ventricular systolic dysfunction and chronic kidney insufficiency showed a significantly worse outcome.

Clinical results at a long-term follow-up of percutaneous coronary intervention in ostial left main coronary artery disease

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left main coronary ostial lesions are notable for being found more commonly among middle-aged women with fewer conventional coronary artery risk factors and for lower long-term patency of internal thoracic grafts. Isolated ostial left main coronary artery (LMCA) disease is involved in the 18% of lesions and have a management approach do well either with percutaneous coronary intervention (PCI) or cardiac surgery. Continuous improvement in the devices and the emergence of better drug-eluting stents (DES) has improved the results of PCI in these high-risk lesions. Purpose The main objective of this study was to evaluate the efficacy and safety of PCI in ostial LMCA disease at a 14-year follow-up. Methods We prospectively included 109 consecutive patients (72± 12 years, 72.5% male) with ostial LMCA disease treated with PCI between June 2006 and June 2020. We evaluated the presence of major adverse cardiovascular events (MACE) defined as cardiac death, non-fatal myocardial infarction, target lesion revascularization (TLR) and stent thrombosis after a 14-year clinical follow-up (median 63.6 months). Results 55.9% had stable coronary disease and 44.1% had acute coronary syndrome (35.9% Non-STEMI and 8.2% STEMI). 45% were diabetic patients and 36.6% presented moderate-severe left ventricular systolic dysfunction. The mean logistic EuroSCORE was 8.1 % and SYNTAX score was ≥ 23 in 72.5% of the patients. We implanted second-generation DES in the 83.5% of patients (76% zotarolimus-eluting stent) and post-dilatation was performed in the 68.8%. The angiographic success rate was 99%. Complication rate in the procedure was 5.5% without intra-procedure deaths. During follow-up, MACE rate at 14 years was 18.3% (13.7% of cardiac death, 4.6% of nonfatal myocardial infarction, 7.3% of TLR and thrombosis rate of 0.9%). 24.2% of patients had an angiographic follow-up. Conclusions In spite of high surgical risk, complex coronary anatomy and older aged patients, PCI in ostial LMCA disease is safe and effective with a low rate of major cardiovascular events at long-term follow-up.

Safety and efficacy of percutaneous coronary intervention versus coronary artery bypass graft in patients with STEMI and unprotected left main stem disease: A systematic review & meta-analysis.

Owing to its large area of supply, left main coronary artery disease (LMCAD) has the highest mortality rate among coronary artery lesions, resulting in debate about its optimal revascularization technique. This meta-analysis compares percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) for the treatment of LMCAD. MEDLINE, TRIP, and Cochrane Central databases were queried from their inception until 25 April 2021, to determine MACCE (major adverse cardiac and cardiovascular events), all-cause mortality, repeat revascularization, myocardial infarction (MI) and stroke rates post-revascularization for different follow-ups. 7 RCTs and 50 observational studies having 56,701 patients were included. A random-effects model was used with effect sizes calculated as odds ratios (odds ratio, OR). In the short term (1year), PCI had significantly higher repeat revascularizations (OR=3.58, 95% CI 2.47-5.20; p<0.00001), but lower strokes (OR=0.55, 95% CI 0.38-0.81; p=0.002). In the intermediate term (2-5years), PCI had significantly higher rates of repeat revascularizations (OR=3.47, 95% CI 2.72-4.44; p<0.00001) and MI (OR=1.39, 95% CI 1.17-1.64; p=0.0002), but significantly lower strokes (OR=0.54, 95% CI 0.42-0.70; p<0.0001). PCI also had significantly higher repeat revascularizations (OR=2.58, 95% CI 1.89-3.52; p<0.00001) in the long term (≥5 years), while in the very long term (≥10years), PCI had significantly lower all-cause mortalities (OR=0.77, 95% CI 0.61-0.96; p=0.02). PCI was safer than CABG for patients with stroke for most follow-ups, while CABG was associated with lower repeat revascularizations. However, further research is required to determine PCI's safety over CABG for reducing post-surgery MI.