Left Main Percutaneous Coronary Intervention Research Articles

Applicability of the EXCEL Trial Criteria to an All-Comers Real-World Cohort of Unprotected Left Main Percutaneous Coronary Intervention

The Evaluation of XIENCE versus EXCEL (Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial is the largest randomized study comparing percutaneous coronary intervention (PCI) with second-generation drug-eluting stents and bypass surgery in unprotected left main disease (ULMD). Our aim was to assess which proportion of patients from a contemporary all-comer population of ULMD PCI would be eligible for the EXCEL trial and whether these patients show different long-term outcomes than the rest of the ULMD population. A total of 246 consecutive patients underwent ULMD PCI between January 2018 and December 2021 and were retrospectively analyzed. After application of the EXCEL trial inclusion and exclusion criteria, 98 patients (39%) were allocated to the "EXCEL-like" cohort and 148 to the "non-EXCEL-like." Baseline characteristics of the 2 groups were substantially comparable. The mean baseline SYNTAX score was lower in the EXCEL-like patients than the non-EXCEL-like group (20.1 ± 7.1 vs 23.0 ± 11.2, p=0.025), with the latter also showing a higher degree of incomplete revascularization (residual SYNTAX score >8:11% vs 26%, p=0.005). At 1year, the cumulative major adverse cardiovascular and cerebral events rate was 7% for the EXCEL-like and 17% for the non-EXCEL-like patients, respectively (p=0.03). At the last follow-up available, the significant difference in major adverse cardiovascular and cerebral events rate persisted (19% vs 37%, p=0.02) and a significant difference in any unplanned revascularization was also shown (1.5% vs 13%, p=0.04). In conclusion, in a contemporary real-world cohort of ULMD PCI, only a minority of patients could be enrolled in the EXCEL trial; the EXCEL-like patients, in our population, showed less clinical events at long-term follow-up than the cohort of patients who were ineligible for EXCEL, despite comparable baseline cardiovascular profiles; these findings may challenge a broad external applicability of the results of the EXCEL trial in routine clinical activity.

Impacto del uso de ultrasonido intravascular en pacientes con infarto agudo de miocardio y alto riesgo isquémico

Introduction and objectivesEvidence for the role of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in patients at high ischemic risk of acute myocardial infarction (AMI) is lacking. This study aimed to investigate the long-term clinical impact of IVUS-guided PCI in patients at high ischemic risk of AMI. MethodsAmong 13 104 patients with AMI enrolled in the Korea Acute Myocardial Infarction Registry-National Institutes of Health, we selected 8890 patients who underwent successful PCI with second-generation drug-eluting stent implantation and classified them into 2 groups based on whether or not they were at high ischemic risk or not, defined as any of the following: number of stents implanted ≥ 3, 3 vessels treated, ≥ 3 lesions treated, total stent length> 60mm, left main PCI, diabetes mellitus, and chronic kidney disease. The primary outcome was target lesion failure including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 3 years. ResultsIn 4070 AMI patients at high ischemic risk, IVUS-guided PCI (21.6%) was associated with a significantly lower risk of target lesion failure at 3 years (6.7% vs 12.0%; HR, 0.54; 95%CI, 0.41-0.72; P <.001) than angiography-guided PCI. The results were consistent after confounder adjustment, inversed probability weighting, and propensity score matching. ConclusionsIn patients at high ischemic risk of AMI who underwent PCI with second-generation drug-eluting stent implantation, use of IVUS guidance was associated with a significant reduction in 3-year target lesion failure.iCreaT study No. C110016.

Left Main Percutaneous Coronary Revascularization.

Left main (LM) coronary artery disease accounts for approximately 4-6% of all percutaneous coronary interventions (PCIs). There has been mounting evidence indicating the non-inferiority of LM PCI as a revascularization option, particularly for those with a low SYNTAX score. The EXCEL and NOBEL trials have shaped current guidelines. The European Society of Cardiology assigned a class 2a (level of evidence B) for isolated LM disease involving the shaft and ostium and a class IIb (level of evidence B) for isolated LM disease involving the bifurcation or additional two- or three-vessel disease and a SYNTAX score <32. However, data on the use of a single stent or an upfront two-stent strategy for distal LM disease are conflicting, wherein the EBC Main trial reported similar outcomes with a stepwise provisional approach and the DKCRUSH-V trial reported better outcomes with an upfront two-stent strategy using the 'double-kissing' crush technique. Although several studies have noted better immediate results with image-guided PCI, there are few data on outcomes in LM disease specifically. In fact, the uptake of imaging in the aforementioned landmark trials was only 40%. More importantly, the role of mechanical circulatory support (MCS) has been less well studied in LM PCI. Indiscriminate use of MCS for LM PCI has been noted in clinical practice. Trials evaluating the benefit of MCS in high-risk PCI demonstrated no benefit. This review highlights contemporary trials as they apply to current practice in LM PCI.

Clinical Characteristics, Procedural Details, and Outcomes of Patients Who Underwent Percutaneous Coronary Intervention in Real-world Practice at a Tertiary Care Center in Sri Lanka

Introduction: Outcomes of percutaneous coronary intervention (PCI) vary across different regions of the world. Despite a substantial increase in the demand for PCI in recent years, there is a lack of comprehensive data on PCI in Sri Lanka. Objective: The objective of this study was to investigate the pattern of PCI procedures in real-world practice in Sri Lanka over a period of time. Methods: This prospective descriptive study included all patients who underwent PCI at one unit of a tertiary care cardiac center in Colombo, Sri Lanka, between March 2022 and December 2022. Patients’ baseline clinical characteristics, procedural details, equipment usage, and complications were analyzed and followed up for 6 months. Results: Among 317 patients included in the analysis, 89.9% were ≥40 years old, with a mean age of 54.7 years (standard deviation: 11), and 73.5% were male. The most common presentation was chronic coronary syndrome, 65.9%, with 6.9% chronic total occlusion (CTO) cases. Within acute coronary syndrome cases, the highest percentage (27.1%) was attributed to ST-elevation myocardial infarction (MI), with 18.3% being anterior MI, suggesting that the left anterior descending artery was most commonly affected. Approximately 86.1% had single-vessel PCI, whereas 2.8% underwent left main PCI. Transradial access was obtained in 87.4%. Despite a 6.9% CTO, a high procedural success rate of 94.3% was observed. The inhospital mortality rate was low at 0.3%, and the 6-month mortality rate was 0.9%. Conclusions: Despite the limited sample size, our study provides valuable insights into the current practices and outcomes of PCI in Sri Lanka. Despite the constraints of limited resources, we observed a high success rate and minimal complications.

Temporal Trends in In-Hospital Outcomes Following Unprotected Left-Main Percutaneous Coronary Intervention: An Analysis of 14 522 Cases From British Cardiovascular Intervention Society Database 2009 to 2017

Percutaneous coronary intervention (PCI) is increasingly used as a treatment option for unprotected left main stem artery (unprotected left main stem percutaneous intervention) disease. However, whether patient outcomes have improved over time is uncertain. Using the United Kingdom national PCI database, we studied all patients undergoing unprotected left main stem percutaneous intervention between 2009 and 2017. We excluded patients who presented with ST-segment-elevation, cardiogenic shock, and with an emergency indication for PCI. Between 2009 and 2017, in the study-indicated population, 14 522 unprotected left main stem percutaneous intervention procedures were performed. Significant temporal changes in baseline demographics were observed with increasing patient age and comorbid burden. Procedural complexity increased over time, with the number of vessels treated, bifurcation PCI, number of stents used, and use of intravascular imaging and rotational atherectomy increased significantly through the study period. After adjustment for baseline differences, there were significant temporal reductions in the occurrence of peri-procedural myocardial infarction (P<0.001 for trend), in-hospital major adverse cardiac or cerebrovascular events (P<0.001 for trend), and acute procedural complications (P<0.001 for trend). In multivariable analysis examining the associates of in-hospital major adverse cardiac or cerebrovascular events, while age per year (odds ratio, 1.02 [95% CIs, 1.01-1.03]), female sex (odds ratio, 1.47 [1.19-1.82]), 3 or more stents (odds ratio, 1.67 [05% [1.02-2.67]), and patient comorbidity were associated with higher rates of in-hospital major adverse cardiac or cerebrovascular events, by contrast use of intravascular imaging (odds ratio, 0.56 [0.45-0.70]), and year of PCI (odds ratio, 0.63 [0.46-0.87]) were associated with lower rates of in-hospital major adverse cardiac or cerebrovascular events. Despite trends for increased patient and procedural complexity, in-hospital patient outcomes have improved after unprotected left main stem percutaneous intervention over time.

Peri-Procedural Troponin Elevation after Percutaneous Coronary Intervention for Left Main Coronary Artery Disease.

Left main (LM) percutaneous coronary interventions (PCI) are challenging and highly invasive procedures. Periprocedural myocardial injury (Troponin (Tn) elevation > 99th percentile) is frequently detected after LM PCI, being identified even in up to 67% of patients. However, the prognostic implications of periprocedural Tn elevation after LM PCI remain controversial. We aim to assess the impact and prognostic significance of the periprocedural troponin elevation on long-term outcomes in patients undergoing LM PCI in a real-world setting. Consecutive 673 patients who underwent LM PCI in our department between January 2015 to February 2021 were included in a prospective registry. The first group consisted of 323 patients with major cardiac Troponin I elevation defined as an elevation of Tn values > 5× the 99th percentile in patients with normal baseline values or post-procedure Tn rise by >20% in patients with elevated pre-procedure Tn in whom the Tn level was stable or falling (based on the fourth universal definition of myocardial infarction). The second group consisted of patients without major cardiac Troponin I elevation. Seven-year long-term all-cause mortality was not higher in the group with major Tn elevation (36.9% vs. 40.6%; p = 0.818). Naturally, periprocedural myocardial infarction was diagnosed only in patients from groups with major Tn elevation (4.9% of all patients). In-hospital death and other periprocedural complications did not differ significantly between the two study groups. The adjusted HRs for mortality post-PCI in patients with a periprocedural myocardial infarction were not significant. Long-term mortality subanalysis for the group with criteria for cardiac procedural myocardial injury showed no significant differences (39.5% vs. 38.8%; p = 0.997). The occurrence of Tn elevation (>1×; >5×; >35× and >70× URL) after LM PCI was not associated with adverse long-term outcomes. The results of the study suggest that the isolated periprocedural troponin elevation is not clinically significant.

Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation.

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.

Four-Year Outcomes of Left Main Percutaneous Coronary Intervention with a Bioresorbable Scaffold in the Circumflex Ostium.

The study aimed to investigate the long-term outcomes of a double stent scaffold strategy in patients with left main (LM) bifurcation lesions involving the ostium of the left circumflex artery (LCX), utilizing a drug-eluting stent (DES) in the LM extending into the left anterior descending artery (LAD) and a bioresorbable vascular scaffold (BVS) in the LCX ostium. The high occurrence of in-stent restenosis of the LCX ostium is the major limitation of percutaneous coronary intervention (PCI) for LM lesions with a two-stent strategy. This was a single-center, prospective, single-arm study of 46 consecutively enrolled patients with a stable coronary artery disease and significant unprotected LM distal bifurcation disease. Patients underwent imaging-guided PCI using DES in the LM-LAD and BVS in the LCX using a T-stent or mini-crush technique. The primary outcome at four years was the composite of death, myocardial infarction, stroke, and target lesion revascularization (TLR). At four years, the primary outcome was identified in 9 patients (19.6%). All events were TLRs except one myocardial infarction due to BVS thrombosis. Seven of the eight TLRs were a result of side branch BVS restenosis. Univariate predictors of the 4-year outcome were higher LDL cholesterol and BVS size ≤2.5 mm. On multivariate analysis, LCX lesion preparation with a cutting balloon and post-procedure use of intravascular ultrasound for optimization were found to be independent protective factors of MACE. In selected patients with LM distal bifurcation disease, an imaging-guided double stent scaffold strategy with DES in the LM and BVS in the LCX ostium was technically successful in all patients and was reasonably safe and effective for four years.

Impact of intravascular ultrasound in acute myocardial infarction patients at high ischemic risk

Introduction and objectivesEvidence for the role of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in patients at high ischemic risk of acute myocardial infarction (AMI) is lacking. This study aimed to investigate the long-term clinical impact of IVUS-guided PCI in patients at high ischemic risk of AMI. MethodsAmong 13 104 patients with AMI enrolled in the Korea Acute Myocardial Infarction Registry-National Institutes of Health, we selected 8890 patients who underwent successful PCI with second-generation drug-eluting stent implantation and classified them into 2 groups based on whether or not they were at high ischemic risk or not, defined as any of the following: number of stents implanted ≥ 3, 3 vessels treated, ≥ 3 lesions treated, total stent length> 60mm, left main PCI, diabetes mellitus, and chronic kidney disease. The primary outcome was target lesion failure including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 3 years. ResultsIn 4070 AMI patients at high ischemic risk, IVUS-guided PCI (21.6%) was associated with a significantly lower risk of target lesion failure at 3 years (6.7% vs 12.0%; HR, 0.54; 95%CI, 0.41-0.72; P <.001) than angiography-guided PCI. The results were consistent after confounder adjustment, inversed probability weighting, and propensity score matching. ConclusionsIn patients at high ischemic risk of AMI who underwent PCI with second-generation drug-eluting stent implantation, use of IVUS guidance was associated with a significant reduction in 3-year target lesion failure.iCreaT study No. C110016.

Intravascular imaging for left main stem assessment: An update on the most recent clinical data.

Left main (LM) stem has different structural and anatomical characteristics compared to all of the other segments of the coronary tree, thus its management through percutaneous coronary intervention (PCI) is a challenge and is associated with worse clinical outcome and higher need for revascularization as compared to other lesion settings. Intravascular imaging, by means of intravascular ultrasound (IVUS) or optical coherence tomography (OCT), is an important tool for LM PCI guidance, aiming at improving the immediate performance and the long term outcome of this procedure. Following current guidelines and recent scientific findings, IVUS becomes important to firstly assess, and finally evaluate the result of LM stenting, according to the experience and preferences of the operator. The role of OCT still remains to be defined, but recent data is shedding light also on this imaging technique. The aim of this review is to highlight the latest scientific advancements regarding intravascular imaging in LM coronary artery disease.

Default distal radial approach for all coronary procedures – a prospective study

Abstract Background Radial artery approach for coronary interventions has substantially improved the outcome especially in acute coronary syndrome patients. However, radial artery occlusion is the achilles' heel of such an approach. Purpose To obviate such problems, distal radial artery (DRA) approach is evolving but technical challenge is the small size of the artery. We looked at the feasibility, safety and advantages of it. Methods Patient population included any patient requiring a diagnostic or percutaneous coronary interventions (PCI) in our catheterization laoratory from March 2020 to March 2022. A primary operator performed all procedures as default, if the patient had a palpable DRA. After local anaesthesia infiltration, using seldinger technique and micropuncture kit, 5 to 7F hydrophilic sheaths were introduced and a cocktail of verapamil and heparin was given routinely. Sheaths were removed immediately after procedure but dedicated side specific compression devices were used but removed 45 min after diagnostic and 2 hours after PCI. Clinical patency of radial artery was assessed at discharge and follow up. Results A total of 682 procedures were performed (50% were diagnostic). Out of all PCIs 59% were for ACS). Elective PCIs included very complex cases including PCI for bifurcation, left main and rota assisted complex PCIs. 651 patients had right distal radial approach and 28 had left. Mean age of patients were 66.8±12.9 years (26 to 97). Females constituted 218 (32%). Mean time from 1st needle puncure to successful vascular access took 1.2±0.8 min (20 sec to 6 min). Average attempts to obtain successful vascular access was 1.3±0.7 (1 to7 attempts). There were 15 failures (2%) to obtain DRA access requiring change over to 6 ipsilateral radial, 2 ulnar, 4 contralateral distal radial, 2 femoral and 1 brachial access. Interestingly, in 5 different occaisions previous procedure related occluded radial arteries were recanalized through this access. Most importantly, no case of radial artery occlusion was encountered at discharge or at follow up by clinical examinations. No other vascular complications were encountered except mild transient bruising in 6 cases and early small hematoma in 3 cases. Patient's comfort, nursing staffs' satisfaction and trend towards early discharges were also noticed. There was a distinct improvement in obtaining faster access with lower failure rates by the operator after initial 90, especially after 150 procedures. Conclusions A default approach through distal radial artery in anatomical snuff box for all coronary interventions is feasible, safe and possibly superior to conventional radial access with better patient comfort and caring staff's satisfaction. Though learning curve is longer and more challenging, success rates were much higher and vascular access was faster after initial phase. Clinically radial artry occlusion was not seen but needs further study and more objective evidence. Funding Acknowledgement Type of funding sources: None.

Rates of Intracoronary Imaging Optimization in Contemporary Percutaneous Coronary Intervention: A Report From the BMC2 Registry.

Intracoronary imaging (ICI) during percutaneous coronary intervention (PCI) improves outcomes, yet hospital- and physician-level variabilities in ICI and its impact on ICI use in contemporary PCI remain unknown. This study was performed to evaluate hospital- and physician-level use of ICI to optimize PCI. Using data from a large statewide registry, patients undergoing PCI between July 2019 and March 2021 were studied. The primary measure of interest was ICI (intravascular ultrasound or optical coherence tomography) optimization during PCI. A fitted hierarchical Bayesian model identified variables independently associated with ICI optimization. The performing hospital and physician were included as random effects in the model. Among 48 872 PCIs, ICI optimization was performed in 8094 (16.6%). Median [interquartile range] hospital- and physician-level frequencies of ICI were 8.8% [3.1%, 16.0%] and 6.1% [1.1%, 25.0%], respectively. Bayesian modeling identified left main PCI (adjusted odds ratio [aOR], 4.41; 95% credible interval [3.82, 5.10]), proximal left anterior descending artery PCI (aOR, 2.28 [2.00, 2.59]), PCI for in-stent restenosis (aOR, 1.55 [1.40, 1.72]), and surgical consult prior to PCI (aOR, 1.21 [1.07, 1.37]) as independent predictors of ICI optimization. The hospital-level median odds ratio, an estimate of the contribution of inter-hospital variability in odds of ICI use, was 3.48 (2.64, 5.04). Physician-level median odds ratio was 3.81 (3.33, 4.45). Substantial hospital- and physician-level variation in ICI was observed. Except for performance of left main PCI, the hospital and physician performing the PCI were more strongly associated with ICI optimization than any patient or procedural factors.

Impact of Intracoronary Imaging-Guided Percutaneous Coronary Intervention on Procedural Outcomes Among Complex Patient Groups.

Background Intracoronary imaging (ICI) has been shown to improve survival after percutaneous coronary intervention (PCI). Whether this prognostic benefit is sustained across different indications remains unclear. Methods and Results All PCI procedures performed in England and Wales between April, 2014 and March 31, 2020, were retrospectively analyzed. The association between ICI use and in-hospital major acute cardiovascular and cerebrovascular events; composite of all-cause mortality, stroke, and reinfarction and mortality was examined using multivariable logistic regression analysis for different imaging-recommended indications as set by European Association for Percutaneous Cardiovascular Interventions consensus. Of 555 398 PCI procedures, 10.8% (n=59 752) were ICI-guided. ICI use doubled between 2014 (7.8%) and 2020 (17.5%) and was highest in left main PCI (41.2%) and lowest in acute coronary syndrome (9%). Only specific European Association for Percutaneous Cardiovascular Interventions imaging-recommended indications were associated with reduced major acute cardiovascular and cerebrovascular events and mortality, including left main PCI (odds ratio [OR], 0.45 [95% CI, 0.39-0.52] and 0.41 [95% CI, 0.35-0.48], respectively), acute coronary syndrome (OR, 0.76 [95% CI, 0.70-0.82] and 0.70 [95% CI, 0.63-0.77]), and stent length >60 mm (OR, 0.75 [95% CI, 0.59-0.94] and 0.72 [95% CI, 0.54-0.95]). Stent thrombosis and renal failure were associated with lower mortality (OR, 0.69 [95% CI, 0.52-0.91]) and major acute cardiovascular and cerebrovascular events (OR, 0.77 [95% CI, 0.60-0.99]), respectively. Conclusions ICI use has more than doubled over a 7-year period at a national level but remains low, with <1 in 5 procedures performed under ICI guidance. In-hospital survival was better with ICI-guided than angiography-guided PCI, albeit only for specific indications.

Comparative Effectiveness and Safety of Ticagrelor Versus Clopidogrel for Elderly Chinese Patients Undergoing Percutaneous Coronary Intervention: A Single-Center Retrospective Cohort Study.

Taking ischemic and bleeding risks into consideration, insufficient data exist on dual antiplatelet therapy after percutaneous coronary intervention in elderly Chinese patients with coronary artery disease. We aimed to investigate the effectiveness and safety of ticagrelor in comparison with clopidogrel on a background of aspirin for elderly Chinese patients with coronary artery disease 12 months after percutaneous coronary intervention. A single-center retrospective cohort study was conducted. Selected from patients with coronary artery disease aged ≥ 75 years from January 2010 to July 2019, 908 eligible subjects receiving dual antiplatelet therapy after percutaneous coronary intervention for up to 12 months were consecutively enrolled in the study. The included patients received ticagrelor in combination with aspirin (n = 264) or clopidogrel in combination with aspirin (n = 644). Effectiveness endpoints were evaluated by the major adverse cardiovascular events, encompassing all-cause death, non-fatal myocardial infarction, and clinically driven revascularization. The safety endpoints were recorded as the incidence of Bleeding Academic Research Consortium bleeding. The patients who were treated with ticagrelor were slightly younger than those who were treated with clopidogrel (79.1 ± 3.7 vs 80.7 ± 4.5 years, p < 0.01). The ticagrelor cohort contained a higher percentage of patients undergoing a prior percutaneous coronary intervention (37.9% vs 24.5%, p < 0.01), and a lower percentage of smokers (19.3% vs 27.2%, p < 0.05), compared with the clopidogrel cohort. The levels of glucose, total cholesterol, and low-density lipoprotein-cholesterol in the ticagrelor group were higher while the level of triglycerides and high-density lipoprotein-cholesterol were lower (p < 0.05) than those in the clopidogrel group. Left main percutaneous coronary intervention was performed more frequently among the ticagrelor-treated patients (23.5% vs 9.3%, p < 0.01), while patients in the clopidogrel group underwent more left circumflex percutaneous coronary intervention (34.3% vs 23.1%, p < 0.01). We found that ticagrelor was associated with a lower incidence of major adverse cardiovascular events than clopidogrel using the inverse probability of treatment weighting model (odds ratio, 0.493; 95% confidence interval 0.356-0.684). There was no difference in terms of the risk of Bleeding Academic Research Consortium bleeding between the two groups (p > 0.05). Ticagrelor was associated with a lower incidence of major adverse cardiovascular events than clopidogrel at 12 months in elderly Chinese patients with coronary artery disease, without a significant increase of Bleeding Academic Research Consortium bleeding events.

One Versus Two Stents Strategies for Unprotected Left Main Intervention: Gulf Left Main Registry.

The optimal stenting strategy for unprotected left main coronary artery (ULMCA) disease remains debated. This retrospective observational study (Gulf Left Main Registry) analyzed the outcomes of 1 vs 2 stents in patients with unprotected left main percutaneous coronary intervention (PCI). Overall, 1222 patients were evaluated; 173 had 1 stent and 1049 had 2 stents. The 2-stent group was older with more comorbidities, higher mean SYNTAX scores, and more distal bifurcation lesions. In the 1-stent group, in-hospital events were significant for major bleeding, and better mean creatinine clearance. At median follow-up of 20months, the 1-stent group was more likely to have target lesion revascularization (TLR). Total mortality was numerically lower in the 1-stent group (.00% vs 2.10%); however, this was not statistically significant (P=.068). Our analysis demonstrates the benefits of a 2-stent approach for ULMCA patients with high SYNTAX scores and lesions in both major side branches, while the potential benefit of a 1-stent approach for less complex ULMCA was also observed. Further studies with longer follow-up are needed to definitively demonstrate the optimal approach.

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

BackgroundCoronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries.ObjectiveThe aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia.MethodsWe will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis.ResultsIn this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022.ConclusionsThis study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of PCI in this limited-income region.Trial RegistrationClinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761International Registered Report Identifier (IRRID)RR1-10.2196/24595

Trends and predictors of radiation exposure in percutaneous coronary intervention: the PROTECTION VIII study.

Percutaneous coronary intervention (PCI) is indispensable in cardiology; however, exposure to potentially harmful ionising radiation remains a concern. This study was designed to assess the PCI-related radiation dose over the last decade and to identify predictors of increased dose exposure. The PROcedural radiaTion dose Exposure in percutaneous Coronary intervenTION (PROTECTION VIII) study included all PCIs reported to a German quality assurance programme between 2008 and 2018. Dose area product (DAP) and radiation time were analysed. Effective dose (ED) was estimated (ED=DAP*k; conversion coefficient k=0.0022 mSv/cGy*cm2). Multivariate linear regression analysis was used to identify predictors associated with a clinically relevant increase of radiation dose (ED ≥1 mSv). We enrolled 3,704,986 patients undergoing PCI (median age 70 years, 30% female). Indications were chronic coronary syndrome (37.5%), unstable angina pectoris and non-ST-segment elevation myocardial infarction (non-STEMI; 33.2%) and STEMI (18.5%). Median DAP was 4,203 (interquartile range [IQR] 2,313-7,300) cGy*cm, ED was 9.2 mSv and median radiation time was 9.2 (IQR 5.8-15.0) min. Within the 10-year period, radiation exposure was reduced by 36% (p<0.001) and resulted in a median DAP of 3,070 cGy*cm (ED 6.8 mSv) in 2018. A significant 5.3-fold variability of median DAP was observed between catheterisation laboratories (p<0.001). We identified patient-related (gender, coronary artery bypass graft surgery, heart failure) and procedure-related (coronary occlusion PCI, ostial lesion PCI, left main PCI, multivessel PCI) predictors of increased radiation dose (all p<0.001). This radiation dose survey demonstrates a considerable reduction of PCI radiation exposure during the last decade. However, large variability between catheterisation laboratories underlines the need for further radiation dose reduction.

Intravascular imaging and drug-coated balloons forunprotected left main percutaneous coronary interventions: Questions with a predictable or unpredictable answer? Author's reply.

Intravascular imaging and drug-coated balloons forunprotected left main percutaneous coronary interventions: Questions with a predictable or unpredictable answer? Author's reply.

Clinical Case of Unprotected Left Main Percutaneous Coronary Intervention in Elderly Patient With Porcelain Aorta

Coronary artery bypass grafting (CABG) has long been considered the gold standard in the treatment of patients with lesions of the left main (LM) coronary artery. Elderly patients are one of the most difficult categories of patients with LM lesions due to severe coronary artery calcification. Thanks to constant progress in the field of engineering and technology, it has become possible to perform percutaneous coronary interventions (PCI) for patients with unprotected stenosis of the LM. Drug-eluting stents and the development of pharmacotherapy have improved the results of PCI in these lesions. Comparative studies of the efficacy and safety of PCI and CABG have shown similar results in terms of the need for revascularization. Patients with severe calcification of the coronary arteries mostly belong to the older age group and hold large part in this cohort. Technological advances enabled to treat patients with complex coronary anatomy and LM lesions not only through CABG, but also through PCI. Comparative studies show that the efficacy and safety of PCI and CABG have similar results in terms of the need in revascularization.&#x0D; The aim. To highlight the importance of discussion of each clinical case by the heart team and comprehensive approach with the use of modern equipment.&#x0D; Stage 1. A 80-year-old woman with type 2 diabetes mellitus was delivered by an ambulance team to the National Amosov Institute of Cardiovascular Surgery with severe pain; the patient was diagnosed with non-ST-elevation myocardial infarction (NSTEMI). Electrocardiography revealed ST-segment depression in leads V1-V5. After performing echocardiographic examination, valvular pathology and segmental contraction defects were not detected, EF 52%.&#x0D; Urgent coronary angiography revealed significant calcification of the ascending aorta (porcelain aorta) and coronary arteries. Coronary artery lesions: 90% unstable LM stenosis, significant calcified stenosis of the circumflex artery (CA), middle left anterior descending artery (mid-LAD), and chronic coronary occlusion of the right coronary artery, besides, 5 episodes of ventricular tachycardia were recorded. Despite the high SYNTAX Score I and SYNTAX Score II, due to the clinical picture and heart rhythm disorders, the heart team decided to perform emergency PCI. Bare-metal stent for LM – mid-LAD was implanted and angioplasty of mid-LAD was performed. Rough calcification of LM caused stent recoil; postdilatation of LM stent by high pressure balloon (p = 25 atm) was performed. The operation ended with a good angiographic result. The woman was discharged in a stable condition to plan further intervention in 1 month.&#x0D; Stage 2. A 81-year-old woman with complaints of severe chest pain was re-hospitalized with NSTEMI to the National Amosov Institute of Cardiovascular Surgery 3 months after the primary PCI. Echocardiography revealed EF 53%; valvular pathology and segmental contraction defects were not detected. Urgent coronary angiography revealed 90% of LM stenosis (stent recoil – loss of radial rigidity). Gradual angioplasty of LM stenosis and CA stenosis were performed.&#x0D; Stage 3. For reinforcing the radial rigidity in LM, LM – CA drug-eluting stent was implanted. Angioplasty of LM and CA using kissing balloon technique was performed. Final proximal optimization of LM showed good angiographic result.

Temporal Trends in Complex Percutaneous Coronary Interventions.

BackgroundAccumulated experience combined with technological advancements in percutaneous coronary interventions (PCI) over the past four decades, has led to a gradual increase in PCI utilization and complexity. We aimed to investigate the temporal trends in PCI complexity and the outcomes of complex PCI (C-PCI) in our institution.MethodsWe analyzed 20,301 consecutive PCI procedures performed over a 12-year period. C-PCI was defined as a procedure involving at least one of the following: Chronic total occlusion (CTO), left main (LM), bifurcation or saphenous vein graft (SVG) PCI. Four periods of 3-year time intervals were defined (2008–10, 2011–2013, 2014–2016, 2017–2019), and temporal trends in the rate and outcomes of C-PCI within these intervals were studied. Endpoints included mortality and major adverse cardiac events [MACE: death, acute myocardial infarction (MI), and target vessel revascularization (TVR)] at 1 year.ResultsA total of 5,647 (27.8%) C-PCI procedures were performed. The rate of C-PCI has risen significantly since 2,017 (31.2%, p < 0.01), driven mainly by bifurcation and LM interventions (p < 0.01). At 1-year, rates of death, acute MI, TVR and MACE, were all significantly higher in the C-PCI group (8.8 vs. 5.1%, 5.6 vs. 4.5%, 5.5 vs. 4.0%, 17.2 vs. 12.2%, p < 0.001 for all, respectively), as compared to the non-complex group. C-PCI preformed in the latter half of the study period (2014–2019) were associated with improved 1-year TVR (4.4% and 4.8% vs. 6.7% and 7.1%, p = 0.01, respectively) and MACE (13.8% and 13.5% vs. 17.3% and 18.2%, p = 0.001, respectively) rates compared to the earlier period (2007–2013). Death rate had not significantly declined with time.ConclusionIn the current cohort, we have detected a temporal increase in PCI complexity coupled with improved 1-year clinical outcomes in C-PCI.