Complex Coronary Artery Lesions Research Articles

Evaluation of Conventional and Novel Risk Factors in Young and Aged Patients, Undergoing Coronary Artery Bypass Grafting

ABSTRACT Aim: The aim of this study was to find out the relationship of conventional and/or novel cardiovascular risk factors with coronary artery disease severity in terms of SYNTAX scores in young (≤45 years) and aged (>45 years) patients. Materials and Methods: The final number of patients included in the study was 132 and divided into 2 groups: Group A was young patients with age less than 45 years, and in group B, the age was more than 45 years. The SYNTAX score was determined for each case based on the preoperative coronary angiogram using the Online SYNTAX score calculator version 2.11. Results: It was seen that 33% of patients in group A had high SYNTAX scores, as compared to only 8% in group B. This definitely shows that the younger population has more COMPLEX coronary artery lesions than the elderly. Conclusion: YOUNG patients have significantly higher levels of homocysteine as compared to the elderly. Serum homocysteine correlates with SYNTAX scores in YOUNG patients, with a sensitivity of 83.33%, specificity 91.67%, and diagnostic accuracy 86.67%. Percentage of Low HDL in YOUNG is significantly higher than in the elderly.

Intravascular Imaging–Guided Optimization of Complex Percutaneous Coronary Intervention by Sex

There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions. To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men. This prespecified substudy evaluates the interaction of sex in the investigator-initiated, open-label, multicenter RENOVATE-COMPLEX-PCI randomized clinical trial, which demonstrated the superiority of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. The trial was conducted at 20 sites in Korea. Patients with complex coronary artery lesions undergoing PCI were enrolled between May 2018 and May 2021, and the median (IQR) follow-up period was 2.1 (1.4-3.0) years. Data were analyzed from December 2022 to December 2023. After diagnostic coronary angiography, eligible patients were randomly assigned in a 2:1 ratio to receive intravascular imaging-guided PCI or angiography-guided PCI. The choice and timing of the intravascular imaging device were left to the operators' discretion. The primary end point was target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Secondary end points included individual components of the primary end point. Of 1639 included patients, 339 (20.7%) were women, and the mean (SD) age was 65.6 (10.2) years. There was no difference in the risk of the primary end point between women and men (9.4% vs 8.3%; adjusted hazard ratio [HR], 1.39; 95% CI, 0.89-2.18; P = .15). Intravascular imaging-guided PCI tended to have lower incidence of the primary end point than angiography-guided PCI in both women (5.2% vs 14.5%; adjusted HR, 0.34; 95% CI, 0.15-0.78; P = .01) and men (8.3% vs 11.7%; adjusted HR, 0.72; 95% CI, 0.49-1.05; P = .09) without significant interaction (P for interaction = .86). In patients undergoing complex PCI, compared with angiographic guidance, intravascular imaging guidance was associated with similar reduction in the risk of target vessel failure among women and men. The treatment benefit of intravascular imaging-guided PCI showed no significant interaction between treatment strategy and sex. ClinicalTrials.gov Identifier: NCT03381872.

Intracoronary imaging of complex coronary artery lesions: A lesion-level analysis from SCAAR simulating the IMPROVE trial

Abstract Background Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are two intracoronary imaging modalities which can be used to optimize stent implantation and expansion. The IMPROVE trial is an ongoing randomized study investigating the impact of IVUS on percutaneous coronary intervention (PCI) of complex lesions. We conducted a nationwide retrospective observational study simulating the IMPROVE trial. Purpose The aim of this study is to determine whether intracoronary imaging is associated with improved outcome after PCI of complex lesions. Methods Using the Swedish Coronary Angiography and Angioplasty registry (SCAAR) we identified complex lesions undergoing PCI between 1 January 2016 and 15 January 2022. Complex lesions were defined as (1) in-stent restenosis, (2) chronic total occlusions, (3) bifurcations and (4) lesions stented with a ≥ 28 mm stent. Lesions were stratified into two groups according to use of intracoronary imaging or not. The groups underwent propensity score (PS) matching to balance baseline demographics. Outcome was assessed with univariable cox regression models and Kaplan Meier estimates. The primary endpoint was target lesion revascularization (TLR) within 2-years assessed on lesion level where each patient could contribute with more than one lesion. Secondary endpoint included all-cause mortality analyzed on patient level. Results After PS-matching, two groups with 9,404 lesions each were formed. Baseline characteristics after PS matching did not show any significant demographic differences. The intracoronary imaging group contributed more often with more than one lesion. Intracoronary imaging was associated with significantly lower rates of TLR (hazard ratio (HR): 0.80 (95% confidence interval (CI): 0.67-0.94), p=0.008) and all-cause mortality (HR: 0.69 (95% CI 0.61-0.78), p<0.001). Conclusion In this study on complex lesions undergoing PCI, the use of intracoronary imaging was associated with an improved outcome. These results encourage intracoronary imaging when assessing complex lesions.Baseline characteristicsOutcome

Abstract 15313: Prognostic Impact of Intravascular Imaging-Guided Percutaneous Coronary Intervention in Chronic Total Occlusion

Background: Limited data exist regarding use of intravascular image during chronic total occlusion (CTO) intervention. Objectives: Current study investigated the prognostic impact of intravascular imaging-guided PCI in CTO lesions. Methods: Study population was derived from the RENOVATE-COMPLEX-PCI (n=1639) which demonstrated superiority of intravascular imaging-guided PCI than angiography-guided PCI in patients with complex coronary artery lesions. Current prespecified study selected patients who underwent CTO intervention and clinical outcomes were compared between intravascular imaging-guided PCI and angiography-guided PCI groups. Results: Among 1639 patients, 319 patients with CTO underwent intravascular imaging-guided PCI (n=220) or angiography-guided PCI (n=99). At a median follow-up of 2.1 years (interquartile range 1.1-3.0 years), the risk of TVF was significantly lower in intravascular imaging-guided PCI group than in the angiography-guided PCI group (5.0% vs. 13.5%; HR 0.303; 95% CI 0.130-0.710, P=0.006). When patients in imaging-guided PCI group were divided according to stent optimization, both patients with (1.3% vs. 13.5%; HR 0.14; 95% CI 0.02-0.56; P=0.003) and without (6.8% vs. 13.5%; HR 0.41; 95% CI 0.17-0.99; P=0.049) stent optimization had significantly lower risk of TVF than the angiography-guided PCI group. Conclusions: In patients with CTO, intravascular imaging-guided PCI was associated with reduced risk of TVF. Graded risk of TVF according to stent optimization by intravascular imaging supports the importance of intravascular imaging-guided PCI and achievement of stent optimization in CTO intervention.

Guiding Intervention for Complex Coronary Lesions by Optical Coherence Tomography or Intravascular Ultrasound

BackgroundOptical coherence tomography (OCT) and intravascular ultrasound (IVUS) have shown comparable outcomes in guiding percutaneous coronary intervention (PCI). However, their comparative effectiveness in complex coronary artery lesions remains unclear. ObjectivesThis study compared the effectiveness and safety of OCT-guided vs IVUS-guided PCI for complex coronary artery lesions. MethodsThis was a prespecified, main subgroup analysis of complex coronary artery lesions in the OCTIVUS (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention) trial, which included unprotected left main disease, bifurcation disease, an aorto-ostial lesion, a chronic total occlusion, a severely calcified lesion, an in-stent restenotic lesion, a diffuse long lesion, or multivessel PCI. The primary endpoint was a composite of death from cardiac causes, target vessel–related myocardial infarction, or ischemia-driven target vessel revascularization. ResultsIn 2,008 randomized patients, 1,475 (73.5%) underwent imaging-guided PCI for complex coronary artery lesions; 719 (48.7%) received OCT-guided and 756 (51.3%) IVUS-guided PCI. At a median follow-up of 2.0 years, primary endpoint event had occurred in 47 patients (6.5%) in the OCT-guided group and in 56 patients (7.4%) in the IVUS-guided group (HR: 0.87; 95% CI: 0.59-1.29; P = 0.50). These findings were consistent in adjusted analyses. The incidence of contrast-induced nephropathy was similar between the 2 groups (1.9% vs 1.5%; P = 0.46). The incidence of major procedural complications was lower in the OCT-guided group than in the IVUS-guided group (1.7% vs 3.4%; P = 0.03). ConclusionsAmong patients with complex coronary artery lesions, OCT-guided PCI showed a similar risk of primary composite event of death from cardiac causes, target vessel–related myocardial infarction, or target vessel revascularization as compared with IVUS-guided PCI. (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention [OCTIVUS]; NCT03394079)

Safety and efficacy of the expressman extension system for complex coronary lesions during percutaneous coronary intervention.

Safety and efficacy of the expressman extension system for complex coronary lesions during percutaneous coronary intervention.

Intravascular Imaging–Guided or Angiography-Guided Complex PCI

BackgroundData regarding clinical outcomes after intravascular imaging–guided percutaneous coronary intervention (PCI) for complex coronary-artery lesions, as compared with outcomes after angiography-guided PCI, are limited.MethodsIn this prospective, multicenter, open-label trial in South Korea, we randomly assigned patients with complex coronary-artery lesions in a 2:1 ratio to undergo either intravascular imaging–guided PCI or angiography-guided PCI. In the intravascular imaging group, the choice between intravascular ultrasonography and optical coherence tomography was at the operators’ discretion. The primary end point was a composite of death from cardiac causes, target-vessel–related myocardial infarction, or clinically driven target-vessel revascularization. Safety was also assessed.ResultsA total of 1639 patients underwent randomization, with 1092 assigned to undergo intravascular imaging–guided PCI and 547 assigned to undergo angiography-guided PCI. At a median follow-up of 2.1 years (interquartile range, 1.4 to 3.0), a primary end-point event had occurred in 76 patients (cumulative incidence, 7.7%) in the intravascular imaging group and in 60 patients (cumulative incidence, 12.3%) in the angiography group (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P=0.008). Death from cardiac causes occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group; target-vessel–related myocardial infarction occurred in 38 (cumulative incidence, 3.7%) and 30 (cumulative incidence, 5.6%), respectively; and clinically driven target-vessel revascularization in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively. There were no apparent between-group differences in the incidence of procedure-related safety events.ConclusionsAmong patients with complex coronary-artery lesions, intravascular imaging–guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel–related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI. (Supported by Abbott Vascular and Boston Scientific; RENOVATE-COMPLEX-PCI ClinicalTrials.gov number, NCT03381872).

Design and evaluation of vascular interventional robot system for complex coronary artery lesions.

At present, most vascular intervention robots cannot cope with the more common coronary complex lesions in the clinic. Moreover, the lack of effective force feedback increases the risk of surgery. In this paper, a vascular interventional robot that can collaboratively deliver multiple interventional instruments has been developed to assist doctors in the operation of complex lesions. Based on the doctor's skills and the delivery principle of interventional instruments, the main and slave manipulators of the robot system are designed. Haptic force feedback is generated through resistance measuring mechanism and active drag system. In addition, a force feedback control strategy based on force-velocity mapping is proposed to realize the continuous change of force and avoid vibration. The proposed robot system was evaluated through a series of experiments. The experimental results show that the system can accurately measure the delivery resistance of interventional instruments, and provide haptic force feedback to doctors. The capability of the system to collaboratively deliver multiple interventional instruments is effective. Therefore, it can be considered that the robot system is feasible and effective.

Veno-Arterial Extracorporeal Membrane Oxygenation in Elective High-Risk Percutaneous Coronary Interventions.

BackgroundThe safety and feasibility of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) as mechanical circulatory support in high-risk percutaneous coronary intervention (HR-PCI) remain unclear.MethodsThis retrospective study included patients with complex and high-risk coronary artery disease who underwent elective PCI with VA-ECMO support pre-operatively during March 2019–December 2020. Rates of VA-ECMO-related complications, complications during PCI, death, myocardial infarction, and stroke during hospitalisation and 1-year post-operatively were analysed.ResultsOverall, 36 patients (average age: 63.6 ± 8.9 years) underwent PCI. The average duration of VA-ECMO support was 12.5 (range, 3.0–26.3) h. Intra-aortic balloon pump counterpulsation was used in 44.4% of patients. The SYNTAX score was 34.6 ± 8.4 pre-operatively and 10.8 ± 8.8 post-operatively (P < 0.001). Intraoperative complications included pericardial tamponade (N = 2, 5.6%), acute left-sided heart failure (N = 1, 2.8%), malignant arrhythmia requiring electrocardioversion (N = 2, 5.6%), and no deaths. Blood haemoglobin levels before PCI and 24 h after VA-ECMO withdrawal were 145.4 ± 20.2 g/L and 105.7 ± 21.7 g/L, respectively (P < 0.001). Outcomes during hospitalisation included death (N = 1, 2.8%), stroke (N = 1, 2.8%), lower limb ischaemia (N = 2, 5.6%), lower limb deep venous thrombosis (N = 1, 2.8%), cannulation site haematoma (N = 2, 5.6%), acute renal injury (N = 2, 5.6%), bacteraemia (N = 2, 5.6%), bleeding requiring blood transfusion (N = 5, 13.9%), and no recurrent myocardial infarctions. Within 1 year post-operatively, two patients (5.6%) were hospitalised for heart failure.ConclusionsVeno-arterial extracorporeal membrane oxygenation mechanical circulation support during HR-PCI is a safe and feasible strategy for achieving revascularisation in complex and high-risk coronary artery lesions. VA-ECMO-related complications require special attention.

High prevalence of complex coronary artery lesions in sport-related myocardial infarction. Contemporary data from the RICO survey

Funding AcknowledgementsType of funding sources: Public Institution(s). Main funding source(s): Agence régionale de santé de Bourgogne Franche-ComtéBackgroundUnderlying mechanisms for sport-related acute myocardial infarction (SR-AMI) are only poorly understood. Moreover, their coronary artery disease (CAD) characteristics and lesion complexity are poorly described.PurposeTo characterize coronary angiographic feature of patients with SR-AMIMethodsFrom the RICO database, a large regional acute MI survey, all consecutive patients hospitalized in our University Hospital from 2010 to 2021 who underwent coronary angiography for SR-MI were retrospectively analysed. SR-MI was defined as MI occurring during sport activity or within the first hour of recovery.ResultsAmong the 174 patients included, most were male (n=157(91%)). Median (IQR) age was 59 y (48-66), and had ST segment elevation MI (STEMI) (n= 112 (64%)). The SR-MI often occurred while cycling (41%), jogging (23%), hiking (9%) or playing soccer (9%). Patients commonly experienced pre-hospital (PH) sudden cardiac arrest (SCA) (17%). Atherothrombotic risk factors were dyslipidaemia (32%), current smoking (31%) or hypertension (28%). A history of CAD was documented in 31 (18%) patients. Most (n=156(91%)) had significant lesions, of whom 140 (81%) were considered as culprit. Culprit lesions were located on left anterior descending (39%), circumflex (14%) and right coronary artery (33%). Median (IQR) Syntax score was 10.5 (6-15). The vast majority of patients (n=152 (87%)) had at least one complex lesion; 114 of them had several characteristics of complex lesion. Lesions were eccentric in 68 (39%) patients; an intraluminal thrombus was documented in 85 patients (49%), in 55% of STEMI and 37% of non-STEMI (p =0.027). However, 18 subjects (10%) had optically normal coronary angiogram or non-significant lesions, suggesting alternative mechanism such as type 2 MI. Treatment of the lesions was mainly achieved by PCI and/or stenting (n=132(77%)) or coronary artery bypass grafting (n=11(6%)). In-hospital death occurred in 11 patients (6%), of whom 10 experienced a PH-SCA and one was admitted with a cardiogenic shock during the Covid-19 pandemics lockdown. Among the 5 patients treated with extracorporeal membrane oxygenator, only one survived.ConclusionIn our large retrospective study, SR-MI was commonly associated with complex coronary lesions, often characterized by intraluminal thrombus. Our findings suggest that the mechanisms of these events could be mainly related to type 1 MI patterns Moreover, PH-SCA was frequent, thus justifying mass-education to basic life support and deployment of automated external defibrillators, especially in the sport settings.

A Comparison Between Two-Dimensional and Three-Dimensional Regional and Global Longitudinal Strain Echocardiography to Evaluate Complex Coronary Lesions in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome.

IntroductionA preliminary assessment of patients who suffer from severe and complex coronary artery lesions, such as three-vessel disease and/or a left main (LM) artery lesion, plays a critical contribution in determining prognosis and treatment plans for non-ST-segment elevation acute coronary syndrome (NSTE-ACS). Therefore, a pre-angiography (i.e., before angiography) predictor was required to cost-effectively evaluate severe and complex coronary lesions to efficiently direct our subsequent dealing.AimThis study aimed to compare two-dimensional (2D) and three-dimensional (3D) global longitudinal strain (GLS) at the regional level to assess extremely complicated coronary lesions using the SYNTAX score as a standard of reference in 100 patients with NSTE-ACS.Materials and methodsThis research included 100 patients with non-ST-segment elevation acute coronary syndrome who presented at the Cardiology Department at Fayoum University from December 2019 to July 2020. All patients underwent a complete history and physical examination, hemoglobin A1c (HbA1c), lipid profile, creatinine assessment, 12-lead electrocardiogram (ECG), and transthoracic echocardiography (TTE) to detect global and regional longitudinal strain by 2D and 3D speckle-tracking echocardiography (STE). Coronary angiography was done on all patients within 24 hours of admission after acquiring echo images. Then, the results of 2D and 3D regional and global longitudinal strain (GLS) to predict the severity and coronary lesion complexity in terms of the SYNTAX score were compared.ResultsThis study revealed that 2D GLS was −12.10 ± 3.51, which is significantly higher than 3D GLS of −11.64 ± 4.05 (p < 0. 001). The left anterior descending coronary artery (LAD) and left circumflex artery (LCX) territories revealed a significantly higher value using 2D regional longitudinal strain (−11.13 ± 4.47 and −12.54 ± 4.11, respectively) than using 3D regional longitudinal strain (−10.84 ± 5.18 and −12.05 ± 4.29, respectively) (p= 0.017 and p < 0.001, respectively). There were significantly lower 2D GLS, 3D GLS, global circumferential strain (GCS), area strain, and global radial strain (GRS) in the intermediate and high score group than in the low score group of patients (p < 0.001 for all).Conclusion2D and 3D strain echocardiography including GLS, GCS, GRS, and area strain are a noninvasive and rapid tool with clinical utility for evaluating coronary lesions in patients with NSTE-ACS. They can be routinely used to diagnose and stratify high-risk patients with NSTE-ACS, thereby potentially resulting in improved patient assessment. GLS as measured by 2D and 3D STE at minimal effort is a significant risk factor for patients with complex NSTE-ACS. In NSTE-ACS cases, the GLS absolute value is significantly associated with the degree of complexity of coronary artery lesions.

Complex coronary angioplasty: Is the same-day discharge a safe alternative?

If the same-day discharge after simple coronary angioplasty (PTCA) is a safe procedure, we don’t know if such an alternative could be attempt in patients (pts) with complex PTCA. To evaluate safety of same-day discharge after coronary angioplaty of complex lesions. Over a 11 months period, all pts referred to our center for a staged PTCA or coronary angiogram and ad-hoc angioplasty of complex coronary artery lesions were prospectively included. Exclusion criteria were pts with acute coronary syndromes, or complicated PTCA. 131 pts (among 328 ambulatory pts with PTCA, 40%), were included, (median age 70, IQR 61-76), (107 men, 81%) (84 pts with ad-hoc PTCA, 64.1%). Median home location to the hospital was 30 kms, (IQR1-3: 10-59) with a median delay of 30 mns, (IQR1-3: 15-50). Procedure was performed through a trans-radial approach in 128 pts (97.7%). PTCA was attempted in 1.54 vessels per pt, 1.79 lesions per pt, with 1.7 stent per pt. 19 pts (14.5%) underwent left main PTCA, 18 (13.7%) total coronary occlusion, 19 (14.5%) bifurcation lesions, and 7 (5.3%) saphenous by pass grafts. Rotablator and shockwave techniques were used in 10 pts, (7.6%). Early ambulation was performed at 1 hour, and discharge at a median time of 5 hours. A call phone was systematically done between 24 and 72 hours after discharge: 20 pts did not answer, (15.3%), and there were no major complication in the 111 remaining pts, (no death, infarction, revascularization or stroke). Same-day discharge after PTCA in pts with complex coronary artery lesions appears to be a very safe procedure and alternative strategy.

Blood lead level in Chinese adults with and without coronary artery disease.

BACKGROUNDThe Trial to Assess Chelation Therapy study found that edetate disodium (disodium ethylenediaminetetraacetic acid) chelation therapy significantly reduced the incidence of cardiac events in stable post-myocardial infarction patients, and a body of epidemiological data has shown that accumulation of biologically active metals, such as lead and cadmium, is an important risk factor for cardiovascular disease. However, limited studies have focused on the relationship between angiographically diagnosed coronary artery disease (CAD) and lead exposure. This study compared blood lead level (BLL) in Chinese patients with and without CAD.METHODSIn this prospective, observational study, 450 consecutive patients admitted to Beijing Anzhen Hospital with suspected CAD from November 1, 2018, to January 30, 2019, were enrolled. All patients underwent coronary angiography, and an experienced heart team calculated the SYNTAX scores (SXscore) for all available coronary angiograms. BLLs were determined with atomic absorption spectrophotometry and compared between patients with angiographically diagnosed CAD and those without CAD.RESULTSIn total, 343 (76%) patients had CAD, of whom 42% had low (0−22), 22% had intermediate (23−32), and 36% had high (≥ 33) SXscore. BLLs were 36.8 ± 16.95 μg/L in patients with CAD and 31.2 ± 15.75 μg/L in those without CAD (P = 0.003). When BLLs were categorized into three groups (low, middle, high), CAD prevalence increased with increasing BLLs (P < 0.05). In the multivariate regression model, BLLs were associated with CAD (odds ratio (OR): 1.023, 95% confidence interval (CI): 1.008−1.039; P = 0.0017). OR in the high versus low BLL group was 2.36 (95% CI: 1.29−4.42,P = 0.003). Furthermore, BLLs were independently associated with intermediate and high SXscore (adjusted OR: 1.050, 95% CI: 1.036–1.066; P < 0.0001). CONCLUSIONBLLs were significantly associated with angiographically diagnosed CAD. Furthermore, BLLs showed excellent predictive value for SXscore, especially for complex coronary artery lesions.

The Association of Morning Surge and Night-Time Dipping Blood Pressure with Significant and Complex Coronary Artery Lesions.

Hypertension responsible for more than 10 million deaths annually worldwide and abnormal diurnal blood pressure (BP) variation is associated with cardiovascular events. This study aimed to investigate the association between the 24-h ambulatory night BP dipping and morning BP surge (MS) with characteristic of coronary artery lesions that may contribute cardiovascular events and mortality burden. A cross sectional study over 1-year, collected 263 cases of hypertensive (80%) and non-hypertensive patients, aged 61 ± 10 years, who undergoing invasive coronary angiography (CAG) and 24-h ambulatory BP monitoring admitted to cardiology department complain of chest pain. The night-time/day-time dip and sleep-trough MS were calculated. Non-dipper status was considered when night-time/day-time dip < 10%, and significant coronary lesion (SCL) when ≥ 50 % stenosis in 1.5 mm vessels. The SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score was used to quantify the complexity of SCL. The mean morning systolic BP (SBP) surge was higher in the high SYNTAX Score subgroup than low and intermediate subgroups (25 ± 11 vs 17 ± 13 and 10 ± 10 mmHg, p < 0.010). Non-dipper SBP status was more frequently in patients with SCL than non-SCL (p < 0.019). In ordinal regression, hypertension was independent predictor of SCL (odd ratio: 0.40, p < 0.003), the night-time/day-time BP dip was independent predictor of being in a higher SYNTAX score subgroup (systolic odd ratio: 0.88, diastolic odd ratio: 1.14 p < 0.05). Hypertension is associated with SCL and the night-time/day-time BP dip as a continuous variable is associated with complex coronary lesion. Non-dipping as categorical variable and morning BP surge were not independent predictors of significant or complex coronary lesions.

TCTAP A-009 Clinical Impact of Direct Rotational Atherectomy in Patients with Complex Coronary Artery Lesions

TCTAP A-009 Clinical Impact of Direct Rotational Atherectomy in Patients with Complex Coronary Artery Lesions

The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.

Optimal Stenting Technique for Complex Coronary Lesions: Intracoronary Imaging-Guided Pre-Dilation, Stent Sizing, and Post-Dilation

ObjectivesThis study compared the 3-year outcomes of intracoronary imaging–guided pre-dilation, stent sizing, and post-dilation (iPSP) for patients with complex coronary artery lesions. BackgroundThe long-term effects of the optimal drug-eluting stent implantation technique in complex coronary artery disease have not been evaluated. MethodsFrom the IRIS-DES (Interventional Cardiology Research In-cooperation Society-Drug-Eluting Stents) registry, the study evaluated 9,525 patients who underwent percutaneous coronary intervention for left main, bifurcation, long or diffuse (>30 mm), or angiographically severely calcified lesions. The primary outcome was a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The inverse probability of treatment weighting method was used to adjust for confounding factors. ResultsAt the index procedure, intravascular ultrasound assessment PSP were performed in 8,522 (89.5%) patients, 5,141 (54.0%) patients, and 5,531 (58.1%) patients, respectively; overall, 3,374 (35.4%) patients underwent stent implantation using all 3 parts of the iPSP strategy and were defined as the iPSP group. At 3 years, the adjusted rate of the primary outcome was significantly lower in iPSP group (5.6% vs 7.9%; adjusted hazard ratio: 0.71; 95% confidence interval: 0.63 to 0.81; p < 0.001). ConclusionsAmong patients undergoing drug-eluting stent implantation in complex coronary artery stenosis, iPSP was associated with a lower risk of cardiac events at 3 years. Therefore, physicians should apply iPSP more actively for the treatment of complex coronary artery stenoses, even in the current era. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)

Safety and Efficacy of Guidezilla Extension Catheter for the Percutaneous Treatment of Complex Coronary Lesions.

The GuidezillaTM support extension catheter is designed to provide extra back-up support and efficient device delivery during complex percutaneous coronary interventions (PCIs), such as in treatment of severe calcification, tortuous chronic total occlusions (CTOs), and coronary anomalies. The aim of this study was to describe our initial experience with the GuidezillaTM extension catheter in the treatment of complex coronary artery lesions. This study retrospectively analyzed data from 165 PCI cases that used the GuidezillaTM guide extension catheter between March 2015 and August 2017. We collected patient clinical characteristics, target lesion characteristics, and procedural details. Eighty-six percent of patients had complex Type C lesions, and 13.9% had Type B lesions. Lesion length ranged from 8 mm to 130 mm (≤ 20 mm, 15.4%; 20-40 mm, 35.8%; > 40 mm, 49.1%). The right coronary artery (59.2%) was the most common intervention vessel followed by the left ascending artery (30.6%) and the left circumflex artery (10.2%). CTO accounted for 38% of all lesions, followed by distortions (28%), heavy calcification (24%), proximal stent thrombosis (9%), and coronary artery origin anomalies (1%). A total of 142 patients underwent successful PCI using the GuidezillaTM extension catheter. The success rate was 86%. The GuidezillaTM guide extension catheter was an effective and safe technique in the transradial treatment of complex coronary lesions. Use of the GuidezillaTM guide extension catheter can shorten the procedure time and ensure overall procedural success with a reduced complication rate in cases where adequate progress using angioplasty devices has not been achieved.

Editorial: Rotational Atherectomy Followed by Drug-Coated Balloons in Calcified Coronary De Novo Lesions – An Alternative to Stent Implantation?

Intravascular ultrasound (IVUS)–guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The “IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact” trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel–related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.

3285Impact of intravascular ultrasound-guided percutaneous coronary intervention in patients with diabetes mellitus and chronic kidney disease

Abstract Background Several studies have shown favorable results using IVUS-guided PCI. Nevertheless, patient background in which use of IVUS is effective is not well elucidated. Patients with diabetes mellitus (DM) or chronic kidney disease (CKD) tend to have complex coronary artery lesions. We sought to assess the impact of IVUS guidance on clinical outcomes in these patients. Methods Kumamoto Intervention Conference Study is a multicenter registry which has enrolled consecutive patients who underwent PCI in 16 centers in Japan. Between August 2008 and March 2014, 11,195 consecutive patients were enrolled in this registry. To elucidate the efficacy of IVUS usage in DM and CKD patients, 10,822 consecutive subjects with 1-year follow-up data were analyzed. In this patient population, 69.2% (n=7,493) of patients were treated with IVUS-guided PCI. Patients were divided into 4 groups: the No Risk Group, the DM only Group, the CKD only Group, and the DM+CKD Group. Results Maximum stent diameter, post dilatation rate, usage of distal protection device, and rotational atherectomy rate were significantly higher in the IVUS-guided PCI patients in all 4 groups. 1-year MACE (cardiovascular death, non-fatal myocardial infarction, and MI with stent thrombosis) was significantly lower in the IVUS-guided PCI patients than angiography-guided PCI patients in each subset, except for the No Risk Group. In contrast to angiography-guided PCI patients, there were no significant differences among the 4 groups as regards 1-year MACE in the IVUS-guided PCI patients except for the DM+CKD Group. In multiple regression analysis, IVUS usage was an independent negative predictor for 1-year MACE in the DM only Group (HR=0.374, 95% CI 0.194–0.719, p=0.003) and in the CKD only Group (HR=0.604, 95% CI 0.379–0.962, p=0.010). When the No Risk Group was used as a reference, the HR has increased according to increased risk factors in the angiography-guided PCI patients, but such tendency was not necessarily observed in the IVUS-guided PCI patients (Table). Risk Stratification of DM and CKD Variable IVUS-Guided PCI Angiography-Guided PCI HR 95% CI P HR 95% CI P The No Risk Group Reference – – Reference – – vs. the DM only Group 0.627 0.321–1.227 0.173 2.036 1.090–3.804 0.026 vs. the CKD only Group 1.334 0.795–2.237 0.275 2.730 1.541–4.836 0.001 vs. the DM+CKD Group 2.114 1.287–3.474 0.014 2.225 1.160–4.266 0.016 Conclusion The efficacy of IVUS usage as regards 1-year MACE was confirmed in DM and CKD patients, but not observed in patients without them or in the combination of DM and CKD patients. Acknowledgement/Funding None