Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention

ObjectivesThe aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding catheters with respect to clinically relevant access site–related bleeding or vascular complications.BackgroundThe femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach.MethodsAn international prospective multicenter trial was conducted, randomizing 388 patients with planned PCI for complex coronary lesions, including chronic total occlusion, left main, heavy calcification, or complex bifurcation, to either 7-F TR access (TRA) or 7-F TF access (TFA). The primary endpoint was defined as access site–related clinically significant bleeding or vascular complications requiring intervention at discharge. The secondary endpoint was procedural success.ResultsThe primary endpoint event rate was 3.6% for TRA and 19.1% for TFA (p < 0.001). The crossover rate from radial to femoral access was 3.6% and from femoral to radial access was 2.6% (p = 0.558). The procedural success rate was 89.2% for TFA and 86.0% for TRA (p = 0.285). There was no difference between TFA and TRA with regard to procedural duration, contrast volume, or radiation dose.ConclusionsIn patients undergoing PCI of complex coronary lesions with large-bore access, radial compared with femoral access is associated with a significant reduction in clinically relevant access-site bleeding or vascular complications, without affecting procedural success. (Complex Large-Bore Radial Percutaneous Coronary Intervention [PCI] Trial [Color]; NCT03846752)     

Retrograde Chronic Total Occlusion Percutaneous Coronary Intervention via Saphenous Vein Graft

ObjectivesThe aim of this study was to examine the use of saphenous vein grafts (SVGs) for retrograde crossing during chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundThe use of SVGs for retrograde crossing during CTO PCI has received limited study.MethodsA total of 1,615 retrograde CTO PCIs performed between 2012 and 2019 at 25 centers were examined. Clinical, angiographic, and technical characteristics and procedural outcomes were compared among retrograde cases via SVGs (SVG group) versus other collateral vessels (non-SVG group).ResultsRetrograde CTO PCI via SVGs was performed in 189 cases (12%). Patients in the SVG group were older (mean age 70 ± 9 years vs. 64 ± 10 years; p < 0.01) and had higher rates of prior myocardial infarction (62% vs. 51%; p < 0.01) and prior PCI (81% vs. 70%; p < 0.01). They were more likely to have moderate or severe calcification (81% vs. 65%; p < 0.01) and moderate or severe tortuosity (53% vs. 44%; p = 0.02) and had similar J-CTO (Multicenter CTO Registry in Japan) scores (3.2 ± 1.0 vs. 3.1 ± 1.1; p = 0.13) but higher PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores (4.7 ± 1.7 vs. 3.1 ± 1.1; p < 0.01). Technical (85% vs. 78%; p = 0.04) and procedural (81% vs. 74%; p = 0.04) success rates were higher in the SVG group, with no difference in in-hospital major adverse events (6.4% vs. 4.4%; p = 0.22). Contrast volume was lower in the SVG group (225 ml [173 to 325 ml] vs. 292 ml [202 to 400 ml]; p < 0.01).ConclusionsUse of SVGs for retrograde crossing is associated with higher rates of technical and procedural success and similar rates of in-hospital major adverse cardiac events compared with retrograde CTO PCI via other collateral vessels.     

Comparative Analysis of Patient Characteristics in Chronic Total Occlusion Revascularization Studies: Trials vs Real-World Registries

BackgroundThe few randomized controlled trials (RCTs) on chronic total occlusion (CTO) percutaneous coronary intervention (PCI) are subject to selection bias.ObjectivesThe purpose of this study was to evaluate the differences between real-world CTO patients and those enrolled in RCTs.MethodsThis study performed a meta-analysis of national and dedicated CTO PCI registries and compared patient characteristics and outcomes with those of RCTs that randomized patients to CTO PCI versus medical therapy. Given the large sample size differences between RCTs and registries, the study focused on the absolute numbers and their clinical significance. The study considered a 5% relative difference between groups to be potentially clinically relevant.ResultsFrom 2012 to 2022, 6 RCTs compared CTO PCI versus medical therapy (n = 1,047) and were compared with 15 registries (5 national and 10 dedicated CTO PCI registries). Compared with registry patients, RCT patients had fewer comorbidities, including diabetes, hypertension, previous myocardial infarction, and prior coronary artery bypass graft surgery. RCT patients had shorter CTO length (29.6 ± 19.7 mm vs 32.6 ± 23.0 mm, a relative difference of 9.2%) and lower Japan–Chronic Total Occlusion Score scores (2.0 ± 1.1 vs 2.3 ± 1.2, a relative difference of 13%) compared with those enrolled in dedicated CTO registries. Procedural success was similar between RCTs (84.5%) and dedicated CTO registries (81.4%) but was lower in national registries (63.9%).ConclusionsThere is a paucity of randomized data on CTO PCI outcomes (6 RCTs, n = 1,047). These patients have lower risk profiles and less complex CTOs than those in real-world registries. Current evidence from RCTs may not be representative of real-world patients and should be interpreted within its limitation.     

Retrograde Chronic Total Occlusion Percutaneous Coronary Interventions: Predictors of Procedural Success From the ERCTO Registry

ObjectivesThe aim of this study was to identify independent predictors of procedural success after retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundRetrograde CTO PCI is an established technique, but predictors of success remain poorly understood.MethodsA multivariable logistic regression model was used to analyze potentially important demographic, clinical, anatomical, and technical aspects of retrograde CTO PCI cases uploaded to the multicenter European CTO (ERCTO) Club Registry.ResultsIn calendar years 2018 and 2019, 2,364 retrograde CTO PCI cases constituted the primary analysis cohort. A primary retrograde strategy was used in 1,953 cases (82.6%), and an initial antegrade approach was converted to retrograde in 411 cases (17.4%). Procedural success was achieved in 1,820 cases (77.0%) and was more likely to occur after a primary retrograde attempt versus conversion from an initial antegrade approach (80.9% vs 58.4%; P < 0.0001). After multivariable analysis, an absence of lesion calcification (OR: 1.86; 95% CI: 1.37-2.51; P < 0.0001), a higher degree of distal vessel opacification (OR: 2.47; 95% CI: 1.72-3.55; P < 0.0001), little or no proximal target vessel tortuosity (OR: 1.84; 95% CI: 1.28-2.64; P = 0.001), Werner collateral connection CC1 (OR: 4.87; 95% CI: 2.90-8.19; P < 0.0001) or CC2 (OR: 5.33; 95% CI: 3.02-9.42; P < 0.0001), and the top tertile of operator volume (>120 cases over 2 years) (OR: 1.88; 95% CI: 1.26-2.79; P = 0.002) were associated with the greatest chance of achieving angiographic success.ConclusionsLess calcification with good distal vessel opacification, little or absent proximal vessel tortuosity, and visible collateral connections, along with high-volume operator status, were all independently predictive of angiographically successful retrograde CTO PCI.     

Use of the Limited Antegrade Subintimal Tracking Technique in Chronic Total Occlusion Percutaneous Coronary Intervention

BackgroundThere are limited data on the limited antegrade subintimal tracking (LAST) technique for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).ObjectivesThe aim of this study was to analyze the frequency of use and outcomes of the LAST technique for CTO PCI.MethodsWe analyzed 2,177 CTO PCIs performed using antegrade dissection and re-entry (ADR) in the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) registry between 2012 and January 2022 at 39 centers. ADR was attempted in 1,465 cases (67.3%).ResultsAmong antegrade re-entry cases, LAST was used in 163 (11.1%) (primary LAST in 127 [8.7%] and secondary LAST [LAST after other ADR approaches failed] in 36 [2.5%]), the Stingray system (Boston Scientific) in 980 (66.9%), subintimal tracking and re-entry in 387 (26.4%), and contrast-guided subintimal tracking and re-entry in 29 (2.0%). The mean patient age was 65.2 ± 10 years, and 85.8% were men. There was no significant difference in technical (71.8% vs 77.8%; P = 0.080) and procedural (69.9% vs 75.3%; P = 0.127) success and major cardiac adverse events (1.84% vs 3.53%; P = 0.254) between LAST and non-LAST cases. However, on multivariable analysis, the use of LAST was associated with lower procedural success (OR: 0.61; 95% CI: 0.41-0.91). Primary LAST was associated with higher technical (76.4% vs 55.6%; P = 0.014) and procedural (75.6% vs 50.0%; P = 0.003) success and similar major adverse cardiac event (1.57% vs 2.78%; P = 0.636) rates compared with secondary LAST.ConclusionsLAST was used in 11.1% of antegrade re-entry CTO PCI cases and was associated with lower procedural success on multivariable analysis, suggesting a limited role of LAST in contemporary CTO PCI.     

In-Stent CTO Percutaneous Coronary Intervention: Individual Patient Data Pooled Analysis of 4 Multicenter Registries

ObjectivesThe authors sought to examine the outcomes of percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) chronic total occlusions (CTOs).BackgroundThe outcomes of PCI for ISR CTOs have received limited study.MethodsThe authors examined the clinical and angiographic characteristics and procedural outcomes of 11,961 CTO PCIs performed in 11,728 patients at 107 centers in Europe, North America, Latin America, and Asia between 2012 and 2020, pooling patient-level data from 4 multicenter registries. In-hospital major adverse cardiovascular events (MACE) included death, myocardial infarction, stroke, and tamponade. Long-term MACE were defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization.ResultsISR represented 15% of the CTOs (n = 1,755). Patients with ISR CTOs had higher prevalence of diabetes (44% vs. 38%; p < 0.0001) and prior coronary artery bypass graft surgery (27% vs. 24%; p = 0.03). Mean J-CTO (Multicenter CTO Registry in Japan) score was 2.32 ± 1.27 in the ISR group and 2.22 ± 1.27 in the de novo group (p = 0.01). Technical (85% vs. 85%; p = 0.75) and procedural (84% vs. 84%; p = 0.82) success was similar for ISR and de novo CTOs, as was the incidence of in-hospital MACE (1.7% vs. 2.2%; p = 0.25). Antegrade wiring was the most common successful strategy, in 70% of ISR and 60% of de novo CTOs, followed by retrograde crossing (16% vs. 23%) and antegrade dissection and re-entry (15% vs. 16%; p < 0.0001). At 12 months, patients with ISR CTOs had a higher incidence of MACE (hazard ratio: 1.31; 95% confidence interval: 1.01 to 1.70; p = 0.04).ConclusionsISR CTOs represent 15% of all CTO PCIs and can be recanalized with similar success and in-hospital MACE as de novo CTOs.     

Impact of Subintimal Plaque Modification on Reattempted Chronic Total Occlusions Percutaneous Coronary Intervention

BackgroundPredictors of success in reattempted chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures remain obscure, mainly owing to the lack of consecutive angiograms and procedural records of initial attempts in the same cohort.ObjectivesThis study sought to investigate the factors predicting the success of reattempted CTO PCI procedures.MethodsA total of 208 consecutive patients who underwent a failed CTO PCI attempt and received reattempted procedure at the same cardiac center were retrospectively analyzed. Predictors of the success of reattempted procedures were evaluated.ResultsThe overall technical success rate of reattempted CTO PCI procedures was 71.2%. Subintimal plaque modification (SPM) was implemented in 35 (16.8%) procedures in initial attempts. The reattempted technical success rate was 93.3% in cases in which SPM with guidewire (GW) crossing was achieved in the initial attempt; however, the success rate was 55.0% for procedures involving SPM without GW crossing. SPM with GW crossing (OR: 11.21; 95% CI: 1.31-96.16; P = 0.028), referral to high-volume operators (OR: 2.38; 95% CI: 1.14-4.98; P = 0.021), and a bidirectional approach (OR: 2.31; 95% CI: 1.12-4.79; P = 0.024) were positive independent predictors of technical success in the subsequent reattempt. The time interval for reattempt (per 90-day increment) was negatively correlated with the technical success of the reattempted procedures (OR: 0.85; 95% CI: 0.73-0.98; P = 0.030).ConclusionsThis study identified independent predictors of success in reattempted CTO PCI procedures. SPM with GW crossing achieved in the initial attempt is associated with a higher success rate in the subsequent reattempt.     

Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center,Randomized Study

ObjectivesThis study aimed to compare the efficacy and safety of the distal transradial approach (dTRA) versus the conventional transradial approach (TRA) for coronary angiography and percutaneous coronary interventions.BackgroundThe recommended approach for coronary procedures is TRA. However, it is associated with radial artery occlusion (RAO). The dTRA could potentially decrease the incidence of RAO.MethodsOne thousand forty-two consecutive patients were randomized (1:1) to right dTRA or TRA. The primary endpoint was the rate of RAO, which was evaluated by Doppler ultrasound at 60 days after randomization.ResultsFive hundred eighteen and 524 patients were randomized to dTRA and TRA, respectively. Follow-up Doppler evaluation of the radial artery was accomplished in 404 (78.0%) patients in the dTRA group and 392 (74.8%) in the TRA group. The rate of RAO was significantly reduced in the dTRA group compared with TRA group (3.7% vs 7.9%, respectively; P = 0.014). The rate of successful sheath insertion was lower in the dTRA group compared with the TRA group (78.7% vs 94.8%, respectively; P < 0.001). More punctures (median = 2 [IQR: 1-3] vs median = 1 [IQR: 1-2]; P < 0.001) and a longer time (120 vs 75 seconds; P < 0.001) were required for sheath insertion in the dTRA group compared with the TRA group. The hemostasis time was shorter in the dTRA group compared with the TRA group (60 vs 120 minutes; P < 0.001). The dose area product was higher in the dTRA group (median = 32,729 in the dTRA vs 28,909 cGy/cm² in the TRA group; P = 0.02). No significant differences were observed in the secondary safety endpoints (bleeding [Bleeding Academic Research Consortium ≥2] and severe radial artery spasm).ConclusionsAccording to our study, dTRA was associated with a lower rate of forearm RAO, a shorter time of hemostasis, a higher crossover rate and dose area product, and a longer procedural time compared with TRA.     

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial

BackgroundCurrently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking.ObjectivesThe aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO.MethodsDISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site–related complications.ResultsOverall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups.ConclusionsWith the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.     

Tratamiento percutáneo de oclusiones coronarias crónicas aorto-ostiales: resultados y consideraciones técnicas de un registro multicéntrico

Introduction and objectivesPercutaneous coronary intervention (PCI) for aorto-ostial chronic total coronary occlusion (CTO) can be a particularly challenging lesion subset. The aim of this study was to analyze the technical aspects and outcomes of aorto-ostial CTO PCI in a multicenter registry.MethodsPatients undergoing aorto-ostial CTO PCI at 4 centers between February 2013 and December 2018 were included. Success rates, as well as procedural aspects and outcomes, were analyzed.ResultsA total of 103 patients were included. Mean age was 64 ± 10 years and the mean J-CTO score was 3.1 ± 1.1. Thirty-one lesions (30.4%) were flush ostial CTOs. Technical and procedural success were achieved in 79 (76.7%) and 78 (75.7%) of the patients, respectively. The retrograde approach was the most frequent successful crossing technique (n = 49; 62.0%), especially in flush vs nonflush aorto-ostial CTOs (82.6% vs 53.5%; P = .02). The only variable independently associated with technical failure was the absence of interventional collaterals (OR, 12.38; 95%CI, 4.02-38.15; P < .001). Coronary perforation occurred in 4 patients (3.9%) requiring covered stent implantation (without subsequent cardiac tamponade) and 2 patients (1.9%) had a stroke (one of which was a transient ischemic attack). During a median follow-up of 31 months, 3 (2.9%) patients died from cardiovascular causes and 13 (12.6%) required repeat target vessel revascularization.ConclusionsAorto-ostial occlusions represent a challenging subset for PCI. However, an acceptable success rate with favorable outcomes during follow-up can be achieved by experienced operators. The presence of interventional collaterals allowing the use of the retrograde approach is key for achieving procedural success.     

Effect of Coronary CTA on Chronic Total Occlusion Percutaneous Coronary Intervention: A Randomized Trial

ObjectivesThe purpose of this study was to test whether the success rate of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) increased with pre-procedural coronary computed tomography angiography (CTA).BackgroundCoronary CTA provides valuable information before and during CTO-PCI. However, there are no randomized data that explore whether coronary CTA increases its success rate.MethodsIn this multicenter, randomized trial, a total of 400 patients with CTO were randomized to receive PCI with pre-procedural coronary CTA (coronary CTA–guided group; n = 200) or without coronary CTA (angiography-guided group; n = 200) between January 2014 and September 2019. The primary endpoint was the successful recanalization rate, a final TIMI (Thrombolysis In Myocardial Infarction) grade ≥2, and ≤30% residual stenosis on the final angiogram.ResultsA total of 10 operators performed PCI. Successful recanalization was achieved in 187 patients (93.5%) in the coronary CTA–guided group and in 168 patients (84.0%) in the angiography-guided group (absolute difference, 9.5% [95% confidence interval: 3.4% to 15.6%]; p = 0.003). When comparing the success rates according to the Multicenter CTO Registry of Japan score (J-CTO), the coronary CTA guidance was favored over the angiography-guidance in the subset of J-CTO ≥2 versus in the subset of J-CTO <2 (p interaction = 0.035). Coronary perforations occurred in 2 (1%) and 8 patients (4%) in the coronary CTA- and angiography-guided groups, respectively (p = 0.055). Periprocedural myocardial infarction was not observed in the coronary CTA–guided group, whereas it occurred in 4 patients (2%) in the angiography-guided group (p = 0.123). Total procedure and fluoroscopic times were not different. There were no differences between the groups in the occurrences of cardiac death, target vessel–related myocardial infarction, or target-vessel revascularization at 1 year.ConclusionsPre-procedural coronary CTA-guidance for CTO resulted in higher success rates with numerically fewer immediate periprocedural complications such as coronary perforations or periprocedural myocardial infarction than angiography guidance. Higher success rates were more prominently observed in patients with CTO who had a high J-CTO score than those who did not. (Role of CT Scan for the Successful Recanalization of Chronic Total Occlusion; a Randomized Comparison Between 3D CT-guided PCI vs. Conventional Treatment [CT-CTO Trial]; NCT02037698)     

Impacto del acceso vascular en el pronóstico tras la angioplastia coronaria en pacientes con alto riesgo hemorrágico: subanálisis predefinido del estudio LEADERS FREE

Introduction and objectivesThe prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up.MethodsThe LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial.ResultsTransradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P = .003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P = .003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P = .003). This difference was driven by both access and nonaccess bleeding.ConclusionsOperators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access.     

Impacto de la adherencia a un algoritmo híbrido para la selección de la estrategia inicial de cruce en la intervención coronaria percutánea de oclusiones crónicas

Introduction and objectivesThe hybrid algorithm was designed to assist with initial and subsequent crossing strategy selection in chronic total occlusion (CTO) percutaneous coronary interventions (PCIs). However, the success of the initially selected strategy has received limited study.MethodsWe examined the impact of adherence to the hybrid algorithm recommendation for initial CTO crossing technique selection in 4178 CTO PCIs from a large multicenter registry.ResultsThe initial crossing strategy was concordant with the hybrid algorithm recommendation in 1833 interventions (44%). Patients in the concordant group had a similar age to those in the discordant group but a lower mean J-CTO score (2.0 ± 1.4 vs 2.8 ± 1.1; P < .01). The concordant group showed higher technical success with the first crossing strategy (68% vs 48%; P < .01) and higher overall technical success (88% vs 83%; P < .01) with no difference in the incidence of in-hospital major adverse events (1.8% vs 2.3%; P  =  .26). In multivariable analysis, after adjustment for age, prior myocardial infarction, prior PCI, prior coronary artery bypass grafting, J-CTO score, and scheduled CTO PCI, nonadherence to the hybrid algorithm was independently associated with lower technical success of the initial crossing strategy (odds ratio, 0.55; 95% confidence interval, 0.48-0.64; P < .01).ConclusionsAdherence to the hybrid algorithm for initial crossing strategy selection is associated with higher CTO PCI success but similar in-hospital major adverse cardiac events.     

Association of Acute Procedural Results With Long-Term Outcomes After CTO PCI

ObjectivesThe aim of this study was to determine the association of procedural outcomes with long-term mortality and myocardial infarction (MI) after chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundThe association between acute procedural results and subsequent outcomes has received limited study.MethodsBetween January 2010 and December 2013, a total of 2,659 CTO PCI patients were consecutively enrolled. Procedural results were categorized into 3 groups: 1) optimal recanalization, with reperfusion of the occluded vessel and side branches (if any) with TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; 2) suboptimal recanalization, meeting any of the following criteria: persistence of significant side branch occlusion, final TIMI flow grade 1 or 2, or residual percentage diameter stenosis >30%; and 3) procedural failure (i.e., failure to cross a lesion with a balloon angioplasty catheter). The primary outcome was the 5-year composite endpoint of cardiac death and MI.ResultsOverall, optimal recanalization was achieved in 1,562 patients (58.7%), suboptimal recanalization was achieved in 399 patients (15.0%), and recanalization failed in 698 patients (26.3%). The 5-year incidence of the primary outcome was significantly higher in the suboptimal recanalization group compared with the optimal recanalization and the failure groups (10.1% vs. 6.5% vs. 6.3%; p = 0.046), which was driven mainly by higher risk for MI. In subgroup analysis, significant side branch occlusion was associated with numerically higher risk for 5-year MI (hazard ratio: 1.55; 95% confidence interval: 0.99 to 2.43; p = 0.054).ConclusionsIn this large cohort of CTO PCI patients, suboptimal recanalization was associated with significantly higher long-term incidence of cardiac death and MI compared with optimal recanalization or procedural failure.     

Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 Trial

ObjectivesThe aim of this trial was to test whether the potassium ferrate hemostatic patch (PFHP) as an adjunct to the TR Band (TRB) facilitated an early deflation protocol.BackgroundShorter TRB compression times may reduce the rate of radial artery occlusion (RAO) and reduce observation time after transradial access.MethodsA total of 443 patients were randomized to the TRB or PFHP + TRB, with complete TRB deflation attempted 60 minutes postprocedure. The primary outcome was the time to successful full deflation of the TRB without bleeding, with secondary outcomes of time to discharge and complications including hematoma, RAO, or bleeding requiring intervention beyond TRB reinflation.ResultsTime to complete TRB deflation was 66 ± 14 minutes with the PFHP vs 113 ± 56 minutes for the TRB alone (P < 0.001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs 67.7%; P < 0.001) with 2.3 ± 1.3 additional reinflation and deflation attempts needed for hemostasis. Hematomas developed in 4.0% of the PFHP group and 6.8% of the TRB group (P = 0.20). RAO was rare (<1%), although 41% of patients received <5,000 U heparin. Among percutaneous coronary intervention patients, time to TRB deflation (68 ± 15 minutes vs 138 ± 62 minutes; P < 0.001) and composite complications (10.0% vs 24.2%; P = 0.04) were reduced with the PFHP.ConclusionsCompared with the TRB alone, the PFHP facilitated early 60-minute TRB deflation following transradial catheterization, with a numeric reduction in vascular complications. RAO occurs rarely with early deflation regardless of heparin dose. (Comparing TR Band to StatSeal in Conjunction With TR Band II [StatSeal II]; NCT04046952)     

Ischemic Burden Reduction and Long-Term Clinical Outcomes After Chronic Total Occlusion Percutaneous Coronary Intervention

ObjectivesThe authors sought to evaluate the impact of ischemic burden reduction after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) on long-term prognosis and cardiac symptom relief.BackgroundThe clinical benefit of CTO PCI is questioned.MethodsIn a high-volume CTO PCI center, 212 patients prospectively underwent quantitative [¹⁵O]H₂O positron emission tomography perfusion imaging before and three months after successful CTO PCI between 2013-2019. Perfusion defects (PD) (in segments) and hyperemic myocardial blood flow (hMBF) (in ml · min^?1 · g^?1) allocated to CTO areas were related to prognostic outcomes using unadjusted (Kaplan-Meier curves, log-rank test) and risk-adjusted (multivariable Cox regression) analyses. The prognostic endpoint was a composite of all-cause death and nonfatal myocardial infarction.ResultsAfter a median [interquartile range] of 2.8 years [1.8 to 4.3 years], event-free survival was superior in patients with ≥3 versus <3 segment PD reduction (p < 0.01; risk-adjusted p = 0.04; hazard ratio [HR]: 0.34 [95% confidence interval (CI): 0.13 to 0.93]) and with hMBF increase above (Δ≥1.11 ml · min^?1 · g^?1) versus below the population median (p < 0.01; risk-adjusted p < 0.01; HR: 0.16 [95% CI: 0.05 to 0.54]) after CTO PCI. Furthermore, event-free survival was superior in patients without versus any residual PD (p < 0.01; risk-adjusted p = 0.02; HR: 0.22 [95% CI: 0.06 to 0.76]) or with a residual hMBF level >2.3 versus ≤2.3 ml · min^?1 · g^?1 (p < 0.01; risk-adjusted p = 0.03; HR: 0.25 [95% CI: 0.07 to 0.91]) at follow-up positron emission tomography. Patients with residual hMBF >2.3 ml · min^?1 · g^?1 were more frequently free of angina and dyspnea on exertion at long-term follow-up (p = 0.04).ConclusionsPatients with extensive ischemic burden reduction and no residual ischemia after CTO PCI had lower rates of all-cause death and nonfatal myocardial infarction. Long-term cardiac symptom relief was associated with normalization of hMBF levels after CTO PCI.     

Percutaneous Coronary Intervention for Chronic Total Occlusion—The Michigan Experience: Insights From the BMC2 Registry

ObjectivesThe aim of this study was to describe the performance and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in Michigan.BackgroundCTO PCI has been associated with reduction in angina, but previous registry analyses showed a higher rate of major adverse cardiac events with this procedure.MethodsTo study uptake and outcomes of CTO PCI in Michigan, patients enrolled in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry (2010 to 2017) were evaluated. CTO PCI was defined as intervention in a 100% occluded coronary artery ≥3 months old.ResultsAmong 210,172 patients enrolled in the registry, 7,389 CTO PCIs (3.5%) were attempted, with 4,614 (58.3%) achieving post-procedural TIMI (Thrombolysis In Myocardial Infarction) flow grade 3. The proportion of PCIs performed on CTOs increased over the study period (from 2.67% in 2010 to 4.48% in 2017). Thirty of 47 hospitals performed >50 CTO interventions in 2017. Pre-procedural angina class ≤2 was present in one-quarter, and functional assessment for ischemia was performed in 46.6% of patients. Major complications occurred in 245 patients (3.3%) and included death (1.4%), post-procedural stroke (0.4%), cardiac tamponade (0.5%), and urgent coronary artery bypass graft surgery (1.3%). Procedural success improved modestly from 44.5% in 2010 to 54.9% in 2017 (p for trend < 0.001). Rates of in-hospital mortality (p for trend = 0.247) and major adverse cardiac event (p for trend = 0.859) for CTO PCI remained unchanged over the study period.ConclusionsThe rate of CTO PCI in Michigan increased over the study period. Although the success rate of CTO PCI has increased modestly in contemporary practice, it remained far below the >80% reported by select high-volume CTO operators. The rate of periprocedural major adverse cardiac events or death remained unchanged over time. These data suggest room for improvement in the selection and functional assessment of CTO lesions before subjecting patients to the increased procedural risk associated with CTO PCI.     

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial

ObjectivesThe aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency.BackgroundThe TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO.MethodsThe authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 μg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound.ResultsA total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO.ConclusionsThe routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).     

Differential Improvement in Angina and Health-Related Quality of Life After PCI in Focal and Diffuse Coronary Artery Disease

BackgroundAn increase in fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is associated with improvement in angina. Coronary artery disease (CAD) patterns (focal vs diffuse) influence the FFR change after stenting and may predict angina relief.ObjectivesThe aim of this study was to investigate the differential improvement in patient-reported outcomes after PCI in focal and diffuse CAD as defined by the pullback pressure gradient (PPG).MethodsThis is a subanalysis of the TARGET-FFR (Trial of Angiography vs. pressure-Ratio-Guided Enhancement Techniques–Fractional Flow Reserve) randomized clinical trial. The 7-item Seattle Angina Questionnaire (SAQ-7) was administered at baseline and 3 months after PCI. The PPG index was calculated from manual pre-PCI FFR pullbacks. The median PPG value was used to define focal and diffuse CAD. Residual angina was defined as an SAQ-7 score <100.ResultsA total of 103 patients were analyzed. There were no differences in the baseline characteristics between patients with focal and diffuse CAD. Focal disease had larger increases in FFR after PCI than patients with diffuse disease (0.30 ± 0.14 vs 0.19 ± 0.12; P < 0.001). Patients with focal disease who underwent PCI for focal CAD had significantly higher SAQ-7 summary scores at follow-up than those with diffuse CAD (87.1 ± 20.3 vs 75.6 ± 24.4; mean difference = 11.5 [95% CI: 2.8-20.3]; P = 0.01). After PCI, residual angina was present in 39.8% but was significantly less in those with treated focal CAD (27.5% vs 51.9%; P = 0.020).ConclusionsResidual angina after PCI was almost twice as common in patients with a low PPG (diffuse disease), whereas patients with a high PPG (focal disease) reported greater improvement in angina and quality of life. The baseline pattern of CAD can predict the likelihood of angina relief. (Trial of Angiography vs. pressure-Ratio-Guided Enhancement Techniques–Fractional Flow Reserve [TARGET-FFR]; NCT03259815)     

1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial

ObjectivesThe aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation.BackgroundIt is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI).MethodsIn this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%).ResultsThe primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference −0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842).ConclusionsAmong patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy. (A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-Eluting Stent Implantation; NCT02513810)