Rangan, Bavana V.

Background: Predicting technical failure in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can assist with decision making and planning of the procedure. Methods: We analyzed 6,946 CTO PCIs performed between 2016 and June 2022 at 36 international centers in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO) and created a score for risk of technical failure. Logistic regression prediction modeling was used to identify independently associated variables with technical failure and model were internally validated with bootstrapping. Results: Mean patient age was 64.0±10 years, 82% were men and technical success was 86%. The following variables were independently associated with technical failure and were included in the final model: age (odds ratio [OR]: 1.08, 95% Confidence Intervals [CI]: [1.00-1.15], p=0.039; age≥ 65 years; 1 point), CTO length (OR: 1.13, 95% CI [1.10, 1.17]; length≥ 20 mm; 1 point), moderate/severe calcification (OR: 1.35, 95% CI [1.17, 1.56]; 1 point), proximal cap ambiguity (OR: 2.25, 95% CI [1.95, 2.59]; 2 points), lack of interventional collaterals (OR: 1.60, 95% CI [1.39, 1.84]; 1 point), and lack of good distal landing zone (OR: 1.51, 95% CI [1.31, 1.75]; 1 point). The resulting score showed acceptable performance on receiver-operating characteristic (ROC) curve, AUC: 0.68 (95% CI [0.67-0.71]). Internal validation with bootstrapping of 1000 samples demonstrated a good agreement with the model, observed AUC: 0.68, (95% bias corrected CI [0.67, 0.70]). PROGRESS-CTO technical failure score and corresponding risk percentage and the percentage of patients in the respective risk group within the PROGRESS-CTO registry are represented in Figure 1. Conclusion: The updated PROGRESS CTO score may be useful for assessing the likelihood of technical failure success in CTO PCI.

Introduction: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with increased risk of periprocedural complications. Estimating the risk of complications facilitates risk-benefit assessment and procedural planning. Methods: We analyzed the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO, NCT02061436) and created a risk score for in-hospital all-cause mortality. Logistic regression prediction modeling was used to identify independently associated variables and the model was internally validated with bootstrapping. Results: Of the 10,480 CTO PCI cases performed between 2012-2022 at 40 US and non-US centers, in-hospital mortality occurred in 47 (0.45%). The final prediction model identified 4 independent predictors of mortality: Age ≥65 years, Odds Ratio [OR]: 2.83 (95% confidence interval [CI], 1.30-6.16), 1-point; Left ventricular ejection fraction ≤45%, OR: 2.13 (95% CI, 1.14-3.98), 1-point; Moderate-severe calcification, OR: 2.45 (95% CI, 1.18-5.08), 1-point; and Antegrade dissection re-entry, OR: 2.81 (95% CI, 1.06-7.43), 1-point; or Retrograde strategy, OR: 3.51 (95% CI, 1.67-7.37), 1-point; with a bootstrap corrected c-statistics of 0.71 (95% confidence interval: 0.63-0.81). The calculated risk percentages for mortality based on the PROGRESS-CTO mortality score ranged from 0.05-2.42% for mortality, and 63% of patients in the PROGRESS-CTO cohort had PROGRESS-CTO mortality score of 1 or 2, corresponding to a mortality risk of 0.1-0.5% (Figure 1). Conclusions: The PROGRESS-CTO in-hospital mortality risk score can facilitate risk-benefit assessment and procedural planning in patients undergoing CTO PCI.

AbstractBackgroundThe use of intravascular lithotripsy (IVL) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study.MethodsWe analyzed the baseline clinical and angiographic characteristics and procedural outcomes of 82 CTO PCIs that required IVL at 14 centers between 2020 and 2022.ResultsDuring the study period, IVL was used in 82 of 3301 (2.5%) CTO PCI procedures (0.4% in 2020 and 7% in 2022; p for trend < 0.001). Mean patient age was 69 ± 11 years and 79% were men. The prevalence of hypertension (95%), diabetes mellitus (62%), and prior PCI (61%) was high. The most common target vessel was the right coronary artery (54%), followed by the left circumflex (23%). The mean J‐CTO and PROGRESS‐CTO scores were 2.8 ± 1.1 and 1.3 ± 1.0, respectively. Antegrade wiring was the final successful crossing strategy in 65% and the retrograde approach was used in 22%. IVL was used in 10% of all heavily calcified lesions and 11% of all balloon undilatable lesions. The 3.5 mm lithotripsy balloon was the most commonly used balloon (28%). The mean number of pulses per lithotripsy run was 33 ± 32 and the median duration of lithotripsy was 80 (interquartile range: 40−103) seconds. Technical and procedural success was achieved in 77 (94%) and 74 (90%) cases, respectively. Two (2.4%) Ellis Class 2 perforations occurred after IVL use and were managed conservatively.ConclusionIVL is increasingly being used in CTO PCI with encouraging outcomes.

AbstractObjectivesTo investigate the perceptions of interventional cardiologists (IC) regarding the frequency, impact, and management strategies of percutaneous coronary intervention (PCI) complications.BackgroundThe perceptions and management strategies of ICs of PCI complications have received limited study.MethodsOnline survey on PCI complications: 46 questions were distributed via email lists and Twitter to ICs.ResultsOf 11,663 contacts, 821 responded (7% response rate): 60% were from the United States and the median age was 46–50 years. Annual PCI case numbers were <100 (26%), 100–199 (37%), 200–299 (21%), and ≥300 (16%); 42% do not perform structural interventions, others reported performing <40 (30%), or >100 (11%) structural cases annually. On a scale of 0–10, participating ICs were highly concerned about potential complications with a median score of 7.2 (interquartile range: 5.0–8.7). The most feared complication was death (39%), followed by coronary perforation (26%) and stroke (9%). Covered stents were never deployed by 21%, and 32% deployed at least one during the past year; 79% have never used fat to seal perforations; 64% have never used coils for perforations. Complications were attributed to higher patient/angiographic complexity by 68% and seen as opportunities for improvement by 70%; 97% of participants were interested in learning more about the management of PCI complications. The most useful learning methods were meetings (66%), webinars (48%), YouTube (32%), and Twitter (29%).ConclusionICs who participated in the survey are highly concerned about complications. Following complication management algorithms and having access to more experienced operators might alleviate stress and optimize patient outcomes.

Background: Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. Methods: We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT 01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. Results: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86–2.08]; P =0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23–68.92]; P =0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23–5.18]; P =0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08–3.40]; P =0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. Conclusions: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT 01121224.

VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drug‐eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared with bare‐metal stents (BMS) in participants undergoing stenting of de novo SVG lesions. Participants undergoing clinically indicated stenting of de novo SVG lesions were randomized in a 1:1 ratio to DES or BMS. Randomization was stratified by presence/absence of diabetes mellitus and the number of target SVG lesions (1 vs ≥2) within each participating site. At sites that did not routinely administer 12‐months of dual antiplatelet therapy after SVG stenting participants without acute coronary syndromes received 1 month of open‐label clopidogrel, followed by 11 months of clopidogrel for those assigned to DES and 11 months of placebo for those assigned to BMS. The primary endpoint was the 12‐month incidence of target‐vessel failure (defined as the composite of cardiac death, target‐vessel myocardial infarction, or target‐vessel revascularization). Secondary endpoints included the incidence of other clinical endpoints and the incremental cost‐effectiveness of DES relative to BMS. Due to lower‐than‐anticipated target‐vessel failure rates, target enrollment was increased from 519 to 762. The study had randomized 599 participants when recruitment ended in December 2015. The DIVA trial will provide clarity on the appropriate stent type for de novo SVG lesions.