Prevalence, Presentation and Treatment of \u27Balloon Undilatable\u27 Chronic Total Occlusions: Insights from a Multicenter US Registry

BACKGROUND: The prevalence, treatment and outcomes of balloon undilatable chronic total occlusions (CTOs) have received limited study. METHODS: We examined the prevalence, clinical and angiographic characteristics, and procedural outcomes of percutaneous coronary interventions (PCIs) for balloon undilatable CTOs in a contemporary multicenter US registry. RESULTS: Between 2012 and 2017 data on balloon undilatable lesions were available for 425 consecutive CTO PCIs in 415 patients in whom guidewire crossing was successful: 52 of 425 CTOs were balloon undilatable (12%). Mean patient age was 65 ± 10 years and most patients were men (84%). Patients with balloon undilatable CTOs were more likely to be diabetic (67 vs. 41%, P \u3c 0.001) and have heart failure (44 vs. 28%, P = 0.027). Balloon undilatable CTOs were longer (40 mm [interquartile range, IQR 20-50] vs. 30 [IQR 15-40], P = 0.016), more likely to have moderate/severe calcification (87 vs. 54%, P \u3c 0.001), and had higher J-CTO score (3.2 ± 1.1 vs. 2.5 ± 1.3, P \u3c 0.001) and PROGRESS-CTO complications score (3.9 ± 1.7 vs. 3.1 ± 2.0, P \u3c 0.005). They were associated with lower technical and procedural success (92 vs. 98%, P = 0.024; and 88 vs. 96%, P = 0.034, respectively) and higher risk for in-hospital major adverse events (8 vs. 2%, P = 0.008) due to higher perforation rates. The most frequent treatments for balloon undilatable CTOs were high pressure balloon inflations (64%), rotational atherectomy (31%), laser (21%), and cutting balloons (15%). CONCLUSIONS: Balloon undilatable CTOs are common and are associated with lower success and higher complication rates

Incidence, Treatment, and Outcomes of Coronary Perforation During Chronic Total Occlusion Percutaneous Coronary Intervention

Coronary perforation is a potential complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We analyzed 2,097 CTO PCIs performed in 2,049 patients from 2012 to 2017. Patient age was 65 ± 10 years, 85% were men, and 36% had prior coronary artery bypass graft surgery. Technical and procedural success were 88% and 87%, respectively. A major periprocedural adverse cardiovascular event occurred in 2.6%. Coronary perforation occurred in 85 patients (4.1%); The frequency of Ellis class 1, 2, and 3 perforations was 21%, 26%, and 52%, respectively. Perforation occurred more frequently in older patients and those with previous coronary artery bypass graft surgery (61% vs 35%, p \u3c 0.001). Cases with perforation were angiographically more complex (Multicenter CTO Registry in Japan score 3.0 ± 1.2 vs 2.5 ± 1.3, p \u3c 0.001). Twelve patients (14%) with perforation experienced tamponade requiring pericardiocentesis. Patient age, previous PCI, right coronary artery target CTO, blunt or no stump, use of antegrade dissection re-entry, and the retrograde approach were associated with perforation. Adjusted odds ratio for periprocedural major periprocedural adverse cardiovascular events among patients with perforation was 15.04 (95% confidence interval 7.35 to 30.18). In conclusion, perforation occurs relatively infrequently in contemporary CTO PCI performed by experienced operators and is associated with baseline patient characteristics and angiographic complexity necessitating use of advanced crossing techniques. In most cases, perforations do not result in tamponade requiring pericardiocentesis, but they are associated with reduced technical and procedural success, higher periprocedural major adverse events, and reduced procedural efficiency

Frequency and Outcomes of Ad Hoc Versus Planned Chronic Total Occlusion Percutaneous Coronary Intervention: Multicenter Experience

BACKGROUND: For patients needing coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI), a planned, staged intervention has been recommended by experts. Ad hoc CTO-PCI, however, occurs in practice. METHODS: Observational, contemporary, multicenter, international registry. Our goals were to determine the frequency, characteristics, procedural techniques, and outcomes of patients who underwent ad hoc vs planned CTO-PCI. RESULTS: Among 2282 patients who underwent CTO-PCI between 2012 and 2017, 318 (14%) were ad hoc. Patients undergoing ad hoc CTO-PCI had lower J-CTO, PROGRESS CTO, and PROGRESS Complications scores. Antegrade-wire escalation was used more often in ad hoc PCI (96% vs 81%; P CONCLUSIONS: Ad hoc CTO-PCI occurs more commonly in less complex lesions and is associated with similarly high success rates as planned CTO-PCI in lower J-CTO score lesions, suggesting that ad hoc CTO-PCI may be an acceptable option for experienced hybrid operators in carefully selected cases. Complex cases, as quantified by the J-CTO score, have a higher in-hospital MACE rate and should preferably be performed following proper planning and preparation

External validation of the PROGRESS-CTO perforation risk score: Individual patient data pooled analysis of three registries

Background: Coronary artery perforation is one of the most feared and common complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Methods: To assess the usefulness of the recently developed PROGRESS-CTO (NCT02061436) perforation risk score in independent cohorts. Individual patient-level data pooled analysis of three registries was performed. Results: Of the 4566 patients who underwent CTO PCI at 25 centers, 196 (4.2%) had coronary artery perforation. Patients with perforations were older (69 ± 10 vs. 65 ± 10, p < 0.001), more likely to be women (19% vs. 13%, p = 0.009), more likely to have a history of prior coronary artery bypass graft (34% vs. 20%, p < 0.001), and unfavorable angiographic characteristics such as blunt stump (62% vs. 48%, p < 0.001), proximal cap ambiguity (52% vs. 34%, p < 0.001), and moderate-severe calcification (60% vs. 49%, p = 0.002). Technical success was lower in patients with perforations (73% vs. 88%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO perforation risk model was 0.76 (95% confidence interval [CI], 0.72−0.79), with good calibration (Hosmer-Lemeshow p = 0.97). We found that the CTO PCI perforation risk increased with higher PROGRESS-CTO perforation scores: 0.3% (score 0), 2.3% (score 1), 3.1% (score 2), 5.5% (score 3), 7.5% (score 4), 14.6% (score 5). Conclusion: Given the good discriminative performance, calibration, and the ease of calculation, the PROGRESS-CTO perforation score may facilitate assessment of the risk of perforation in patients undergoing CTO PCI

External validation of the PROGRESS-CTO complication risk scores: Individual patient data pooled analysis of 3 registries

Background: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with a considerable risk of complications, and risk stratification is of utmost importance. Aims: To assess the clinical usefulness of the recently developed PROGRESS-CTO (NCT02061436) complication risk scores in an independent cohort. Methods: Individual patient data pooled analysis of 3 registries was performed. Results: Of the 4569 patients who underwent CTO PCI, 102 (2.2%) had major adverse cardiovascular events (MACE). Patients with MACE were older (69 ? 11 vs. 65 ? 10, p < 0.001), more likely to have a history of prior coronary artery bypass graft surgery, and unfavorable angiographic characteristics J-CTO score (2.4 ? 1.2 vs. 2.1 ? 1.3, p = 0.007), including blunt stump (59% vs. 49%, p = 0.047). Technical success was lower in patients with MACE (59% vs. 86%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO complication risk models were as follows: MACE 0.72 (95% confidence interval [CI], 0.67?0.76), mortality 0.73 (95% CI, 0.61?0.85), and pericardiocentesis 0.69 (95% CI, 0.62?0.77) in the validation dataset. The observed complication rates increased with higher PROGRESS-CTO complication scores. The PROGRESS-CTO MACE score showed good calibration in this external cohort, with MACE rates similar to the original study: 0.7% (score 0?1), 1.5% (score 2), 2.2% (score 3), 3.8% (score 4), 4.9% (score 5), 5.8% (score 6?7). Conclusion: Given the good discriminative performance, calibration, and ease of calculation, the PROGRESS-CTO complication scores could help assess the risk of complications in patients undergoing CTO PCI

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost

Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial

BackgroundFew studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions.MethodsPatients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. 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 revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224.FindingsBetween Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (&gt;99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached.InterpretationIn patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy.FundingUS Department of Veterans Affairs Cooperative Studies Program