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

In-Stent Restenosis in Saphenous Vein Grafts (from the DIVA Trial)

Saphenous vein grafts (SVGs) have high rates of in-stent restenosis (ISR). We compared the baseline clinical and angiographic characteristics of patients and lesions that did develop ISR with those who did not develop ISR during a median follow-up of 2.7 years in the DIVA study (NCT01121224). We also examined the ISR types using the Mehran classification. ISR developed in 119 out of the 575 DIVA patients (21%), with similar incidence among patients with drug-eluting stents and bare-metal stents (BMS) (21% vs 21%, p = 0.957). Patients in the ISR group were younger (67 ± 7 vs 69 ± 8 years, p = 0.04) and less likely to have heart failure (27% vs 38%, p = 0.03) and SVG lesions with Thrombolysis In Myocardial Infarction 3 flow before the intervention (77% vs 83%, p <0.01), but had a higher number of target SVG lesions (1.33 ± 0.64 vs 1.16 ± 0.42, p <0.01), more stents implanted in the target SVG lesions (1.52 ± 0.80 vs 1.31 ± 0.66, p <0.01), and longer total stent length (31.37 ± 22.11 vs 25.64 ± 17.42 mm, p = 0.01). The incidence of diffuse ISR was similar in patients who received drug-eluting-stents and BMS (57% vs 54%, p = 0.94), but BMS patients were more likely to develop occlusive restenosis (17% vs 33%, p = 0.05). © 202

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

OBJECTIVES: The authors sought to examine the outcomes of percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) chronic total occlusions (CTOs). BACKGROUND: The outcomes of PCI for ISR CTOs have received limited study. METHODS: The 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. RESULTS: ISR represented 15% of the CTOs (n = 1,755). Patients with ISR CTOs had higher prevalence of diabetes (44% vs. 38%; p \u3c 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 \u3c 0.0001). At 12 months, patients with ISR CTOs had a higher incidence of MACE (hazard ratio: 1.31; 95% confidence intervals: 1.01 to 1.70; p = 0.04). CONCLUSIONS: ISR CTOs represent 15% of all CTO PCIs and can be recanalized with similar success and in-hospital MACE as de novo CTOs

Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention

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; ) 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

Angiographic Features and Clinical Outcomes of Balloon Uncrossable Lesions during Chronic Total Occlusion Percutaneous Coronary Intervention

Background: Balloon uncrossable lesions are defined as lesions that cannot be crossed with a balloon after successful guidewire crossing. Methods: We analyzed the association between balloon uncrossable lesions and procedural outcomes of 8671 chronic total occlusions (CTOs) percutaneous coronary interventions (PCIs) performed between 2012 and 2022 at 41 centers. Results: The prevalence of balloon uncrossable lesions was 9.2%. The mean patient age was 64.2 ± 10 years and 80% were men. Patients with balloon uncrossable lesions were older (67.3 ± 9 vs. 63.9 ± 10, p \u3c 0.001) and more likely to have prior coronary artery bypass graft surgery (40% vs. 25%, p \u3c 0.001) and diabetes mellitus (50% vs. 42%, p \u3c 0.001) compared with patients who had balloon crossable lesions. In-stent restenosis (23% vs. 16%. p \u3c 0.001), moderate/severe calcification (68% vs. 40%, p \u3c 0.001), and moderate/severe proximal vessel tortuosity (36% vs. 25%, p \u3c 0.001) were more common in balloon uncrossable lesions. Procedure time (132 (90, 197) vs. 109 (71, 160) min, p \u3c 0.001) was longer and the air kerma radiation dose (2.55 (1.41, 4.23) vs. 1.97 (1.10, 3.40) min, p \u3c 0.001) was higher in balloon uncrossable lesions, while these lesions displayed lower technical (91% vs. 99%, p \u3c 0.001) and procedural (88% vs. 96%, p \u3c 0.001) success rates and higher major adverse cardiac event (MACE) rates (3.14% vs. 1.49%, p \u3c 0.001). Several techniques were required for balloon uncrossable lesions. Conclusion: In a contemporary, multicenter registry, 9.2% of the successfully crossed CTOs were initially balloon uncrossable. Balloon uncrossable lesions exhibited lower technical and procedural success rates and a higher risk of complications compared with balloon crossable lesions

Use of Intravascular Imaging During Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From a Contemporary Multicenter Registry

Background: Intravascular imaging can facilitate chronic total occlusion (CTO) percutaneous coronary intervention. Methods and Results: We examined the frequency of use and outcomes of intravascular imaging among 619 CTO percutaneous coronary interventions performed between 2012 and 2015 at 7 US centers. Mean age was 65.4±10 years and 85% of the patients were men. Intravascular imaging was used in 38%: intravascular ultrasound in 36%, optical coherence tomography in 3%, and both in 1.45%. Intravascular imaging was used for stent sizing (26.3%), stent optimization (38.0%), and CTO crossing (35.7%, antegrade in 27.9%, and retrograde in 7.8%). Intravascular imaging to facilitate crossing was used more frequently in lesions with proximal cap ambiguity (49% versus 26%, P<0.0001) and with retrograde as compared with antegrade‐only cases (67% versus 31%, P<0.0001). Despite higher complexity (Japanese CTO score: 2.86±1.19 versus 2.43±1.19, P=0.001), cases in which imaging was used for crossing had similar technical and procedural success (92.8% versus 89.6%, P=0.302 and 90.1% versus 88.3%, P=0.588, respectively) and similar incidence of major cardiac adverse events (2.7% versus 3.2%, P=0.772). Use of intravascular imaging was associated with longer procedure (192 minutes [interquartile range 130, 255] versus 131 minutes [90, 192], P<0.0001) and fluoroscopy (71 minutes [44, 93] versus 39 minutes [25, 69], P<0.0001) time. Conclusions: Intravascular imaging is frequently performed during CTO percutaneous coronary intervention both for crossing and for stent selection/optimization. Despite its use in more complex lesion subsets, intravascular imaging was associated with similar rates of technical and procedural success for CTO percutaneous coronary intervention. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02061436

Subintimal external crush technique for a balloon uncrossable chronic total occlusion

Chronic total occlusion (CTO) revascularization is traditionally limited by the challenges related to lesion crossing. In a smaller number of cases, however, inability to advance the balloon catheter to the crossing site can account for recanalization failure ( balloon uncrossable CTO). We describe a case of a balloon uncrossable CTO in which balloon crossing was achieved after subintimal dilation and external crushing of the CTO lesion resulting in significant modification of the CTO atheromatous plaque

Further validation of the hybrid algorithm for CTO PCI; difficult lesions, same success

OBJECTIVES: To evaluate the success rates and outcome of the hybrid algorithm for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) by a single operator in two different clinical settings. METHODS: We compared 279 consecutive CTO PCIs performed by a single, high-volume operator using the hybrid algorithm in two different clinical settings. Data were collected through the PROGRESS CTO Registry. We compared 145 interventions performed in a community program (cohort A) with 134 interventions performed in a referral center (cohort B). RESULTS: Patient in cohort B had more complex lesions with higher J-CTO (3.0 vs. 3.41; p CONCLUSIONS: In spite of higher lesion complexity in the setting of a quaternary-care referral center, use of the hybrid algorithm for CTO PCI enabled similarly high technical and procedural success rates as compared with those previously achieved by the same operator in a community-based program at the expense of a higher rate of MACE