Retrograde chronic total occlusion percutaneous coronary intervention via ipsilateral collaterals.

BACKGROUND: There is limited data on retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) via ipsilateral epicardial collaterals (IEC). AIMS: To compare the clinical and angiographic characteristics, and outcomes of retrograde CTO PCI via IEC versus other collaterals in a large multicenter registry. METHODS: Observational cohort study from the Prospective Global registry for the study of Chronic Total Occlusion Intervention (PROGRESS-CTO). RESULTS: Of 4466 retrograde cases performed between 2012 and 2023, crossing through IEC was attempted in 191 (4.3%) cases with 50% wiring success. The most common target vessel in the IEC group was the left circumflex (50%), in comparison to other retrograde cases, where the right coronary artery was most common (70%). The Japanese CTO score was similar between the two groups (3.13 ± 1.23 vs. 3.06 ± 1.06, p = 0.456); however, the IEC group had a higher Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO) score (1.95 ± 1.02 vs. 1.27 ± 0.92, p < 0.0001). The most used IEC guidewire was the SUOH 03 (39%), and the most frequently used microcatheter was the Caravel (43%). Dual injection was less common in IEC cases (66% vs. 89%, p < 0.0001). Technical (76% vs. 79%, p = 0.317) and procedural success rates (74% vs. 79%, p = 0.281) were not different between the two groups. However, IEC cases had a higher procedural complications rate (25.8% vs. 16.4%, p = 0.0008), including perforations (17.3% vs. 9.0%, p = 0.0001), pericardiocentesis (3.1% vs. 1.2%, p = 0.018), and dissection/thrombus of the donor vessel (3.7% vs. 1.2%, p = 0.002). CONCLUSION: The use of IEC for retrograde CTO PCI was associated with similar technical and procedural success rates when compared with other retrograde cases, but higher incidence of periprocedural complications.

Validation of the BCIS CHIP Score in chronic total occlusion percutaneous coronary intervention.

BACKGROUND: The complex high-risk indicated percutaneous coronary intervention (CHIP) score is a tool developed using the British Cardiovascular Intervention Society (BCIS) database to define CHIP cases and predict in-hospital major adverse cardiac or cerebrovascular events (MACCE). AIM: To assess the validity of the CHIP score in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We evaluated the performance of the CHIP score on 8341 CTO PCIs from the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO) performed at 44 centers between 2012 and 2023. RESULTS: In our cohort, 7.8% (n = 647) of patients had a CHIP score of 0, 50.2% (n = 4192) had a CHIP score of 1-2, 26.2% (n = 2187) had a CHIP score of 3-4, 11.7% (n = 972) had a CHIP score of 5-6, 3.3% (n = 276) had a CHIP score of 7-8, and 0.8% (n = 67) had a CHIP score of 9+. The incidence of MACCE for a CHIP score of 0 was 0.6%, reaching as high as 8.7% for a CHIP score of 9+, confirming that a higher CHIP score is associated with a higher risk of MACCE. The estimated increase in the risk of MACCE per one score unit increase was 100% (95% confidence interval [CI]: 65%-141%). The AUC of the CHIP score model for predicting MACCE in our cohort was 0.63 (95% CI: 0.58-0.67). There was a positive correlation between the CHIP score and the PROGRESS-CTO MACE score (Spearman's correlation: 0.37; 95% CI: 0.35-0.39; p < 0.001). CONCLUSIONS: The CHIP score has modest predictive capacity for MACCE in CTO PCI.

A novel, proof-of-concept radiofrequency renal denervation strategy to improve procedural efficiency: 12-month results from the SPYRAL DYSTAL pilot study.

BACKGROUND: Catheter-based renal sympathetic denervation (RDN) reduced blood pressure (BP) in multiple randomized sham-controlled trials of patients with uncontrolled hypertension (HTN). We tested proof-of-concept for a more selective treatment strategy, exclusively targeting these areas to improve the efficiency of the procedure. METHODS: The SPYRAL DYSTAL Pilot study was designed to mirror the SPYRAL HTN-OFF MED Pivotal study, enabling comparison with a propensity score adjusted active-control group. Patients were antihypertensive medication-free for one month before undergoing BP assessment. Those with office BP of 150-180/>90 mmHg and with an ambulatory systolic BP of 140-170 mmHg were selected to undergo open label treatment, delivering energy only to the distal main renal arteries and first order branches. Patients from DYSTAL were compared with patients who underwent maximized RF RDN treatment in the prior randomized OFF MED trial at 3 months. After 3 months, patients resumed antihypertensive medications as indicated. Safety and efficacy outcomes were assessed post hoc through 12 months. RESULTS: The SPYRAL DYSTAL Pilot study treated 56 HTN patients. Baseline office systolic BP (OSBP) and 24-h ambulatory systolic BP (ASBP) were similar between DYSTAL and OFF MED patient groups. The number of ablations (32.3 ± 8.0 vs 46.6 ± 15.3, p < 0.001), procedure time (67 ± 21 min vs 99 ± 36 min; p < 0.001), and contrast volume (173 ± 77 cc vs 208 ± 96 cc; p = 0.014) were significantly lower with the simplified treatment strategy. OSBP and ASBP changes compared with baseline were -9.0 and -1.4 mmHg at 3 months, -20.3 and -13.9 mmHg at 6 months, and -20.3 and -16.6 mmHg at 12 months, respectively. During the medication up-titration phase, BP reductions among DYSTAL patients were similar to reductions observed in OFF MED through 12 months, with comparable number of drugs (1.4 and 1.5 medications, respectively (P=NS)). Two adverse events related to guidewire placement were reported. CONCLUSION: In this pilot study, focusing ablation treatment on the distal main and proximal branch renal arteries was performed, resulting in fewer RF lesions, and reduced contrast volume and procedure time. Whether BP reductions are similar between a selective vs. maximized RDN approach requires further prospective study.

Emergency coronary artery bypass surgery after chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: Emergency coronary artery bypass surgery (eCABG) is a serious complication of chronic total occlusion (CTO) percutaneous coronary artery intervention (PCI). METHODS: We examined the incidence and outcomes eCABG among 14,512 CTO PCIs performed between 2012 and 2023 in a large multicenter registry. RESULTS: The incidence of eCABG was 0.12% (n = 17). Mean age was 68 ± 6 years and 69% of the patients were men. The most common reason for eCABG was coronary perforation (70.6%). eCABG patients had larger target vessel diameter (3.36 ± 0.50 vs. 2.90 ± 0.52; p = 0.003), were more likely to have moderate/severe calcification (85.7% vs. 45.8%; p = 0.006), side branch at the proximal cap (91.7% vs. 55.4%; p = 0.025), and balloon undilatable lesions (50% vs. 7.4%; p = 0.001) and to have undergone retrograde crossing (64.7% vs. 30.8%, p = 0.006). eCABG cases had lower technical (35.3% vs. 86.7%; p < 0.001) and procedural (35.3% vs. 86.7%; p < 0.001) success and higher in-hospital mortality (35.3% vs. 0.4%; p < 0.001), coronary perforation (70.6% vs. 4.6%; p < 0.001), pericardiocentesis (47.1% vs. 0.8%; p < 0.001), and major bleeding (11.8% vs. 0.5%; p < 0.001). CONCLUSIONS: The incidence of eCABG after CTO PCI was 0.12% and associated with high in-hospital mortality (35%). Coronary perforation was the most common reason for eCABG.

Update on chronic total occlusion percutaneous coronary intervention.

Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) continues to evolve. This review summarizes recent publications categorized by outcomes, techniques, complications, and ongoing studies in this rapidly growing area.

Racial disparities in chronic total occlusion percutaneous coronary interventions: insights from the PROGRESS-CTO registry.

OBJECTIVES: There is limited data on race and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The authors sought to evaluate CTO PCI techniques and outcomes in different racial groups. METHODS: We examined the baseline characteristics and procedural outcomes of 11 806 CTO PCIs performed at 44 US and non-US centers between 2012 and March 2023. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, repeat target-vessel revascularization, pericardiocentesis, cardiac surgery, and stroke prior to discharge. RESULTS: The most common racial group was White (84.5%), followed by Black (5.7%), "Other" (3.9%), Hispanic (2.9%), Asian (2.4%), and Native American (0.7%). There were significant differences in the baseline characteristics between different racial groups. When compared with non-White patients, the retrograde approach and antegrade dissection re-entry were more likely to be the successful crossing strategies in White patients without any significant differences in technical success (86.4% vs 86.4%; P = .93), procedural success (84.8% vs 85.0%; P = .79), and in-hospital MACE (2.0% vs 1.5%; P = .15) between the 2 groups. The technical success rate was significantly higher in the "Other" racial group (91.0% vs 86.4% in White, 86.9% in Asian, 84.5% in Black, 84.5% in Hispanic, and 83.3% in Native American; P = .03) without any significant differences in procedural success or in-hospital MACE rates between the groups. CONCLUSIONS: Despite differences in baseline characteristics and procedural techniques, the procedural success and in-hospital MACE of CTO PCI were not significantly different between most racial groups.

Predictors of successful primary antegrade wiring in chronic total occlusion percutaneous coronary intervention.

BACKGROUND: Antegrade wiring is the most commonly used chronic total occlusion (CTO) crossing technique. METHODS: Using data from the PROGRESS CTO registry (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; Clinicaltrials.gov identifier: NCT02061436), we examined the clinical and angiographic characteristics and procedural outcomes of CTO percutaneous coronary interventions (PCIs) performed using a primary antegrade wiring strategy. RESULTS: Of the 13 563 CTO PCIs performed at 46 centers between 2012 and 2023, a primary antegrade wiring strategy was used in 11 332 (83.6%). Upon multivariable logistic regression analysis, proximal cap ambiguity (odds ratio [OR]: 0.52; 95% CI, 0.46-0.59), side branch at the proximal cap (OR: 0.85; 95% CI, 0.77-0.95), blunt/no stump (OR: 0.52; 95% CI: 0.47-0.59), increasing lesion length (OR [per 10 mm increase]: 0.79; 95% CI, 0.76-0.81), moderate to severe calcification (OR: 0.73; 95% CI, 0.66-0.81), moderate to severe proximal tortuosity (OR: 0.67; 95% CI, 0.59-0.75), bifurcation at the distal cap (OR: 0.66; 95% CI, 0.59-0.73), left anterior descending artery CTO (OR [vs right coronary artery]: 1.44; 95% CI, 1.28-1.62) and left circumflex CTO (OR [vs right coronary artery]: 1.22; 95% CI, 1.07-1.40), non-in-stent restenosis lesion (OR: 0.56; 95% CI, 0.49-0.65), and good distal landing zone (OR: 1.18; 95% CI, 1.06-1.32) were independently associated with primary antegrade wiring crossing success. CONCLUSIONS: The use of antegrade wiring as the initial strategy was high (83.6%) in our registry. We identified several parameters associated with primary antegrade wiring success.

Use of plaque modification microcatheters during percutaneous coronary interventions for chronic total occlusion: insights from the PROGRESS-CTO Registry.

Plaque modification microcatheters (PM) (Tornus [Asahi] and Turnpike Gold [Teleflex]) are devices that are mainly used to modify the cap or lesion and maintain good support in chronic total occlusion (CTO) percutaneous coronary artery intervention (PCI). We evaluated the frequency of use and outcomes of plaque modification microcatheters in an international multicenter registry. Plaque modification microcatheters were utilized in 242 cases (1.6%: Tornus in 51% and Turnpike Gold in 49%) with decreasing frequency over time (P-for-trend: 0.007 and 0.035, respectively). Technical and procedural success and the incidence of major cardiac adverse events were similar with Tornus and Turnpike Gold use. PM are infrequently utilized in CTO-PCI and are associated with high success and acceptable complication rates.

Equipment entrapment/loss during chronic total occlusion percutaneous coronary intervention.

BACKGROUND: There is limited data on equipment loss or entrapment during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We analyzed the baseline clinical and angiographic characteristics and outcomes of equipment loss/entrapment at 43 US and non-US centers between 2017 and 2023. RESULTS: Equipment loss/entrapment was reported in 40 (0.4%) of 10 719 cases during the study period. These included guidewire entrapment/fracture (n = 21), microcatheter entrapment/fracture (n = 11), stent loss (n = 8) and balloon entrapment/fracture/rupture (n = 5). The equipment loss/entrapment cases were more likely to have moderate to severe calcification, longer lesion length, higher J-CTO and PROGRESS-CTO complications scores, and use of the retrograde approach compared with the remaining cases. Retrieval was attempted in 71.4% of the guidewire, 90.9% of the microcatheter, 100% of the stent loss, and 100% of the balloon cases, and was successful in 26.7%, 30.0%, 50%, and 40% of the cases, respectively. Procedures complicated by equipment loss/entrapment had higher procedure and fluoroscopy time, contrast volume and patient air kerma radiation dose, lower procedural (60.0% vs 85.6%, P less than .001) and technical (75.0% vs 86.8%, P = .05) success, and higher incidence of major adverse cardiac events (MACE) (17.5% vs 1.8%, P less than .001), acute MI (7.5% vs 0.4%, P less than .001), emergency coronary artery bypass graft (CABG) (2.5% vs 0.1%, P = .03), perforation (20.0% vs 4.9%, P less than .001), and death (7.5% vs 0.4%, P less than .001). CONCLUSIONS: Equipment loss is a rare complication of CTO PCI; it is more common in complex CTOs and is associated with lower technical success and higher MACE.

Comparative Analysis of Polymer Versus Non-Polymer Jacketed Wires in Chronic Total Occlusion Percutaneous Coronary Intervention.

There is significant variation in wire utilization patterns for chronic total occlusion (CTO) percutaneous coronary intervention. This study aimed to compare the outcomes of polymer-jacketed wires (PJWs) versus non-PJWs in anterograde procedures. We analyzed clinical and angiographic characteristics, and procedural outcomes of 7,575 anterograde CTO percutaneous coronary interventions that were performed at 47 centers between 2012 and 2023. Cases in which PJWs were exclusively used were classified in the PJW group, whereas cases where at least one non-PJW was employed were classified in the non-PJW group. Study end points were as follows: technical success, coronary perforation, major adverse cardiac event. PJWs were exclusively used in 3,481 cases (46.0%). These cases had lower prevalence of proximal cap ambiguity, blunt stump, and moderate/severe calcification. They also had lower Japanese CTO (J-CTO), Prospective Global Registry for the Study of Chronic Total Occlusion (PROGRESS-CTO), and PROGRESS-CTO complications scores, higher technical success (94.3% vs 85.7%, p <0.001), and lower perforation rates (2.2% vs 3.2%, p = 0.013). Major adverse cardiac event rates did not differ between groups (1.3% vs 1.5%, p = 0.53). Exclusive use of PJWs was independently associated with higher technical success in both the multivariable (odds ratio [OR] 2.66, 95% confidence interval [CI] 2.13 to 3.36, p <0.001) and inverse probability of treatment weight analysis (OR 2.43, 95% CI 2.04 to 2.89, p <0.001). Exclusive use of PJWs was associated with lower risk of perforation in the multivariable analysis (OR 0.69, 95% CI 0.49 to 0.95, p = 0.02), and showed a similar trend in the inverse probability of treatment weight analysis (OR 0.77, 95% CI 0.57 to 1.04, p = 0.09). Exclusive use of PJWs is associated with higher technical success and lower perforation risk in this non-randomized series of patients.

1- Versus 3-Month DAPT in Older Patients at a High Bleeding Risk Undergoing PCI: Insights from the XIENCE Short DAPT Global Program.

This analysis aimed to evaluate the effect of 1- versus 3-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in older patients. Data from 3 prospective, single-arm studies (XIENCE Short DAPT Program), including patients with high bleeding risk successfully treated with an everolimus-eluting stent (XIENCE, Abbott) were analyzed. DAPT was discontinued at 1 or at 3 months in patients free from ischemic events and adherent to DAPT. Patients were stratified according to age (≥75 and <75 years). The primary end point was all-cause death or myocardial infarction (MI). The key secondary end point was Bleeding Academic Research Consortium type 2 to 5 bleeding. The outcomes were assessed from 1 to 12 months after index PCI. Of 3,364 patients, 2,241 (66.6%) were aged ≥75 years. The risk of death or MI was similar with 1- versus 3-month DAPT in patients aged ≥75 (8.5% vs 8.0%, adjusted hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.69 to 1.30) and <75 years (6.9% vs 7.8%, adjusted HR 0.97, 95% CI 0.60 to 1.57, interaction p = 0.478). Bleeding Academic Research Consortium type 2 to 5 bleeding was consistently lower with 1- than with 3-month DAPT in patients aged ≥75 years (7.2% vs 9.4%, adjusted HR 0.66, 95% CI 0.48 to 0.91) and <75 years (9.7% vs 11.9%, adjusted HR 0.86, 95% CI 0.57 to 1.29, interaction p = 0.737). In conclusion, in patients at high bleeding risk who underwent PCI, patients older and younger than 75 years derived a consistent benefit from 1- compared with 3-month DAPT in terms of bleeding reduction, with no increase in all-cause death or MI at 1 year.

PI3K signaling promotes formation of lipid-laden foamy macrophages at the spinal cord injury site.

After spinal cord injury (SCI), infiltrating macrophages undergo excessive phagocytosis of myelin and cellular debris, forming lipid-laden foamy macrophages. To understand their role in the cellular pathology of SCI, investigation of the foamy macrophage phenotype in vitro revealed a pro-inflammatory profile, increased reactive oxygen species (ROS) production, and mitochondrial dysfunction. Bioinformatic analysis identified PI3K as a regulator of inflammation in foamy macrophages, and inhibition of this pathway decreased their lipid content, inflammatory cytokines, and ROS production. Macrophage-specific inhibition of PI3K using liposomes significantly decreased foamy macrophages at the injury site after a mid-thoracic contusive SCI in mice. RNA sequencing and in vitro analysis of foamy macrophages revealed increased autophagy and decreased phagocytosis after PI3K inhibition as potential mechanisms for reduced lipid accumulation. Together, our data suggest that the formation of pro-inflammatory foamy macrophages after SCI is due to the activation of PI3K signaling, which increases phagocytosis and decreases autophagy.

An Ultrasound Array of Emitter-Receiver Stacks for Microbubble-Based Therapy.

Most therapeutic ultrasound devices place emitters and receivers in separate locations, so that the long therapeutic pulses (>1 ms) can be emitted while receivers monitor the procedure. However, with such placement, emitters and receivers are competing for the same space, producing a trade-off between emission efficiency and reception sensitivity. Taking advantage of recent studies demonstrating that short-pulse ultrasound can be used therapeutically, we aimed to develop a device that overcomes such trade-offs. The array was composed of emitter-receiver stacks, which enabled both emission and reception from the same location. Each element was made of a lead zirconate titanate (PZT)-polyvinylidene fluoride (PVDF) stack. The PZT (frequency: 500 kHz, diameter: 16 mm) was used for emission and the PVDF (thickness: 28 µm, diameter: 16 mm) for broadband reception. 32 elements were assembled in a 3D-printed dome-shaped frame (focal length: 150 mm; [Formula: see text]-number: 1) and was tested in free-field and through an ex-vivo human skull. In free-field, the array had a 4.5 × 4.5 × 32 mm focus and produced a peak-negative pressure (PNP) of 2.12 MPa at its geometric center. The electronic steering range was ±15 mm laterally and larger than ±15 mm axially. Through the skull, the array produced a PNP of 0.63 MPa. The PVDF elements were able to localize broadband microbubble emissions across the skull. We built the first multi-element array for short-pulse and microbubble-based therapeutic applications. Stacked arrays overcome traditional trade-offs between the transmission and reception quality and have the potential to create a step change in treatment safety and efficacy.

Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging.

BACKGROUND: Patients with high bleeding risk (HBR) are often treated with abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) to reduce bleeding risk, however this strategy is associated with an increase in ischemic events, especially if the acute PCI result is suboptimal. We compared clinical outcomes among patients with HBR treated with 1-month DAPT who underwent intravascular ultrasound (IVUS)- or optical coherence tomography (OCT)-guided PCI versus those who underwent angiography-guided PCI without intravascular imaging. METHODS: The Onyx ONE Clear study includes patients with HBR from the Onyx ONE US/Japan and Onyx ONE randomized studies who were treated with the Resolute Onyx zotarolimus-eluting stent. The primary endpoint was the composite of cardiac death (CD) or myocardial infarction (MI) between 1 month and 2 years after PCI. Propensity-score adjustments and matching were performed for differences in baseline and procedural characteristics between groups. RESULTS: Among the 1507 patients in Onyx ONE Clear, 271 (18.0 %) had IVUS or OCT used during PCI (Imaging-guided group) and 1236 (82.0 %) underwent Angiography-guided PCI (Angio-guided group). Imaging-guided patients were less likely to present with atrial fibrillation, acute coronary syndrome, and left ventricle ejection fraction ≤35 %. Conversely, Imaging-guided patients were more likely to have complex (ACC/AHA type B2/C), longer, and heavily calcified lesions. Between 1 month and 2 years, the composite rate of CD or MI was similar between Imaging-guided and Angio-guided patients (9.9 % vs. 12.4 %, P = 0.33). There was also no difference between groups after adjustment; (P = 0.56). However, CD was significantly lower among Imaging-guided patients (2.7 % vs. 6.1 %, P = 0.048). There were no between-group differences in MI or stent thrombosis. Propensity score matching results were similar. CONCLUSION: Despite higher lesion complexity, using intravascular imaging guidance for PCI between 1-month and 2-years follow-up had comparable outcomes with angiographic guidance alone in patients with HBR treated with 1-month DAPT. (ClinicalTrials.gov: Identifier: NCT03647475 and NCT03344653). NON-STANDARD ABBREVIATIONS AND ACRONYMS: BARC: Bleeding Academic Research Consortium; DAPT: dual antiplatelet therapy; DES: drug-eluting stent; HBR: high bleeding risk; IVUS: intravascular ultrasound; OCT: optical coherence tomography; SAPT: single antiplatelet therapy.

Activated clotting time and outcomes of chronic total occlusion percutaneous coronary intervention: insights from the PROGRESS-CTO Registry.

BACKGROUND: The optimal range of activated clotting time (ACT) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We examined the association between ACT and in-hospital ischemic and bleeding outcomes in patients who underwent CTO PCI in the Prospective Global Registry for the Study of CTO Intervention. RESULTS: ACT values were available for 4377 patients who underwent CTO PCI between 2012 and 2023 at 29 centers. The mean ACT distribution was less than 250 seconds (19%), 250 to 349 seconds (50%), and greater than or equal to 350 seconds (31%). The incidence of ischemic events, bleeding events, and net adverse cardiovascular events (NACE) was 0.8%, 3.0%, and 3.8%, respectively. In multiple logistic regression analysis, increasing nadir ACT was associated with decreasing ischemic events (adjusted odds ratio [aOR] per 50-second increments: 0.69 [95% confidence interval (CI), 0.50-0.94; P=.017]; and increasing peak ACT was associated with increasing bleeding events (aOR per 50-second increments: 1.17 [95% CI ,1.01-1.36; P=.032]). A U-shaped association was seen between mean ACT and NACE, where restricted cubic spline analysis demonstrated that patients with a low ( less than 200 seconds) or high ( greater than 400 seconds) ACT had increasing NACE risk compared with an ACT of 200 to 400 seconds (aOR 2.06, 95% CI 1.18-3.62; P=.012). CONCLUSIONS: Among patients who underwent CTO PCI, mean ACT had a U-shaped relationship with NACE, where patients with a low ( less than 200 seconds) ACT (driven by ischemic events) or high ( greater than 400 seconds) ACT (driven by bleeding) had higher NACE compared with an ACT of 200 to 400 seconds.

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications.

BACKGROUND: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. OBJECTIVES: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. METHODS: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. RESULTS: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. CONCLUSIONS: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).

Atrial fibrillation and chronic total occlusion percutaneous coronary intervention outcomes: insights from the Progress-CTO registry.

BACKGROUND: We examined the effect of atrial fibrillation on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the baseline characteristics and procedural outcomes of 9,166 CTO PCIs performed at 39 US and non-US centers between 2012 and 2023. RESULTS: Atrial fibrillation was present in 1122 (12%) patients. These patients were older and had a higher incidence of comorbidities, such as hypertension, dyslipidemia, heart failure, cerebrovascular disease, and peripheral arterial disease, lower left ventricular ejection fraction, and lower eGFR. Their CTOs were more likely to have moderate to severe calcification and longer lesion length. They also had higher mean J-CTO and PROGRESS-CTO complications (Acute MI, MACE, Mortality, Perforation, and Pericardiocentesis) scores. Patients with atrial fibrillation had higher prevalence of uncrossable and undilatable CTO lesions and required longer procedure (107 vs 119 min; P less than .001) and fluoroscopy (40 vs 43 min; P=.005) time. Technical success and MACE, including procedural/in-hospital bleeding, were similar in patients with and without atrial fibrillation. Although the crude incidence of MACE on follow-up (median 61 days) was significantly higher in patients with atrial fibrillation, the latter was not independently associated with adverse events on Cox proportional hazards analysis. CONCLUSIONS: Patients with atrial fibrillation undergoing CTO PCI are older, have more comorbidities, higher lesion complexity, and longer procedure time, but similar technical success and in-hospital MACE. They have higher MACE and mortality during follow-up, but the difference is not significant after adjusting for potential confounding variables.

Impact of target vessel on the procedural techniques and outcomes of chronic total occlusion percutaneous coronary intervention.

BACKGROUND: There is limited information on the impact of the target vessel on the procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We analyzed the baseline clinical and angiographic characteristics and procedural outcomes of 11,580 CTO PCIs performed between 2012 and 2022 at 44 centers. RESULTS: The most common CTO target vessel was the right coronary artery (RCA) (53.1%) followed by the left anterior descending artery (LAD) (26.0%) and the left circumflex artery (LCX) (19.8%). RCA CTOs were longer and more complex, with a higher Japanese CTO score compared with LAD or LCX CTOs. Technical success was higher among LAD (88.8%) lesions when compared with RCA (85.7%) or LCX (85.8%) lesions (P less than .001). The incidence of major adverse cardiovascular events (MACE) was overall 1.9% (n = 220) and was similar among target vessels (P=.916). There was a tendency toward more frequent utilization of the retrograde approach for more proximal occlusions in all 3 target vessels. When compared with all other RCA lesions combined, distal RCA lesions had higher technical success (87.7% vs 85.3%; P=.048). Technical success was similar between various locations of LAD CTOs (P=.704). First/second/third obtuse marginal branch had lower technical success when compared with all other LCX lesion locations (82.7% vs 86.8%; P=.014). There was no association between MACE and CTO location in all 3 target vessels. CONCLUSIONS: LAD CTO PCIs had higher technical and procedural success rates among target vessels. The incidence of MACE was similar among target vessels and among various locations within the target vessel.

The Retrograde Approach to Chronic Total Occlusion Percutaneous Coronary Interventions: Technical Analysis and Procedural Outcomes.

BACKGROUND: Retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with lower success and higher complication rates when compared with the antegrade approach. OBJECTIVES: This study sought to assess contemporary techniques and outcomes of retrograde CTO PCI. METHODS: We examined the baseline characteristics, procedural techniques and outcomes of 4,058 retrograde CTO PCIs performed at 44 centers between 2012 and 2023. Major adverse cardiac events (MACE) included any of the following in-hospital events: death, myocardial infarction, repeat target vessel revascularization, pericardiocentesis, cardiac surgery, and stroke. RESULTS: The average J-CTO (Multicenter CTO Registry in Japan) score was 3.1 ± 1.1. Retrograde crossing was successful in 60.5% and lesion crossing in 81.6% of cases. The collaterals pathways successfully used were septals in 62.0%, saphenous vein grafts in 17.4%, and epicardials in 19.1%. The technical and procedural success rates were 78.7% and 76.6%, respectively. When retrograde crossing failed, technical success was achieved in 50.3% of cases using the antegrade approach. In-hospital MACE was 3.5%. The clinical coronary perforation rate was 5.8%. The incidence of in-hospital MACE with retrograde true lumen crossing, just marker antegrade crossing, conventional reverse controlled antegrade and retrograde tracking (CART), contemporary reverse CART, extended reverse CART, guide-extension reverse CART, and CART was 2.1%, 0.8%, 5.5%, 3.0%, 2.1%, 3.2%, and 4.1%, respectively; P = 0.01). CONCLUSIONS: Retrograde CTO PCI is utilized in highly complex cases and yields moderate success rates with 5.8% perforation and 3.5% periprocedural MACE rates. Among retrograde crossing strategies, retrograde true lumen puncture was the safest. There is need for improvement of the efficacy and safety of retrograde CTO PCI.