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Objective: We performed a post hoc analysis of the Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial to determine the effect an on-versus off-pump strategy had on outcomes when compared with percutaneous coronary intervention. Methods: All randomized patients in EXCEL (n = 1905) were included. The outcomes of interest were the primary end point composite of death from any cause, stroke, or myocardial infarction; the composite study end point or ischemia-driven revascularization; and the rate of death from any cause at 5 years. Event rates were based on Kaplan–Meier estimates in time-to-first-event analyses. Results: Propensity matching resulted in groups of 1142 patients (571 each) for on-pump coronary artery bypass grafting versus percutaneous coronary intervention and 472 patients (236 each) for off-pump coronary artery bypass grafting versus percutaneous coronary intervention. In the on-pump coronary artery bypass grafting versus percutaneous coronary intervention matched groups, the composite end point was similar (18.0% vs 22.1%, P = .19) and the composite end point or ischemia-driven revascularization (23.3% vs 31.0%, P = .01) was lower, and mortality (7.6% vs 11.8%, P = .025) was lower in the on-pump coronary artery bypass grafting group at 5 years. In the off-pump coronary artery bypass grafting versus percutaneous coronary intervention matched groups, the composite end point (19.4% vs 22.2%, P = .47), composite end point or ischemia-driven revascularization (25.9% vs 34.2%, P = .07), and mortality (12.5% vs 14.2%, P = .59) were similar at 5 years. Conclusions: In the EXCEL trial, on-pump coronary artery bypass grafting was associated with a decreased 5-year rate of the composite outcome of death, stroke, myocardial infarction, or ischemia-driven revascularization, and decreased mortality when compared with percutaneous coronary intervention, whereas outcomes of off-pump coronary artery bypass grafting were similar to percutaneous coronary intervention.

Background: Reshaping the dilated left ventricle using a surgically implanted papillary muscle sling has been shown to provide long-term improvement in cardiac function compared to annuloplasty alone in patients with systolic heart failure. A papillary muscle sling which can be implanted via a transcatheter approach has the potential to make this treatment more widely available to patients. Methods: The Vsling transcatheter papillary muscle sling device was evaluated in a chronic animal model (sacrificed at 30 and 90 days), in a simulator, and in a human cadaver. Results: The Vsling device was successfully implanted in 10 pigs, 6 simulator procedures, and 1 human cadaver. Procedure complexity and device usability were rated as reasonable or better by 6 interventional cardiologists. Gross and histological analysis in chronic pigs through 90 days demonstrated near-complete endothelial coverage with mild inflammation and small hematoma formation but without adverse tissue reactions, thrombi, or embolization. Conclusions: Preliminary feasibility and safety of the Vsling implant and implantation procedure have been demonstrated. Human trials are planned to begin in the summer of 2022.

Coronary artery disease (CAD) is the most common cause of left ventricular systolic dysfunction (LVSD) and heart failure (HF). Revascularization with coronary artery bypass grafting (CABG) reduces all-cause mortality compared with medical therapy alone for these patients. Despite this, CABG is performed in a minority of patients with HF, partly due to patient unwillingness or inability to undergo major cardiac surgery and partly due to physician reluctance to refer for surgery due to high operative risk. Percutaneous coronary intervention (PCI) is a less-invasive method of revascularization that has the potential to reduce periprocedural complications compared with CABG in patients with HF. Recent advances in PCI technology and technique have made it realistic to achieve more complete revascularization with PCI in high-risk patients with HF, although no randomized controlled clinical trials (RCTs) of PCI in HF compared with either medical therapy or CABG have been performed. In this review, we discuss the currently available evidence for PCI in HF and the association between the extent of revascularization and clinical outcomes in HF. We also review recent advances in PCI technology and techniques with the potential to improve clinical outcomes in HF. Finally, we discuss emerging clinical trial evidence of revascularization in HF and the large, persistent evidence gaps that should be addressed with future clinical trials of revascularization in HF.

Background: Coronary calcification impairs stent delivery and optimal expansion, a significant predictor of subsequent stent thrombosis and restenosis. Current calcium ablative technologies may be limited by guidewire bias and periprocedural complications. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance, and optimize stent deployment. The Disrupt CAD III study demonstrated high (92.4%) procedural success and low (7.8%) 30-day major adverse cardiac event (MACE) rates following IVL, but longer term follow-up is required to determine the durability of clinical benefit and the late impact of optimized stent implantation associated with IVL. This analysis evaluates 1-year outcomes from the Disrupt CAD III study. Methods: Disrupt CAD III (NCT03595176) was a prospective, single-arm approval study designed to assess the safety and effectiveness of IVL as an adjunct to coronary stenting in de novo, severely calcified coronary lesions (n = 384). MACE was defined as the composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization; target lesion failure was defined as cardiac death, MI, or ischemia-driven target lesion revascularization (ID-TLR). Results: At 1 year, MACE occurred in 13.8% of patients (cardiac death: 1.1%, MI: 10.5%, ischemia-driven target vessel revascularization: 6.0%) and target lesion failure occurred in 11.9% (ID-TLR: 4.3%), both driven by non-Q-wave MI (9.2%). Stent thrombosis (definite or probable) occurred in 1.1% of patients (including 1 event [0.3%] beyond 30 ​days). Conclusions: Disrupt CAD III represents the largest long-term (1-year) analysis of coronary IVL to date. IVL treatment prior to coronary stent implantation in severely calcified lesions was associated with low 1-year rates of MACE, ID-TLR, and stent thrombosis.

Background: Coronary artery calcification increases the procedural complexity of percutaneous coronary intervention and is associated with worse outcomes, especially in women. Intravascular lithotripsy (IVL) has been demonstrated to be safe and effective for vessel preparation in severely calcified stenotic lesions before stent implantation. Sex-based outcomes of IVL-facilitated stenting have not been defined. Methods: We performed a patient-level pooled analysis of the 4 prospective, single-arm Disrupt CAD studies that evaluated the safety and efficacy of IVL-facilitated stenting. Patient baseline and procedural characteristics and clinical outcomes were examined based on sex. The primary safety end point was 30-day major adverse cardiovascular events, defined as the composite of cardiac death, myocardial infarction, or target vessel revascularization. The primary efficacy end point was procedural success, defined as stent delivery with residual in-stent stenosis ≤30% without in-hospital major adverse cardiovascular events. Results: A total of 628 patients were included, of which 144 (22.9%) were women. Women were older (P < .001) and more likely to have hyperlipidemia (P = .03), renal insufficiency (P = .05), and prior myocardial infarction (P = .05). Women had smaller mean reference vessel diameter (2.7 ​ ± ​0.4 ​mm vs 3.0 ​ ± ​0.5 ​mm, P < .001), shorter lesion length (22.4 ​ ± ​10.3 ​mm vs 25.0 ​ ± ​11.7 ​mm, P = .01), and less side branch involvement (22.9% vs 32.4%, P = .03). Severe coronary calcification defined by angiography, stent delivery success, lesion predilatation, post-IVL dilatation, and poststent dilatation was similar between groups. There were no significant differences between women and men in the primary safety end point (8.3% vs 7.1%, P = .61; adjusted odds ratio 1.66; 95% confidence interval 0.78, 3.34; P = .17) or the primary efficacy end point (91.7% vs 92.6%, P = .72; adjusted odds ratio 0.58; 95% confidence interval 0.29, 1.24; P = .15). Post-IVL serious angiographic complications (flow-limiting dissection, perforation, abrupt closure, slow flow, no reflow) were similar for women and men (1.6% vs 2.3%, P = .75). Conclusions: Despite more comorbidities and smaller vessel size, IVL-facilitated stenting of severely calcified lesions achieves similar safety and efficacy in women and men.