Clinical and angiographic success and safety comparison of coronary intravascular lithotripsy: An updated meta-analysis

Background Intravascular lithotripsy (IVL) can be used to assist stent deployment in severe coronary artery calcifications (CAC). Methods Studies employing IVL for CAC lesions were included. The primary outcomes included clinical and angiographic success. The secondary outcomes, including lumen gain, maximum calcium thickness, and calcium angle at the final angiography site, minimal lumen area site, and minimal stent area site, were analyzed by the random-effects model to calculate the pooled standardized mean difference. Tertiary outcomes included safety event ratios. Results Seven studies (760 patients) were included. The primary outcomes: pooled clinical and angiographic success event ratio parentage of IVL was 94.4% and 94.8%, respectively. On a random effect model for standard inverse variance for secondary outcomes showed: minimal lumen diameter increase with IVL was 4.68 mm (p-value < 0.0001, 95% CI 1.69–5.32); diameter decrease in the stenotic area after IVL session was −5.23 mm (95 CI –22.6–12.8). At the minimal lumen area (MLA) and final minimal stent area (MSA) sites, mean lumen area gain was 1.42 mm2 (95% CI 1.06–1.63; p < 0.00001) and 1.34 mm2 (95% CI 0.71–1.43; p < 0.00001), respectively. IVL reduced calcium thickness at the MLA site (SMD −0.22; 95% CI −0.40–0.04; P = 0.02); calcium angle was not affected at the MLA site. The tertiary outcomes: most common complication was major adverse cardiovascular events (n = 48/669), and least common complication was abrupt closure of the vessel (n = 1/669). Conclusions Evidence suggests that IVL safely and effectively facilitates stent deployment with high angiographic and clinical success rates in treating severely calcified coronary lesions

Ticagrelor with or without Aspirin in High-Risk Patients after PCI.

BACKGROUND: Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS: In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS: We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% CI, -0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority). CONCLUSIONS: Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.)

Outcomes of orbital atherectomy in severely calcified small (2.5 mm) coronary artery vessels

© 2018 HMP Communications.All Rights Reserved. OBJECTIVES: We evaluated the outcomes of plaque modification with orbital atherectomy followed by percutaneous coronary intervention (PCI) with small-diameter stents for severely calcified coronary arteries. BACKGROUND: PCI of severely calcified lesions is technically complex due to difficulties in predilating the lesion, delivering the stent, and achieving optimal stent expansion. PCI of small-diameter vessels is associated with an increased risk of adverse clinical events. METHODS: In our retrospective multicenter registry of 458 all comers with severe coronary artery calcification treated with orbital atherectomy, a total of 38 patients (8.3%) underwent stenting with a 2.5 mm diameter stent (small-vessel group) and 420 patients (91.7%) had a reference vessel diameter \u3e2.5 mm (large-vessel group). The primary endpoint was the 30-day rate of major adverse cardiac and cerebrovascular events, which was the composite of death, myocardial infarction (MI), target-vessel revascularization (TVR), and stroke. RESULTS: The small-vessel and large-vessel groups had similar rates of perforation (0.0% vs 0.7%; P≤.80), dissection (2.6% vs 0.7%; P≤.20), and no-reflow (0.0% vs 0.7%; P≤.80). The primary endpoint was similar in both groups (0.0% vs 1.9%; P≤.40), as were the rates of death (0.0% vs 1.4%; P≤.40), MI (0.0% vs 1.2%; P≤.50), TVR (0.0% vs 0.0%; P\u3e.99), and stroke (0.0% vs 0.2%; P≤.90). The small-vessel and large-vessel groups had similar rates of stent thrombosis (0.0% vs 1.0%; P≤.70). CONCLUSIONS: Orbital atherectomy followed by stenting of small-diameter vessels appears to be feasible and safe. Further studies are needed to determine the ideal revascularization strategy for these patients. perforation stent thrombosis

Orbital Atherectomy: A Comprehensive Review

© 2018 Elsevier Inc. Successful percutaneous coronary intervention (PCI) can be challenging in the presence of heavily calcified lesions. Severely calcified lesions are associated with worse clinical outcomes. Recognition of calcification is important before stenting to ensure adequate stent expansion can be attained. Orbital atherectomy is a safe and effective method to ablate calcified plaque. Lesion preparation through plaque modification with orbital atherectomy before stent implantation can help to optimize the results of PCI in these complex lesions

Multicenter Registry of Real-World Patients with Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy: 1-Year Outcomes

© 2018 HMP Communications. All rights reserved. OBJECTIVES: We report the 1-year outcomes of real-world patients with severely calcified coronary arteries who underwent orbital atherectomy. BACKGROUND: Percutaneous coronary intervention of heavily calcified lesions is technically challenging and associated with worse clinical outcomes. Modification of severely calcified coronary lesions with orbital atherectomy facilitates stent delivery and expansion. Although we previously reported the safety of orbital atherectomy at 30 days in all comers with severely calcified coronary lesions, including patients who were excluded from the ORBIT II trial, longer-term follow-up is unknown. METHODS: We retrospectively analyzed 458 all-comer patients who underwent orbital atherectomy followed by stenting from October 2013 to December 2015 at three centers. The primary endpoint was the 1-year major adverse cardiac and cerebrovascular event (MACCE) rate, defined as the composite of death, myocardial infarction, target-vessel revascularization, and stroke. RESULTS: One-year data were available for 453/457 patients (98.9%). At 1-year follow-up, the MACCE rate was 12.6%, death rate was 4.0%, myocardial infarction rate was 1.8%, target-vessel revascularization rate was 7.5%, stroke rate was 1.3%, and stent thrombosis rate was 1.3%. CONCLUSION: Orbital atherectomy is a valuable option for the treatment of severely calcified coronary arteries, including patients with very complex coronary anatomy and severe underlying comorbid conditions. Orbital atherectomy provided acceptable outcomes at 1 year and compared favorably to historical controls. A randomized trial with longer follow-up is needed to determine the optimal treatment strategy for patients with severely calcified coronary lesions

OCT-Guided Treatment of Calcified Coronary Artery Disease: Breaking the Barrier to Stent Expansion

© 2019, Springer Science+Business Media, LLC, part of Springer Nature. Purpose of Review: Our objective is to review the current status of OCT-guided treatment of calcified coronary artery disease. Recent Findings: New treatment modalities provide multiple options for approaching interventions involving calcified lesions. Summary: Coronary artery calcification is associated with stent underexpansion and worse procedural outcomes. Optimizing stent expansion is essential to reduce restenosis and the need for revascularization. Optical coherence tomography (OCT) allows for accurate diagnosis and detailed characterization of calcified lesions. The features of coronary artery calcification are determinant of the optimal lesion preparation and treatment strategy. We recommend an OCT-guided treatment approach for calcified coronary lesions

One-Year Outcomes of Orbital Atherectomy of Long, Diffusely Calcified Coronary Artery Lesions

© 2018 HMP Communications. All rights reserved. Objectives: The aim of this study was to determine the clinical outcomes of patients with long, diffusely calcified coronary artery lesions who underwent orbital atherectomy. Background: The presence of severe coronary artery calcification increases the complexity of percutaneous coronary intervention. Orbital atherectomy of long, diffusely calcified lesions may increase the risk of periprocedural angiographic complications. Furthermore, the rate of ischemic complications, including target-vessel revascularization (TVR), in these long, calcified lesions is historically high. Methods: In this retrospective multicenter registry, which included 458 real-world patients who underwent orbital atherectomy, a total of 154 patients (33.6%) required a total stent length of ≥50 mm (long-stent group). The primary endpoint was the 1-year major adverse cardiac and cerebrovascular event (MACCE) rate, defined as the composite of death, myocardial infarction, TVR, and stroke. Results: The long stent group had a higher rate of perforation (1.9% vs 0.0%; P≤.01) and dissection (2.6% vs 0.0%; P.90). The stent thrombosis rate was similar in both groups (1.3% vs 1.3%; P\u3e.90). Conclusions: Despite the higher angiographic complication rates, orbital atherectomy of long, diffusely calcified lesions was associated with acceptable rates of ischemic complications in this challenging lesion subset at 1-year follow-up