BackgroundWe sought to examine the efficacy and safety of 2 PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors: alirocumab and evolocumab.Methods and ResultsWe performed a systematic review and meta‐analysis of randomized controlled trials comparing treatment with and without PCSK9 inhibitors; 35 randomized controlled trials comprising 45 539 patients (mean follow‐up: 85.5 weeks) were included. Mean age was 61.0±2.8 years, and mean baseline low‐density lipoprotein cholesterol was 106±22 mg/dL. Compared with no PCSK9 inhibitor therapy, treatment with a PCSK9 inhibitor was associated with a lower rate of myocardial infarction (2.3% versus 3.6%; odds ratio [OR]: 0.72 [95% confidence interval (CI), 0.64–0.81]; P<0.001), stroke (1.0% versus 1.4%; OR: 0.80 [95% CI, 0.67–0.96]; P=0.02), and coronary revascularization (4.2% versus 5.8%; OR: 0.78 [95% CI, 0.71–0.86]; P<0.001). Overall, no significant change was observed in all‐cause mortality (OR: 0.71 [95% CI, 0.47–1.09]; P=0.12) or cardiovascular mortality (OR: 1.01 [95% CI, 0.85–1.19]; P=0.95). A significant association was observed between higher baseline low‐density lipoprotein cholesterol and benefit in all‐cause mortality (P=0.038). No significant change was observed in neurocognitive adverse events (OR: 1.12 [95% CI, 0.88–1.42]; P=0.37), myalgia (OR: 0.95 [95% CI, 0.75–1.20]; P=0.65), new onset or worsening of preexisting diabetes mellitus (OR: 1.05 [95% CI, 0.95–1.17]; P=0.32), and increase in levels of creatine kinase (OR: 0.84 [95% CI, 0.70–1.01]; P=0.06) or alanine or aspartate aminotransferase (OR: 0.96 [95% CI, 0.82–1.12]; P=0.61).ConclusionsTreatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes. Although no overall benefit was noted in all‐cause or cardiovascular mortality, such benefit may be achievable in patients with higher baseline low‐density lipoprotein cholesterol.
Background
We sought to examine the efficacy and safety of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the retrograde approach.
Methods and Results
We compared the outcomes of the retrograde vs. antegrade-only approach to CTO PCI among 1,301 procedures performed at 11 experienced US centers between 2012 and 2015. Mean age was 65.5±10 years and 84% of the patients were men with a high prevalence of diabetes mellitus (45%) and prior coronary artery bypass graft surgery (CABG, 34%). Overall technical and procedural success rates were 90% and 89%, respectively, and in-hospital major adverse cardiovascular events (MACE) occurred in 31 patients (2.4%). The retrograde approach was employed in 539 cases (41%), either as the initial strategy (46%) or after a failed antegrade attempt (54%). As compared with antegrade-only cases, retrograde cases were significantly more complex, both clinically (prior CABG prevalence: 48% vs. 24%, p<0.001) and angiographically (mean J-CTO score: 3.1±1.0 vs. 2.1±1.2, p<0.001) and had lower technical success (85% vs. 94%, p<0.001) and higher MACE (4.3% vs. 1.1%, p<0.001) rates. On multivariable analysis, the presence of suitable collaterals, no smoking, no prior CABG and left anterior descending artery target vessel were independently associated with technical success using the retrograde approach.
Conclusions
The retrograde approach is commonly used in contemporary CTO PCI, especially among more challenging lesions and patients. While associated with lower success and higher MACE rates in comparison to antegrade-only crossing, retrograde PCI remains critical for achieving overall high success rates.
The transradial approach (TRA) for coronary angiography and interventions is increasingly utilized around the world. Radial artery occlusion (RAO) is the most common significant complication after transradial catheterization, with incidence varying between 1% and 10%. Although RAO is rarely accompanied by hand ischemia, it is an important complication because it prohibits future transradial access and radial artery utilization as a conduit for coronary artery bypass grafting or arteriovenous fistula formation. In this review, we discuss factors predicting the occurrence of RAO, aspects of accurate and prompt recognition, methods that contribute to its prevention and possible treatment options.
BackgroundHigh success rates are achievable for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the hybrid approach, but periprocedural complications remain of concern. Although scores estimating success and efficiency in CTO PCI have been developed, there is currently no available score for estimation of the risk for periprocedural complications. We sought to develop a scoring tool for prediction of periprocedural complications during CTO PCI.Methods and ResultsWe analyzed data from 1569 CTO PCIs in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO) using a derivation and validation sampling ratio of 2:1. Variables independently associated with periprocedural complications in multivariable analysis in the derivation set were assigned points based on their respective odds ratios. Forty‐four (2.8%) patients experienced complications. Three factors were independent predictors of complications and were included in the score: patient age >65 years, +3 points (odds ratio, OR=4.85, CI 1.82‐16.77); lesion length ≥23 mm, +2 points (OR=3.22, CI 1.08‐13.89); and use of the retrograde approach +1 point (OR=2.41, CI 1.04‐6.05). The resulting score showed good calibration and discriminatory capacity in the derivation (Hosmer‐Lemeshow χ2 6.271, P=0.281, receiver‐operating characteristic [ROC] area=0.758) and validation (Hosmer‐Lemeshow χ2 4.551, P=0.473, ROC area=0.793) sets. Score values of 0 to 2, 3 to 4, and ≥5 were defined as low, intermediate, and high risk of complications (derivation cohort 0.4%, 1.8%, 6.5%, P<0.001; validation cohort 0.0%, 2.5%, 6.8%, P<0.001).ConclusionsThe PROGRESS CTO complication score is a useful tool for prediction of periprocedural complications in CTO PCI.Clinical Trial Registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02061436.
Background
We assessed efficacy and safety of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection re-entry (ADR).
Methods
We examined outcomes of ADR among 1,313 CTO PCIs performed at 11 US centers between 2012-2015.
Results
84.1% of patients were men. Prevalence of prior coronary artery bypass graft surgery was 34.3%. Overall technical and procedural success were 90.1% and 88.7%, respectively. In-hospital major adverse cardiovascular events (MACE) occurred in 31 patients (2.4%).
ADR was used in 458 cases (34.9%), and was the first strategy in 169 cases (12.9 %). ADR cases were angiographically more complex than non-ADR cases (mean J-CTO score: 2.8±1.2 vs. 2.4±1.2, p<0.001). ADR was performed using the CrossBoss catheter in 246 of 458 (53.7%) and the Stingray system in 251 ADR cases (54.8%). Compared with non-ADR cases, ADR cases had lower technical (86.9% vs. 91.8%, p=0.005) and procedural success (85.0% vs. 90.7%, p=0.002), but similar risk for MACE (2.9% vs. 2.2%, p=0.42). ADR was associated with longer procedure and fluoroscopy time, and higher patient air kerma dose and contrast volume (all p<0.001). After excluding retrograde cases, ADR and antegrade wire escalation (AWE) had similar technical success (92.7% vs. 94.2%, p=0.43) procedural success (91.8% vs. 94.1%, p=0.23), and MACE (2.1% vs. 0.6%, p=0.12).
Conclusions
ADR is used relatively frequently in contemporary CTO PCI, especially for challenging lesions and after failure of other strategies. ADR is associated with similar success rates and risk for complications as compared with AWE, and is important for achieving high procedural success.
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