Advances in Percutaneous Coronary Interventions for Elderly Patients

Coronary heart disease (CHD) is one of the leading causes of morbidity and the most common cause of death in older adults. Paradoxically, elderly patients tend to be systematically excluded from randomized-controlled cardiovascular trials, which complicates decision-making in this population. Management of CHD in the elderly is frequently more difficult in virtue of chronic comorbid conditions and aging-intrinsic dynamics. Despite these challenges, the number of elderly and very elderly patients undergoing percutaneous coronary interventions (PCI) is increasing. Elderly patients in many registries and large clinical series exhibit even a greater benefit from interventional procedures than younger patients, but they have a higher rate of overall complications. We present an overview of the current available evidence of PCI in older adults with stable and unstable CHD, including comparisons between drug-eluting and bare-metal stents, transfemoral and transradial access, and methods of revascularization. Adjuvant antiplatelet and antithrombotic therapies are also discussed.     

Percutaneous Coronary Intervention for Chronic Total Occlusion—The Michigan Experience: Insights From the BMC2 Registry

ObjectivesThe aim of this study was to describe the performance and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in Michigan.BackgroundCTO PCI has been associated with reduction in angina, but previous registry analyses showed a higher rate of major adverse cardiac events with this procedure.MethodsTo study uptake and outcomes of CTO PCI in Michigan, patients enrolled in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry (2010 to 2017) were evaluated. CTO PCI was defined as intervention in a 100% occluded coronary artery ≥3 months old.ResultsAmong 210,172 patients enrolled in the registry, 7,389 CTO PCIs (3.5%) were attempted, with 4,614 (58.3%) achieving post-procedural TIMI (Thrombolysis In Myocardial Infarction) flow grade 3. The proportion of PCIs performed on CTOs increased over the study period (from 2.67% in 2010 to 4.48% in 2017). Thirty of 47 hospitals performed >50 CTO interventions in 2017. Pre-procedural angina class ≤2 was present in one-quarter, and functional assessment for ischemia was performed in 46.6% of patients. Major complications occurred in 245 patients (3.3%) and included death (1.4%), post-procedural stroke (0.4%), cardiac tamponade (0.5%), and urgent coronary artery bypass graft surgery (1.3%). Procedural success improved modestly from 44.5% in 2010 to 54.9% in 2017 (p for trend < 0.001). Rates of in-hospital mortality (p for trend = 0.247) and major adverse cardiac event (p for trend = 0.859) for CTO PCI remained unchanged over the study period.ConclusionsThe rate of CTO PCI in Michigan increased over the study period. Although the success rate of CTO PCI has increased modestly in contemporary practice, it remained far below the >80% reported by select high-volume CTO operators. The rate of periprocedural major adverse cardiac events or death remained unchanged over time. These data suggest room for improvement in the selection and functional assessment of CTO lesions before subjecting patients to the increased procedural risk associated with CTO PCI.     

Lower Extremity Revascularization Using Directional Atherectomy: 12-Month Prospective Results of the DEFINITIVE LE Study

ObjectivesThe aim of this study was to assess the safety and effectiveness of directional atherectomy (DA) for endovascular treatment of peripheral arterial disease (PAD) in infrainguinal arteries in patients with claudication or critical limb ischemia.BackgroundTo date, no prospective, multicenter, independently-adjudicated study has evaluated the effectiveness and durability of DA in the treatment of PAD. Previous DA studies have not been prospectively powered to evaluate any differences in outcomes in patients with and without diabetes.MethodsDEFINITIVE LE (Determination of EFfectiveness of the SilverHawk® PerIpheral Plaque ExcisioN System (SIlverHawk Device) for the Treatment of Infrainguinal VEssels / Lower Extremities) prospectively enrolled subjects at 47 multinational centers with an infrainguinal lesion length up to 20 cm. Primary endpoints were defined as primary patency at 12 months for claudicants and freedom from major unplanned amputation for critical limb ischemia (CLI) subjects. A pre-specified statistical hypothesis evaluated noninferiority of primary patency in diabetic versus nondiabetic claudicants. Independent angiographic and sonographic core laboratories assessed outcomes, and events were adjudicated by a clinical events committee.ResultsA total of 800 subjects were enrolled. The 12-month primary patency was 78% (95% confidence interval: 74.0% to 80.6%) in claudicants, with a 77% rate in the diabetic subgroup versus 78% in the nondiabetic subgroup (noninferior, p < 0.001). The rate of freedom from major unplanned amputation of the target limb at 12 months in CLI subjects was 95% (95% confidence interval: 90.7% to 97.4%). Periprocedural adverse events included embolization (3.8%), perforation (5.3%), and abrupt closure (2.0%). The bail-out stent rate was 3.2%.ConclusionsThe DEFINITIVE LE study demonstrated that DA is a safe and effective treatment modality at 12 months for a diverse patient population with either claudication or CLI. Furthermore, DA was shown to be noninferior for treating PAD in patients with diabetes compared with those without diabetes. (Study of SilverHawk/TurboHawk in Lower Extremity Vessels [DEFINITIVE LE]; NCT00883246).     

An ultra-low-profile 0.85 mm Nano Hydro balloon to treat wire-crossable balloon-uncrossable lesions: A useful tool in CTO armamentarium

Balloon uncrossable lesions are commonly encountered during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). A sequential strategy and planning are required to tackle such lesions. We present a case series of severely calcified, device uncrossable lesions where the traditional strategies failed and an ultra-low-profile (0.85 mm) balloon was crucial to successful PCI. To our best knowledge, this is the first case series describing the use of this balloon in real world.     

Prevalence,Trends, and Outcomes of Higher-Risk Percutaneous Coronary Interventions Among Patients Without Acute Coronary Syndromes

Background/purpose

Patients and lesions at a higher procedural risk for percutaneous coronary intervention (PCI) are an understudied population. We examined the frequency, clinical characteristics, and outcomes of higher risk and non-higher risk PCIs at a large tertiary center.

Intravascular ultrasound-guided wiring for chronic total occlusion.

This report describes a wiring technique for a blunt chronic total occlusion with a side branch at the site of occlusion for which the operator has difficulty of awareness of the proper entry point angiographically.     

Effectiveness,safety, and patient reported outcomes of a planned investment procedure in higher-risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest-CTO study

Background

The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated.

Study Design

Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8–12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported.

Conclusion

This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.     

A Clinical and Angiographic Scoring System to Predict the Probability of Successful First-Attempt Percutaneous Coronary Intervention in Patients With Total Chronic Coronary Occlusion

ObjectivesThis study sought to develop a scoring model predicting percutaneous coronary intervention (PCI) success in chronic total occlusions.BackgroundCoronary chronic total occlusion is the lesion subtype in which angioplasty is most likely to fail. Chronic total occlusion for PCI (CTO-PCI) failure is associated with higher 1-year mortality and major adverse cardiac events compared with successful CTO-PCI. Although several independent predictors of final procedural success have been identified, no study has yet produced a model predicting final procedural outcome.MethodsData from 1,657 consecutive patients who underwent a first-attempt CTO-PCI were prospectively collected. The scoring model was developed in a derivation cohort of 1,143 patients (70%) using a multivariable stepwise analysis to identify independent predictors of CTO-PCI failure. The model was then validated in the remaining 514 (30%).ResultsThe overall procedural success rate was 72.5%. Independent predictors of CTO-PCI failure were identified and included in the clinical and lesion-related score (CL-score) as follows: previous coronary artery bypass graft surgery +1.5 (odds ratio [OR]: 2.49, 95% confidence interval [CI]: 1.56 to 3.96), previous myocardial infarction +1 (OR: 1.6, 95% CI: 1.17 to 2.2), severe lesion calcification +2 (OR: 2.72, 95% CI :1.78 to 4.16), longer CTOs +1.5 (≥20 mm OR: 2.04, 95% CI: 1.54 to 2.7), non–left anterior descending coronary artery location +1 (OR: 1.56, 95% CI: 1.14 to 2.15), and blunt stump morphology +1 (OR: 1.39, 95% CI: 1.05 to 1.81). Score values of 0 to 1, >1 and <3, ≥3 and <5, and ≥5 identified subgroups at high, intermediate, low, and very low probability, respectively, of CTO-PCI success (derivation cohort: 84.9%, 74.9%, 58%, and 31.9%; p < 0,0001; validation cohort: 88.3%, 73.1%, 59.4%, and 46.2%; p < 0.0001).ConclusionsThis clinical and angiographic score predicted the final CTO-PCI procedural outcome of our study population.