Impact of Platelet Glycoprotein IIb/IIIa Inhibitor Therapy on In-Hospital Outcomes and Long-Term Survival Following Percutaneous Coronary Rotational Atherectomy

Background: Percutaneous coronary rotational atherectomy (PCRA) is a potent stimulus of platelet activation and aggregation in vivo. For this reason, many patients undergoing PCRA are treated with platelet glycoprotein (GP) IIb/IIIa inhibitors. However, there is limited data regarding the ability of GP IIb/IIIa inhibitors to reduce ischemic complications of PCRA and no data regarding their effect on long-term survival.Methods: Data on 1138 consecutive patients undergoing PCRA in 5 hospitals in 1998–1999 were pooled and analyzed. Long-term survival was available for all 530 patients treated in 3 of the hospitals.Results and conclusions: GP IIb/IIIa inhibitors were administered to 315 of 1138 (28%) PCRA patients. There was no difference in age, gender or race among patients treated with and without GP IIb/IIIa antagonists. The prevalence of hypertension, diabetes, renal insufficiency and peripheral vascular disease did not differ between groups. Unstable angina was more common among patients treated with GP IIb/IIIa inhibitors (45% vs. 38%, P = 0.036)Patients treated with GP IIb/IIIa inhibitors had lower ejection fractions (50% vs. 55%, P < 0.001) and more 3-vessel coronary disease (24% vs. 16%, P = 0.002). Angiographic success was over 99% in both groups (P = NS). The frequency of major adverse cardiovascular events (MACE) was slightly greater in GP IIb/IIIa inhibitor treated patients (3.8% vs. 2.2%, P = 0.126). At a mean follow-up of 3 years, mortality was 13.3% in the GP IIb/IIIa treated patients and 12% in the untreated patients (P = 0.224). On Cox proportional hazards analysis, treatment with a GP IIb/IIIa inhibitor was not significantly associated with increased survival (Hazard Ratio, 0.81, 95% Confidence Interval, 0.631–1.039, P = 0.098). These data do not indicate a significant association between GP IIb/IIIa inhibitor treatment during PCRA and MACE or survival.Condensed Abstract. There is limited data regarding the ability of GP IIb/IIIa inhibitors to reduce ischemic complications of percutaneous coronary rotational atherectomy (PCRA) and no data regarding their effect on long-term survival. These data do not indicate a significant association between GP IIb/IIIa inhibitor treatment during PCRA and MACE or survival.     

Operator Volumes and In-Hospital Outcomes: An Analysis of 7,740 Rotational Atherectomy Procedures From the BCIS National Database

ObjectivesThe aims of this study were to use a national percutaneous coronary intervention (PCI) registry to study temporal changes in procedure volumes of PCI using rotational atherectomy (ROTA-PCI), the patient and procedural factors associated with differing quartiles of operator ROTA-PCI volume, and the relationship between operator ROTA-PCI volumes and in-hospital patient outcomes.BackgroundWhether higher operator volume is associated with improved outcomes after ROTA-PCI is poorly defined.MethodsData from the British Cardiovascular Intervention Society national PCI database were analyzed for all ROTA-PCI procedures performed in the United Kingdom between 2013 and 2016. Individual logistic regressions were performed to quantify the independent association between annual operator ROTA-PCI volume and in-hospital outcomes.ResultsIn total, 7,740 ROTA-PCI procedures were performed, with a negatively skewed distribution and an annualized operator volume median of 2.5 procedures/year (range 0.25 to 55.25). Higher volume operators undertook more complex procedures in patients with greater comorbid burdens than lower volume operators. A significant inverse association was observed between operator ROTA-PCI volume and in-hospital mortality (odds ratio [OR]: 0.986/case; 95% confidence interval [CI]: 0.975 to 0.996; p = 0.007) and major adverse cardiac and cerebral events (OR: 0.983/case; 95% CI: 0.975 to 0.993; p < 0.001). Additionally, lower rates of emergency cardiac surgery (OR: 0.964/case; 95% CI: 0.939 to 0.991; p = 0.008), arterial complications (OR: 0.975/case; 95% CI: 0.975 to 0.982; p < 0.001) and in-hospital major bleeding (OR: 0.985/case; 95% CI: 0.977 to 0.993; p < 0.001) were associated with higher ROTA-PCI operator volume. Sensitivity analyses in several subgroups demonstrated a consistency of improved outcomes as annual ROTA-PCI volume increased. An annual volume of <4 ROTA-PCI procedures/year was observed to be associated with increased major adverse cardiac and cerebral events, with 239 of 432 operators (55%) not exceeding this threshold.ConclusionsIn-hospital adverse outcomes occurred less frequently as ROTA-PCI operator volume increased. These data suggest that operator volume is an important factor determining outcome after ROTA-PCI.     

SYNTAX Score and Outcomes of Coronary Revascularization in Diabetic Patients

Purpose of Review

This review describes the dynamic relationship between diabetes mellitus (DM) and coronary artery disease (CAD) with respect to different revascularization strategies and how angiographic tools such as the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score can supplement clinical decision-making.

Recent Findings

The SYNTAX score characterizes the anatomical extent of CAD in terms of the number of lesions, functional importance, and complexity. Studies not limited to patients with DM suggest that percutaneous coronary intervention (PCI) is a reasonable alternative to coronary artery bypass grafting (CABG) in patients with low-medium SYNTAX scores, while patients with high SYNTAX scores should be revascularized with CABG if operable. Similar findings were also observed for diabetes patients with multivessel disease in retrospective pooled analysis. The SYNTAX II score combines anatomical and clinical risk to improve upon the decision regarding the optimal revascularization strategy. The SYNTAX II score can be applied to patients with DM.

Summary

The SYNTAX scores provide guidance to clinicians faced with determining the optimal revascularization strategy in patients with DM and advanced CAD. Using a heart team approach, the information can be considered along with other factors that influence PCI or CABG risk.

     

Impact of SYNTAX Score on 10-Year Outcomes After Revascularization for Left Main Coronary Artery Disease

ObjectivesThe aim of this study was to investigate the long-term impact of SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS) on differential outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease.BackgroundThe very long term prognostic effect of SS on mortality and major cardiovascular events after LMCA revascularization is still undetermined.MethodsIn the MAIN-COMPARE (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease) registry, patients with baseline SS measurements were analyzed. The 10-year rates of all-cause mortality, the composite of death, Q-wave myocardial infarction, or stroke, and target vessel revascularization after PCI or CABG were compared according to baseline SS.ResultsAmong 1,580 patients with baseline SS, 547 patients (34.6%) had low SS (≤22), 350 (22.2%) had intermediate SS (23 to 32), and 683 (43.2%) had high SS (≥33). In patients with low to intermediate SS, the adjusted 10-year risks for death and serious composite outcome were similar between the PCI group and the CABG group. However, in patients with high SS, PCI with stenting, compared with CABG, was associated with a higher risk for death (hazard ratio: 1.39; 95% confidence interval: 1.00 to 1.92; p = 0.048) and serious composite outcome (hazard ratio: 1.27; 95% confidence interval: 0.94 to 1.74; p = 0.123). In each revascularization group, conventional tertiles of SS had a differential prognostic impact on 10-year clinical outcomes in the PCI arm but not in the CABG arm.ConclusionsIn this 10-year extended follow-up of patients undergoing LMCA revascularization, CABG showed a clear prognostic benefit over PCI in patients with high anatomic complexity measured by SS at baseline. The discriminative capacity of SS on long-term outcomes was relevant in the PCI group but not in the CABG group. (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease [MAIN-COMPARE]; NCT02791412)     

Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database

Background/purposeCoronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.Methods/materialsWe queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis.ResultsPercentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery.ConclusionAn analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality.     

Predictors of Peak Troponin Level in Acute Coronary Syndromes: Prior Aspirin Use and SYNTAX Score

The peak troponin level has been associated with cardiovascular (CV) mortality and adverse CV events. The association of peak troponin with CV risk factors and severity and complexity of coronary artery disease remains unknown. We assessed the predictors of peak troponin in patients with acute coronary syndrome (ACS). This study aims to determine the predictors of peak troponin in ACS. Cardiac catheterization (CC) reports and electronic medical records from 2010 to 2013 were retrospectively reviewed. A total of 219 patients were eligible for the study. All major CV risk factors, comorbidities, laboratory data, CC indications, and coronary lesion characteristics were included. Univariate and multivariate regression analyses were done. On multivariate linear regression analysis, ST-elevation myocardial infarction (p = 0.001, β = 65.16) and increasing synergy between percutaneous coronary intervention with Taxus and cardiac surgery (SYNTAX) score (p = 0.002, β = 1.15) were associated with higher peak troponin. The Pearson correlation between SYNTAX score and peak troponin was r = 0.257, p = 0.001. History of daily aspirin use was associated with lower peak troponin (p = 0.002, β = −24.32). Prior statin use (p = 0.321, β = −8.98) and the presence of CV risk factors were not associated with peak troponin. Coronary artery disease severity and complexity, urgency of CC, and prior aspirin use are associated with peak troponin levels in ACS. Our findings may help predict patient population with ACS who would be at a greater risk for short- and long-term CV morbidity and mortality due to elevated peak troponin.     

Rotational Atherectomy for Severely Calcified Lesions in Patients With Left Ventricular Systolic Dysfunction: One-Year Outcomes From aSingle-Center Registry Analysis

BackgroundHigh-risk percutaneous coronary intervention (PCI) in patients with left ventricular (LV) systolic dysfunction has been proven to induce reverse LV remodeling. However, the impact of high-risk PCI focusing on rotational atherectomy (RA) in patients with severe LV systolic dysfunction has not been completely addressed.MethodsAmong 4339 consecutive patients who underwent PCI, 178 patients with 192 lesions were treated with RA. The reduced ejection fraction (EF) group (LVEF ≤35%) included 25 patients, the mid-range EF group (LVEF 36–50%) included 44 patients, and the preserved EF group (LVEF >50%) included 109 patients. The primary outcome was a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization, and ischemic stroke.ResultsThe cumulative 1-year incidence of the primary outcome was similar among the three groups (reduced EF, 29%; mid-range EF, 25%; preserved EF, 26%; p = 0.95). After adjusting for confounding factors, the incidence of the primary outcome in the reduced EF group (hazard ratio [HR], 1.07; 95% confidence interval [CI], 0.43–2.37; p = 0.87) and the mid-range EF group (HR, 0.99; 95% CI, 0.47–1.94; p = 0.97) was similar to that in the preserved EF group. LVEF was significantly improved in the reduced EF and mid-range EF groups compared with the preserved EF group (absolute change in LVEF: 13.6 ± 11.3%, 9.0 ± 10.1%, and −0.7 ± 7.8%, respectively; p < 0.0001).ConclusionsReduced EF was not associated with increase in the primary outcome in patients undergoing RA. This seemed to result from the improved LV function after PCI.Summary for annotated table of contentsThis single center analysis study investigated 1-year composite outcome of cardiac death, non-fatal myocardial infarction, target-vessel revascularization, and ischemic stroke in patients with severe LV systolic dysfunction undergoing RA compared with that in patients with preserved LV function. The cumulative 1-year incidence of the composite outcome was similar among the three groups (reduced EF, 29%; mid-range EF, 25%; preserved EF, 26%; p = 0.95). LVEF was significantly improved in the reduced EF and mid-range EF groups compared with the preserved EF group (absolute change in LVEF: 13.6 ± 11.3%, 9.0 ± 10.1%, and −0.7 ± 7.8%, respectively; p < 0.0001).     

Predictors and Prognostic Implications of Major Adverse Cardiovascular Events after Renal Transplant: 10 Years Outcomes in 321 Patients

Renal transplantation is the treatment of choice in patients with end-stage renal disease. Major adverse cardiac events (MACE) are common after renal transplant, especially in the perioperative period, leading to excess morbidity and mortality. The predictors and long-term prognostic implications of MACE are poorly understood. We analyzed predictors and implications of MACE in a cohort of 321 consecutive adult patients, who received renal allograft transplantation between 1995 and 2003 at our institution. The characteristics of 321 patients were: age at transplant 44 ± 13 years, 60% male, 36% diabetes mellitus (DM), left ventricular ejection fraction (LVEF) 60 ± 16%. MACE occurred in 21 patients with cumulative rate of 6.5% over 3 years after renal transplant, 57% occurring within 30 days, 67% within 90 days, and 86% within 180 days. MACE was not predicted by any clinical or pharmacological variables including age, gender, hypertension, DM, prior myocardial infarction, smoking, duration of dialysis, LVEF, or therapy with β-blockers (BB), angiotensin converting enzyme inhibitors, or calcium channel blockers. However, a clinical decision to perform a stress test or a coronary angiogram was predictive of higher MACE rate. MACE, irrespective of type, was independently associated with higher mortality over a period up to 15 years and this seemed to be blunted by BB therapy. MACE rate after renal transplantation decreases over time, most occurring in the first 90 days and is not predicted by any of the traditional risk factors or drug therapies. It is associated with higher long-term mortality.     

Outcomes after Atherectomy Treatment of Severely Calcified Coronary Bifurcation Lesions: A Single Center Experience

BackgroundCoronary bifurcation and calcified lesions account for 15–20% and 6%–20% of percutaneous coronary interventions (PCI), respectively. Treatment of these lesions is associated with high periprocedural complication rates and unfavorable long-term clinical outcomes, including high rates of revascularization. This retrospective, single-center study evaluated the outcomes of atherectomy treatment for heavily calcified coronary bifurcation lesions.MethodsPatients who underwent a coronary atherectomy procedure to treat a heavily calcified lesion between January 2010 and March 2016 at Metropolitan Heart and Vascular Institute (Minneapolis, MN) were included in this retrospective study. Data were stratified to compare atherectomy treatment of coronary bifurcation lesions vs non-bifurcation lesions. Additionally, data were compared based on type of atherectomy utilized during the index procedure, either orbital (OAS) or rotational (RA) atherectomy. Major adverse cardiac events (MACE), defined as a composite of death, myocardial infarction (MI), and target vessel revascularization (TVR), were assessed at 30 days post-procedure.ResultsAmong the 177 patients treated with atherectomy, 72 patients had bifurcation lesions. Compared to patients with non-bifurcation lesions, patients with bifurcation lesions were more likely to have a history of prior PCI or coronary artery bypass grafting. Bifurcation lesions required a higher volume of contrast. There were similar low rates of slow flow/no-reflow (2.8% bifurcations vs 1.0% non-bifurcation; p = 0.355). The 30-day rates of death (1.4% vs 1.9%; p = 0.794), MI (0% vs 0%; p = NA), and TVR (0% vs 1.0%; p = 0.406) were similar in patients with bifurcation lesions versus those without, respectively. An atherectomy sub-analysis (OAS vs RA) of the patients with bifurcation lesions showed that OAS utilization was associated with shorter procedure time (81 min vs 109 min; p = 0.026) and fluoroscopy time (18 min vs 27 min; p = 0.007) compared to RA, respectively—no significant differences in baseline demographic or lesion characteristics were noted in the bifurcation atherectomy sub-groups, except for higher beta/calcium blocker use in RA bifurcation subjects.ConclusionsThe results of this study demonstrated that atherectomy treatment in patients with heavily calcified coronary bifurcation lesions is feasible, resulting in similar low 30-day MACE rates as compared to patients with non-bifurcation lesions. In addition, in this study OAS utilization versus RA in bifurcation lesions was associated with significantly shorter procedure and fluoroscopy time. Further studies are needed to assess the safety and efficacy of atherectomy in patients with severely calcified bifurcation lesions.Summary for annotated table of contentsThis retrospective, single-center study evaluated the outcomes of orbital and rotational atherectomy treatment for heavily calcified coronary bifurcation lesions as compared to non-bifurcation lesions. The results demonstrate that atherectomy treatment in patients with heavily calcified coronary bifurcation lesions is feasible, resulting in similarly low 30-day MACE rates as compared to patients with non-bifurcation lesions. In addition, in this study OAS utilization versus RA in bifurcation lesions was associated with significantly shorter procedure and fluoroscopy time.