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.     

Procedural and Long-Term Ischemic Outcomes of Tight Subtotal Occlusions Treated with Orbital Atherectomy: An ORBIT II Subanalysis

Background/purposeOrbital atherectomy is an effective treatment strategy to modify severely calcified coronary lesions prior to stent placement. Traversing a severely calcified subtotal occlusion with the crown may be more challenging compared with a less severely stenotic lesion. The purpose of this ORBIT II subanalysis was to evaluate outcomes post-orbital atherectomy (OA) treatment of lesions with ≥95% stenosis.Methods/materialsORBIT II, a single-arm, prospective, multicenter trial, enrolled 443 subjects with severely calcified coronary lesions. Patients with chronic total occlusions were excluded from the trial. Subjects with the OA device activated were stratified based on pre-procedure percent stenosis: ≥95% stenosis (N = 91) and <95% stenosis (N = 341). Procedural success and 3-year major adverse cardiac event (MACE) rates were compared.ResultsThe severe angiographic complications rates were 6.6% and 6.7% in the ≥95% and <95% stenosis groups, respectively. There was no significant difference in procedural success (94.5% vs. 88.3%, p = 0.120). 3-year MACE rates were similar (27.1% vs. 22.5%, p = 0.548), as were the rates of cardiac death (5.7% vs. 7.1%, p = 0.665) and MI (7.9% vs. 12.1%, p = 0.244). The TVR rate was higher in the ≥95% stenosis group (19.1% vs. 7.5%, p = 0.004).ConclusionsIn ORBIT II, OA treatment of lesions with ≥95% stenosis resulted in a high rate of procedural success. Although the 3-year revascularization rate was higher in the ≥95% stenosis group, it is not unexpected given the challenge of treating such complex lesions. The results of this analysis suggest that OA may be a reasonable treatment strategy for tight, severely calcified subtotal occlusions.SummaryThe purpose of this ORBIT II subanalysis was to evaluate outcomes post-orbital atherectomy (OA) treatment of lesions with ≥95% stenosis. In ORBIT II, OA treatment of lesions with ≥95% stenosis resulted in a high rate of procedural success. Although the 3-year revascularization rate was higher in the ≥95% stenosis group, it is not unexpected given the challenge of treating such complex lesions. The results of this analysis suggest that OA may be a reasonable treatment strategy for tight, severely calcified subtotal occlusions.     

Orbital Atherectomy for the Treatment of Long (≥25–40 mm) Severely Calcified Coronary Lesions: ORBIT II Sub-Analysis

BackgroundOrbital atherectomy (OA) is an effective method of lesion preparation of severely calcified vessels prior to stent deployment. Long calcified lesions may lead to higher risk of post-procedural complications, yet the optimal treatment strategy has not been established. In this study we sought to determine the safety and efficacy of OA in patients with long (≥25–40 mm) calcified target lesions.MethodsORBIT II was a single-arm trial that enrolled 443 patients at 49 U.S. sites. De novo, severely calcified coronary lesions were treated with OA prior to stenting. Patients treated with the OA device were stratified into two groups according to target lesion length as visually estimated by the investigator: those with short (<25 mm; N = 314) vs. long (≥25–40 mm; N = 118) lesions. Lesions >40 mm were excluded per protocol. The primary endpoint was the 3-year major adverse cardiac event (MACE) rate, defined as a composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).ResultsThe 3-year MACE rates in patients with short (<25 mm) vs. long (≥25–40 mm) lesions were 21.1% vs. 29.9% respectively (p = 0.055). The rate of cardiac death (6.5% vs. 7.8%, p = 0.592) and TVR (8.5% vs. 13.7%, p = 0.153) did not significantly differ. The rate of MI (CK-MB > 3× ULN) at 3 years was significantly higher in patients with long (≥25–40 mm) lesions (9.0% vs. 17.0%, p = 0.024), with the majority occurring in-hospital (7.0% vs. 13.6%, p = 0.037).ConclusionsPatients with long (≥25–40 mm) calcified target lesions had similar outcomes in terms of MACE at 3 years despite higher rates of MI, which mostly occurred in-hospital. Using the more contemporary SCAI definition of MI, there was no significant difference in rates of MI between the short (<25 mm) and long (≥25–40 mm) groups. Further studies are warranted to determine how OA compares to focal force balloon angioplasty, rotational atherectomy and other novel treatment options for long severely calcified lesions.Summary for annotated table of contentsPercutaneous coronary intervention of long calcified lesions is inherently more complex and higher risk and may require more intensive lesion preparation. This sub-analysis of ORBIT II revealed that orbital atherectomy treatment of longer (≥25–40 mm) lesions was associated with a higher rate of MACE at 30 days, but not at 3 years. This difference, however, was driven primarily by a higher in-hospital non-Q-wave MI rate; using the more contemporary SCAI definition of MI, there was no significant difference in rates of MI between the short (<25 mm) and long (≥25–40 mm) groups.     

Direct Stenting in Patients Treated with Orbital Atherectomy: An ORBIT II Subanalysis

BackgroundDirect stenting offers many potential advantages in appropriately selected lesions. Coronary artery calcification increases the complexity and risk of adverse events associated with percutaneous coronary intervention. This study aimed to examine the feasibility of direct stenting after treatment with orbital atherectomy (OA).MethodsORBIT II was a single-arm trial enrolling 443 subjects with de novo severely calcified coronary lesions treated with OA; direct stenting was utilized in 59.0% of cases. Procedural outcomes and 3-year major adverse cardiac event (MACE) rates were compared in subjects treated with pre-stent balloon dilatation versus direct stenting after OA.ResultsProcedural success (84.2% vs. 93.3%; p = 0.004) was significantly higher in the direct stenting cohort. 3-year MACE occurred less frequently in the direct stenting cohort (29.9% vs. 19.1%; p = 0.006), driven by lower rates of myocardial infarction and target lesion revascularization. In a propensity matched analysis, procedural success and 3-year MACE rates were similar in the pre-stent balloon dilatation and direct stenting groups (85.0% vs. 91.8%; p = 0.122 and 28.2% vs. 19.6%; p = 0.078, respectively).ConclusionsOrbital atherectomy facilitates direct stenting and is associated with high procedural success and favorable 3-year outcomes in carefully selected patients. Randomized studies are needed to assess the optimal strategy after lesion preparation with OA.     

Outcomes in Diabetic Patients Undergoing Orbital Atherectomy System

Objectives

We evaluated the angiographic and clinical outcomes of orbital atherectomy to treat severely calcified coronary lesions in diabetic and non‐diabetic patients.

Background

Diabetics have increased risk for death, myocardial infarction, and target vessel revascularization after percutaneous coronary intervention. Severely calcified coronary lesions are associated with increased cardiac events. Orbital atherectomy facilitates stent delivery and optimizes stent expansion by modifying severely calcified plaque. Outcomes in diabetic patients who undergo orbital atherectomy have not been reported.

Methods

Our retrospective multicenter registry included 458 consecutive real‐world patients with severely calcified coronary arteries who underwent orbital atherectomy. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events at 30 days.

Results

Diabetics represented 42.1% (193/458) of the entire cohort. The primary endpoint was similar in diabetics and non‐diabetics (1.0% vs. 3.0%%, P = 0.20), as were 30‐day rates of death (0.5% vs. 1.9%, P = 0.41), myocardial infarction (0.5% vs. 1.5%, P = 0.40), target vessel revascularization (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P > 0.9). Angiographic complications and stent thrombosis rate were low and did not differ between the 2 groups.

Conclusion

Diabetics represented a sizeable portion of patients who underwent orbital atherectomy. Diabetics who had severely calcified coronary arteries and underwent orbital atherectomy had low event rates that were similar to non‐diabetics. Orbital atherectomy appears to be a viable treatment strategy for diabetic patients. Randomized trials with longer‐term follow‐up are needed to determine the ideal treatment strategy for diabetics.

     

Outcomes of patients with severely calcified aorto‐ostial coronary lesions who underwent orbital atherectomy

Objectives

We assessed the feasibility and safety of orbital atherectomy in patients with severely calcified aorto‐ostial coronary artery lesions.

Background

The treatment of calcified aorta‐ostial coronary artery lesions is technically challenging. Orbital atherectomy can potentially damage the guiding catheter if it is not retracted sufficiently during treatment of ostial lesions. Orbital atherectomy can also excessively whip if the guiding catheter is not close enough to the ostium to provide sufficient support. Several techniques can be performed to successfully treat ostial lesions with orbital atherectomy.

Methods

Our retrospective multicenter registry included 548 real‐world patients who underwent orbital atherectomy, 59 (10.8%) of whom underwent treatment for aorto‐ostial coronary artery lesions (left main artery [n = 35] and right coronary artery [n = 24]). The primary endpoint was the rate of 30‐day major adverse cardiac and cerebrovascular events (MACCE), defined as the occurrence of death, myocardial infarction, target vessel revascularization, and stroke.

Results

The primary endpoint was similar in patients with and without ostial lesions (3.4% vs 2.2%, P = 0.2), as were the 30‐day rates of death (1.7% vs 1.4%, P = 0.7), myocardial infarction (1.7% vs 1.0%, P = 0.3), target vessel revascularization (0% vs 0%, P > 0.91), and stroke (0% vs 0.2%, P > 0.9). Angiographic complications and stent thrombosis did not occur in patients with ostial lesions.

Conclusions

Despite its technical challenges, orbital atherectomy appears to be a feasible and safe treatment option for calcified aorto‐ostial coronary lesions.     

Orbital Atherectomy for Treatment of Severely Calcified Coronary Artery Bifurcation Lesions: A Multicenter Analysis

ObjectiveThis study evaluated the safety and efficacy of orbital atherectomy (OA) for the treatment of severely calcified coronary artery bifurcation lesions.BackgroundPercutaneous coronary intervention (PCI) of severely calcified coronary artery lesions is associated with lower procedural success and higher rates of target lesion failure compared to non-calcified lesions. OA is an effective treatment for calcified coronary artery lesions prior to stent implantation. However, there is little data regarding the safety and efficacy of OA in patients with coronary artery bifurcation lesions.MethodsData were obtained from analysis of patients with severe coronary artery calcification who underwent OA and coronary stent implantation at ten high-volume institutions. Data were pooled and analyzed to assess peri-procedural outcomes and 30-day major adverse cardiac events (MACE).ResultsA total of 1156 patients were treated with OA and PCI. 363 lesions were at a coronary artery bifurcation. There were no statistically significant differences in baseline characteristics between the bifurcation and non-bifurcation groups. In the bifurcation group, treatment involved the left anterior descending artery and its branches more frequently and right coronary artery less frequently. After propensity score matching, the 30-day freedom from MACE was not statistically significant between the two groups.ConclusionIn this multicenter cohort analysis, patients with severely calcified coronary bifurcation lesions had low rates of MACE and target vessel revascularization at 30 days at rates comparable to non-bifurcation lesions. This analysis demonstrates that OA is safe and effective for complex coronary lesions at both bifurcation and non-bifurcation locations.     

Long-term prognosis after reperfusion therapy for acute myocardial infarction in elderly patients

Although it has been well demonstrated that TIMI grade 3 flow is associated with improved survival after acute myocardial infarction in non-elderly patients, its implication in elderly patients has not been clarified. To assess this issue, 1,115 patients with acute myocardial infarction who underwent coronary angiography within 24 hours after the onset of chest pain were studied: there were 131 elderly patients (age > or = 75 years) and 984 non-elderly patients (age < 75 years). Follow-up was achieved for 1,092 patients (98%). Elderly patients were associated with more female, Killip class > or = 2, 3 vessel disease and non-smokers. Although modality of reperfusion therapy was not different, final TIMI flow grade was less frequently obtained in elderly patients (53% vs 65%, p = 0.005). Elderly patients were associated with higher in-hospital mortality (25% vs 9%, p < 0.001) and lower 10 years cardiac death free rate (p < 0.001). Cox proportional hazards model showed that final TIMI flow grade 3 was an independent predictor of 10 years cardiac death free in elderly patients (odds ratio (OR) = 0.39, 95% confidence interval (CI) = 0.20-0.74, p = 0.004) as well as non-elderly patients (OR = 0.41, 95% CI = 0.29-0.58, p < 0.001). In conclusion, our data suggest that final TIMI grade 3 flow is an important determinant to improve short- and long-term survival after acute myocardial infarction in elderly patients as well as in non-elderly patients.     

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement

BackgroundCoronary artery disease (CAD), often with severe calcification, is present in up to 75% of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). Management of CAD in such patients is challenging. Orbital atherectomy (OA) is an effective treatment of severely calcified coronary lesions prior to stent implantation. However, there is limited data on the use of OA for percutaneous coronary intervention (PCI) to treat calcific CAD patients prior to TAVR (OA PCI + TAVR).MethodsRetrospective analysis of patients with moderate/severe calcific CAD and moderate/severe AS who underwent staged OA PCI + TAVR at one high-volume institution. Data were analyzed to assess the 1-year major adverse cardiac events after index OA PCI [MACE: death, target lesion revascularization (TLR), and myocardial infarction (MI)].ResultsThere were 18 patients (mean age of 82) treated with staged OA PCI + TAVR, and of those, 10 (56%) were male, 7 (39%) Caucasian, and 11 (61%) Hispanic/Latino. The average left ventricular ejection fraction was 49% and congestive heart failure was present in 12 patients (67%). There were no angiographic complications (0%), stent thrombosis (0%), or stroke events (0%). The 30-day and 1-year MACE rates were 5.6% (0% death, 0% TLR, 5.6% MI) and 17% (0% death, 11% TLR, and 17% MI [all non-Q-wave MI]), respectively.ConclusionsIn this single-center observational cohort series, patients with heavily calcified coronary lesions treated with OA prior to TAVR had low rates of MACE at 30 days and 1 year. The results demonstrate the feasibility and safety of OA for the treatment of complex calcific coronary lesions prior to TAVR. An up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD is also provided.Table of contents summaryThere is limited data on the use of orbital atherectomy (OA) for percutaneous coronary intervention (PCI) to treat calcific coronary artery disease (CAD) patients prior to transcatheter aortic valve replacement (TAVR). Our primary aim was to evaluate the feasibility, safety, and 1-year outcome of OA PCI pre-TAVR in patients with complex CAD and severe aortic stenosis (AS). We also aimed to provide a brief up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD. This retrospective cohort study found that OA is feasible and safe for the treatment of severely calcified coronary lesions before TAVR, resulting in acceptable 30-day and 1-year outcomes.     

Impact of aging on the clinical outcomes of Japanese patients with coronary artery disease after percutaneous coronary intervention

Japan has become an aging society, resulting in an increased prevalence of coronary artery disease. However, clinical outcomes of elderly Japanese patients after percutaneous coronary intervention (PCI) remain unclear. Of the 15,227 patients in the Shinken Database, a single-hospital-based cohort of new patients, 1,214 patients who underwent PCI, was evaluated to determine the differences in clinical outcomes between the elderly (≥75 years) (n = 260) and the non-elderly (<75 years) (n = 954) patients. A major adverse cardiac event (MACE) was defined as a composite end point, including all-cause death, myocardial infarction (MI), and target lesion revascularization. Male gender and obesity were less common, and the estimated glomerular filtration rate (eGFR) was significantly lower in the elderly than in the non-elderly. Left ventricular ejection fraction (LVEF) was comparable between these groups. Left main trunk disease and multivessel disease were more common in the elderly than in the non-elderly group. Occurrence of MACE was frequent, and the incidences of all-cause death, cardiac death, and the admission rate for heart failure were significantly higher in the elderly patients. Multivariate analysis showed that prior MI, low eGFR, and poor LVEF were independent predictors for all-cause death in the elderly patients. Elderly patients had worse clinical outcomes than the non-elderly patients. Low eGFR and LVEF were independent predictors of all-cause death after PCI, suggesting that left ventricular dysfunction and renal dysfunction might synergistically contribute to the adverse clinical outcomes of the elderly patients undergoing PCI.     

Utilizing intravascular ultrasound imaging prior to treatment of severely calcified coronary lesions with orbital atherectomy: An ORBIT II sub‐analysis

Objectives

We sought to assess the clinical outcomes when intravascular ultrasound (IVUS) was used prior to orbital atherectomy treatment (OA) versus angiography alone for lesion assessment.

Background

Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with high rates of major adverse cardiac events (MACE). IVUS provides additional diagnostic information to optimize PCI.

Methods

ORBIT II was a single‐arm study of 443 patients with de novo, severely calcified coronary lesions treated with OA before stent placement. Patients with IVUS imaging prior to OA (N = 35) were compared to patients without IVUS imaging for initial lesion assessment (N = 405). In this post‐hoc sub‐analysis procedural outcomes and the 3‐year MACE rate were evaluated.

Results

The rates of severe angiographic complications were low in patients with and without IVUS imaging prior to OA. There was a significant reduction in the number of stents used in patients with IVUS imaging prior to OA (1.0 ± 0.2 vs 1.3 ± 0.6; P = 0.006) and increased post‐OA mean minimal lumen diameter (MLD) (1.6 ± 0.6 mm vs 1.2 ± 0.5 mm; P < 0.001). The 3‐year MACE rate was similar in both groups (IVUS: 14.3% vs No IVUS: 24.2%; P = 0.26).

Conclusions

There were significantly fewer stents placed, increased post‐OA MLD, and similar 3‐year MACE outcomes in patients with IVUS assessment of the degree of lesion calcification prior to OA as compared to patients with angiographic assessment of the degree of lesion calcification. Further studies are needed to determine the optimal integration of intravascular imaging with OA.

     

Safety of Same-Day Discharge after Percutaneous Coronary Intervention with Orbital Atherectomy

BackgroundSeverely calcified lesions present many challenges to percutaneous coronary intervention (PCI). Orbital atherectomy (OA) aids vessel preparation and treatment of severely calcified coronary lesions. Same-day discharge (SDD) after PCI has numerous advantages including cost savings and improved patient satisfaction. The aim of this study is to evaluate the safety of SDD among patients treated with OA in a real-world setting.MethodsThis was a single-center retrospective analysis of patients undergoing OA. In-hospital and 30-day outcomes were assessed for major adverse cardiac events (MACE), device-related events and hospital readmissions.ResultsThere were 309 patients treated with OA of whom 94 had SDD (30.4%). Among SDD patients, there were no acute procedural complications and all patients were safely discharged on the day of the procedure. MACE at 30 days occurred in 1 patient (1.06%) due to major bleeding in the setting of a gastric arteriovenous malformation. There were 8 patients with unplanned 30-day readmissions (8.5%).ConclusionSDD after OA in patients with heavily calcified lesions appears to be safe, with low rates of adverse events and readmissions in select patients. In patients with SDD treated with OA, unplanned readmission occurred at a similar rate to the statewide average 30-day PCI readmission rate. Larger studies are needed to confirm the safety of this treatment paradigm and the potential cost savings.     

Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy

Objectives

We evaluated the clinical outcomes of elderly patients who underwent orbital atherectomy for the treatment of severe coronary artery calcification (CAC) prior to stenting.

Background

Percutaneous coronary intervention (PCI) of severe CAC is associated with worse clinical outcomes including death, myocardial infarction (MI), and target vessel revascularization (TVR). The elderly represents a high‐risk group of patients, often have more comorbid conditions, and have worse outcomes after PCI compared to younger patients. Clinical trials and a large multicenter registry have demonstrated the safety and efficacy of orbital atherectomy for the treatment of severe CAC. Clinical outcomes of elderly patients who undergo orbital atherectomy are unknown.

Methods

Of the 458 patients, 229 were ≥75 years old (elderly) and 229 were <75 years old (younger). The primary endpoint was rate of 30‐day major adverse cardiac and cerebrovascular events (MACCE), comprised of cardiac death, MI, TVR, and stroke.

Results

The primary endpoint was similar in the elderly and younger groups (2.2% vs. 2.2%, P = 1), as were the individual endpoints of death (2.2% vs. 0.4%, P = 0.1), MI (0.9% vs. 1.3%, P = 0.65), TVR (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P = 0.32). The rates of angiographic complications and stent thrombosis were similarly low in both groups.

Conclusions

The elderly represented a sizeable number of patients who underwent orbital atherectomy. It is a safe and effective treatment strategy for elderly patients with severe CAC as the clinical outcomes were similar to their younger counterparts. A randomized trial should further clarify the role of orbital atherectomy in these patients.

     

Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients.

BACKGROUND: Previous studies have demonstrated similar efficacy of the drug-eluting stent (DES) in patients with and without calcified lesions. However, most of the randomized trials have excluded patients with severe calcified lesions. This study aimed to examine the impact of lesion calcium on clinical and angiographic outcome after sirolimus-eluting stent (SES) implantation in real-world patients. METHODS: Consecutive 380 patients with 556 lesions treated with SES were enrolled. Lesions were divided into Calc lesions (moderate or sever calcification; 195 lesions) and non-Calc lesions (none or mild calcification; 361 lesions) according to the lesion calcium. Quantitative coronary angiography (QCA) parameters, binary restenosis rate (%restenosis), target lesion revascularization (TLR) rate, and major adverse cardiac events (MACE) during follow-up were compared between the two groups. All patients were contacted at 1, 6, and 12 months after the procedure. RESULTS: Lesion success rate was similar in the two groups. %Restenosis (9.2% vs. 3.6%; P<.05) and TLR (7.3% vs. 2.8%; P<.05) were significantly higher in Calc lesions. Stent thrombosis was observed in 0.7% of overall lesions with no difference between the two groups. The MACE rate in Calc patients (13.8%) was significantly higher than in non-Calc patients (6.1%). By multivariate analysis, hemodialysis (HD) and requirement of rotational atherectomy (RA) were predictive factors of TLR in the Calc lesions. CONCLUSIONS: Coronary lesions with calcification comprise a high-risk cohort and are associated with a higher TLR and binary restenosis rates in real-world patients treated with SES. Moreover, patients with calcified lesions and on HD are associated with higher MACE rate.     

Outcomes After Coronary Orbital Atherectomy at Centers Without On-Site Surgical Backup: Diabetics Versus Non-Diabetics and Impact of Access Site

Background/purposeThere is limited data available on atherectomy usage in hospitals or centers without on-site surgical backup. The purpose of this retrospective analysis was to gain further knowledge by analyzing the in-hospital and 30-day outcomes of complex PCI patients (including diabetics) treated with coronary orbital atherectomy (OA) at centers without on-site surgical back-up.Methods/materialsAll comers treated with OA at two centers without on-site surgical backup were included. Baseline, procedure, and outcome data were compared in diabetic and non-diabetic patients. The impact of transfemoral (TFA) versus transradial (TRA) vascular access was also assessed.ResultsOf the 221 patients treated with OA, 43% were diabetics. The diabetes and no-diabetes groups had similar baseline demographic and lesion characteristics, except for the higher rate of chronic kidney disease seen in the diabetics. Overall, there was a high freedom from major adverse cardiac events (MACE; in-hospital: 99.5%; 30-day: 98.6%), as well as a high success in stent delivery (99.5%) and procedural success (97.3%). The rate of angiographic complications was low in both the diabetes and no-diabetes groups (3.1% vs. 1.6%, p = 0.450). TFA and TRA were used in 36% and 64% of the patients, respectively—resulting in low angiographic complications in both groups (3.8% vs. 1.4%, p = 0.263).ConclusionsDespite the complexity of patient co-morbidities and the presence of heavily calcified lesions, the results indicate that coronary OA can be used safely and effectively without on-site surgical back-up. OA treatment resulted in a high rate of successful stent delivery and procedural success, as well as low rates of angiographic complications and MACE, in diabetic and non-diabetic patients, regardless of access site.Table of contents summaryThere is limited data available on atherectomy usage in centers without on-site surgical backup. The purpose of this retrospective analysis was to gain further knowledge by analyzing the outcomes of complex PCI patients (including diabetics) treated with coronary orbital atherectomy (OA) at centers without on-site surgical back-up. The impact of transfemoral (TFA) versus transradial (TRA) vascular access was also assessed. Despite the complexity of patient co-morbidities and the presence of heavily calcified lesions, the results indicate that coronary OA can be used safely and effectively without on-site surgical back-up. OA treatment resulted in a high rate of successful stent delivery and procedural success, as well as low rates of angiographic complications and major adverse cardiac events, in diabetic and non-diabetic patients, regardless of access site (TFA or TRA).     

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: Two‐year angiographic and three‐year clinical results from the SPIRIT II study

Background : Little is known about the impact of treatment with drug‐eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus‐eluting stent (EES) in patients with calcified or noncalcified culprit lesions. Methods : The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six‐month and 2‐year angiographic follow‐up and clinical follow‐up up to 3 years were completed. Results : The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6‐month in‐stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia‐driven target lesion revascularization (ID‐TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in‐stent ABR (7.4% vs. 0%, P = 0.08) and ID‐TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID‐TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). Conclusions: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley‐Liss, Inc.     

Aggressive Plaque Modification with Rotational Atherectomy and/or Cutting Balloon before Drug‐Eluting Stent Implantation for the Treatment of Calcified Coronary Lesions

Introduction: Calcified coronary lesions may be associated with stent underexpansion, malapposition, and high rates of restenosis. The use of drug‐eluting stents (DES) in such lesions has not been fully addressed in the major trials. We sought to examine the outcomes of patients who were treated with plaque modification (PM) to facilitate DES implantation. Methods: We analyzed 164 calcified coronary lesions in 145 consecutive patients who underwent aggressive PM with either rotational atherectomy (RA) and/or cutting balloon (CB) before DES implantation. CB was used in moderate calcified lesions and RA alone or followed by CB in severe calcified lesions. Results: Patients were 68.7 ± 10.1 years old, 47% were diabetic, 34% had left ventricular ejection fraction (LVEF) ≤50%, and 39% had 3‐vessel disease. Ninety‐five percent of lesions were classified as B2/C, 100% as moderately/severely calcified. PM was achieved by using CB in 57% and by RA alone or followed by CB in 43%. In 100%, a DES was implanted. There was no failure to deliver a stent. At 15 ± 11 months follow‐up, the overall major adverse cardiac events (MACE) rate was 9.6% (3.4% cardiac death, 2.3% myocardial infarction, and 3.4% target lesion revascularization [TLR]). The only independent predictor of MACE was LVEF ≤50% (odds ratio 3.88; 95% confidence interval: 1.15–13.1; P = 0.03). The incidence of stent thrombosis (ST) was 2.1%. There were no significant differences in MACE and TLR based on the type of PM used. Conclusions: In this population at high risk of restenosis, aggressive PM by CB and/or RA before DES implantation provides excellent mid‐term outcomes with only 3.4% TLR and 2.1% ST. (J Interven Cardiol 2010;23:240–248)     

Safety and efficacy of transradial coronary angiography and intervention in patients older than 80 years: from the Korean Transradial Intervention Prospective Registry

Background Radial artery access for coronary procedures is a safe and beneficial technique. However, elderly patients have been considered as a higher risk group of access site related complications compared to younger patients. This study was conducted to investigate the feasibility and safety of transradial coronary angiography or intervention in the elderly. Methods A total of 6132 patients from Korean Transradial Intervention Prospective Registry at 20 centers were analyzed. Patients were divided into the non-elderly group (n = 5667) and the elderly (? 80 years) group (n = 465). Using propensity score matching, the elderly group (n = 465) was compared with one-to-one matched the non-elderly group (n = 465). Results After propensity score matching, mean age was 64.3 ± 10.3 years in the non-elderly group and 83.5 ± 3.3 years in the elderly group. There was no difference of procedural characteristics, procedural and fluoroscopic times. Access site cross-over rate was not different between the non-elderly group and elderly group (7.5% vs. 6.2%, P = 0.074). Bleeding complications occurred similarly in two groups (2.6% of the non-elderly group vs. 1.9% of the elderly group, P = 0.660). Access site complications were 1.9% of the non-elderly group and 0.9% of the elderly group (P = 0.263). Both of in hospital death and cardiovascular death for one year were also similar between two groups. Conclusions Transradial angiography or intervention was safe and feasible in elderly patients. Complication rates and clinical outcomes in elderly patients were comparable with those in non-elderly patients.     

Long-term clinical outcome of elderly patients with acute coronary syndrome treated with early percutaneous coronary intervention: Insights from the BASE ACS randomized controlled trial: Bioactive versus everolimus-eluting stents in elderly patients

BackgroundThe BASE ACS trial demonstrated an outcome of titanium–nitride–oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial.MethodsWe randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Follow-up was planned at 12 months and yearly thereafter for up to 7 years. Elderly age was defined as ≥ 65 years.ResultsOf the 827 patients enrolled in the BASE ACS trial, 360 (43.5%) were elderly. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in elderly versus younger patients (19.7% versus 12.0%, respectively, p = 0.002), probably driven by more frequent cardiac death and non-fatal MI events (5.3% versus 1.5%, and 9.7% versus 4.5%, p = 0.002 and p = 0.003, respectively). The rates of ischemia-driven TLR were comparable (p > 0.05). In propensity score-matched analysis (215 pairs), only cardiac death was more frequent in elderly patients (6% versus 1.4%, respectively, p = 0.01). Diabetes independently predicted both MACE and cardiac death in elderly patients.ConclusionsElderly patients treated with stent implantation for ACS had worse long-term clinical outcome, compared with younger ones, mainly due to a higher death rate.     

Outcomes of percutaneous coronary intervention for chronic total occlusions in the elderly: A systematic review and meta‐analysis

ObjectiveThis study aimed to compare outcomes of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in the elderly (≥75 years) versus nonelderly and assess the impact of successful CTO‐PCI in the elderly.MethodsPubMed, Embase, ScienceDirect, CENTRAL, and Google Scholar databases were searched up to October 1, 2020. Mortality rates and major adverse cardiac events (MACE) were compared between elderly and nonelderly patients and successful versus failed CTO‐PCI in the elderly.ResultsEight studies were included. Meta‐analysis indicated no statistically significant difference in the risk of in‐hospital mortality (RR: 1.97 95% CI: 0.78, 4.96 I² = 0% p = .15) but higher tendency of in‐hospital MACE (RR: 2.30 95% CI: 0.99, 5.35 I² = 49% p = .05) in the elderly group. Risk of long‐term mortality (RR: 3.79 95% CI: 2.84, 5.04 I² = 41% p < .00001) and long‐term MACE (RR: 1.53 95% CI: 1.14, 2.04 I² = 80% p = .004) were significantly increased in the elderly versus nonelderly. Elderly patients had a significantly reduced odds of successful PCI as compared to nonelderly patients (OR: 0.63 95% CI: 0.54, 0.73 I² = 1% p < .00001). Successful CTO‐PCI was associated with reduction in long‐term mortality (HR: 0.51 95% CI: 0.34, 0.77 I² = 27% p = .001) and MACE (HR: 0.60 95% CI: 0.37, 0.97 I² = 53% p = .04) as compared to failed PCI in elderly.ConclusionsElderly patients may have a tendency of higher in‐hospital MACE with significantly increased long‐term mortality and MACE after CTO‐PCI. The success of PCI is significantly lower in the elderly. In elderly patients with successful PCI, the risk of long‐term mortality and MACE is significantly reduced.