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.     

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.     

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.     

The Importance of Bifurcation Lesions in Patients Undergoing Percutaneous Coronary Interventions in ST-segment Elevation Myocardial Infarction

BackgroundBifurcation lesions at the time of emergent PCI for STEMI are relatively common. However, there are little data regarding their significance. The objective of this study is to evaluate the impact of bifurcation lesions in the setting of emergent percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).MethodsIn 391 patients who underwent primary and rescue PCI, the clinical characteristics, procedural success, and in-hospital cardiac events were compared retrospectively between the patients with and without bifurcation lesions. The PCI strategy was at the discretion of the operator.ResultsThe culprit artery involved a bifurcation lesion in 54/391 (14%) patients. The baseline clinical characteristics between the groups with and without bifurcation lesions were similar. The majority of bifurcation lesions (81%) were seen in the left anterior ascending (LAD) artery. All lesions were treated with the provisional stenting approach, and only 2 (3%) patients required 2 stents. There were no difference in the procedural success and the final TIMI-3 flow, but PCI of bifurcation lesion required higher amount of contrast use. There was no in-hospital MACE in the bifurcation group. The peak cardiac enzyme, left ventricular function, and length of stay were similar in these 2 groups.ConclusionsBifurcation lesions are relatively common in emergent PCI for STEMI involving the LAD. It can be safely treated with a provisional stenting approach, and the immediate outcome is similar to non-bifurcation lesions.     

Polymer-Free Biolimus-Eluting Stents or Polymer-Based Zotarolimus-Eluting Stents for Coronary Bifurcation Lesions

BackgroundA polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed.MethodsAll consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up.Results1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12–12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES.ConclusionsIn this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted.     

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).     

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.     

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.     

Dedicated Tryton Side Branch Stents used in the treatment of coronary bifurcation lesions

IntroductionCoronary bifurcation lesions account for 15–20% of all percutaneous coronary interventions.Dedicated bifurcation stents have recently been introduced with the aim to simplify treatment and improve early and late outcomes following stenting of bifurcation lesions.The purpose of our study was to assess the safety and effectiveness of the Tryton dedicated side branch stent at a 6-month clinical and angiography follow-up.MethodsForty-two patients with bifurcation lesions were included in our study. The primary endpoint was a 6-month MACE and angiographic stent patency was also evaluated by MS-CT coronarography.ResultsTwenty-two patients (52.38%) were treated for acute coronary syndromes, 39 (92.85%) lesions were “true bifurcations”. The 6-month clinical follow-up was performed in all patients. The 6-month MACE rate (cardiac death, myocardial infarction and target lesion revascularization) was 9.52% (95% CI: 2.66–22.62%); of these one patient (2.38%; 95% CI: 0.06–12.57%) died due to cardiogenic shock caused by early stent thrombosis and three patients (7.14%; 95% CI: 1.50–19.48%) required repeated revascularization (TVR) due to in-stent restenosis, all of them in bare metal stents. Tryton stent implantation was successful in 100% lesions.6-Month MS-CT coronarography was performed in 39 (92.85%) patients. The implanted bifurcation Tryton stents were satisfactorily visualized in 97.43% of them and a satisfactory 6-month angiographic patency was demonstrated in 37 patients (88.1%).ConclusionThe usage of a dedicated bifurcation Tryton Side Branch Stent for PCI of the bifurcation lesions is technically feasible with satisfactory long-term results.     

Cutting-balloon angioplasty before drug-eluting stent implantation for the treatment of severely calcified coronary lesions

Background Severely calcified coronary lesions respond poorly to balloon angioplasty, resulting in incomplete and asymmetrical stent expansion. Therefore, adequate plaque modification prior to drug-eluting stent （DES） implantation is the key for calcified lesion treat- ment. This study was to evaluate the safety and efficacy of cutting balloon angioplasty for severely calcified coronary lesions. Methods Ninety-two consecutive patients with severely calcified lesions （defined as calcium arc 〉 180% calcium length ratio 〉 0.5） treated with bal- loon dilatation before DES implantation were randomly divided into two groups based on the balloon type： 45 patients in the conventional balloon angioplasty （BA） group and 47 patients in the cutting balloon angioplasty （CB） group. Seven cases in BA group did not satisfactorily achieve dilatation and were transferred into the CB group. Intravascular ultrasound （IVUS） was performed before balloon dilatation and after stent implantation to obtain qualitative and quantitative lesion characteristics and evaluate the stent, including minimum lumen cross-sectional area （CSA）, calcified arc and length, minimum stent CSA, stent apposition, stent symmetry, stent expansion, vessel dissection, and branch vessel jail. In-hospital, 1-month, and 6-month major adverse cardiac events （MACE） were reported. Results There were no statistical differences in clinical characteristics between the two groups, including calcium arc （222.2° ± 22.2° vs. 235.0° ± 22.1 °, p=0.570）, calcium length ratio （0.67 ± 0.06 vs. 0.77± 0.05, P = 0.130）, and minimum lumen CSA before PCI （2.59 ±0.08 mm2 vs. 2.52 ± 0.08 mm2, P = 0.550）. After stent implantation, the final minimum stent CSA （6.26 ± 0.40 mm2 vs. 5.03 ± 0.33 mm2; P = 0.031） and acute lumen gain （3.74 ±0.38 mm2 w. 2.44 ± 0.29 mm2, P = 0.015） were significantly larger ila the CB group than that of the BA group. There were not statis tically differences in stent expansion, stent symmetry, incomplete stent apposition, vessel dissection and branch vessel jail between two groups. The 30-day and 6-month MACE rates were also not different. Conclusions Cutting balloon angioplasty before DES implantation in severely calcified lesions appears to be more efficacies including significantly larger final stent CSA and larger acute lumen gain, without increasing complications during operations and the MACE rate in 6-month.     

经桡动脉行复杂冠状动脉病变的介入治疗

目的探讨经桡动脉行复杂冠状动脉病变介入治疗的可行性。方法将178例左主干开口病变、分叉病变、慢性闭塞病变、长度≥30mm的长病变、纡曲成角病变及严重钙化病变等复杂冠状动脉病变患者经桡动脉途径进行PCI。结果经桡动脉PCI完成率97.2%。因导引导管支撑力不够,采用双导丝技术18例,采用子母导管技术5例,微导管技术6例,锚技术3例。左主干开口病变8处即刻全部成功。左主干分叉病变双支架置入17例,单支架置入9例。其他分叉病变67处,单支架置入47处,双支架置入20处。双支架置入后对吻球囊扩张成功率100%。34处慢性闭塞病变PCI成功27处。长度≥30mm的长病变91处、纡曲成角病变23处、严重钙化病变27处全部PCI成功。术中支架内血栓2例,住院期间亚急性血栓形成2例。死亡1例。穿刺处并发症:桡动脉闭塞8例,前臂肿胀4例,无血肿及神经损伤。结论经桡动脉途径进行冠状动脉复杂病变的PCI有较高的成功率。     

Optimal Stenting Technique for Complex Coronary Lesions: Intracoronary Imaging-Guided Pre-Dilation,Stent Sizing,and Post-Dilation

ObjectivesThis study compared the 3-year outcomes of intracoronary imaging–guided pre-dilation, stent sizing, and post-dilation (iPSP) for patients with complex coronary artery lesions.BackgroundThe long-term effects of the optimal drug-eluting stent implantation technique in complex coronary artery disease have not been evaluated.MethodsFrom the IRIS-DES (Interventional Cardiology Research In-cooperation Society-Drug-Eluting Stents) registry, the study evaluated 9,525 patients who underwent percutaneous coronary intervention for left main, bifurcation, long or diffuse (>30 mm), or angiographically severely calcified lesions. The primary outcome was a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The inverse probability of treatment weighting method was used to adjust for confounding factors.ResultsAt the index procedure, intravascular ultrasound assessment PSP were performed in 8,522 (89.5%) patients, 5,141 (54.0%) patients, and 5,531 (58.1%) patients, respectively; overall, 3,374 (35.4%) patients underwent stent implantation using all 3 parts of the iPSP strategy and were defined as the iPSP group. At 3 years, the adjusted rate of the primary outcome was significantly lower in iPSP group (5.6% vs 7.9%; adjusted hazard ratio: 0.71; 95% confidence interval: 0.63 to 0.81; p < 0.001).ConclusionsAmong patients undergoing drug-eluting stent implantation in complex coronary artery stenosis, iPSP was associated with a lower risk of cardiac events at 3 years. Therefore, physicians should apply iPSP more actively for the treatment of complex coronary artery stenoses, even in the current era. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)     

Clinical Outcomes Following Coronary Bifurcation PCI Techniques: A Systematic Review and Network Meta-Analysis Comprising 5,711 Patients

ObjectivesThe aim of this study was to compare clinical outcomes of different bifurcation percutaneous coronary intervention (PCI) techniques.BackgroundDespite several randomized trials, the optimal PCI technique for bifurcation lesions remains a matter of debate. Provisional stenting has been recommended as the default technique for most bifurcation lesions. Emerging data support double-kissing crush (DK-crush) as a 2-stent technique.MethodsPubMed and Scopus were searched for randomized controlled trials comparing PCI bifurcation techniques for coronary bifurcation lesions. Outcomes of interest were major adverse cardiovascular events (MACE). Secondary outcomes of interest were cardiac death, myocardial infarction, target vessel or lesion revascularization, and stent thrombosis. Summary odds ratios (ORs) were estimated using Bayesian network meta-analysis.ResultsTwenty-one randomized controlled trials including 5,711 patients treated using 5 bifurcation PCI techniques were included. Investigated techniques were provisional stenting, T stenting/T and protrusion, crush, culotte, and DK-crush. Median follow-up duration was 12 months (interquartile range: 9 to 36 months). When all techniques were considered, patients treated using the DK-crush technique had less occurrence of MACE (OR: 0.39; 95% credible interval: 0.26 to 0.55) compared with those treated using provisional stenting, driven by a reduction in target lesion revascularization (OR: 0.36; 95% credible interval: 0.22 to 0.57). No differences were found in cardiac death, myocardial infarction, or stent thrombosis among analyzed PCI techniques. No differences in MACE were observed among provisional stenting, culotte, T stenting/T and protrusion, and crush. In non–left main bifurcations, DK-crush reduced MACE (OR: 0.42; 95% credible interval: 0.24 to 0.66).ConclusionsIn this network meta-analysis, DK-crush was associated with fewer MACE, driven by lower rates of repeat revascularization, whereas no significant differences among techniques were observed for cardiac death, myocardial infarction, and stent thrombosis. A clinical benefit of 2-stent techniques was observed over provisional stenting in bifurcation with side branch lesion length ≥10 mm.     

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.     

The Frontier stent registry: safety and feasibility of a novel dedicated stent for the treatment of bifurcation coronary artery lesions

OBJECTIVES: The goal of this study was to evaluate the safety and performance of the Multi-Link Frontier coronary bifurcation stent system (Guidant Corp., Santa Clara, California), a novel dedicated device designed for permanent side branch (SB) access, stent delivery by simultaneous kissing balloon inflation, and optimal main branch (MB) and SB ostium scaffolding. BACKGROUND: The treatment of coronary bifurcation lesions remains challenging, and various approaches using stents have been proposed. METHODS: The primary end point was the 180-day incidence of major adverse cardiac events (MACE) per intent-to-treat analysis. Secondary end points included device success, 30-day MACE, angiographic restenosis, and target lesion revascularization (TLR) rates at 180 days. RESULTS: After a learning phase of two cases per center, 105 patients were prospectively included in 11 centers. The left anterior descending coronary artery/diagonal bifurcation was the target in 80% of cases. The Frontier stent was successfully implanted in 96 patients (91%), and procedural success was obtained in 93%. Two patients suffered in-hospital myocardial infarction (MI) secondary to SB occlusion, and one patient underwent elective coronary artery bypass grafting. At 30 days and 6 months, the MACE rates were 2.9% and 17.1% (no death, no subacute stent thrombosis, Q-wave MI 1.0% and 1.9%, non-Q-wave MI 1.0% and 1.9%, TLR 1.0% and 13.3%). The MB in-stent restenosis was 25.3%, in-segment 29.9%. The SB restenosis was 29.1%. The overall restenosis rate for any branch was 44.8%. CONCLUSIONS: The results of this Frontier registry demonstrate the safety and performance of this dedicated stent system for the treatment of bifurcation lesions. The device can be successfully implanted in more than 90% of all cases, with a high procedural success rate and low 30-day and 6-month MACE rates.     

Impact of age following treatment of severely calcified coronary lesions with the orbital atherectomy system: 3-year follow-up

ObjectivesWe investigated the safety and efficacy of coronary orbital atherectomy to treat severely calcified lesions prior to stenting based upon age.BackgroundThe ORBIT II study reported the safety and efficacy with orbital atherectomy in 443 patients with severely calcified lesions. Elderly patients undergoing percutaneous coronary intervention may be at increased risk for major adverse cardiac events (MACE) and death compared with younger patients.MethodsPatients were stratified according to age (≥75 year old [174/443, 39.3%] vs. <75 year old [269/443, 60.7%]). The MACE rate, defined as cardiac death, myocardial infarction (CK-MB > 3X ULN), and target vessel revascularization, was examined at 30-day and 3-year follow-up.ResultsElderly and non-elderly groups had similar rates of procedural (87.9% vs. 89.5%, p = 0.64) and angiographic success (91.4% vs. 91.4%, p = 1.00). Severe angiographic complications were also similar in both groups (6.9% vs. 7.4%, p = 1.00). There was no statistically significant difference in MACE rates in the elderly and younger groups at 30 days (10.9% vs. 10.1%; p = 0.76) and 3 years (27.8% vs. 20.7%, p = 0.13). The individual endpoints of cardiac death (9.1% vs. 5.1%, p = 0.14), myocardial infarction (13.4% vs. 9.7%, p = 0.27), and target vessel revascularization (10.6% vs. 10.0%, p = 0.91) were also similar in both groups at 3 years.ConclusionsThe rates of adverse clinical events in elderly patients who underwent orbital atherectomy were low and similar to the non-elderly patients, suggesting that it could be a reasonable treatment strategy for elderly patients with severely calcified lesions.     

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 and effectiveness of percutaneous coronary intervention using rotational atherectomy and new-generation drug-eluting stents for calcified coronary artery lesions in patients with chronic kidney disease

AimCoronary artery calcification is an important factor influencing revascularisation outcomes in patients with chronic kidney disease (CKD). Lesion preparation using rotational atherectomy (RA) may help adequately modify calcified plaques and facilitate the achievement of optimal clinical outcomes in these patients. In this study, we assessed the safety and effectiveness of percutaneous coronary intervention (PCI) using RA followed by new-generation drug-eluting stent (DES) implantation in patients with CKD and calcified coronary artery disease (CAD).Methods and resultsFrom November 2014 to October 2019, a total of 203 patients with calcified CAD who underwent RA followed by second- or third-generation DES implantation at our centre were included in the study. Mild, moderate, and severe CKD was present in 38%, 55.5%, and 6.5% of the patients, respectively. Diffused coronary calcifications were present in 85%. Procedural success was 97.5% with minimal periprocedural complications. In-stent restenosis occurred in one patient (0.5%); major adverse cardiovascular and cerebrovascular events were reported in 22 patients (10.8%); cardiac death occurred in eight patients during follow-up.ConclusionPercutaneous coronary intervention using RA followed by second- or third-generation DES implantation is feasible and safe with high procedural success and low in-stent restenosis in CKD patients with calcified coronary lesions.     

Orbital atherectomy system in treating calcified coronary lesions: 3-Year follow-up in first human use study (ORBIT I trial)

Background/PurposeThe ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) in treating de novo calcified coronary lesions. Severely calcified coronary arteries pose ongoing treatment challenges. Stent placement in calcified lesions can result in stent under expansion, malapposition and procedural complications. OAS treatment may be recommended to facilitate coronary stent implantation in these difficult lesions.Materials/MethodsFifty patients with de novo calcified coronary lesions were enrolled in the ORBIT I trial. Patients were treated with the OAS followed by stent placement. Our institution treated 33/50 patients and continued follow-up for 3 years.ResultsAverage age was 54.4 years and 90.9% were males. Mean lesion length was 15.9 mm. The average number of OAS devices used per patient was 1.3. Procedural success was achieved in 97% of patients. Angiographic complications were observed in five patients (two minor dissections, one major dissection and two perforations). The cumulative major adverse cardiac event (MACE) rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, and 18.2% at 3 years. The MACE rate included two in-hospital non Q-wave myocardial infarctions (MI), one additional non Q-wave MI at 30 days leading to target lesion revascularization (TLR), and three cardiac deaths.ConclusionsThe ORBIT I trial suggests that OAS treatment may offer an effective method to modify calcified coronary lesion compliance to facilitate optimal stent placement in these difficult-to-treat patients with acceptable levels of safety up to 3 years post-index procedure.     

Drug-coated balloon strategy following orbital atherectomy for calcified coronary artery compared with drug-eluting stent: One-year outcomes and optical coherence tomography assessment

Background

Percutaneous coronary intervention (PCI) for calcified coronary artery remains challenging in the drug-eluting stent (DES) era. While recent studies reported the efficacy of orbital atherectomy (OA) combined with DES for calcified lesion, the effectiveness of drug-coated balloon (DCB) following OA has not been fully elucidated.

Methods

Between June 2018 and June 2021, 135 patients who received PCI for calcified de novo coronary lesions with OA were enrolled and divided into two groups; OA followed by DCB (n = 43) if the target lesion achieved acceptable preparation, or second- or third-generation DESs (n = 92) if the target lesion showed suboptimal preparation between June 2018 and June 2021. All patients underwent PCI with optical coherence tomography (OCT) imaging. The primary endpoint was 1-year major adverse cardiac event (MACE), that was a composite of cardiac death, nonfatal myocardial infarction, or target lesion revascularization.

Results

Mean age was 73 years and 82% was male. In OCT analysis, maximum calcium plaque was thicker (median: 1050 µm [interquartile range (IQR): 945–1175 µm] vs. 960 µm [808–1100 µm], p = 0.017), calcification arc tended to larger (median: 265° [IQR: 209–360°] vs. 222° [162–305°], p = 0.058) in patients with DCB than in DES, and the postprocedure minimum lumen area was smaller in DCB compared with minimum stent area in DES (median: 3.83 mm² [IQR: 3.30–4.52 mm²] vs. 4.86 mm² [4.05–5.82 mm²], p < 0.001). However, 1 year MACE free rate was not significantly different between 2 groups (90.3% in DCB vs. 96.6% in DES, log-rank p = 0.136). In the subgroup analysis of 14 patients who underwent follow-up OCT imaging, late lumen area loss was lower in patients with DCB than DES, despite lower lesion expansion rate in DCB than DES.

Conclusions

In calcified coronary artery disease, DCB alone strategy (if acceptable lesion preparation was performed with OA) was feasible compared with DES following OA with respect to 1-year clinical outcomes. Our finding indicated using DCB with OA might be reduce late lumen area loss for severe calcified lesion.