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.     

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).     

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.     

In-hospital and mid-term adverse clinical outcomes of a direct stenting strategy versus stenting after predilatation for the treatment of coronary artery lesions

Background

Direct stenting without balloon dilatation may reduce procedural costs and duration, and hypothetically, the restenosis rate. This study was designed to compare the in-hospital and long-term outcomes of direct stenting (DS) versus stenting after pre-dilatation (PS) in our routine clinical practice.

Methods

The 1 603 patients treated with stenting for single coronary lesions were enrolled into a prospective registry. Patients with acute myocardial infarction (MI) within the preceding 48 hours, and those with highly calcified lesions, total occlusions, or a lesion in a saphenous graft were excluded. The baseline, angiographic and procedural data, inhospital outcomes and follow-up data were recorded in our database and analysed with appropriate statistical methods.

Results

Eight hundred and fifty-seven patients (53.5%) were treated with DS and 746 (46.5%) underwent PS. In the DS group, lesions were shorter in length, larger in diameter and had lower pre-procedural diameter stenosis. Type C and diffuse lesions and drug-eluting stents were found less often (p < 0.001). With univariate analysis, dissection and non-Q-wave MI occurred less frequently in this group (0.2 and 0.6% vs 3.9 and 2.1%, p < 0.001 and p = 0.01, respectively). However, the cumulative major adverse cardiac events (MACE) did not differ significantly (4.9 vs 4.6%, p = 0.79). With multivariate analysis, direct stenting reduced the risk of dissection (OR = 0.07, 95% CI: 0.01–0.33, but neither the cumulative endpoint of MACE (OR = 1.1, 95% CI = 0.58–2.11, p = 0.7) nor its constructing components were different between the groups.

Conclusions

Direct stenting in the real world has at least similar long-term outcomes in patients treated with stenting after pre-dilatation, and is associated with lower dissection rates.     

Direct coronary stent implantation does not reduce the incidence of in-stent restenosis or major adverse cardiac events: six month results of a randomized trial.

STUDY OBJECTIVE: To compare the long-term angiographic, clinical and economic outcome of direct stenting vs stenting after balloon predilatation. PATIENT POPULATION AND METHODS: Four hundred patients with coronary stenoses in a single native vessel were randomized to direct stenting vs stenting after predilatation. A major adverse cardiac and cerebral event (MACCE) was defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke. RESULTS: Stents were successfully implanted in 98.3% of patients randomized to direct stenting vs 97.8% randomized to stenting preceded by predilatation. The primary success rate of direct stenting was 88.3%, vs 97.8% for stenting preceded by balloon dilatation (P=0.01). The angiographic follow-up at 6 months included 333 of the 400 patients (83%). The binary in-stent restenosis rate was 23.1% of 163 patients randomized to direct stenting vs 18.8% of 166 patients randomized to balloon predilatation (P=0.32). By 185+/-25 days, MACCE had occurred in 31 of 200 (15.5%) patients randomized to direct stenting, vs 33 of 200 (16.5%) randomized to predilatation (P=0.89). At 6 months, costs associated with the direct stenting strategy (Euros 3222/patient) were similar to those associated with predilatation (Euros 3428/patient, P=0.43). However, procedural costs were significantly lower. It is noteworthy that, on multivariate analysis, a baseline C-reactive protein level >10 mg l(-1)was a predictor of restenosis (odds ratio: 2.10, P=0.025) as well as of MACCE (odds ratio: 1.94, P=0.045). CONCLUSIONS: Compared to stenting preceded by balloon predilatation, direct stenting was associated with similar 6-month restenosis and MACCE rates. Procedural, but not overall 6-month costs, were reduced by direct stenting. An increased baseline CRP level was an independent predictor of adverse long-term outcome after coronary stent implantation.     

Drug‐eluting stents in bifurcation lesions: To stent one branch or both?

OBJECTIVES: The objective of this study was to compare two techniques to treat bifurcation lesions: a single drug-eluting stent (DES) implanted in the main branch combined with balloon dilatation for the side branch vs. stenting of both branches (double stent). BACKGROUND: Percutaneous coronary intervention in coronary bifurcation lesions remains challenging. Although DES reduce restenosis in lesions, the double stent procedure has not shown clear advantages over a single stent with balloon dilation. METHODS: Fifty-three symptomatic patients with true bifurcation lesions were treated using either the double stent technique (n = 25) or one stent in the parent vessel plus balloon angioplasty of the side branch (n = 28). Procedural results and major adverse cardiac event rates (MACE: cardiac death, myocardial infarction, target vessel revascularization (TVR)) were compared. RESULTS: Angiographic procedural success (residual stenosis <30% in both branches) was 75% in the single stent group and 100% in the double stent group (P = 0.01). All differences were due to residual stenosis of the side branch. Clinical follow-up (6-18 months) was available for all patients; 90.5% of patients had a coronary angiography or nuclear stress test. Three patients (11%) in the single stent group and two (8%) in the double stent group had ischemia-driven TVR (P = NS). Asymptomatic angiographic restenosis (>50% diameter stenosis) in the ostium of the side branch was seen in two patients in the double-stent group. At 6 months, MACE-free was comparable between groups (89.3% vs. 88%, P = 0.7). CONCLUSIONS: When treating bifurcation lesions with sirolimus-eluting stents, restenosis following a single stent procedure is comparable to stenting both parent and side branch vessels. Thus, stenting the main-branch lesion, coupled with balloon angioplasty in the side branch, produces a high success rate and good clinical outcomes at 6 months.     

Rotational atherectomy for fibro‐calcific coronary artery disease in drug eluting stent era: Procedural outcomes and angiographic follow‐up results

Objectives: The aim of this study was to examine the binary re‐stenosis rates, procedural success, and in hospital outcomes following treatment of fibro‐calcified coronary lesion with rotational atherectomy in drug eluting stent era. Background: Binary restenosis rates have remained high with the use of bare metal stents following rotational atherectomy in calcified lesions. There is limited data available following rotational atherectomy in drug eluting stent era. Methods: We evaluated the procedural and angiographic outcomes following a consecutive series of 516 procedures treated with rotational atherectomy followed by stenting. We compared the results between Rota + Drug eluting stent (DES) and Rota + bare metal stent (BMS) groups. Results: Procedural success was achieved in 97.1% of the lesions with overall low in hospital adverse events (death in 1.1%, Q MI in 1.3%, Non Q MI in 5.3%, and urgent repeat PCI in 0.4%). There was significant reduction in the binary restenosis rates following Rota + DES use as compared to Rota + BMS use (11% vs. 28.1%, P < 0.001; OR = 3.17, 95% CI: 1.76–5.93) and similar reduction was seen in the target lesion revascularization (10.6% vs. 25%, P = 0.001; OR = 2.81, 95% CI: 1.53–5.14). We have identified ostial lesions, chronic total occlusion lesions, and use of bare metal stents as independent predictors of restenosis in this group of patients. Conclusions: Rotational atherectomy can be performed with high success rates and low complications, and rotational atherectomy followed by drug eluting stent implantation significantly reduces binary restenosis rates in fibrocalcific lesions as compared to rotational atherectomy and bare metal stents. © 2010 Wiley‐Liss, Inc.     

Clinical Experience with Very High-Pressure Dilatation for Resistant Coronary Lesions

BackgroundCalcific coronary lesions can be so resistant to prevent symmetric stent dilatation with high risk of ISR/thrombosis. The aim of the current study is to evaluate the safety and efficacy of super high-pressure dilatation (>30-to-45Atm) using a dedicated NC-balloon (OPN, SIS-Medical-AG, Winterthur-Switzerland).MethodsWe retrospectively evaluated 326 consecutive undilatable lesions in which conventional NC-balloons failed to achieve adequate post-dilatation luminal gain. After the failed attempt an OPN-balloon was inflated up to achieve a uniform balloon expansion (maximal dilatation pressure of 45–50 Atm). Lesions were divided into two groups according to the final inflation pressure: Group-I: lesion responsive to 30-40Atm and Group-2:>40 Atm. Angiographic success was defined as residual angiographic stenosis<30% assessed by visual estimation with TIMI3-flow. Procedural success was defined as the achievement of angiographic success without any MACE.ResultsAngiographic success was achieved in 97.5%, procedural success in 96.6%; 53% of the lesions were responsive to a slower inflation pressure (Group I) while in the remaining 47%, the optimal expansion required a pressure > 40ATM (Group II). In 3 patients coronary rupture occurred after balloon inflation and was successfully treated with stent implantation with a final TIMI3-flow. The OPN alone was able to achieve adequate expansion in >90%. 0.9% days MACE were reported.ConclusionThe OPN-dedicated high-pressure balloon provides an effective and safe strategy for treatment of severe resistant coronary lesions.     

Comparison of Rotational with Orbital Atherectomy During Percutaneous Coronary Intervention for Coronary Artery Calcification: A Systematic Review and Meta-Analysis

BackgroundPercutaneous coronary intervention (PCI) outcomes for patients with significant calcification have been consistently inferior compared to patients without significant calcification. Procedural success and long-term outcomes after PCI have been worse in patients with severe coronary calcium.ObjectiveA Bayesian meta-analysis of outcomes comparing rotational atherectomy (RA) with orbital atherectomy (OA) was performed.MethodsPubMed, Embase, and Cochrane Library databases were searched through 30th November 2018 and identified 4 observational studies.ResultsThe primary end-point, Major Adverse Cardiac Event (MACE) composing of death, MI and stroke at 1 year was more likely with RA (OR = 1.61; 95% CI: 1.11–2.33; p = 0.01) as compared to OA. The driver of the difference in MACE between the two groups was a statistically significant difference in mortality favoring OA (OR = 4.65; 95% CI: 1.36–15.87; p = 0.01). Peri-procedural MI, the other component of the primary end-point was 1.3 times more likely in the RA arm (OR = 1.35; 95% CI 0.95–1.92; p-0.09) and was not statistically different between the groups. The odds of a vascular complication were not different in the two groups (OR = 1.26; 95% CI: 0.73–2.17; p = 0.41).In an adjusted Bayesian analysis, mortality (OR = 3.69; 95% CI: 0.30–38.51), MACE (OR = 1.68; 95% CI: 0.55–5.49), MI (OR = 1.42; 95% CI: 0.50–4.29) and dissections/perforations (OR = 0.38; 95% CI: 0.10–1.38) were not different in RA and OA groups.ConclusionOur study is the first published Bayesian meta-analysis comparing MACE and peri-procedural outcomes in RA compared to OA. These findings lay the foundation for a randomized comparison between the two competing technologies.     

Rotational Atherectomy in Acute Coronary Syndrome: A Meta-Analysis

BackgroundThe use of rotational atherectomy (RA) in percutaneous coronary intervention (PCI) of acute coronary syndrome (ACS) is considered relatively contraindicated. There have been several observational studies showing RA use in ACS, however, no systemic studies have been undertaken. We sought to evaluate the feasibility and outcomes of RA PCI in ACS by performing a meta-analysis.MethodsWe searched PUBMED, EMBASE, CINAHL, and Cochrane Central Register of Clinical Trials for any studies that evaluated the role of RA PCI in ACS. The outcomes analyzed were all-cause mortality, cardiac mortality, short and long-term major adverse cardiac events (MACE), procedural complications and cardiac perforations.ResultsThere was a total of 8 retrospective studies with a total population of 1237 with a median follow up of 23 months. The median age of the included patient was 73. Angiographic success rate was 97.4%. The rate of all-cause mortality and cardiac mortality were 5% (range 1–12%, p < 0.001, I² = 92%) and 2% (range 0–5%, P = 0.03, I² = 58%) respectively. In-hospital MACE and long-term MACE were 7% (range 3–13%, p < 0.001, I² = 87%) and 29% (range 21–37%, p = 0.21, I² = 34%) respectively. The incidence of total procedural complications was noted to be 7% (range 2–14%, p < 0.001, I² = 90%). Rate of perforation was 1% (range 0–1%, p = 0.9, I² = 0%).ConclusionOur results show that RA PCI is feasible in ACS with comparable procedural complications and short-term MACE, but with a higher long-term MACE rate compared to RA PCI in routine cases.     

Long‐term outcomes of rotational atherectomy for the percutaneous treatment of chronic total occlusions

Objectives . To study the long‐term outcomes of rotational atherectomy (RA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background . There is little evidence on the incidence, procedural results and long‐term outcomes of RA for CTO PCI. Methods . This registry included data from consecutive patients undergoing CTO PCI at four specialized centers. Major adverse cardiac events (MACE: cardiac death, target‐vessel myocardial infarction and ischemia‐driven target‐vessel revascularization) on follow‐up were the primary endpoint. Results . A total of 1003 patients were included. Of these, 35 (3.5%) required RA. As compared with Conventional PCI, RA patients were older (68.9 ± 9.5 vs. 64.6 ± 10.7 years, P = 0.02), had higher prevalence of diabetes (58% vs. 37%, P = 0.01) and of a J‐CTO score ≥2 (80% vs. 58%, P = 0.009), driven by severe calcification. Antegrade wire escalation was used more frequently in RA (74% vs. 53%, P = 0.08). RA was performed for balloon failure‐to‐cross in 51% and failure‐to‐expand in 49%. One burr was utilized in 86%. The 1.25‐mm burr was the largest burr used in 43%. Slow flow/no‐reflow was observed in 17%. No other serious RA‐related complications were observed. Procedural success was 77% vs. 89% (P = 0.04) in RA vs. Conventional PCI. After a mean follow‐up of 658 ± 412 days, MACE rates were similar between groups (15% vs. 13%, P = 0.70). Conclusions . The use of RA in CTO PCI was safe, despite a worse patient risk profile and higher procedural complexity, as compared with conventional techniques. Although procedural success was lower in the RA group, there were no differences in long‐term clinical outcomes between groups. © 2016 Wiley Periodicals, Inc.     

Rotational Atherectomy for the Management of Undilatable In-Stent Restenosis with Single or Multiple Stent Layers

BackgroundThere is no consensus on the best treatment of undilatable coronary in-stent restenosis (ISR) regardless of the number of stent layers. We aimed to evaluate the procedural and clinical outcomes of rotational atherectomy (RA) to treat undilatable coronary ISR with single or multiple stent layers.MethodsWe retrospectively evaluated consecutive patients treated with RA for undilatable ISR with single or multiple stent layers in the Mount Sinai catheterization laboratory between January 2016 and September 2018. Procedural success was defined as angiographic success without in-hospital major adverse cardiac events (MACE): a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Clinical outcomes were assessed at one-year post-procedure.ResultsA total of 26 patients were included in the study, in which 18 (69.2%) patients were with multiple stent layers. After RA, 9 (34.6%) were received a new drug-eluting stent, and 6 (23.1%) were treated with intravascular brachytherapy. Angiographic success was achieved in 24 (92.3%) patients, and procedural success was achieved in 22 (84.6%) patients. In-hospital MACE occurred in 4 (15.4%) patients, all due to periprocedural non-Q wave MI. Within one year, MACE occurred in 9 (34.6%) patients with 5 (19.2%) TLR.ConclusionsRA for undilatable ISR with single or multiple stent layers was performed with favorable procedural outcomes and a relatively high MACE rate driven by TLR within one year.     

Safety and Efficacy of Stentablation with Rotational Atherectomy for the Management of Underexpanded and Undilatable Coronary Stents

IntroductionCoronary stent underexpansion is associated with in-stent restenosis and few interventions are available for the management of undilatable underexpanded stents. Stentablation (SA) with rotational atherectomy (RA) is a unique application and has previously been described with encouraging results. Data regarding SA is limited to case reports and small case series; therefore, reasonable concern persists regarding procedural safety and long-term outcomes.MethodsThis is a single-center retrospective study analyzing twenty consecutive patients who underwent SA with RA. The primary endpoint was procedural success and secondary endpoints included procedural safety outcomes and major adverse cardiac events (MACE) over a 12-month follow-up period.ResultsStentablation and secondary stenting were guided by intravascular ultrasound and procedural success was achieved in all cases. No in-hospital death or MACE was observed. The prevalence of MACE was 5% at 30 days as one patient developed recurrent MI without target lesion revascularization (TLR). At 12 months, MACE had occurred in 40% of patients, however this was strongly driven by a high prevalence of TLR (30%). Only one cardiac death (5%) and one additional NSTEMI were observed during the 11 additional months of follow up.ConclusionStentablation with RA is a feasible and effective option for the acute management of symptomatic, underexpanded, and undilatable coronary stents. SA is associated with a high rate of procedural success as well as excellent in-hospital and short-term outcomes. However, our study population demonstrated substantial MACE at 12 months which was strongly driven by TLR and associated with minimal mortality.     

Direct coronary stenting without balloon or device pretreatment: acute success and long-term results.

Improvements in coronary stents have made planned direct coronary stenting technically feasible, though safety, acute success, cost-effectiveness, and long-term results remain to be determined. Sequential patients eligible for direct stenting were prospectively characterized and treated with either direct or secondary stenting. Major adverse cardiovascular events (MACE) such as cardiac death, myocardial infarction (MI), target vessel ischemia, or revascularization (TVR) were followed for 6 months post-PCI. Enrollment included 128 direct (1.38 lesions/patient) and 69 secondary (1.39 lesions/patient) stented patients. Direct stenting was successful in 99% (with 5% crossover to secondary stenting) without major procedural complications and with a similar rate of vessel wall dissection or no-reflow phenomenon (2.3% vs. 2.1%; P > 0.05) as the secondary stenting group. There was a trend toward less postprocedural CPK-MB elevation in the nonacute MI patients with direct vs. secondary stenting (3% vs. 11%, respectively). At 6 months, there were no statistically significant differences in overall MACE. Direct stenting has a high success rate, low complication rate, and durable long-term results. Procedural cost and time savings, less contrast use and radiation exposure make direct stenting attractive in properly selected patients.     

Effectiveness of rotational atherectomy of right coronary artery ostial stenosis

Balloon angioplasty and stenting of right coronary ostial stenosis may frequently be impeded by lesion calcification, whereas rotational atherectomy, which ablates calcified plaque, should treat these lesions effectively. Accordingly, we evaluated procedural success and longterm clinical outcome of rotational atherectomy of right coronary ostial stenosis. Procedural data were obtained from a comprehensive interventional registry and follow-up information was obtained by chart review and patient enquiry. All patients who developed recurrent angina underwent angiographic restudy. During a 5-year interval, 119 patients underwent rotational atherectomy of right coronary ostial stenosis. Multilesion interventions were performed in 55% of patients. Ostial lesions were 3.73+/-3.69 mm in length (mean +/- SD), and 57.1% were significantly calcified. Reference vessel diameter was 3.42+/-0.56 mm. Maximum burr:artery ratio was 0.64+/-0.1 with adjunct balloon angioplasty in 89.1% and adjunct stenting in 9.2%. Procedural success (<50% residual stenosis without major complication) was 97.5%, with 1.7% uncomplicated failure and 0.8% Q-wave infarction. Maximum residual stenosis was 15+/-17%. During 6-month follow-up, available in 94% of patients, 82.7% remained angina-free, 10.9% developed recurrent angina due to right coronary ostial restenosis, and 6.4% developed recurrent angina due to another lesion. Two years after intervention, target lesion revascularization rate was 16%. Predictors of symptomatic angiographic restenosis were dissection >10 mm, final minimal luminal diameter <2.5 mm, lesion length >10 mm, restenotic lesion, and diabetes. We conclude that rotational atherectomy of right coronary ostial stenosis results in excellent acute procedural success and in low incidence of clinical recurrence, with a high proportion of patients remaining angina-free 2 years after intervention.     

Early and late clinical outcomes after rotational atherectomy with stenting versus rotational atherectomy with balloon angioplasty for complex coronary lesions

Limited data are available on the effect of rotational atherectomy plus stenting versus rotational atherectomy plus balloon angioplasty for complex coronary lesions. We compared the early and late clinical outcomes between rotational atherectomy plus stenting (158 patients, 171 lesions) and rotational atherectomy plus balloon angioplasty (165 patients, 186 lesions) for complex lesions. Baseline characteristics were similar between the two groups. The procedural success rate was similar between the 2 groups (94% in rotational atherectomy plus stenting versus 96% in rotational atherectomy plus balloon angioplasty; p = 0.54). There were no significant differences in the in-hospital complications between the 2 groups. During mean follow-up of 40.4 +/- 20.2 months, fourteen patients died: 6 in rotational atherectomy plus stenting and 8 in rotational atherectomy plus balloon angioplasty. Target lesion revascularization was similar between the 2 groups (20% in rotational atherectomy plus stenting versus 24% in rotational atherectomy plus balloon angioplasty; p = 0.46). Three-year event (death, nonfatal myocardial infarction and target lesion revascularization)-free survival rate was 79 +/- 4% in the rotational atherectomy plus stenting group and 75 +/- 3% in the rotational atherectomy plus balloon angioplasty group (p = 0.44). In conclusion, rotational atherectomy followed by stenting or balloon angioplasty is associated with favorable long-term outcomes. Compared with rotational atherectomy plus balloon angioplasty, routine stenting after rotational atherectomy does not provide additional benefits in the clinical outcomes in complex coronary lesions.     

Hyperexpansion of coronary stents and clinical outcomes

The complication rates and late clinical follow-up of patients who experience stent hyperexpansion have not been well studied. We designed this prospective study to evaluate the influence of stent hyperexpansion on clinical outcomes in patients with coronary artery disease. Patients who underwent coronary stenting were divided into 2 groups according to whether or not their stents hyperexpanded (defined as stent/artery luminal diameter ratio of > or =1.1/1.0 with no residual stenosis) during implantation. Clinical, angiographic, and procedural characteristics were evaluated at baseline, and clinical outcomes were analyzed in-hospital and at 1 year. The primary endpoint comprised 1-year major adverse cardiovascular events (MACE): death, myocardial infarction, and target-vessel revascularization. Clinical characteristics were not statistically different between patients with hyperexpansion (n=94) and those without (n=542; controls). The hyperexpansion group had significantly smaller mean target-vessel diameters and less severe stenoses; their stents were implanted at higher pressures (13.51 +/- 12.93; P=0.01); and they had higher balloon/artery ratios (1.07 U vs 0.99 U; P <0.0001) and higher aggressiveness scores (14.5 U vs 12.79 U; P <0.0001). Rates of angiographic success and in-hospital MACE were similar, although the hyperexpansion group more often had occlusions of large side branches (5.3% vs 1.5%; P=0.03). At 1 year, the groups had similar rates of MACE (10.8% vs 10.7%), including target-vessel revascularization (8.2% vs 6.5%). Multivariate analysis revealed associations between stent hyperexpansion and higher aggressiveness scores, higher balloon/artery ratios, and narrower target vessels; the hyperexpansion group also had more target-vessel large-side-branch occlusions. Hyperexpansion was not associated with lower rates of MACE.     

Implementation of Robotic-Assisted Percutaneous Coronary Intervention Into a High-Risk PCI Program

BackgroundHow to implement robotic-assisted PCI safely and when to escalate to more complex cases has not been previously described. We sought to evaluate clinical outcomes in patients undergoing robotic-assisted PCI in the first year of a newly established robotic-assisted PCI program.MethodsAll patients who underwent robotic-assisted PCI in the first 12 months at a single academic center were included in the study. Lesion complexity was characterized as “PRECISE-like”, “CORA-PCI-like”, or “CORA-PCI excluded” based on established criteria. The primary outcome was clinical success, defined as <30% residual stenosis after stenting with a final TIMI flow grade 2–3 and no procedural complications. Secondary outcomes included robotic success, defined as clinical success with robotic completion, unintentional manual conversion rate, procedure time, and procedural complications.ResultsOf the 57 consecutive lesions treated, 12 (22.6%) had a PRECISE-like lesion complexity while 32 (56.1%) had a CORA- PCI-like, and 13 (22.8%) a CORA-PCI excluded lesion complexity. There was no significant difference in clinical success (100.0% vs. 96.7% vs. 100.0%, p = 1.00) among the groups but robotic success was numerically lower as complexity increased (100.0% vs. 80.0% vs. 72.7%, p = 0.15), with an increased frequency of manual conversion. There was no significant difference in procedural complication rates among the groups. The robotic completion rate improved during the study period.ConclusionRobotic-assisted PCI, can be safely implemented in a moderate-sized academic center, with a rapid escalation in patient and lesion complexity.     

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.