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.

Safety Assessment of Microcatheter-Protected Rotational Atherectomy with the Double Guiding Catheter Technique for Severely Calcified Left Main Bifurcation.

Background: Rotational atherectomy (RA) is a tool for calcium modification, but there is a risk of losing the side branch in left main coronary artery (LM) bifurcation lesions, resulting in disastrous consequences. Microcatheter-protected RA with the double guiding catheter (GC) technique for severely calcified LM bifurcations has been described previously, but its safety warrants further investigation. Methods: Various sizes of coronary calcification vascular simulators were utilized to model calcified LM bifurcation lesions for RA in in vitro. The damage to the side branch protective microcatheters and guidewires was accessed after microcatheter-protected RA with the double GC technique. In clinical practice, microcatheter-protected RA with the double GC technique was carried out in two patients. Results: In vitro, none of the protective microcatheters or guidewires were completely fractured, although the majority of them were damaged to varying degrees. In clinical practice, we successfully carried out two cases of percutaneous coronary intervention for severely calcified LM bifurcation with microcatheter-protected RA using the double GC technique. Conclusion: RA of severely calcified LM bifurcation lesions may be successfully performed using microcatheter-protected RA with the double GC technique, potentially reducing the risk of side branch occlusion. Since majority of protective microcatheters or guidewires were damaged, there was still some risk, and it is recommended to use this technique only in highly selected patient population of severely calcified true (Medina 1, 1, 1) LM bifurcations.

Optical Coherence Tomography Assessment in Patients Treated With Rotational Atherectomy Versus Modified Balloons: PREPARE-CALC OCT.

[Figure: see text].

Comparison of rotational and orbital atherectomy for the treatment of calcific coronary lesions: Insights from the VA clinical assessment reporting and tracking (CART) program.

BACKGROUND: Previous studies suggested that pre-treatment of coronary artery calcification (CAC) with rotational atherectomy (RA) prior to stent deployment improved procedural success but was not associated with a concomitant improvement in clinical outcomes. Orbital atherectomy (OA) has demonstrated similar benefits, though there are few data comparing the safety and efficacy of the two modalities. METHODS: Patients who underwent PCI of a native coronary lesion with RA or OA from 2014 to 2018 within the Veterans Affairs Healthcare System were identified. Propensity matched cohorts were generated to compare the clinical and safety outcomes following either RA or OA. The primary endpoint was the rate of 30-day major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause mortality, repeat myocardial infarction, target vessel revascularization, and stroke. RESULTS: We identified 1,091 patients that underwent atherectomy during the study period, 640 (59%) treated with RA and 451 (41%) treated with OA. Among a propensity-matched cohort consisting of 950 patients, there was no significant difference in MACCE for patients who underwent RA or OA (7.1 vs. 8.2%, p = .36). Components of the primary outcome including 30-day mortality, myocardial infarction, target vessel revascularization, and stroke were also similar in the matched cohort. Additionally, procedural complications including perforation, no-reflow, dissection, and in-stent thrombosis were comparable across both treatment strategies. CONCLUSIONS: Both rotational and orbital atherectomy are safe and effective strategies for the treatment of calcified coronary plaque prior to stent deployment, with similarly low rates of peri-procedural adverse events.

Treatment of In-Stent Restenosis by Excimer Laser Coronary Atherectomy and Drug-Coated Balloon: Serial Assessment with Optical Coherence Tomography.

OBJECTIVES: We aimed to compare the results of neointimal modification before drug-coated balloon (DCB) treatment with excimer laser coronary atherectomy (ELCA) plus scoring balloon predilation versus scoring balloon alone in patients presenting with in-stent restenosis (ISR). BACKGROUND: Treatment of ISR with ELCA typically results in superior acute gain by neointima debulking. However, the efficacy of combination therapy of ELCA and DCB remains unknown. METHODS: A total of 42 patients (44 ISR lesions) undergoing DCB treatment with ELCA plus scoring balloon (ELCA group, n = 18) or scoring balloon alone (non-ELCA group, n = 24) were evaluated via serial assessment by optical coherence tomography (OCT) performed before, after intervention, and at 6 months. RESULTS: Although there was significantly greater frequency of diffuse restenosis and percent diameter stenosis (%DS) after intervention in the ELCA group, comparable result was shown in %DS, late lumen loss, and binary angiographic restenosis at follow-up. On OCT analysis, a decreased tendency in the minimum lumen area and a significant decrease in the minimum stent area were observed in the ELCA group between 6-month follow-up and after intervention (-0.89 ± 1.36 mm2 vs. -0.09 ± 1.25 mm2, p = 0.05, -0.49 ± 1.48 mm2 vs. 0.28 ± 0.78 mm2, p = 0.03, respectively). The changes in the neointimal area were similar between the groups, and target lesion revascularization showed comparable rates at 1 year (11.1% vs. 11.4%, p = 0.85). CONCLUSIONS: Despite greater %DS after intervention, ELCA before DCB had possible benefit for late angiographic and clinical outcome.

Prevalence, indications and management of balloon uncrossable chronic total occlusions: Insights from a contemporary multicenter US registry.

BACKGROUND: Balloon uncrossable lesions can be challenging to treat, requiring specialized techniques and equipment. METHODS: We examined the prevalence, clinical and angiographic characteristics, management and procedural outcomes of balloon uncrossable lesions in a multicenter chronic total occlusion (CTO) percutaneous coronary intervention (PCI) registry. RESULTS: Between 2012 and 2016, 718 CTO PCIs (in which the occlusion was successfully crossed with a guidewire) were performed in 701 patients at 11 US centers. Mean age was 65.6 ± 10 years and 84% of the patients were men. Balloon uncrossable lesions represented 9% of all CTOs. Balloon uncrossable CTOs had more moderate/severe calcification (82% vs. 52%, P < 0.0001), moderate/severe tortuosity (61% vs. 35% P < 0.0001) and higher J-CTO score (2.95 ± 1.32 vs. 2.43 ± 1.23, P = 0.005) as compared with the remaining lesions. Technical and procedural success was significantly lower for balloon uncrossable lesions (90.5% vs. 98.3%, P < 0.0001 and 88.9% vs. 96.6% P = 0.004), respectively, but the incidence of major adverse events was similar (1.6% vs. 2.2%, P = 0.751). Balloon uncrossable lesions required longer procedure (208 [interquartile range: 135, 258] vs. 135 [94, 194] min, P < 0.0001) and fluoroscopy (77 [52, 100] vs. 45 min [27, 75], P < 0.0001) time. Techniques used to treat balloon uncrossable lesions included balloon-assisted microdissection (23%), excimer laser atherectomy (18%), and rotational atherectomy (16%). Excimer laser atherectomy and balloon-assisted microdissection were associated with the highest technical and procedural success rates. CONCLUSIONS: Balloon uncrossable CTOs are common, are associated with high rates of technical failure, and require specialized techniques for successful treatment. © 2016 Wiley Periodicals, Inc.

Gender differences in acute and 30-day outcomes after orbital atherectomy treatment of de novo, severely calcified coronary lesions.

OBJECTIVES: The aim of this analysis is to evaluate potential differences according to gender in terms of acute and 30-day clinical outcomes in patients enrolled in the ORBIT II trial with de novo, severely calcified coronary lesions treated with orbital atherectomy to facilitate stent delivery. BACKGROUND: Previous studies have shown an increased risk of safety events in females compared to males undergoing percutaneous coronary intervention. METHODS: ORBIT II, a prospective, nonrandomized, multicenter, single arm study conducted in the US evaluated the safety and efficacy of the coronary OAS to facilitate stent placement in de novo, severely calcified coronary lesions in 443 subjects (286 males and 157 females). The rate of major adverse cardiac events (MACE) defined as a composite of myocardial infarction, target vessel revascularization, and cardiac death was evaluated in-hospital and 30-days postprocedure. For this analysis, the ORBIT II safety and efficacy results were stratified by gender. RESULTS: At baseline, females were significantly older than males and had a lower mean estimated glomerular filtration rate. Males had a higher rate of previous coronary artery bypass grafting and history of smoking. The rates of successful stent delivery and <50% residual stenosis were similar in males and females. In-hospital and 30-day MACE rates did not differ by gender. CONCLUSIONS: Despite females being older, having smaller arteries, and more renal dysfunction, preparation of severely calcified coronary lesions with orbital atherectomy to facilitate stent deployment results in similar rates of in-hospital and 30-day MACE, irrespective of gender.

Incidence, correlates, management, and clinical outcome of coronary perforation: analysis of 16,298 procedures.

BACKGROUND: Coronary perforation is a serious but uncommon complication of percutaneous coronary intervention (PCI) and is associated with significant morbidity and mortality. METHODS: We performed an analysis of the Mayo Clinic PCI database. Clinical records, procedural reports, and angiographic studies were reviewed. Multiple logistic regression analysis was performed to identify clinical, procedural, anatomic, and angiographic correlates of coronary perforation. RESULTS: A total of 16,298 PCI procedures were performed between January 1990 and December 2001. We identified 95 coronary perforations (0.58%; 95% CI, 0.47-0.71). The incidence of coronary perforation varied with time. Correlates of coronary perforation included the use of an atheroablative device and female sex. Twelve patients (12.6%) sustained an acute myocardial infarction, and cardiac tamponade developed in 11 patients (11.6%). Management strategies included reversal of heparin, pericardiocentesis, placement of a covered stent, and surgical repair. Seven patients died (7.4%). CONCLUSIONS: Coronary perforation during PCI is rare, but is associated with significant morbidity and mortality. The variable frequency of perforation may be explained by temporal variations in the use of atheroablative devices.

Incidence, management, and outcome of coronary artery perforation during percutaneous coronary intervention.

We have analyzed the incidence, management, and outcome of 84 cases of coronary artery perforation in patients who underwent percutaneous coronary intervention at our institution. This complication was more frequent in female patients and in patients who underwent lesion modification with atheroablative devices. A total of 8 patients (9.5%) died after the procedure. They were usually older and had a higher incidence of cardiac tamponade; a larger percentage of these patients underwent emergency surgery than those who survived.

Acute and late clinical outcome after rotational atherectomy for complex coronary disease.

Rotational atherectomy is effective acutely in treating complex coronary disease, but less is known about its long-term clinical outcome. We examined the acute results and late clinical outcome in 178 patients undergoing treatment with this device. Rotational atherectomy was used to treat 240 lesions in 178 individual patients. Nineteen percent had multilesion or staged multivessel procedures, and 71% had AHA-ACC Type B2/C lesions. The procedure was completed successfully in 94% of patients. Major complications occurred in 6% (death 1%, Q-MI 2.8%, and emergency bypass surgery 2.2%). Clinical follow-up was available for 167 (94%) patients at 13+/-6 months. Thirty-five percent required additional catheterization because of recurrent symptoms or an abnormal stress test. Clinical restenosis was confirmed in 18%, and an additional 2.2% of patients had progression of disease in previously untreated segments. At the end of 1 year, 14% had undergone repeat target vessel revascularization. Cumulatively at follow-up, approximately 80% had avoided an acute major complication and repeat revascularization for restenosis. Rotational atherectomy provides excellent acute and good late clinical results. At 1 year follow-up, the likelihood of developing clinical restenosis or significant progression of disease was 1 in 5, and patients had a 1 in 7 chance of requiring revascularization because of restenosis. These findings are encouraging and indicate that rotational atherectomy can be performed safely and with a high degree of acute and late clinical success in complex coronary disease characterized by multivessel or multilesion involvement and a predominance of B2 and C lesions.

Influence of a randomized clinical trial on practice by participating investigators: lessons from the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT). CAVEAT I and II Investigators.

OBJECTIVES: We sought to determine whether the results of the first Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) influenced subsequent practice patterns among the investigators. BACKGROUND: CAVEAT-I demonstrated that directional coronary atherectomy (DCA) resulted in higher rates of early complications at a higher cost and with no clinical benefit. We sought to determine whether these results influenced subsequent use of procedures among CAVEAT-I investigators. METHODS: We compared the results of a week-long registry of all coronary interventions performed at 35 CAVEAT-I sites in 1994 with those of a similar registry obtained in 1992 before the trial, the results of which were published in 1993. For control purposes, the use of procedures was studied at 24 additional sites to provide insight into practice at hospitals not participating in the trial. A total of 1,465 interventions were analyzed. RESULTS: Ninety-four percent of CAVEAT-I sites responded. Utilization rates differed between CAVEAT-I and CAVEAT-I follow-up (p < 0.001). Balloon angioplasty decreased from 83.8% to 68.5%, DCA increased slightly from 10.7% to 14.1%, and the use of other devices increased from 5.4% to 17.5%. Stand-alone balloon use was more prevalent at nonparticipating control sites than at sites that took part in CAVEAT-I (p < 0.001). CONCLUSIONS: Paradoxically, despite the negative findings of CAVEAT-I, there was a noteworthy trend toward an increase in the use of DCA and other devices at CAVEAT-I sites. Our findings suggest that among investigators in the trial, there may have been a lack of influence of trial data on clinical practice patterns 1 year after publication of the results. Ethics of protocol: Both CAVEAT I and II were approved by the Institutional Review Board at each study site.

Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I).

OBJECTIVES: In-hospital peripheral vascular complications of balloon angioplasty were compared with those of directional atherectomy in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) to identify patients at risk and evaluate costs and outcomes. BACKGROUND: The incidence, costs and outcomes of peripheral vascular complications after coronary intervention have not been fully characterized as a function of randomly assigned therapy. METHODS: At 35 sites in the United States and Europe, 1,012 patients were randomized. Peripheral vascular complications were defined as the composite of pulse loss, pseudoaneurysm, hematoma > 4 cm in diameter or groin hemorrhage necessitating blood transfusion. Logistic models were derived to 1) predict these complications from baseline and procedural characteristics, 2) test the relevance of randomization assignment, and 3) assess their impact on hospital costs and long-term outcomes. RESULTS: Sixty-seven patients (6.6%) developed peripheral vascular complications, of whom 15 (22.4%) required a blood transfusion, 14 (20.9%) underwent vascular surgery, and 2 (3.0%) died. Both in-hospital deaths occurred in patients with peripheral vascular complications. There was no difference in composite peripheral vascular complication rates among patients randomized to angioplasty or atherectomy. Greater age, female gender, postprocedural heparin and intraaortic balloon counterpulsation were predictive of increased risk. In a representative 60% subset, mean hospital costs increased from $9,583 in patients without to $18,350 in those with peripheral vascular complications (p = 0.0001). The unadjusted mortality rate at 1 year was 7.5% for patients with peripheral vascular complications compared with 1.1% for all others (p = 0.0001). These complications identified patients at greater risk of death, myocardial infarction or repeat revascularization at 30 days and 1 year. The atherectomy group had a trend toward more frequent deaths and myocardial infarction. CONCLUSIONS: Directional atherectomy and balloon angioplasty had similar in-hospital peripheral vascular complication rates. Female gender, greater age, postprocedural heparin and intraaortic balloon counterpulsation were predictive of higher risk. The twofold increase in cost and sevenfold increase in long-term deaths highlight the need to prevent these periprocedural events and monitor patients closely.

Complications of directional coronary atherectomy: incidence, causes, and management.

An assessment of complications is essential to the evaluation of directional coronary atherectomy. Major complications--such as death, Q wave myocardial infarction, or the need for emergency bypass surgery to correct acute vessel closure--result from a variety of familiar mechanisms, including dissection, thrombosis, or guiding catheter injury. In addition, unique complications of this device, such as catheter nose cone injury or vascular perforation, may also result in severe ischemia. With prompt recognition of the cause, most ischemic complications can be successfully treated in the catheterization laboratory. Less severe complications, such as femoral vascular injury, also require recognition and appropriate treatment in order to minimize sequelae. Although several large series have now documented that the overall incidence of atherectomy complications appears similar to that reported for conventional balloon angioplasty, no direct comparisons can be made until randomized trials (such as Coronary Angioplasty Versus Excisional Atherectomy Trial [CAVEAT]) are analyzed, to control for potential demographic or lesion-specific influences on complication rates.