Novel Method for Real Time Co‐Registration of IVUS and Coronary Angiography

Objectives

We present our experience with a novel method for real time co‐registration of intravascular ultrasound (IVUS) and coronary angiography.

Background

A major limitation of the current practice of concomitant use of coronary angiography and IVUS is that the locations of the acquired IVUS images are not correlated with their exact locations on the vessel roadmap obtained by coronary angiography.

Methods

Phantoms simulating the coronary tree were used to test the accuracy and potential of co‐registration. Subsequently we examined patients who underwent IVUS during cardiac catheterization. Analysis and feasibility were performed in 42 arteries of 36 patients.

Results

The statistical validation in phantoms resulted in a co‐registration accuracy of 1.12 mm. The length measurement on an angiogram resulted in an accuracy of 0.38 mm. Co‐registration in patients was successful in all cases and four categories were assisted by 1(bad) to 5 (good) grading. Accuracy (the co‐registration precision in pointing at the exact corresponding location): 4.8±0.41; Ease of use and workflow: 4.74±0.44; Stent landing zone detection and evaluation: 4.58±0.5; Stent landing zone length and diameter measurement: 4.94±0.23. The co‐registration error was estimated as no more than 1 mm.

Conclusion

In this pilot study, we found that the novel IVUS and coronary angiography co‐registration method is accurate, easy to use, fast and user‐friendly. This method precludes the need to use motorized automated pull back device. (J Interven Cardiol 2016;29:225–231)

     

Usefulness of Frequency Domain Optical Coherence Tomography Compared with Intravascular Ultrasound as a Guidance for Percutaneous Coronary Intervention

Objectives

To compare outcomes and rates of optimal stent placement between optical coherence tomography (OCT) and intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI).

Background

Unlike IVUS‐guided PCI, rates of clinical outcomes and optimal stent placement have not been well characterized for OCT‐guided PCI.

Methods

The study enrolled 290 patients who underwent implantation of a second generation drug eluting stent under OCT (122 patients) or IVUS (168 patients) guidance. The two groups were compared after adjusting for baseline differences using 1:1 propensity score matching (PSM) (114 patients in each group). Optimal stent placement was defined as achieving an adequate lumen (optimal minimum stent area [MSA > 4.85 mm² for OCT, >5 mm² for IVUS] or a final MSA ≥ 90% of the distal reference lumen area, without edge dissection, incomplete stent apposition, or tissue prolapse), or otherwise performing additional interventions to address suboptimal post‐stenting OCT or IVUS findings. The primary endpoint was one‐year cumulative incidence of major adverse cardiac events (MACE; cardiac death, myocardial infarction and target lesion revascularization). Definite or probable stent thrombosis (ST) rates were evaluated.

Results

In adjusted comparisons between OCT and IVUS groups, there was no significant difference in rates of MACE (3.5% vs. 3.5%, P = 1.000) and ST (0% vs. 0.9%, P = 1.000) at 1 year, optimal stent placement (89.5% vs. 92.1%, P = 0.492), and further intervention (7.9% vs.13.2%, P = 0.234), despite OCT significantly more frequently detecting tissue prolapse (97.4% vs. 47.4%, P < 0.001), and numerically more edge dissection (10.5% vs. 4.4%, P = 0.078) or incomplete stent apposition (48.2% vs. 36.8%, P = 0.082).

Conclusions

OCT guidance showed comparable results to IVUS in mid‐term clinical outcomes, suggesting that OCT can be an alternative tool for stent placement optimization. (J Interven Cardiol 2016;29:216–224)

     

An Audit of Outcomes After Same‐Day Discharge Post‐PCI in Acute Coronary Syndrome and Elective Patients

Objectives

To investigate the outcomes of a cohort of acute and elective percutaneous coronary intervention (PCI) patients who were discharged home 6 hours postprocedure.

Background

Contemporary PCI is safe with a low rate of acute complications. It is well established as a day procedure in elective cases; however, data are lacking in acute cases.

Methods

We describe a prospective observational audit of routine clinical practice in the 3 PCI centers in Northern Ireland. Patients were selected for same‐day discharge after 6 hours of post‐PCI observation. Both elective and acute coronary syndrome (ACS) cases were included. Criteria for same‐day discharge were based on the technical result of the procedure rather than lesion complexity or clinical presentation. Radial access was preferred but not mandatory. Patients were contacted directly to assess for 30‐day major adverse cardiovascular events (MACE). Reported events were corroborated with the general practitioner or hospital notes.

Results

A total of 1,059 patients were selected for same‐day discharge with 30‐day follow‐up available for all cases. Of these, 766 (72.3%) were elective and 293 (27.7%) were ACS patients. Radial access was almost universal (98%). A total of 1,224 lesions were stented, of which 432 (40.8%) were high risk (highest risk lesion in each case by AHA/ACC classification). MACE rate at 30 days was 0.85% with a sub‐acute stent thrombosis rate of 0.4%. There were no MACE events from discharge to 24 hours.

Conclusions

Selected acute and elective patients with a range of lesion complexity and risk can be discharged safely home early after PCI.

     

Impact of stent deformity induced by the kissing balloon technique for bifurcating lesions on in‐stent restenosis after coronary intervention

Objectives

To investigate the impact of stent deformity induced by final kissing balloon technique (KBT) for coronary bifurcation lesions on in‐stent restenosis (ISR).

Background

In experimental models, the detrimental effects of KBT have been clearly demonstrated, but few data exists regarding the impact of proximal stent deformity induced by KBT on clinical outcomes.

Methods

We examined 370 coronary lesions where intravascular ultrasound (IVUS)‐guided second‐generation drug‐eluting stent (DES) implantation for coronary bifurcation lesions was performed. Based on IVUS analysis, the stent symmetry index (minimum/maximum stent diameter) and stent overstretch index (the mean of stent diameter/the mean of reference diameter) were calculated in the proximal main vessel.

Results

The stent symmetry index was significantly lower (0.75 ± 0.07 vs 0.88 ± 0.06, P < 0.0001) and the stent overstretch index was significantly higher (1.04 ± 0.08 vs 1.01 ± 0.06, P = 0.0007) in lesions with KBT (n = 174) compared to those without KBT (n = 196). The number of two‐stent technique in lesions with KBT was 31 (18%). In multivariate analysis, the degree of stent deformity indices was not associated with ISR in lesions with KBT; however, two‐stent technique use was the only independent predictor of ISR at 8 months (hazard ratio: 3.96, 95% confidence interval: 1.25‐12.5, P = 0.01).

Conclusions

Second‐generation DES deformity induced by KBT was not associated with mid‐term ISR.

     

Edge‐to‐Edge Technique to Minimize Ovelapping of Multiple Bioresorbable Scaffolds Plus Drug Eluting Stents in Revascularization of Long Diffuse Left Anterior Descending Coronary Artery Disease

Background

Implantation of Drug Eluting Stents (DES) plus bioresorbable scaffolds (BVS) in very long diffuse left anterior descending coronary artery (LAD) disease may be problematic because of multiple devices overlapping. We sought to assess the short and mid‐tern outcomes of combined implantation of DES and BVS using a novel “edge‐to‐edge” technique in patients with diffuse LAD disease.

Methods

Patients with long diffuse LAD disease were enrolled in a prospective registry from 1st August 2014 to 1st August 2015 and treated with IVUS‐aided percutaneous coronary intervention using a DES plus a single or multiple BVS using a novel “edge‐to‐edge” technique. Clinical follow up and invasive follow up driven by clinical justification was performed.

Results

Twenty‐three patients (5 females, mean age 59.1± 9.1 years) were enrolled. Mean length of LAD disease was 73.1 ± 20.6 mm. Mean number of DES and BVS implanted was 1.2 ± 0.4 and 1.7 ± 1.3, respectively. At a mean follow‐up of 11.3 ± 3.8 months, no stent thrombosis or MACE were observed. Angiographic and IVUS follow‐up at a mean of 6.6 ± 0.7 months showed no significant angiographic restenosis and no appreciable stent gaps.

Conclusions

In revascularization of long diffuse disease of the LAD, the edge‐to‐edge implantation technique appears to be feasible resulting in no restenosis or thrombosis on the short‐term follow‐up. (J Interven Cardiol 2016;29:275–284)

     

Intravascular ultrasound guided wiring re‐entry technique for complex chronic total occlusions

Background

The successful recanalization rate of chronic total occlusion (CTO) lesions without retrograde collaterals available is always low. Intravascular ultrasound (IVUS) may be useful to guide the subintimal guidewire to re‐enter the true lumen. We evaluated the clinical feasibility and efficacy of the IVUS‐guided wiring re‐entry technique for these complex CTO lesions.

Methods

Twenty consecutive patients (19 male, mean age: 65.3 ± 12.8 years) with both failed antegrade and retrograde approaches were enrolled. The IVUS catheter was introduced into the subintimal space to identify the entry point into the subintimal space, and guide another stiff wire to re‐enter the true lumen with the adjacent side‐branch or first wire as markers, or using IVUS‐guided parallel wire technique.

Results

The entry point into the subintimal space was identified by IVUS in all cases, and the IVUS‐guided wiring re‐entry technique succeeded in 17 cases (85%). No procedure‐related complication was noted except one case of delayed cardiac tamponade due to the wire perforation. During the mean follow‐up period of 1.9 ± 1.3 years, there was no adverse cardiac event, except one patient died of the complication of cardiac transplantation.

Conclusion

The IVUS‐guided wiringre‐entry technique might be feasible and safe for the recanalization of complex CTO lesions.

     

Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Coronary Lesions Complicated by Coronary Artery Dissection (RAISE)

Objectives

To examine the safety and efficacy of immediate rotational atherectomy (RA) in nondilatable calcified coronary lesions complicated by coronary dissection during percutaneous coronary intervention (PCI).

Background

In the presence of coronary dissection in nondilatable calcified coronary lesions, conservative management is suggested to permit the dissection to heal prior to treatment with RA. However, many patients have frequent angina attacks and some patients develop serious complications during this period.

Methods

One hundred and nighty‐eight patients with severe coronary calcification underwent PCI, and were randomized into immediate (n = 105) or delayed RA group (n = 93) when coronary dissections occur. The primary endpoint of the present study was all‐cause death including cardiac and non‐cardiac death in 4 years follow‐up. Non‐fatal myocardial infarction, stent thrombosis, cardiac tamponade, stroke, target lesion revascularization, New York Heart Association (NYHA) class IV heart failure were analyzed as secondary end points.

Results

At a follow‐up of 4 years, event‐free survival rates were not statistically different between the immediate and delayed RA group (81.9% vs 80.6%, P = 0.820). Rates of PCI‐ and RA‐related major adverse cardiac events (MACE) and severe RA‐related complications were not statistically different between groups. Luminal loss was not significantly different between the immediate and delayed RA group as evaluated by Intravascular ultrasound (IVUS). Two cases in the delayed RA group experienced myocardial infarction during the 4‐week waiting.

Conclusion

This study indicates that immediate RA during PCI is safe and effective in patients with coronary artery dissection. (J Interven Cardiol 2015;28:456–463)

     

Impact of Calcified Target Lesions on the Outcome of Percutaneous Coronary Intervention for Acute Coronary Syndrome: Insights From the BASE ACS Trial

Objectives

We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial.

Background

The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown.

Methods

The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium‐nitride‐oxide‐coated stents or everolimus‐eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non‐fatal myocardial infarction or ischemia‐driven target lesion revascularization. Follow‐up was planned at 12 months, and yearly thereafter for up to 7 years.

Results

Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow‐up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non‐fatal myocardial infarction events (P < 0.05, both). The rates of ischemia‐driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity‐score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions.

Conclusions

Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long‐term clinical outcome, compared with those treated for non‐calcified lesions, mainly due to more frequent safety events. In the propensity score‐matched analysis, the outcome was comparable.

     

Real‐life data regarding acute procedural success and 1‐year clinical outcome of desolve bioresorbable scaffolds

Objectives

We aimed to evaluate the peri‐procedural success of DESolve bio‐resorbable scaffolds (BRSs) and analyzed real‐life data about major cardiac events during 1‐year follow‐up.

Background

There is little information about real‐life data of DESolve BRS which is a novel stent technology offering various advantages over drug eluting stents and commonly used in daily cardiology practice.

Methods

We conducted this single‐center and non‐randomized cross‐sectional study from June 2015 through August 2016 in Medipol University Department of Cardiology and included 117 patients undergoing single or multivessel percutaneous coronary interventions (PCI) with novolimus‐eluting BRS devices (152 scaffolds) (Elixir Medical Corporation). Study end points were acute device and procedural success, scaffold thrombosis and major adverse cardiac event (MACE) rates of DESolve BRS.

Results

Device success was 96.7% and procedural success was 99.3%. We detected MACE rate as 0.9% while clinical‐driven target lesion revascularization was performed in one patient. None of the patients experienced scaffold thrombosis or death. Peri‐procedural complications were reported in three patients.

Conclusions

High rates of successful scaffold implantations, low rates of peri‐procedural complications, and major cardiac events in long‐term suggest that DESolve scaffolds can safely and effectively be used in daily intervention practice by particularly experienced operators.

     

Assessment of Angiographic Coronary Calcification and Plaque Composition in Virtual Histology Intravascular Ultrasound

Objectives

We assessed the relation between coronary plaque composition and angiographic calcification by using virtual histology intravascular ultrasound (VH‐IVUS).

Background

The plaque vulnerability according to angiographic calcification is unclear.

Methods

Subjects were 140 consecutive patients (145 lesions) undergoing VH‐IVUS before percutaneous coronary intervention. Subjects were divided into 4 groups: no calcification group (n = 27), spotty group (n = 65) that had calcium deposits under 90° in grayscale IVUS, intermediate group (n = 37) had calcium deposits with 90° or more and under 180°, and extensive group (n = 16) had calcium deposits with 180° or more.

Results

The number of VH thin‐cap fibroatheromas in spotty group was significantly larger than no calcification group, intermediate group, and extensive group (0.66 ± 0.71 vs 0.22 ± 0.42 [P < 0.01], 0.32 ± 0.48 [P < 0.05], 0.13 ± 0.34 [P < 0.01], respectively). Spotty group without angiographic calcification had significantly larger %necrotic core than with angiographic calcification (24.5 ± 6.7% vs 19.9 ± 7.2%, P < 0.05). Intermediate group without angiographic calcification had significantly larger necrotic core area than with angiographic calcification (2.5 ± 0.9 mm² vs 1.7 ± 0.9 mm², P < 0.05). Extensive group with angiographic calcification had significantly larger %dense calcium than without angiographic calcification (18.3 ± 4.0% vs 13.4 ± 4.4%, P < 0.05).

Conclusions

Lesions with spotty calcification was highly vulnerable in VH‐IVUS. Spotty or intermediate plaque calcification without angiographic calcification was more vulnerable than those with angiographic calcification. Extensive plaque calcification with angiographic calcification had more dense calcium than those without angiographic calcification.

     

Impella 2.5 initiated prior to unprotected left main PCI in acute myocardial infarction complicated by cardiogenic shock improves early survival

Objectives

To assess post‐procedural outcomes when Impella 2.5 percutaneous left ventricular assist device (pLVAD) support is initiated either prior to or after percutaneous coronary intervention (PCI) on unprotected left main coronary artery (ULMCA) culprit lesion in the context of acute myocardial infarction cardiogenic shock (AMICS).

Background

Initiation of Impella 2.5 pLVAD prior to PCI is associated with significant survival benefit in the setting of AMICS. Outcomes of those presenting with a ULMCA culprit lesion in this setting have not been well characterized.

Methods

Thirty‐six consecutive patients in the cVAD Registry supported with Impella 2.5 pLVAD for AMICS who underwent PCI on ULMCA culprit lesion were included in our multicenter study.

Results

The average age was 69.8 ± 14.2 years, 77.8% were male, 72.7% were in CS at admission, 44.4% sustained one or multiple cardiac arrests, and 30.6% had anoxic brain injury. Baseline characteristics were comparable between the Pre‐PCI group (n = 20) and Post‐PCI group (n = 16). Non‐ST segment elevation myocardial infarction and greater coronary disease burden were significantly more frequent in the Pre‐PCI group but they had significantly better survival to discharge (55.0% vs 18.8%, P = 0.041). Kaplan‐Meier 30‐day survival analysis showed very poor survival in Post‐PCI group (48.1% vs 12.5%, Log‐Rank P = 0.004).

Conclusions

Initiation of Impella 2.5 pLVAD prior to as compared with after PCI of ULMCA for AMICS culprit lesion is associated with significant early survival. As previously described, patients supported after PCI appear to have very poor survival at 30 days.

     

Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP‐PCI study)

Background

Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy.

Methods

A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end‐point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias.

Results

After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups.

Conclusion

In this non‐randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in‐hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.

     

Approach for Chronic Total Occlusion With Intravascular Ultrasound–Guided Reverse Controlled Antegrade and Retrograde Tracking Technique: Single Center Experience

Background

Controlled antegrade and retrograde subintimal tracking (CART) or reverse CART techniques is the final step for percutaneous revascularization of coronary chronic total occlusion (CTO), but it still represents technical challenges and risk in interventional procedures.

Objectives

Our purpose was to utilize intravascular ultrasound (IVUS)‐guided reverse CART approach for percutaneous revascularization of CTO in our heart center, focusing on its safety, efficacy, and latest technical developments.

Methods

From November 2006 to November 2012, 49 patients with CTO failed to antegrade and/or retrograde percutaneous revascularization of CTO from true lumen to true lumen were enrolled in and underwent IVUS guided reverse CART approach.

Results

The mean J‐CTO score of cases was 2.5. IVUS guidance was successfully implemented in 95.9%; IVUS identified that 61.7% of retrograde wires were located at intimal space, and 59.5% of antegrade wires were located at subintimal space. A Corsair channel dilator was used in 77.6% of cases. The success rates of technique and procedure were 95.9% and 93.9%, respectively; the technical minor complications were observed in 10.2% of cases, without significant clinic outcomes; 2.0% of cases occurred with a major adverse cardiac event of non‐ST‐elevation myocardial infarction; and no case occurred with target vessel revascularization or death. The mean length of stent implanted in a single CTO vessel was 51.3 mm. No patient appeared with radiation dermatitis and contrast‐induced rise of creatinine.

Conclusions

IVUS guided reverse CART approach is effective and safe for percutaneous revascularization of complex CTO, with a high success and a low complication rate. It is feasible to develop this approach for percutaneous revascularization of complex CTO. However, suitable case selection and lately device handling by experienced operators are the crucial points of success. (J Interven Cardiol 2013;26:434‐443)

     

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug‐Coated Balloon After Rotational Atherectomy

Objectives

We investigated the safety and efficacy of PCI using drug‐coated balloon (DCB) after rotational atherectomy (rotablation) in a retrospective single center study in patients with calcified de novo coronary lesions. The majority of patients had an increased risk for bleeding.

Background

DCB has been effective in the treatment of in‐stent restenosis, small vessels, and bifurcations. DCB enables short one month dual antiplatelet treatment. No published data exist on the use of DCB after rotablation.

Methods

82 PCIs were performed in 65 patients (mean age 72 ± 10 years) using rotablation followed by DCB treatment. The median follow‐up time was 17 months. 82% of the patients had at least one risk factor for bleeding such as oral anticoagulation. 32% had an acute coronary syndrome. Median duration of dual antiplatelet treatment was 1 month.

Results

MACE (the composite of cardiovascular death, ischemia‐driven target‐lesion revascularization [TLR] or non‐fatal myocardial infarction) occurred in 14% and 20% of the patients at 12 and 24 months, respectively. The rate of ischemia‐driven TLR was 1.5% at 12 months and 3.0% at 24 months. No acute closure of the treated vessel occurred. Bailout stenting was needed in 10% of the PCIs. The incidence of significant bleeding was 9% at 12 months.

Conclusions

This is the first study to show that PCI using DCB after preparation of calcified lesions with rotablation is safe and effective. This novel strategy may be considered especially in patients with a bleeding risk such as those using an oral anticoagulant.

     

Application of an enhanced device to transluminal retrieval of malappositioned coronary stents: An experimental study

Objectives

This study investigated the application of a novel enhanced device to retrieval of deployed stents in a porcine coronary model.

Background

Recurrence of in‐stent restenosis and stent thrombosis still remains to be resolved. Under these conditions, it is sometimes necessary to retrieve malfunctional stents responsible for thrombosis. However, few data exist regarding the feasibility and safety of retrieval device use in previously deployed coronary stents.

Methods

We have developed an enhanced device consisting of an asymmetric forceps, conducting shaft (1.6 mm diameter, 150 cm length), and control handle. Bare‐metal stents (3 mm diameter) were implanted in four pigs to create a malapposition model. Coronary artery injury was evaluated by intravascular ultrasound (IVUS) and histological imaging on the first and 14th days.

Results

The device was delivered to the coronary artery using the existing catheter (7 Fr). After opening the forceps, the blade was forced into the space between the vessel wall and the stent, and the stent struts were then grasped with the forceps. This was then pulled back into the catheter, still grasping the stent struts with the forceps. All stents were successfully retrieved by this method (n = 4). On the first day, no apparent vessel wall injury was detectable by IVUS, although histological findings revealed damage to endothelial monolayer on retrieval of deployed stent. On the 14th day, mild intimal thickening was observed by IVUS and histology.

Conclusions

These results demonstrate that the present device can be applied to transluminal retrieval of acquired malappositioned coronary stents.

     

Second‐Generation Everolimus‐Eluting Stents Compared to First‐Generation Drug‐Eluting Stents in Patients Treated for Multivessel Disease

Objective

This study aimed to compare the safety and efficacy of everolimus‐eluting stents (EES) to first‐generation drug‐eluting stents (DES) in multivessel disease (MVD).

Background

Second‐generation EES have demonstrated superiority over first‐generation DES for single‐vessel disease, although the merits of EES in MVD are less established.

Methods

A cohort of 1,285 patients (3,124 lesions) with ≥2 diseased vessels were treated with either first‐generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non‐fatal myocardial infarction, were compared at 1 year.

Results

Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first‐generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38–0.87]; P = 0.009; 95% confidence interval).

Conclusions

The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first‐generation DES. Randomized trials comparing new‐generation DES to coronary artery bypass grafting surgery are warranted.

     

Clinical and angiographic outcome of a single center,real world population treated with a dedicated technique of implantation for bioresorbable vascular scaffolds. The FAtebenefratelli Bioresorbable Vascular Scaffold (FABS) registry

Objectives

With this prospective study we aim at investigating the long‐term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation.

Background

It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome.

Methods

Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow‐up. After a run‐in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high‐pressure post‐dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1‐year angiographic follow‐up and ischemia‐driven target‐lesion revascularization (ID‐TLR) at 2‐year clinical follow‐up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years.

Results

A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow‐up LLL was 0.38 ± 0.9. At 2‐year clinical follow‐up, ID‐TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR.

Conclusions

In a complex, all‐comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid‐term angiographic and long‐term clinical outcome.

     

Mid‐term outcomes of consecutive 998 cases of coronary atherectomy in contemporary clinical practice

Objectives

To compare clinical and safety endpoints with use of rotational (RA) and orbital (OA) atherectomy in a large patient population with moderate to severely calcified lesions undergoing percutaneous coronary intervention (PCI).

Background

Coronary artery calcification (CAC) has been recognized as a risk factor for adverse outcomes with coronary artery disease (CAD). Though atheroablative techniques, RA and OA have been used extensively, comparison of their clinical and safety endpoints is lacking. Comparison of these two modalities formed the basis of our study.

Methods and Results

Of 12 001 patients who underwent PCI at our institution between January 2013‐December 2015, we studied 998 consecutive patients with severe calcification treated with atheroablation. We assessed clinical outcomes including death, myocardial infarction (MI) and target lesion revascularization (TLR) at 30 days and 6 months in addition to post‐procedural complications. Device perforation occurred more frequently with use of OA at high burr speed versus RA (1.9%, n = 3 vs. 0.2%, n = 2, P = 0.03). Rates of composite adverse events were similar between groups at 6 months (18.55 vs. 11.46%; P = 0.11)

Conclusion

In this retrospective, single center study, we observed no significant differences in 6‐month rates of adverse events associated with use of OA vs. RA in patients with moderate to severe calcification undergoing PCI. Larger, prospective studies are needed to confirm our findings.

     

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in‐stent restenosis

Objectives

The objective of this study was to assess the 12‐month clinical outcomes in patients with drug‐eluting stent in‐stent restenosis (DES‐ISR) who were either pre‐dilated with non‐compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty.

Methods

This monocentric, retrospective study included patients with DES‐ISR who were routinely treated over a 2‐year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES‐ISR lesion were analyzed. The primary endpoint was the clinically driven target‐lesion revascularization (TLR) rate at 12 months. Secondary endpoints included post‐interventional lumen gain and late lumen loss (LLL) at 6 months.

Results

The 12‐month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs 0.40 ± 0.46 mm, P = 0.468).

Conclusions

Scoring Balloon Angioplasty can safely and effectively prepare DES‐ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

     

Comparison between Plain Old Balloon Angioplasty and Drug‐Eluting Stent Implantation for the Treatment of Stent Fracture

Objectives

The aim of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) for stent fracture (SF).

Background

SF has been reported as a predictor of in‐stent restenosis (ISR) and stent thrombosis (ST).

Methods

Between January 2009 and December 2012, consecutive SF cases treated with either drug‐eluting stent (DES) or plain old balloon angioplasty (POBA) were retrospectively enrolled in this study. The study endpoints were all‐cause death, cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), ST, re‐stent fracture (re‐SF), and major adverse cardiac events (MACE) defined as the composite of cardiac death, MI, and TLR.

Results

Of 135 SF cases, 67 (49.6%) cases were treated with DES, whereas 68 (50.4%) cases with POBA. Median follow‐up period was 1,401 (IQR: 967–1,771) days. The estimated MACE rate at 3 years was significantly lower in the DES group as compared with the POBA group largely driven by less TLR (25.7 vs. 55.8%, P < 0.001). Moreover, 1‐year landmark analysis after PCI for SF revealed that MACE continued to occur even after 1 year irrespective of the treatment option (P = 0.47). On multivariable Cox regression analysis, POBA and large post‐procedure angle (Δ) defined as the degree difference between the end systolic and diastolic angle were identified as independent predictors for TLR.

Conclusions

DES implantation for SF is associated with better clinical outcomes as compared to POBA alone, due to a lower need for TLR. Large post‐procedural angle (Δ) appears to be an independent predictor of TLR.