Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry).

Introduction: Data regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous. Aim: To evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES. Material and methods: Overall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs. > 3 and ≤ 6 vs. > 6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes. Results: Pairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs. > 6 months) before PSM revealed superiority of DES + DAPT > 6 months vs. DEB + DAPT > 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Also, DES + DAPT ≤ 6 months was found to be superior compared to DEB + DAPT ≤ 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Kaplan-Meier estimate analysis confirmed that DAPT > 6 months is related to a higher stroke rate (p = 0.01) when compared to ≤ 6 months. Conclusions: Treatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT > 6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.

Percutaneous Coronary Intervention vs. Coronary Artery Bypass Grafting for Treating In-Stent Restenosis in Unprotected-Left Main: LM-DRAGON-Registry.

Background: Data regarding management of patients with unprotected left main coronary artery in-stent restenosis (LM-ISR) are scarce. Objectives: This study investigated the safety and effectiveness of percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) for the treatment of unprotected LM-ISR. Methods: Consecutive patients who underwent PCI or CABG for unprotected LM-ISR were enrolled. The primary endpoint was a composite of major adverse cardiac and cerebrovascular events (MACCE), defined as cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and stroke. Results: A total of 305 patients were enrolled, of which 203(66.6%) underwent PCI and 102(33.4%) underwent CABG. At 30-day follow-up, a lower risk of cardiac death was observed in the PCI group, compared with the CABG-treated group (2.1% vs. 7.1%, HR 3.48, 95%CI 1.01-11.8, p = 0.04). At a median of 3.5 years [interquartile range (IQR) 1.3-5.5] follow-up, MACCE occurred in 27.7% vs. 29.6% (HR 0.82, 95%CI 0.52-1.32, p = 0.43) in PCI- and CABG-treated patients, respectively. There were no significant differences between PCI and CABG in cardiac death (9.9% vs. 18.4%; HR 1.56, 95%CI 0.81-3.00, p = 0.18), MI (7.9% vs. 5.1%, HR 0.44, 95%CI 0.15-1.27, p = 0.13), or stroke (2.1% vs. 4.1%, HR 1.79, 95%CI 0.45-7.16, p = 0.41). TVR was more frequently needed in the PCI group (15.2% vs. 6.1%, HR 0.35, 95%CI 0.15-0.85, p = 0.02). Conclusions: This analysis of patients with LM-ISR revealed a lower incidence of cardiac death in PCI compared with CABG in short-term follow-up. During the long-term follow-up, no differences in MACCE were observed, but patients treated with CABG less often required TVR. Visual overview: A visual overview is available for this article. Registration: https://www.clinicaltrials.gov; Unique identifier: NCT04968977.

Long-term outcomes following drug-eluting balloons vs. thin-strut drug-eluting stents for treatment of recurrent restenosis in drug-eluting stents.

BACKGROUND: There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR). AIMS: To compare the long-term outcomes of patients treated with either a thin-strut drug-eluting stent (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES). METHODS: A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. The primary outcome was target lesion revascularization (TLR). RESULTS: Out of 311 patients (mean age, 67 years; 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3%, respectively; HR, 0.38; 95% CI, 0.17-0.86; P = 0.01). The risks of device-oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model, the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13-0.84; P = 0.02). CONCLUSIONS: In patients with R-ISR implantation of a thin-DES is associated with a lower risk of repeated revascularization compared with angioplasty with a DEB.

Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry.

Background: Whereas the efficacy and safety of intravascular lithotripsy (IVL) have been confirmed in de novo calcified coronary lesions, little is known about its utility in treating stent underexpansion. This study aimed to investigate the impact of IVL in treating stent underexpansion. Methods and Results: Consecutive patients with stent underexpansion treated with IVL entered the multicenter IVL-Dragon Registry. The procedural success (primary efficacy endpoint) was defined as a relative stent expansion >80%. Thirty days device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. A total of 62 patients were enrolled. The primary efficacy endpoint was achieved in 72.6% of patients. Both stent underexpansion 58.5% (47.5−69.7) vs. 11.4% (5.8−20.7), p < 0.001, and the stenotic area 82.6% (72.4−90.8) vs. 21.5% (11.1−37.2), p < 0.001, measured by quantitative coronary angiography improved significantly after IVL. Intravascular imaging confirmed increased stent expansion following IVL from 37.5% (16.0−66.0) to 86.0% (69.2−90.7), p < 0.001, by optical coherence tomography and from 57.0% (31.5−77.2) to 89.0% (85.0−92.0), p = 0.002, by intravascular ultrasound. Secondary endpoint occurred in one (1.6%) patient caused by cardiac death. There was no target lesion revascularization or target vessel myocardial infarction during the 30-day follow-up. Conclusions: In this real-life, largest-to-date analysis of IVL use to manage underexpanded stent, IVL proved to be an effective and safe method for facilitating stent expansion and increasing luminal gain.

Clinical Outcomes following Large Vessel Coronary Artery Perforation Treated with Covered Stent Implantation: Comparison between Polytetrafluoroethylene- and Polyurethane-Covered Stents (CRACK-II Registry).

Data on the clinical outcomes comparing synthetic fluorocarbon polymer polytetrafluoroethylene- (PTFE, GraftMaster) and polyurethane- (Papyrus) covered stents (CSs) to seal coronary artery perforations (CAPs) are limited. We aimed to evaluate 30-day and 1-year clinical outcomes after PCI complicated by CAP and treated with CS. We assessed 106 consecutive patients with successful CAP sealing (122 CSs): GraftMaster (51 patients, 57 CSs) or Papyrus CS (55 patients, 65 CSs). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac death, target lesion revascularisation (TLR), and myocardial infarction (MI). The mean age of subjects was 69 ± 9.6 years (53.8% males). No significant differences were identified between the GraftMaster and Papyrus groups at the 30-day follow-up for MACE, cardiac death, MI and stent thrombosis (ST), while significantly lower rate of TLR and TVR (p = 0.02) were confirmed in the Papyrus group. At one year, differences remained similar between stents for MACE, a trend towards a lower rate of TLR (p = 0.07), MI (p = 0.08), and ST (p = 0.08), and higher for cardiac death (p = 0.07) was observed in the Papyrus group. This real-life registry of CAP illustrated that the use of Papyrus CS is associated with lower rates of TLR and TVR at 30-day follow-up in comparison to the GraftMaster CSs and no significant differences between both assessed CS at one year of follow-up.

Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry).

[Figure: see text].

Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: Multicentre CRACK registry.

BACKGROUND: Data regarding the clinical outcomes of covered stents (CSs) used to seal coronary artery perforations (CAPs) in the all-comer population are scarce. The aim of the CRACK Registry was to evaluate the procedural, 30-days and 1-year outcomes after CAP treated by CS implantation. METHODS: This multicenter all-comer registry included data of consecutive patients with CAP treated by CS implantation. The primary endpoint was the composite of major adverse cardiac events (MACEs), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI). RESULTS: The registry included 119 patients (mean age: 68.9 ± 9.7 years, 55.5% men). Acute coronary syndrome, including: unstable angina 21 (17.6%), NSTEMI 26 (21.8%), and STEMI 26 (21.8%), was the presenting diagnosis in 61.3%, and chronic coronary syndromes in 38.7% of patients. The most common lesion type, according to ACC/AHA classification, was type C lesion in 47 (39.5%) of cases. A total of 52 patients (43.7%) had type 3 Ellis classification, 28 patients (23.5%) had type 2 followed by 39 patients (32.8%) with type 1 perforation. Complex PCI was performed in 73 (61.3%) of patients. Periprocedural death occurred in eight patients (6.7%), of which two patients had emergency cardiac surgery. Those patients were excluded from the one-year analysis. Successful sealing of the perforation was achieved in 99 (83.2%) patients. During the follow-up, 26 (26.2%) patients experienced MACE [7 (7.1%) cardiac deaths, 13 (13.1%) TLR, 11 (11.0%) MIs]. Stent thrombosis (ST) occurred in 6 (6.1%) patients [4(4.0%) acute ST, 1(1.0%) subacute ST and 1(1.0%) late ST]. CONCLUSIONS: The use of covered stents is an effective treatment of CAP. The procedural and 1-year outcomes of CAP treated by CS implantation showed that such patients should remain under follow-up due to relatively high risk of MACE.

Acute Angulation and Sequential Lesion Increase the Risk of Rotational Atherectomy Failure.

BACKGROUND: The aim of the study was to assess anatomical and procedural predictors of clinical and procedural failure of rotational atherectomy (RA) in an all-comers population.Methods and Results:A total of 534 consecutive patients who underwent RA were included in a double-center observational study. The primary composite endpoint consisted of: rota-wire introduction failure, burr-passage failure, periprocedural complications and procedure-related major adverse events. The second primary endpoint included rota-wire introduction failure and burr-passage failure. The primary endpoint occurred in 76 (14.2%) patients and the second primary endpoint occurred in 64 (12%) Periprocedural complications occurred in 23 (4.3%) and procedure-related adverse events in 23 (4.3%) patients. Multivariable analysis revealed angulation on lesion ≤90° (HR=2.18, 95% CI: 1.21-3.94, P=0.0096) and sequential lesion (HR=1.89, 95% CI: 1.01-3.54, P=0.046) as independent predictors of no clinical success of RA. Multivariable analysis revealed again that angulation on lesion ≤90° (HR=2.26, 95% CI: 1.16-4.40, P=0.02) and sequential lesion (HR=3.77, 95% CI: 1.64-8.69, P<0.01) as independent predictors of no procedural success of RA. CONCLUSIONS: The presence of an acute angulation on lesion and sequential lesion are independent determinants of clinical and procedural failure of RA. Further research is necessary to establish a score predicting RA failure, which can help in preproceduralrisk stratification of patients undergoing complex percutaneous coronary intervention with RA.

Utility of the SYNTAX Score in the risk stratification of patients undergoing rotational atherectomy.

INTRODUCTION: The SYNTAX Score (SS) evaluates the angiographic complexity of coronary artery disease to assess the cardiovascular risk after coronary revascularization. The aim of the study was to evaluate whether SS results are associated with in-hospital and 1-year outcomes of patients undergoing percutaneous coronary intervention (PCI) requiring rotational atherectomy (RA). MATERIAL AND METHODS: We analyzed data of 207 consecutive patients who underwent PCI with RA. Patients were divided into two groups: those with high SS (> 33 points) and those with low/intermediate SS (0-33 points). RESULTS: In 21 (10%) patients SS was high and 186 (90%) patients had low/intermediate SS. Patients with high SS were older (76 vs. 71 years, p = 0.008) and more frequently diagnosed with chronic kidney disease (38% vs. 18%, p = 0.03) and heart failure (71% vs. 30%, p = 0.0001). In patients with high SS the RA procedure was longer (p = 0.004), required more contrast (p = 0.005) and higher radiation doses (p = 0.04), and contrast-induced nephropathy was more frequent (14% vs. 2%, p = 0.001). CONCLUSIONS: In our RA patients there was no significant difference between the frequency of in-hospital and 1-year adverse cardiovascular events depending on the SS result. High SS correlates only with parameters describing the extensity and technical complexity of the procedure. However, the unavailability of other risk assessment tools in this population raises the need to create a new more specific risk score for patients requiring RA.

Safety and efficacy of self-apposing Stentys drug-eluting stent in left main coronary artery PCI: Multicentre LM-STENTYS registry.

BACKGROUND: There is a paucity of data on left main (LM) percutaneous coronary intervention (PCI) therapy with dedicated DES platforms. The LM-STENTYS is a multicenter registry aimed at evaluating clinical outcome after PCI of LM performed with a self-apposing Stentys DES implantation. METHODS: The registry consists of 175 consecutive patients treated with Stentys DES implanted to LM. The primary endpoint was the composite of major adverse cardiac and cerebral events (MACCE) defined as cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stroke assessed after 1 year. The secondary endpoint was stent thrombosis (ST) at 1 year. RESULTS: The median age was 69 years (IQR, 62-78 years). Acute coronary syndrome (ACS) was the presenting diagnosis in 117 (66.9%) patients [74 (63.2%) unstable angina, 31 (26.5%) NSTEMI, 12 (10.3%) STEMI] and stable angina (SA) was present in 58 (33.1%) patients. The median SYNTAX score was 23.0 (IQR, 18.7-32.2) in the SA group and 25.0 (IQR, 20.0-30.7) in the ACS group. During 1-year follow-up in the SA group two (3.4%) MACCE occurred, both of them were cardiac deaths. In ACS patients there were 19 (16.2%) MACCE [9 (7.7%) cardiac deaths, 11 (9.4%) MIs, 11(9.4%) TLR, 1(0.9%) stroke]. Altogether, three (1.7%) cases of acute ST were noted, all of them in ACS subset. CONCLUSION: LM PCI using self-apposing Stentys DES showed favorable clinical outcomes at 1-year in patients with SA. Events of ST in the ACS group warrant further research.

The use of rotational atherectomy in high-risk patients: results from a high-volume centre.

BACKGROUND: Rotational atherectomy (RA) is indicated for fibrocalcified lesions when traditional percutaneous coronary intervention (PCI) could not be successfully performed. In some of the high-risk patients the RA procedure is the last resort for successful revascularisation. Such patients are, among others, those in whom coronary artery bypass grafting (CABG) is not feasible. AIM: The aim of the study was to assess in-hospital and one-year outcomes of PCI with RA in high-risk patients without other revascularisation options (RA-only group), in comparison to lower-risk patients undergoing RA. METHODS: We evaluated data of 207 consecutive patients who underwent PCI with RA. Primary endpoints were one-year all-cause mortality and one-year major adverse cardiac events (MACEs). Secondary endpoints were in-hospital outcomes. RESULTS: During the study 35% of patients fulfilled the inclusion criteria to the high-risk group. Those patients had significantly lower left ventricular ejection fraction, more often prior CABG, higher admission glucose level, and higher EuroSCORE II and Syntax Score. Procedural success was similar in both groups (85% in RA-only group vs. 91% in remaining patients, p = 0.18). In-hospital outcomes were similar, except more frequent no/slow-flow phenomenon in the RA-only group. The MACE and mortality rates in one-year follow-up were not statistically different in both groups (19% vs. 18%, p = 0.82 and 11% vs. 9%, p = 0.64, respectively). CONCLUSIONS: Despite the high-risk characteristics of the study subgroup, no significant differences between in-hospital and one-year outcomes were found in comparison to lower-risk RA patients. Complex PCI with RA in patients without other revascularisation options should be taken into consideration.

Novel predictors of outcome after coronary angioplasty with rotational atherectomy. Not only low ejection fraction and clinical parameters matter.

INTRODUCTION: Most established risk factors after rotational atherectomy (RA) of heavily fibro-calcified lesions are associated with patients' general risk and clinical related factors and are not specific for either coronary and culprit lesion anatomy or the RA procedure. AIM: To assess novel predictors of poor outcome after percutaneous coronary intervention using RA in an all-comers population. MATERIAL AND METHODS: A total of 207 consecutive patients after RA were included in a single-center observational study. Primary endpoints were 1-year mortality and 1-year major adverse cardiac events (MACE). Secondary endpoints were angiographic and procedural success and in-hospital complications. RESULTS: Procedural complications occurred in 19 (8%) patients. In-hospital mortality was 1%, peri-procedural myocardial infarction (MI) was 9%, and acute stroke occurred in one patient. The 1-year MACE rate was 20% with all-cause mortality 10%, MI 10% and stroke 1%. Multivariable analysis revealed heart failure with left ventricle ejection fraction (LVEF) ≤ 35% (p = 0.02) and uncrossable lesion, as compared to undilatable lesion (p = 0.01), as independent predictors of 1-year mortality and residual SYNTAX score ≤ 8 as an independent predictor of favorable outcome (p = 0.04). Heart failure with LVEF ≤ 35% (p < 0.01) and uncrossable lesion (p = 0.04) were independent predictors of 1-year MACE. CONCLUSIONS: The presence of a novel factor, uncrossable lesion, as compared to undilatable lesion, is associated with poor outcome, and low residual SYNTAX score ≤ 8 is associated with favorable outcome in 1-year follow-up after the RA procedure and can help in risk stratification of patients undergoing complex coronary intervention with RA.

In patients undergoing percutaneous coronary intervention with rotational atherectomy radial access is safer and as efficient as femoral access.

INTRODUCTION: Transfemoral approach (TFA) may be preferred access site in order to facilitate complex percutaneous procedures such as rotational atherectomy (RA). Notwithstanding, there is a growing evidence that transradial approach (TRA) is associated with lower access site complication rates and even lower mortality. The aim was to assess in-hospital and 1-year outcomes in patients undergoing RA using TRA, in comparison to TFA. METHODS: A single center observational study included all consecutive patients, who underwent RA from 2010 to 2015. Primary endpoints were procedural success, in-hospital mortality and major adverse cardiovascular events (MACE). Secondary endpoints were 1-year all-cause mortality and MACE. RESULTS: The study included 177 patients, 69% in TRA group and 31% in TFA group. Except for male sex and logistic Euroscore II there were no differences in common risk factors. There was no difference in procedural success (95% vs 87%, P = 0.07) with even a trend in favor of TRA. Performing RA via TRA lower amount of contrast volume (P = 0.009) was used and hospital stay after the procedure was shorter (P = 0.004). Periprocedural complication rates were similar, however patients with TFA had significantly higher rate of major access site bleedings (13% vs 1%, P = 0.001), with no differences in mortality and other adverse events both in-hospital and during 1-year observation. CONCLUSIONS: Even though RA is a demanding technique, when performed via TRA allows to maintain the same procedural success and long-term results in comparison to TFA, reduces in-hospital major access site bleedings, lowers the amount of contrast media and shortens hospital stay.

Acute coronary syndrome - Still a valid contraindication to perform rotational atherectomy? Early and one-year outcomes.

BACKGROUND: Rotational atherectomy (RA) is an acknowledged method of percutaneous treatment of highly calcified or fibrotic coronary lesions. However, using the rotablator system in patients presenting with acute coronary syndromes (ACS) remains controversial and is considered as a relative contraindication. The aim of our study was to assess in-hospital and 1-year outcomes in patients undergoing RA presenting with ACS, in comparison to elective RA procedures. METHODS: This single-center observational study included all consecutive patients who underwent RA and PCI in our institution from April 2008 to October 2015. All patients were subsequently divided into two groups based on clinical presentation: stable angina group (SA) and ACS group. Primary endpoints were in-hospital and 1-year all-cause mortality and 1-year major adverse cardiac events (MACE). Secondary endpoints were procedural success and in-hospital complications. RESULTS: The study included 207 patients, 164 (79%) in SA group and 43 (21%) in ACS group. In-hospital mortality was higher in patients with ACS (4.7% vs. 0%, p=0.01). Procedural success was similar in both groups, 93% in ACS groups vs. 92.7% in SA group, p=0.94. There were no significant differences in the rate of periprocedural complications (4.7% vs. 10.4%, p=0.25), however postprocedural complications were more frequent in ACS group. At 1-year follow-up MACE rate and mortality were numerically higher, however statistically not significant (25.6% vs. 16.5%, p=0.17 and 16.3% vs. 7.9%, p=0.10; respectively). CONCLUSIONS: Despite higher mortality and complication rate in ACS group observed in postprocedural period, we found no significant difference in 1-year outcomes in comparison to elective patients. Procedural success of RA in ACS patients is similar to elective patients with SA and this procedure should be considered in case of urgent indications, if no other options of treatment exist.

Patients with acute myocardial infarction and severe target lesion calcifications undergoing percutaneous coronary intervention have poor long-term prognosis.

BACKGROUND: To assess the influence of severe target lesion calcification (TLC) on the outcomes of patients undergoing percutaneous coronary interventions (PCI) due to acute myocardial infarction (AMI). AIM: Contemporary data concerning coronary artery calcifications (CAC) are based on pooled analyses from randomised trials with short follow-up. We still lack the knowledge on how CAC in target lesions affect long-term prognosis of patients with AMI in everyday practice. METHODS: We evaluated clinical and laboratory data of 206 consecutive patients who underwent coronary angiography and PCI due to AMI. Primary endpoints were all-cause death and recurrent hospitalisations due to acute coronary syndrome (ACS). RESULTS: Severe TLC lesions were present in 17% of patients. These patients were older (71 vs. 65 years, p = 0.02) and more often diagnosed with non-ST segment elevation myocardial infarction (77% vs. 58%, p = 0.03). Patients with severe TLC had lower rates of PCI success (80% vs. 97%, p < 0.0001) and less often achieved full revascularisation during index procedure (14% vs. 41%, p = 0.003). During 30 months follow-up patients with severe TLC more often suffered from another ACS (37% vs. 13%, p = 0.0005) and had higher all-cause mortality (31% vs. 16%, p = 0.04). Multivariate Cox regression model showed severe TLC to be an independent predictor of another ACS (HR 2.8; 95% CI 1.4-5.6; p = 0.004). CONCLUSIONS: Severe TLC are not uncommon in patients with ACS. The presence of severe TLC is a prognostic factor of another ACS in AMI patients undergoing PCI.