Target Lesion Revascularization Rate Research Articles

Clinical outcomes following percutaneous coronary intervention for bifurcation lesions: kissing balloon inflation vs. sequential dilation.

Percutaneous coronary intervention for bifurcation lesions remains challenging, with there being several debatable issues, including the requirement for kissing balloon inflation (KBI). The objective of this study was to assess the clinical outcomes following single crossover stent implantation with KBI or sequential dilation alone. Data were examined for 255 non-left main bifurcation lesions (246 patients) treated with single crossover stent implantation, followed by side branch (SB) strut dilation with KBI (n = 74 lesions) or sequential dilation (n = 181 lesions) in three hospitals. Target lesion revascularization (TLR) was the primary endpoint. There was no significant difference in the pre-procedural reference diameter of both the main vessel (MV) and SB between the KBI and sequential dilation groups. However, MV post-dilation balloon size was smaller with lower pressure and post-procedural minimal lumen diameter was significantly smaller in the KBI group. During the median follow-up period of approximately 3years, TLR incidence was significantly higher in the KBI group than in the sequential dilation group; in particular, the TLR rate at the distal MV was higher in the former. For bifurcation lesions treated with single crossover stent implantation, the TLR rate was higher after KBI than after sequential dilation; this was mainly due to higher revascularization in the distal MV. For bifurcation lesions treated with KBI, MV post-dilation balloon diameter tended to be smaller with lower pressure, which might lead to poorer stent expansion and a higher TLR rate.

Predictors of long-term outcomes of coronary bifurcation stenting: 6-year results from international, randomized POLBOS I and POLBOS II clinical trials

Abstract Introduction Bifurcation lesions pose a therapeutic challenge during percutaneous coronary intervention (PCI). Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. Purpose The aim of this study was to analyze the 6-year follow-up of BiOSS (Balton, Poland) stents in patients enrolled into two randomized clinical trials POLBOS I (NCT02192840) and POLBOS II NCT02198300). Methods The BiOSS stent is a coronary dedicated bifurcation balloon expandable stent made of 316L stainless steel and coated with a biodegradable polymer as well as the drug. The stent consists of two parts with different diameters connected with two struts of 1.9 - 2.5 mm length each. The aim of randomized POLBOS trials was to compare the BiOSS stents with regular drug eluting stents (rDES) in patients with stable CAD or NSTE-ACS (POLBOS I: paclitaxel eluting BiOSS Expert vs rDES; POLBOS II: sirolimus eluting BiOSS LIM vs rDES). Provisional T-stenting was the default strategy. Angiographic control was performed at 12 months in all patients. The primary end-point was composed MACE defined as cardiac death, myocardial infarction or target lesion revascularization (TLR). Clinical assessment was performed every year after index procedure. Results In POLBOS I trial BiOSS Expert was implanted in 120 patients (49.4%), and rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In rDES group, 38.2% of patients received paclitaxel-eluting stents. Side branch treatment with rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% (P=0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with rDES group (11.5% vs 7.3%; P=0.02). Significantly lower rates of restenosis were observed in final kissing balloon (FKB) subgroups of both the BiOSS Expert (8.1% vs 13.2%; P<0.05) and rDES groups (4.9% vs 9.5%; P<0.05). In POLBOS II 202 patients were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with rDES (n=100). The target vessel was the LAD (44% vs 43%) followed by the LMS (35.3% vs 38%). Side branch treatment was required in 8.8% (rDES) and 7% (BiOSS). At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [BiOSS] vs. 15% [rDES, p=0.08]), as was the TLR rate (9.8% vs. 9% [p=0.8]). The binary restenosis rates were significantly lower in the FKBI subgroup of the BiOSS group (5.9% vs. 11.8%, p<0.05). At the time of ESC Congress 2020 we will present data from 6-year follow-up from POLBOS I trial and POLBOS II trial focusing on LM stenting and patients with diabetes. Conclusions BiOSS® stents provided satisfactory 1-year results which seemed comparable with rDES. Long-term data are pending. Funding Acknowledgement Type of funding source: None

Comparison of coronary bifurcation lesions stenting techniques- a network meta-analysis

Abstract Background Coronary bifurcations lesions (CBL) are account for 15–20% of all percutaneous coronary interventions (PCI) and constitute a major challenge for interventionists in terms of procedural success rate and long-term cardiac events. Based on data from multiple randomized trials and registries, current guidelines advocate the use of provisional side branch (SB) stenting strategy for the majority of CBL's. However, for true or complex CBL's (long side branches lesions, difficult side branches access or high risk of side branches compromise), which account for up to 25% of CBL's, this strategy may by unsafe and ineffective due to a potential risk of intraprocedural or long-term occlusion of a significant side branch and a two-stenting technique may be needed in order to achieve optimal results. Up to date, the optimal two- stenting technic for CBL remains in debate. Accordingly, our aim was to compare different stenting techniques in coronary bifurcation lesions. Methods We performed a MEDLINE search for randomized controlled trials (RCT) and observational studies comparing stenting techniques in CBL's with reported clinical outcomes. Mixed treatment comparison model generation was performed to directly and indirectly compare culotte, T and protrusion (TAP), crush and provisional techniques Results A total of 13 RCT and 12 observational studies were identified including 6806 patients, among whom 1,201 were treated with cullotte, 2,731 with crush, 797 with TAP and 2077 with provisional stenting. The Bayesian hierarchical random-effects model demonstrated a significant reduction in target lesion revascularization (TLR) rate with crush techniques compared with provisional technique (OR 0.64 95% CI 0.42–0.97) along with a trend for reduction in major adverse cardiovascular (MACE) events (OR 0.75, 95% CI 0.55–1.02). TAP and culotte techniques did not show similar results. Equality of other endpoints, including mortality, myocardial infarction and re-stenosis was found between all CBL's techniques (Figure 1). Discussion Our findings suggest improved outcomes with crush technique compared to other double stenting techniques in terms of TLR with a trend towards MACE reduction. Further research is required to determine the optimal stenting technique for coronary bifurcations lesions along with the utility of imaging and physiology in this complex subset. Figure 1. Comparison of double stentin techniques Funding Acknowledgement Type of funding source: None

Long term clinical outcome after self-expandable nitinol stent implantation for femoropopliteal occlusive disease in hemodialysis patients

Abstract Background Endovascular therapy (EVT) using self-expandable bare nitinol stent (BNS) has been commonly accepted in patients with symptomatic femoropopliteal (FP) occlusive disease. However, poor clinical outcomes in hemodialysis (HD) patients are major problems. We investigated the impact of HD on clinical outcome after EVT in patients with FP disease. Methods A total of 427 consecutive HD patients undergoing successful EVT with BNS for FP disease were enrolled with 157 non-HD patients as a control group. They were followed-up for 5 years. We collected data on target lesion revascularization (TLR) rate, and limb salvage rate as well as survival rate. Propensity-score matching analysis was performed to investigate the true impact of HD on the outcome. Results Critical limb ischemia was observed in 44.0% of overall population (43.0% in HD group vs. 46.8% in non-HD group, p=0.42). Rates of diabetes (67.1% vs. 58.1%, p=0.045) and coronary artery disease (73.5% vs. 58.3%, p=0.0008) were higher, while age (70±10 years old vs. 76±10 years old, p<0.0001) and TASC2 C/D lesion (27.9% vs. 44.6%, p=0.0002) were lower in HD group compared to non-HD group. Pre-procedural C-reactive protein level (0.4mg/l vs. 0.3mg/l, p=0.045) was higher and serum albumin level (3.6g/dl vs. 3.8g/dl, p=0.0045) was lower in HD group than those in non-HD group. The freedom rate from TLR at 5 years was significantly lower in HD group than in non-HD group [47.2% vs. 65.2%, hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.23–2.64, p=0.0017]. The limb salvage rate was comparable between the groups (93.3% vs. 97.1%, HR 1.57, 95% CI 0.58–5.47, p=0.41), while the survival rate was significantly lower in HD group compared to non-HD group (60.6% vs. 86.0%, HR 2.53, 95% CI 1.56–4.36, p=0.0002). After propensity-score analysis, 250 patients (125 in each group) were matched without any difference of clinical characteristics in both groups. In the matched cohort, the freedom rate from TLR was still lower in HD group compared to non-HD group (46.7% vs. 66.6%, HR 2.25, 95% CI 1.35–3.87, p=0.0019). The adjusted limb salvage rate was consistently similar between the groups (95.4% vs. 97.3%, HR 1.10, 95% CI 0.20–5.94, p=0.91). Also, the adjusted survival rate was lower in HD group than in non-HD group (47.6% vs. 89.9%, HR 3.60, 95% CI 1.89–7.44, p<0.0001). Conclusion The freedom rate from TLR at 5 years after BNS implantation for FP disease were significantly lower in HD group than in non-HD group, though the limb salvage rate was similar between the groups. The survival rate was consistently lower in HD group compared to non-HD group. HD status had a great impact on TLR and mortality after EVT with BNS in patients with FP disease. Funding Acknowledgement Type of funding source: None

Long-term efficacy and safety of newer generation ultrathin strut drug-eluting stents: a systematic review and meta-analysis

Abstract Background Recent trials have demonstrated that short-term efficacy and safety of ultrathin strut drug-eluting stents (DES) were non-inferior to contemporary stents but long-term benefit remains uncertain. Purpose The main objective of this meta-analysis was to evaluate efficacy and safety of ultrathin strut DES with an extended follow-up in comparison to 2nd and 3rd generations DES. Methods A double-blind review of randomized controlled trials (RCT) comparing ultrathin strut DES to contemporary DES was performed from MEDLINE and CENTRAL databases and from cardiological congresses. The primary efficacy endpoint was target vessel failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) and the primary safety endpoint was occurrence of stent thrombosis (ST). Short (1 year) and long term (≥2 years) effects were estimated separately. This analysis was pre-specified in PROSPERO (CRD42019142206). Results The meta-analysis included 13 RCT including 19,490 patients. In short term, we found TLF decrease with ultrathin strut DES (RR 0.85, CI [0.75–0.97], p=0.01), driven by lower TV-MI (RR 0.83, CI [0.66–1.03], p=0.1) and TLR (RR 0.77, CI [0.58–1.01], p=0.1) rates, and a non-significant downward trend in ST (RR 0.85 CI [0.64–1.14]). In long term, from the 5 trials with extended follow-up, there was no significant difference between ultrathin strut DES and thicker strut stents in rate of TLF at the longest available follow-up (RR 0.90, CI [0.76–1.06], p=0.2), despite a numerically reduction of TV-MI (RR 0.81, CI [0.61–1.08], p=0.05) and TLR (RR 0.85, CI [0.69–1.04], p=0.1) in favor of ultrathin strut stents. However, we observed a persistent numerically reduction in ST (RR 0.79, CI [0.61–1.02], p=0.01). Conclusion Ultrathin strut DES was associated with a lower target lesion failure rate at one year but not beyond 2-years follow-up. Nevertheless, the safety of the ultrathin strut stents was sustained over time with a numerically reduction of ST. Funding Acknowledgement Type of funding source: None

Reewarm™ PTX drug-coated balloon in the treatment of femoropopliteal artery disease: A multi-center, randomized controlled trial in China

BackgroundDrug-coated balloons (DCB) have demonstrated satisfactory clinical results in the treatment of femoropopliteal artery diseases. ObjectiveTo evaluate the efficacy and safety of the Reewarm™ PTX DCB in the treatment of femoropopliteal artery lesions compared with plain balloon. MethodsThis was a multi-center, parallel-group, randomized controlled trial in patients with femoropopliteal artery lesions in China,. The participants were randomized 1:1 to percutaneous transluminal angioplasty with Reewarm™ PTX DCB or with standard plain balloon (PTA group) after pre-dilatation with a residual stenosis less than 70%. The primary endpoint was late lumen loss (LLL) at 6 months in the intent-to-treat set. The secondary endpoints included the target lesion revascularization (TLR) and major advance events(MAE)rate at 12 months. ResultsBetween July 2014 and April 2017, a total of 200 patients were enrolled. The mean age of the subjects was 67.8 ± 9.2 years in the DCB group (n = 100) and 69.4 ± 10.3 years in the PTA group (n = 100). The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001). The TLR rate in the DCB group was lower than in the PTA group at 12 months (15.0% vs. 29.0%, P < 0.05). The occurrence of MAE4 in the DCB group by 12 months was lower than in the PTA group (23.0% vs. 38.0%, P < 0.05). ConclusionReewarm-PTX drug-coated balloon is associated with better efficacy and safety than the plain balloon for femoropopliteal lesion.

Incidence and Predictors of Target Lesion Failure in Patients With Lesions in Small Vessels Undergoing PCI With Contemporary Drug-Eluting Stents: Insights From the BIONICS Study

Treatment of lesions in small coronary vessels is associated with an increased risk of adverse cardiovascular events after percutaneous coronary intervention (PCI).We aimed to evaluate the outcomes of patients undergoing small-vessel PCI in the BIONICS trial and to identify predictors of stent failure. 1910 patients were randomized to treatment with the EluNIR™ ridaforolimus-eluting stent (RES) or Resolute™ zotarolimus-eluting stent (ZES). Small vessels were defined as reference vessel diameters (RVD) ≤2.5 mm. A Cox proportional hazards model was used to identify predictors of target lesion failure (TLF) through 2 years. Patients undergoing small vessel disease PCI had a higher frequency of diabetes, prior myocardial infarction (MI), and prior PCI. 2 year TLF was higher among patients with small vessels (9.7% vs. 5.9%, HR 1.7 [95% CI 1.22–2.37], p < 0.01), driven by increased rates of target vessel-MI and target lesion revascularization (TLR). Stent thrombosis at 2 years was higher among patients with small vessel disease (1.4% vs. 0.3%, HR 5.25 [95% CI 1.47–18.8], p < 0.01). 2 year TLF rates were similar in the RES and ZES patient groups (Pinteraction 0.86). In conclusion, patients undergoing PCI in small vessels have significantly worse outcomes despite the use of contemporary stents.

Cardiovascular outcomes following percutaneous coronary intervention with drug-eluting balloons in chronic kidney disease: a retrospective analysis

BackgroundChronic kidney disease (CKD) is associated with poorer outcomes following percutaneous coronary intervention (PCI) with drug-eluting stents. Drug-eluting balloons are used for in-stent restenosis and selected cases of de-novo coronary lesions. Little is known regarding the outcomes of individuals with CKD who undergo PCI with drug-eluting balloons. The goal of this study was to assess outcomes of PCI with drug-eluting balloons in individuals with CKD.MethodsIn a retrospective analysis, outcomes of PCI with drug-eluting balloons were compared between 101 patients with CKD and 261 without CKD. CKD was defined as estimated glomerular filtration rate < 60 ml/min/1.73m2. We compared demographics, procedure data and clinical outcomes in the first and second years following the procedure.ResultsRates of major adverse cardiac events (MACE) and myocardial infarction were higher in patients with than without CKD: 23.8% vs. 13.8%, P < 0.005 and 15.9% vs. 3.8%, P < 0.001, respectively. Rates of target lesion revascularization were similar, 14.9 and 11.5%, respectively, P = 0.4. Shorter duration of dual anti-platelet therapy was observed among patients with than without CKD (10.0 + 3.4 vs. 10.9 + 3.7 months, P < 0.05). First-year hemorrhage episodes were similar in the two groups (0.08 ± 0.4 and 0.03 ± 0.2, respectively, P = 0.2). In a multivariate regression analysis, CKD was associated with increased risks of first year MACE (OR 2.1; 95% confidence interval 1.0-4.3, P < 0.001).ConclusionsPCI with drug-eluting balloons was associated with increased cardiovascular morbidity and mortality in patients with than without CKD. However, rates of target lesion revascularization were similar in the two groups. Shorter duration of dual anti-platelet therapy was observed in the CKD group.

Sealing of Coronary Perforations With a Second-Generation Covered Stent Graft - Results From the PAST-PERF Registry

BackgroundThe PAST-PERF registry was initiated to collect data on the PK Papyrus covered stent, a second-generation device for the treatment of coronary artery perforations with enhanced mechanical properties, but with limited available data. MethodsPatients treated for coronary artery perforations with the PK Papyrus stent at 14 international centers were retrospectively identified. The primary effectiveness outcome was successful sealing of the perforation. The primary safety outcome was a composite of all-cause mortality, definite or probable stent thrombosis, myocardial infarction and target lesion revascularization. ResultsAmong the 94 included patients, 72.3% (68/94) had Ellis type III and cavity spilling perforations. Complete sealing was achieved in 93.6% (n = 88), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). Pericardiocentesis was required in 25.0% (n = 23), emergency cardiac surgery was needed in 7.6% (n = 7), acute stent thrombosis was observed in 1.1% (n = 1), and in-hospital mortality occurred in 11.7% (n = 11). The median follow-up duration was 283 (IQR:40;670) days. At 6 and 12 months, the incidence of the primary safety endpoint was 26.6% [95%CI:18.6;37.1] and 32.0% [95%CI:22.8;43.4], mortality 15.0% [95%CI:9.0;24.6] and 19.0% [95%CI:11.3;30.0], and target lesion revascularization 5.5% [95%CI:2.0;14.6] and 7.7% [95%CI:3.1;18.2]. Two definite stent thrombosis occurred, one during the procedure and one on post-procedure day 233. ConclusionsThe registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. Annotated table of contentThe PAST-PERF registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. Specifically, complete sealing was achieved in 93.6% of patients (n = 88/94), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). The 12-month mortality was 19.0% [95%CI:11.3;30.0], the rate of target lesion revascularization was 7.7% [95%CI:3.1;18.2], and two definite stent thromboses occurred (one during procedure and one on post-procedure day 233).

Overlapping Drug-Eluting Stent Is Associated with Increased Definite Stent Thrombosis and Revascularization: Results from 15,561 Patients in the AUTHENTIC Study.

This study was to analyze the incidence of definite stent thrombosis (ST) after the implantation of drug-eluting stents (DESs) and cutoff value of overlapping length for predicting definite ST. An overlapping stent is associated with a high rate of clinical events after DES implantation compared with a non-overlapping stent. However, the rates of definite ST and clinical outcomes from a large patient population remain underreported. A total of 15,561 patients with 24,183 lesions who underwent DES implantation from January 2005 to February 2017 were retrospectively included in 5 tertiary hospitals in China. The main endpoint was the incidence of definite ST after procedures. With a median of 1932 (IQR = 1194-2929) days, clinical follow-up was available in 7484 patients in the overlap group and in 8077 patients in the non-overlap group. The rates of definite ST were 3.1% in the overlap group and 1.2% in the non-overlap group (HR: 2.67 (95% CI: 2.11-3.38), p < 0.001). Of the 24,183 treated lesions, the incidences of definite ST were 2.4% in the overlap group and 0.9% in the non-overlap group (HR: 2.96 (95% CI: 2.38-3.69), p < 0.001). Stent overlap was associated with a higher rate of target lesion revascularization (TLR) (9.4%) compared with stent non-overlap (6.4%, p < 0.001). The length of overlapping stent ≥ 2.93mm strongly correlated with definite ST. The present study shows that overlapping DES increases definite ST and revascularization in patients during long-term follow-up. In addition, the longer overlapping zone was associated with worse clinical outcomes.

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry

To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS). CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP. This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST). Data from 130 patients were analyzed (mean age 72.5± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2± 12.8month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion. The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.

Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions

BackgroundThe Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices. MethodsThe Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. ResultsCohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality. ConclusionsThe Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance

Impact of Chronic Kidney Disease in Patients With Diabetes Mellitus after Percutaneous Coronary Intervention for Left Main Distal Bifurcation (From the Milan and New–Tokyo (MITO) Registry)

The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention for unprotected left main distal bifurcation lesions in patients with diabetes mellitus (DM) is not fully understood in drug eluting stent era. We identified 512 consecutive DM patients who underwent percutaneous coronary intervention for unprotected left main distal bifurcation lesions at New Tokyo Hospital, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus between January 2005 and December 2015. We analyzed according to estimated glomerular filtration rate (eGFR). Each group was defined as follows; no CKD (60 ≤ eGFR), mild CKD (45 ≤ eGFR < 60), moderate CKD (30 ≤ eGFR < 45), and severe CKD (15 ≤ eGFR < 30). The primary end point was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. The rate of TLF was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 3.64, [1.86 to 7.11], p < 0.001). Cardiac mortality was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 6.43, [2.19 to 18.9], p = 0.001). Target lesion revascularization rate was comparable in 4 groups (Adjusted HR of severe CKD relative to the others 1.71, [0.60 to 4.82], p = 0.31). In conclusions, in DM patients, those with severe CKD was extremely associated with worse clinical outcomes.

Long-term results of a prospective, single-arm evaluation of everolimus-eluting bioresorbable vascular scaffolds in infrapopliteal arteries.

The aim of this study was to perform a long-term evaluation of an everolimus eluting, bioresorbable vascular scaffold (BVS) in the treatment of de novo atherosclerotic disease within crural arteries. A prospective, single-arm study was performed enrolling patients with chronic lower limb ischemia between 2013 and 2018. Fifty-five limbs in 48 patients (56% male; mean age 82.1 ± 8.0 years, range 65-97) were treated for critical limb ischemia (72.7%) or severe claudication (27.3%). Seventy-one scaffolds were used to treat 61 lesions with a mean length of 20.1 ± 10.8 mm. During a mean follow-up period of 35.2 ± 20.4 months, 22 (45.8%) patients had died. No late or very-late scaffold thrombosis was observed. Overall, clinical improvement was observed in 90.9% and a limb-salvage rate of 100% was observed. Binary restenosis was detected in 11/71(15.5%) scaffolds. Primary patency and freedom from clinically driven target lesion revascularization rates at 12, 24, 36, 48, and 60 months were 90.8% (95% confidence interval 80.7-95.8), 90.8% (80.7-95.8), 79.7% (65.8-88.4), 76.3% (61.1-86.2), 72.3% (55.5-83.4) and 97.2% (89.2-99.3), 97.2% (89.2-99.3), 90.7% (78.7-96.1), 90.7% (78.7-96.1), and 90.7% (78.7-96.1), respectively. This long-term study shows excellent rates of patency and freedom from target lesion revascularization using the absorb BVS below-the-knee. This proof of concept study lays the foundation for the next generation of BVS to be evaluated in infrapopliteal arteries.

Four-year outcomes of unprotected left main lesion treated with one-stent versus two-stent technique

Introduction – Most reports on left main bifurcation lesions have demonstrated that treatment with a singlestent strategy is superior to a two-stent strategy but have excluded patients with acute coronary syndromes (ACS). Aims – The aim of the current study was to compare the four year outcomes of patients with unprotected left main coronary artery disease (ULMCAD) treated by percutaneous coronary intervention (PCI) with a one-stent or two-stent strategies in a population including those presenting as ACS. Methods – A total of 135 patients with ULMCAD treated by PCI were included, of which 75 (55.6%) had a one-stent strategy (Group A) and 60 (44.4%) had a two-stent strategy (Group B). Results – Fewer patients in Group A had a TIMI III flow at the end of the procedure (89.4% vs 100%, p=0.03) and complete revascularization (65.3% vs 88.3%, p=0.002). We found a higher early mortality in Group A without reaching statistical significance (13.4% vs 3.3%, p=0.1). Mortality rate at 4-year follow up was higher with Group A after multivariable analysis (adjusted HR 0.36, CI 0.15-0.85, p=0.02). We found no significant differences between the groups in terms of major adverse cardiac event (MACE) (adjusted HR 0.85, CI 0.34-1.48, p=0.7) or target lesion revascularization (TLR) (adjusted HR 1.37, CI 0.42-4.47, p=0.6) at 4-year follow up. Conclusions – Among unselected patients with ULMCAD PCI, with or without ACS, the early mortality rate is similar between one and two-stent strategy. Although, 4 year TLR and MACE rates were similar between the two groups, the 4-year all-cause mortality rate was lower in the two-stent strategy group.

Is transradial access the way to go to prevent post PCI readmission?

Small vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels.We examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration.The COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods.The study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74–1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93–5.00, p = 0.07.One-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.

Ultrathin Biodegradable-Polymer Orsiro Drug-Eluting Stent Performance in Real Practice Challenging Settings

BackgroundThe Orsiro cobalt-chromium stent platform (Biotronik, Bülach, Switzerland) is one of the first devices in the era of ultrathin struts. However, data regarding the efficacy of Orsiro stent in patients with challenging anatomical conditions obtained from daily clinical practice are scant. MethodsWe retrospectively reviewed the long-term outcomes, defined as target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis (ST) and cardiovascular (CV) mortality over a six years period, in 1161 consecutive patients (mean age 64.3 ± 11.2 years old, 681 males) treated with 2327 Orsiro stents in our institution who presented with challenging anatomic/angiographic features. ResultsThe mean number of implanted stents was 1.7 ± 2.1 whereas the mean stent diameter and length were 3.6 ± 1.1 and 32.7 ± 15.6 mm, respectively. Mean follow-up duration was 35.6 ± 17 months (range 1–77 months); 923 patients (79.5%) reached the 3-year follow-up. The global rates of TLR, TVR, ST and CV mortality were 0.1%, 1.37%, 0.002%, and 1.9%, respectively with scarce statistically significant differences in multivessel disease, severe calcification, and lesion length > 41 mm. Multivariate regression analysis revealed that age, stent dislodgement, early stent thrombosis (p = 0.001) and lesion length ≥ 41 mm (p = 0.001) were independent predictors of TVR. Similarly, the occurrence of TLR was independently predicted by age, severe calcification, use of IVUS and Rotablator (p = 0.002), early stent thrombosis, LM bifurcation and length ≥ 41 mm (p = 0.001). ConclusionsThe Orsiro stent confirmed a very high efficacy profile in all anatomical scenarios with very low rates of clinically driven TLR and TVR, CV mortality and ST at 3-years.

Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III.

The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon. Critical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices. BIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to6. The CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n=227), below-the-knee lesions were present in 27.0% (n=114), and lesions were moderate or heavily calcified in 45.0% (n=190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6months, in 14.9% through 12months, and in 19.4% through 24months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates. In a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.

Clinical trial of carotid artery stenting using dual-layer CASPER stent for carotid endarterectomy in patients at high and normal risk in the Japanese population

BackgroundThe dual-layer nitinol CASPER stent was designed to prevent plaque prolapse into its strut and periprocedural stroke.ObjectiveTo conduct a clinical trial for government approval of the device in patients at...

Laser Atherectomy for Infrapopliteal Lesions in Patients With Critical Limb Ischemia

BackgroundInfrapopliteal (IP) lesions are common in patients with critical limb ischemia (CLI). Optimal revascularization strategies including the use of adjunctive atherectomy have the potential to improve the outcomes for these patients. ObjectiveTo compare laser atherectomy (LA) vs. balloon angioplasty alone for the treatment of IP lesions in patients with CLI. MethodsThis was a two-center retrospective study of patients with CLI who underwent endovascular interventions for IP lesions. One and 2-year target lesion revascularization (TLR) was the primary outcome. One and 2-year limb loss and major adverse limb events (MALE) were secondary outcomes. Propensity score matching was performed. A Cox regression analysis was used to compare 1- and 2-year outcomes of the two groups. Logistic regression analysis was used to compare the two groups in terms of bail-out stenting and procedural complications. ResultsA total of 313 patients with CLI were included; 76 were treated with LA. There was a high degree of lesion complexity in both groups. Consistent with the application of LA in the most complex lesions, lesions in the LA group were significantly longer (165.7 mm vs. 94.1 mm; p < 0.001) and were more frequently TASC C/D (82% vs. 45%; p < 0.001). In-stent restenosis (ISR) lesions were also more common among the LA group (14% vs. 0.4%; p < 0.001). Thrombotic lesions were present in 11% of the LA group vs. 4% in the no LA group (p = 0.04). CTOs were also more common in the LA group (58% vs. 43%; p = 0.024). After propensity matching, there was no difference in the 1 or 2-year TLR rates between the two groups. Similarly, there were no differences between the two groups in terms of 1 or 2-year limb loss or 2-year major adverse limb events. ConclusionsLA is safe and effective for IP lesions in patients with CLI. There was a higher baseline angiographic complexity in patients treated with LA, suggesting that operators tend to use LA for the treatment of more complicated lesions. There was no difference among the two groups in 1- or 2-year outcomes of TLR of major amputation.