Target Lesion Revascularization Rate Research Articles

Long-term outcomes following DCB vs. DES for ISR treatment

Abstract Background The-long term outcomes of patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. Purpose This study aims to investigate the outcomes of patients with drug-eluting stents (DES)-ISR presenting with CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES. Methods Consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin-DES or paclitaxel-DCB for DES-ISR were enrolled. Primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint [DOCE: cardiac death, TLR or target vessel myocardial infarction (TV-MI)]. Propensity-score matching was used to adjust for baseline differences. Results A total of 846 patients were included in the pooled analysis, of whom 381 (45%) were treated with a thin-DES and 465 (55%) with paclitaxel-DCB. Patients who received thin-DES compared with those who received paclitaxel-DCB had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74], P<0.001) TVR (HR, 0.56 [95% CI, 0.39-0.86], P<0.001) and DOCE (HR, 0.63 [95% CI, 0.45-0.88], P=0.007).The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33–0.88], P=0.013), TVR (HR, 0.57 [95% CI, 0.41–0.80], P=0.009), and DOCE (HR, 0.65 [95% CI, 0.42–0.99], P=0.046) between the thin-DES and DCB group, respectively. Conclusions In long term observation in patients with CCS undergoing PCI of ISR, the use of thin-DES is associated with reduced rates of TLR, TVR and DOCE compared with patients treated with DCB.

Percutaneous coronary intervention of in-stent restenosis: A three-arm analysis from SWEDEHEART

Abstract Background During the last decades, there have been substantial improvements in treatment techniques for percutaneous coronary intervention (PCI). Yet, in-stent restenosis (ISR) continues to pose significant challenges as they account for 10% of all PCI cases and are associated with worse outcome compared to de-novo lesions. When assessing ISR with PCI, balloon angioplasty with drug-coated balloons (DCB) is frequently used. Purpose Despite frequent use of DCB, there is a lack of long-term data ensuring the safety of DCB for ISR as no randomized trial has extended beyond a 3-year follow-up. We aimed to study the long-term outcome and conducted a nationwide three-arm investigation on the outcome of ISR, comparing DCB with drug-eluting stents (DES) or plain old balloon angioplasty (POBA) within a 5-year follow-up. Methods We conducted a nationwide analysis using the SWEDEHEART (Swedish Web System for Enhancement of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry. The SWEDEHEART registry was used to include any ISR undergoing coronary angiography between June 11, 2013, and December 31, 2020. Target lesion revascularization (TLR) was the primary outcome. Secondary outcomes included all-cause mortality, myocardial infarction, and any PCI. The outcomes were analysed using a multivariable Cox regression model. Results A total of 9304 segments from 7987 patients were eligible. Compared to POBA, the use of DCB was associated with lower rates of TLR, hazard ratio (HR) 0.62 (95% confidence interval [CI]: 0.50-0.78), all-cause mortality, HR 0.60 (95% CI: 0.50-0.72), and any PCI, HR 0.78 (95% CI: 0.66-0.93). No difference was observed for myocardial infarction. Compared to DES, the use of DCB was associated with higher rates of TLR, HR 1.24 (95% CI: 1.08-1.42). No difference was observed for all-cause mortality, cardiovascular mortality, myocardial infarction, or any PCI. Conclusions In this nationwide analysis including any ISR undergoing PCI, the use of DCB showed superior outcomes compared to POBA within 5 years but higher rates of repeat revascularizations compared to DES. While DES demonstrated lower TLR rates than DCB, the lack of mortality differences indicates that DCB is a viable option, particularly for patients where DES might not be suitable, but that DES should be considered as the first line strategy.Table 1.5-year outcomeFigure 1.Kaplan-Meier curves

Lesion Localization and Limb Outcomes in Elderly Patients with and Without Type 2 Diabetes Mellitus Who Undergo Atherectomy-Assisted Endovascular Revascularization due to Symptomatic Peripheral Artery Disease

Background/Objectives: Type 2 diabetes mellitus (T2DM) represents a major risk factor for peripheral artery disease (PAD). We aimed to evaluate the impact of T2DM on lesion localization and complexity, clinical presentation by Rutherford categories, and limb outcomes in elderly patients with symptomatic PAD undergoing endovascular revascularization. Methods: Five hundred consecutive patients with symptomatic infra-inguinal PAD who underwent rotational atherectomy-assisted endovascular revascularization were included. PAD clinical presentation and lesion localization were recorded. The primary endpoints were clinically driven target lesion revascularization (CD-TLR) and major amputation rates during follow-up. Results: Overall, 245/500 (49.0%) patients had T2DM, whereas 179 (35.8%) presented with lifestyle limiting claudication and 321 (64.2%) with critical limb-threatening ischemia (CLTI). Median age was 78.0 (IQR = 70.0–84.0) years, and 201 (40.2%) patients were female. The presence of T2DM was significantly more frequent in patients with CLTI vs. those with claudication (58.6 vs. 31.8%; p < 0.001). Furthermore, the percentage of patients with below-the-knee (BTK) lesions was significantly higher in patients with vs. without T2DM (40.7 vs. 27.5%, p = 0.0002). During median follow-up of 21.9 (IQR = 12.8–28.8) months, CD-TLR rates were similar in patients with vs. without T2DM (HR = 1.2, 95%CI = 0.8–2.0, p = 0.39). However, patients with T2DM had a ~5.5-fold increased risk for major above-the-ankle amputation (HR = 5.5, 95%CI = 1.6–19.0, p = 0.007). After adjustment for age, gender, lesion complexity, and calcification, T2DM remained predictive for major amputation (p = 0.04). Conclusions: T2DM is more frequently associated with CLTI, BTK-PAD, and amputations despite successful endovascular revascularization. More stringent surveillance of patients with PAD and T2DM is warranted to prevent atherosclerosis-related complications.

Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population.

Sirolimus-coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long-term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de-novo lesions from a real-world practice. To report long-term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions. We analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high-volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE). During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty-two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST-segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions ( 20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67). During the median follow-up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure. The results from this long-term follow-up in a real-world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

Clinical Outcomes After Percutaneous Coronary Intervention for Left Main Coronary Artery Disease in Patients of Diverse Race/Ethnicity

Data on percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease in patients of diverse race/ethnicity is scant. The aim of the study was to assess the impact of race/ethnicity on clinical outcomes at 12-month follow-up of patients with LMCA disease undergoing PCI with drug-eluting stent implantation. All patients undergoing PCI for LMCA disease between 2010 and 2019 at a tertiary care center were prospectively enrolled. Clinical outcomes were assessed per each race/ethnic group. The primary endpoint was the composite of all-cause death, myocardial infarction (MI), or stroke at 12 months. A total of 774 consecutive patients with known race/ethnicity were prospectively enrolled, 62.1% (n=481) Caucasians, 17.2% (n=133) Hispanics, 12.7% (n=98) Asians and 8.0% (n=62) African Americans. Compared with Caucasians, the hazard rate of the primary endpoint tended to be lower in Asian patients (6.1% vs 14.2%; hazard ratio [HR]: 0.41; 95% confidence interval [CI]: 0.16-1.03), and similar in African American (13.7% vs 14.2%; HR: 0.93; 95% CI: 0.40-2.16) and Hispanic patients (14.2% vs 14.2%; HR: 1.02; 95% CI: 0.58-1.78). Hazard rates of target vessel or lesion revascularization were comparable in the four groups. Cox multivariable regression adjustment confirmed consistent findings and revealed higher hazard rate of post-discharge bleeding in African Americans vs. Caucasians (HR: 5.89; 95% CI: 1.00-34.5). In conclusion, within a racially/ethnically diverse cohort of patients undergoing PCI for LMCA disease, when compared with Caucasians, Asians are at lower risk of all-cause death, MI or stroke, while African Americans are at increased risk of post-discharge bleeding.

De Novo Atherosclerotic Renal Artery Stenosis Covered Stent Treatment for Resistant Hypertension (ARTISAN) Results

BackgroundAtherosclerotic renal artery stenosis (ARAS) may provoke hypertension and/or impaired kidney function. Some patients develop uncontrolled hypertension and deteriorating kidney function despite optimal medical therapy. In these patients, endovascular treatment is an important therapeutic option. ARTISAN was a prospective, open-label, single-arm, multicenter clinical trial to evaluate the safety and effectiveness of the iCast RX covered stent both functionally for reestablishing renal artery flow, and clinically for controlling resistant hypertension. MethodsPatients considered for enrollment had average systolic blood pressure (SBP) ≥155 mm Hg despite taking 3 antihypertensive medications. Prior to enrollment and covered stent placement, angiographic confirmation of ARAS ≥80% with physiologic significance was required. Clinical assessments were performed at 30 days, 9 months, and annually through 36 months. Covered stent safety and efficacy were based on 9-month coprimary end points, including primary vessel patency and SBP improvement at 9 months. Secondary outcomes included target lesion revascularization, major adverse events, and secondary patency. ResultsSixty-eight of the planned 138 subjects were enrolled. Primary patency was seen in 94.3% of subject lesions; the mean SBP reduction was 15.7 mm Hg. The functional and clinical end points met prespecified performance goals of 70% primary patency (P < .0001) and ≥10 mm Hg SBP decrease (P = .0192), respectively, at 9 months. Six subjects (8.8%) experienced 7 major adverse events within 36 months. The clinically driven target lesion revascularization rate was 7.3% at 36 months. ConclusionsThe high primary patency and improvement in SBP, persisting through 36 months, suggest that the iCast RX covered stent is safe and effective for the treatment of appropriately selected patients with ARAS.

Compensating for Angiographic Underestimation With Oversized Balloon Angioplasty in Patients With Chronic Limb-Threatening Ischemia and Occluded Below-the-Knee Vessels.

Our study aims to determine optimal sizing of below-the-knee (BTK) artery angioplasty without intravascular ultrasound (IVUS), compensating for conventional angiography underestimation by selecting a balloon size one size larger than the 1-to-1 angiographic sizing. Our study is a retrospective, single-center study. Patients were separated into 2 groups as over and angiographic reference group which the over group is larger balloon diameter selection (0.5-mm larger balloon diameter selection), and angiographic reference group is 1-to-1 balloon diameter selection by angiographic images. Primary end point was the target vessel reocclusion, whereas major and minor amputation was the secondary end point. Eighty-four patients with occluded BTK lesions treated with balloon angioplasty (Opt=43, Over=41). Primary patency was 62.8% at 12 months in angiographic reference group and 82.9% in over group (p=0.039). Amputation rate at 1-year follow-up was 9.8% in angiographic reference group and 16.3% in over group (p=0.382). TLR rate is 4.9% in over group versus 20.9% in angiographic reference group (20.9%) at 1-year follow-up (p=0.029). Our study demonstrates that oversizing the balloon diameter by one size larger in BTK artery angioplasty, guided by conventional angiography, results in a higher patency rate and a lower target lesion revascularization (TLR) rate, while amputation rate remains statistically similar between the 2 groups. Our study highlights the importance of compensating for conventional angiography's underestimation in BTK artery angioplasty by using a balloon size one size larger than the 1-to-1 angiographic sizing. Our findings demonstrate that oversizing the balloon leads to significantly higher patency rates and lower TLR rates, with no increase in amputation risk. This approach provides a practical, cost-effective solution for clinicians performing angioplasty without IVUS, allowing for better vessel treatment and outcomes in patients with chronic limb-threatening ischemia. Clinicians can implement this strategy to optimize long-term results in BTK interventions.

Catheter-Directed Thrombolysis in the Management of Thrombotic Peripheral Artery Occlusions-Acute and Mid-Term Clinical Outcomes.

Objectives: To evaluate the safety and efficacy of catheter-directed thrombolysis (CDT) with the recombinant tissue plasminogen activator (rt-PA) in all patients with symptomatic peripheral artery disease in real world practice. Methods: Consecutive patients treated with CDT between January 2013 and December 2020 were included in this retrospective analysis. The primary endpoint was the rate of serious adverse events (SAEs) until discharge. Secondary endpoints included interventional success, predictors for SAEs, bleeding and reperfusion edema/compartment syndrome, limb salvage, and clinical outcomes including target lesion revascularization rate (TLR). Results: Overall, 1238 patients were treated with CDT. SAEs occurred in 511 (41.3%) of the patients, 314 (25.4%) being bleeding complications. There were 95 cases of reperfusion edema/compartment syndrome. Forty-two patients underwent amputation and 33 patients (2.7%) died. CDT was successful in 1177 cases (95.1%). Multivariate logistic regression analysis identified age, abciximab and alprostadil usage, and lysis duration as predictors for SAEs and the use of abciximab as a predictor of reperfusion edema/compartment syndrome. Predictors for bleeding were age, alprostadil usage, and lysis duration. At 12 and 24 months, the limb salvage rate was 91.6% and 88.8%, and TLR rate was 46% and 57.2%, respectively. Conclusions: CDT is an effective endovascular method for the treatment of thrombotic peripheral artery occlusions but is associated with a high complication rate. For SAEs in general and bleeding specifically, increasing age, alprostadil use, and lysis duration were independent risk factors.

The Midterm Outcomes of Endovascular Therapy for Femoropopliteal Lesions via Drug-Coated Balloon, Directional Atherectomy and Bare Metal Stent Angioplasty.

This study investigated the midterm primary patency of drug-coated balloons (DCBs), directional atherectomy plus balloon angioplasty (DA), and bare metal stent (BMS) angioplasty for the treatment of femoropopliteal lesions. This two-center retrospective cohort study included 105 patients (110 limbs) undergoing DCB, DA, and BMS angioplasty-32 patients (34 limbs), 31 patients (32 limbs), and 42 patients (44 limbs), respectively. The demographic, baseline, and procedure data were collected, and the complications and midterm outcomes (patency, amputation-free survival, and clinically driven target lesion revascularization rates) were analyzed. All three procedures achieved a 100% success rate. Significant improvements were noted in ankle brachial index, walking distance, and Rutherford classification at 30 days post-procedure (p < 0.001), with no differences or severe complications among the groups. The all-cause mortality rate during the follow-up period, was 5.5%, and amputation-free survival rates at 24 months were 97.0%, 90.6% and 90.9% in the DCB, DA, and BMS angioplasty groups, respectively. The primary patency rate for the DCB group (79.4%) exceeded those of the DA (56.2%) and BMS (52.2%) groups (p < 0.05), with no significant difference between the DA and BMS groups at 24 months. The secondary patency and clinically driven target lesion revascularization rates were similar among the three groups. A runoff number ≤1, Trans-Atlantic Intersociety Consensus (TASC) D, and severe calcification were found to be independent risk factors for primary patency. The DCB procedure demonstrated superior primary patency, compared to both BMS and DA procedures, in the treatment of femoropopliteal lesions.

Kidney disease, diabetes, and diameter stenosis predict Rotablation bailout in modified balloon application for severely calcified coronary lesions.

Modified balloon (MB) treatment in severely calcified coronary artery lesions is an established technique. However, some lesions require Rotablation (RA) as bailout strategy. This study aimed to assess predictors of switch from MB to RA and its impact on procedural and midterm outcomes. Four hundred and eighty-three consecutive patients were included undergoing MB treatment (n = 204) with a scoring or cutting balloon, or upfront RA treatment (n = 279) serving as control cohort. Strategy switch from MB to RA was performed in 19 of 204 patients. Procedural success was defined as successful stent implantation and TIMI III flow. In the MB cohort, median age was 72 [63-78] years, 75.5% were male and 42.1% had acute coronary syndrome. Procedure success was achieved in 89.4% of the switch group versus 98.4% of the MB only group (p < 0.001) and in 96.4% of the RA cohort. In the switch group, periprocedural complications (31.6% vs. 8.1% vs. 11.8%, p = 0.007), radiation dose (149 [126-252] vs. 59 [30-97] vs. 102 [59-156] Gcm2; p < 0.001) and contrast volume (250 [190-250] vs. 190 [150-250] vs. 195 [190--250] mL; p < 0.001) were significantly higher. Diabetes (OR 3.8, 95%CI 1.1-13.9, p = 0.042), chronic kidney disease stage 4 or 5 (OR 19.0, 95%CI 3.3-108.6, p < 0.001) and pronounced calcification resulting in higher angiographic diameter stenosis (OR 1.13, 95%CI 1.1-1.2, p = 0.001) independently predicted strategy switch. Midterm results were not affected by strategy switch regarding 1-year target lesion revascularization rates (86% vs. 89% vs. 89%; log-rank p = 0.95). Primary RA strategy might be considered in patients with severely calcified coronary artery lesions with high angiographic diameter stenosis, diabetes or impaired renal function due to increased periprocedural complication rates, radiation dose, and contrast volume following strategy switch.

Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.

Evaluation of balloon and self-expandable stents for common femoral artery stenosis

BackgroundEndovascular treatment of the common femoral artery (CFA) and its bifurcation is currently recommended for patients with hostile groin (prior femoral bifurcation open surgery, history of radiotherapy) or severe comorbidities (advanced age, frailty, obesity). Preliminary results have shown favorable outcomes. Among the different endovascular techniques (atherectomy, intravascular lithotripsy, plain balloon angioplasty, drug-coated balloon angioplasty, stenting), stents are mainly used but the best type of stent to use is still debated. The aim of this study was to assess the value of balloon-expandable stents (BES) and self-expandable stents (SES) for stenosis of the femoral bifurcation. MethodsConsecutive patients with stenosis of the CFA and its bifurcation were included from 2016 to 2022. Demographic data, the type of stent used, procedural data, and angiographic variables were collected. Groups were defined according to the type of stent implanted. Primary patency was defined as a binary end point based on a duplex ultrasound peak systolic velocity ratio of ≤2.4 as assessed by duplex ultrasound examination, in the absence of clinically driven target lesion revascularization (TLR) or bypass of the target lesion. Secondary outcomes were clinical sustained improvement, freedom from TLR at 12 months, mean ankle-brachial index improvement, primary-assisted patency, and secondary patency. ResultsA total of 90 procedures conducted in 77 patients were included in this study, 26 in the SES group and 64 in the BES group. The most common symptomatology according to the Rutherford classification was class 2, 3, and 4 (28%, 48%, and 8%, respectively). The type of lesions in the CFA, assessed using the Azema classification, were comparable between both groups (SES/BES group type 2: 31%/27%; type 3: 54%/62%). At 12 months, the primary patency rates for SES and BES were 88% (26/26 patients) and 72% (58/64 patients) (P = .10). At 12 months, freedom from TLR rates for SES and BES were 97% vs 81%, respectively (P = .13). ConclusionsSES for CFA stenosis show a trend toward better patency and freedom from TLR rates at 12 months. However, controlled studies are warranted to further investigate the significance of this trend.

Treatment extent of femoropopliteal disease and clinical outcomes following endovascular therapy.

Endovascular therapy (EVT) has become the preferred treatment modality for femoropopliteal disease. However, there is limited evidence regarding its procedural and clinical outcomes according to the affected area. The aim of this study is to investigate clinical outcomes and device effectiveness according to treatment extent in the superficial femoral artery (SFA), popliteal artery (PA), or both. In this study, we analysed EVT for SFA (2,404 limbs), PA (155 limbs), SFA/PA (383 limbs) using the population in the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) registry. The primary endpoint was target lesion revascularisation (TLR) at 2 years. The SFA/PA group exhibited a higher prevalence of anatomical complexity, characterised by long lesions, moderate to severe calcification, and total occlusion. The procedures were successful in 97.2% of SFA, 92.9% of PA, and 95.6% of SFA/PA EVTs. The 2-year TLR rates were 21.1%, 18.6%, and 32.7% in the SFA, PA, and SFA/PA groups, respectively. SFA/PA EVT was associated with a significantly increased risk for TLR compared to the SFA group (adjusted hazard ratio [HR] 1.48 [1.09-2.00]; p=0.008) and a trend towards an increased risk compared to the PA group (adjusted HR 1.80 [1.00-3.27]; p=0.052). After overlap weighting, the use of a drug-coated balloon (DCB) was shown to be beneficial, with the lowest TLR rate after SFA and SFA/PA EVT. In this large real-world registry, SFA/PA EVT was associated with an increased risk for TLR at 2 years compared to the SFA or PA EVT groups, with favourable outcomes when using a DCB or drug-eluting stent in the SFA/PA EVT group.

Comparative Study between Mechanical Rotational Atherectomy Combined with Drug-Coated Balloon versus Drug-Coated Balloon Alone for Treatment of In-Stent Restenosis during Peripheral Endovascular Interventions: A Multicentric Trial

Purpose: To compare the efficacy and safety of percutaneous mechanical debulking (PMD) using mechanical rotational atherectomy combined with paclitaxel drug-coated balloon (DCB) versus using paclitaxel DCB alone in the treatment of in-stent restenosis. Material and Methods: This is a multicentric retrospective observational study conducted over a period of 2 years from 2020 to 2022. The study included 49 patients presented with chronic limb-threatening ischemia (CLTI) associated with in-stent restenosis, either acute (&lt;14 days), subacute (&lt;3 months) or chronic (&gt;3 months). The enrolled patients underwent endovascular revascularization using either PMD combined with paclitaxel DCB or paclitaxel DCB only. They were followed up for 6 months after the intervention clinically and by duplex evaluation. Results: The lesion length was about 14.2 mm in the group treated by PMD+ DCB and 9.3 mm in the group treated by DCB alone. The technical success rate was the same between the two groups. However, the follow-up after 6 months showed that patencies for PMD + DCB and DCB alone were 15 (68.2%) patients and 15 (55.6%) patients, respectively (significant p value = 0.028). Procedural-related complications for PMD + DCB are distal embolization (9%) of cases and no vessel perforation. Regarding the candidates who were treated by DCB alone, there were minor groin hematomas (11.1%), distal arterial thrombosis (11.1%) and contrast-induced nephropathy (CIN) (11.1%) cases. Conclusion: The endovascular management of in-stent restenosis using percutaneous mechanical debulking (PMD) in conjunction with paclitaxel drug-coated balloon (DCB) showed that PMD combined with DCB is a safe and effective modality for achieving recanalization. It gives a satisfactory outcome in terms of technical success, freedom from clinically driven target lesion revascularization rate (CD-TLR) and mortality. Despite these promising results, further research with a large enrolled population may be required to determine the cost/benefit.

Evaluation of acute and midterm outcomes after complex combined antegrade/retrograde recanalization for occlusions of the femoropopliteal and infrapopliteal arteries

IntroductionWhen antegrade recanalization of femoro- and/or infrapopliteal occlusions fails, retrograde access has become an established option. To evaluate the results of combined antegrade and retrograde recanalization of femoropopliteal and infrapopliteal occlusions, patients undergoing secondary retrograde recanalization attempts were analyzed retrospectively. MethodsPrimary endpoint was the success of the procedure (successful occlusion crossing using the ante-/retrograde technique). Secondary endpoints include complication rate, primary patency and target lesion revascularization (TLR) rate, amputation rate, changes in ankle-brachial index (ABI), and Rutherford-Becker class (RBC). Predictors for procedure failure and TLR were analyzed. ResultsWe included 888 patients: 362 with femoropopliteal (group 1), 353 with infrapopliteal (group 2), and 173 with multi-level (group 3) recanalization. Critical limb threatening ischemia (CLTI) was present in group 1, 2, and 3 in 36%, 62%, and 76%, respectively. The intervention was successful in 92.5%, 93.8%, 90.8% of respective cases (p=0.455). The overall peri-interventional complication rate was 7.2%.At 6, 12 and 24 months, primary patency was highest in group 1 (63.9%, 45.8%, 33.3%), followed by group 3 (59.8%, 46.1%, 33.3%), and group 2 (58.5%, 43.1%, 30.4%), p=0.537).The risk of undergoing repeated TLR within 24 months was 31.4% for group 1, 39.1% for group 2, and 45.7% for group 3.At 24 months, the survival rate in groups 1, 2, 3 was 93.8%, 79.4% and 87.5%, respectively. During 24 months, 75 patients (8.4%) had to undergo amputation. Significant improvements in both ABI and RBC were present at discharge as well as at 6, 12 and 24 months (p<0.001).Dialysis dependency was a predictor of unsuccessful ante/retrograde recanalization (p=0.048).Lesion length (p=0.0043), dialysis (p=0.033) and recanalization level (p=0.013) increase the risk of TLR. ConclusionUsing a combined antegrade/retrograde access, recanalization of occluded femoropopliteal and/or infrapopliteal arteries can be achieved in a large number of cases. Due to the high rate of repeated TLR across all lesion localizations, the indication for ante- and retrograde recanalization may be limited to patients with CLTI.

Impact of Chronic Kidney Disease on the Coronary Revascularization Guided by Intracoronary Physiology: Results of the First Registry with Long-Term Follow-Up in a Latin American Population.

The use of invasive physiology methods in patients with renal dysfunction is not well elucidated. Our objective was to evaluate the in-hospital and long-term results of using intracoronary physiology to guide revascularization in patients with chronic kidney disease. In this retrospective study, we evaluated 151 patients from January 2018 to January 2022, divided into 2 groups: CKD (81 patients [114 lesions]) and non-CKD (70 patients [117 lesions]). The mean age was higher (p < 0.001), body mass index was lower (p = 0.007), contrast volume used was lower (p = 0.02) and the number of ischemic lesions/patients was higher (p = 0.005) in the CKD group. The primary outcomes (rate of major adverse cardiac events during follow-up, defined as death, infarction, and need for new revascularization) in the CKD and non-CKD groups were 22.07% and 14.92%, respectively (p = 0.363). There was a significant difference in the target lesion revascularization (TLR) rate (11.68%, CKD group vs. 1.49%, non-CKD group, p = 0.02), this initial statistical difference was not significant after adjusting for variables in the logistic regression model. There was no difference between the rates of death from all causes (6.49%, CKD group vs. 1.49%, non-CKD group, p = 0.15), reinfarction (3.89%, CKD group vs. 1.49%, non-CKD group, p = 0.394), and need for new revascularization (11.68%, CKD group vs. 5.97%, non-CKD group, p = 0.297). As there was no difference in the endpoints between groups with long-term follow-up, this study demonstrated the safety of using intracoronary physiology to guide revascularization in patients with CKD.

Safety and efficacy of single antiplatelet therapy in a large cohort of patients treated with sirolimus-coated balloon: Post hoc analysis from the prospective EASTBOURNE registry

BackgroundDrug coated balloons (DCB) are potentially less thrombogenic than drug eluting stents (DES). AimsTo explore the safety and the feasibility of single antiplatelet therapy in percutaneous coronary intervention with sirolimus-coated balloons. MethodsThe All-comers Sirolimus-coated Balloon European Registry (EASTBOURNE) is a prospective investigator-driven registry assessing the performance of a novel sirolimus-coated balloon (SCB) in a real-world population. This prespecified post hoc analysis aimed at comparing the outcome in patients prescribed either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT); choice of antiplatelet agent and duration of the regimen were at operator's discretion in both groups. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were bleeding grade 3–5 according to The Bleeding Academic Research Consortium (BARC) criteria and major adverse cardiovascular events (MACE) at 12 months follow-up. ResultsAmong 2123 patients enrolled in the study between September 2016 and November 2020, 113 patients (5.8 %) received SAPT while 1826 patients (94.1 %) received DAPT after SCB. The majority of the patients underwent DCB PCI for de novo lesions (n = 1091, 56.3 %) while 848 patients (47.7 %) had DCB revascularization for in-stent restenosis. No cases of TLR occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. Moreover, no differences in terms of TLR were observed between SAPT vs DAPT regimens nor in case of de novo treatment with an overall rate of TLR at 12 months of 7.7 % for SAPT and 5.6 % for DAPT (p = 0.6). The cumulative rate of MACE at 12 months was not different between SAPT and DAPT regimens (n = 12 [11.2 %] vs. n = 162 [8.9 %], p = 0.4), and results were consistent in the de novo and in-stent restenosis groups. ConclusionsOur post hoc analysis of the EASTBOURNE registry suggests that the use of single antiplatelet agent after sirolimus-DCB PCI for both de novo or in-stent restenosis lesions is safe and effective and can help to contain the risk of bleeding in a selected population. Condensed abstractThe manuscript aims to explore the feasibility of a single antiplatelet regimen following angioplasty using drug coated balloon with sirolimus. Among 2123 patients treated with sirolimus coated balloon (SCB), 113 patients (5.8 %) received a single antiplatelet therapy (SAPT) while 1826 patients (94.1 %) received dual antiplatelet therapy DAPT. No cases of target lesion revascularization occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. The cumulative rate of major adverse cardiovascular events at 12 months was not different between SAPT and DAPT regimens and results were consistent in the de novo and in-stent restenosis groups.

Directional atherectomy with anti-restenotic therapy versus open repair in patients with restenotic disease after surgical revascularization of the common femoral artery.

This study evaluated the performance of directional atherectomy with anti-restenotic therapy (DAART) compared to surgery in patients with restenosis of the groin arteries after endarterectomy or femoral bypass anastomosis. Consecutive patients with restenotic lesions from two vascular surgery units were retrospectively evaluated. Detailed medical history, type of previous reconstruction, anatomical and perioperative data, 30-day mortality and morbidity as well as data during follow-up were documented. The primary outcome measure was primary patency, whereas technical success, secondary patency, target lesion revascularization (TLR), freedom from major amputation, overall morbidity and mortality were additionally evaluated. The endovascular (25 patients) and surgical (17 patients) groups were comparable regarding the initial surgical reconstruction, demographics, comorbidities and medication. In the DAART group technical success was 100% without any residual stenosis >30%, distal embolization, perforation or bailout stenting. Hospital stay was shorter after DAART (medial 2 vs. 7 days, P<0.001), while more wound complications were documented in the surgical group within the first 30-days (29.4% vs. 0%, P=0.004). Primary patency, secondary patency and TLR were comparable between the groups (66.7% vs. 64.7%, HR 0.95, 95% CI 0.3-2.9, P=0.93, 86.4% vs. 93.8%, HR 0.65, 95% CI 0.65-6.6, P=0.71, 68% vs. 70.6%, HR 0.95, 95% CI 0.3-2.9, P=0.93, respectively). During follow-up no major amputation was observed, the improvement of the Rutherford class was comparable between the two groups and there were two deaths in the surgical group. In this study, DAART for restenotic atherosclerotic disease of the common femoral artery and its branches is a safe alternative to redo surgery and is associated with shorter hospital stay, fewer wound complications, comparable patency and freedom from TLR rates.

Angiographic and clinical impact of balloon inflation time in percutaneous coronary interventions with sirolimus-coated balloon: A subanalysis of the EASTBOURNE study

IntroductionPercutaneous coronary intervention (PCI) with drug-coated balloon (DCB) is an attractive strategy for the treatment of obstructive coronary artery disease (CAD). The implantation technique strongly influences the outcome of DCB PCI: accurate and adequate lesion preparation, short delivery time and sufficient DCB inflation time are deemed crucial to warrant adequate drug transfer and mitigate the risk of immediate vessel recoil and flow-limiting dissections. However, the optimal DCB inflation time is unclear, current consensus documents suggesting 30–60 s based on Experts' opinion. However, clinical studies comparing the prognostic role of different inflation times are scarce and mainly involve paclitaxel-coated balloons. In this study we aimed to assess the impact of different inflation times in patients undergoing PCI with a sirolimus-coated balloon (SCB). MethodsWe conducted a post-hoc analysis of the prospective, multicenter, EASTBOURNE study, classified into two study groups according to balloon inflation time: long (>30 s) versus short (≤30 s). The primary endpoint was target lesion revascularization (TLR) at 24-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, non-fatal myocardial infarction (MI), and BARC 2–5 bleedings. Furthermore, angiographic endpoints (the rate of bailout stenting and post-procedural TIMI flow <3) were also addressed. ResultsA total of 2289 lesions (2092 in the long inflation group, 197 in the short inflation group) were included in the analysis. Median balloon inflation time was 60 s in the long inflation and 30 s in the short inflation group. The two study groups experienced a similar rate of TLR [6.2 % in the short versus 6.3 % in the long inflation group, p = 1.00] as well MACE (p = 0.683), death (p = 0.102), non-fatal MI (p = 0.822), and BARC 2–5 bleedings (p = 0.252). These results were consistent when considering subpopulations with different target lesion phenotypes (in-stent restenosis, de-novo lesions, large and small vessels). Interesting, the rate of bailout stent implantation and post-procedural TIMI flow <3 was higher in the short SCB inflation time, as compared to the standard strategy. ConclusionsShort vs. long SCB inflation time is associated with a higher need of bailout stenting after PCI with SCB, with similar clinical outcomes at 24-month follow-up.

Long-term outcomes following paclitaxel-coated balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis in chronic coronary syndrome (CCS Dragon-Registry).

The long-term outcomes for patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. We aimed to investigate the outcomes for patients with drug-eluting stents (DES)-ISR and CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES. A total of 846 consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin (strut thickness <100 μm) strut-DES (381 [45%]) or paclitaxel-DCB (465 [55%]) for DES-ISR were enrolled between February 2008 and October 2021. The median follow-up was 1006 (IQR 426-1770) days. The primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint (DOCE: cardiac death, TLR, or target vessel myocardial infarction [TV-MI]). Patients who received DES, compared with those who received DCB, had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74]; P <0.001), TVR (HR, 0.56 [95% CI, 0.39-0.86]; P <0.001), and DOCE (HR, 0.63 [95% CI, 0.45-0.88]; P = 0.007). The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33-0.88]; P = 0.013), TVR (HR, 0.57 [95% CI, 0.41-0.80]; P = 0.009) and DOCE (HR, 0.65 [95% CI, 0.42-0.99]; P = 0.046) between the DES and DCB groups, respectively. In long-term follow-up of CCS patients undergoing PCI of ISR, the use of DES was associated with reduced rates of TLR, TVR, and DOCE compared with patients treated with DCB.