Target Lesion Revascularization Rate Research Articles

Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study

Aim: Percutaneous transluminal angioplasty (PTA) for peripheral artery disease (PAD) commonly leads to dissections which are associated with higher target lesion revascularization (TLR) rates. Clinical and economic consequences of dissection management in the femoropopliteal artery following PTA, and specifically the potential economic benefit of focal dissection repair using the novel Tack Endovascular System, remain unknown. Methods: A decision-analytic model was used to estimate 24-month clinical events, costs and quality-adjusted life year (QALY) gain for a Tack-supported versus status-quo PTA strategy. Patient and lesion characteristics and TLR rates were derived from the PTA cohort of the TOBA II clinical trial, an observational cohort, and literature. Cost–effectiveness was determined from a US payer and provider perspective separately for the non-severe (grade A or B), severe (grade C and higher) and the entire dissection cohort. Results: TLR rates were lower for the Tack-supported strategy compared with PTA (7.7 vs 27.4% in the non-severe, 13.9 vs 25.8% in the severe and 12.0 vs 26.3% in the entire dissection cohort). Cost and QALY differences were +$297/ + 0.0110 in the non-severe dissection cohort and -$1602/ + 0.0067 in the severe dissection cohort, resulting in an incremental cost–effectiveness ratio (ICER) of $25,622 in the non-severe cohort and dominance in the severe cohort and the entire cohort. Conclusion: Compared with a ‘status-quo’ approach, proactive focal stenting may lead to fewer reinterventions and improved quality of life. There appears to be a graded economic benefit of focal dissection treatment, being cost-effective in non-severe dissections and even cost saving in severe dissections.

Application of Drug-Eluting Stent With Drug-Coated Balloon Strategy for the Endovascular Treatment of Long-Segment Femoropopliteal Artery Disease.

Endovascular therapy (EVT) has emerged as a primary approach for managing femoropopliteal artery (FPA) lesions, leveraging drug-eluting stents (DESs), and drug-coated balloons (DCBs), to enhance clinical outcomes. Although a full DES coverage strategy is effective in treating complex lesions, concerns over long-term complications prompt the exploration of alternative strategies. The aim of this study was to investigate clinical result of combination therapy of DES with DCB and compare them with full DES implantation. This retrospective, single-center study analyzed 131 patients with occlusive FPA lesions treated at our institution between 2019 and 2022. Patients with Rutherford classification stages 2 to 5 who underwent successful EVT were included. The study compared the outcomes of the drug-within-drug (DWD) strategy, ie, combining DES for failed vessel preparation segments and DCB for successful ones, with those of full DES implantation. The primary outcomes were the primary patency rates, and the secondary outcomes included clinically-driven target lesion revascularization (CD-TLR) rates, restenosis patterns, and survival outcomes. Of the 131 patients initially considered, 118 met the inclusion criteria, with 45 in the DWD group and 73 in the full metal jacket (FMJ) stent group. The DWD group demonstrated equivalent 1-year primary patency rates (85.3%) to the FMJ group (87.9%, p=0.239). Similarly, no significant differences in CD-TLR rates were found between the 2 groups. The restenosis patterns and subsequent treatment strategies were not significantly different. The DWD strategy offers a viable alternative to full DES coverage in treating long-segment FPA lesions, with comparable restenosis and target lesion revascularization (TLR) rates. This approach may mitigate risks associated with full-length stenting, such as thrombosis, and challenges in repeat revascularizations by tailoring treatment to lesion characteristics. The DWD strategy represents a promising approach for complex FPA lesions, providing a balanced solution that potentially reduces long-term complications while maintaining effective patency and revascularization rates. The efficacy of drug-eluting stents (DES) in treating femoropopliteal artery (FPA) lesions has been well demonstrated. However, concerns remain regarding complications such as thrombotic occlusion and aneurysmal degeneration, especially when full stemt coverage of whole lesions is performed. The "Drug-with-Drug" (DWD) strategy, which involves implanting DES only at sites with severe dissection or residual stenosis after pre-balloon dilation and using drug coated balloons (DCB) for segments successfully prepared without stenting, has shown comparable outcomes to full stent coverage. Unlike traditional bailout stenting or spot stenting, the DWD approach maximizes the benefits of drug technology and presents a valuable option for treating long-segment FPA lesions.

Drug-Coated Balloons Versus Drug-Eluting Stents or Plain Old Balloon Angioplasty: A Long-Term in-Stent Restenosis Study.

Balloon angioplasty with drug-coated balloons (DCBs) is frequently used during percutaneous coronary intervention for in-stent restenosis. Despite its frequent use, there is a lack of long-term data on the efficacy of DCB angioplasty. We conducted an investigation on the long-term efficacy outcome of in-stent restenosis, comparing DCBs, drug-eluting stents, and plain old balloon angioplasty. We conducted a nationwide analysis from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) including in-stent restenosis lesions undergoing coronary angiography between June 11, 2013, and January 14, 2022. The primary outcome of this study was target-lesion revascularization within a 5-year follow-up. Secondary outcomes included all-cause death, cardiovascular death, myocardial infarction, and any percutaneous coronary intervention. The outcomes were analyzed using a multivariable Cox proportional hazard model or Poisson regression, as appropriate. A total of 10 561 lesions from 9062 patients were included. Compared with plain old balloon angioplasty, the use of DCB angioplasty was associated with less target-lesion revascularization (risk ratio, 0.69 [95% CI, 0.57-0.82]), all-cause death (risk ratio, 0.72 [95% CI, 0.59-0.88]), and cardiovascular death (hazard ratio [HR], 0.59 [95% CI, 0.45-0.78]). No difference was observed for myocardial infarction or any percutaneous coronary intervention. Compared with drug-eluting stents, the use of DCBs was associated with higher rates of target-lesion revascularization (HR, 1.20 [95% CI, 1.06-1.37]). No difference was observed for all-cause death, cardiovascular death, myocardial infarction, or any percutaneous coronary intervention. In this long-term nationwide analysis, the use of DCB angioplasty showed superior outcomes compared with plain old balloon angioplasty within 5 years but higher rates of repeat revascularizations compared with drug-eluting stents.

Long-Term Clinical Outcomes of Biodegradable- Versus Durable-Polymer-Coated Everolimus-Eluting Stents in Real-World Post-Marketing Study.

Long-term clinical data on biodegradable-polymer (BP) drug-eluting stents (DES) are limited. The objective of this study was to assess the long-term safety and efficacy of the BP-DES SYNERGY compared to XIENCE V, a durable-polymer (DP)-DES. We compared patients treated with BP-DES or DP-DES at our center from 2008 to 2020. The primary outcome was major adverse cardiac events (MACE), defined as the composite of all-cause death, Q-wave myocardial infarction (MI), and target vessel revascularization (TVR). Secondary endpoints were all-cause death, Q-wave MI, target lesion revascularization (TLR), and stent thrombosis (ST). A total of 4255 patients underwent propensity-score matching, and 380 patients from each cohort were matched. There was no significant difference between BP-DES and DP-DES concerning MACE (5-year estimates: 21.6% vs. 26.6%, log-rank p = 0.259). Furthermore, there was no difference in the TLR rate (5-year estimates: 7.3% vs. 8.6%, log-rank p = 0.781). All-cause death (5-year estimates: 13.6% vs. 12.9%, log-rank p = 0.72) and Q-wave MI (5-year estimates: 0.53% vs. 1.7%, log-rank p = 0.427) were also comparable between the two groups. Of note, the rate of very late ST was very low and similar between the groups (5-year estimates: 0.26% vs. 0.64%, log-rank p = 0.698). BP-DES and DP-DES demonstrate similar safety and efficacy at 5-year follow-up. Both can be used for the effective treatment of coronary artery disease.

Efficacy and safety of the needle rendezvous technique for infrainguinal arterial calcified lesions

BackgroundLower extremity artery disease is increasingly prevalent, and complex lesions such as calcified chronic total occlusions pose significant challenges during endovascular therapy. The needle rendezvous technique, which involves puncturing a needle toward the guidewire within the lesion or lumen and advancing the guidewire into the needle lumen to achieve guidewire externalization, offers a potential solution. If device passage remains challenging, the Rendezvous-PIERCE technique can be subsequently employed by advancing the needle over the externalized guidewire to modify the lesion directly. This study aimed to evaluate the procedural outcomes of needle rendezvous in infrainguinal arterial occlusive lesions.MethodsThis single-center, retrospective, single-arm study included patients treated with needle rendezvous between August 2020 and March 2024. The primary outcome was technical success rate, defined as the device passage following guidewire externalization using needle rendezvous. Secondary outcomes included the rates of procedural success, complications, and 30-day clinical-driven target lesion revascularization (CDTLR).ResultsTwenty-five patients (25 limbs) with 52% on hemodialysis and 80% having chronic limb-threatening ischemia in 52% and 80% were enrolled. All cases involved bilateral calcified occlusions, and 72% targeted the infrapopliteal artery segment. The average needle rendezvous time was 3.7 ± 2.0 min. Rendezvous-PIERCE was performed in 28% of cases. All cases achieved 100% technical and procedural success, with no procedure-related complications. The 30-day CDTLR rate was 8%, limited to below-the-knee lesions.ConclusionsNeedle rendezvous is a safe and effective technique for treating complex infrainguinal arterial occlusions, providing a viable alternative when conventional methods fail.

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.

Impact of Successful Antegrade &amp; Retrograde CTO PCI on Short Term Prognosis

Abstract Background Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) carries risk of complications and should be attempted when the anticipated benefits exceed the potential risks. The primary indication for CTO-PCI is symptom improvement. However, the impact of CTO PCI on angina and subsequent incidence of major adverse cardiovascular event (MACE) rate remains controversial. Objective Our aim was to study the impact of the antegrade and retrograde approaches for elective CTO PCI on the procedural success rate &amp; short-term MACE. Patients and Methods The current study was a prospective cohort study that included a total of 80 patients who were referred to our center (Ain Shams University Hospitals) for elective CTO PCI and underwent technically successful CTO PCI. Data was collected on patient arrival to our department and then the patients were observed during hospital admission to record any In-Hospital MACE. These patients were then followed up for 6 months to record improvement or worsening of their symptoms and to assess occurrence of any MACE including hospitalization and undergoing symptom driven coronary angiography. Results The mean age of our patients was 56±9.6 years and 91% of the patients were men. Seventy- seven % of patients were done via an ante-grade approach and 23% were done via a retro-grade approach with an overall procedural success rate of 91.25% (Antegrade 93.5%, Retrograde 83.3%). The overall mean procedure time was 102 minutes, the mean contrast volume used was 371 ml and the mean cumulative Air Kerma dose was 7.2 Gy. The retrograde group required longer procedure times, larger volumes of contrast and higher exposure to radiation. The overall in-hospital MACE was 8.75%. 81.25% of patients in our study showed an improvement in the grade of their exertional dyspnea or angina within the 6-month follow-up period. 16.25% of patients in our study needed re-hospitalization within a 6-month period after PCI. The overall Target lesion re-vascularization rate at 6 months was 8.75%. Three out of the 7 patients (42.86%) who suffered from in-hospital MACE developed another Major adverse cardiac event during the 6 months follow up period. This was a higher percentage than the patients who did not suffer from in-hospital MACE and was statistically significant. Conclusion Technically successful CTO PCI in a well-equipped center with highly qualified CTO operators resulted in high procedural success rates and low incidence of short-term MACE.

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 are scant. This study aimed to assess the impact of race/ethnicity on clinical outcomes at 12-month follow-up of patients with LMCA disease who underwent PCI with drug-eluting stent implantation. All patients who underwent 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 end point was the composite of all-cause death, myocardial infarction, or stroke at 12 months. A total of 774 consecutive patients with known race/ethnicity were prospectively enrolled (62.1% [n = 481] Caucasian, 17.2% [n = 133] Hispanic, 12.7% [n = 98] Asian, and 8.0% [n = 62] African-American). Compared with Caucasians, the hazard rate of the primary end point tended to be lower in Asian patients (6.1% vs 14.2%; hazard ratio [HR] 0.41, 95% confidence interval [CI] 0.16 to 1.03) and similar in African-American (13.7% vs 14.2%; HR 0.93, 95% CI 0.40 to 2.16) and Hispanic patients (14.2% vs 14.2%; HR 1.02, 95% CI 0.58 to 1.78). Hazard rates of target vessel or lesion revascularization were comparable among the 4 groups. Cox multivariable regression adjustment confirmed consistent findings and revealed higher hazard rates of postdischarge bleeding in African-Americans compared with Caucasians (HR 5.89, 95% CI 1.00 to 34.5). In conclusion, within a racially/ethnically diverse cohort of patients who underwent PCI for LMCA disease, when compared with Caucasians, Asians had lower risk of all-cause death, myocardial infarction, or stroke, whereas African-Americans had increased risk of postdischarge bleeding. Condensed abstract Evidence on percutaneous coronary intervention for left main coronary artery disease in patients of diverse race/ethnicity is limited. Among 774 consecutively enrolled patients from diverse racial/ethnic backgrounds, Asians tended to experience a lower hazard for all-cause death, myocardial infarction, or stroke compared with Caucasians. A higher hazard rate of postdischarge bleeding was observed in African-Americans compared with Caucasians. Further dedicated prospective studies enrolling racial/ethnic minorities are needed to confirm the presence of effect modification in clinical outcomes based on racial/ethnic background.What is knownWhat the study adds.

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.

Percutaneous Coronary Intervention in Patients with Coronary Artery Ectasia: A Retrospective Single-center Study.

This retrospective single-center study aimed to compare the outcomes of ad-hoc versus planned percutaneous coronary intervention (PCI) in patients with coronary ectasia. We investigated baseline characteristics, primary and secondary outcomes, and predictors of mortality in a cohort of patients who underwent PCI procedures. Data from 3,179 patients (ad-hoc PCI, n = 1,286; planned PCI, n = 1,893) with coronary ectasia were analyzed. Baseline characteristics, including age, gender, comorbidities, and lesion characteristics, were compared between the two groups. Primary outcomes included technical success and stent deployment success, while secondary outcomes encompassed major adverse cardiovascular events (MACE), all-cause mortality, recurrent angina, and target lesion revascularization. Logistic regression was utilized to identify predictors of mortality. The ad-hoc PCI group exhibited a higher prevalence of comorbidities, including hypertension, diabetes mellitus, smoking history, and multi-vessel disease (all p < 0.05). While technical success and stent deployment success rates were lower in the ad-hoc PCI group (p < 0.05), patients undergoing planned PCI demonstrated significantly lower rates of MACE, all-cause mortality, recurrent angina, and target lesion revascularization (all p < 0.05). Logistic regression analysis identified older age, male gender, hypertension, diabetes mellitus, smoking history, and multi-vessel disease as independent predictors of mortality (all p < 0.05). Importantly, coronary ectasia emerged as an additional predictor of mortality (p = 0.002). Our study indicates that planned PCI is associated with improved procedural outcomes and lower rates of mortality and adverse events compared to ad-hoc PCI in patients with coronary ectasia.

Impact of aging on long-term cardiac outcomes of true-lumen recanalized chronic total occlusions in patients with overweight/obesity

BackgroundObesity paradox addressing all-cause mortality has been described in several chronic total occlusion (CTO) studies. However, the impact of aging on long-term cardiac events in patients with overweight and obesity with CTO recanalization were less studied.MethodsA total of 458 patients (64.4 ± 11.3 years, 403 male) with CTO interventions were enrolled. The overweight/obesity group included 311 patients with body mass index (BMI) ≧24 kg/m2 and the non-obesity group included 147. With a median follow-up of 40.0 (17.9–61.4) months, 422 patients with successful true-lumen recanalization were further assessed for target lesion failure [TLF: cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR)].ResultsAt follow-up, the rates of cardiac death, TVMI, TLR, TLF, and stent thrombosis were 1.9%, 1.9%, 9.2%, 10.7%, and 0.5%, respectively. The TVMI-free survival was borderline better (p = 0.067 by log-rank test) in overweight/obesity than non-obesity group. Among patients <65 years of age, the TVMI-free survival was significantly better in the overweight/obesity group (p = 0.013 compared to non-obesity group by log-rank test). In multivariate Cox regression model, the non-obesity patients younger than 65 years were at a higher risk of TVMI, not only among those <65 years of age (hazard ratio = 11.0, 95% CI = 1.1–106.0) but also among the whole patients (hazard ratio=6.9, 95% CI = 1.4–35.1) with successful CTO recanalization.ConclusionsFor those with true-lumen recanalized CTO, the higher risk of TVMI after successful recanalization was rather evident in patients <65 years of age and without overweight/obesity, suggesting that aging might attenuate prognostic significance of “obesity paradox” for CTO interventions.

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.