Vessel Calcification as a Risk Factor for In-Stent Restenosis in Complex Femoropopliteal Lesions After Zilver PTX Paclitaxel-Coated Stent Placement

Purpose: To evaluate the effect of vessel calcification on in-stent restenosis (ISR) after drug-coated stent (DCS) placement in the femoropopliteal segment. Materials and Methods: A retrospective multicenter study was undertaken involving 220 consecutive symptomatic patients (mean age 73.1±8.3 years; 175 men) with femoropopliteal lesions in 230 limbs treated with the Zilver PTX DCS and having duplex surveillance after the endovascular procedures. Mean lesion length was 16.4±9.8 cm (range 2–40); there were 104 (45.2%) total occlusions and 68 (29.6%) in-stent restenoses (ISR). Twenty (8.7%) vessels had no runoff. The majority of lesions (148, 64.3%) were calcified according to the peripheral arterial calcium scoring system (PACSS). Primary patency was evaluated by duplex. Lesions were classified as either PACSS 0–2 (none or unilateral wall calcification) or PACSS 3 and 4 (bilateral wall calcification). Multivariate analysis was performed to identify variables associated with ISR; the results are given as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 1-, 2-, and 5-year primary patency and freedom from clinically-driven target lesion revascularization estimates were 75.9%, 63.6%, and 45.0%, and 84.7%, 73.7%, and 54.2%, respectively. Major amputations were performed on 4 limbs during follow-up. In multivariate analysis, vessel calcification (adjusted HR 1.718, 95% CI 1.035 to 2.851, p=0.036) was significantly correlated with the occurrence of ISR, along with lesion length (adjusted HR 1.041, 95% CI 1.013 to 1.070, p=0.003), and cilostazol administration (adjusted HR 0.476, 95% CI 0.259 to 0.876, p=0.017). Conclusion: This study suggested that bilateral vessel wall calcification was an independent risk factor for ISR in complex femoropopliteal lesions after Zilver PTX DCS placement, along with lesion length; cilostazol administration had a protective effect.

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Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis

Journal of Endovascular Therapy ◽

10.1177/1526602817745668 ◽

2017 ◽

Vol 25 (1) ◽

pp. 81-88 ◽

Cited By ~ 21

Author(s):

Damianos G. Kokkinidis ◽

Prio Hossain ◽

Omar Jawaid ◽

Bejan Alvandi ◽

T. Raymond Foley ◽

...

Keyword(s):

Balloon Angioplasty ◽

Cox Regression ◽

Multivariable Analysis ◽

Limb Ischemia ◽

Target Lesion ◽

Lesion Length ◽

Stent Restenosis ◽

Kaplan Meier ◽

Laser Atherectomy ◽

In Stent Restenosis

Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.

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Rotational and aspiration atherectomy for infrainguinal in-stent restenosis

VASA ◽

10.1024/0301-1526/a000256 ◽

2013 ◽

Vol 42 (2) ◽

pp. 127-133 ◽

Cited By ~ 19

Author(s):

Ulrich Beschorner ◽

Hans Krankenberg ◽

Dierk Scheinert ◽

Horst Sievert ◽

Thilo Tübler ◽

...

Keyword(s):

Ankle Brachial Index ◽

Primary Patency ◽

Study Endpoint ◽

Primary Study ◽

Lesion Length ◽

Secondary Patency ◽

Peripheral Vascular ◽

Stent Restenosis ◽

In Stent Restenosis

Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. Patients and methods: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex Results: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. Conclusions: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.

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Abstract 288: Role of Cilostazol in Preventing Instent Restenosis Among Patients With Peripheral Arterial Disease: A Meta-analysis

Arteriosclerosis Thrombosis and Vascular Biology ◽

10.1161/atvb.35.suppl_1.288 ◽

2015 ◽

Vol 35 (suppl_1) ◽

Author(s):

Omer Iftikhar ◽

Karla Oliveros ◽

Alfonso Tafur ◽

Ana Casanegra

Keyword(s):

Peripheral Arterial Disease ◽

Odds Ratio ◽

Random Effect ◽

Random Effect Model ◽

Arterial Disease ◽

Primary Patency ◽

Stent Restenosis ◽

Number Of Patients ◽

Peripheral Arterial ◽

In Stent Restenosis

Objective: Peripheral arterial disease (PAD) is associated with two to six fold increase in the cardiovascular mortality. Revascularization is indicated to relieve life limiting ischemic symptoms and improve wound healing. Primary patency for balloon angioplasty has been reported to be around 40 to 60% in the first year[8]. Stents have improved rates of primary patency but long-term patency rates are not comparable to bypass surgery, with many patients at high risk of in-stent restenosis. Many adjunctive therapies have been proposed to reduce the high restenosis rate. Our aim is to evaluate the use of cilostazol to prevent in-stent restenosis among patients with lower extremity arterial stenting. Methods: We performed a MEDLINE and EMBASE search, and reviewed the abstracts and manuscripts following the PRISMA guidelines. Patency rate after stenting was the primary efficacy outcome. At least 2 abstractors reviewed the study list and selected manuscripts. We calculated Q statistic and a homogeneity formal test. The odds ratio (OR) estimates were pooled by using the Mantel-Haenszel random-effects method. Data were analyzed using the R META package Results: We identified 524 studies, 20 articles were fully abstracted and 4 included in the metaanalysis. The total number of patients was 2434. The cilostazol and control groups were evenly divided. All studies were of moderate quality. Clinical characteristics including age and BMI were similar in the two groups. Stents were placed to treat de novo lesions. Two of the studies compared cilostazol to ticlopidine. Cilostazol group patients had better primary patency rates after endovascular therapy than patients not taking cilostazol (OR 0.55, 95% CI 0.43 - 0.71). Heterogeneity was moderate with I2 of 38% and of moderate clinical relevance not statistically significant thus random effect model was kept. Omitting a single study did not affect the overall odds ratio of the other studies. Funnel plot suggested no publication bias. Conclusions: In stent stenosis among revascularized patients with PAD was 45% lower for patients who were on cilostazol.

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Restenosis After Tack Implantation is Associated with Less Complex Patterns of Restenosis Compared to Stent Implantation

Vascular and Endovascular Review ◽

10.15420/ver.2019.03.r1 ◽

2020 ◽

Vol 3 ◽

Author(s):

Raghu Kolluri ◽

William A Gray ◽

Ehrin Armstrong ◽

Brian C Fowler

Keyword(s):

Stent Implantation ◽

Neointimal Hyperplasia ◽

Treatment Options ◽

Target Lesion ◽

Class I ◽

Lesion Length ◽

Index Procedure ◽

Stent Restenosis ◽

In Stent Restenosis

In-stent restenosis is complex, difficult to treat and has led to a ‘leave less metal behind’ approach to femoropopliteal intervention. Postangioplasty dissection often requires scaffolding to maintain patency. The Tack Endovascular System provides minimal-metal dissection repair that preserves future treatment options. Tack implants are designed to minimise the inflammation and neointimal hyperplasia that lead to in-stent restenosis. An independent angiographic core laboratory evaluated the restenosis patterns in clinically driven target lesion revascularisation (CD-TLR) during the 12 months following the index procedure in the Tack Optimized Balloon Angioplasty (TOBA) II study and compared these results to those published for nitinol stent implantation. Of the 213 patients in TOBA II, 31 (14.6%) required a CD-TLR. Of these, 28 had angiograms that were evaluated by the core laboratory, and 45.2%, 16.1%, and 29% were graded as Tosaka class I, II and III, respectively. There were no significant differences (p>0.05) in lesion length, degree of calcification or dissection class between the three groups. Tack restenotic lesion classification and analysis show a prevalence of both class I and shorter lesions relative to in-stent restenosis, which may be beneficial to long-term patient outcomes.

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Long-term clinical effectiveness of a drug-coated balloon for in-stent restenosis in Femoropopliteal lesions

CVIR Endovascular ◽

10.1186/s42155-021-00205-x ◽

2021 ◽

Vol 4 (1) ◽

Author(s):

Kazunori Horie ◽

Akiko Tanaka ◽

Kenji Suzuki ◽

Masataka Taguri ◽

Naoto Inoue

Keyword(s):

Clinical Effectiveness ◽

Target Lesion ◽

Major Amputation ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Level Of Evidence ◽

Stent Restenosis ◽

All Cause Mortality ◽

Based Medicine ◽

In Stent Restenosis

Abstract Background The short-term efficacy of paclitaxel-coated balloons (PCBs) has been established in femoropopliteal in-stent restenosis (ISR) lesions. The aim of this study was to compare 5-year clinical outcomes of patients with femoropopliteal ISR lesions undergoing percutaneous transluminal angioplasty (PTA) with and without PCB. Methods After 1:1 propensity score matching, we extracted 50 patients with femoropopliteal ISR lesions undergoing PTA with (n = 25) and without (n = 25) IN.PACT PCB (Medtronic, Minneapolis, MN) from 106 consecutive ISR patients treated in our hospital between 2009 and 2015. We compared the 5-year outcomes between PCB and non-PCB groups. The primary endpoint was the cumulative 5-year incidence of recurrent restenosis. All-cause mortality, target lesion revascularization (TLR) and unplanned major amputation were also assessed. Results The primary patency after PCB treatment at 5 years was significantly higher than the patency after non-PCB treatment (65.7% vs. 18.7%; hazard ratio [HR]: 6.11; 95% confidence intervals [CI]: 2.57–16.82; p < 0.001), as well as freedom from TLR (77.6% vs. 53.8%; HR: 3.55; 95% CI: 1.21–12.83; p = 0.020). All-cause mortality and unplanned major amputation rates did not significantly differ between the two groups. The Cox proportional hazard multivariate analysis showed that PCB was independently associated with preventing recurrent restenosis (HR: 0.17; 95% CI: 0.06–0.41; p < 0.001). Conclusions At 5 years, patients with femoropopliteal ISR lesions undergoing PCB treatment showed significantly lower recurrent restenosis than those that underwent non-PCB treatment. Evidence-based medicine Level of Evidence: Level 2b, Non-randomized controlled cohort/follow-up study.

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Arterial Preparation by Longitudinal Micro-Incisions Before Balloon Angioplasty of the Superficial Femoral and Popliteal Artery: Acute and 12-Month Results

Journal of Endovascular Therapy ◽

10.1177/15266028211057089 ◽

2021 ◽

pp. 152660282110570

Author(s):

Jean-Baptiste Dexpert ◽

Daniel Hayoz ◽

Rolf P. Engelberger ◽

Caroline Krieger ◽

Marie-Antoinette Rey Meyer ◽

...

Keyword(s):

De Novo ◽

Arterial Disease ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Target Lesion Revascularization ◽

Lesion Length ◽

Stent Restenosis ◽

Stent Length ◽

Peripheral Arterial ◽

Vessel Preparation

Purpose: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. Materials and Methods: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. Results: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%–100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10–480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. Conclusion: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.

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JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study

Journal of Endovascular Therapy ◽

10.1177/1526602820951916 ◽

2020 ◽

pp. 152660282095191

Author(s):

Nicolas W. Shammas ◽

Nicholas Petruzzi ◽

Steven Henao ◽

Ehrin J. Armstrong ◽

Thomas Shimshak ◽

...

Keyword(s):

Target Lesion ◽

Lesion Length ◽

Chronic Total Occlusions ◽

Stent Restenosis ◽

Kaplan Meier ◽

Class D ◽

Secondary Endpoints ◽

Drug Eluting ◽

One Year ◽

In Stent Restenosis

Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR ( ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

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Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial

Journal of Endovascular Therapy ◽

10.1177/1526602820907917 ◽

2020 ◽

Vol 27 (2) ◽

pp. 276-286

Author(s):

Gunnar Tepe ◽

Henrik Schroeder ◽

Thomas Albrecht ◽

Peter Reimer ◽

Nicolas Diehm ◽

...

Keyword(s):

Single Dose ◽

Randomized Study ◽

Target Lesion ◽

Lesion Length ◽

Double Dose ◽

Stent Restenosis ◽

Late Lumen Loss ◽

Drug Coated Balloon ◽

In Stent Restenosis

Purpose: To investigate the efficacy and sustainability of drug-coated balloon (DCB) treatment of femoropopliteal in-stent restenosis (ISR). Materials and Methods: An investigator-initiated, prospective, multicenter, 1:1 randomized study enrolled 88 patients for treatment of ISR with DCB (n=47; mean age 68.3±9.6 years; 26 men) or uncoated balloon (n=41; mean age 67.6±10.2 years; 26 men) angioplasty ( ClinicalTrials.gov identifier NCT01594684). Additionally, the protocol provided for an observational arm composed of patients from either randomized arm who experienced recurrent ISR ≥30 days after the index treatment. Redo treatment consisted of 2 DCBs sequentially inflated at the same location (double dose therapy). The majority of patients (66, 78%) had Rutherford category 3 ischemia. The mean lesion length was 140 mm; a third (27, 31%) were total occlusions. The primary endpoint was angiographic late lumen loss (LLL) at 6 months evaluated by an independent core laboratory. Results: Twenty-two patients (7 DCB +15 uncoated) were treated for recurrence with fully overlapping double DCB angioplasty. Six-month LLL was lower after DCB (0.34±1.12 mm) treatment than after angioplasty with an uncoated balloon (1.58±1.10 mm, p<0.001). At the 12-month follow-up, target lesion revascularization (TLR) was performed in 18 (49%) of 37 patients in the uncoated group, 6 (14%) of 43 patients in the single-dose DCB group (p=0.001), and no patients from the recurrent ISR group. At ~2 years after treatment, a remarkable number (14/27, 52%) of TLRs were recorded in the single-dose DCB group. Conclusion: Treatment with DCBs resulted in significantly less 6-month LLL and fewer TLRs up to 24 months than treatment with uncoated balloons. The double dose for treating recurrent ISR did not cause recognizable adverse events or require TLR up to 24 months.

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Drug-Coated Balloon for the Treatment of Femoropopliteal Tosaka Class III In-stent Restenosis Lesions

Frontiers in Surgery ◽

10.3389/fsurg.2020.616414 ◽

2021 ◽

Vol 7 ◽

Author(s):

Bihui Zhang ◽

Guochen Niu ◽

Ziguang Yan ◽

Yinghua Zou ◽

Xiaoqiang Tong ◽

...

Keyword(s):

Clinical Symptoms ◽

Ankle Brachial Index ◽

Primary Patency ◽

Lesion Length ◽

Efficacy And Safety ◽

Class Iii ◽

Stent Restenosis ◽

Drug Coated Balloon ◽

In Stent Restenosis

Background: To date, there have been few studies examining the efficacy and safety of drug-coated balloon (DCB) angioplasty in the treatment of Tosaka class III in-stent restenosis (ISR) lesions in the clinical setting. Therefore, this study aimed to investigate the clinical efficacy and safety of DCBs in patients with Tosaka class III ISR femoropopliteal lesions.Methods: This single-center study enrolled 28 femoropopliteal ISR Tosaka III patients who were treated by DCB angioplasty from September 2016 to September 2018. The patency, the freedom from target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints were analyzed during a 14-month follow-up period.Results: Out of the 28 patients, 32.1% presented with critical limb ischemia. The mean lesion length was 250.4 ± 93.9 mm. Technical success was achieved in all lesions (100%). Debulking devices were used in 50% of lesions, and bailout stents were performed in 3.6% of patients. Kaplan Meier estimates that the 14-month primary patency was 79.2% (95% CI 60.6–97.8%), whereas the freedom from TLR rate was 91.5% (95% CI 80.1–100%). Clinical symptoms improved by at least 1 Rutherford category in 82.1% of limbs. The ankle-brachial index (ABI) values improved from 0.51 ± 0.30 to 1.05 ± 0.22 at the final follow-up (P < 0.001). The rate of freedom from 30-day major adverse limb events (MALEs) was 100%. The mortality rate was 7.1%.Conclusion: These results suggested that the use of DCBs is safe and effective in treating femoropopliteal Tosaka class III ISR lesions.

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Abstract 11845: Impaired Peripheral Endothelial Function Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis

Circulation ◽

10.1161/circ.130.suppl_2.11845 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Naohiro Komura ◽

Kenichi Tsujita ◽

Kenshi Yamanaga ◽

Kenji Sakamoto ◽

Takashi Miyazaki ◽

...

Keyword(s):

Endothelial Function ◽

Prognostic Value ◽

Reactive Hyperemia ◽

Characteristic Analysis ◽

Peripheral Arterial Tonometry ◽

Stent Restenosis ◽

Arterial Tonometry ◽

Stent Length ◽

Peripheral Arterial ◽

In Stent Restenosis

Introduction: Drug-eluting stents (DESs) are replacing bare-metal stents (BMSs), but in-stent restenosis (ISR) remains a problem. Impaired endothelial function is a key event in the atherosclerosis process and a predictor of future cardiovascular events. Reactive hyperemia index (RHI) assessed by peripheral arterial tonometry (PAT) evaluates endothelial function noninvasively. Hypothesis: We prospectively assessed the prognostic value of RHI in predicting ISR after percutaneous coronary intervention (PCI). Methods: RHI was measured using Endo-PAT 2000 before PCI (initial RHI) and at follow-up angiography (F/U RHI) in 249 consecutive patients who had successful PCI. F/U angiography was performed at six and nine months after PCI with BMS and DES, respectively. ISR was defined as percent diameter stenosis >50% at F/U angiography assessed by quantitative coronary angiography. Results: At F/U, ISR was seen in 68 patients (27.3%). F/U ln(RHI) was significantly lower in patients with ISR than in those without (0.52 ± 0.23 vs. 0.65 ± 0.27, p < 0.01); no between-group difference in initial ln(RHI) was seen (0.60 ± 0.26 vs. 0.62 ± 0.25, p = 0.56). By multivariate logistic regression analysis, even after adjusting for other significant parameters in univariate analysis (BMS use, total stent length, HDL-Cholesterol, HbA1c, calcium antagonist use, and post-PCI minimum lumen diameter), F/U ln(RHI) independently predicted ISR (odds ratio: 0.13; 95% confidence interval [CI]: 0.04-0.48; p = 0.002). In receiver operating-characteristic analysis, F/U RHI was the strongest predictor of ISR (area under the curve [AUC]: 0.67; 95% CI: 0.60-0.75; p < 0.01; RHI < 1.73 had 67.6% sensitivity, 64.1% specificity); AUC significantly improved from 0.62 to 0.70 when RHI was added to traditional ISR risk factors (diabetes mellitus, total stent length, minimum stent diameter) (p = 0.02). Net reclassification index was significant after addition of RHI (26.5%, p = 0.002). Conclusions: To our knowledge, this is the first study indicating that impaired RHI at F/U angiography independently predicts occurrence of ISR. The simple and noninvasive assessment of endothelial function by RH-PAT adds incremental prognostic value to ISR-risk stratification following PCI.

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