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Efficacy and Safety of Polymer-Free Ultrathin Strut Sirolimus-Probucol Coated Drug-Eluting Stents for Chronic Total Occlusions: Insights from the Coroflex ISAR 2000 Worldwide Registry.

1. Introduction

The prevalence of chronic total occlusion (CTO) is reported to be around 18.4% among patients with significant coronary artery disease [1]. Of these CTO patients, only 36% underwent percutaneous revascularization [1]. The lack of predictability in terms of procedural success and vessel patency post percutaneous coronary interventions (PCI) have made CTO revascularization not as attractive as non-total occlusive lesions. Furthermore, the failure rate of CTO revascularization is reported to be around 40% [2,3]. However, the development of new CTO guidewires and techniques together with the use of new generation DES in CTO revascularization has increased the procedural success and safety to the level similar to non-CTO revascularization [4-6].

Ultrathin strut polymer-free, sirolimus-probucol coated drug-eluting stents (PF-SES) are safe and effective in large scale all-comers population with low rate of target lesion revascularization (TLR) [7]. The polymer-free matrix of these stents consists of sirolimus and its matrix builder probucol. Their safety and efficacy have been proven similar to the one reported with zotarolimus stents in ISAR-TEST 5 trial [8]. The objective of this study was to assess the safety and efficacy of PF-SES in the treatment of "real-world" denovo and restenotic CTO lesions.

2. Methods

2.1. Patient Population and Centers. The ISAR 2000 all-comers registry (http://ClinicalTrials.gov identifier NCT02629575) is a prospective data collection of patients in 26 Asian (South Korea and Malaysia) and 36 European (Czech Republic, France, Germany, Slovakia, and Spain) cardiac centers.

2.2. Inclusion and Exclusion Criteria. Patients 18 years or older with stable angina, objective evidence of myocardial ischemia, and acute coronary syndrome (ACS) who met the requirement for PCI [9] were recruited into the international ISAR 2000 all-comers registry. However, for this study, we only selected patients who were treated for CTO lesions (de novo or restenotic). The numbers of stents or treated vessels with reference vessel diameters from 2.0 mm to 4.0 mm were not limited.

2.3. Stents, Periprocedure Details, and Medications. PF-SES (Coroflex ISAR, B. Braun Melsungen, Melsungen AG, Germany) were implanted according to each institution's guidelines and in accordance with proper indications for national reimbursement. The polymer-free stent platform consists of a premounted, thin strut (50/60 [micro]m) cobaltchromium stent whose abluminal surface only is sandblasted to permit a microporous surface for the polymer-free matrix consisting of sirolimus and probucol. Sirolimus with a concentration of 1.2 [micro]g/[mm.sup.2] is available on the abluminal stent surface only. Sirolimus is the active antiproliferative drug whereas the anti-inflammatory probucol is an excipient which controls the release of sirolimus. Probucol mimics the function of a polymer by retarding the sirolimus release.

Vascular accesses via the femoral or radial artery were both permitted with a recommended introducer sheath of at least 5 Fr in diameter. The technique of stent implantation was up to the operators' discretion. Intravenous heparin (70 IU/kg) was given to all patients and supplemented on an as-needed basis. Platelet aggregation inhibitor loading was not mandatory but recommended if possible prior to PCI according to institutional preferences of the cardiac center.

The use of various antiplatelet inhibition agents (6 months or more) such as clopidogrel (75 mg/day), prasugrel (10 mg/day), or ticagrelor (90 mg twice daily) was permissible (as recommended by the treating physician) while acetylsalicylic acid 100-325 mg daily was prescribed life-long.

2.4. Data Collection. To handle the wealth of the data, an electronic data capture system was used. This database was previously used in prior large scale unselected patient cohorts [10, 11] and also used for this assessment [7]. The national principal investigators in each country verified the accuracy of the data when routinely performed web-based plausibility checks indicated any discrepancies. To assure the data quality, automatic queries were sent directly to the investigators.

2.5. Endpoints and Definitions. The primary endpoint was the 9-month clinically driven target lesion revascularization (TLR) rate, whereas secondary endpoints were the 9-month major adverse cardiac events (MACE) rate, the in-hospital MACE rate, and the corresponding rates of myocardial infarction (MI) and TLR (coronary artery bypass grafting and percutaneous coronary intervention). Cardiac death was only defined in-hospital, whereas the all-cause death rate was used to define MACE at 9 months (MI, TLR, in-hospital cardiac death, and all deaths post discharge). The Academic Research Consortium (ARC) criteria were used to define acute/subacute stent thrombosis [12].

For simplicity reason and based on a previous protocol [10], a glomerular filtration rate (GFR) of <90 mL/min/1.73 [m.sup.2] with a cut-off GFR rate for mandatory dialysis of <15 mL/ min/1.73 [m.sup.2] was used to define renal insufficiency. The angulation criterion of >45[degrees] was used to define severe vessel tortuosity.

2.6. Statistical Analysis. The statistical methods were also reported elsewhere [7]. The two-sided Fisher's exact and chisquared tests were used for categorical variables. In case the Shapiro-Wilk test revealed a strong deviation from a normal distribution, the Mann-Whitney test was used instead of the unpaired t-test. A cut-off p value of 0.05 was considered statistically significant. Statistical analyses were conducted with SPSS V. 24.0 (IBM Munich, Germany). The biometric estimate in the original study [7] was calculated with nQuery/nTerim V.2.0 Advisor (Statistical Solutions Ltd, Cork, Ireland).

2.7. Ethical Approval. Ethics committees of all participating centers approved the study protocol prior to patient recruitment. In France, this noninterventional study was nationally approved by Comite Consultative sur le Traitement de I'Information en matiere de Recherche dans le domaine de la Sante (CTIRS dossier number 14.613) and the Commission Nationale de I'informatique et des Libertes (CNIL, demande d'autorisation number 915019).

3. Results

3.1. Patient Characteristics. A total of 111 patients with CTO (Table 1) were enrolled in the international ISAR 2000 all-comers registry which had an overall recruitment of 2877 patients [7]. This amounted to 3.6% (111/2977) of the overall patient cohort. They were stratified into two groups: patients with lesions < 25 mm and [greater than or equal to]25 mm in length. Patient baseline characteristics are described in Table 1. Mean age for the cohort with CTO was 64.9 years. Diabetes mellitus was present in 45.0% (50/111) of patients who were predominantly male (73.9%, 82/111). The rate of acute coronary syndrome (ACS) in CTO cohort; STEMI and NSTEMI were 8.1% (9/111) and 12.6% (14/111), respectively. In general, the two groups were not significantly different in terms of their baseline characteristics except for higher rate of hypertension in the [greater than or equal to]25 mm lesion length group (79.0% versus 61.2%, p = 0.040).

3.2. Lesion Characteristics and Procedural Data. There were 127 CTO lesions (Table 2) which were treated with PF-SES which constituted 3.9% (127/3254) of the total number of lesions in ISAR 2000 all-comers registry [7]. Revascularizations in the right coronary artery (RCA) were most common as compared to the left anterior descending (LAD) and left circumflex artery (LCx), that is, 43.3% versus 29.1% versus 27.6% (p = 0.005). Of note were the significant differences in lesion characteristics between the short and the long lesion length groups. Diffuse disease (55.2% versus 73.9%, p = 0.027), instent restenosis (1.7% versus 15.9%, p = 0.006) and B2/C morphologies (89.7% versus 100.0%, p = 0.006) were more frequent in lesions [greater than or equal to]25 mm in length. The average lesion lengths were 16.9 mm versus 35.2 mm, and the average DES lengths were 20.3 mm versus 36.9 mm. The overall technical success rate of PF-SES implantations in CTO lesions was high with 99.2% with no significant differences between groups (p = 0.357).

3.3. PeriProcedural Medications. Preprocedural antiplatelet therapy (Tables 3 and 4) did not differ between the two groups (Table 3). Clopidogrel remained the most preferred P2Y12 inhibitor to combine with aspirin as preprocedural dual antiplatelet therapy (DAPT) regime. The same DAPT distribution consisting of 55-60% clopidogrel, 15% prasugrel, and 10-15% ticagrelor was documented in both subgroups (Table 3). The average duration of DAPT duration was 9.7 months without differences between the groups (Table 4). Most of the patients were treated with DAPT for at least 6 months. There was only one patient exposed to oral anticoagulant in this cohort.

3.4. Clinical Outcomes. At 9 months, there were two patients (2%, 2/101) with TLR (primary endpoint). The rates of acute myocardial infarction (MI) and all-cause death at 9 months were 2% (2/101) and 3% (3/101), respectively. Hence, the composite MACE rate at 9 months was 5.9% (6/101). The in-hospital follow-up was event free except for one acute MI (1%, 1/111). There seems to be a higher 9-month MACE rate for the >25 mm lesion group, but the difference did not reach statistical significance (p = 0.536). There was no report of acute, subacute, or late stent thrombosis (Table 5).

4. Discussions

Despite the conflicting data regarding the clinical benefit [3,4], CTO revascularizations are associated with better clinical outcomes as those in patients with low ejection fraction or ischemic burden [13-15]. Data on long-term outcomes also show lower mortality in patients with successful CTO PCI [16-18].

Unfortunately, due to the technical complexity, relatively lower procedure success rates, and higher periprocedural complications [2,3], CTO-PCI from the outset is not as appealing as PCI in less complex coronary lesions. Predictors of unsuccessful PCI are identified to be absence of tapered stump structure, TIMI flow grade 0 pre-PCI, high serum creatinine concentrations, and lesion length [19]. However, with the ever-improving PCI techniques and dedicated devices, CTO-PCI has seen significant improvement in terms of procedural success [4-6].

For patients to benefit long term and to justify the risk of CTO-PCI, to maintain the target vessel patency is important. A large CTO registry of 800 patients with 6- to 9-month angiographic follow-up reported a reocclusion rate of 7.5% [20]. This study demonstrated the importance of the choice of stents used in maintaining vessel patency. The use of DES in the registry dramatically reduced both reocclusion and nonocclusive angiographic restenosis compared to BMS [21]. The overall restenosis rate of DES in CTO was 11% [21]. A randomized controlled trial also reported that there is a 55% relative risk reduction (RRR) in MACE with the use of DES compared to BMS in CTO PCI [22].

Our study described the outcomes of CTO-PCI from "real-world" data using polymer-free ultrathin strut sirolimus-probucol coated drug-eluting stents (PF-SES). CTO-PCIs in this study were conducted in various centers with a broad spectrum of operator experience and revascularization techniques. Overall, the results of this study reflect the unrestricted, day-to-day practice from various European and Asian centers in the treatment of CTO.

The outcome of CTO lesions stented with PF-SES from this study is encouraging. The overall 9-month TLR rate of both <25 mm and >25 mm CTO lesions is low at around 2%. We did not observe any acute, subacute, or late stent thrombosis in this study. The MACE rate at 9-month follow-up is also favorably low at 5.9% (4.3% for lesions < 25 mm and 7.3% for lesions > 25 mm, p = 0.358). By crude comparison, the EXPERT-CTO trial of XIENCE reported a clinically driven TLR rate of 6.3% and 0.9% subacute stent thrombosis and 0.5% late probable stent thrombosis at one year [23].

5. Conclusion

The results support the use of PF-SES as an efficacious and safe therapeutic option in the treatment of CTO. The result at least for short term (9 months) is promising, and a longer follow-up would be of interest to determine if PF-SES angioplasty is able to maintain vessel patency in the long-term (>1 year).

5.1. Strengths and Limitations of This Study. The CTO cohort in this study was extracted from the largest all-comers registry under routine use of PF-SES, which can be safely and effectively implanted with favorable rates of TLR and MACE. The data suggest that the use of PF-SES in high-risk patients with complex lesions (diabetes mellitus, ACS, diffuse disease, and CTO) is feasible. However, since this is a subgroup analysis from a "real-world" observational study, data collection and monitoring may not have been as stringent as in randomized control trials with the possibility of some underreporting of events. Although the number of patients reported in this assessment was small, the results nevertheless described the potential of PF-SES performance in the specific cohort of CTO patients. It also would have been useful to provide more details on the chronic kidney disease stages relative to their glomerular filtration rates, which was not done in this assessment. Likewise, the use of the J-SCORE and/or the time course of the occlusion along with the lesion crossing (antegrade/retrograde) would have helped to provide additional details of the performed CTO recanalization.

https://doi.org/10.1155/2018/8053168

Conflicts of Interest

Florian Krackhardt received lecturing fees, and Matthias W. Waliszewski and Michael Boxberger served full time employment at the Department of Medical Scientific Affairs, B. Braun Melsungen AG.

Authors' Contributions

Ahmad Syadi Mahmood Zuhdi and Muhammad Dzafir Ismail drafted and prepared the manuscript. Florian Krackhardt, Matthias W. Waliszewski, and Michael Boxberger contributed to the conception, design, data analysis, and interpretation. Wan Azman Wan Ahmad critically revised the manuscript for submission. All authors gave final approval of the version to be published.

Acknowledgments

The authors would like to express gratitude to Denny Herberger (Germany) and Ms. Zoey Hooi (Malaysia) for their relentless efforts providing regulatory and logistic support to conduct this study.

References

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[23] D. E. Kandzari, A. S. Kini, D. Karmpaliotis et al., "Safety and effectiveness of everolimus-eluting stents in chronic total coronary occlusion revascularization: results from the EXPERT CTO multicenter trial (Evaluation of the XIENCE coronary stent, performance, and technique in chronic total occlusions)," JACC: Cardiovascular Interventions, vol. 8, no. 6, pp. 761-769, 2015.

Ahmad Syadi Mahmood Zuhdi, (1) Florian Krackhardt, (2) Matthias W. Waliszewski, (2,3) Muhammad Dzafir Ismail [ID], (1) Michael Boxberger, (3) and Wan Azman Wan Ahmad (1)

(1) Cardiology Unit, University Malaya Medical Centre, 59100 Kuala Lumpur, Malaysia

(2) Department of Cardiology and Internal Medicine, Charite-Universitats Medizin Berlin, Campus Virchow, Berlin, Germany

(3) Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany

Correspondence should be addressed to Muhammad Dzafir Ismail; dzafir@ummc.edu.my

Received 30 October 2017; Revised 5 January 2018; Accepted 11 January 2018; Published 1 March 2018

Academic Editor: Terrence D. Ruddy
Table 1: Patient demographics.

Variable                        Patients, n (%)       <25 mm lesion
                                                      length, n (%)

Number of patients                 111 (100%)            49 (44.1%)
Number of lesions                  127 (100%)            58 (45.7%)
Number of DES used                 160 (100%)            65 (40.6%)
Age (years)                    64.9 [+ or -] 11.6    64.8 [+ or -] 12.3
Male gender                        82 (73.9%)            35 (71.4%)
Diabetes                           50 (45.0%)            19 (38.8%)
Hypertension                       79 (71.2%)            30 (61.2%)
Renal insufficiency                 6 (5.4%)              3 (6.1%)
Dialysis dependence                 1 (0.9%)              0 (0.0%)
STEMI                               9 (8.1%)              2 (4.1%)
NSTEMI                             14 (12.6%)             8 (16.3%)
Region                Europe       71 (64.0%)            29 (59.2%)
                       Asia        40 (36.0%)            20 (40.8%)

Variable                       [greater than or equal to]25    p value
                                  mm lesion length, n (%)

Number of patients                      62 (55.8%)               --
Number of lesions                       69 (54.3%)               --
Number of DES used                      95 (59.4%)               --
Age (years)                         65.0 [+ or -] 11.0          0.942
Male gender                             47 (75.8%)              0.602
Diabetes                                31 (50.0%)              0.238
Hypertension                            49 (79.0%)              0.040
Renal insufficiency                      3 (4.8%)               0.766
Dialysis dependence                      1 (1.6%)               0.372
STEMI                                    7 (11.3%)              0.257
NSTEMI                                   6 (9.7%)
Region                Europe            42 (67.7%)              0.351
                       Asia             20 (32.3%)

Table 2: Lesion characteristics and procedural data.

Variable                                 Patients, n (%)

Number of lesions                           127 (100%)
                               LAD          37 (29.1%)
Target vessel                  LCx          35 (27.6%)
                               RCA          55 (43.3%)
                              Graft          0 (0.0%)
                            1-vessel       103 (81.1%)
Multivessel disease         2-vessels       22 (17.3%)
                            3-vessels        2 (1.6%)
Thrombus burden                             10 (7.9%)
Diffuse vessel disease                      83 (65.4%)
Calcification                               54 (42.4%)
Ostial lesion                                9 (7.1%)
Bifurcations                                 8 (6.3%)
In-stent restenosis                         12 (9.4%)
Severe tortuosity                           17 (13.4%)
AHA/ACC type B2/C lesion                   121 (95.3%)
Reference diameter (mm)                 2.76 [+ or -] 0.40
Lesion length (mm)                      26.8 [+ or -] 13.1
DESs used                                   160 (100%)
DES per patient                          1.8 [+ or -] 1.3
DES diameter (mm)                        2.7 [+ or -] 0.4
DES length (mm)                         29.4 [+ or -] 15.8
DES inflation                           14.3 [+ or -] 3.4
pressure (atm)
Final result (% stenosis)               4.9 [+ or -] 11.3
Overall technical success                  126 (99.2%)
per lesion

Variable                                <25 mm lesion length,
                                                n (%)

Number of lesions                            58 (45.7%)
                               LAD           15 (25.9%)
Target vessel                  LCx           24 (41.4%)
                               RCA           19 (32.8%)
                              Graft           0 (0.0%)
                            1-vessel         46 (79.3%)
Multivessel disease         2-vessels        10 (17.2%)
                            3-vessels         2 (3.4%)
Thrombus burden                               5 (8.6%)
Diffuse vessel disease                       32 (55.2%)
Calcification                                24 (41.4%)
Ostial lesion                                 5 (8.6%)
Bifurcations                                  5 (8.6%)
In-stent restenosis                           1 (1.7%)
Severe tortuosity                             7 (12.1%)
AHA/ACC type B2/C lesion                     52 (89.7%)
Reference diameter (mm)                   2.7 [+ or -] 0.4
Lesion length (mm)                        16.9 [+ or -] 4.5
DESs used                                    65 (40.6%)
DES per patient                           1.4 [+ or -] 1.2
DES diameter (mm)                         2.7 [+ or -] 0.4
DES length (mm)                           20.3 [+ or -] 8.4
DES inflation                             14.5 [+ or -] 3.2
pressure (atm)
Final result (% stenosis)                 5.7 [+ or -] 14.6
Overall technical success                    58 (100.0%)
per lesion

Variable                                [greater than or equal to]25
                                           mm lesion length, n (%)

Number of lesions                                 69 (54.3%)
                               LAD                22 (31.9%)
Target vessel                  LCx                11 (15.9%)
                               RCA                36 (52.2%)
                              Graft                0 (0.0%)
                            1-vessel              57 (82.6%)
Multivessel disease         2-vessels             12 (17.4%)
                            3-vessels              0 (0.0%)
Thrombus burden                                    5 (7.2%)
Diffuse vessel disease                            51 (73.9%)
Calcification                                     30 (43.5%)
Ostial lesion                                      4 (5.8%)
Bifurcations                                       3 (4.3%)
In-stent restenosis                               11 (15.9%)
Severe tortuosity                                 10 (14.5%)
AHA/ACC type B2/C lesion                         69 (100.0%)
Reference diameter (mm)                        2.8 [+ or -] 0.4
Lesion length (mm)                            35.2 [+ or -] 11.9
DESs used                                         95 (59.4%)
DES per patient                                2.1 [+ or -] 1.4
DES diameter (mm)                              2.7 [+ or -] 0.4
DES length (mm)                               36.9 [+ or -] 16.5
DES inflation                                 14.2 [+ or -] 3.5
pressure (atm)
Final result (% stenosis)                      4.3 [+ or -] 7.7
Overall technical success                         68 (98.6%)
per lesion

Variable                                p value

Number of lesions                         --
                               LAD
Target vessel                  LCx       0.005
                               RCA
                              Graft
                            1-vessel
Multivessel disease         2-vessels    0.298
                            3-vessels
Thrombus burden                          0.775
Diffuse vessel disease                   0.027
Calcification                            0.812
Ostial lesion                            0.537
Bifurcations                             0.324
In-stent restenosis                      0.006
Severe tortuosity                        0.689
AHA/ACC type B2/C lesion                 0.006
Reference diameter (mm)                  0.059
Lesion length (mm)                      <0.001
DESs used                                 --
DES per patient                          0.008
DES diameter (mm)                        0.690
DES length (mm)                         <0.001
DES inflation                            0.638
pressure (atm)
Final result (% stenosis)                0.478
Overall technical success                0.357
per lesion

Table 3: Periprocedural drug therapy.

Drug type                                         Drug

                                              Clopidogrel
                                               Prasugrel
            Antiplatelet therapy               Ticagrelor
                    (APT)                     Ticlopidine
Pre-PCI                                       Aspirin only
                                             No preloading
                                                All OAC
            Oral anticoagulation       Vitamin K antagonist (VKA)
                    (OAC)           New oral anticoagulation (NOAC)
                                              Clopidogrel
            Antiplatelet therapy               Prasugrel
Post-PCI            (APT)                      Ticagrelor
                                              Aspirin only
                                                Unknown

Drug type                           Patients,    <25 mm lesion
                                      n (%)      length, n (%)

                                    59 (53.9%)     29 (59.2%)
                                    18 (16.2%)     7 (14.3%)
            Antiplatelet therapy    12 (10.8%)     7 (14.3%)
                    (APT)            1 (0.9%)       0 (0.0%)
Pre-PCI                             10 (9.0%)       2 (4.1%)
                                    11 (9.9%)       4 (8.2%)
                                     1 (0.9%)       1 (2.0%)
            Oral anticoagulation     0 (0.0%)       0 (0.0%)
                    (OAC)            1 (0.9%)       1 (2.0%)
                                    92 (82.9%)     40 (81.6%)
            Antiplatelet therapy     4 (3.6%)       0 (0.0%)
Post-PCI            (APT)           12 (10.8%)     4 (16.3%)
                                     1 (0.9%)       0 (0.0%)
                                     2 (1.8%)       1 (2.0%)

Drug type                           [greater than or equal to]25
                                       mm lesion length, n (%)

                                              30 (48.4%)
                                              11 (17.7%)
            Antiplatelet therapy               5 (8.1%)
                    (APT)                      1 (1.6%)
Pre-PCI                                       8 (12.9%)
                                              7 (11.3%)
                                               0 (0.0%)
            Oral anticoagulation               0 (0.0%)
                    (OAC)                      0 (0.0%)
                                              52 (83.9%)
            Antiplatelet therapy               4 (6.5%)
Post-PCI            (APT)                      4 (6.5%)
                                               1 (0.9%)
                                               1 (0.9%)

Drug type                           p value

            Antiplatelet therapy     0.391
                    (APT)
Pre-PCI

                                     0.258
            Oral anticoagulation
                    (OAC)            0.258

            Antiplatelet therapy
Post-PCI            (APT)            0.167

Table 4: Recommended duration of dual antiplatelet therapy during
follow-up.

Variable                  Patients, n (%)    <25 mm lesion length,
                                                     n (%)

Number of patients           111 (100%)           49 (44.1%)
DAPT duration in months   9.7 [+ or -] 2.8     9.8 [+ or -] 2.8
1 month                       1 (0.9%)             1 (2.0%)
1-3 months                    0 (0.0%)             0 (0.0%)
3-6 months                    0 (0.0%)             0 (0.0%)
6 months                     30 (27.0%)           11 (22.4%)
>6-12 months                  8 (7.2%)             4 (8.2%)
12 months                    50 (45.0%)           20 (40.8%)
> 12 months                   0 (0.0%)             0 (0.0%)
Unknown status               22 (19.8%)           13 (26.5%)

Variable                  [greater than or equal to]25     p value
                             mm lesion length, n (%)

Number of patients                  62 (55.8%)               --
DAPT duration in months          9.6 [+ or -] 2.9           0.773
1 month                              0 (0.0%)
1-3 months                           0 (0.0%)
3-6 months                           0 (0.0%)
6 months                            19 (30.4%)              0.355
>6-12 months                         4 (6.5%)
12 months                           30 (48.4%)
> 12 months                          0 (0.0%)
Unknown status                      9 (14.5%)

Table 5: Clinical outcomes.

Variable                                 Patients, n (%)

Number of patients                         111 (100%)
Patients with clinical follow-up           101 (91.0%)
at 9 months or early event
Follow-up time (months)                 8.7 [+ or -] 2.5
Time to discharge median (IQR)          4.5 [+ or -] 16.5
(days)
In-hospital MACE                            1 (1.0%)
In-hospital TLR                             0 (0.0%)
In-hospital MI                              1 (1.0%)
In-hospital cardiac death                   0 (0.0%)
9-month MACE                                6 (5.9%)
9-month TLR (Re-PCI/CABG)                   2 (2.0%)
9-month MI                                  2 (2.0%)
9-month death all causes                    3 (3.0%)
9-month accumulated definite/probable       0 (0.0%)
stent thrombosis
Acute stent thrombosis, [less than or       0 (0.0%)
equal to]24 hours
Subacute stent thrombosis, 1-30 days        0 (0.0%)
Late stent thrombosis, [greater than        0 (0.0%)
or equal to]30 days
BARC 1-5                                    6 (5.9%)
BARC 2-5                                    2 (2.0%)
BARC 3-5                                    0 (0.0%)

Variable                                <25 mm lesion length,
                                                n (%)

Number of patients                           49 (44.1%)
Patients with clinical follow-up             46 (93.6%)
at 9 months or early event
Follow-up time (months)                   8.1 [+ or -] 2.2
Time to discharge median (IQR)            3.2 [+ or -] 5.7
(days)
In-hospital MACE                              0 (0.0%)
In-hospital TLR                               0 (0.0%)
In-hospital MI                                0 (0.0%)
In-hospital cardiac death                     0 (0.0%)
9-month MACE                                  2 (4.3%)
9-month TLR (Re-PCI/CABG)                     1 (2.2%)
9-month MI                                    0 (0.0%)
9-month death all causes                      1 (2.2%)
9-month accumulated definite/probable         0 (0.0%)
stent thrombosis
Acute stent thrombosis, [less than or         0 (0.0%)
equal to]24 hours
Subacute stent thrombosis, 1-30 days          0 (0.0%)
Late stent thrombosis, [greater than          0 (0.0%)
or equal to]30 days
BARC 1-5                                      1 (2.2%)
BARC 2-5                                      0 (0.0%)
BARC 3-5                                      0 (0.0%)

Variable                                [greater than or equal to]25
                                           mm lesion length, n (%)

Number of patients                                62 (55.8%)
Patients with clinical follow-up                  55 (88.7%)
at 9 months or early event
Follow-up time (months)                        9.2 [+ or -] 2.6
Time to discharge median (IQR)                5.6 [+ or -] 21.7
(days)
In-hospital MACE                                   1 (1.8%)
In-hospital TLR                                    0 (0.0%)
In-hospital MI                                     1 (1.8%)
In-hospital cardiac death                          0 (0.0%)
9-month MACE                                       4 (7.3%)
9-month TLR (Re-PCI/CABG)                          1 (1.8%)
9-month MI                                         2 (3.6%)
9-month death all causes                           2 (3.6%)
9-month accumulated definite/probable              0 (0.0%)
stent thrombosis
Acute stent thrombosis, [less than or              0 (0.0%)
equal to]24 hours
Subacute stent thrombosis, 1-30 days               0 (0.0%)
Late stent thrombosis, [greater than               0 (0.0%)
or equal to]30 days
BARC 1-5                                           5 (9.1%)
BARC 2-5                                           2 (3.6%)
BARC 3-5                                           0 (0.0%)

Variable                                p value

Number of patients                        --
Patients with clinical follow-up         0.345
at 9 months or early event
Follow-up time (months)                  0.020
Time to discharge median (IQR)           0.45
(days)
In-hospital MACE                         0.358
In-hospital TLR                           --
In-hospital MI                           0.358
In-hospital cardiac death                 --
9-month MACE                             0.536
9-month TLR (Re-PCI/CABG)                0.898
9-month MI                               0.191
9-month death all causes                 0.666
9-month accumulated definite/probable     --
stent thrombosis
Acute stent thrombosis, [less than or
equal to]24 hours
Subacute stent thrombosis, 1-30 days      --
Late stent thrombosis, [greater than
or equal to]30 days
BARC 1-5                                 0.143
BARC 2-5                                 0.191
BARC 3-5                                  --
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Article Details
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Title Annotation:Clinical Study
Author:Zuhdi, Ahmad Syadi Mahmood; Krackhardt, Florian; Waliszewski, Matthias W.; Ismail, Muhammad Dzafir;
Publication:Cardiology Research and Practice
Geographic Code:4EUGE
Date:Jan 1, 2018
Words:5067
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