2.1

Patient selection

Valentines I included 250 patients who presented with stable or unstable angina pectoris and/or documented ischemia due to an ISR (> 50%) of a previously placed BMS or DES. Excluded were patients presenting with acute myocardial infarction (MI), short life expectancy (< 12 months), lesions requiring additional stenting prior to PCB treatment, prior radiation therapy to target vessel, and patients unable to take dual antiplatelet therapy (DAPT) for ≥ 3 months. In this analysis, we included 76 patients from the Valentines I cohort who presented with DES restenosis (identified as either paclitaxel DES or limus DES restenosis), were treated with the DIOR PCB, and had clinical follow-up data.

2.2

Interventional procedure

Enrolled patients received peri- and post-procedural aspirin (80–325 mg per day) and clopidogrel (300–600 mg loading dose, followed by 75 mg per day). Intravenous heparin was used as anticoagulation during the procedure maintained at targeted activated clotting time. The use of glycoprotein IIb/IIIa inhibitors was left to the operator’s discretion. Post procedure, DAPT was recommended for ≥ 3 months, followed by aspirin indefinitely.

Following coronary angiography, predilatation of the ISR lesion was recommended with regular short-length balloons sized to the original stent diameter in a 0.7–0.8:1 ratio. If a good angiographic result was obtained [e.g., thrombolysis in myocardial infarction (TIMI) 3 flow and residual stenosis < 30%], the DIOR balloon was inflated for ≥ 30 seconds at the lesion with an overlap of ≥ 2 mm on each edge of the predilatation balloon-treated segment. The DIOR balloon was sized to the original stent diameter in a 1:1 ratio. Special emphasis was placed on avoiding geographical miss (i.e. predilated area not covered by the PCB). Additional bailout stenting using a BMS was left to the operator’s discretion in cases of suboptimal angiographic result (TIMI flow grade < 3 and/or residual stenosis > 30%).

The second-generation DIOR PCB used in the Valentines trial contains paclitaxel as the active drug, in a concentration of 3 μg/mm ² of balloon surface using a shellac coating method. The un-inflated balloon is thrice-folded which protects the drug from early wash-off during balloon catheter insertion and tracking. The recommended inflation time is 30–45 seconds to achieve adequate paclitaxel delivery to the vessel wall. The DIOR balloon is available in lengths of 15–30 mm, and diameters of 2.0–4.0 mm.

2.3

Follow-up/end points

Clinical follow-up was performed 6–9 months after the index procedure. Outcomes were reported based on definitions included in the study protocol. The primary end point was the occurrence of major adverse cardiac events (MACE), defined as all-cause death, MI and target vessel revascularization (TVR). Vessel thrombosis follows the Academic Research Consortium criteria for stent thrombosis. MI was defined as any elevation of troponin (or other cardiac enzymes if troponin was not recorded) in combination with ischemic chest pain. Target lesion revascularization (TLR) was defined as any repeat revascularization (percutaneous or surgical) due to a restenosis in the PCB-treated segment (which includes 5 mm beyond the treated segments proximally and distally). TVR was defined as any repeat revascularization of the PCB-treated vessel. Device success was defined as without bailout stenting and/or without device complications; procedural success was defined as TIMI 3 flow and final residual stenosis of < 30% after PCB treatment and possible bailout stenting.

2.4

Statistical analysis and manuscript preparation

Statistical analysis was performed using SAS version 9.1 (SAS Institute Inc, Cary, NC). Continuous variables are expressed as mean ± SD. Categorical variables are expressed as frequencies and percentages. For continuous variables, the groups were compared with a parametric Student’s t test or a nonparametric Mann–Whitney U test. Categorical variables were compared with chi-square test or Fisher’s exact test as appropriate. p < 0.05 was considered statistically significant. Event-free survival from MACE was shown as Kaplan–Meier curves and compared using log-rank tests.

The data acquisition, data analysis and writing of the manuscript were independently generated by the principal investigators and their teams. Eurocor GmbH was involved in the clinical monitoring of recruiting sites and the review of data accuracy.

2.1

Patient selection

Valentines I included 250 patients who presented with stable or unstable angina pectoris and/or documented ischemia due to an ISR (> 50%) of a previously placed BMS or DES. Excluded were patients presenting with acute myocardial infarction (MI), short life expectancy (< 12 months), lesions requiring additional stenting prior to PCB treatment, prior radiation therapy to target vessel, and patients unable to take dual antiplatelet therapy (DAPT) for ≥ 3 months. In this analysis, we included 76 patients from the Valentines I cohort who presented with DES restenosis (identified as either paclitaxel DES or limus DES restenosis), were treated with the DIOR PCB, and had clinical follow-up data.

2.2

Interventional procedure

Enrolled patients received peri- and post-procedural aspirin (80–325 mg per day) and clopidogrel (300–600 mg loading dose, followed by 75 mg per day). Intravenous heparin was used as anticoagulation during the procedure maintained at targeted activated clotting time. The use of glycoprotein IIb/IIIa inhibitors was left to the operator’s discretion. Post procedure, DAPT was recommended for ≥ 3 months, followed by aspirin indefinitely.

Following coronary angiography, predilatation of the ISR lesion was recommended with regular short-length balloons sized to the original stent diameter in a 0.7–0.8:1 ratio. If a good angiographic result was obtained [e.g., thrombolysis in myocardial infarction (TIMI) 3 flow and residual stenosis < 30%], the DIOR balloon was inflated for ≥ 30 seconds at the lesion with an overlap of ≥ 2 mm on each edge of the predilatation balloon-treated segment. The DIOR balloon was sized to the original stent diameter in a 1:1 ratio. Special emphasis was placed on avoiding geographical miss (i.e. predilated area not covered by the PCB). Additional bailout stenting using a BMS was left to the operator’s discretion in cases of suboptimal angiographic result (TIMI flow grade < 3 and/or residual stenosis > 30%).

The second-generation DIOR PCB used in the Valentines trial contains paclitaxel as the active drug, in a concentration of 3 μg/mm ² of balloon surface using a shellac coating method. The un-inflated balloon is thrice-folded which protects the drug from early wash-off during balloon catheter insertion and tracking. The recommended inflation time is 30–45 seconds to achieve adequate paclitaxel delivery to the vessel wall. The DIOR balloon is available in lengths of 15–30 mm, and diameters of 2.0–4.0 mm.

2.3

Follow-up/end points

Clinical follow-up was performed 6–9 months after the index procedure. Outcomes were reported based on definitions included in the study protocol. The primary end point was the occurrence of major adverse cardiac events (MACE), defined as all-cause death, MI and target vessel revascularization (TVR). Vessel thrombosis follows the Academic Research Consortium criteria for stent thrombosis. MI was defined as any elevation of troponin (or other cardiac enzymes if troponin was not recorded) in combination with ischemic chest pain. Target lesion revascularization (TLR) was defined as any repeat revascularization (percutaneous or surgical) due to a restenosis in the PCB-treated segment (which includes 5 mm beyond the treated segments proximally and distally). TVR was defined as any repeat revascularization of the PCB-treated vessel. Device success was defined as without bailout stenting and/or without device complications; procedural success was defined as TIMI 3 flow and final residual stenosis of < 30% after PCB treatment and possible bailout stenting.

2.4

Statistical analysis and manuscript preparation

Statistical analysis was performed using SAS version 9.1 (SAS Institute Inc, Cary, NC). Continuous variables are expressed as mean ± SD. Categorical variables are expressed as frequencies and percentages. For continuous variables, the groups were compared with a parametric Student’s t test or a nonparametric Mann–Whitney U test. Categorical variables were compared with chi-square test or Fisher’s exact test as appropriate. p < 0.05 was considered statistically significant. Event-free survival from MACE was shown as Kaplan–Meier curves and compared using log-rank tests.

The data acquisition, data analysis and writing of the manuscript were independently generated by the principal investigators and their teams. Eurocor GmbH was involved in the clinical monitoring of recruiting sites and the review of data accuracy.

3.1

Patient and procedural characteristics

A total of 76 patients with DES restenosis treated with DIOR PCB were analyzed. There were 34 patients (with 41 lesions) with paclitaxel-eluting DES restenosis and 42 patients (with 43 lesions) with limus-eluting DES restenosis. The limus-eluting DES restenosis group consisted of sirolimus-eluting (n = 19), zotarolimus-eluting (n = 9), and everolimus-eluting (n = 14) DES. Table 1 shows the baseline characteristics of the study population, which were similar between groups. Table 2 describes the groups’ lesion characteristics. There were numerically more left anterior descending artery lesions with paclitaxel DES restenosis and more circumflex artery lesions with limus DES restenosis treated. The majority of lesions treated were in the proximal and mid segments of the target vessel. There were significantly more diffuse lesions > 20 mm with paclitaxel DES restenosis compared to limus DES restenosis (50% vs. 26.8%, p = 0.032) treated with PCB. One-third of lesions treated with PCB had focal or multifocal restenosis. Proliferative and occlusive restenosis morphology constitutes a small percentage of cases treated. The majority of ISR occurred beyond 6 months of stent implantation, and the majority of lesions had one prior intervention for ISR before this current procedure. There were no differences between the 2 groups with regard to timing of restenosis and number of prior ISR interventions. Table 3 describes the procedural characteristics, which were similar between the 2 groups. Predilatation before PCB treatment was 75%. Procedural success was 100%, and device success was 96% overall. Bailout stenting occurred in 1 patient with paclitaxel DES restenosis for residual stenosis, and in 2 patients with limus DES restenosis for residual stenosis and coronary dissection.

Table 1

Patient characteristics.

Variable (patient-based)	All (n = 76)	Paclitaxel DES restenosis (n = 34)	Limus DES restenosis (n = 42)	p value
Age (years)	61.8 ± 10.3	62.6 ± 11.6	61.1 ± 9.1	0.55
Men	60 (78.9%)	29 (85.3%)	31 (73.8%)	0.22
Left ventricular ejection fraction (%)	54.3 ± 11.8	52.9 ± 9.9	55.5 ± 13.2	0.40
Risk factors
Diabetes mellitus	29 (38.2%)	10 (29.4%)	19 (45.2%)	0.16
Insulin-treated diabetes mellitus	5 (6.6%)	2 (5.9%)	3 (7.1%)	1.00
Hypertension	61 (80.3%)	29 (85.3%)	32 (76.2%)	0.32
Hyperlipidemia	49 (64.5%)	18 (52.9%)	31 (73.8%)	0.06
Smoking (current or previous)	11 (14.5%)	7 (20.6%)	4 (9.5%)	0.20
Renal insufficiency	5 (6.6%)	4 (11.8%)	1 (2.4%)	0.17
Peripheral vascular disease	1 (1.3%)	1 (2.9%)	0	0.45
Previous myocardial infarction	23 (30.3%)	11 (32.4%)	12 (28.6%)	0.72
Previous coronary bypass surgery	11 (14.5%)	5 (14.7%)	6 (14.3%)	1.00
Clinical presentation
Stable angina pectoris	40 (52.6%)	19 (55.9%)	21 (50.0%)	0.61
Unstable angina pectoris	18 (23.7%)	8 (23.5%)	10 (23.8%)	0.98
Positive functional stress test	19 (25.0%)	6 (17.6%)	13 (31.0%)	0.18

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