Table 1 Baseline characteristics and quality assessment of the included studies

AIDA [55]

2020

Consecutive patients from the general all-comer interventional cardiology population with 1 or more target lesions suitable for DES implantation according to the applicable local and European guidelines and the IFU of the AbsorbBVS are candidates for enrollment

1. Visually estimated target lesions more than 70 mm in length, 2. A reference vessel diameter visually estimated of < 2.5 mm or more than 4.0 mm, 3. Bifurcation lesions for which the use of two devices were needed, and 4. in-stent restenosis

Demographics

n

324

1521

Not available

The protocol mandates the prescription of dual-antiplatelet therapy (75–100 mg aspirin daily and 75 mg clopidogrel or

10 mg prasugrel or 180 mg ticagrelor daily) for a minimum of 1 year

in the index and control strategies

Age

66.28

64.26

Male sex (74.25%)

218 (67.28%)

1152 (75.74%)

Restenosis

31

92

Treatment

Oral medication

196 (60.49%)

-

Insulin

110 (33.95%)

None

18 (5.56%)

Unknown

4 (1.23%)

Risk factors

Hypertension (45.1%)

130 (40.12%)

702 (46.15%)

Hyperlipemia (37.6%)

176 (54.32%)

518 (34.06%)

Family history

of CAD

146 (45.06%)

774 (50.89%)

Current smoker (28.2%)

66 (20.37%)

455 (29.91%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

ABSORB everolimus-eluting bioresorbable vascular scaffold vs. the XIENCE family everolimus-eluting coronary stent system

Follow-up

3 years

Artery

Coronary

BELLO [56]

2016

Eligible patients were age 18 years or older, with a diagnosis of stable or unstable angina or documented silent ischemia and a maximum of 2 angiographically significant de novo target lesions < 25 mm in length in native coronary arteries with a visually estimated RVD < 2.8 mm

Clinical exclusion criteria included acute

myocardial infarction (MI) within the previous 48 h; previous percutaneous coronary intervention within the last 3 months; elective surgery planned within 6 months after the procedure; left ventricular ejection fraction < 30%; serum creatinine ≧2.0 μmol/l; contraindication or suspected intolerance to paclitaxel, aspirin, thienopyridines, or iodinated contrast that cannot be pretreated; platelet count < 50,000 cells/mm; positive pregnancy test; and stroke within the previous 6 months

Demographics

N

74

108

All patients were pretreated with aspirin and either ticlopidine or clopidogrel, anticoagulation

was achieved with either intravenous unfractionated heparin or bivalirudin per standard of care

The protocol recommended that patients receive aspirin

indefinitely and daily clopidogrel for a minimum of 1) 30 days in case of treatment with only DEB; 2) 3 months in case of provisional BMS after DEB; and 3) 12 months after DES implantation

Age

68

64

Male sex (78.02%)

60

82

Restenosis

7

6

Treatment

Insulin

25 (33.78%)

-

Risk factors

Hypertension (80.2%)

65 (87.8%)

81 (75%)

Hyperlipemia (78.6%)

58 (78.38%)

85 (78.7%)

Family history of CAD

11 (14.86%)

35 (32.41%)

Current smoker (45.1%)

31 (41.89%)

51 (46.3%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, Europe

Endpoint of interest

QA-R

Comparison

Drug-eluting balloons vs. paclitaxel-eluting stents

Follow-up

3 years

Artery

Coronary

BIONICS [57]

2018

Patients with ischemic heart disease undergoing planned stent implantation were eligible for enrollment. Angiographic inclusion criteria included a reference vessel diameter between 2.5 mm and 4.25 mm, with a maximum of 2 lesions per vessel in up to 2 major coronary arteries

Patients with recent (< 24 h) ST-segment elevation MI, left ventricular ejection fraction < 30%, active stent thrombosis (ST), creatinine clearance < 30 ml/min, prior PCI within 12 months, and those unlikely to adhere to dual antiplatelet therapy were excluded

Demographics

N

559

1360

Before PCI, all patients received treatment with aspirin (325 mg if no prior therapy, 75–325 mg if chronic therapy) and either clopidogrel, ticagrelor or prasugrel per investigator discretion

Dual antiplatelet therapy use was mandatory for a minimum of 6 months following the procedure

Age

64.0

63.2

Male sex (80.6%)

437 (78.2%)

1110 (80.9%)

Restenosis

38

46

Treatment

Not available

Risk factors

Hypertension (72.5%)

480 (86.5%)

911 (67.7%)

Hyperlipemia (78.3%)

504 (90.6%)

999 (74.5%)

Current smoker (21.4%)

104 (18.6%)

306 (22.5%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, America

Endpoint of interest

TLR

Comparison

Ridaforolimus-eluting stents vs. zotarolimus-eluting stents

Follow-up

2 years

Artery

Coronary

BIOSCIENCE [58]

2015

Patients with coronary artery disease and at least 1 lesion with a diameter stenosis > 50% (de novo or restenosis) in a native vessel or in bypass graft were eligible for inclusion

Not clear

Demographics

N

486

1633

Intraprocedural medications included unfractionated heparin (with a dose of 5000 IU or 70–100 IU/kg of body weight) or bivalirudin. Dual antiplatelet therapy was started before or at the time of PCI and consisted of acetylsalicylic acid (> 250 mg) in combination with clopidogrel (loading dose, 600 mg; maintenance dose, 75 mg QD), prasugrel (loading dose, 60 mg; maintenance dose, 10 mg QD), or ticagrelor (loading dose, 180 mg; maintenance dose, 90 mg BID) for the recommended duration of 12 months

Dual antiplatelet therapy consisted of acetylsalicylic acid (> 250 mg) in combination with clopidogrel (loading dose, 600 mg; maintenance dose, 75 mg QD), prasugrel (loading dose, 60 mg; maintenance dose, 10 mg QD), or ticagrelor (loading dose, 180 mg; maintenance dose, 90 mg BID) for the recommended duration of 12 months

Age

Male sex (77.1%)

371 (76.3%)

1263 (77.3%)

Restenosis

29

44

Treatment

Oral medication

345 (71.0%)

Insulin

160 (32.9%)

Diet only

152 (31.3%)

No treatment

21 (4.3%)

Risk factors

Hypertension (67.7%)

409 (84.2%)

1025 (62.8%)

Hyperlipemia (67.4%)

361 (74.3%)

1067 (65.3%)

Current smoker (28.7%)

109 (22.4%)

500 (39.6%%)

Family history of CAD

127 (26.1%)

460 (36.4%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Biodegradable polymer sirolimus-eluting stents vs. durable polymer everolimus-eluting stents

Follow-up

1 year

Artery

Coronary

CIBELES [59]

2010

Patients with total coronary occlusions with an estimated time since occlusion of > 2 weeks

Acute myocardial infarction at the area supplied by the target vessel within 2 weeks before the inclusion in the study; The lesion cannot be crossed with the guidewire and balloon angioplasty; The target lesion has been previously treated percutaneously; The lesion is not suitable for 2.25–3.5 mm coronary stent implantation; The patient is not willing to undergo angiographic follow-up; The patient has contraindications for prolonged double antiplatelet therapy; Pregnancy or absence of a negative pregnancy test result in women of childbearing age; Chronic renal failure; Plasma platelet count < 100.000 mm–3 or > 700.000 mm–3; The patient has any severe noncardiac disease that reduces his or her life expectancy to < 1 year; The patient is currently included in another randomized trial

Demographics

N

75

132

Unfractionated heparin will be administered IV during PCI

Not available

Age

64.9 ± 9.2

63.8 ± 11.0

Male sex (84.1%)

60 (77.3%)

114 (86.4%)

Restenosis

3

14

Risk factors

Hypertension (68.1%)

53 (70.7%)

88 (66.7%)

Hyperlipemia (71.5%)

57 (76.0%)

91 (68.9%)

Current smoker (55.6%)

43 (57.3%)

72 (54.5%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Everolimus-eluting stents vs. sirolimus-eluting stents

Follow-up

9 months

Artery

Coronary

ENDEAVOR IV [60]

2010

Consecutive adult patients with clinical evidence of ischemic coronary disease or a positive functional study were enrolled at 80 centers in the US

Key clinical exclusion criteria included recent acute MI, another planned PCI within the next 30 days or previous PCI in the target vessel

within the previous 9 months, recent stroke or transient ischemic attack, left ventricular ejection fraction 30%, and contraindication to dual antiplatelet therapy (aspirin and a thienopyridine)

Demographics

N

477

1071

Patients were treated with 75 mg of aspirin within 24 h before the procedure

All patients received a loading dose of clopidogrel of at least 300 mg followed by 75 mg/day for at least 6 months and aspirin 75 mg indefinitely

Age

Male sex (67.7%)

288 (60.38%)

760 (70.96%)

Restenosis

29

29

Treatment

Medications for diabetes

426 (89.31%)

No drugs

51 (10.69%)

Risk factors

Hypertension (81%)

432 (90.57%)

822 (76.75%)

Hyperlipemia (83.1%)

415 (87.00%)

871 (81.33%)

History of smoking (60.8%)

255 (53.46%)

686 (64.05%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, America

Endpoint of interest

TLR

Comparison

Zotarolimus-Eluting vs. Paclitaxel-Eluting Stents

Follow-up

1 year

Artery

Coronary

HORIZONS AMI [61]

2009

Consecutive patients 18 years of age or older who presented within 12 h after the onset of symptoms and who had ST-segment elevation of 1 mm or more in two or more contiguous leads, new left bundle-branch block, or true posterior myocardial infarction were considered for enrollment

The clinical exclusion criteria were contraindications to study medications, conditions that increase the risk of hemorrhage, and an inability to take clopidogrel for 6 months after the procedure

Demographics

N

533

2732

Aspirin (324 mg administered in chewable form or 500 mg administered intravenously) was given in the emergency room, after which 300 to 325 mg was given orally every day during the hospitalization

A loading dose of clopidogrel (either 300 mg or 600 mg, at the discretion of the investigator) was administered before catheterization

A loading dose of aspirin 75 to 81 mg every day thereafter indefinitely, clopidogrel 75 mg orally every day for at least 6 months

Age

64.1

59.4

Male sex (77.2%)

392 (73.5%)

2127 (77.9%)

Restenosis

30

122

Treatment

Oral medication

282 (52.9%)

Insulin

145 (27.2%)

Diet only

102 (19.1%)

Risk factors

Hypertension (41.9%)

379 (71.7%)

1329 (48.6%)

Hyperlipemia (42.9%)

318 (59.7%)

1082 (39.6%)

Current smoker (46.8%)

194 (36.5%)

1334 (49.1%)

Study design

Randomization

RCT

Blinding

Not blinded

Center

Multicenter, America

Endpoint of interest

TLR

Comparison

Paclitaxel-eluting stents vs. bare metal stents

Follow-up

1 year

Artery

Coronary

ICE [62]

2017

Patients were eligible for inclusion if they had peripheral artery disease of Rutherford stage 1 to 4 due to a single significant common or external iliac artery lesion of 10 to 200 mm in length, not extending into the aorta or the common femoral artery. Sequential lesions at a distance of < 10 mm counted as a single lesion

Key exclusion criteria were dialysis dependent end-stage renal disease and treatment with oral anticoagulants other than antiplatelet agents

Demographics

N

164

496

Patients not on chronic antiplatelet therapy were premedicated with acetylsalicylic acid (100 mg/day) and clopidogrel (75 mg/day) for at least 10 days. Patients not on this regimen were administered an intravenous bolus of 500 mg acetylsalicylic acid and an oral loading dose of 600 mg clopidogrel before or immediately after the procedure. After sheath placement, a bolus of 5,000 U of heparin was administered

All patients had to be maintained on clopidogrel (75 mg/day) for at least 1 month and on acetylsalicylic acid (100 mg/day) indefinitely after the procedure

Age

63.6

Male sex

497 (75.3%)

Restenosis

6

32

Treatment

Not available

Risk factors

Hypertension

485 (73.5%)

Hyperlipemia

416 (63%)

Current smoker

397 (60.2%)

Study design

Randomization

RCT

Blinding

Not blinded

Center

Multicenter, Europe

Endpoint of interest

QA-R

Comparison

Balloon-expandable stent vs. self-expanding stent

Follow-up

1 year

Artery

Femoropopliteal Arteries

IMAP [63]

2011

The study included patients with stable angina or acute coronary syndrome (unstable angina or myocardial infarction) with de novo multivessel coronary artery lesions of ≥ 70% by quantitative coronary angiographic analysis who were suitable for stent implantation

Patients were excluded if there was failure to provide written informed consent, contraindication to any emergency myocardial revascularization surgery, patients with single-vessel disease, restenotic lesions, chronic total occluded lesions, significant left main disease, patients undergoing primary angioplasty, contraindications to the use of acetylsalicylic acid or clopidogrel and a left ventricular ejection fraction of < 30%. Patients with cardiogenic shock, malignancies or other comorbidities with life expectancy < 12 months or that may result in noncompliance with the protocol, or pregnancy were considered ineligible for the study

Demographics

N

68

119

Patients were treated with 200 mg of aspirin daily and 300 mg of clopidogrel on the day before the procedure. Isosorbide-5 mononitrate (20 mg) was administered intracoronarily before the analysis of quantitative coronary angiography (before and immediately after), and heparin at a dose of 100 IU/kg was administered intravenously before implantation

75 mg of clopidogrel was administered for 30 days and aspirin indefinitely

Age

59.5

Male sex

124 (66.3%)

Restenosis

27

33

Risk factors

Hypertension

146 (78%)

Hyperlipemia

85 (45.5%)

Current smoker

71 (37.9%)

Family history of CAD

116 (62%)

Study design

Randomization

RCT

Blinding

Unclear

Center

Single center, America

Endpoint of interest

QA-R

Comparison

Cobalt–chromium stent vs. stainless steel stent implantation

Follow-up

6 months

Artery

Coronary

ISAR-DESIRE 2 [64]

2020

Patients > 18 years of age with ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a restenosis ≧50% located in the native vessel segment treated with SES were considered eligible

Patients with a target lesion located in the left main stem, acute myocardial infarction within the preceding 48 h, cardiogenic shock, malignancies, or other comorbid conditions with life expectancy < 12 months or that may result in protocol noncompliance, known allergy to the study medications (sirolimus, paclitaxel), or pregnancy (present, suspected, or planned) were considered ineligible for the study

Demographics

N

154

288

An oral loading dose of 600 mg clopidogrel was administered to all patients before the intervention, regardless of whether the patient was receiving clopidogrel before admission. During the procedure, patients were given intravenous aspirin, heparin, or bivalirudin

After the intervention, all patients, irrespective of treatment allocation, were prescribed 200 mg/day aspirin indefinitely, clopidogrel 150 mg for the first 3 days (or until discharge) followed by 75 mg/day for at least 6 months

Age

Male sex (6.79%)

10 (6.49%)

20 (6.94%)

Restenosis

36

52

Risk factors

Hypertension (73.8%)

120 (77.92%)

206 (71.5%)

Hyperlipemia (77.1%)

129 (83.8%)

212 (73.6%)

Current smoker (12.2%)

12 (7.8%)

42 (14.6%)

Study design

Randomization

RCT

Blinding

Double-blind

Center

Multicenter, Europe

Endpoint of interest

QA-R

Comparison

Sirolimus-eluting stent vs. paclitaxel-eluting stent

Follow-up

8 mouths

Artery

Coronary

ISAR-TEST 4 [65]

2021

Patients older than age 18 years with ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of ≥ 50% de novo stenosis located in native coronary vessels were enrolled

Patients with a target lesion located in the left main stem or in cardiogenic shock were considered

ineligible for the study

Demographics

N

560

1391

An oral loading dose of 600 mg clopidogrel was administered to all patients at least 2 h prior to the intervention, regardless of whether the patient was taking clopidogrel prior to admission. During the procedure, patients were given intravenous aspirin, heparin, or bivalirudin

After the intervention, all patients, irrespective of treatment allocation, were prescribed 200 mg/day aspirin indefinitely, clopidogrel 150 mg for the first 3 days (or until discharge) followed by 75 mg/day for at least 6 months

Age

67.1

65.5

Male sex (76.1%)

413 (73.8%)

1072 (77.1%)

Restenosis

109

219

Treatment

Oral medication

286 (51.1%)

Unknown

274 (48.9%)

Risk factors

Hypertension (68.6%)

431 (77.0%)

908 (65.3%)

Hyperlipemia (66.2%)

374 (66.8%)

917 (65.9%)

Current smoker (15.5%)

74 (13.2%)

229 (16.5%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Biodegradable polymer drug-eluting stent vs. permanent polymer drug-eluting stent

Follow-up

10 years

Artery

Coronary

ISAR-TEST 5 [66]

2021

It enrolled patients older than 18 years of age with ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of written, informed consent by the patient or her or his legally authorized representative for participation in the study was obtained

Patients with a target lesion located in the left main stem, cardiogenic shock, malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance, known allergy to the study medications (probucol, sirolimus, zotarolimus) or pregnancy (present, suspected or planned) were considered ineligible for the study

Demographics

N

870

2132

An oral loading dose of 600-mg clopidogrel was administered to all patients at least 2 h before the intervention, regardless of whether the patient was taking clopidogrel before being admitted. During the procedure, patients were given intravenous aspirin,

heparin, or bivalirudin

After the intervention, all patients, irrespective of treatment allocation, were prescribed 200 mg/d aspirin indefinitely, clopidogrel 150 mg for the first 3 days (or until discharge) followed by 75 mg/d for at least 6 months

Age

Male sex (76.45%)

641

1645

Restenosis

192

354

Treatment

Oral medication

438 (50.3%)

Insulin

288 (33.1%)

Unknown

144 (16.6%)

Risk factors

Hypertension (66.7%)

637 (73.2%)

1365 (64.0%)

Hyperlipemia (63.5%)

577 (66.3%)

1330 (62.4%)

Current smoker (17.4%)

157 (18.0)

366 (17.2%)

Study design

Randomization

RCT

Blinding

Double-blind

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Polymer-free sirolimus- and probucol-eluting stents vs. permanent polymer zotarolimus-eluting stents

Follow-up

10 years

Artery

Coronary

SIRIUS [67]

2004

Selection criteria included patients who were willing and able to comply with the requirements of the protocol who had a history of angina and signs of myocardial ischemia clinically correlated with a de novo target lesion of 50% diameter stenosis, 15 to 30 mm in length, in a native coronary artery of 2.5 to 3.5 mm diameter based on angiographic visual estimates

Major exclusion criteria included (1) myocardial infarction within the previous 24 h, (2) left ventricular ejection fraction 25%, (3) a target lesion located in an ostial or bifurcation location or one that had a thrombotic or severely calcified appearance, or (4) significant (50% diameter) stenosis within the target coronary artery proximal or distal to the target lesion

Demographics

N

275

783

All patients received oral aspirin (325 mg daily) and clopidogrel (loading dose of 300 to 375 mg, commencing 24 h before the index procedure. Intraprocedural intravenous heparin was given to maintain an activated clotting time of ≥ 250 s

Aspirin (325 mg daily) and clopidogrel (loading dose of 75 mg for 3 months)

Age

62.3

Male sex

751 (71%)

Restenosis

42

65

Risk factors

Hypertension

719 (68%)

Hyperlipemia

783 (74%)

Current smoker

211 (20%)

Study design

Randomization

RCT

Blinding

Double-blind

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Sirolimus-eluting stents vs. bare metal stents

Follow-up

9 months

Artery

Coronary

SIRTAX [68]

2012

Eligible patients had a history of stable angina or acute coronary syndrome and presented with at least one lesion with a diameter stenosis ≥ 50% in a vessel with a reference vessel diameter (RVD) between 2.25 and 4.00 mm suitable for stent implantation

Unclear

Demographics

N

201

811

Before or at the time of the procedure, patients received at least 100 mg of aspirin, a 300 mg loading dose of clopidogrel, and unfractionated heparin (70–100 U/kg of body weight)

After the procedure, all patients were advised to maintain aspirin lifelong, and clopidogrel therapy was prescribed for 12 months irrespective of stent type

Age

65.9

61.4

Male sex (76.98%)

140 (70.7%)

639 (78.8%)

Restenosis

24

81

Risk factors

Hypertension (51.5%)

162 (80.6%)

460 (50.7%)

Hyperlipemia (59%)

123 (61.2%)

474 (58.5%)

Current smoker (36.1%)

41 (20.4%)

324 (40%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Sirolimus-eluting stents vs. paclitaxel-eluting stents

Follow-up

5 years

Artery

Coronary

SORT OUT III [69]

2011

The trial included patients ≥ 18 years old with stable chronic coronary artery disease or acute coronary syndromes. Patients were eligible if they had ≥ 1 target lesion defined as a lesion to be treated with a drug-eluting stent

Exclusion criteria were inability to provide informed consent, life expectancy of < 1 year, allergy to acetylsalicylic acid, clopidogrel, ticlopidine, sirolimus, or zotarolimus, or participation in another randomized trial

Demographics

N

337

1995

Patients were pretreated with acetylsalicylic acid ≥ 75 mg, clopidogrel 300 to 600 mg loading dose, and unfractionated heparin (5,000 IU or 70 to 100 IU/kg)

Dual antiplatelet regimens included recommendations of lifelong acetylsalicylic acid (75 mg/day) and clopidogrel (75 mg/day) for 1 year

Age

66

64

Male sex (73.5%)

241 (71.5%)

1473(73.8%)

Restenosis

23

68

Risk factors

Hypertension (50.3%)

236 (70.2%)

938 (47.0%)

Hyperlipemia (66%)

263 (78.0%)

1275 (63.9%) (63.91%)

Current smoker (29.5%)

89 (26.41%)

599 (30.0%)

Study design

Randomization

RCT

Blinding

Not blinded

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Zotarolimus-eluting stents vs. sirolimus-eluting stents

Follow-up

1 year

Artery

Coronary

SORT OUT IV [70]

2012

Patients were eligible if they were ≥ 18 years old, had chronic stable coronary artery disease or acute coronary syndromes, and ≥ 1 coronary lesion with ≥ 50% diameter

stenosis

Exclusion criteria were life expectancy of < 1 year; allergy to aspirin, clopidogrel, sirolimus, or everolimus; participation in another randomized trial; or inability to provide written informed consent

Demographics

N

390

2384

Before or at the time of the procedure, patients received aspiring ≥ 75 mg, clopidogrel 600-mg loading dose, and an unfractionated heparin dose (5,000 IU or 70 to 100 IU/kg)

Recommended postprocedure dual antiplatelet regimens were aspirin 75 mg/day lifelong and clopidogrel 75 mg/day for 1 year

Age

63.6

64.3

Male sex (75.56%)

290 (74.4%)

1806 (75.6%)

Restenosis

21

50

Risk factors

Hypertension (48.2%)

273 (70.0%)

1065 (44.7%)

Hyperlipemia (62.2%)

305 (78.2%)

1420 (59.6%)

Current smoker (25.1%)

89 (22.8%)

608 (25.5%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Everolimus-eluting stent vs. sirolimus-eluting stent

Follow-up

18 months

Artery

Coronary

SORT OUT VIII [71]

2019

Patients were eligible if they had chronic stable coronary artery disease or acute coronary syndromes, including myocardial infarction (MI) with or without ST-segment elevation, and at least 1 coronary or vein graft lesion with more than 50% diameter stenosis in a vessel with a reference diameter of minimum 2.25 mm

Exclusion criteria were life expectancy of < 1 year; allergy to aspirin, P2Y12 platelet inhibitors, everolimus, or biolimus; clinical indication of inability to tolerate dual-antiplatelet treatment for 12 months; and inability to provide written informed consent

Demographics

N

512

2252

Before implantation, patients received at least 75 mg of aspirin and a loading dose of a P2Y12 platelet inhibitor (600 mg clopidogrel, 180 mg ticagrelor, or 60 mg prasugrel) orally and unfractionated heparin intravenously (5,000 to 10,000 IU or 70 to 100 IU/kg)

Recommended postprocedural dual-antiplatelet regimens were aspirin 75 mg/day lifelong and a P2Y12 platelet inhibitor for 12 months

Age

66.9

66.2

Male sex (76.56%)

374 (73.0%)

1742 (77.4%)

Restenosis

15

52

Treatment

Oral medication

264 (51.6%)

Insulin

166 (32.4%)

Diet only

34 (6.6%)

Risk factors

Hypertension (56.9%)

395 (77.1%)

1177 (52.3%)

Hyperlipemia (53.3%)

384 (75.0%)

1088 (48.3%)

Current smoker (29.1%)

122 (23.8%)

681 (30.2%)

Study design

Randomization

RCT

Blinding

Unknown

Center

Multicenter, Europe

Endpoint of interest

TLR

Comparison

Everolimus-eluting stent (EES) with the biolimus-eluting stainless-steel stent (BES)

Follow-up

1 year

Artery

Coronary

TAXUS IV [72]

2009

Patients who were at least 18 years of age, had stable or unstable angina or provokable ischemia, and were undergoing percutaneous coronary intervention for a single, previously untreated lesion in a native coronary artery were considered for enrollment

Clinical exclusion criteria included previous or planned use of intravascular brachytherapy in the target vessel or of any drug-eluting stent; myocardial infarction within 72 h before enrollment; a left ventricular ejection fraction of less than 25 percent; hemorrhagic diatheses; contraindications or allergy to aspirin, thienopyridines, paclitaxel, or stainless steel; a history of anaphylaxis in response to iodinated contrast medium; use of paclitaxel within 12 months before study entry or current use of colchicine; a serum creatinine level of more than 2.0 mg per deciliter, a leukocyte count of less than 3500 per cubic millimeter, or a platelet count of less than 100,000 per cubic millimeter; a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy; coexisting conditions that limited life expectancy to less than 24 months or that could affect a patient’s compliance with the protocol; and current participation in other investigational trials

Demographics

N

318

996

Patients were pretreated with aspirin 325 mg and clopidogrel 300 mg before the procedure, and unfractionated heparin was administered per standard practice

Treated with aspirin 325 mg daily indefinitely and clopidogrel 75 mg daily for at least 6 months

Age

62.2

62.6

Male sex (72.1%)

202 (63.5%)

745 (74.8%)

Restenosis

64

126

Treatment

Insulin

105 (33.0%)

Unknown

213

Risk factors

Hypertension (69.9%)

256 (81.1%)

663 (66.6%)

Hyperlipemia (66.3%)

227 (71.4%)

644 (64.7%)

Study design

Randomization

RCT

Blinding

Double-blind

Center

Single center, America

Endpoint of interest

TLR

Comparison

Bare-metal stent vs. paclitaxel-eluting stent

Follow-up

6 months

Artery

Coronary

TOSCA [73]

2005

Patients 18 to 80 years old undergoing clinically indicated coronary interventions were eligible provided that 1 target segment met the study definition of occlusion: a high-grade native coronary stenosis accompanied by TIMI grade 0 or 1 antegrade flow

Exclusion criteria were (1),72 h since onset of ST-segment elevation, (2) extensive lesion-related thrombus (TIMI thrombus grade 3 or 4, Appendix 2), (3) occlusions previously revascularized by patent bypass grafts, (4) uncontrolled heart failure or shock, (5) patient unwilling or unsuitable for protocol-required 6-month angiography, (6) patient of child-bearing potential, and (7) inability to cross occlusion with guidewire

Demographics

N

68

342

All patients received aspirin 325 mg/d before the procedure

Unknown

Age

Male sex (89.3%)

48 (70.6%%)

318 (93.0%)

Restenosis

45

213

Risk factors

Hypertension (38.8%)

35 (51.5%)

124(36.3%)

Current smoker (18.8%)

8 (11.8%)

69 (20.2%)

Study design

Randomization

RCT

Blinding

Not blinded

Center

Multicenter, America

Endpoint of interest

QA-R

Comparison

Stenting vs. balloon angioplasty alone

Follow-up

6 months

Artery

Coronary

ZEST [74]

2012

We sought to enroll consecutive patients aged 18 years or older with either stable angina or acute coronary syndromes who had at least 1 coronary lesion (defined as stenosis of more than 50%) suitable for stent implantation

Exclusion criteria were ST-segment elevation MI necessitating primary PCI; severely compromised ventricular dysfunction (ejection fraction < 25%) or cardiogenic shock; allergy to antiplatelet drugs, heparin, stainless steel, contrast agents, zotarolimus, sirolimus, or paclitaxel; left main coronary artery disease (defined as stenosis of more than 50%); in-stent restenosis of drug-eluting stents; terminal illness; and participation in another coronary-device study

Demographics

N

760

1885

All patients received at least 100 mg of aspirin and a 300- to 600-mg loading dose of clopidogrel before or during the procedure. Heparin was administered throughout the procedure to maintain an activated clotting time of 250 s or longer

Patients received 100 mg/day of aspirin continuously and 75 mg/day clopidogrel for at least 12 months after the procedure

Age

Male sex (66.5%)

462 (60.8%)

1297 (68.8%)

Restenosis

37

104

Treatment

Insulin

101 (13.3%)

Unknown

659

Risk factors

Hypertension (60.8%)

549 (72.2%)

1060 (56.2%)

Hyperlipemia (51.5%)

369 (48.6%)

994 (52.7%)

Current smoker (27.8%)

188 (24.7%)

547 (29%)

Family history of CAD

34 (4.5%)

110 (%)

Study design

Randomization

RCT

Blinding

Single-blind

Center

Single center, Asia

Endpoint of interest

TLR

Comparison

Zotarolimus-eluting stents vs. sirolimus-eluting stents (SES), and paclitaxel-eluting stents (PES)

Follow-up

2 years

Artery

Coronary