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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 1

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1: 'Non‐complex' coronary lesions, Outcome 1: Procedural success

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Analysis 1.1

Comparison 1: 'Non‐complex' coronary lesions, Outcome 1: Procedural success

Comparison 2: Complex coronary lesions, Outcome 1: Re‐stenosis rates

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Analysis 2.1

Comparison 2: Complex coronary lesions, Outcome 1: Re‐stenosis rates

Comparison 3: In‐stent re‐stenosis, Outcome 1: Re‐stenosis rates

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Analysis 3.1

Comparison 3: In‐stent re‐stenosis, Outcome 1: Re‐stenosis rates

Comparison 3: In‐stent re‐stenosis, Outcome 2: Minimum luminal diameter

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Analysis 3.2

Comparison 3: In‐stent re‐stenosis, Outcome 2: Minimum luminal diameter

Comparison 4: Major adverse cardiac events, Outcome 1: MACE as a composite event

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Analysis 4.1

Comparison 4: Major adverse cardiac events, Outcome 1: MACE as a composite event

Comparison 4: Major adverse cardiac events, Outcome 2: Myocardial infarction

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Analysis 4.2

Comparison 4: Major adverse cardiac events, Outcome 2: Myocardial infarction

Comparison 4: Major adverse cardiac events, Outcome 3: Emergency CABG

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Analysis 4.3

Comparison 4: Major adverse cardiac events, Outcome 3: Emergency CABG

Comparison 4: Major adverse cardiac events, Outcome 4: Death

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Analysis 4.4

Comparison 4: Major adverse cardiac events, Outcome 4: Death

Comparison 5: Adverse events, Outcome 1: Perforation

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Analysis 5.1

Comparison 5: Adverse events, Outcome 1: Perforation

Comparison 5: Adverse events, Outcome 2: Angiographic dissection

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Analysis 5.2

Comparison 5: Adverse events, Outcome 2: Angiographic dissection

Comparison 5: Adverse events, Outcome 3: Bailout stenting

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Analysis 5.3

Comparison 5: Adverse events, Outcome 3: Bailout stenting

Comparison 5: Adverse events, Outcome 4: Spasm

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Analysis 5.4

Comparison 5: Adverse events, Outcome 4: Spasm

Comparison 5: Adverse events, Outcome 5: Transient vessel occlusion

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Analysis 5.5

Comparison 5: Adverse events, Outcome 5: Transient vessel occlusion

Comparison 5: Adverse events, Outcome 6: 'Slow flow'

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Analysis 5.6

Comparison 5: Adverse events, Outcome 6: 'Slow flow'

Table 1. Joint AHA/ACC Task Force stenosis characteristic classification

Lesion type

Characteristics

Note

Type A

Discrete (< 10 mm), concentric, readily accessible, non‐angulated segment (< 45°), smooth contour, little or no calcification, less than totally occlusive, not ostial in location, no major branch involvement, absence of thrombus

Type B

Tubular (10 to 20 mm), eccentric, moderate tortuosity of proximal segment, moderately angulated segment (between 45° and 90°), irregular contour, moderate to heavy calcification, total occlusion < 3 months old, ostial in location, bifurcation lesions requiring double guidewires, some thrombus present

Type B lesions with only 1 adverse characteristic were classified further as Type B1 lesions, while those with more than 1 adverse characteristic were classified as Type B2 lesions (Ellis 1990)

Type C

Diffuse (> 20 mm), excessive tortuosity of proximal segment, extremely angulated segments (> 90°), total occlusion > 3 months old, Inability to protect major side branches, degenerated vein grafts with friable lesions

ACC: American College of Cardiology; AHA: American Heart Association.

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Table 1. Joint AHA/ACC Task Force stenosis characteristic classification
Table 2. Descriptive characteristics of randomised controlled trials

Study ID

Location

Dates of enrolment

Sample size

Age (years) mean (SD)†

Males (%) †

Follow‐up

ARTIST

Europe; multicentre

Unknown

298

61 (11)

97.9

6 months

COBRA

Germany; multicentre

May 1992 to May 1996

502

PTCRA = 62 (9);

PTCA = 61 (9)

PTCRA = 74;

PTCA = 73

6 months

DART

USA; multicentre

Jun 1995 to Jun 1996

447

PTCRA = 61 (10);

PTCA = 61 (11)

PTCRA = 60;

PTCA = 70.0

6 months to 1 year

EDRES

Saudi Arabia; single centre

To Feb 1997

150

Unknown

PTCRA = 86.7;

PTCA = 88.0

6 months

Eltchaninoff

France; single centre

Unknown

50

PTCRA = 61 (11);

PTCA = 56 (11)

PTCRA = 81.8;

PTCA = 91.7

In‐hospital

ERBAC

Germany; single centre

Oct 1991 to Aug 1991;

Jan 1993 to Dec 1993

685

PTCRA = 61.6 (10);

PTCA = 62.5 (9.5);

ELCA = 61.7 (8.8)

PTCRA = 79.6;

PTCA = 72.0;

ELCA = 77.6

6 months to 1 year

Guerin

France; single centre

Apr 1992 to Sep 1993

64

PTCRA = 64.6 (10.8);

PTCA = 63.3 (10.4)

PTCRA = 78.1;

PTCA = 71.9

6 months

Kwon

Korea; single centre

Apr 1999 to Jan 2001

41

PTCRA = 62.5 (8.6);

PTCA = 61.6 (10.4)

PTCRA = 61.6;

PTCA = 70.0

In‐hospital

1 month

3 months

6 months

Lee

Korea; single centre

Jun 2001 to Jan 2003

113

PTCRA = 58 (9);

PTCA = 59 (10)

PTCRA = 36.0;

PTCA = 37.0

In‐hospital

6 months

Mehran

Unknown

Unknown

249

PTCRA = 62 (13);

ELCA = 63 (11)

PTCRA = 68.1;

ELCA = 67.7

ROSTER

USA; single centre

Unknown

200

Unknown

Unknown

In‐hospital

SPORT

USA

675

PTCRA = 63.6;

PTCA = 64.4

PTCRA = 68.0;

PTCA = 69.9

In‐hospital

ELCA: excimer laser coronary angioplasty; PTCA: percutaneous transluminal coronary angioplasty; SD: standard deviation; PTCRA: percutaneous transluminal coronary rotational atherectomy.
† Information is given for intervention and comparison groups, where available. In one case (ARTIST), total population figures are given.

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Table 2. Descriptive characteristics of randomised controlled trials
Table 3. Patient criteria in randomised controlled trials

Study

Patient criteria

ARTIST

Symptomatic, diffuse in‐stent re‐stenosis (10 to 50 mm in length) at least 3 months after stent implantation

COBRA

Patients aged 20 to 80 years with angiographically documented coronary artery disease and clinical symptoms of angina or anginal equivalents. The target coronary stenosis was considered haemodynamically significant and eligible for the study if there was a reduction in luminal area of 70% to 99% and absolute stenosis diameters were < 1 mm for a length of at least 5 mm as visually estimated by the operator. In addition, 1 secondary criterion had to be fulfilled, such as a heavily calcified, ostial or bifurcation location, or 1 that was eccentric, diffuse or within an angulated (> 45°) segment. Exclusions: unstable angina, MI within the previous 4 weeks, previous coronary angioplasty of the target vessel within the last 2 months, poor left ventricular function (ejection fraction ≤ 30%), or any other condition that will limit long‐term prognosis

DART

No specific entry criteria reported. Tested effectiveness of rotational atherectomy versus PTCA in vessels < 3 mm

EDRES

No specific entry criteria reported

Eltchaninoff

Patients were eligible for the study if they had stable or unstable angina with at least 1 lesion (> 50% stenosis) in a native vessel suitable for angioplasty. Additional inclusion criteria for angioscopy were coronary artery lumen diameter between 2.5 and 3.5 mm; location of the target lesion in a straight segment of the artery; location of the lesion at least 20 mm away from the coronary ostium; absence of left main coronary artery disease. Exclusions: acute MI within 24 hours before the procedure, a re‐stenotic lesion, a total occlusion or a vein graft lesion

ERBAC

Patients were included if they had target lesions and vessels suitable for all 3 techniques. Patients with multi‐vessel coronary disease were also eligible, but the culprit lesion was specified as the target before coronary intervention began. Exclusions: lesion characteristics (stenosis angulation > 60°, bend stenosis with an outwardly eccentric lumen, and bifurcational lesions requiring double guidewires) and vessel (extreme proximal vessel tortuosity, saphenous bypass graft or presence of intraluminal thrombus (filling defect), and total occlusion deemed not transferable with guidewires). Patients with acute MI and those who had undergone PTCA of any other vessel within the last 4 months were also excluded

Guerin

Patients presenting with a significant stenosis (defined as > 60% reduction of the lumen diameter as assessed by quantitative computed angiography) in ≥ 1 major coronary vessels, a clinical indication for re‐vascularisation, and a left ventricular ejection fraction > 40%. Exclusions: MI within the last month, re‐stenosis, bypass graft lesions, presence of intraluminal defect, ostial lesions and total occlusions

Kwon

Patients with long, 'denovo lesions'. Lesion length > 20 mm, stenosis diameter > 50% in a native left anterior descending artery between 2 and 2.9 mm in size. Exclusions: contraindication to antiplatelet therapy, total occlusion, infarct‐related artery, left ventricular dysfunction (ejection fraction < 40%) or an inability to follow the protocol

Lee

Diffuse in‐stent re‐stenosis (lesion length > 10 mm, diameter stenosis N50%) in a native coronary artery with angina, demonstrable myocardial ischaemia

ROSTER

No specific entry criteria reported. Tested effectiveness of PTCRA versus PTCA in diffuse in‐stent re‐stenosis

SPORT

No specific entry criteria reported

MI: myocardial infarction; PTCA: percutaneous transluminal coronary angioplasty; PTCRA: percutaneous transluminal coronary rotational atherectomy.

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Table 3. Patient criteria in randomised controlled trials
Table 4. Definitions of myocardial infarction (MI) used in the RCTs

Study

Definition of MI

ARTIST

New Q waves or creatine kinase and creatine kinase MB greater than twice normal, or both

COBRA

Rise in creatine kinase of more than 3 times the normal limit in the presence of Q waves

Eltchaninoff

Not stated. Standard 12‐lead electrocardiogram and serial measurement of total and MB fraction of creatine kinase was performed while in hospital

ERBAC

New Q waves in ≥ 2 contiguous leads and a creatine kinase elevation of 2 or more times the upper limit of normal and/or elevated creatine kinase‐MB fraction to at least twice the upper limit of normal

Guerin

Not stated. Electrocardiographic descriptors used

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Table 4. Definitions of myocardial infarction (MI) used in the RCTs
Comparison 1. 'Non‐complex' coronary lesions

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Procedural success Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

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Comparison 1. 'Non‐complex' coronary lesions
Comparison 2. Complex coronary lesions

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

2.1 Re‐stenosis rates Show forest plot

5

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1.1 Six months

5

855

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.83, 1.33]

2.1.2 One year

1

254

Risk Ratio (M‐H, Random, 95% CI)

1.21 [0.95, 1.55]

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Comparison 2. Complex coronary lesions
Comparison 3. In‐stent re‐stenosis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

3.1 Re‐stenosis rates Show forest plot

3

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

3.1.1 Six months

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

3.1.2 One year

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

3.2 Minimum luminal diameter Show forest plot

4

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.2.1 Six months

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.2.2 One year

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

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Comparison 3. In‐stent re‐stenosis
Comparison 4. Major adverse cardiac events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

4.1 MACE as a composite event Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.1.1 In‐hospital period

4

1315

Risk Ratio (M‐H, Random, 95% CI)

1.27 [0.86, 1.90]

4.1.2 Six months' follow‐up

1

396

Risk Ratio (M‐H, Random, 95% CI)

1.25 [0.99, 1.59]

4.2 Myocardial infarction Show forest plot

9

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.2.1 In‐hospital period

9

2218

Risk Ratio (M‐H, Random, 95% CI)

1.42 [0.75, 2.70]

4.2.2 Six months' follow‐up

3

932

Risk Ratio (M‐H, Random, 95% CI)

1.08 [0.35, 3.40]

4.3 Emergency CABG Show forest plot

9

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.3.1 In‐hospital period

9

2218

Risk Ratio (M‐H, Random, 95% CI)

1.21 [0.43, 3.40]

4.3.2 Six months' follow‐up

2

819

Risk Ratio (M‐H, Random, 95% CI)

0.93 [0.54, 1.61]

4.4 Death Show forest plot

9

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.4.1 In‐hospital period

9

2218

Risk Ratio (M‐H, Random, 95% CI)

0.67 [0.22, 2.05]

4.4.2 Six months' follow‐up

3

932

Risk Ratio (M‐H, Random, 95% CI)

0.67 [0.21, 2.06]

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Comparison 4. Major adverse cardiac events
Comparison 5. Adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

5.1 Perforation Show forest plot

5

1948

Risk Ratio (M‐H, Random, 95% CI)

4.28 [0.92, 19.83]

5.2 Angiographic dissection Show forest plot

3

949

Risk Ratio (M‐H, Random, 95% CI)

0.48 [0.34, 0.68]

5.3 Bailout stenting Show forest plot

2

955

Risk Ratio (M‐H, Random, 95% CI)

0.29 [0.09, 0.87]

5.4 Spasm Show forest plot

3

1019

Risk Ratio (M‐H, Random, 95% CI)

9.23 [4.61, 18.47]

5.5 Transient vessel occlusion Show forest plot

5

1700

Risk Ratio (M‐H, Random, 95% CI)

2.49 [1.25, 4.99]

5.6 'Slow flow' Show forest plot

4

1442

Risk Ratio (M‐H, Random, 95% CI)

2.68 [1.28, 5.59]

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Comparison 5. Adverse events