Antiplatelet agents for preventing thrombosis after peripheral arterial bypass surgery

Julie Brown; Anne Lethaby; Heather Maxwell; Andrew J Wawrzyniak; Martin H Prins

doi:10.1002/14651858.CD000535.pub2

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Analysis 1.1

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 1 Primary graft patency at 12 months.

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Analysis 1.2

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 2 Amputation rate.

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Analysis 1.3

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 3 Cardiovascular events.

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Analysis 1.4

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 4 Gastrointestinal side‐effects.

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Analysis 1.5

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 5 Death.

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Analysis 1.6

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 6 Side effects.

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Analysis 1.7

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 7 Major Bleeding.

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Analysis 1.8

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 8 Minor bleeding.

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Analysis 1.9

Comparison 1 ASA or ASA/DIP vs nothing, all grafts, Outcome 9 Wound or graft infection.

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Analysis 2.1

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 1 Primary graft patency, venous grafts, 1 month.

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Analysis 2.2

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 2 Primary graft patency, venous grafts, 3 months.

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Analysis 2.3

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 3 Primary graft patency, venous grafts, 6 months.

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Analysis 2.4

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 4 Primary graft patency, venous grafts, 12 months.

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Analysis 2.5

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 5 Primary graft patency, venous grafts, 24 months.

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Analysis 2.6

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 6 Primary graft patency, prosthetic grafts, 1 month.

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Analysis 2.7

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 7 Primary graft patency, prosthetic grafts, 3 months.

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Analysis 2.8

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 8 Primary graft patency, prosthetic grafts, 6 months.

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Analysis 2.9

Comparison 2 ASA or ASA/DIP vs nothing, subgroups, Outcome 9 Primary graft patency, prosthetic grafts, 12 months.

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Analysis 3.1

Comparison 3 Aspirin or ASA/DIP versus pentoxifylline (PTX), all grafts, Outcome 1 Primary graft patency, 1 month.

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Analysis 3.2

Comparison 3 Aspirin or ASA/DIP versus pentoxifylline (PTX), all grafts, Outcome 2 Primary graft patency, 3 months.

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Analysis 3.3

Comparison 3 Aspirin or ASA/DIP versus pentoxifylline (PTX), all grafts, Outcome 3 Primary graft patency, 6 months.

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Analysis 3.4

Comparison 3 Aspirin or ASA/DIP versus pentoxifylline (PTX), all grafts, Outcome 4 Primary graft patency, 12 months.

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Analysis 4.1

Comparison 4 ASA/DIP versus indobufen, prosthetic grafts, Outcome 1 Primary graft patency, 3 months.

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Analysis 4.2

Comparison 4 ASA/DIP versus indobufen, prosthetic grafts, Outcome 2 Primary graft patency, 6 months.

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Analysis 4.3

Comparison 4 ASA/DIP versus indobufen, prosthetic grafts, Outcome 3 Primary graft patency, 9 months.

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Analysis 4.4

Comparison 4 ASA/DIP versus indobufen, prosthetic grafts, Outcome 4 Primary graft patency, 12 months.

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Analysis 5.1

Comparison 5 ASA/DIP versus LMWH, all grafts, Outcome 1 Primary graft patency, 6 months.

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Analysis 5.2

Comparison 5 ASA/DIP versus LMWH, all grafts, Outcome 2 Primary graft patency, 12 months.

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Analysis 6.1

Comparison 6 Ticlopidine versus nothing, venous grafts, Outcome 1 Primary graft patency, 1 month.

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Analysis 6.2

Comparison 6 Ticlopidine versus nothing, venous grafts, Outcome 2 Primary graft patency, 6 months.

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Analysis 6.3

Comparison 6 Ticlopidine versus nothing, venous grafts, Outcome 3 Primary graft patency, 12 months.

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Analysis 6.4

Comparison 6 Ticlopidine versus nothing, venous grafts, Outcome 4 Primary graft patency, 24 months.

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Analysis 7.1

Comparison 7 ASA versus prostaglandin (PGE1), venous grafts, Outcome 1 Early occlusion.

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Analysis 8.1

Comparison 8 ASA/DIP versus vitamin K antagonists, all grafts, Outcome 1 Primary graft patency, 3 months.

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Analysis 8.2

Comparison 8 ASA/DIP versus vitamin K antagonists, all grafts, Outcome 2 Primary graft patency, 6 months.

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Analysis 8.3

Comparison 8 ASA/DIP versus vitamin K antagonists, all grafts, Outcome 3 Primary graft patency, 12 months.

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Analysis 8.4

Comparison 8 ASA/DIP versus vitamin K antagonists, all grafts, Outcome 4 Primary graft patency, 24 months.

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Analysis 9.1

Comparison 9 ASA versus naftidrofuryl, Outcome 1 Adverse events.

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Analysis 9.2

Comparison 9 ASA versus naftidrofuryl, Outcome 2 Reocclusion, 12 months.

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Analysis 9.3

Comparison 9 ASA versus naftidrofuryl, Outcome 3 Death.

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Table 1. Patient characteristics

Study ID	% CLI	% below knee	% vein	%1‐vessel run‐off	dose	preoperative start	treatm. duration	randomisation before	ABI preop to postop
Clyne1987	70	85	63	24	ASA 2x300 mg, DIP 2x200 mg	DIP	6 weeks	before	0.38 to 0.78
Donaldson 1985	0	32	0	37	ASA 3x330 mg, DIP 75 mg	1xASA/DIP	12 months	before	0.62 to nd
Goldman 1984	80	47	0	nd	ASA 3 x300 mg, DIP 3x75mg	2 days ASAIDIP	12 months	before	nd
Green 1982	82	47	0	nd	ASA 3 x 325 mg, DIP 3x75mg	2 days ASA/DIP	12 months	before	0.42 to 1.01
Kohler 1984	76	52	69	nd	ASA 3 x 325 mg, DIP 3x 75 mg	first postop day	24 months	before	nd
McCollum 1991	60	59	100	nd; vein<4mm:38	ASA 2x300mg, DIP 2x 150mg	2 days ASA/DIP	continuing indefinitely	before	0.47 to nd
Lucas 1984	55	nd	27	nd	ASA 1050 mg,DIP 150 mg or 1200 mg PTX	preop	6 months	before	0.4
Raithel 1987	95	nd	0	56	ASA 1500 mg vs PTX1200 mg	48 h	12 months	before	nd
d'Addato 1992	70	25	0	56	ASA 900 mg, DIP 225 mg vs 400 mg IND	48 h	12 months	before	nd
BOA 2000	50	52	58.5	nd	ASA 80 mg vs coumarin INR 3.0‐4.5 reached in 50%	within 5 days until 1 month postop	21 months	before	nd
Noppeney 1988	nd	nd	nd	nd	ASA 1500mg vs naftidrofuryl 600 mg daily orally	Day 1 postop	12 months	before	nd
Schneider 1979	nd	nd	100	nd	ASA 1000 mg, DIP225 mg vs coumarin	postoperatively	24 months	postop	nd

Table 1. Patient characteristics

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Comparison 1. ASA or ASA/DIP vs nothing, all grafts

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary graft patency at 12 months Show forest plot	6	966	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.59 [0.45, 0.79]

2 Amputation rate Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Cardiovascular events Show forest plot	4	811	Odds Ratio (M‐H, Fixed, 95% CI)	0.71 [0.47, 1.08]

4 Gastrointestinal side‐effects Show forest plot	6	966	Odds Ratio (M‐H, Fixed, 95% CI)	1.44 [0.92, 2.24]

5 Death Show forest plot	3	750	Odds Ratio (M‐H, Fixed, 95% CI)	0.82 [0.54, 1.23]

6 Side effects Show forest plot	6	966	Odds Ratio (M‐H, Fixed, 95% CI)	1.55 [1.00, 2.41]

7 Major Bleeding Show forest plot	2	598	Odds Ratio (M‐H, Fixed, 95% CI)	1.88 [0.85, 4.16]

8 Minor bleeding Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

9 Wound or graft infection Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 1. ASA or ASA/DIP vs nothing, all grafts

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Comparison 2. ASA or ASA/DIP vs nothing, subgroups

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary graft patency, venous grafts, 1 month Show forest plot	2	642	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.76 [0.26, 2.24]

2 Primary graft patency, venous grafts, 3 months Show forest plot	2	642	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.85 [0.54, 1.35]

3 Primary graft patency, venous grafts, 6 months Show forest plot	2	642	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.88 [0.59, 1.31]

4 Primary graft patency, venous grafts, 12 months Show forest plot	2	642	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.69 [0.48, 0.99]

5 Primary graft patency, venous grafts, 24 months Show forest plot	2	620	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.72 [0.51, 1.00]

6 Primary graft patency, prosthetic grafts, 1 month Show forest plot	4	222	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.22 [0.10, 0.50]

7 Primary graft patency, prosthetic grafts, 3 months Show forest plot	4	222	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.33 [0.17, 0.68]

8 Primary graft patency, prosthetic grafts, 6 months Show forest plot	4	222	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.23 [0.13, 0.42]

9 Primary graft patency, prosthetic grafts, 12 months Show forest plot	4	222	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.22 [0.12, 0.38]

Comparison 2. ASA or ASA/DIP vs nothing, subgroups

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Comparison 3. Aspirin or ASA/DIP versus pentoxifylline (PTX), all grafts

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary graft patency, 1 month Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Primary graft patency, 3 months Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

3 Primary graft patency, 6 months Show forest plot	2	151	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.31 [0.56, 3.05]

4 Primary graft patency, 12 months Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

Comparison 3. Aspirin or ASA/DIP versus pentoxifylline (PTX), all grafts

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Comparison 4. ASA/DIP versus indobufen, prosthetic grafts

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary graft patency, 3 months Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

2 Primary graft patency, 6 months Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

3 Primary graft patency, 9 months Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

4 Primary graft patency, 12 months Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

Comparison 4. ASA/DIP versus indobufen, prosthetic grafts

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Comparison 5. ASA/DIP versus LMWH, all grafts

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary graft patency, 6 months Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Primary graft patency, 12 months Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 5. ASA/DIP versus LMWH, all grafts

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Comparison 6. Ticlopidine versus nothing, venous grafts

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary graft patency, 1 month Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Primary graft patency, 6 months Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Primary graft patency, 12 months Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 Primary graft patency, 24 months Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 6. Ticlopidine versus nothing, venous grafts

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Comparison 7. ASA versus prostaglandin (PGE1), venous grafts

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Early occlusion Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 7. ASA versus prostaglandin (PGE1), venous grafts

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Comparison 8. ASA/DIP versus vitamin K antagonists, all grafts

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary graft patency, 3 months Show forest plot	2	2741	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.89 [0.69, 1.15]

2 Primary graft patency, 6 months Show forest plot	2	2741	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.99 [0.81, 1.22]

3 Primary graft patency, 12 months Show forest plot	2	2741	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.92 [0.77, 1.11]

4 Primary graft patency, 24 months Show forest plot	2	2741	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.91 [0.77, 1.08]

Comparison 8. ASA/DIP versus vitamin K antagonists, all grafts

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Comparison 9. ASA versus naftidrofuryl

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Adverse events Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

1.1 Side effects	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Gastrointestinal side effects	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 Vertigo	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.4 Stomach bleeding	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Reocclusion, 12 months Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

3 Death Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Totals not selected

Comparison 9. ASA versus naftidrofuryl

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