Table 1 Study characteristics

Al-Lamee, 2011 [31]

Retrospective case series

All patients received aspirin and a loading dose of thienopyridine prior to procedure. All patients then received intravenous heparin with an initial 100-U/kg bolus followed by additional heparin until targeted clotting time >250 s was achieved.

Perforation caused by intracoronary compliant balloon: 15/56; 26.8%

Italy and UK

May 1993 to December 2009

Source of funding: NR

PCI was conducted with pre-dilation and stent implantation using standard techniques via the femoral artery. Following the procedure, all patients received aspirin or dual antiplatelet therapy with aspirin and thienopyridine therapy if patient received intracoronary stents.

Perforation caused by intracoronary non-compliant balloon: 13/56; 23.2%

Perforation caused by intracoronary cutting balloon: 4/56; 7.1%

Werner, 2011 [21]

Single-arm prospective cohort multi-centre study

All patients were recanalized on aspirin (100 mg) and received clopidogrel (75 mg) with a loading dose of 600 mg for 12 months from the start of procedure.

In-hospital complications in patients with BridgePoint devices:

Germany

July 2008 to June 2009

Lesions were crossed with guidewires (Stingray®, BridgePoint devices) supported by an exchange catheter (CrossBoss™ Catheter, BridgePoint devices) or a low profile over-the-wire catheter (Stingray®, BridgePoint devices).

NSTEMI: 2/42; 4.2%

Source of funding: NR

Balloon dilation was conducted with increasing sizes, and a stent of an appropriate size was implanted. A balloon-to-artery ratio of 1.1 with inflation pressures of 12 to 16 atm was used.

No penetrations external to adventitia occurred with BridgePoint devices.

Failure of CrossBoss catheter to cross the proximal cap: 5/18; 27.8%

Failure of Stingray balloon advancement into proper position: 2/14; 14.3%

Failure of Stingray balloon advancement after re-entry attempt: 3/10; 30%

Failure of re-entry puncture because of loss of distal contrast filling: 2/10; 20%

Kandzari, 2011 [29]

Single-arm prospective cohort multicentre study

All patients received aspirin (75 to 325 mg/day) before procedure and clopidogrel (75 mg/day for ≥72 hr pre-procedure or ≥300 mg if <72 hr).

There were no occurrences of balloon ruptures or failure of delivery

US

Study period not specified

Dual antiplatelet therapy and peri-procedural anticoagulation were administered per guideline and protocol recommendations.

Procedural success rate: 51/51 patients; 100%

Source of funding: several authors received research grants from industry

Device under investigation was a low-profile, zero-fold 1.25-mm-diameter angioplasty balloon (Medtronic CardioVascular, Santa Rosa, CA, US).

Lesion success rate: 54/54 lesions; 100%

Balloon length, number of catheters and number of inflations used during procedures were up to investigators’ discretion.

Cortese, 2010 [25]

Single-centre randomized trial

All patients received aspirin (either 100 mg/day for at least three days prior or pre-PCI 300 mg intravenous bolus), and clopidogrel (300 or 600 mg as a loading dose, followed by 75 mg daily).

Procedural success:

Italy

Two investigators were blinded to patient treatment allocation

28 patients were randomized to Dior paclitaxel-coated balloon (PCB) (Eurocor, Bonn, Germany)

PCB: 27/28; 96.4%

CTR number (EudraCT code): 2009-012268-15

29 patients were randomized to Taxus™ Liberté™ DES

Taxus stent: 29/29; 100%

P = 0.30

August 2007 to August 2008

Source of funding: NR

Shimony, 2009 [27]

Case–control study

Group 1: 57 patients with CP

Equipment causing CP:

Israel

January 2001 to December 2008

Group 2: 171 patients without CP

Wire: 30/57; 53%

Source of funding: NR

Balloon: 15/57; 26%

Stents: 12/57; 21%

Equipment causing Grade I CP (Ellis classification):

Wire: 3/7

Balloon: 2/7

Stents: 2/7

Equipment causing Grade II CP (Ellis classification):

Wire: 18/30

Balloon: 7/30

Stents: 5/30

Equipment causing Grade III CP (Ellis classification):

Wire: 9/20

Balloon: 6/20

Stents: 5/50

Unverdorben, 2009 [22]

Randomized non-blinded multicentre trial

All patients were treated with 250 mg of aspirin intravenously, heparin as an initial bolus of 70 to 200 U/kg body weight adjusted according to the activated clotting time with a target of 200 to 250 seconds. One day before the procedure, a loading dose of 300 mg of clopidogrel was administered or 600 mg before the intervention. All patients were assessed based on angiographic inclusion and exclusion criteria.

Success rate with crossing the lesion:

Germany

January 2006 to December 2006

Group 1: 65 patients in DES group (Taxus)

Balloon catheter: 65/65; 100%

Source of funding: industry

Group 2: 66 patients in coated-balloon catheter group (SeQuent Please)

DES: 61/66; 92.4%

Sardella, 2009 [26]

Three-arm retrospective cohort study

57 patients were treated with POBA

No in-hospital adverse events, including death, acute stent thrombosis, myocardial infarction, or new revascularization occurred

Italy

18 months

39 patients were treated with homo-DES implantation (patients eluted with same drug used in previous DES implantation)

Source of funding: NR

26 patients were treated with hetero-DES implantation (patients eluted with different drug used in previous DES implantation)

Chua, 2008 [28]

Single-arm retrospective cohort study

All patients received intravenous heparin (100 units/kg) at the beginning of the procedure.

Occurrence of CP:

Taiwan

October 1992 to December 2006

All patients were treated with percutaneous transfemoral or transradial approach through an angiography sheath. The standard angioplasty technique was applied.

Guidewire manipulation: 5/21; 20.8%

Source of funding: NR

Coronary balloon angioplasty: 13/21; 61.9%

Coronary stenting: 3/21; 14.3%

Saito, 2008 [30]

Single-arm retrospective cohort study

Two 7-French guiding catheters were used in all patients. Microcatheters were inserted into targeted collateral artery with support from guidewires.

One case of transient ischemia in target region caused by a false spasm of tortuous epicardial collateral artery by guidewire and balloon catheter insertion was reported. No residual ischemia was found.

Japan

January 2006 to January 2007

If microcatheters did not pass into target artery, balloon catheters (Ryujin® -OTW 1.25 mm × 10 mm, Terumo, Lacross® 1.30 mm × 10 mm, Goodman, Japan or Maverick® -OTW 1.50 mm × 15 mm, Boston Scientific, US) were used.

Source of funding: NR

If both microcatheters and balloon catheters did not cross, Tornus® catheter (ASAHI Intecc) was used. Following the successful crossing of collateral channels, a Miracle® 3 g guidewire (Miracle 3: ASAHI Intecc) was used.

Braun, 2007 [23] Germany

Non-blinded randomized multi-centre trial

Group 1: 106 patients were treated with standard angioplasty balloon (PEGASO™, SORIN Biomedica, Italy) of 2.5 mm diameter at 6 atm.

In-hospital MACE (MI):

Six months

Group 2: 116 patients received a 2.5-mm carbon-coated stent (SYNCRO™, SORIN Biomedica Italy) available in 9, 12, 15 and 19 mm of length with or without pre-dilation with a PEGASO™ balloon

POBA: 1/106; 0.9%

Source of funding: NR

Stent: 0/116; 0%

P = 0.294

Other events:

Hematoma at puncture site:

POBA: 2/106; 1.9%

Stent: 0/116; 0%

Aneurysm at puncture site:

POBA: 0/106; 0%

Stent: 1/116; 0.01%

Pericardial effusion:

POBA: 0/106; 0%

Stent: 1/116; 0.01%

Contrast reaction:

POBA: 2/106; 1.9%

Stent: 0/116; 0%

P = 0.347

Völzke, 2007 [24] Germany

Three-arm prospective cohort

CABG Group: 240 patients were administered heparin in a dose of 2 to 3 mg/kg before surgery. Aspirin and coumarin were administered following discharge, as necessary

Mortality:

Approximately 8.5 years

PTCA Group: 478 patients received heparin (10,000 IU) prior to the procedure. All patients received aspirin and coumarin upon discharge as necessary.

PTCA: 95/478; 19.9%

Source of funding: government

CABG Group: 278 patients received heparin (10,000 IU). These patients had an unsuccessful PTCA or experienced acute complications during the procedure. Subsequently, they received stent implantation. Patients received aspirin (100 mg o.d.) and ticlopidine (250 mg b.d.). All patients received aspirin and coumarin upon discharge after the first 28 days.

CS: 45/278; 16.2%

CABG: 53/240; 22.1%

MACE:

PTCA: 317/478; 66.3%

CS: 138/278; 49.6%

CABG: 80/240; 33.3%

Incident MI:

PTCA: 31/478; 6.5%

CS: 22/278; 8.0%

CABG: 18/240; 7.5%

Incident percutaneous TVR:

PTCA: 210/478; 44.1%

CS: 83/278; 30.2%

CABG: 26/240; 10.9%

Incident operative TVR:

PTCA: 76/478; 16.0%

CS: 35/278; 12.7%

CABG: 1/240; 0.4%