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Table 1 Study characteristics

From: Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review

First author, year and country of publication Study design, length of study, source of funding Population Interventions and comparators Outcomes: adverse events and device malfunctions associated with balloon angioplasty
Al-Lamee, 2011 [31] Retrospective case series 56 patients who underwent PCI and had grade III coronary perforation 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 42 patients with coronary CTOs 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 51 patients with single or multi-vessel CAD 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 Patients who intended to undergo treatment of target lesion(s) within native coronary artery or bypass graft with angiographic stenosis ≥70%, including CTOs 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 60 adult patients with stable or unstable angina and clinical indication for PCI of at least one small coronary artery (≤2.75 mm) 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 228 patients who underwent PCI (including wires, balloons and stents) 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 131 patients for the treatment of coronary in-stent restenosis 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 93 patients who underwent DES implantation and subsequently developed DES ISR 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 21 patients with CAD who underwent PCI and experienced procedure-related CP 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 45 patients treated with PCI for CTO lesions of coronary arteries 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 222 patients with stable or specific categories of unstable angina (negative troponin test) and ischaemia or silent ischaemia due to one or two de novo lesions in coronary arteries of less than 2.8 mm in diameter 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 996 patients with CAD 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%
  1. CAD coronary artery disease, CP coronary artery perforation, CS coronary stent, CTO coronary total occlusion, CTR clinical trial registration, DES drug eluting stent, ISR in-stent restenosis, MACE major adverse cardiac event, MI myocardial infarction, NR not reported, NSTEMI non-ST elevation myocardial infarction, PCI percutaneous coronary intervention, POBA plain old balloon angioplasty, PTCA percutaneous transluminal coronary angioplasty, TVR target vessel revascularization.